2015 NDI 6WS---FDA Aff & Neg

AFF
1AC
 1AC---Pharma Advantage
Surveillance of whistleblowers enables widespread FDA corruption – this enables Big
Pharma to reap huge benefits
Mercola 12 (Dr. Mercola, anonymous whistleblower against the FDA, “Shocking Story Reveals How the
FDA Is Recklessly Abandoning Drug Safety,” August 13, 2012,
http://articles.mercola.com/sites/articles/archive/2012/08/13/drug-safety-whistleblower.aspx)//ghs-VA

In the wake of shocking reports on how the FDA , terrified of being outed for its questionable practices, spied on its own
employees in the hopes of rooting them out before they could become whistleblowers, a new story
has emerged on how deep the deceit goes. From marginalizing safety reports to not reading them at all―and then going
ahead and approving the drugs in question―the FDA once more stands accused of being little more than a rubber-

stamping agency for Big Pharma. Explosive revelations of an intensive spy operation by the FDA on its own scientists emerged last month. Using
sophisticated spy software, the agency tracked and logged every move made by the targeted individuals. The program even intercepted personal emails and copied
documents on their personal thumb drives. The targeted scientists had expressed concern over the agency's approval of
dangerous medical imaging devices for mammograms and colonoscopies, which they believe expose patients to dangerous levels of radiation.
Now, another whistleblower has stepped forward, and what he has to say about the agency's drug safety reviews is shocking even to the jaded... Former FDA
Reviewer Speaks Out About Systemic Suppression of Safety Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from
1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for
the online news magazine Truth-Out, he tells Martha Rosenberg1: "In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for
Devices, the honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER have placed the nation
at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety
and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We
were prevented, except in rare instances, from presenting findings at advisory committees. In 2007, formal policies were instituted so that speaking in any way that
could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug's approval - which of course was our job as
drug reviewers - management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-
censor." According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are
typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be
taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the
medical safety reviewer completely failed to make such evaluations prior to the drug's approval. FDA Actively Thwarts Serious Safety Investigations There's no
telling how many ineffective and/or dangerous drugs and medical devices have been approved and
ushered into market through sheer intimidation and bullying, either by pharmaceutical companies or FDA
management. Perhaps even more shocking are the revelations that some of the internal rules and regulations of the FDA are clearly designed to thwart
serious safety reviews from the get-go. According to Kavanagh: "[H]uman clinical pharmacology trials are typically done in Europe, yet clinical pharmacology
reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US. Without being able to do this, we are unable to
detect evidence of risks early and cannot provide guidance that would help with the development of the drug in terms not only of safety and proving efficacy, but
also with the efficiency and cost effectiveness of the drug's development." Another loophole that can put your health in serious jeopardy is that drug companies are
not required to include adverse events on the drug's label if the adverse reaction is: Below a certain percentage, and/or Below double the rate of the adverse event
found in a placebo According to Kavanagh: "By this rule, certain
serious and potentially lethal adverse events that
eventually resulted in a drug being withdrawn from the market would not have had any mention of
the adverse events made in the labeling at all." Kavanagh also claims to have discovered another common loophole used by
pharmaceutical companies to circumvent safety issues. They'd simply submit bits and pieces of data to different places, effectively preventing the reviewer to pull it
all together. Then, because the safety issues falsely appeared to be negligible, it would be decided that no further evaluation would be necessary... "On one
occasion, the company even told me they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated,
which I then saw happen. On another occasion a company clearly stated in a meeting that they had "paid for an approval," Kavanagh says. " Sometimes we
were literally instructed to only read a 100-150 page summary and to accept drug company claims
without examining the actual data, which on multiple occasions I found directly contradicted the summary document. Other times I was
ordered not to review certain sections of the submission, but invariably that's where the safety issues would be. This could only occur if FDA management was told
about issues in the submission before it had even been reviewed. In addition, management would overload us with huge amounts of material that could not
possibly be read by a given deadline and would withhold assistance. When you are able to dig in, if you found issues that would make you turn down a drug, you
could be pressured to reverse your decision or the review would then be handed off to someone who would simply copy and paste whatever claims the company
made in the summary document." Examples of Dangerous Drug Approvals In his interview, Kavanagh
discusses some of the dangerous
drugs that were approved in the face of unequivocal safety concerns. One is the nerve gas drug pyridostigmine—a
prophylactic drug against the nerve agent Soman. The drug was approved under the "Animal Rule," which allows drugs to be approved
based on animal data alone. There were multiple problems with this approval. First, the animal studies did not reflect how the drug would be used in humans.
Second, the drug actually increases lethality if nerve agents other than Soman are used. According to Kavanagh: "This information was not secret - both
FDA
and DoD public documents acknowledge increased lethality with other nerve agents such as Sarin,
and DoD and other government documents that are public also document that Saddam Hussein was
not using Soman and was instead using these other nerve agents exclusively . Yet because I raised this as an objection,
I was immediately replaced as the primary reviewer so that I could not document my concerns and so that pyridostigmine could be approved. It's since been
proposed that if we ever face the prospect of nerve agents in the future, that this approval will be used as a justification to convince the President at that time to
waive informed consent without presenting a full picture." Pediatric drugs also end up posing unnecessary risks due to the FDA's failure to adequately review safety
risks, and the many scientific loopholes employed by pharmaceutical companies. For example, the following flawed parameters are typically used in pediatric drug
studies: Dosages are based on approved adult dosages, without regard for metabolic differences between a developing child's body and an adult Exposure studies
oftentimes use overweight children, and include too few children to adequately evaluate risks No allowances are made for race, age, puberty, or actual weight

Dangers to pregnant women and their developing fetuses are also frequently ignored. All in all, the FDA appears to be engaged in a
systematic hush-operation designed to give just about anything Big Pharma develops the green light .
Essentially, dangerous drugs are given a rubber stamp of approval—the necessary go-ahead to make
obscene profits while killing and injuring hundreds of thousands of people every year. It is, quite simply,
inexcusable. The mainstream media has a lot to answer for as well, as their lack of reporting on these issues contributes to the problem by keeping a lid on reality.
According to Kavanagh: "FDA's response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a
watered down warning in the labeling. In fact, when patients exhibit drug toxicity, it is usually attributed to an underlying condition which we know is likely to make
the drug toxicity worse. This also allows the toxicity to be dismissed as being unrelated to the drug in any way. Consequently, toxicities are only attributed to the
drug when the evidence is irrefutable. Thus the majority of cases where there is a contributing factor are simply dismissed. When you do raise potential safety
issues, the refrain that I heard repeatedly from upper management was‚"where are the dead bodies in the street?" Which I took to mean that we only do something
if the press is making an issue of it." FDA Safety Reviewers Made to Fear for Their Lives ? Kavanagh was not surprised to learn about
the agency's retaliation against the five whistleblowers, giving several examples of how he was personally intimidated, to the point of fearing for his life, and the
safety of his children! "After FDA management learned I had gone to Congress about certain issues, I found my office had been entered and my computer physically
tampered with," Kavanagh tells Rosenberg. "... After I gave Representative Waxman's (D-CA) office a USB drive with evidence, FDA staff was admonished that it was
prohibited to download information to USB drives. Then, after I openly reported irregularities in an antipsychotic drug review and FDA financial collusion with
outsiders to Senator Grassley's office and the House Committee on Oversight and Government Reform, I was threatened with prison if I should release trade secret
information to Congress... [T]he Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most
people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they
got Senator Grassley's staff to destroy the evidence I provided them. The threats, however, can be much worse than prison. One manager threatened my children -
who had just turned 4 and 7 years old - and in one large staff meeting, I was referred to as a 'saboteur.' Based on other things that happened and were said, I was

afraid that I could be killed for talking to Congress and criminal investigators." We Now Know What Domestic Surveillance of
Whistleblowers Looks Like The following video features attorney, Stephen Kohn, executive director of the National Whistleblowers Center and

attorney for the FDA whistleblowers in the recently revealed FDA spy operation against them2. "For the first time, we
now have a glimpse into
what domestic surveillance of whistleblowers looks like in this country with the modern technological
developments," Kohn says. "The agency [sought] to destroy the reputation of these whistleblowers
forever." FDA Failures Place Health of Americans and Nation at Grave Risk The FDA's mission statement reads as
follows: "The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products,
medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to
speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information
they need to use medicines and foods to improve their health." In 2007, a report bearing the revealing title "FDA Science and Mission at Risk" by the Subcommittee
on Science and Technology3, detailed how the FDA cannot fulfill its stated mission because : Its scientific base has eroded and its
scientific organizational structure is weak Its scientific workforce does not have sufficient capacity and capability, and Its information technology (IT) infrastructure is
inadequate Furthermore, the report found that "the
development of medical products based on "new science" cannot
be adequately regulated by the FDA, and that the agency does not have the capacity to carry out risk
assessment and analysis. Additionally, the agency's science agenda "lacks coherent structure and vision, as well as effective coordination and
prioritization." The fact that the FDA does not have its ducks in a row; has sorely misplaced its priorities; and is not working to fulfill its mission is clearly evidenced
in the numerous cases where hundreds and sometimes thousands of complaints about dangerous drugs (like Vioxx and Avandia), vaccines (like Gardasil), and
additives (like aspartame) are stubbornly ignored, while SWAT-style teams armed to the teeth are sent to raid supplement makers, whole food businesses, organic
farmers, and raw dairies when oftentimes not a single incidence of harm can be attributed to their products. According to the Science and
Technology Subcommittee's report, the failures of the FDA is placing the health of Americans, and
indeed the economic health of the entire nation, at grave risk : "The FDA constitutes a critical
component of our nation's healthcare delivery and public health system. The FDA , as much as any public or private
sector institution in this country, touches the lives, health and wellbeing of all Americans and is integral to the nation's economy and its
security. The FDA's responsibilities for protecting the health of Americans are far-reaching. The FDA protects our nation's food supply through regulatory activities
designed to cover 80 percent of the food consumed in this country. The FDA also regulates all drugs, human vaccines, and medical devices, and hence plays a critical
role in ensuring the appropriate safety and efficacy of rapidly emerging medical products. ... The
FDA is also central to the economic health
of the nation, regulating approximately $1 trillion in consumer products or 25 cents of every consumer
dollar expended in this country annually.. Thus, the nation is at risk if FDA science is at risk . The
Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious

scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. "

Big Pharma’s reach is global---it’s underpinned by FDA corruption

Hagopian 15 Joachim Hagopian is a West Point graduate and former US Army officer with a masters degree in Clinical
Psychology, “The Evils of Big Pharma Exposed”, 1/18/15, http://www.globalresearch.ca/the-evils-of-big-pharma-
exposed/5425382//OF

To further control the global health system, Big Pharma has largely dictated what’s been taught in
medical schools throughout North America, heavily subsidizing them as a means of dictating the conventional dogma that’s standard curriculum down to even the textbooks. Several years ago a revolt at Harvard
amongst med students and faculty went public. For a long time now doctors have been educated primarily to treat their patients with drugs, in effect becoming drug pushing, pharmaceutical whores, mere foot soldiers in Big
Pharma’s war on health. Starting in the final year of med school, Big Pharma insidiously hones in on young med students, seductively wining and dining prospective physicians, showering them with money in the form of
educational handouts, gifts, trips and perks galore to recruit its legions of loyal, thoroughly indoctrinated drug peddlers around the world. Thousands of doctors in the US are on Big Pharma payrolls. Typically early on in their

careers physicians are unwittingly co-opted into this corrupt malaise of an irreparable system that’s owned and operated by Big Pharma. And here’s why the drug companies control
the global healthcare empire. Since 1990 Big Pharma has been pumping at least $150 million that we know about (and no doubt lots more we don’t know about) buying off politicians who no

longer represent the interests of their voting public. Thanks to Big Law via last spring’s Supreme Court decision, current campaign financing laws permit unlimited, carte blanche bribery power for America’s most wealthy and
powerful to fill the pockets of corrupt politicians with absolutely no oversight. Though the corporate buyoff of other nations around the globe may not appear quite so extreme and blatantly criminal as in the United States,
international drug companies make certain that every national government allows full access and flow of their prescription drugs into each nation, including rubber stamped approval by each nation’s regulatory body to ensure

because far more money is spent on the healthcare industry in the US, twice as
global maximization of record setting profit. But

much as the next nation Canada and equal to the next ten combined, it’s no surprise that hapless
Americans end up having to pay far higher exorbitant costs for their made-in-the-USA drugs than
anyone else on the planet. The average US citizen spends about $1000 on pharmaceutical drugs each year, 40% higher than Canadians. Big Pharma also invests more dollars into advertising than any
other industry in America, transmitting its seductively deceptive message direct to its consumers, explicitly giving them marching orders to request specific drugs from their doctors. In 2012 alone, pharmaceutical corporations paid
nearly $3.5 billion to market their drugson television, radio, internet, magazines, saturating every media outlet. Their message – pleasure, relief, peace of mind, joy, love and happiness are all just a pill away. No problem or pain in
life can’t be conquered by a quick fix - compliments of Big Pharma. Much of Big Pharma’s success over the last couple decades has been the result of specifically targeting special new populations to con and win over, resorting to
creating new diseases and maladies to entice troubled, stressed out, gullible individuals into believing there’s something abnormally wrong with them, that they are among always a growing segment of our population who quietly
suffer from whatever discomforting symptoms, deficits, dysfunctions, ailments, syndromes and disorders that enterprising Big Pharma connives to slyly invent, promote, package and sell. This unethical practice has been called
“disease mongering.” Drug companies today operate no different from the snake oil salesmen of yesteryear. Saturating the market with their alluring, promising ads, check out any half hour of national network news on television
targeting the baby boomer and geriatric crowd and you’ll notice 95% of the commercials are all brought to you by none other than Big Pharma. Of course they pay big bucks for slick ad marketing campaigns that shrewdly target the
oldsters most apt to suffer health problems in addition to being virtually the only Americans left still watching the nightly network news. Three out of four people under 65 in the US today recognize that mainstream news media is
nothing less than pure Gov. Corp. propaganda. Also in recent years Big Pharma has become deceitfully masterful at repackaging and rebranding old meds at higher prices ever in search of expanded consumers. It’s a lot easier and
far less money to engage in this unethical industry-wide practice of recycling an old pill than to manufacture a new one. Prozac became the biggest drug sold until it was learned that it caused so many people to kill themselves or
others, especially adolescents. Then Eli Lilly deceptively repackaged and relabeled it under the less threatening name Sarafem at a much higher price tailored to target unsuspecting women seeking relief from menstrual pain. Like
Prozac as another Selective Serotonin Reuptake Inhibitor antidepressant, Paxil was suddenly repackaged as the cure-all for shyness under the guise of treating social anxiety. Taking full advantage of knowing that millions of humans
feel unsure of themselves dealing with strangers and groups, Big Pharma to the rescue exploiting people’s nervousness by clinically labeling it as social anxiety and reintroducing the antidepressant pink pill as their panacea to
personal happiness, lifelong self-confidence and success in life. This most prevalent industry pattern of reusing the same old drugs all dressed up with new custom designed names for new purposes on new custom designed

populations for yet more price gouging is nothing less than resorting to a predatory practice of criminal false advertising. Perhaps as sinister as any aspect of the drug
business is how Big Pharma has completely taken over the FDA . A recent Harvard study slammed the
FDA making the accusation that it simply “cannot be trusted” because it’s owned and operated by Big
Pharma. With complete autonomy and control, now pharmaceutical companies knowingly market drugs that carry high risk dangers for consumers. But because they so tightly control its supposed regulatory
gatekeeper, drugs are commonly mass marketed and before the evidence of potential harm becomes overwhelming, by design when the slow bureaucratic wheels turn issuing a drug recall, billions in profit have already been
unscrupulously reaped at the deadly expense of its victims. Additionally, doctors, pharmacists and patients rarely even hear about important recalls due to dangerous side effects or contamination. Yet hundreds of Big Pharma

Many FDA approved drugs like FenPhen, Vioxx, Zohydro and Celebrex kill hundreds
drugsare recalled every year.

before they’re finally removed from the shelf. This withholding the truth from the professionals and public consumers is yet more evidence that Big Pharma
protects its profits more than people.
Scenario 1 is the TPP:

Big pharma advocates pressure TPP negotiators into slashing access to generics
worldwide
Lazare 15 (Sarah, Common Dreams, staff writer, 7/10/15, “Latest TPP Draft Benefits Big Pharma By
Slashing Access to Generics”, http://www.commondreams.org/news/2015/07/10/latest-tpp-draft-
benefits-big-pharma-slashing-access-generics, Accessed 7/25/15)//LD

With another round of Trans-Pacific Partnership negotiations slated for the end of this month , the
administration of President Barack Obama is aiming to force developing nations to adopt Big Pharma-friendly

policies that are so bad for public health Obama himself has opposed them in the United States. Citing leaked drafts of the
agreement, as well as officials "familiar with the latest May 11 version," Bloomberg journalist Peter Gosselin reported Friday
that the deal is likely to include provisions that are almost certain to hike medicine costs while slashing access
to generic drugs around the world: "At stake: hundreds of billions of dollars or more in extra costs that
consumers may have to pay if the proposals make it harder for cheaper generics to win approval ." In
the negotiations, Obama is pursuing corporate-friendly policies he has rejected at home. For example, "U.S.
negotiators want to win makers of advanced drugs 12 years of exclusivity for data that might
otherwise help competitors produce similar, cheaper versions," wrote Gosselin. However, the Obama administration has
sought, within the United States, to reduce that period to seven years. But it doesn't stop there. " Negotiators are also seeking language to

make it easier for the big drugmakers to win 'secondary' patents to strengthen their control over
products," Gosselin continued. But domestically, the administration "has proposed changing U.S. law to make it harder to get such add-ons," Gosselin
explained. Obama is poised to not only foist these policies on other countries, but to trap the U.S. in them as well. What's more, said Gosselin, the United

States "has negotiators pressing the region’s developing countries to sign onto a schedule for
adopting the stronger rules, reversing previous exemptions to allow them easier access to cheap
medicines." Obama is reportedly meeting opposition from countries involved in the negotiations. Meanwhile, global civil society and social movement groups
have staged their strong opposition to the deal with protests, open letters, and organizing. However, resistance would likely be even greater if the contents of the
talks were shared with the global public. Under negotiation since at least 2008, the deal is poised to be the largest corporate
agreement in history yet has been negotiated in extreme secrecy, with almost all of what's publicly known about the deal revealed through leaks. It
includes the U.S. and 11 Pacific Rim countries—Australia, Brunei, Canada, Chile, Japan, Malaysia,
Mexico, New Zealand, Peru, Singapore, and Vietnam —which together account for 40 percent of the world's GDP. The information
that is publicly available is bleak. In a recent video, humanitarian organization Doctors Without Borders/Medecins Sans

Frontieres put it bluntly: "As it stands today, the TPP is slated to become the most harmful trade
agreement ever for access to medicines." As Common Dreams previously reported, the TPP would be a huge boon for
pharmaceutical corporations while posing a threat to public health on a global scale . The deal also makes
domestic health programs vulnerable, including Medicare. The watchdog group Public Citizen recently warned: " Pharmaceutical companies

could attempt to exploit the general language of the annex to mount challenges to Medicare and
health programs in many TPP negotiating countries." Concerns with the deal extend far beyond access
to medicines, however, with civil society groups sounding the alarm about the deal's implications for
democracy, the environment, and corporate power. Among its many provisions, the agreement includes an "investor-state dispute
settlement" system (ISDS)—which creates secret tribunals that allow multinationals to sue governments for loss of "expected future profit."
Generics are the only way to solve for pandemics---cheap access
Orsi et al 3 (6/25, Fabienne, Lia Hasenclever, Beatriz Fialho, Paulo Tigre, Benjamin Coriat, “Anti-AIDS
Policy and Generic Drugs. Lessons from the Brazilian Public Health Program”, http://www.lepublieur.
com/anrs/ecoaids8.pdf)

The evidence, after some20 years of fight against the AIDS pandemic, has led to outcomes that seem totally
different from the ones predicted by the proponents of strong protection . This is because the multinational
companies, sitting on their monopolies and protected by international law, have not at all delocalized their activities to
the South. On the contrary, after the clauses that used to be beneficial to the locally established firms were suspended, certain
multinational companies began to abandon some of their facilities in the Sout h, regrouping their world- wide
manufacturing units in an attempt to achieve economies of scale [7]. [17]. Furthermore, even before generics began to be produced and
distributed locally, multinational
drugs manufacturers did anything but lower their prices . In other words, they
preempted a situation in which access to treatment remained totally out of reach for patients in the
South. Lastly, local firms, the vast majority of whom lack sufficient R&D capabilities, have tended to
regress rather than progress. As for the fine chemicals firms that used to produce active principles. Brazil witnessed a mass
destruction of its stock of manufacturing once the free-trade agreements that were signed in 1994 came into effect (remember
that TRIPS are only one aspect of the general agreements signed under the WTO framework). In addition, it was only once the Brazilian
authorities made a commitment to local production that the multinational firms, for once under considerable pressure, began to lower prices
visibly. In other words, aside from its remarkable effects in terms of Public Health, one of the main achievements of the Brazilian program is
that it provided unambiguous elements for dealing with key issues in the country's political economy. 4. For all of these reasons, the ensuing
phase (the 2001 Doha Declaration) has been crucial, with WTO members now openly admitting that it is essential that
countries facing epidemic threats be able to use compulsory licenses of patented drugs . Depending on
whether this statement of intent is followed by tangible after-effects and enacted in law. the circumstances surrounding the
continuation of the battle against tliis epidemic could vary greatly 14. The United States' recent opposition (the U.S. is
the only country to refuse a compromise text accepted by the 143 other countries represented in Geneva) was a disastrous signal for the
wealthy nations to send to the countries of the South. In any event, and even if "South-South" exports of ARVs and other active principles are
finally authorized (something that was refused in Geneva in 2002). the
Brazilian experience clearly shows that the use of
a "compulsory licensing" clause (or the credible threat to use it) constitutes a key strategic tool for achieving
the significantly lower prices of drugs that are needed to fight the epidemic.

Disease causes extinction

Keating 9 (Joshua, Foreign Policy web editor, “The End of the World”, 11-13-09,
http://www.foreignpolicy.com/articles/2009/11/13/the_end_of_the_world?page=full,)

How it could happen: Throughout history, plagues have brought civilizations to their knees. The Black Death killed more off
more than half of Europe's population in the Middle Ages. In 1918, a flu pandemic killed an estimated 50 million people,
nearly 3 percent of the world's population , a far greater impact than the just-concluded World War I. Because of
globalization, diseases today spread even faster - witness the rapid worldwide spread of H1N1 currently unfolding. A

global outbreak of a disease such as ebola virus -- which has had a 90 percent fatality rate during its flare-ups in rural Africa --
or a mutated drug-resistant form of the flu virus on a global scale could have a devastating, even
civilization-ending impact . How likely is it? Treatment of deadly diseases has improved since 1918, but so have the diseases.
Modern industrial farming techniques have been blamed for the outbreak of diseases, such as swine flu, and as
the world’s
population grows and humans move into previously unoccupied areas, the risk of exposure to
previously unknown pathogens increases. More than 40 new viruses have emerged since the 1970s, including
ebola and HIV. Biological weapons experimentation has added a new and just as troubling complication .

Scenario 2 is India:

Big Pharma lobbies decimate Indian medical industry---intellectual property law

revisions
Cox 13 (Joseph, Vice, 10/18/13, “Surprise! Big Pharma Don't Want Developing Countries Having Access
to Cheap Medicine”, https://www.vice.com/en_uk/read/american-lobbyists-are-fighting-to-halt-the-
availability-of-affordable-medicine-to-the-3rd-world, Accessed 7/24/15)//LD

Compared to a number of other nations, India has done an incredible job of keeping medicine cheap enough that its
citizens can afford to buy whatever it is that they need . Most importantly, it avoids handing out patents for drugs unless they're
completely new or have some sort of therapeutic advantage over already-available treatments, meaning that the vast majority of life-saving

medicines are free to be replicated and sold by any company that wishes to do so . For example, in 2012,
German Big Pharma company Bayer were charging $4,500 (£2,780) per month for a kidney and liver
cancer medicine. Deeming that a little too pricey in a country where the average yearly wage is around a quarter of that number, the Indian
government granted a license to manufacturer Natco to produce a generic alternative to the branded
medicine, as long as they paid some royalties to Bayer. As a result, the price of the medicine decreased by a massive 97
percent. However, aggressive lobbying from US pharmaceutical companies is set to change all that.
America's pharmaceutical plutocrats are attempting to revise intellectual property laws in India,
meaning that many people seeking treatment will be forced to buy expensive US imports instead of
domestically produced replicas. Which obviously isn't great news for the 96.9 percent of citizens living with less than $5 (£3) a day. In most
drug-producing countries that aren't India, once a drug has been developed and a first patent filed and granted, pharmaceutical
companies then engage in a practice called "evergreening". That practice basically involves undermining access to
affordable medicines by using a variety of tactics to extend the company's monopoly on the drug past
its initial 20-year patent period. By obtaining multiple secondary patents, often for trivial modifications to the original, companies are
able to protect their product for decades, preventing production of cheaper generic replicas . Because
Indian patent law forbids evergreening, the country's generic pharmaceutical companies have been able to produce affordable versions of
foreign medicines to suit their nation's income. But it's that law that's coming under pressure from the US government

and international drug companies, with both institutions wanting India to allow evergreening , therefore
further tightening the companies' grasp on drug monopolies . That, of course, means that low-cost generic
medicines will simply disappear , leaving India's sick the choice of whether to submit to severe poverty in order to raise the cash for US imports,
or forego treatment altogether. Either way, India loses. Nolitha Tsilana, a Médecins Sans Frontières nurse, delivers TB pills to a patient in Khayelitsha

township, Cape Town. (Photo courtesy of Médecins Sans Frontières) And it's just not those needing medical treatment in India

who should be worried about the lobbying. India has been referred to as "the pharmacy of the developing
world", exporting more than half of its generic medicine to the world's poorest countries every year .
And the exports include more than just paracetamol and basic painkillers; the Indian pharmaceutical industry produces

treatments for life-threatening diseases, like hepatitis C and HIV – treatments that the countries
importing them don't have the resources to make themselves . In fact, speaking to Rohit Malpani from
Médecins Sans Frontières (an organisation that relies heavily on affordable generic drugs), he stressed that even a tiny
alteration in the law "would have enormous impacts on public health systems in sub-Saharan Africa,
Latin America and Southeast Asia". The crushing irony of the whole thing is that the vast majority of medicines taken in
the US – and those distributed by US aid programmes – are of the generic variety, many of which are developed by
Indian manufacturers. So that's Indians, US aid agencies, Médecins Sans Frontières, the world's poor and
vulnerable and US citizens that US pharmaceutical companies could be screwing over with the proposed change
in law. According to the letter sent to President Obama that outlines the proposals to force India into buying American-made medicine, Representatives Erik
Paulsen, John Larson and 170 other members of Congress are "deeply concerned about the growing trade imbalance between the United States and India". The
lobbyists claim that India is "harming" US industry by "jeopardising jobs and innovation here at
home" and having "a negative impact on […] investment in the United States ". You'd been forgiven for thinking that
these were the words of a right-wing venture capitalist with no ability to value human life over the prospect of making a little more money. But Rohit pointed out
that the support is "decidedly non-partisan", saying that "we don't see any empathy or understanding of the measures that the Indian government or other
governments are taking to ensure affordable medicine prices. In some ways, we often see very little space between the approaches of either political party".
Medicine distributed in Kenya by Médecins Sans Frontières. (Photo courtesy of Sven Torfinn / Médecins Sans Frontières) Paulsen and his patriotic friends are also
worried that other countries may take up India's abhorrent stance on producing medicine domestically for the benefit of its own people and join the attack on
America's economy, because "[India] is a thought leader among emerging countries". The justification the lobbyists have provided for their attack is that the Indian
government's attitude towards producing affordable alternatives is illegal – that they're breaking intellectual property laws by replicating branded drugs. However,
Rohit told me that "every sort of impartial legal expert has validated India's measures as being consistent with global trade rules". Rather than just take Rohit’s word
for it, I consulted a report from the World Health Organisation (WHO). The report explained that member states should "consider, whenever necessary, adapting
national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights". These flexibilities
in the law include compulsory licenses, just like the one awarded to Natco to produce a cheaper alternative to the kidney and liver cancer medication that Bayer
were trying to peddle for almost 100 times more. After approaching Pfizer – one of the main pharmaceutical companies behind the lobbying – and being bounced
between multiple media departments, I wasn't provided any comment. Instead, I was forwarded testimony that Chief Intellectual Property Counsel Roy Waldron
delivered to the House of Representatives back in June. He stated that India's actions lower their ability to "provide faster access to life-saving medicines", and that
the country was a "hostile innovation and investment environment". Which basically translates to: " Because
Indians have made their own
medicine that people there can actually afford, nobody wants to waste thousands of dollars on the stuff we
make that does exactly the same thing. Which is a mean and selfish thing to do to America's
billionaire pharmaceutical bosses."

Indian pharma strength is key to their soft power

Jha 12—The Hindu
(Prem Shankar, “Let India unleash its soft power”, http://www.thehindu.com/opinion/lead/let-india-unleash-its-soft-power/article2854513.ece,
dml)

And why stop at food grains? In drought-struck regions, contaminated water kills much faster than hunger and takes the very young and the
very old first. The Indian pharmaceuticals industry is the envy of the world, because it produces and sells medicines at a
tenth to a thirtieth of the retail prices abroad. Can
Delhi not buttress its food aid with medicines and vitamins? This will
give an entirely new meaning to the concept of Soft Power for, unlike the West in its present
incarnation, it would be seeking to build influence by protecting and preserving, not destroying; by expanding
peoples' futures instead of ending them in darkness. We have been relatively slow to realise our full potential for the
exercise of soft power. This could be because of our too-ready acceptance of a concept that was created by an American to address
American foreign policy concerns. In Joseph Nye's original definition, soft power originated in the capacity to attract others to your country's
culture, values and institutions. Indian policymakers have taken this to heart and relied mainly upon India's open society, democratic
institutions, lack of aggressive intent and willingness to share the burden of U.N. peacekeeping and policing the global commons, to garner
respect and support in the international community. It
is only in the last half-decade, as the Westphalian international order
crumbled and India's neighbourhood became increasingly unstable, that New Delhi has begun to explore the economic
dimensions of ‘soft power' seriously. Afghanistan has been the focus of its initial efforts, and its success is attested to by the threat
(irrational though it is) that Pakistan feels from it.
Prevents extinction
Diamond 7 – senior fellow at Stanford’s Hoover Institution(Larry, Times of India, "India, Take the
Lead,"
timesofindia.indiatimes.com/Opinion/Editorial/LEADER_ARTICLE_India_Take_The_Lead/articleshow/26
17945.cm)

India is becoming a global power. In the years to come, India will have to decide what kind
Whether it wants to be so or not, whether it is ready for this role or not,

With its economic might, its military power, and its " soft power" all increasing steadily,
of global power it wants to be.

India will find it increasingly difficult to continue its traditional foreign policy of non-alignment and non-
intervention. Americans are in an awkward position to appeal to another rising power to promote democracy, as our own engagement for demo-cracy abroad over time has
contained more than a little neocolonialism, unilateralism and hypocrisy. However, in the last three decades, this has been partially supplanted by increasingly effective efforts (especially when
multilateral, practical and soft-spoken) to assist democratic development around the world. One must also acknowledge the serious problems with India's own democracy: tenacious poverty
and inequality, troubling levels of political violence and criminality in some states, and a fragmented political party system that makes it difficult to take decisions. In the face of acute

challenges, it is understandable for India to want to be able to focus on its own problems. Yet the established democracies of the world share a
strong common interest in trying to bring about a more democratic world, and India's help is sorely
needed in this cause. The global balance of power, of economic energy, and of moral authority is tilting
from North to South. And the global environment for democracy is less favourable than at any time
since the fall of the Berlin Wall, as an oil-rich Russia turns its back on Europe and democracy, a booming authoritarian China casts a lengthening shadow over Asia and
now Africa as well, and democracy gasps for life in such crucially important countries as Pakistan, Bangladesh, Thailand, the Philippines, Nigeria and Venezuela. There are still a

lot more democracies in the world than there were in 1989, but the momentum is reversing, and many
democracies are in danger. There are several reasons why India should care. First, India's own democracy could be affected by what happens regionally and globally.
Recall that emergency rule fell upon India at a low-point for democracy in Asia and the world. Democracies thrive in regions where they enjoy the reinforcing legitimacy and mutual security of

other democracies. Second, by engaging other democracies around the world, India will also draw solidarity and
some lessons that could be useful for its own democratic reform . All democracies in the world today are imperfect, and we all need to
learn from one another. Third, a more democratic world will be a more secure world for us all. Democracies do not go

to war against one another. And they do a much better job of advancing human well-being and
protecting the environment. Moreover, terrorism emanates disproportionately from authoritarian soil.
We are threatened in common with a global crisis of climate change that dwarfs anything human
civilisation has ever confronted. And the pathologies of badly governed states – terrorism, crime,
corruption, environmental stress, infectious disease – spill across borders more quickly and vengefully
than ever before. India does not need a radical reorientation of its foreign policy in order to make a difference to democracy in the world. It has an
exceptionally rich history of democratic practice and experience to share with other developing
democracies. Some of the obvious realms of experience that India has to share include: the evolution and functioning of federalism, the management of ethnic and religious conflict,
the constitutional court, state and local government, electoral administration, the independent mass media and civil society. A very useful first step would be to bring practitioners and scholars
from emerging democracies to India for periods of time to study how democracy works and has developed here. New institutions could be established and existing Indian think tanks and
organisations could be supported to host such visits. Of course the United States does quite a bit of this. But how relevant is the highly expensive and decentralised American (or even
European) model of democracy for Asia and Africa? We would all be better off sending more democrats to countries like India and South Africa. And conducting these exchanges would be an

If India were to
excellent and also ethical way for India to extend its soft power at a time when China is doing so for much more brazenly commercial and strategic ends.

establish an institution to coordinate and organise exchanges with democrats around the world, richer
democracies in the world would want to join with it and help to fund it. And in the near term, we have a ready potential vehicle. The
UN Democracy Fund has recently been established, with a substantial budget that includes sizable contributions from India and the United States. It is a natural candidate to provide early

India should join the worldwide movement for democracy because doing so is in India's
support for such a new initiative.

own national interest, not because the West asks it. But the democratic West has obligations to India that it must fulfil in the process. If we are asking India to play more of a
leader-ship role on the world stage, than we must make room for that leadership. This should include India's permanent membership on the UN Security Council and its inclusion in global
agenda-setting dialogues, such as the G8.

Scenario 3 is Africa:
Big Pharma campaigns wreck the local African pharmaceutical industry---blocks IPR
amendments
Kardas-Nelson 14 (Mara, award-winning journalist who focuses on health, environment, international development,
local culture and women's issues, work has appeared in North American, European and African publications, including Al
Jazeera, AlterNet, The Nation and the Mail & Guardian, 4/29/14, “Hand in Hand With US Government, Big Pharma Pushes for
More Profits”, http://www.truth-out.org/news/item/23279-hand-in-hand-with-us-government-big-pharma-pushes-for-more-
profits, Accessed 7/24/15)//LD

In January of this year, South

African Minister of Health Aaron Motsoaledi cried foul: he was publicly pissed
about a US-created astroturf campaign (a faux "grassroots movement" actually led by moneyed interests) meant to undermine
the country's efforts to lower drug prices through amending its intellectual property (IP) legislation .
Labeling the plot as being of "satanic magnitude" and tantamount to "genocide," Motsoaledi slammed the
creators of the campaign, a veritable who's who of pharmaceutical companies and conservative, pro-business groups. The
tripartite alliance responsible for the plot consisted of Public Affairs Engagement (PAE), a DC-based PR firm headed by US Ambassador James Glassman, formerly the
undersecretary of state for public diplomacy and public affairs in the George W. Bush administration; the Pharmaceutical Research and Manufacturers of America,
or PhRMA, one of the most powerful drug industry bodies on the planet; and a local pharmaceutical body, Innovative Pharmaceutical Association of South Africa
(IPASA). The
group would seek to persuade the South African public that strong intellectual property
policy is good for investment and that the country's health woes are a result of a failed public health system rather than patent laws and the price
of medicines. The draft South African policy that the groups sought to undermine seeks to more strictly define how patents should be given, what is patentable and
what measures the government can take if pharmaceutical patents negatively impact public health, all in an attempt to stem rising health costs. With its burgeoning
middle class, "diseases of the rich" like diabetes, hypertension, obesity, heart disease and cancers are on the rise. This, matched with a high rate of HIV, TB, and
other historically "poor" diseases, and coupled with the excessive cost of patented drugs, means that drugs are in high demand, but prices are sometimes
inaccessibly high. The astroturfing plot was simple: For just under half a million dollars, paid for in large part by PhRMA, the US public relations firm would support
IPASA's efforts to stem South Africa's IP reform by setting up a puppet front group, to be named Forward South Africa and led from Washington DC. The group
would seek to persuade the South African public that strong intellectual property policy is good for investment and that the country's health woes are a result of a
failed public health system rather than patent laws and the price of medicines. What's more, South
Africa is trying to stem costs just as
pharmaceutical companies want a bigger slice of its pie - with its growing wealth, its patent-friendly
laws and its sick population, South Africa looks like a deliciously ripe, relatively untapped market . If South
Africa pushes back, not only could current and future profits be reduced within the country, but also, and more importantly, other emerging economies that also
appeal to pharma could follow suit, eliminating potential profits for companies hungry for new markets. It's easy to see how multinational

pharmaceutical companies would be scared of South Africa's potential reforms . The country currently offers IP
protection beyond what is required under international law and does not review patents before they are granted. As a result, it hands out thousands of drug patents
annually and readily gives out multiple patents on a singular medicine, offering monopoly protection on a single drug for decades. Nearly all of the country's
pharmaceutical patents are granted to multinational firms, and the country's department of trade and industry cites drugs as a key reason for South Africa's trade
deficit. The country is also a continental leader that other African countries and middle-income countries look to for general policy guidance. Motsoaledi's harsh
words in reaction to the PAE-led scandal represent anger, but not necessarily shock: After all, the country has dealt with US and industry meddling in its
pharmaceutical policy before. In 1998, Nelson Mandela's administration was sued by dozens of pharmaceutical companies in reaction to the country's attempts to
make minor amendments to its drug laws (the case was eventually dropped in 2001, after years of public pressure). The PAE-led astroturfing campaign, which has
died in the wake of public outcry, is just one example of many in which US
pharmaceutical companies, with the help of high-
profile Americans connected to the US government, pressure poorer countries battling high rates of
disease to ensure that the IP playing field is set as they like it .

Local pharma production is key to African health and economic growth

ADBG 14 (African Development Bank Group, 4/6/14, “Revitalizing Africa’s pharmaceutical industry”,
http://www.afdb.org/en/news-and-events/article/revitalizing-africas-pharmaceutical-industry-13289/,
Accessed 7/24/15)//LD

Africa’s pharmaceutical industry has great potential for boosting economic growth and creating jobs. Given

current sustained and rapid economic growth, the African pharmaceutical industry , like that of other emerging
markets, is expected to grow tremendously in the coming years . “Pharmerging markets” across the world show the potential for
rapid growth in the industry. In the past five years China’s pharmaceutical industry grew 20%, Russia’s 14%, India’s 11% and Brazil’s 7%. During the past decade
the African continent has been home to some of the fastest-growing economies in the world, creating
a large window of opportunity for the development of the pharmaceutical sector . The growing numbers of Africans
with significant disposable income and spending power, the strong demographic dynamics, including fast urbanization, steady economic growth in most parts of the
continent, and improved infrastructure in both rural and urban areas are all potential drivers of Africa’s pharmaceutical boom. Investments in the
pharmaceutical sector are investments in the health sector with the greatest potential both in terms of
financial viability and individual deal size. Job creation prospects are also immense all along the pharmaceutical value chain. Although it is relatively small
in global terms (worth US $23.1 billion in 2011, or less than 2% of the global market), Africa’s pharmaceutical industry is the fastest

growing in the world and is driven by a small number of countries: South Africa, Nigeria, Ghana, some Eastern African countries and
North Africa. Local production remains weak and limited : local manufacturers produce 25 to 30% of pharmaceuticals and less than 10%
of medical supplies that are on the African market. The pharmaceutical industry is mostly composed of small, privately owned companies that serve their national
markets, and there are few large manufacturers ( Aspen
in South Africa is in the top 10 largest generic manufacturers in
the world) as well as public sector manufacturers. Africa bears the greatest burden of disease in the world, but in most
cases depends on externally developed and procured drugs, vaccines, medical devices and diagnostics to support the
health of its people, which significantly affects health expenditures and household incomes. The need for drugs is tremendous: 75% of the world’s
HIV/AIDS cases, 90% of the deaths from malaria and the majority of tuberculosis cases are all in Africa. In addition, the rise of non-communicable diseases, coupled
with the burden of communicable ones and emergent infections, require new medical services and new treatments. There
is clear momentum in
Africa for developing the pharmaceutical industry. African Heads of State stressed the potential for
local production and technology transfer in the Pharmaceutical Manufacturing Plan for Africa. Developing the pharmaceutical industry on the continent
would contribute to removing financial barriers to medicines and improving access to essential medicines. Still, the conditions for the private sector to bloom have
not been met.

Epidemics in Africa cause regional instability and wars

Brantly 14 (Dr. Kent, House Subcommittee on Africa, Global Health, Global Human Rights, and
International Organizations, 9/17/14, “Global Efforts to Fight Ebola”,
http://docs.house.gov/meetings/FA/FA16/20140917/102676/HHRG-113-FA16-Wstate-BrantlyK-
20140917.pdf, Accessed 7/24/15)//LD

As Ebola spreads throughout West Africa, there is increasing civil unrest that could easily lead to
regional instability. I had one patient in early July who died after spending two days in our Ebola Treatment Unit. Although we tried
to explain the cause of death to her family, some of them—with the help of a witch doctor— determined that she died because of a curse
placed on her by her best friend. They sought revenge, which meant taking the life of the person they thought
was responsible. In societies like this, where fear and distrust of authority are the norm, many still deny that
Ebola is real and actively seek other explanations for the deaths of their loved ones . There are many conspiracy
theories, including the belief that Ebola is a government plot for monetary gain. You can see how this sort of thinking can easily lead
to large-scale violence. There is a palpable sense of tension on the streets that is priming the pump of
society for skirmishes that could quickly lead to war . The world cannot afford to allow more conflict in
this region that is home to dictators-in-hiding and terrorist groups like Boko Haram. This epidemic must be
brought to a halt as soon as possible to regain order and re-establish confidence in local governments. Since I fell sick less than
two months ago, the death toll from Ebola has tripled. At that rate of growth, there will be hundreds of thousands of deaths within the next
nine months. This is a global problem, and the U.S. must take the lead immediately to extinguish the hellish fire of Ebola before it consumes
entire nations. We
cannot wait for international agencies tied up in bureaucracy or organizations that rely
on volunteers and funding from private donors. The longer we wait, the greater the cost of the battle—in dollars and lives.
We must act immediately and decisively to bring healing and stability to the people of West Africa, the African continent, the United States, and
the entire world.

African conflicts cause great power war

Glick 7 (Caroline – senior Middle East fellow at the Center for Security Policy, Condi’s African holiday, p.
http://www.centerforsecuritypolicy.org/home.aspx?sid=56&categoryid=56&subcategoryid=90&newsid=11568 )

The Horn of Africa is a dangerous and strategically vital place. Small wars, which rage continuously, can easily escalate
into big wars. Local conflicts have regional and global aspects. All of the conflicts in this tinderbox , which
controls shipping lanes from the Indian Ocean into the Red Sea, can potentially give rise to regional, and indeed global
conflagrations between competing regional actors and global powers . Located in and around the Horn of Africa are the states of
Eritrea, Djibouti, Ethiopia, Somalia, Sudan and Kenya. Eritrea, which gained independence from Ethiopia in 1993 after a 30-year civil war, is a major source of regional conflict. Eritrea has a
nagging border dispute with Ethiopia which could easily ignite. The two countries fought a bloody border war from 1998-2000 over control of the town of Badme. Although a UN mandated
body determined in 2002 that the disputed town belonged to Eritrea, Ethiopia has rejected the finding and so the conflict festers. Eritrea also fights a proxy war against Ethiopia in Somalia and
in Ethiopia's rebellious Ogaden region. In Somalia, Eritrea is the primary sponsor of the al-Qaida-linked Islamic Courts Union which took control of Somalia in June, 2006. In November 2006, the
ICU government declared jihad against Ethiopia and Kenya. Backed by the US, Ethiopia invaded Somalia last December to restore the recognized Transitional Federal Government to power
which the ICU had deposed. Although the Ethiopian army successfully ousted the ICU from power in less than a week, backed by massive military and financial assistance from Eritrea, as well
as Egypt and Libya, the ICU has waged a brutal insurgency against the TFG and the Ethiopian military for the past year. The senior ICU leadership, including Sheikh Hassan Dahir Aweys and
Sheikh Sharif Ahmed have received safe haven in Eritrea. In September, the exiled ICU leadership held a nine-day conference in the Eritrean capital of Asmara where they formed the Alliance
for the Re-Liberation of Somalia headed by Ahmed. Eritrean President-for-life Isaias Afwerki declared his country's support for the insurgents stating, "The Eritrean people's support to the
Somali people is consistent and historical, as well as a legal and moral obligation." Although touted in the West as a moderate, Ahmed has openly supported jihad and terrorism against
Ethiopia, Kenya and the West. Aweys, for his part, is wanted by the FBI in connection with his role in the bombing of the US embassies in Kenya and Tanzania in 1998. Then there is Eritrea's
support for the Ogaden separatists in Ethiopia. The Ogaden rebels are Somali ethnics who live in the region bordering Somalia and Kenya. The rebellion is run by the Ogaden National
Liberation Front (ONLF) which uses terror and sabotage as its preferred methods of warfare. It targets not only Ethiopian forces and military installations, but locals who wish to maintain their
allegiance to Ethiopia or reach a negotiated resolution of the conflict. In their most sensationalist attack to date, in April ONLF terror forces attacked a Chinese-run oil installation in April killing
nine Chinese and 65 Ethiopians. Ethiopia, for its part has fought a brutal counter-insurgency to restore its control over the region. Human rights organizations have accused Ethiopia of massive
human rights abuses of civilians in Ogaden. Then there is Sudan. As Eric Reeves wrote in the Boston Globe on Saturday, "The brutal regime in Khartoum, the capital of Sudan, has orchestrated
genocidal counter-insurgency war in Darfur for five years, and is now poised for victory in its ghastly assault on the region's African populations." The Islamist government of Omar Hasan
Ahmad al-Bashir is refusing to accept non-African states as members of the hybrid UN-African Union peacekeeping mission to Darfur that is due to replace the undermanned and demoralized
African Union peacekeeping force whose mandate ends on December 31. Without its UN component of non-African states, the UN Security Council mandated force will be unable to operate
effectively. Khartoum's veto led Jean-Marie Guehenno, the UN undersecretary for peacekeeping to warn last month that the entire peacekeeping mission may have to be aborted. And the
Darfur region is not the only one at risk. Due to Khartoum's refusal to carry out the terms of its 2005 peace treaty with the Southern Sudanese that ended Khartoum's 20-year war and
genocide against the region's Christian and animist population, the unsteady peace may be undone. Given Khartoum's apparent sprint to victory over the international community regarding

Darfur, there is little reason to doubt that once victory is secured, it will renew its attacks in the south. The conflicts in the Horn of Africa have
regional and global dimensions. Regionally, Egypt has played a central role in sponsoring and fomenting conflicts. Egypt's meddling advances its interest of
preventing the African nations from mounting a unified challenge to Egypt's colonial legacy of extraordinary rights to the waters of the Nile River which flows through all countries of the
region.
 1AC---Whistleblowing Advantage
Status quo surveillance is damaging credibility---only plan has potential to solve
Nakashima and Rein 12 (Ellen Nakashima, national security reporter for The Washington Post, Lisa
Rein, covers the federal workforce and issues that concern the management of government, “FDA
lawyers authorized spying on employees, senator says,” July 16, 2012,
https://www.washingtonpost.com/world/national-security/2012/07/16/gJQAoNvLpW_story.html)//ghs-
VA
Congressional investigators said Monday that the chief counsel’s office at the Food and Drug Administration authorized wide-ranging surveillance of a group of the
agency’s scientists, the first indication that the effort was sanctioned at the highest levels. In a letter to the FDA, Sen. Charles E. Grassley (R-Iowa)
said that his staff had learned that the spying was “ explicitly authorized , in writing” by the agency’s top
legal office. “The FDA’s actions represent serious impediments to the right of agency employees to
make protected disclosures about waste, fraud, abuse, mismanagement, or public safety,” wrote Grassley, who demanded that the agency release
a copy of the memo authorizing the surveillance and the name of the FDA official who requested it. FDA spokeswoman Erica Jefferson said that the agency is looking
into the matter. She said that the surveillance was limited in scope and reiterated that it was relegated to government computers. “We did not impede or interfere
with any employee communication to Congress, their staff, media or federal investigators,” she said. The disclosure marked the latest turn in an investigation of the
FDA’s past efforts to monitor the communications of a group of its doctors who were expressing concerns about the safety of medical devices. As part of the effort,
the FDA secretly collected thousands of private e-mails that the employees sent to one another , members
of Congress, journalists, lawyers and others. The FDA acknowledged Friday that targeted surveillance of five employees began in mid-2010, but it said that was not
ongoing today, according to a letter sent to Grassley by Jeanne Ireland, the agency’s assistant commissioner for legislation. The FDA said Monday that the computer
The
surveillance was limited to five employees. But an internal document shows that the agency targeted at least seven employees beginning in 2010.

targeting of the employees’ communications, including e-mail and other online activities, was
reported by The Washington Post in January. The agency monitored personal e-mail accounts accessed from government computers, took electronic
snapshots of computer desktops and reviewed documents saved on hard drives. The New York Times reported over the weekend that the scope of the surveillance
was wider than first suspected, with the agency creating a database of 80,000 pages of computer documents collected from the scientists’ communications. The
database, apparently posted inadvertently online by an FDA contractor, included an FDA “scoping” document of targets for future e-mail interception that included
congressional staff members. Also captured were draft complaints being prepared by the scientists to the Office of Special Counsel, an independent federal agency
that investigates disclosures of government wrongdoing and retaliation against those who report it. The OSC is investigating the FDA’s monitoring of its employees.
In June, OSC
special counsel Carolyn Lerner warned federal agencies that monitoring their employees’
personal e-mail violated the law if the intent was to retaliate against whistleblowers . The White House
distributed her warning to agencies across the government, an acknowledgment by the Obama administration that there are limits to employee surveillance. Two
years ago, the FDA’s parent agency, the Department of Health and Human Services, reminded it that employees have a right to air their concerns to Congress and
journalists. The reminder accompanied a rejection by the HHS inspector general of the FDA’s request that it pursue a criminal investigation of the scientists’
activities. Grassley, a member of the Senate Judiciary Committee, has been seeking answers from the FDA since January on the extent of the surveillance and who
authorized it. On Friday, he accused the agency of “stonewalling” him after officials there responded to his inquiries by saying in a letter they are “still identifying
and gathering evidence” in the matter. “It
is simply not credible that FDA went to such great lengths over the course
of two years to monitor employees’ personal e-mail accounts, then spent six months crafting a reply to my questions about it,
and yet still cannot identify who authorized the spying,” he said. FDA computers post a warning to users, visible when they log on, that they should have “no
reasonable expectation of privacy” in any data passing through or stored on the system, and that the government may intercept any such data at any time for any
lawful government purpose. Internal documents obtained under the Freedom of Information Act by the scientists, some of whom have been fired, show that the
FDA was concerned that they had improperly disclosed confidential business information about several
medical devices used to screen patients for colon cancer and breast cancer.

Effective whistleblowing is key to reduce corruption

LaBovick 12 LaBovick Law Group (quoting the whistleblowers’ attorney) is a consumer plaintiff’s law firm, “Illegal FDA
Surveillance of Whistleblowers”, 8/3/12, https://www.labovick.com/qui-tam/illegal-fda-surveillance-whistleblowers-2//OF

On July 14, 2012, the

New York Times issued an article that uncovered a U.S. government secret spying
program that targeted a group of whistleblowers working for the Food and Drug Administration
(FDA). The government program that the story uncovered is illegal. It shows how high government officials used
a spy program that intended to undermine federal employees’ rights to lawfully report significant
health threats and concerns to Congress, law enforcement officials and the American people. Stephen M.
Kohn, the Executive Director of the National Whistleblower Center and the head attorney for the FDA whistleblowers stressed that these
employees do not give up their First or Fourth Amendment rights while holding government positions .
Kohn stated that it is in fact more important for government workers to make note of wrongdoing in
order to expose crimes, misconduct, corruption and wasted taxpayer dollars. In reference to the news article,

Stephen M. Kohn also stated: “We

hope that the revelations in today’s New York Times will mark a turning
point in the battle to stop the retaliatory surveillance of whistleblowers who risk their careers to
report misconduct.” Mr. Kohn hopes that the individuals responsible for attempting to prevent FDA agents from uncovering serious
health and safety violations will be punished.

FDA whistleblower policy spills over to all governmental organizations and these
protections are important to prevent abuses of power
HCOGR 14 “HEARING BEFORE THE COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE
HUNDRED THIRTEENTH CONGRESS LIMITLESS SURVEILLANCE AT THE FDA: PROTECTING THE RIGHTS OF FEDERAL WHISTLEBLOWERS
http://www.gpo.gov/fdsys/pkg/CHRG-113hhrg87176/pdf/CHRG-113hhrg87176.pdf, this except is taken from page 4”.CC

I am not suggesting that. Just the opposite. The

Federal workforce is a highly trusted force, and trust is what we
depend on. At times, it is clear that that trust is broken and, when it is, there are appropriate
remedies. But until that trust is broken, we depend on a skilled and motivated workforce that believes, as they should, that they
are not working for Big Brother, that, in fact, they are trusted in their VerDate Aug 31 2005 11:40 Mar 31, 2014 Jkt 000000 PO 00000 Frm 00007
Fmt 6633 Sfmt 6633 C:\DOCS\87176.TXT APRIL 4 roles and not being unreasonably spied on or targeted for disciplinary action. For
that
reason, we are holding this hearing today not as just an indictment of the FDA , which I think Senator
Grassley will speak to, but as a recognition that all Federal employees need to be protected from an
unreasonable activity, which, at least in this chairman’s opinion, is part of what went on at the FDA in
targeting these five whistleblowers. Again, I will put the rest of my opening statement in the record. And I yield to the ranking
member. Mr. CUMMINGS. Thank you very much, Mr. Chairman. Today we examine two distinct, but related, issues. First, we will review
allegations that the FDA employees leaked trade secret and other confidential business information from companies seeking FDA approval of
medical device applications. We will also review allegations by these employees that they were whistleblowers concerned about the safety of
these medical devices and that the FDA retaliated against them by monitoring their computers. Whistleblowers play a critical role
in rooting out waste, fraud, and abuse at Federal agencies and making our government more effective
and efficient. They sometimes risk their careers. They sometimes risk their reputations to challenge
the abuse of power. Our committee must take every allegation very seriously with regard to retaliation. I have said it before and I will
say it again. We must at every point protect our whistleblowers. I am committed to that, and we are all committed to that.

Whistleblower protection in the G20 has the unique ability to set international norms
for anti-corruption policy
Wolfe et al 14 “Simon, Head of Research, Blueprint for Free Speech Visiting Scholar, University of Melbourne Law School
“Whistleblower protection rules in g20 countries the next action plan”, http://app.griffith.edu.au/news/wp-
content/uploads/2014/06/Whistleblower-Protection-Rules-in-G20-Countries-Action-Plan-June-2014.pdf”.CC

As critical players in the global economy, G20 countries are in an ideal position to promote
transparency and anti-corruption initiatives in government and corporations alike . These initiatives are of
particular import in the wake of the global financial crisis, and as political instability and citizen unrest persist in many regions and countries –
both within and outside the G20. History has shown that economic growth and development cannot
be sustained if they are built on corrupt practices. Given their significant role in shaping financial systems and practices
worldwide, G20 countries have a special responsibility to build sustainability into these processes. The G20 itself acknowledges that corruption
increases costs for businesses and causes the loss of billions of dollars in economic activity. The G20 also recognises that all of its members can
take practical steps to reduce the costs of corruption for growth and development. As an illustration of this, all but two G20 countries have
signed and ratified the UN Convention against Corruption, and all but four have implemented the OECD AntiBribery Convention. In terms of
whistleblower protection, G20 countries have taken various steps that are at different stages of development. As will be seen below,
considerable progress can be noted and acknowledged. However, the analysis confirms the
experience of G20 countries that
action to implement this commitment is not easy. The whistleblower frameworks of most G20
countries still fall measurably short of recognised international standards. Some countries lag significantly behind
prevailing best practices, thus offering neither protections nor disclosure opportunities for whistleblowers. Many G20 countries did not fulfil
their own pledge to establish whistleblower protections by the end of 2012. The fact that the task remains only partially complete in 2014,
dictates the need for a better analysis of where the key problem areas lie. Although formal legal practice on whistleblower protection dates
back 25 years in some countries, it is only recently that effective laws and procedures have begun to be studied comparatively, in sufficient
detail to enable this kind of analysis. While one
explanation for patchy progress is a lack of political will, G20 and
other countries have lacked detailed insight into the critical problem areas on which action might be
focused. To guide G20 countries in fulfilling their commitments under the G20 Anti-Corruption Action Plan, the OECD in 2011 released an in-
depth report that catalogues and details many whistleblower laws and practices currently in place within G20 counties. The analysis presented
here builds on this report. The OECD report also includes a compendium of best practices and guiding principles necessary for whistleblower
laws to be effective. These standards take into account the diversity of legal systems in G20 countries. This offers sufficient flexibility to enable
countries to effectively apply such principles in accordance with their own legal systems.

US is key to the G20 shaping international anti-corruption norms

Bloom 10 (Lauren Bloom, graduated from Georgetown University Law, General Counsel and Vice
President for Governmental Affairs at Navy Mutual Aid Association, General Counsel & Director of
Professionalism at American Academy of Actuaries, “Why We Need New Whistleblower Rules”,
11/11/10, 7/13/15, MEM)
Still, is there a real need for the new whistleblower rules ? Apparently, yes. Transparency International, an international
corruption watchdog group, recently released its 2010 Corruptions Perceptions Index. Embarrassingly, the United States lost its place among
the 20 least corrupt nations on the list, falling to number 22 based on perceptions that, in the US, financial regulatory oversight is less effective
and political campaign funding is less transparent than they ought to be. Transparency International's President, Nancy Boswell, has been
quoted as saying that "the American public is concerned that there is an integrity deficit here, that ethics isn't as foremost as it should be."
Perhaps the new whistleblower rules will help remedy that concern. And why is all of this of interest to investors? Just ask the participants in
this week's G20 Summit in Seoul, where leaders of the top 20 world economies are working to take on corruption .
At its June meeting in Toronto, the
G20 issued a blunt declaration that corruption "threatens the integrity of
markets, undermines fair competition, distorts resource allocation, destroys public trust and
undermines the rule of law." Put another way, corruption creates an unstable and untrustworthy
environment that heightens investment risk. Ordinarily, one would expect the United States to take a
leading role in defining the G20's anti- corruption efforts. If the United States is widely perceived as
being less concerned about corruption than it should be, however, its credibility in the G20 summits
and similar settings can only be diminished. The G20 countries have clearly expressed their concerns about corruption. That
means they'll move forward to combat it with or without the United States. Far better for the US to help shape international
anti-corruption initiatives than for US companies to be stuck with whatever the other G-20 nations
ultimately develop.

In a corrupt state, government and corporate interest become intertwined and create
economic nationalism which perpetuates more corruption---empirics prove
Yorgos et al 8 (“Rizopoulos, “Corruption and economic nationalism evidence from the Russian oil
sector”, professor at the universite paris Diderot, http://idec.gr/iier/new/CORRUPTION
%20CONFERENCE/Rizopoulos%20Sergakis%20-%20Corruption%20and%20Ecoonomic
%20Nationalism.pdf”.CC)

Two strategies describe the patterns of corruption in the evolution of Business – State Interaction in Russia: the
corruption networks during the State Capture period (early, mid – and late 1990s) and the emergency of the rent seeking from the super bureaucratic elite during
the Business Capture period (1999 to present). During the State Capture period (Hellman 1998), corruption in Russia has
entered the phase whereby individually isolated criminal transactions have formed a well organized
and coordinated corruption networks. State weakness has long been a feature key of the creation of this kind of networks. The breakdown of
the administrative system (early 1990s) created a range of opportunities to take over business, using formerly state-

owned property, and making money on the structural distortions that that have been typical for the planned economy. The
distortions gave rise to a transformational rent. Meanwhile, weakened and half-destroyed public institutions in Russia were

unable to build an effective resistance to the attempts of various informal interest groups to capture and
privatize this rent. These groups organized and set up for a joint extraction of profit from corrupted activities. The patron-client relationship

from certain networks of individual ties between officials and particular corporate interests in
commercial and financial spheres. Sometimes these connections involved the bribing of a particular bureaucrat in the interests of a specific
organization. But in most of the cases, officials must join a network of shared services where no bribes are received or passed on. In such situations, the obligation
to join a corruption network is accompanied with mercenary temptations: as a rule, compensation is a stake in the network profits. These are illegal payments which
are in proportion to the official’s government position and function in the corrupt transactions (Rimsky, 2004). The
corruption networks formed
are both vertical and horizontal. The vertical relationships are informal, illegal interdependences
between bureaucrats within the organization. The horizontal ones are between different agencies and
other structures. These relationships are used for organized implementation of corrupt transactions that are aimed at: personal enrichment; allocation of
budget funds in favor of the networks; enhancement of the networks’ illegal profits; or, receipt of competitive advantages by financial and commercial structures
within the corrupt network to generate future earnings. Obtaining financial resources is practically always the leading goal of each corruption network. These
interrelations are specifically directed to the fulfillment of corrupt transactions, distribution of state
funds in favor of its structure and
profitability, or receiving of competitive financial advantages for members of the networks . It is important to
stress that the accumulation of financial resources and the involvement of federal officials in allocating them from the federal source in favor of corruption networks
in the main goal of each network. This financial structure transfers money to confidential accounts and then redistributes the funds among the network members
(Mendras, 1998). Generally, the holders of these accounts use free economic zones throughout Russia, such as Ingushetia, Kakmyk and Far East regions. It often
occurs that the same financial structure simultaneously finances several corruption networks. For instance, one bank department conducts business with a specific
ministry, other departments of the same bank, with another ministry. Initially in Russia, the only means to generate capital was from the rights to oversee banking
transactions and state ownership of industry. Therefore, corruption
networks in Russia developed from the basis of existing
state structures, which, before privatization, were in control of the state . Corruption networks were created for
financing the operations by the structures engaged in the export of raw materials. These networks simply tried to undermine the state structures that were bringing
in the fast earnings. Thus corruption networks receive financing from the export of oil and gas, energy, transportation and defense subsidies. Each Russian
corruption network includes three basic subsystems: the commercial or financial branch; government officials; and, law enforcement. The commercial converts the
received privileges into cash. The government officials provide cover at the decision – making level. This group includes officials whose status guarantees the desired
outcomes. Because most of these decisions are coordinated between several ministries, there are also interdepartmental groups. However, the relationships and
decisions are usually shaded by “the state interests”, which makes them very difficult to detect. The protection of corruption networks is provided by law
enforcement, which provides information, destroys compromising files, or even closes criminal cases. A large company was created in a form of multiple structures,
A good
including an off-shore corporation. It is owned by former Russian citizens, leaders of two criminal groups and two influential businessmen .

example of such a corporation can be seen in Gazprom, the Russian United Power Systems and Lukoil. The company
literally controls one of the Russian Federation regions, i.e., completely determines the results of the
elections, legislative processes, supervises law enforcement bodies, and large and small businesses in
the region. It owns large business in some other region and through its governor supports the opposition to the government. Through the Moscow – based
banks, a company provides direct communication with the President of the Russian Federation administration. As a result, all company structures, with

enormous networks, operate in sphere of business, financial institutions, and federal and regional
government structures. After the election of Putin In practice there are two ways to form a corruption network. One is from below and the other is
from above. To form a corruption network from below, a successful, expanding business company needs a relationship and contacts with higher-level officials. Such
connections and contacts are made through expensive gift giving and bribes. Therefore, officials lobby the interests of a few companies, banks, and businesses. If
the official does not have enough authority, he starts seeking connections with higher level bureaucrats. Thus, local or regional corruption networks gradually grow
into networks at the national level. These national networks, as a rule, are very large and the same official can simultaneously be a member of different networks.
To form a corruption network from above, high-ranking officials select loyal subordinates who construct the network. The purpose of such actions is to maintain
strict personal relations focused on certain operations for the sake of the organization. Economic losses from the corruption, during the State Capture period, can be
examined from two perspectives. There is money which remains in the country and is invested, ultimately being spent on goods and services. There is also a direct
outflow of capital abroad, which is close to $2 billion per month. In some cases, 90% of the international loans escape abroad, both in the form of illegal
appropriations and embezzlement, and in the form of kickbacks to the international officials responsible for the loan decisions. Therefore, the problem of corruption
is directly linked to capital exports and money laundering. Despite the negative impact, most of Russian businessmen agree that corruption creates the mechanism
for overcoming its complicated legal and administrative systems. In conditions where transaction costs are unacceptably high, the corruption is actually a salvation.
The Business Capture period (1999 to present) consolidated mainly the federal bureaucracy. Putin’s election implies a redistribution of cards and new policy
orientations: the emergency of the new federal super elite. The super elite concerns a circle of politicians and top bureaucrats, which, having ascended to the
highest level of authority, face the need to take into account not only the interests of the groups they arose from, but also strategic interests of the nation (Zudin,
2003). At
this time, the relations between big business and the federal government were fundamentally
changed. In contrast to the situation in the 1990s, the link between economic nationalism and
corruption is the use by individual bureaucrats to directly capture business. The collective interests of
a bureaucratic body are personified by its head executive. Such individuals can extract a much larger
volume of rent than their subordinates are able to, and can do this on a regular basis. It is only to be expected that such high-ranking
officials try to expand the sphere of competence and responsibility of their departments as this involves an expansion of potential rent. The consolidation of a
department in itself will widen the range of many opportunities for corruption and rent seeking behavior, because in this case business clients will be forced to
interact with a monopolistic department instead of individual bureaucrats. As a consequence, the prices for “services” charged by this monopoly can be higher. At
the same time, a consolidated department will also be more capable of guaranteeing the fulfillment of its “obligations”, because the officers responsible tend to
have a higher rank, and the decisions of high-ranking officials are more difficult to revise. In the business community, the situation is quite different. It is very hard
for a single businessman to achieve individual privileges, especially since such privileges can be contested by other actors. In this contexte, collective actions seem
not only less costly, but could also render more reliable results. Oligarchic enterprises, on the other hand, emerged mostly out of informal arrangements with the
authorities. Each of the oligarchs maintained their own contacts with representatives of the state. Their business was a kind capitalization of these contacts

Economic nationalism creates a backlash against globalization and the interconnected

nature of states
Roubini 14 “Nouriel, “Economic insecurity and the rise of nationalism”, He served as a senior adviser to the White House council of economic advisers and
the US Treasury and is a professor of economics at New York University's Stern School of Business, http://www.theguardian.com/business/economics-
blog/2014/jun/02/economic-insecurity-nationalism-on-the-rise-globalisation-nouriel-roubini”.CC

In the immediate aftermath of the 2008 global financial crisis, policymakers' success in preventing the Great Recession from turning into Great Depression II held in
check demands for protectionist and inward-looking measures. But now
the backlash against globalisation – and the freer
movement of goods, services, capital, labour, and technology that came with it – has arrived. This new
nationalism takes different economic forms: trade barriers, asset protection, reaction against foreign
direct investment, policies favouring domestic workers and firms, anti-immigration measures, state
capitalism, and resource nationalism. In the political realm, populist, anti-globalisation, anti-immigration, and in some cases outright racist
and antisemitic parties are on the rise. These forces loath the alphabet soup of supranational governance institutions – the EU, the UN, the WTO, and the IMF,
among others – that globalisation requires. Even the internet, the epitome of globalisation for the past two decades, is at risk of being balkanised as more
authoritarian countries – including China, Iran, Turkey, and Russia – seek to restrict access to social media and crack down on free expression. The main causes of
these trends are clear. Anaemic economic recovery has provided an opening for populist parties, promoting protectionist policies, to blame foreign trade and
foreign workers for the prolonged malaise. Add to this the rise in income and wealth inequality in most countries, and it is no wonder that the perception of a
winner-take-all economy that benefits only elites and distorts the political system has become widespread. Nowadays,
both advanced
economies (like the United States, where unlimited financing of elected officials by financially
powerful business interests is simply legalised corruption) and emerging markets (where oligarchs
often dominate the economy and the political system) seem to be run for the few . Advertisement For the many, by
contrast, there has been only secular stagnation, with depressed employment and stagnating wages. The resulting economic insecurity for

the working and middle classes is most acute in Europe and the eurozone, where in many countries
populist parties – mainly on the far-right – outperformed mainstream forces in last weekend's European parliament
election. As in the 1930s, when the Great Depression gave rise to authoritarian governments in Italy, Germany and Spain – and a similar trend now may be
underway. If
income and job growth do not pick up soon, populist parties may come closer to power at
the national level in Europe, with anti-EU sentiments stalling the process of European economic and political integration. Worse,
the eurozone may again be at risk: some countries (the UK) may exit the EU; others (the UK, Spain, and Belgium) eventually may break up. Even in the US, the
economic insecurity of a vast white underclass that feels threatened by immigration and global trade can be seen in the rising influence of the extreme right and Tea
Party factions of the Republican party. These groups are characterised by economic nativism, anti-immigration and protectionist leanings, religious fanaticism, and
geopolitical isolationism. A variant of this dynamic can be seen in Russia and many parts of eastern Europe and central Asia, where the fall of the Berlin Wall did not
usher in democracy, economic liberalisation, and rapid output growth. Instead, nationalist and authoritarian regimes have been in power for most of the past
quarter-century, pursuing state-capitalist growth models that ensure only mediocre economic performance. In this context, President Vladimir Putin's
destabilisation of Ukraine cannot be separated from his dream of leading a "Eurasian Union" – a thinly disguised effort to recreate the former Soviet Union. In Asia,
too, nationalism is resurgent. New leaders in China, Japan, South Korea, and now India are political nationalists in regions where territorial disputes remain serious
and long-held historical grievances fester. These leaders – as well as those in Thailand, Malaysia, and Indonesia, who are moving in a similar nationalist direction –
must address major structural-reform challenges if they are to revive falling economic growth and, in the case of emerging markets, avoid a middle-income trap.
Economic failure could fuel further nationalist, xenophobic tendencies – and even trigger military conflict. The Middle East remains a region mired in backwardness.
The Arab spring – triggered by slow growth, high youth unemployment, and widespread economic desperation – has given way to a long winter in Egypt and Libya,
where the alternatives are a return to authoritarian strongmen and political chaos. In Syria and Yemen, there is civil war; Lebanon and Iraq could face a similar fate;
Iran is both unstable and dangerous to others; and Afghanistan and Pakistan look increasingly like failed states. In all of these cases, economic failure and a lack of
opportunities and hope for the poor and young are fuelling political and religious extremism, resentment of the west and, in some cases, outright terrorism. In the
1930s, the failure to prevent the Great Depression empowered authoritarian regimes in Europe and Asia, eventually leading to the second world war. This

time, the damage caused by the Great Recession is subjecting most advanced economies to secular
stagnation and creating major structural growth challenges for emerging markets. This is ideal terrain
for economic and political nationalism to take root and flourish. Today's backlash against trade and
globalisation should be viewed in the context of what, as we know from experience, could come next .

Causes war
Von Mises 10 “Ludwig, “Economic nationalism is a philosophy of war”, Ludwig von Mises was the
acknowledged leader of the Austrian School of economic thought, a prodigious originator in economic theory, and
a prolific author, https://mises.org/library/economic-nationalism-philosophy-war”

Popular opinion sees the source of the conflicts which bring about the civil wars and international
wars of our age in the collision of "economic" interests inherent in the market economy . Civil war is the rebellion
of the "exploited" masses against the "exploiting" classes. Foreign war is the revolt of the "have-not" nations against those nations who have appropriated to themselves an unfair share of the
earth's natural resources and, with insatiable greed, want to snatch even more of this wealth destined for the use of all. He who in face of these facts speaks of the harmony of the rightly
understood interests is either a moron or an infamous apologist of a manifestly unjust social order. No intelligent and honest man could fail to realize that there prevail today irreconcilable

conflicts of material interests which can be settled only by recourse to arms. It is certainly true that our age is full of conflicts which
generate war. However, these conflicts do not spring from the operation of the unhampered market
society. It may be permissible to call them economic conflicts because they concern that sphere of human life which is, in common speech, known as the sphere of economic activities.
But it is a serious blunder to infer from this appellation that the source of these conflicts are conditions which develop within the frame of a market society. It is not capitalism

that produces them, but precisely the anticapitalistic policies designed to check the functioning of
capitalism. They are an outgrowth of the various governments' interference with business, of trade
and migration barriers and discrimination against foreign labor, foreign products, and foreign capital.
None of these conflicts could have emerged in an unhampered market economy . Imagine a world in which everybody
were free to live and work as entrepreneur or as employee where he wanted and how he chose, and ask which of these conflicts could still exist. Imagine a world in which the principle of
private ownership of the means of production is fully realized, in which there are no institutions hindering the mobility of capital, labor, and commodities, in which the laws, the courts, and the
administrative officers do not discriminate against any individual or group of individuals, whether native or alien. Imagine a state of affairs in which governments are devoted exclusively to the
task of protecting the individual's life, health, and property against violent and fraudulent aggression. In such a world the frontiers are drawn on the maps, but they do not hinder anybody
from the pursuit of what he thinks will make him more prosperous. No individual is interested in the expansion of the size of his nation's territory, as he cannot derive any gain from such an
aggrandizement. Conquest does not pay and war becomes obsolete. In the ages preceding the rise of liberalism and the evolution of modern capitalism, people for the most part consumed
only what could be produced out of raw materials available in their own neighborhood. The development of the international division of labor has radically altered this state of affairs. Food
and raw materials imported from distant countries are articles of mass consumption. The most advanced European nations could do without these imports only at the price of a very
considerable lowering of their standard of living. They must pay for the badly needed purchase of minerals, lumber, oil, cereals, fat, coffee, tea, cocoa, fruit, wool, and cotton by exporting
manufactures, most of them processed out of imported raw materials. Their vital interests are hurt by the protectionist trade policies of the countries producing these primary products.
Imagine a world in which the principle of private ownership of the means of production is fully realized. In such a world, conquest does not pay and war becomes obsolete. Two hundred years
ago it was of little concern to the Swedes or the Swiss whether or not a non-European country was efficient in utilizing its natural resources. But today economic backwardness in a foreign
country, endowed by rich natural resources, hurts the interests of all those whose standard of living could be raised if a more appropriate mode of utilizing this natural wealth were adopted.

The principle of each nation's unrestricted sovereignty is in a world of government interference with
business a challenge to all other nations. The conflict between the have-nots and the haves is a real
conflict. But it is present only in a world in which any sovereign government is free to hurt the
interests of all peoples — its own included — by depriving the consumers of the advantages a better
exploitation of this country's resources would give them. It is not sovereignty as such that makes for war but sovereignty of governments not
entirely committed to the principles of the market economy. Liberalism did not and does not build its hopes upon abolition of the sovereignty of the various national governments, a venture
which would result in endless wars. It aims at a general recognition of the idea of economic freedom. If all peoples become liberal and conceive that economic freedom best serves their own
interests, national sovereignty will no longer engender conflict and war. What is needed to make peace durable is neither international treaties and covenants nor international tribunals and
organizations like the defunct League of Nations or its successor, the United Nations. If the principle of the market economy is universally accepted, such makeshifts are unnecessary; if it is not
accepted, they are futile. Durable peace can only be the outgrowth of a change in ideologies. As long as the peoples cling to the Montaigne dogma and think that they cannot prosper
economically except at the expense of other nations, peace will never be anything other than a period of preparation for the next war. Economic nationalism is incompatible with durable
 Yet economic nationalism is unavoidable where there is government interference with business.
peace.

Protectionism is indispensable where there is no domestic free trade. Where there is government
interference with business, free trade even in the short run would frustrate the aims sought by the
various interventionist measures. It is an illusion to believe that a nation would lastingly tolerate
other nations' policies which harm the vital interest of its own citizens . Let us assume that the United Nations had been
established in the year 1600 and that the Indian tribes of North America had been admitted as members of this organization. Then the sovereignty of these Indians would have been
recognized as inviolable. They would have been given the right to exclude all aliens from entering their territory and from exploiting its rich natural resources which they themselves did not
know how to utilize. Does anybody really believe that any international covenant or charter could have prevented the Europeans from invading these countries? Many of the richest deposits
of various mineral substances are located in areas whose inhabitants are too ignorant, too inert, or too dull to take advantage of the riches nature has bestowed upon them. If the
governments of these countries prevent aliens from exploiting these deposits, or if their conduct of public affairs is so arbitrary that no foreign investments are safe, serious harm is inflicted
upon all those foreign peoples whose material well-being could be improved by a more adequate utilization of the deposits concerned. It does not matter whether the policies of these
governments are the outcome of a general cultural backwardness or of the adoption of the now fashionable ideas of interventionism and economic nationalism. The result is the same in both

What generates war is the

cases. There is no use in conjuring away these conflicts by wishful thinking. What is needed to make peace durable is a change in ideologies.

economic philosophy almost universally espoused today by governments and political parties. As this
philosophy sees it, there prevail within the unhampered market economy irreconcilable conflicts
between the interests of various nations. Free trade harms a nation; it brings about impoverishment. It is the duty of government to prevent the evils of
free trade by trade barriers. We may, for the sake of argument, disregard the fact that protectionism also hurts the interests of the nations which resort to it. But there can be no doubt that
protectionism aims at damaging the interests of foreign peoples and really does damage them. It is an illusion to assume that those injured will tolerate other nations' protectionism if they

. The philosophy of protectionism is a philosophy of war. The

believe that they are strong enough to brush it away by the use of arms

wars of our age are not at variance with popular economic doctrines; they are, on the contrary, the
inescapable result of a consistent application of these doctrines . The League of Nations did not fail because its organization was
deficient. It failed because it lacked the spirit of genuine liberalism. It was a convention of governments imbued with the spirit of economic nationalism and entirely committed to the principles
of economic warfare. While the delegates indulged in mere academic talk about good will among the nations, the governments whom they represented inflicted a good deal of evil upon all
other nations. The two decades of the League's functioning were marked by each nation's adamant economic warfare against all other nations. The tariff protectionism of the years before
1914 was mild indeed when compared with what developed in the 1920s and '30s — viz., embargoes, quantitative trade control, foreign-exchange control, monetary devaluation, and so on.
The prospects for the United Nations are not better, but rather worse. Every nation looks upon imports, especially upon imports of manufactured goods, as upon a disaster. It is the avowed
goal of almost all countries to bar foreign manufactures as much as possible from access to their domestic markets. Almost all nations are fighting against the specter of an unfavorable balance
of trade. They do not want to cooperate; they want to protect themselves against the alleged dangers of cooperation.
 1AC---Plan
Plan: The Food and Drug Administration should substantially curtail surveillance of
employees suspected of being whistleblowers.
 1AC---Solvency
Electronic surveillance precludes whistleblowing
Johnson 12 [January 31, 2012 Reporter for Federal Times http://archive.federaltimes.com/article/20120131/IT03/201310302/FDA-
whistle-blowers-lawsuit-raises-questions-about-email-surveillance “FDA whistle-blowers' lawsuit raises questions about email surveillance”]
(Vaibhav)

The six filed a lawsuit Jan. 25 in U.S. District Court of Washington, claim that top
FDA managers monitored and seized emails
from their personal Gmail and Yahoo accounts for at least two years. Documents they obtained through the
Freedom of Information Act and other means show that FDA began monitoring electronic conversations in 2009 , after
the employees expressed concerns to the incoming Obama administration and Congress that FDA had approved unsafe medical devices,
Stephen Kohn, executive director of the National Whistleblowers Center and attorney for the six employees, said in an interview with Federal
Times. Until now, Kohn said he hadn't heard of agencies carrying out this type of surveillance. FDA's
electronic equipment policy
allows employees to use government devices and systems for personal use but warns that
information created, stored or transmitted on a government device is public information, unless
exempted by law. The policy also instructs office managers to monitor and review "all activities" using
government electronic equipment and disclose the content of inappropriate documents. "If they are
doing just basic monitoring to make sure people aren't violating the law," that's one thing, Kohn said. "The
biggest problem with what has occurred here is that they targeted whistleblowers." Targeted
monitoring, he said, could have a chilling effect on potential whistleblowers who fear their complaints
will not be kept confidential.
Pharma Advantage
 2AC---Ext. Corruption k2 Pharma
FDA corruption enables big Pharma to reap in huge profits
Collins 15 Sam P.K. Collins (Citing NYU researchers) is a health reporter for ThinkProgress, “Study Finds ‘Disturbing
Examples’ Of The FDA Failing To Disclose Scientific Fraud”, 2/11/15, http://thinkprogress.org/health/2015/02/11/3621855/fda-
transparency-study//OF

The communication issue that Steinbrook mentions may stem from “publication bias” — defined as
the tendency of researchers, editors, and pharmaceutical companies to tout the positive outcomes of
research while sweeping the negative findings under the rug. That could create an outcome that
advances their agenda , whether it’s securing a medication’s place on the market or telling a specific narrative about a health issue.
This issue is not new to the FDA , an agency that has long enjoyed a profitable relationship with
pharmaceutical companies. The passage of the Prescription User Drug Fee Act in 1992 sped up the
drug approval process using fees collected from Big Pharma companies . The increased workload caused
deficiencies within the federal agency’s drug approval process, including the manner in which
researchers conduct clinical trials. A 2005 report found that nearly 20 percent of authors in clinical drug trials
said they personally knew of lies made in research going back at least 10 years. In 2007, the agency attempted
to curb publication bias with the passage of the Food and Drug Administration Acts, which would require researchers to register clinical trials of
FDA-regulated products at ClinicalTrials.gov. The mandate, however, did little to compel researchers to fully disclose
the findings of their studies, positive or negative. A 2009 investigation published in Nature, an international weekly science
journal, found that fewer than half of studies published in peer-reviewed journals followed these guidelines. Of the clinical trials that complied
with the regulations, the findings of more than 50 percent of them didn’t make it into academic journals, mainly because investigators didn’t

think that the negative results would interest readers. Handling investigations into potentially faulty research in-
house often allows the FDA to keep the drugs in question on pharmacy shelves , even with no
additional evidence of their safety or efficacy. Such was the case in early 2010 when the federal agency zeroed in a Houston-
based pharmaceutical research firm that tested more than 100 drugs, including chemotherapy compounds and prescription painkillers. While
FDA officials determined more than 1,400 drug trials conducted within a span of five years to be tainted, industry officials remained reluctant to
issue recalls and retest the medication out of fear of “alarm[ing] the public and the providers for a large portion of drugs.” “If there are

problems with the scientific studies, as there have been in this case, then the FDA’s review of those problems needs to be
transparent ,” David Kessler, who sat at the helm of the FDA from 1990 to 1997, told ProPublica in 2013. “Putting its reviews in public view
would let the medical community understand the basis for the agency’s actions. The FDA may be right here, but if it wants public confidence,
they should be transparent. Otherwise it’s just a black box.” Whenever
the FDA actively investigates allegations of
researchers’ wrongdoing, investigators generate a host of documents — including 483 Forms, Establishment
Inspection Reports, and Warning Letters — that often leave observers asking more questions. The edits of key portions of
the documents can make it difficult for those who read them to decipher the name and sponsor of the study, the drug involved in the clinical
trial, and the effect of the misconduct on the reliability of the results. Earlier this week, Charles Seife, lead author of the new JAMA study,
described his attempt to gather data from 600 FDA clinical trial investigation documents in an article published on Slate. He said that his team
of university students ultimately found the information they sought in less than 100 reports. In the piece, Seife calls on the FDA to stop
protecting drug companies and excusing the actions of those who manufacture scientific findings, saying that the agency has lost the public
trust by putting patients at risk. “The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are

proven safe and effective by reputable scientific trials,” Seife writes. “Yet, over and over again, the agency has proven itself
willing to keep scientists, doctors, and the public in the dark about incidents when those scientific
trials turn out to be less than reputable . It does so not only by passive silence, but by active deception. It’s a sign that
the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s
supposed to regulate.”
FDA corruption is used to profit big pharmaceutical companies
Fauber and Fiore 15 John Fauber is a reporter with the Journal Sentinel, and Kristina Fiore is a reporter with MedPage
Today, “Opana gets FDA approval despite history of abuse, limited effectiveness in trials”, 4/9/2015,
http://www.jsonline.com/watchdog/watchdogreports/opana-gets-fda-approval-despite-history-of-abuse-limited-effectiveness-
in-trials-b99494132z1-303198321.html//OF

In 2006, in the midst of a growing national opioid epidemic, the U.S. Food and Drug Administration
approved the new narcotic painkiller Opana. It was a familiar drug. Known generically as oxymorphone, the
drug is 10 times as potent as morphine when injected. Under the name Numorphan, it had been abused in the 1960s and
'70s until it was removed from the market. And now there is a familiar problem. After initially approving Opana as both an
immediate-release and extended-release product, the FDA in December 2011 approved a formulation designed to
prevent abuse by making the drug tough to crush or dissolve. But users have been able to foil the anti-
injection mechanism and have continued to shoot up Opana. In addition to overdose risk, the abuse of Opana
by injection has been associated with a blood-clotting disorder and permanent organ damage — a
problem that didn't occur with the earlier version. And it has been tied to a recent outbreak of HIV in rural Indiana as well as a surge in hepatitis
C infections in Kentucky, Tennessee, West Virginia and Virginia. When the FDA approved Opana, manufactured by Endo Pharmaceuticals, the
drug joined more than a dozen other narcotic painkillers on the market. "There certainly didn't seem to be a need for it,"
said James Roberts, a professor of emergency medicine at Drexel University College of Medicine in Philadelphia. "There
are plenty of narcotics around for pain relief." As Numorphan, the drug's popularity among addicts was due to its quick
and sustained effect, according to the 1974 report "Drugs and Addict Lifestyle" by the National Institute on Drug Abuse. The report said
the drug — which carried the street name "blues" — was used primarily by white males. The report focused on 309 Philadelphia-area
Numorphan addicts who were interviewed in 1970, with many saying they preferred the drug over heroin. The drug was taken off the market in
1979. Asked about the basis for approving Opana, FDA spokesman Eric Pahon said opioids are important medications for the treatment of pain,
when used properly. "The FDA is concerned about the misuse and abuse of prescription opioids, which is a serious public health challenge, and
is working in many ways to help prescribers and patients make the best possible choices about how to use these powerful drugs," he wrote in
an email. "We must balance this effort, however, with ensuring prescribers and patients maintain access to these medications and a variety of
treatment options are available." The extended release version of Opana alone generated 756,000 prescriptions and sales of $385 million in
2013, according to data supplied by IMS Health, a drug market research firm. Since 2009, its annual sales have ranged from $246 million to
$640 million. In an email, Endo spokeswoman Heather Zoumas-Lubeski said the drug "was approved by the FDA based upon its demonstration
of safety and effectiveness in clinical trials and its successful submission of an application for approval." Drug's reappearance A Milwaukee

Journal Sentinel/MedPage Today examination found oxymorphone's reappearance on the market followed a pattern
identified in past investigations, including cozy relationships between regulators and drug company
executives and the use of questionable clinical testing methods allowed by the FDA. Endo
Pharmaceuticals was a frequent participant at meetings of an organization funded by pain drug
companies that brought together pharmaceutical executives and federal regulators during the 2000s, records show. The group, known as
IMMPACT, was the subject of a 2013 Journal Sentinel/MedPage Today investigation. That investigation examined how federal
health industry officials, members of academia and executives of companies that make pain drugs
held private meetings at expensive hotels at least once a year beginning in 2002 , according to emails obtained
through a public records request. Each year, a handful of drug companies paid up to $35,000 each to send a
representative to the meetings, where they could discuss clinical trial design with FDA officials. In 2014,
two U.S. senators wrote to the medical school dean at the University of Rochester demanding financial records related to the IMMPACT
meetings. A researcher at the school was a co-founder of the group. Sens. Joe Manchin (D-W.Va.) and David Vitter (R-La.) wrote that they were
"deeply troubled by allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars to the
University of Rochester Medical Center for the privilege to attend private meetings with FDA officials." Pahon, the FDA spokesman, said it is
misleading to describe the sessions as private meetings between FDA officials and members of industry. Though the meetings were invitation
only, he said, they were attended by a variety of government officials, academics and pain advocates. "These were large scientific meetings at
which the outside experts almost always outnumbered the attending companies," he said. "We are not aware of any separate, private meetings
between FDA and pharmaceutical companies during or as a result of IMMPACT meetings." He said the meetings had no bearing on the approval
of Opana and did not include the discussion of any particular product or the standards for FDA approval of pain products. 'Enriched enrollment'
Those meetings did help lead to a new approach to winning approval of drugs known as "enriched
enrollment." The approach, which is faster and less expensive for drug-makers , allows companies to weed out people
who don't respond well to a drug or who can't tolerate taking it before an actual clinical trial for the drug begins. Independent doctors say
that approach makes it much more likely a drug will be found effective and win FDA approval. More importantly,
experts say, drugs tested that way are not likely to reflect what will happen when a medication gets on
the market and is prescribed for large numbers of people. When Endo first tried to get Opana
approved in 2003, the FDA said the drug didn't appear effective enough in clinical trials. It also raised safety
concerns after several postoperative pain patients overdosed on the drug. So Endo conducted new clinical trials using
enriched enrollment. In those trials, only the patients who initially responded to the drug were entered into the trial, where they were
given either Opana or a placebo. The idea was that the drug's effects can be clearly demonstrated in comparison to a placebo, because it is
already known to work for these patients. Pahon of the FDA said companies use a variety of strategies to select those in the general population
in which the effect of a drug can be more shown. He would not say whether the FDA encouraged Endo to use the enriched enrollment
approach for Opana. When the drug was approved in 2006, the FDA's own medical review acknowledged that, given the enriched study design,
"one could argue that the results may not be generalizable to the wider chronic pain population."
Opana is not the only opioid approved using enriched enrollment. In 2013, drug-maker Zogenix used
the strategy to win approval for Zohydro, a high-dose, hydrocodone-only drug that was originally
approved without any abuse-deterrent mechanisms. The FDA approved that drug despite its own
advisory committee voting 11-2 against it . "The FDA should be in the business of requiring high-
quality evidence and not shortcut evidence," said Lewis Nelson, a medical toxicologist at NYU Langone Medical Center.
"Unfortunately, they're under pressure to make pharmaceuticals available to the general public ."

Corruption fuels big pharma

Loudon and Graham 12 Interview between Dr. David Graham (senior drug safety researcher at the FDA), and
Manette Loudon, the lead investigator for Dr. Gary Null, “The FDA Exposed: An Interview With Dr. David Graham, the Vioxx®
Whistleblower”, October 2012, http://www.lef.org/Magazine/2012/10/The-FDA-Exposed-An-Interview-With-Dr-David-
Graham/Page-01//OF

MANETTE: In that same PBS program, you were also quoted saying, "The organizational structure within the CDER is
currently geared towards the review and approval of new drugs. When a serious safety issue arises at
post marketing, the immediate reaction is almost always one of denial, rejection and heat. They
approved the drugs, so there can't possibly be anything wrong with it. This is an inherent conflict of
interest." Based on what you're saying it appears that the FDA is responsible for protecting the interests of pharmaceutical companies and
not the American people. Do you believe the FDA can protect the public from dangerous drugs? DR. GRAHAM: As currently configured, the

FDA is not able to adequately protect the American public. It's more interested in protecting the
interests of industry. It views industry as its client, and the client is someone whose interest you
represent. Unfortunately, that is the way the FDA is currently structured. Within the Center for Drug Evaluation and Research about 80
percent of the resources are geared towards the approval of new drugs and 20 percent is for
everything else. Drug safety is about five percent. The "gorilla in the living room" is new drugs and approval. Congress has not
only created that structure, they have also worsened that structure through the PDUFA, the
Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review
and approve its drug. So you have that conflict as well. MANETTE: When did that go into effect? DR. GRAHAM: The
Prescription Drug User Fee Act came into play in 1992. It was passed by Congress as a way of providing the FDA with more funds so that it could
hire more physicians and other scientists to review drug applications so that drugs would be approved more quickly. For industry, every day a

drug is held up from being marketed, represents a loss of one to two million dollars of profit. The incentive is to review and
approve the drugs as quickly as possible, and not stand in the way of profit-making. The FDA cooperates
with that mandate. MANETTE: And what about those new drugs? Are they any better than what already exists on the market? DR. GRAHAM:
It's a myth that is promulgated not only by industry but also by the FDA itself. It's a misperception that our lawmakers in Congress have as well
and they've been fed this line by industry. Industry is saying there are all these lifesaving drugs that the FDA is
slow to approve and people are dying in the streets because of it. The fact is that probably about two-
thirds to three-quarters of the drugs that the FDA reviews are already on the market and are being
reviewed for another indication. So, for example, if I've got a drug that can treat bronchitis and now it's going to be used to treat a
urinary tract infection well, that's a new indication. But it's the same drug and we already know about the safety of the drug. There is
nothing lifesaving there. There is nothing new. There is nothing innovative . A very small proportion of
drugs represent a new drug that hasn't been marketed before. Most of those drugs are no better than the ones that
exist. If you want to talk about breakthrough drugs - the ones that really make a difference in patients' lives
and represent a revolution in pharmacology - we're talking about maybe one or two drugs a year . Most
of them aren't breakthroughs and most of them aren't lifesaving, but they get treated as if they were.
**TPP Scenario**
 2AC---Ext. Pharma TPP Kills Generics
Big pharma’s version of the TPP decimates the generic drug industry---stricter
protections for biologics
Overly 15 (Jeff, Law360, 7/17/15, “Big Pharma's TPP Protections For Biologics Face New Attacks”,
http://www.law360.com/articles/680522/big-pharma-s-tpp-protections-for-biologics-face-new-attacks,
Accessed 7/22/15)//LD

Law360, New York (July 17, 2015, 4:37 PM ET) -- A group of lawmakers, generic-drug industry advocates and public health experts on Friday
denounced proposals in the Trans-Pacific Partnership to strengthen exclusivity protections for brand-
name biologics, warning that the provisions would seriously harm access to affordable copycat
medicines. The objections were voiced in a media briefing with Democratic Reps. Jan Schakowsky of Illinois and Rosa DeLauro of Connecticut as well as
representatives of Mylan Inc., AARP, Doctors Without Borders and the American Foundation for AIDS Research. The briefing represented a marked contrast with
advocacy from Republicans who’ve steadfastly supported robust TPP protections for biologics, which have shown great potential to fulfill unmet medical needs. At

issue are draft provisions of the TPP that would expand monopoly power for branded biologics, in
part by extending the 12 years of U.S. market exclusivity to the other 11 countries that are parties to
the deal. Those parties instead prefer biologics exclusivity ranging from zero to eight years. If the 12-year standard goes through, it would weaken biosimilars
overseas and effectively doom Democratic efforts to dial back the 12-year standard domestically. “ This is a bad deal for people around the

world who are fighting disease and [for people] here at home as well ,” said Schakowsky, ranking member on the trade
panel of the House Energy and Commerce Committee. Other concerns relate to the TPP’s proposed system of so-called patent linkage, which refers to generic-drug
approval depending on the existence of valid patents for a branded product. Critics say the draft TPP would introduce a much
stricter form of patent linkage for biologics than currently exists in the TPP countries, making it all but
impossible for biosimilars to get around hundreds of patents that can cover biologics . “In the TPP, the U.S.
government is asking for all the countries to block generic approval without a single safeguard that we
use at home,” Nawel Rojkjaer, Mylan’s senior director of international affairs, told reporters. Speakers on Friday also warned that the TPP will be
used as a template for future trade agreements, meaning that any agreements on intellectual
property protections could eventually spread to many more nations . Such expansion would be
particularly significant in the context of pricey biologics that can strain the budgets of advanced
economies and be unattainable for developing nations unless steep discounts are offered . Rohit Malpani,
a policy director at Doctors Without Borders, labeled the draft provisions “life-threatening” and
asserted that they amount to “wholesale rejection by the U.S. government of its commitment to
ensuring access to affordable medicines in developing countries.” One of the most curious aspects of the proposals is that
they are emerging from a Democratic White House that has been consistently critical of the U.S. market protections afforded to biologics. Clouding

matters further is the fact that TPP negotiations are conducted in secret, forcing the public to rely on
leaked documents and barring lawmakers from providing clear updates on talks . Schakowsky on Friday only offered
vague descriptions of how the biologic exclusivity provisions have evolved, saying that “there have been a number of changes ... but none have sufficiently
addressed the problems." The TPP patent provisions have been quietly discussed behind the scenes for some time. For example, public disclosures by the
Biotechnology Industry Organization describe tens of thousands of dollars in quarterly payments to Akin Gump Strauss Hauer & Feld LLP for lobbying on TPP patent
protections going back to at least 2011. A
key meeting among TPP trade ministers is set for July 28-31 in Maui,
Hawaii, to iron out remaining wrinkles in the deal, meaning that the years of closed-door jockeying on biologics could be
coming to a head.
 2AC---AT: Generics Bad
Generics are good - alleviates unfair medicinal distribution and doesn’t harm the
pharmaceutical industry
Harrelson 1 (John, “TRIPS, Pharmaceutical Patents, and the HIV/AIDS Crisis: Finding the Proper
Balance between Intellectual Property Rights and Compassion”,
http://heinonline.org/HOL/LandingPage?handle=hein.journals/wlsj7&div=12&id=&page=)
One reason cited for the high cost of HTV treatment is that the cost of bringing a drug from idea, through development, testing and approval to
market is about $500 million.'" Shannon S.S. Herzteld, senior vice president of international affairs at Pharmaceutical Research and
Manufacturers of America (PhRMA) states " '[f]or every 15,000 compounds that you look at, three become medicines. Of those three, one
makes a profit. . .The International Federation of Pharmaceutical Manufacturers Association (IFPMA), representing research-based
pharmaceutical companies in over fifty countries, argues that compulsory licensing only benefits the company receiving the license.1" IFPMA
further argues that granting an adequate period of exclusive rights is the only way to promote innovation.1SS Without innovation, patients will
suffer from lack of new treatments in the future.'56 A second argument against compulsory licensing, is that it leads to
drugs of lower quality.'5 This argument, however, is not persuasive because drug quality does not directly
correlate with compulsory licensing.15* Industry standards in the country granting the compulsory license would
be responsible for the manufacturing quality.159 Despite the opposition of the pharmaceutical industry to compulsory
licensing, many developing countries have traditionally avoided the high costs of drugs by developing
generic equivalents.'60 Compulsory licensing can decrease the cost of pharmaceutical drugs by seventy-five
percent or more.'61 For example, in India, one can obtain a two dollar generic form of Pfizer's patented fluconazole,
an AIDS related meningitis drug, that originally cost seventeen dollars.162 An argument in favor of allowing
compulsory licensing is that compulsory licensing will promote increased sales that will offset lower prices .'" As a
result of the increased sales, if a reasonable license fee is granted, pharmaceutical companies will not be significantly
harmed Furthermore, developing countries account for only ten percent of pharmaceutical profits
internationally, with Africa accounting for only 1.6%.163 Therefore, compulsory Licensing in these countries will not
impact the ability of pharmaceutical companies to make sufficient profits to support research and
development.166 The United States has been accused of being hypocritical in its opposition to compulsory licensing.'67 The United States has
required compulsory licensing to the military on satellite technology and night-vision glasses for public interest reasons.163 Several United
States statutes provide for compulsory licensing. For example, the United States government can issue a compulsory license for air pollution
control patents,'69 for nuclear power paten ts,,7n for public health related patents,171 and for items needed for government use.'72

India proves generics are a huge success and key to spurring medicinal development
Lanoszka 3 (Ana, International Political Science Review, “The Global Politics of Intellectual Property
Rights and Pharmaceutical Drug Policies in Developing Countries”, http://www.jstor.org.turing.library.
northwestern.edu/stable/1601639)

India has argued within the WTO that compulsory licensing is perfectly justified with respect to pharmaceutical
inventions because the public interest should prevail when it comes to assuring the supply of life-saving
medicines. Compulsory licensing can create a strong domestic generic drug industry and is generally
associated with greater competition and lower consumer prices. It can also lead to a necessary transfer of
technology to less developed countries. Prior to the global consolidation of the pharmaceutical industry in the past decade,
compulsory licenses had been routinely used in North America and Europe to facilitate the distribution
of new (generic or not) medications. The use of generic medicines, in turn, has resulted in important economies for the
public healthcare system, thereby contributing to its viability and the protection of public health . The World
Health Organization (WHO) has endorsed the legitimacy of measures to promote the use of generic drugs as a
means of protecting public health. In its resolution of the Revised Drug Strategy, the WHO (1999) encourages its members "to
explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs."

Current Pharmaceutical Prices prohibit developing countries from accessing medicine.

Pecoul et al 99 (Benard, Pierre Chirac, Patrice Trouiller, Jacques Pinel, “Access to Essential Drugs in
Poor Countries A Lost Battle?”

Increasingly Prohibitive Prices? A

study sponsored by US pharmaceutical companies shows that granting drug
patents does not tend to increase the price of drugs on the marke t.30 This study, however, does not examine
the prices of new innovative drugs and declares that, logically, the price of these new drugs should be
higher. Naturally, when the manufacturing company is assured that its product cannot be copied, it holds a stronger position to negotiate
prices with public health authorities. Moreover, the liberalization of international pharmaceutical trade entails the development of parallel
imports between countries where the same drug is sold at different prices. Pharmaceutical
companies, which are
consequently less inclined to grant significantly lower prices to less developed countries, may instead set
unique world- wide prices or delay marketing their drugs in developing countries.28 In either case, access to
drugs is jeopardized. WHO's Revised Drug Strategy and the essential drugs concept are still key strategies to help
improve access to essential drugs and worldwide health. The essential drugs concept is evidence based, is simple,
promotes equity, and is rooted in firm public health principles. WHO's assistance to countries and advocacy work to promote the essential
drugs concept and support countries in the formulation and implementation of national drug policies has resulted in change for the better. This
strategy is a proven success but it needs to be continued and strengthened, and new ways of implementation have to be explored, given the
changing context. In this spirit, the
following recommendations are made with respect to the 4 main issues that
have been developed in this article. Procurement of Quality Drugs To improve the quality of existing
drugs and their procurement, it is important to develop a permanent "Observatory of Drug Quality," established by WHO in collaboration
with organizations involved in the provision of essential drugs (eg, UNICEF, World Bank, the European Union, and nongovernmental
organizations), that would oversee the implementation of adequate and effective control procedures. The practical knowledge acquired by
international organizations to ensure the quality of generic drugs must be shared with health authorities in developing countries. Invitations to
bid, required by big sponsors such as the World Bank, European Union, and the US Agency for International Development, must combine
quality criteria and lower costs. Furthermore, procurement
of drugs should be centralized at a national level to rein-
force the responsibility of governments to make procurement, quality control, stock management, and
distribution of essential drugs a priority.

Empirics prove IPR doesn’t spur investment and hurts domestic growth of
pharmaceuticals
Scherer 2k (F.M., “Taking Stock: The Law and Economics of Intellectual Property Rights: The Pharmaceutical Industry and
World Intellectual Property Standards”, http://www.lexisnexis.com.turing.library.northwestern.edu/hottopics/lnacademic/?
verb=sr&csi=7362&sr=AUTHOR(Scherer)%2BAND%2BTITLE(TAKING+STOCK
%3A+THE+LAW+AND+ECONOMICS+OF+INTELLECTUAL+PROPERTY+RIGHTS
%3A+The+Pharmaceutical+Industry+and+World+Intellectual+Property+Standards)%2BAND%2BDATE%2BIS%2B2000)

Evidence on the first of these possibilities is provided by the experience of Italy. During the 1950s and 1960s, Italy did not grant drug
product patents. A thriving "knock-off" drug industry emerged , selling drugs at bargain prices in the home market and
becoming the world's leading exporter of new drugs to other nations that also denied patent protection to drug products. n10 During the
1970s, however, multinational enterprises challenged the Italian law, and in 1978, the Italian Supreme Court ruled that
the law denying drug product patents was unconstitutional. It ordered that the law be amended and that the Italian
authorities begin accepting drug patent applications immediately . Analyses of events during the decade
that followed yield three principal conclusions: (1) no significant increase in Italian drug R&D
expenditures relative to world trends; (2) no significant increase in the number of new drug entities
introduced by Italian firms; and (3) a sharp deterioration of the Italian trade balance in drugs into the
negative realm as export sales faltered and multinational firms imported many of their products into
Italy from elsewhere in Europe. In addition, numerous Italian drug manufacturers were acquired by multinational
firms seeking to strengthen their foothold in the Italian market. It is unclear why Italy failed to make the transition from drug imitator to drug
innovator. It may be that a decade is too short a time to do so, or price controls may have impaired domestic market incentives for the
development of pioneering drugs. Also, Italy lacked the university research infrastructure and cooperative university-industry relationships
needed to nourish drug innovation. What is clear is that leadership in the production and export of knock-off drugs to nations lacking product
patent protection shifted to India. There is little evidence on the second possibility--an increase in the targeting of drug development efforts
toward low-income nations' health problems by multinational drug companies. An early investigation of this possibility and also the hypothesis
that the
anticipation of domestic future product patent protection [*2251] stimulated Indian
manufacturers' new drug discovery efforts up to 1997 yielded equivocal finding s. n11 What some multinational
drug companies have done is to donate already developed drugs such as Zithromax (effective against trachoma blindness), Ivermectin (effective
against river blindness), and Albendazole (effective against lymphatic filariasis parasites) to especially poor nations with a high incidence of such
diseases. n12 Four pharmaceutical companies led the list of U.S. corporations, ranked by the total amount of money devoted to philanthropic
giving in 1998.

IPR kill Pharmaceutical Industry Innovation

Glasgow 1 (Lara J, “Stretching the Limtis of Intellectual Property Rights: Has the Pharmaceutical
Industry Gone Too Far”, http://www.heinonline.org.turing.library.northwestern.edu /HOL/Page?
handle=hein.journals/idea41&id=239&collection=journals&index=journals/idea#244)

One of the primary justifications advanced by intellectual property law proponents for asset protection is the
incentive such protection provides inventors to invest in risky or otherwise costly endeavors necessary
to create innovative works that may contribute to the public good. An examination of the findings presented in this article,
however, suggests that this justification is not being met when dealing with the pharmaceutical industry.
The risk inherent in bringing brand name drugs to market cannot be used to validate the strong intellectual
property protection that has been described in the present article. "The top 10 drug companies are reported to spend on average about
20 percent of their revenues on research and development.*"" These companies have "so many drugs in the pipeline at any given time that
they can count on being able to bring a certain number of drugs to market regularly."'*' To illustrate just how financially sound the drug
business actually is, consider the research and development costs of the large drug companies relative to their profits. The top ten drug
companies report profits averaging 30% of their revenues—a substantial margin.1** "[l]n 1999, the pharmaceutical industry realized on
average an 18.6 percent return on revenues," which exceeds that of commercial banking (15.8%)."* These profits are over and above the
considerable governmental assistance available from the National Institutes of Health (NIH) that subsidize much of the early pre-clinical
research, as well as favorable tax treatment that enables a rate of 16.2%."' It is difficult, therefore, to characterize an industry that is
consistently the most profitable industry in the United States as risky.Despite low risks, the American drug industry fails to
achieve true innovation. While the benefits enjoyed by consumers for the hundreds of recently launched drugs cannot be
underestimated, it is difficult to reconcile the observation that many other new drugs add little to the
therapeutic arsenal except expense and confusion for consumers. Recall the layering of patents that are secured on several
elements of a blockbuster drug so as to preserve its monopoly power and profit potential; or the cleaning up of old drugs in order to secure a
new patent on what is essentially a minimal variation on the old version. The surplus of "me-too" drugs additionally
exemplifies the dearth of innovation in the drug industry. For instance, there are currently several effective drugs to treat
high cholesterol, yet each one varies modestly in terms of therapeutic benefit. To make a profitable cholesterol drug, a company need only
synthesize a chemical derivative of a preexisting blockbuster drug that is sufficiently capable of meeting the requirements of patentability.
With some extensive marketing, the new drug can then return revenues to the maker with minimal
research and development costs. Thus, instead of expending funds on research and development for
drugs that treat ailments not yet treatable , many drug companies attempt to focus on developing
patentable5 distinct derivatives of preexisting drugs. The American drug industry cannot be cited as the
world leader in pharmaceutical innovation. "The United States accounts for 36 percent of global pharmaceutical research and
development.""1 "Europe accounts for 37 percent and Japan for 19 percent."'" Many other countries contribute significantly to the research
and development of new drugs, many operating under government regulations that provide far less protection for individual intellectual
property rights. The evidence suggests that the extension of patent rights over the past decad e, due to
exploitation of various legislative loopholes and clever patent applications, does little to stimulate the research and
development of new therapies
**India Scenario**
 2AC---AT: Indian Pharma Resilient
Now is key---Modi is softening hardline India’s hardline on IPR---recent pact proves
Kaushik 2/15 (Preetam, Mumbai Correspondent, SwissInfo, 2/15/15, “Is the tide against Big Pharma
in India turning?”, https://www.swissinfo.ch/eng/is-the-tide-against-big-pharma-in-india-
turning-/41271018, Accessed 7/28/15)//LD

A recent ruling by the Delhi High Court in favour of Novartis’ patent on the respiratory drug Onbrez
could be more than a temporary victory for Big Pharma in its war in India to protect intellectual property. In January the court barred Cipla
from making or selling a cheaper copy of Onbrez, citing infringement of patents held by the Swiss company. The decision lends support to a growing

belief among industry analysts that the government of Narendra Modi is slowly distancing itself from
an approach to make blockbuster drugs available to poor patients at a tiny fraction of the price at
which they are sold in the west. This is accomplished using the following approach: give Western pharma firms only ‘limited’ patent protection for their drugs in
India and make it very difficult for them to receive a patent for enhanced versions of patented medicines. Big Pharma want to protect their patents arguing that the hefty price tag of their
drugs is justified by the high costs involved in research and development. “Generic firms such as Cipla do not make such investments and are hence able to offer drugs at lower prices,” a
Novartis spokesperson said in response to the Delhi court decision. However, analyst Rahul Dev from Tech Corp Legal cautions that, when regarded from a neutral standpoint, the ruling is
“totally in line with existing laws, rules and judicial precedents. For example, the Indian patents act provides provisions for revocation of patent rights in case such rights are against public

Perhaps more indicative of the tide turning in favour of Big Pharma is a recent
interest”. (Keystone) BIG PHARMA US pact

pact signed by Modi during his visit to the United States , where he agreed to set up a bilateral working
group on intellectual property as part of the Trade Policy Forum . This was a sign that India is ready to allow the
US a role in its decisions on intellectual property, including those for drugs . “It indicates that the US has
managed to get the Modi government to provide it with a forum from which to pressure India to
adopt tougher patent protection measures,” said Raghuram Selvaraju, managing director and senior healthcare analyst at New York-based MLV & Co’s
Equity Research department. According to Selvaraju, the recent decision by the Indian government to revoke the price

controlling powers of the National Pharmaceutical Pricing Authority (NPPA) is yet a clearer indication that
the Modi government is more than ready to lessen its hostility towards mutinational pharmaceutical
companies. In July 2014, the Indian government capped the prices of 108 medicines, in addition to the 348 drugs that were brought under the essential list of medicines following the
Drug Price Control Order in 2012. However, only two months later, the government instructed the NPPA to revoke the guidelines that gave it the power to fix prices of drugs that are not on

this would seem to be an

the national list of essential medicines. “If the government is removing the ability of regulators to control the prices of essential medicines,

indication that the Modi administration is bowing to external pressures to make life easier for
Western pharmaceutical companies,” said Selvaraju. Fierce fight Big Pharma’s fight for protecting patent rights has
been particularly fierce in India - characterised by the world’s biggest generics industry, adolescent
patent laws, growing demand for medicines and an inability to pay for them - than anywhere else .
(Reuters) A HEALTHY BALANCE? 2 Sci & Tech Business For more than three decades, India refused to recognise pharmaceutical

patents, allowing domestic firms to copy medicines to make them cheap. However, after the country joined the World Trade Organization (WTO) in 1995, it had to change its patent
policy. But the patent law it launched in 2005 denies ‘evergreening’ - making minor alterations to existing drugs to secure a new patent. The country’s patent system

also has a provision for ‘compulsory licensing’ under which the government can force a firm to license
a patented drug to a generic company under a WTO pact. “Indian patent law looks similar to Western law, except for the provision that the Indian government
can amend it on a case-by-case basis to enable ‘access to lifesaving medicines’ for those who would not be able to get access to such medications if they are allowed to be priced as brand-
name products,” explains Selvaraju. While one section of the amended Indian Patents Act allows drug companies to obtain product patents for new medicines, another permits only
breakthrough innovations and bars new use of known drugs. Swiss firms including Novartis and Roche have had a tough time in India. Since 2006, Novartis has been fighting to win a patent for
the enhanced form of Glivec. It lost the fight to protect the patent for the major cancer drug in the Supreme Court in 2013. Legal battles In the case of Roche, it lost a courtroom battle to Cipla
for its blockbuster lung cancer drug Tarceva. The court ruled that Cipla’s generic Erlocip did not violate Roche’s patent. In addition to Novartis and Roche, German pharma giant Bayer AG and

US firm Gilead Sciences have also been entangled in legal war over patented drugs. Big Pharma are willing to put up the fight in India and
other developing nations where demand for life-saving drugs is surging . Rising incomes and rates of chronic disease may push
drug sales in India from $12 billion in 2010 to $74 billion in 2020, according to consulting firm PwC. Nearly three quarters of the sales are expected to come from generic drugs. Going

by the court ruling against Cipla, revoking of price caps on non-essential drugs and the decision to set up a patent working group with the US, there is
ample reasons for Big Pharma to believe that the Indian government will be a less fierce foe in their
struggle for patent protection.
 2AC---Ext. Wrecks Indian Pharma
Big Pharma locks out the Indian medical industry---specifically generics
Carter 13 (Zach, senior political economy writer for Huffington Post, “Obama Administration, Congress
Intensify Opposition To Global Generic Drug Industry”,
http://www.huffingtonpost.com/2013/06/28/obama-generic-drugs_n_3513011.html)

The Obama administration and members of Congress are pressing India to curb its generic medication
industry. The move comes at the behest of U.S. pharmaceutical companies, which have drowned out
warnings from public health experts that inexpensive drugs from India are essential to providing life-
saving treatments around the world. Low-cost generics from India have dramatically lowered medical
costs in developing countries and proved critical to global AIDS relief programs ; about 98 percent of the drugs
purchased by President George W. Bush's landmark PEPFAR AIDS relief program are generics from India. Before Indian companies rolled out
generic versions priced at $1 a day, AIDS medication cost about $10,000 per person per year. But
India's generic industry has also
cut into profits for Pfizer and other U.S. and European drug companies. In response, these companies
have sought to impose aggressive patenting and intellectual property standards in India, measures
that would grant the firms monopoly pricing power over new drugs and lock out generics producers .
 2AC---Ext. India k2 Generics
India is key to producing generics – the American model is too focused on IPR
Kumar, writer for Pakistani newspaper The Dawn, 2/17/2014
(Anand, “US concerns about Indian generic drugs,” http://www.dawn.com/news/1087496)

THOUGH India is one of the largest exporters of generic drugs to the US , ties between the two nations
are often tetchy over issues relating to protection of patents and intellectual property rights and the quality of drugs that are
manufactured in India. A major crisis is currently brewing between the two countries over the issue, with the bipartisan US International Trade
Commission (USITC) launching an investigation – backed by both the US Senate finance committee and the House of Representatives’ ways and
means committee – on ‘Trade, investment and industrial policies in India: effects on the US economy.’ And later this month, the US Trade
Representative (USTR) will also start hearings as a prelude to its ‘Special 301 report,’ reviewing IPR rules and practices by America’s trade
partners. Trade bodies, activists and other organisations both from the US and India have begun lobbying for or against the Indian
pharmaceutical industry. The US Chamber of Commerce, for instance, has demanded that the USTR classify India
as a ‘Priority Foreign Country,’ which is a label generally given to the worst intellectual property
offenders and which could result in trade sanctions . “We highlight India as a country with particular challenges with
respect to intellectual property protections,” the global intellectual property center of the chamber told the bipartisan commission. “Because
India has not shown a record of engagement on these issues and the environment has deteriorated significantly since last year, we are now
recommending that India be designated a Priority Foreign Country.” Last year, India
annoyed the international pharmaceutical
industry and several western governments when it denied patents to cancer drugs Glivec (by Novartis) and Nexavar
(Bayer) and allowed domestic producers to churn out generic versions of these expensive drugs. Even the Indian
Supreme Court dismissed the plea by Novartis for patent protection of its blood cancer drug. The Indian Patent Office also gave a compulsory
licence allowing a domestic firm to make Nexavar, Bayer’s advanced kidney cancer drug by paying a revised royalty of seven per cent.
Organisations that are testifying against India include the Alliance for Fair Trade with India, the National Association of Manufacturers, the
International Intellectual Property Alliance, Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry
Organisation. But non-profits including Public Citizen and Doctors without Borders, besides a few academics are backing India. “Recently, some
pharmaceutical industry groups have criticised India’s patent rules and practices,” Peter Mayburdak of Public Citizen, told the commission. “But
India’s practice complies with the WTO’s agreement on trade-related intellectual property rights.” Representatives
from the Confederation of Indian Industry, the Indian Pharmaceutical Alliance (IPA), the US-India Business Council and others are defending
India’s IPR and patent regime at the hearings. According to the submission by the IPA, after India implemented the TRIPS agreement in 2005,
over 1,500 patents have been granted to nine leading international pharma firms, for products and compositions and for manufacturing
processes. “When the innovator pharmaceutical industry talks of ‘denial’ of patents, it is not talking of
patents for medicinal products in general , but actually of second or third patents for the same
product,” it said.
 2AC---Ext. India k2 Global Health
Indian pharma leadership key to global health.
Neelakantan 8/21—consejero general global de Cipla Limited
(Murali, “Indian Pharmaceutical Industry: Affordable Access to Healthcare for all”, http://abcmundial.com/en/news/brics/technology/3838-
indian-pharmaceutical-industry-affordable-access-healthcare-all/, dml)

The story of the Indian pharma sector could well have been like the IT sector if only enough attention was
paid to its achievements and the huge impact it has had on healthcare around the world. Unlike other
manufacturing or heavy industries in India, the pharma sector is innovative, widely acknowledged as

making a global impact in the treatment of diseases like HIV AIDS [1] and also able to support the
healthcare needs of the world[2]. The fact that Indian factories are licensed to produce 3,685 drugs compared with 3,815 made
within the UK suggests that Indian factories meet global quality standards and are able to produce complex drugs.[3] While news of regulators
visiting Indian manufacturing facilities and finding fault with processes is widely reported, very little is said about how routine this is. Gerald
Heddell, director of inspections, enforcement and standards at the MHRA, stressed that the number of problems identified by regulators in
India was in proportion to the volume of medicines they produced. “When we look back over 110 inspections we conducted over the last two
years in India, we had significant concerns with 9 or 10 companies,” he said. “That does not represent a statistically higher proportion than in
other parts of the world. India stands out because it is just such a big supplier.”[4] The Indian pharma Industry
produces about 20% [5] of the global generic drugs with the US accounting for nearly 28 per cent of
Indian pharmaceutical exports[6], followed by the European Union at 18 per cent and Africa at over 17 per cent.[7] This should
be a clear acknowledgement of the global leadership that Indian pharma industry has achieved which
would have been impossible without following global quality standards . Another popular criticism of Indian
pharma has been that there is insufficient investment in innovation and R&D . Despite over 500 new
drugs being discovered by Indian pharma companies during 1985 – 2005, there seems a perception that India thrives on
copying foreign products[8]. A recent study by Evaluate[9], a leading independent specialist pharma consultancy, reports that there
is little difference in the investment by “innovators” and “generics” and it is just a myth that “innovators” invest heavily in
research while “generics” don’t. Despite well publicised claims of the Western world, there seems to be a
marked decrease in R&D investments [10] and this trend is expected to continue .[11] When one realises
that almost 50% of the European pharma patents are either lying dormant or filed in order to block
competitors[12] one wonders how innovation is being defined and encouraged . Is it innovation if the

effect is stifling further innovation and competition and creating barriers for improvements?
Indian pharma industry has clearly demonstrated that it has the potential to be a part of the solution for
universal access to healthcare. India’s strength is innovating to improve global access to medicines as opposed to
developing more and more “me too” drugs which have been traditionally defined by the West as
innovation. There is now a growing acknowledgment that the existing IPR regime that is being touted by the West
doesn’t foster innovation. As such, the current patent system is itself reeling from the ill effects of patent
assertion entities (trolls) that do not produce anything of value but merely hold patents with a view to
threatening businesses with infringement actions to obtain licensing revenue . Patents have other flaws that
relate to monopoly power, both because it harms consumers who have to pay high prices and because it can hinder

improvements and subsequent innovations.[ 13] Static distortions , too little incentive for original
research, and wasteful duplication of research are some of the most serious problems of the patent
system.[14]In addition to TRIPs - compliant patent regimes which ostensibly promote innovation and discourage copying, the next
generation of barriers to competition seems to be set up as global standards. Just as IPR was addressed by the WTO in TRIPs, the more recent
barriers are likely to be in the form of harmonised regulations. Patent linkage[15] (in Canada and the US for example) denies access to markets
on a mere allegation of patent infringement. Despite the US Supreme Court[16] indicating that patent linkage needs to be reconsidered and
access to medicines should not be denied on allegation of patent infringement and recent attempts by Italy to introduce a system of patent
linkage resulted in a notice from the European Commission asking for the removal of these provisions from Italian law,[17] patent linkage is a
real barrier to competition in healthcare which is beset with unaffordable drugs. Data exclusivity extends the term of
monopoly enjoyed by patent holders and keeps out competition and innovation without any benefits to
society. This concept does not exist in sectors other than pharma and there seems to be no real rationale for pharma to
get special treatment. In fact, data exclusivity raises several ethical and moral issues. Countries have always been allowed to
customise their IP policy and regulation based on their unique local conditions. Some countries are more
technologically proficient than others, and this distinction may warrant separate norms in areas of
technology that they are strong in.[18] Even where harmonisation has been accepted as a concept, like the EU for example, it has
been implemented in a manner that is sympathetic to the local conditions of individual countries. India’s strength and expertise lies
in developing drugs which are accessible for patients across the globe. India’s stand on IPR regime
acknowledges that diverse countries cannot be forced to one uniform regulatory system. This principled stand
was recently demonstrated during the Bali round of talks on the Trade Facilitation Agreement.[19] In the background of the Trans Pacific and

Trans Atlantic Partnerships being negotiated, India has the opportunity to demonstrate leadership in the global
market place by pioneering the opposition to using harmonisation as a proxy for barriers to
competition. While the US and its allies may officially oppose India’s view of the IPR regime they have realised that the key
to their sustainable development is the ability of government to ensure that healthcare is accessible to
everyone, not just the rich. Cost of healthcare has increased significantly causing an alarming number of patients to
go off treatment, risk importing counterfeits[20] or in many cases, declare bankruptcy[21]. The issue of access to healthcare in
the developing world has, despite some efforts by the UN, The Global Fund, PEPFAR and other aid institutions, not had the
impact that it should have. There is a realisation, albeit unarticulated, that Indian Pharma companies have the
potential to be, like Indian technology companies averted the y2K crisis, a key element of the solution to world's
healthcare crisis. Now is a great opportunity for India to demonstrate leadership in IPR regimes as
more and more countries like South Africa and Brazil are following India’s example .
**Africa Scenario**
 2AC---Africa Econ Addon
African economic growth is key to global economic growth
Stetter 9 (Ernst, Secretary General of Federation for European Progressive Studies, “Why Africa
matters! – The economic crisis and Africa,” Contribution to the Shadow GN 2009, February 4 and 5,
http://www.feps-europe.eu/fileadmin/downloads/globalisation/090204_Stetter_Africa.pdf)

If there is no doubt that Africa is endowed with abundant natural resources, it is also true that Africa
is still struggling to address
the multiple challenges facing the continent, this includes poverty, under-development, protracted conflicts,
environmental degradation, HIV/AIDS pandemic, tuberculosis and malaria . It has been suggested that all over
Africa, poverty is a common denominator and it is not surprising that people’s immune systems have been damaged. Reports on
Africa’s HIV/AIDS pandemic have all come to the conclusion that HIV/AIDS on the continent is closely associated to poverty. It is clear that the
absence of technological investment and the contemning human resource capacity has prevented Africa from making optimal use of its
abundant resources for the benefit of its people. Nevertheless, the new scramble for natural resources in the continent is
likely to create a new awareness of the geopolitical importance of the African region. Therefore, Africa
remains a critical partner for the world’s economic viability . However, for Africa to benefit more from its vast natural
resources it must be finally enabled to add value to these products rather than export them raw to Europe and elsewhere in the developed
world. Africa needs to be helped in manufacturing value-added products that yield higher profit and income to African economies. In addition,
there are, at least, five significant factors that provide a plausible explanation as to why Africa matters, especially concerning Europe: Firstly, it
is the history of Africa and its relationship with Europe. The history of Africa has been a history of integration into the
European economy and markets. Therefore, Africa has historically held a significant place in the
European economy, trade and investments . If Africa matters to Europe it matters also to the globalised
world. Secondly, there is also the inherent link between environment and sustainable development. While the history of Africa and its
integration into the European economy is clearly defined by historical circumstances, the environmental aspects are not clearly discernible.
Environmentally, Africa matters to the world because it provides the largest capacity in the world
necessary for maintaining equilibrium in the biosphere and avoid further depletion of the ozone
layer . At the same time the raid of depletion of Africa’s biodiversity including its tropical forests,
medicinal plants remain threatened by the levels of poverty on the continent. Africa’s most prevailing source of
energy is biomass which means depletion and an exponential raid of its forestation. If this is left to continue, the World will
suffer serious climate change which is likely to erode its socio-economic prosperity and a consequent negative impact to its
population. This is an area which needs a strong partnership with the rest of the world, to protect its environment and avoid further depletion
of the ozone layer. Thirdly, Africa
matters because it still provides easy market access to Europe, the US and
China and can give, in some cases, extraordinary investment opportunities with high rates of return . With the
changing political climate in the continent towards democracy, respect for the rule of law and protection of human and people’s rights the
investment climate in Africa could rapidly change. The historical and cultural links, geographical proximity, and deep knowledge and
understanding of the continent gives international European investors a comparative advantage over Northern America and Asia, including
China. With these investments the average rate of growth in Africa has been increasing most significantly in most
African countries ranging from 3% to 7% in many countries during recent years. The income disparities in the continent have been
narrowing and the purchasing power parity increasing. This, coupled with the population of the continent, provides
a market with huge potential especially for European goods. Indeed, any visitor to Africa would quickly realize that there is still a
very significant quantity of European products traded in the continent. However, if you are in Europe you can hardly see the presence of African
products on the market. This is mainly because Africa cannot compete in the European market either because of European subsidies or other
protectionist measures that stifle Africa’s competitiveness and ability to sell in the European market. This problem needs to be addressed to
ensure the sustainability of African-European partnership. Fourthly, Africa matters because of its abundance nature of human resources which
provided the back-bone of industrialisation in Europe. Africa is a rich continent and not as poor as it is depicted elsewhere in the world. Africa
is richly endowed with mineral reserves. The continent ranks first in terms of the amount of global
reserves of bauxite, chromites, cobalt, diamond and gold. It also ranks first in terms of palladium,
phosphates, platinum group metals, titanium minerals, vanadium and zircon . Africa was, and still is, among
the world’s largest exporters . An ecological survey realised by the mineral industries of Africa has estimated that production in Africa
alone accounts as much as 80 % of the world’s platinum group metals, 55% of chromites, 49 % of the palladium, 45% of the vanadium and up to
55 % of the world’s gold and diamond. Moreover, Africa has emerged as a critical exporter of cheap and skilled labor that has been
instrumental in moving Europe’s economy forward.

Econ decline causes nuclear war

Hutchinson 14 (Martin, Business and Economics Editor at United Press International, MBA from
Harvard Business School, former international merchant banker, 1-3-14, “The chilling echoes of 1914, a
century on” Wall Street Journal) http://online.wsj.com/articles/william-galston-secular-stagnation-may-
be-for-real-1409095263,

The years before 1914 saw the formation of trade blocs separated by high tariff barriers. Back then, the world was
dominated by several roughly equivalent powers, albeit with different strengths and weaknesses. Today, the world is similarly multi-polar. The
United States is in a position of clear leadership, but China is coming up fast. Europe is weaker than it was, but is still a force to be reckoned
with. Japan, Russia, Brazil, India are also too powerful to ignore. A hundred years ago, big international infrastructure projects such as the
Berlin-Baghdad Railway, and before it the Suez Canal, were built to protect favored trading. Today’s equivalent may be the bilateral mining
partnerships forged between, for instance, China and mineral-rich African states. Today, the World Trade Organization offers some defence
against tariffs. But protectionism could be become entrenched if prolonged economic stagnation leads countries to pursue their own narrow
interests. Germany, Austria, Russia and France lost between 20 and 35 percent of national output between 1913 and 1918, according to Angus
Maddison’s data used in Stephen Broadberry’s “The Economics of World War One: A Comparative Analysis”. British GDP declined in 1914 and
1915, but grew 15 percent over the four years, as did the U.S. economy. The 37 million military and civilian casualties may tell a more accurate
story but if
history were to repeat itself, the global conflict could be both more universal and more destructive.
Nuclear weapons proliferate. Warped diplomatic anger could lead to the deployment of chemical and
biological devices. Electromagnetic pulses could wipe out our fragile electronic networks. Like the assassination of
Archduke Ferdinand that sparked World War One, the catalyst for cataclysm might be something quite surprising. A global run on bank and
other investment assets or an outbreak of hyperinflation, maybe? These threats get more serious the more policymakers pump up equity,
bond, property and banking bubbles. If global
wealth evaporates, or is proven to be an illusion, today’s largely cordial global
entente could be smashed with precipitous speed.
Whistleblowing Advantage
 2AC---Ext. WB Solves Cred
Whistleblower protections enable better FDA accountability
FDA 9 A group of FDA whistleblowers writing a letter to the presidential transition team, “FDA Whistleblowers’ Letter to
Obama Transition Team”, 1/7/2009,
http://www.whistleblowers.org/storage/whistleblowers/documents/FDAwhistleblowers/letter2transitionteam.pdf//OF

We, physicians and scientists at FDA, seek your immediate attention for change and reform at FDA. To bring real change and reform to FDA, it
is absolutely necessary that Congress pass, and the President sign, new legislation providing the
strongest possible protections for all government employees, especially physicians and scientists, who
speak out about wrongdoing and corruption that interferes with their mission and responsibility to
the American public. We desperately need honesty without fear of retaliation for our evaluations and
recommendations on medical devices, as well as accountability and transparency, to become the law and thus
the foundation of the FDA mission and workplace. We totally agree with the following statement of President Oban1a:22 “Often the
best source of information about waste, fraud, and abuse in government is an existing government employee committed to public integrity and
willing to speak out. Such acts of courage and patriotism, which can sometimes save lives and often save taxpayer dollars, should be

encouraged rather than stifled. We need to empower federal employees as watchdogs of wrongdoing and partners in performance. Barack
Obama will strengthen whistleblower laws to protect federal workers who expose waste, fraud, and
abuse of authority in government. Obama will ensure that whistleblowers have full access to courts and
due process. As President Obama has emphasized, he intends to govern the nation and to bring about change from the bottom up. We
believe that, as applied to FDA, this means a complete restructuring of the evaluation and approval process such that it is driven by science and
carried out by clinical and scientific experts in their corresponding areas of expertise who are charged with review of regulatory submissions in
accordance with the laws, rules and regulations. It is necessary that FDA expert physicians and scientists approve final regulatory
determinations of safety and effectiveness, rather than multiple layers of managers who are not qualified experts and who often ignore
scientific evidence and the law. President Obama has also emphasized the need for complete transparency in government. His
Transparency Policy should be mandatory for all FDA regulatory decisions and associated
documentation. The long-standing FDA practice of secret meetings and secret communications between FDA managers and regulated
industry must be strictly prohibited. Complete transparency in the regulatory decision-making process would serve as a deterrent to
wrongdoing and an incentive for excellence.
 2AC---Ext. WB k2 Transparency
FDA Whistleblowing is critical to transparency.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R. Allison Professor of Law,
Texas Tech University School of Law and Director, “What to Do When You Can't Hear the
Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for
Medical Researchers,” 2011 / 2012, lexis)//ghs-VA

Section IV outlined the financial dependence of academic medicine on the pharmaceutical industry. One aspect of this is the
reliance on income from drug trials which is why academic medical centers were eager to host clinical
trials and were, therefore, interested in remaining on good terms with their sponsors. The influence is just as strong, however, when the
clinical trials are over, and the drug companies are marketing their new drug. This is because the same physicians whose institutions hosted the
trials are also in a position to promote a specific product directly through talks given to other doctors and much more broadly by putting their
names to articles which change clinical standards and therefore increase the need for a specific drug. This can either be done by visits from
pharmaceutical representatives known as detailing or more directly by physicians talking to their peers at pharmaceutical company-sponsored
conferences. n193 The details of [*44] the extent of both of these activities have been coming to light through the hearings conducted by the
Senate Finance Committee, Chaired by Senator Charles Grassley of Iowa, n194 who is conducting an on-going investigation of conflicts of
interest between physicians and pharmaceutical companies. n195 To
prevent situations in which doctors are directly paid
by or hold shares in pharmaceutical industries, the late Senator Edward Kennedy and Senator Grassley
proposed the Physician Payments Sunshine Act of 2009 that would "provide for transparency in the
relationship between physicians and [applicable] manufacturers " with respect to payments and other transfers of
value and physician ownership or investment interests in manufacturers. n196 [*45] The message is clear. If Emory insists on the disclosure to
the NIH, it may well jeopardize their receipt of future grants. This means not just the individual doctor but the institution itself will suffer
serious financial loss. A whistleblower could serve at least two important functions in these situations. First, he or
she could disclose the financial arrangements themselves. Second, given both the investigators and the universities'
financial interest in the study, a whistleblower would be even more valuable in disclosing harm to human
subjects or lack suppression of negative results .
 2AC---WB Info Good
Lack of whistleblowers increases the risk to participants and the public.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R. Allison Professor of Law,
Texas Tech University School of Law and Director, “What to Do When You Can't Hear the
Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for
Medical Researchers,” 2011 / 2012, lexis)//ghs-VA
... Part II of this article reviews the dangers to the public from participating in clinical drug trials research and from taking prescription drugs. ...
Because there is no positive international law mandating that private companies running clinical trials (Clinical Research Organizations) comply
with the relevant domestic laws of the clinical studies' sponsors, the resulting "regulatory vacuum" makes it difficult for these countries to
ensure the welfare of trial participants and forces them to rely on foreign data and foreign review processes. ... Although the early stages of
drug testing, in which the subjects are healthy volunteers, are still primarily conducted by pharmaceutical companies, it is fair to say that any
study involving a subject who is already ill is overseen both by employees of pharmaceutical companies and by doctors who work for or are
associated with the hospitals which both provide treatment and serve as a site for research. ... While there has always been a close relationship
between the physicians who ran clinical drug trials in their hospitals and the companies who sponsored them, drug companies are increasingly
becoming intertwined with the actual operation of these institutions. ... Second, given
both the investigators and the
universities' financial interest in the study, a whistleblower would be even more valuable in disclosing
harm to human subjects or lack suppression of negative results . . ... The system of law and regulation in
the United States to provide protection against retaliation for insiders who know of dangers to the
public's health and safety during human subject research or drug development is as fragmented and inconsistent as
regulating the research itself. ... The lack of protection for whistleblowers means that those with the best
information about dangers to participants in medical research and to the patients, who will eventually use the
products developed from, the scientists, researchers, and doctors conducting the experiments and analyzing the data, risk their
jobs and their futures if they bring this information to light either within their own company, to
government regulators or to the press.

Whistleblowing prevents potential danger, which causes controversy.

Bard 13 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R. Allison Professor of Law,
Texas Tech University School of Law and Director, “Putting Patients First: How the FDA Could Use Its
Existing Powers To Reduce Post-Market Adverse Events,” 2013, lexis)//ghs-VA
F. Effective Solutions 1. Expanding Whistleblower Protection This article asserts that the burden for creating early detection systems, including
whistleblower protection, should be on the drug companies themselves because they are the ones with the greatest financial interest in the
drug's success and the greatest access to information about potential dangers. Moreover, Congress
has already identified
extending whistleblowing protection for employees of pharma ceutical companies as an important
method of ensuring compliance with federal anti-fraud laws such as Dodd-Frank n99 and the Affordable Care Act. n100
Whistleblower protection must, then, extend to every individual who may come into contact with
information about dangers to the public's health. This protection must be geared to what these people know, substance
based, not how they know it, job title based. n101 This section provides some suggestions for how that change should occur. [*530] 2. Models
of Strong Whistleblower Protection in Recent Federal Statutes In the last ten years, there has been significant interest by Congress in extending
protection to consumers from corporate fraud by developing new statutes, and amending old ones, that provide strong incentives for
whistleblowers as well as greater protection from employer retaliation. The Sarbanes-Oxley Act (SOX) exceeds all previous federal
whistleblower statutes by actually requiring disclosure. n102 It was enacted in response to a series of public scandals in which companies'
outside lawyers and accountants failed to report what was obvious fraud and wrong-doing. n103 Another enhancement to a whistleblowing
statute is the provision of an incentive for a whistleblower such as is available in the 2010 Dodd-Frank Consumer Protection Act. n104 Dodd-
Frank amends both SOX n105 and the False Claims Act n106 to provide greater protection against retaliation for whistleblowers. n107 [*531]
For example, companies must now prove by clear and convincing evidence that they would have terminated a whistleblower even if they were
unaware of his complaints. n108 These examples of increased whistleblower protection provided by federal statutes
are a model of what more could be done to protect employees of pharma ceutical companies who bring
forward information about a potential danger associated with a drug for which their company is
either seeking approval or which is already on the market .
 2AC---AT: SQ Solves Protections
Current laws and protections are fractured and inefficient
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R. Allison Professor of Law,
Texas Tech University School of Law and Director, “What to Do When You Can't Hear the
Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for
Medical Researchers,” 2011 / 2012, lexis)//ghs-VA

VI. Why Existing

Whistleblower Protection Laws Don't Work Existing statutes are of little use in
protecting those with knowledge of danger from human subject research because the location and employment status of
potential whistleblowers are so broad. Most existing whistleblower statutes privilege employment status as a starting point for offering
protection against retaliation. In many cases this is reasonable because the most likely source of retaliator is the specific entity for which the
whistleblower works. However, the
area of drug development employment status is far too narrow. Because
not all who report are employed by the company, they do not face retaliation from their employer . This
is especially true in the case of doctors, scientists, and their staffs ("researchers"), n246 who de- [*55] sign and run the clinical trials before, and
sometimes after, the drugs go on the market. Despite their important role, researchers who see problems and who express their concerns,
even within their own institutions, do so at the risk of their careers and livelihood. n247 There
are model statutes that provide
protection based on the content of the information, rather than on employment status . They must be the
foundation of any new FDA rule. The system of law and regulation in the United States to provide protection against retaliation for insiders who
know of dangers to the public's health and safety during human subject research or drug development is as fragmented and inconsistent as
regulating the research itself. Arguing
that the current laws intended to encourage whistleblowing were
ineffective, former Supreme Court Justice Souter described the uncoordinated and inconsistent federal
and state whistleblowing statutes as inadequate because the protection they provided was "piecemeal," 'patchwork," and
"hodgepodge." n248 It is the lack of comprehensive protection over research and over whistleblowers that makes it so easy to hide dangers at
every stage of the process. Another
problem is that the existing laws often narrowly describe who [*56] is
protected for disclosing various kinds of information. Professor Richard Moberly, an expert in
whistleblower law, described research showing that in the existing statutory and common law
"[p]rotections consistently fail to redress retaliation against whistleblowers , in large part because whistleblowers
fail to fit their claim into the narrowly-drawn boundaries of the law." n249 A system this broken cannot be fixed by a stroke of the pen. Rather,
protection of the public must be pursued using several different legal and policy interventions .

Whistleblower protections are based on employment status which doesn’t protect

FDA employees.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R. Allison Professor of Law,
Texas Tech University School of Law and Director, “What to Do When You Can't Hear the
Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for
Medical Researchers,” 2011 / 2012, lexis)//ghs-VA
2. Federal Whistleblower Laws There are at least twenty-one federal statutes that incorporate explicit whistleblower protection for employees of private
companies. n276 These include "protect[ing] employees who report violations of various airline, commercial motor carrier, consumer product, environmental,
financial reform, food safety, health care reform, nuclear, pipeline, public transportation agency, railroad, maritime and securities laws," and are overseen by the
Occupational Safety & Health Administration (OSHA) through its office of the Whistleblower Protection Program (OWPP). n277 The OWPP defines its protection as
follows, The Occupational Safety and Health Act (OSH Act) and a number of other laws protect workers against retaliation for complaining to their employers,
unions, [*65] the Occupational Safety and Health Administration (OSHA), or other government agencies about unsafe or unhealthful conditions in the workplace,
environmental problems, certain public safety hazards, and certain violations of federal provisions concerning securities fraud, as well as for engaging in other
related protected activities. n278 According to the Act, "[w]histleblowers may not be transferred, denied a raise, have their hours reduced, or be fired or punished
in any other way because they have exercised any right afforded to them under one of the laws that protect whistleblowers." n279 However, even if the OWPP
could effectively manage the retaliation complaints it receives, it would not provide protection for those who learn of danger to the public's health and safety unless
that danger was of the type prohibited by a federal law or regulation. Here again, the fragmentation of human subject research is a substantial barrier to
comprehensive whistleblower protection. The question isn't then whether there are federal statutes protecting whistleblowers; it is whether they are effective. C.
State Whistleblower Laws Do Not Protect Most Medical Researchers Most states provide some kind of legal protection to their
employees who disclose waste, fraud, or abuse in government. n280 Thirty-nine states have whistleblower statutes that provide general whistleblower protection
to public employees; twenty-three states provide general protection for all employees; and, fourteen states provide specific protection to persons reporting certain
environmental misconduct. n281 The literature describing the flaws of this existing system , usually called a patchwork, is
extensive. The failure of the existing statutes comes from their misplaced emphasis on the
employment status of the whistleblower rather than the potential danger to the public if the potential whistleblower does not feel safe
disclosing what she knows. For example, most whistleblower laws protect only those individuals who have disclosed

information exactly in the manner described by the statute . An individual with knowledge of a danger to the public's health or
safety may find herself fired because she reported it to her direct supervi- [*66] sor rather than public entity specified by a specific statute. n282 States vary widely
both in the terms of who is defined as a whistleblower and what protections are available to meet the criteria. These statutes protect researchers working at state
universities, but the protection offered them is far from complete . In addition, by definition, statutes intended to protect state employees would
not be available for researchers at private universities. For example, a physician overseeing a drug trial at the University of California at Berkley will have different
protection if he or she reports a dangerous situation involving human protection than one at Stanford University who may well be over- seeing a trial of the same
drug. This lack of consistency is exactly what concerned Justice Souter in Garcetti who wrote, "[T]he current understanding of statutory protection: individuals doing
the same sorts of governmental jobs and saying the same sorts of things addressed to civic concerns will get different protection depending on the local, state, or
federal jurisdictions that happened to employ them." n283
 2AC---Econ Addon
Status quo has a chilling effect – whistleblowers need to be able to openly disclose
info to save the FDA billions of dollars.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R. Allison Professor of Law,
Texas Tech University School of Law and Director, “What to Do When You Can't Hear the
Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for
Medical Researchers,” 2011 / 2012, lexis)//ghs-VA
A. Lack of Constitutional Protection 1. Medical Researchers Are Not Protected by the First Amendment? In Garcetti v. Cebalos, the Supreme Court concluded that there is no First Amendment
protection for employees of public institutions who disclose information against the wishes of their employers. n250 Finding that wrongdoing is part of their jobs makes it unlikely that medical
researchers employed by public universities would have First Amendment protection from retaliation for disclosing their concerns about dangers to the public's health from a clinical trial or a
newly issued prescription drug. n251 Those who argue Garcetti v. Ceballos has not resulted in any diminution of whistleblower protection for public employees because the plaintiff, Mr. Ce-

The minority's strongest objection was the chilling effect this

[*57] ballos, was not himself a whistleblower miss the point. n252

decision would have, and it specifically identified the reduced protections for whistleblowers by eliminating
any possible extension of First Amendment rights. n253 Although employees of state universities will still have the state whistleblower protection, these statutes are often

narrowly focused on reports about waste fraud and abuse in state government and would not apply
to a study funded privately. n254 The Supreme Court recently reaffirmed the importance of these regulations, writing that "[e]xposing governmental inefficiency and
misconduct is a matter of considerable significance" but pointed to a "powerful network of legislative enactments-such as whistle-blower protection laws and labor [*58] codes-available to
those who seek to expose wrongdoing." n255 However, noting an inconsistency between the Court's holding in Pickering and Garcetti, Justice Souter wrote, [It] is not a whit less true when an
employee's job duties require him to speak about such things: when, for example, a public auditor speaks on his discovery of embezzlement of public funds, when a building inspector makes
an obligatory report of an attempt to bribe him, or when a law enforcement officer expressly balks at a superior's order to violate constitutional rights he is sworn to protect. (The majority,
however, places all these speakers beyond the reach of First Amendment protection against retaliation.) n256 Furthermore, despite the existence of both federal and state whistleblower
statutes, most people know that disclosing information one's employer chooses to keep secret will likely lead not only to being fired but also to becoming unemployable. The lack of protection
for whistleblowers means that those with the best information about dangers to participants in medical research and to the patients, who will eventually use the products developed from, the
scientists, researchers, and doctors conducting the experiments and analyzing the data, risk their jobs and their futures if they bring this information to light either within their own company,
to government regulators or to the press. n257 It is as an employee of a public institution that a research scientist would be able to claim protections beyond that available to those employed
by private universities or indeed private companies. n258 Interpreting Garcet- [*59] ti, the Fifth Circuit found that there was no constitutional protection "when a public employee raises
complaints or concerns up the chain of command at his workplace about his job duties." n259 Writing four years after Garcetti, however, it is possible to see that Garcetti is already being cited
to support ruling against professors engaged in disputes with administrators at public universities. n260 , n261 a. Federal whistleblower law provides little protection for federal employees and
none for private employees There is a long tradition of government employees as whistleblowers in the United States. In a 1991 article describing the role that whistleblow- [*60] ers play in

Federal whistleblowers have exposed alleged defense contractor

the federal government, n262 Professor Bruce D. Fisher wrote,

accounting improprieties, described possible misconduct and federal prison mismanagement,

highlighted mismanagement of federal health care for Native Americans, questioned the
administration of the United States' system of justice, and alleged numerous improprieties in the
administration of federal agencies. Whistleblowing can occur at high and low levels of the federal government. Whistleblowers can save
the federal government--and federal taxpayers--billions of dollars . Whistleblowers can serve as a vital
communication link between the middle echelon federal employee , who sees the workings and shortcomings of federal programs on
a daily basis, and the policy-makers in Congress . n263 Yet, the title of Professor Fisher's article, The Whistleblower Protection Act of 1989: A False Hope for
Whistleblowers, reflects the fact that despite substantial efforts on the part of Congress to provide a regulatory scheme to protect whistleblowers, they still very much face retaliation and, in
many cases, disgrace. All federal employees, including scientists, are protected under the existing federal whistleblower statute. n264 However, that act is focused narrowly and weakly
enforced. Whatever protection it provides federal employees is inadequate to protect human subjects or consumers of prescription drugs. n265 In not just health and safety issues but rather
in all areas of possible wrong- doing, the federal government has moved beyond a passive posture [*61] of relying on laws that protect those who come forward to laws which both provide
bounties as an incentive and punishments for not doing so. b. Characterizing hiding information about a drug as a false claim against the government Congress has long seen the need for
providing protection to federal employees who learn of fraud, waste, or abuse in government as well as employees of private companies who receive federal money, but this protection does
not usually extend to dangers to the public's health and safety. Writing to sixteen of the largest pharmaceutical companies on July 1, 2010, Senator Chuck Grassley of Iowa demanded that they
each send his Committee their company's policies on protecting whistleblowers. As he explains in a press release, The False Claims Act is a proven success in both identifying and deterring

My appeal to drug makers

fraud and recovering fraudulently obtained taxpayer dollars. The more that can be done to create awareness of it, the more good it can do.

is based on the fact that they have a public responsibility to safeguard the tax dollars that pay for
their products, and promoting a Congress has long seen the need for providing protection to federal employees who learn of fraud, waste or abuse in government culture where
those who speak up about possible fraud are rewarded rather than retaliated against is one way to fulfill that responsibility . . . . There can never be too many taxpayer watchdogs, so I see this
letter as an opportunity to foster a mindset that recognizes the value of whistleblowers and the duty these companies have to act honestly when seeking taxpayer dollars. n266 B. Neither Qui

Tam Statutes nor Bounty Programs are not a Substitute for Whistleblower Protection The federal government has recently stepped up its
efforts to fight fraud in a variety of settings by making it easier for individuals who know of fraud, waste, or abuse of federal funds to receive a substantial financial benefit by
coming forward with the information. These efforts include [*62] strengthening a very old incentive, qui tam suits, and a newer one focusing on bounties. Both link the

whistleblower's recovery directly to the amount recovered by the government . These programs are successful because
they directly address the problem for which they were designed: fraud, waste, and abuse against the federal government. The whistleblower provisions in this article, however, are aimed at
saving money, they are aimed at saving lives. Courts have supported the government's recent efforts to characterize actions by pharmaceutical companies to hide dangers as false claims
because the drugs themselves were subsequently purchased through the Medicare or Veterans Health Administration systems. However, neither the availability of a qui tam suit nor a Bounty
program will make it more likely than informant who knows of a danger which does not involve a substantial financial loss to the federal government.

Statistics show economic decline causes war – miscalculation and diversionary theory
Royal 10 – Jedediah Royal, Director of Cooperative Threat Reduction at the U.S. Department of
Defense, 2010, “Economic Integration, Economic Signaling and the Problem of Economic Crises,” in
Economics of War and Peace: Economic, Legal and Political Perspectives, ed. Goldsmith and Brauer, p.
213-214

Less intuitive is how periods of economic decline may increase the likelihood of external conflict. Political science literature
has contributed a moderate degree of attention to the impact of economic decline and the security and defence behaviour of interdependent states. Research in
this vein has been considered at systemic, dyadic and national levels. Several notable contributions follow. First, on the systemic level, Pollins (2008) advances
Modelski and Thompson's (1996) work on leadership cycle theory, finding that rhythms
in the global economy are associated with
the rise and fall of a pre-eminent power and the often bloody transition from one pre-eminent leader
to the next. As such, exogenous shocks such as economic crises could usher in a redistribution of relative
power (see also Gilpin. 1981) that leads to uncertainty about power balances, increasing the risk of miscalculation (Feaver,
1995). Alternatively, even a relatively certain redistribution of power could lead to a permissive environment

for conflict as a rising power may seek to challenge a declining power (Werner. 1999). Separately, Pollins (1996) also shows
that global economic cycles combined with parallel leadership cycles impact the likelihood of conflict among major, medium and small powers, although he suggests
that the causes and connections between global economic conditions and security conditions remain unknown. Second, on a dyadic level, Copeland's (1996, 2000)
theory of trade expectations suggests that 'future expectation of trade' is a significant variable in understanding
economic conditions and security behaviour of states. He argues that interdependent states are likely to gain pacific benefits from
trade so long as they have an optimistic view of future trade relations. However, if the expectations of future trade decline, particularly for

difficult to replace items such as energy resources, the likelihood for conflict increases, as states will be inclined to use

force to gain access to those resources. Crises could potentially be the trigger for decreased trade expectations
either on its own or because it triggers protectionist moves by interdependent states.4 Third, others have considered the link between

economic decline and external armed conflict at a national level. Blomberg and Hess (2002) find a strong
correlation between internal conflict and external conflict, particularly during periods of economic
downturn. They write: The linkages between internal and external conflict and prosperity are strong and mutually reinforcing. Economic conflict tends to
spawn internal conflict, which in turn returns the favour. Moreover, the presence of a recession tends to amplify the extent to
which international and external conflicts self-reinforce each other. (Blomberg & Hess, 2002. p. 89) Economic
decline has also been linked with an increase in the likelihood of terrorism (Blomberg, Hess, & Weerapana, 2004), which
has the capacity to spill across borders and lead to external tensions. Furthermore, crises generally reduce the popularity of a sitting government.
"Diversionary theory" suggests that, when facing unpopularity arising from economic decline, sitting
governments have increased incentives to fabricate external military conflicts to create a 'rally around
the flag' effect. Wang (1996), DeRouen (1995). and Blomberg, Hess, and Thacker (2006) find supporting evidence showing that economic decline and use of
force are at least indirectly correlated. Gelpi (1997), Miller (1999), and Kisangani and Pickering (2009) suggest that the tendency towards

diversionary tactics are greater for democratic states than autocratic states, due to the fact that democratic leaders are generally
more susceptible to being removed from office due to lack of domestic support. DeRouen (2000) has provided evidence showing that periods of weak

economic performance in the United States, and thus weak Presidential popularity, are statistically
linked to an increase in the use of force. In summary, recent economic scholarship positively correlates economic integration with an
increase in the frequency of economic crises, whereas political science scholarship links economic decline with external

conflict at systemic, dyadic and national levels.5 This implied connection between integration, crises and armed conflict has not
featured prominently in the economic-security debate and deserves more attention.
Solvency
 2AC---Oversight Bad
FDA independence solves and is key to credibility internationally
Harris 12 (Gardiner- author for the NY Times. “White House and the F.D.A. Often at Odds”. April 2, 2012.
http://www.nytimes.com/2012/04/03/health/policy/white-house-and-fda-at-odds-on-regulatory-issues.html//GH)

Consumer advocates credit the Obama administration with bolstering the F.D.A.’s budget and championing landmark legislation that
strengthened the agency’s authority to regulate food and tobacco. But they also express concerns that the
administration has been
overly cautious, sitting on important regulatory policies regarding foods and medical devices to avoid
giving Republicans fodder for attacks. And some analysts worry that the administration’s increased
engagement could erode the F.D.A.’s reputation for regulatory thoroughness and integrity. “In a
globalizing world, where trust is a huge part of what American manufacturers have to sell, the
politicization of the F.D.A. could hurt not only consumer protection but industry profits as well,” said

Daniel Carpenter, an F.D.A. historian at Harvard University. “If

this trend continues, one could easily see major
government purchasing programs in Europe, India, China and elsewhere saying, ‘We’re not going to
follow F.D.A. recommendations anymore.’ ” The tensions between the White House and the F.D.A. are also a window on Mr.
Obama’s governing style. The White House is concerned about managing its message, and news reports or announcements — even mundane
ones — that catch advisers unaware lead to sharp rebukes, according to health officials across the government. “ The
White House
wants to know everything, but telling everything takes a huge amount of work,” a health official at
the Centers for Disease Control and Prevention said. “ And in the end, it can’t really be done .”
AT: Politics
 2AC---No Link
No link---Blame goes to the FDA, not the president
Lasagna and Wardell 75 (Louis and William- MD. “The FDA, Politics, and the Public”.
http://jama.jamanetwork.com/article.aspx?articleid=336011)

SINCE it was begun in 1907, the Food and Drug Administration (FDA) has often been the center of controversy. Recent
scandals in the executive branch of the government have reminded us that public officials are not above
either the law or the public they are supposed to serve. It is therefore appropriate that the FDA be responsive to public
concerns, and be held accountable when criticism erupts, be it from consumerists, the medical profession,
the drug industry, or the Congress. Still, it is also crucial that a regulatory agency not become so
embroiled in defensive maneuvers that it loses its ability to serve the public properly. During the last decade,
the FDA has been accused both of overregulation and underregulation. Such a situation is not as paradoxical as it might seem. On the one hand,
the FDA might be considered culpable if it fails to police drug manufacturers and allows inferior brands of digoxin on the market, and on the
other hand, it might be held to ac¬ count if it demands so much evidence on new drugs that valuable medicaments are withheld from the
American patient. Of late, theFDA has been severely chastized for actions that are not only eminently
defensible but reflect a welcome change in agency policy. At hearings in the House chaired by Mr. Fountain and in the
Senate chaired by Mr. Kennedy, FDA officials have been reprimanded for being "soft" on industry and too ready to
approve new drugs. At the August Senate hearings, a parade of disgruntled FDA employees and advisors were solicitiously listened to as they
voiced criticisms of the top administrative echelons in the FDA for going against their negative advice, and then, Commissioner Schmidt was
lectured by Senator Ken¬ nedy and warned not to take punitive action against his malcontent employees.
 2AC---GOP Link Turn
Republicans are against FDS surveillance in status quo- aff reverses that
AP 14 [February 26, 2014 http://www.foxnews.com/politics/2014/02/26/republicans-blast-fda-for-secretly-monitoring-emails-agency-
whistleblowers/ “Republicans blast FDA for secretly monitoring emails of whistleblowers”] (Vaibhav)

WASHINGTON – Republican lawmakers blasted the Food and Drug Administration on Wednesday for
secretly monitoring the emails of agency scientists who went public with allegations that they were
pressured to approve certain medical devices. In a report published in conjunction with a congressional hearing, two
Republicans said that the FDA's computer surveillance may have overstepped federal laws designed
to protect government whistleblowers. Using software that took rapid-fire screen shots of employees' desktops, the FDA
swept up emails from several whistleblowers to members of Congress and their private attorneys.
Such communications are protected from disclosure by federal law. The report is the product of a two-year
investigation by Rep. Darrell Issa, R-Calif., and Sen. Chuck Grassley, R-Iowa. Issa acknowledged in his opening statement
that federal workers have no right to privacy when using government computers or property.
 2AC---Health Link Turn
Reform popular---21st Century Cures proves
Mukherjee 5/21/2015 (Sy- Associate Editor at Industry Dive, managing and writing content for BioPharma
Dive and occasionally contributing to sister publication Healthcare Dive. “House committee unanimously passes
21st Century Cures FDA overhaul”. “http://www.healthcaredive.com/news/house-committee-unanimously-passes-
21st-century-cures-fda-overhaul/399631///GH)

The 21st Century Cures initiative is sailing through Congress with notable bipartisan support . In fact,
one committee member noted that Thursday's 51-0 vote marked the first time in just under three
decades that such major legislation had been passed by the committee without a single detractor .
Given the bill's popularity, it seems extremely likely that it will pass the full House. What's less clear is its
prospects in the Senate, although Sens. Richard Burr (R-NC) and Bill Cassidy (R-LA) have both indicated the upper chamber will take up the bill
by the fall. The goal is to get a final bill to President Barack Obama's desk by the end of the year.
 1AR---Health Link Turn
Plan is popular
Scott 7/28/2015 (Dylan- staff correspondent for National Journal. “Upton Wants to Keep Pressure on Senate to
Take Up FDA Reform Bill. http://www.nationaljournal.com/health-care/upton-wants-to-keep-pressure-on-senate-
to-take-up-fda-reform-bill-20150728//GH)

House Energy and Commerce Chairman Fred Upton is working to push his much beloved 21st Century Cures bill over
the finish line—and to do it, he'll have to keep the pressure on his colleagues in the upper chamber. So on Tuesday, he is sitting down with
Senate health committee chairman Lamar Alexander and ranking member Patty Murray, Upton said at National Journal's Conversation with the
Chair event sponsored by PG&E. The Cures Act, which Upton has worked on for more than a year, would expedite prescription-drug and
medical-device approvals by the Food and Drug Administration and inject more research funding into the National Institutes of Health. It
passed the House this month with 344 votes, and Upton clearly wants to use that big bipartisan vote as
a tool in his talks with the Senate. "As we have learned already, certainly in this Congress, when you can pass
something with 300 votes, the other body is going to take it ," the Michigan Republican said. He added that he was
going to meet later in the afternoon with Alexander, Murray, and other senators. "Our goal is to work with them to get them
to do a similar type bill, go to conference, and really get it done ," he said. Alexander had previously been much less
definitive about his committee's plans, telling National Journalin May that they were "taking the time … to get it right." But on Monday at the
Bipartisan Policy Center, he said he would work to have a bill ready by the end of the year, which is likely the soonest that the Senate would
have time to bring it up on the floor anyway. "With
the kind of support it has now, and I expect it to have at the
end of the year, I fully expect it to be the kind of legislation that even could be considered by the
Congress in an election year, something a lot of people can take pride in," he said.
AT: Disease CP
 2AC---No Solvency
The CP can’t solve---internal issues
CSIS 10 (Center for Strategic and International Solutions- policy proposal institution based on coming up with
international policies for growing problems. “From Conflict to Pandemics Three Papers from the CSIS Global Health
and Security Working Group A Report of the CSIS Global Health Policy Center”.pg 5. May 2010.
http://csis.org/files/publication/100506_Bonventre_FromConflictToPandemics_Web.pdf//GH)

There are several actions DOD could take internally to better reach its potential for contributing to the
national effort to improve global preparedness. In this report, we have discussed only a few of the many DOD programs that
contribute to global public health surveillance networks either as their primary mission, or as a useful secondary consequence of that mission.
However, just
as coordination between agencies is challenging, coordination of diverse programs within
DOD can be complex, requiring ongoing active dialogue. DOD’s efforts to contain dangerous pathogens
should be part of a more holistic effort to address biodefense, including global laboratory and research cooperation,
development of mitigation strategies, stockpiling of countermeasures, and building surveillance and outbreak response capacities in developing
nations. Partners in the GEIS surveillance network have also contributed to the seasonal influenza vaccine by identifying and providing at least
five different reference or seed virus strains. These successes are highlights of many years of DOD’s work in health surveillance, vaccine
development, and in strengthening partnerships within the U.S. government and with governments abroad. 12 Indeed, the offices of several
senior DOD officials have begun increasing their information sharing and examining their biosecurity and health programs to identify ways to
work together more efficiently where their objectives intersect.13 Intensifying
such collaborative efforts and focusing on
public health capacity building might identify areas of synergy that would permit each individual
program to achieve its primary objectives and still allow a contribution to global preparedness as a
secondary objective.
AT: Corruption CP
 2AC---IAAC Bad
The IAAC is unnecessary, ineffective, and trivializes genocide and war crimes
Shaefer et al 14 (Brett- Senior Research Fellow in International Regulatory Affairs. Steven Groves- Senior
Research Fellow The Margaret Thatcher Center for Freedom. James Robert- Research Fellow For Economic
Freedom and Growth Center for Trade and Economics (CTE). “Why the U.S. Should Oppose the Creation of an
International Anti-Corruption Court”. Abstract. http://www.heritage.org/research/reports/2014/10/why-the-us-
should-oppose-the-creation-of-an-international-anti-corruption-court//GH)
Advocates believe that “grand corruption” (extensive, large-scale corruption by high-level government officials) should be classified as a crime
against humanity, subject to jurisdiction under the International Criminal Court or a new International Anti-Corruption Court (IACC).
Corruption is a real problem, but classifying it as a crime against humanity subject to international
criminal courts would be impractical, ineffective, and, where it could be pursued, often unnecessary. Among other
problems, it would not address widespread and deeply entrenched petty corruption, would prove
ineffective in cases of true impunity, and arguably would trivialize genocide and war crimes by
equating them with theft and abuse of power. Long-term, sustainable anti-corruption measures
cannot be instilled from above via international treaties and courts—they must be cultivated
domestically from the ground up. The U.S. should oppose proposals to create an IACC.
AT: Biotech Turn
 2AC---No Biotech Bubble
No biotech bubble---industry is set for long-term growth
Chang 3/27 (Sue, Markets Reporter, MarketWatch, 3/17/15, “Biotech bubble may just be an optical
illusion”, http://www.marketwatch.com/story/biotech-bubble-may-just-be-an-optical-illusion-2015-03-
27, Accessed 7/25/15)//LD

SAN FRANCISCO (MarketWatch)—The

stellar performance of biotechnology stocks in the past few years has
predictably sparked fears of an impending crash. But for all the talk of a bubble, biotechs are far from
being overbought, according to analysts at Credit Suisse. “There are optics suggesting that we are in a biotech bubble,” wrote Ravi Mehrotra at Credit
Suisse in a note to investors on Friday. Biotech was the best-performing sector between 2011 to 2014 and the NYSE Arca Biotechnology Index BTK, -3.46% rose
204% since January 2011 versus the S&P 500’s SPX, -1.07% 64%. The combined market cap of the top five biotech companies is $513 billion, quadrupling from $128
billion in 2011. But a multiyear rally does not a bubble make, according to Mehrotra. “Yes, we are in unprecedented
times with regards to performance, interest levels, valuations of SMID caps but we are also seeing
unprecedented success in the sector—success that is fundamental and long-lasting ,” he said. At the core of
Mehrotra’s analysis is that the biotech industry business model has changed and evolved over the past three

years from Biotech 1.0 to Biotech 2.0. “Biotech 1.0 is the ‘Hopes And Dreams Model’— make great drugs for unmet medical needs and sell
them thus creating a unique infrastructure.” Biotech 2.0 is the “Nirvana Model” where companies develop next-

generation blockbuster drugs that bring with it record growth and profitability . “Biotech 2.0 not only delivered
exceptional top-line growth that was further leveraged to even higher bottom line growth but a massive improvement in operating margins,” he said. Biogen

Inc. BIIB, -22.08% Gilead Sciences Inc. GILD, -4.11% and Celgene Corp. CELG, -2.96% are prime
examples of companies that successfully adopted the Biotech 2.0 model , he said. Aside from a fundamental shift in the
industry, he also claims the “cool” factor of gene therapy, stem cells, and cell engineering—along with

new scientific discoveries make these technologies “drug-able”--will fuel greater investors’ interest in
biotech stocks. Mehrotra said he believes biotechs must dominate in their chosen fields to sustain the upward
trajectory. “We view domain domination as the best pathway for yielding the highest chances of post
2020 growth.” Among large caps, Biogen and Celgene are almost on the verge of domain domination while small-
cap names that bear watching are Celladon Corp. CLDN, -1.98% Ironwood Pharmaceuticals Inc. IRWD, -6.13% Ovascience Inc. OVAS, +0.76% Esperion Therapeutics
Inc. ESPR, -20.71% PTC Therapeutics Inc. PTCT, -2.94% and Amana Takaful PLC ATLN, +7.69%
 1AR---Ext. No Biotech Bubble
No biotech bubble---innovation, aging population, full pipelines, visible growth
Greenberg 4/6 (Gregg, staff reporter, The Street, M.B.A. from Cornell University's Johnson School of
Business, and a B.A. in history from Amherst College, 4/6/15, “Biotech Stocks Still Feeling Healthy
Despite Bubble Talk”, http://www.thestreet.com/story/13102754/1/biotech-stocks-still-feeling-healthy-
despite-bubble-talk.html, Accessed 7/26/15)//LD

NEW YORK (TheStreet) -- Shareholders

feeling a touch of vertigo following the steep run-up in health care and
biotech stocks need not reach for the medicine cabinet -- or the exit -- just yet, said Marshall Gordon,
senior research analyst at ClearBridge Investments. "You really have some powerful long-term
tailwinds including innovation and the aging of the population which can continue to drive the
stocks higher," says Gordon. The health care sector, as represented by the Health Care Select Sector SPDR ETF (XLV), climbed 6% in
the first quarter of 2015 compared to a flat S&P 500 index. Nearly a quarter of the XLV is comprised by pharmaceutical giants Johnson &
Johnson (JNJ) (10%), Pfizer (PFE) (8%) and Merck (MRK) (6%). As for which major drug companies will fare best in the coming months, Gordon
said thewinners will be those companies that repeatedly deliver encouraging clinical results, as well as
solid drug launches. He cites the Food and Drug Administration's early approval last month of Bristol-Myers Squibb's (BMY - Get Report)
advanced lung cancer drug Opdivo as an example of how a clinical success can generate momentum for a pharma giant's shares. Bristol's stock
spiked 6% on the approval and have risen over 28% in the past 12 months. Must Read: 10 Stocks Carl Icahn Is Buying Gordon also
dismissed the idea that investors may want to avoid U.S. drug companies due to the strengthening
dollar and bet on European players instead. "Currencies can make a difference in the short term but long-term success depends on bringing
new drugs to market," said Gordon. Meanwhile, Gordon is even more bullish on the biotech sector, despite growing
worries that the space is piercing bubble territory. The sector, as widely tracked by the iShares Nasdaq Biotechnology ETF
(IBB), spiked 12% in the first three months of 2015 as a result of merger deals that included AbbVie's (ABBV) $21 billion acquisition of
Pharmacyclics to gain access to its Imbruvica blood cancer treatment. "Certainly valuations are toward the higher end of
historical ranges, but I don't see it as overvalued," said Gordon. "The big-cap biotechs have very full
pipelines and visible earnings growth for the next few years, so they remain attractive." Among Gordon's top biotech picks are
Biogen Idec (BIIB - Get Report) and BioMarin Pharmaceutical (BMRN - Get Report).
 2AC---Credibility Turn
Only increased FDA cred can save the biotech bubble from bursting
Baghda 7 (Ramsey, Regulation Policy Market Access, September, Vol. 2, No. 9, Avandia and the
Commercial Impact of FDA’s Credibility Gap, www.consumersunion.org/pdf/RPMreport0907.pdf)

The last thing industry needs right now is more damage to FDA ’s already battered cred ibility. But that is precisely
what happened in the Avandia review. The “Whipsaw Effect”: The Cost of FDA’s Loss of Credibility If you don’t think a weak FDA
can hurt the drug industry, think again. The cost may be impossible to quantify—or it may be surprisingly easy. How
about $13 billion? That is how much value GSK lost from Wall Street’s initial reaction to the Avandia safety signal. On May 21, a
meta-analysis showing a 43% increased risk of heart attack for Avandia patients compared to control
was published in an electronic version of the New England Journal of Medicine. The analyis was conducted by Cleveland Clinic cardiologist
Steve Nissen and his colleague Kathy Wolski. That same day, GSK lost 8% of its market cap, or $13 billion . The stock
market was in no mood to wait for FDA to speak on the issue. The market sees, for all practical purposes, that
drug safety
determinations have been ceded to outside figures with the reputation and ability to generate
headlines. Would GSK have lost billions if the investment community trusted FDA as the final word on
drug safety? There’s little doubt Glaxo’s stock price would have taken a hit, but a $13 billion hit in one day? “ No , I think [the hit]
would have been less,” MedImmune Inc. CEO David Mott says. Mott isn’t alone. “If there was a stronger FDA, then
people wouldn’t have been as quick to judge Avandia based on what may not be a thorough analysis,” agrees Sam Colella,
cofounder and managing director of the hedge fund Versant Ventures.
 1AR---Ext. Credibility Turn
Only FDA cred can save the biotech bubble
LaMattina 14 (John, Forbes pharma contributor, “How Did A 30 Year Big Pharma Veteran Become An
FDA Apologist?”, http://www.forbes.com/sites/johnlamattina/2014/04/01/how-did-a-30-year-big-
pharma-veteran-become-an-fda-apologist/)

So, how did a big pharma guy become an FDA apologist? Basically, it stems from the fact that a
strong, independent FDA is
crucial to the success of any company doing drug R&D. The primary role of the FDA is to protect Americans
from unsafe drugs and poorly effective agents. Patients and physicians need to be assured that the medicine being prescribed has
undergone vigorous and thorough testing. FDA credibility makes moot the accusations of pharma critics like Ben Goldacre that:
“Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresented
patients, and analyzed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatment.” Anyone who
has worked with the FDA knows that the FDA reviews all clinical trials and would never allow a key clinical trial to proceed if it was poorly
designed or was to include weird, unrepresented patients, or analyzed with flawed techniques. Such comments are absurd. Yet, unless we
have a strong and well respected FDA, such challenges are accepted as fact. The same can be said about the side
effects of new drugs. Some critics charge that the industry hides adverse events of their experimental medicines. Few realize, however, that a
company is legally bound to report every adverse drug event within 15 days of its occurrence .
Furthermore, when a company files a New Drug Application for FDA approval, every shred of data ever accumulated by the company is

included. Thus, the credibility of the biopharmaceutical industry is directly connected with the credibility
of the FDA . Should the public believe that the FDA is inadequately doing its job, then they will be concerned that the medicines they are
being prescribed are not what they are made out to be. In effect, pharma’s
reputation is directly tied to the strength of
the FDA. Given that I believe that pharma’s biggest challenge is improving its poor reputation, you can
see why I believe that the FDA’s role is important for so many reasons .
 1AR---AT: ABR Impact
No antibiotic resistance impact
Jesse Pines 10, Professor, Emergency Medicine and Health Policy, George Washington University,
“Should We Be Afraid of the Superbug?” FOREIGN POLICY, 9/3,
www.foreignpolicy.com/articles/2010/09/03/should_we_be_afraid_of_the_superbug, accessed 9-14-
14.
For a few days this August, much of the news media in the West became convinced that we were headed back to the 1800s, medically
speaking. A study in the September 2010 issue of British medical journal the Lancet argued that bacteria carrying genes for NDM-1, a gene that
imparts resistance to a key family of antibiotics, had made their way through India and Pakistan into Britain and were now threatening to derail
medical treatment across the developed world. Linked with the always shady-sounding concept of "medical tourism" -- the practice of traveling
to other countries for budget surgery -- the so-called "superbug," able to breed vicious and deadly infections, became an instant media panic
during a slow news month. The Drudge Report and Andrew Breitbart's news website both featured it. A Guardian science columnist wrote,
"Now, the post-antibiotic apocalypse is in sight."¶ Er, not so much. As with most August stories, the
reality of superbugs is a bit
more complex than the media has portrayed it. Yes, antibiotic-resistant bacteria are a threat, as this week's news of an
outbreak among premature infants in London reminds us. But no one yet knows how bad NDM-1-related infections could be. Not only is it far
too early to say we're headed for apocalypse, we've also got a lot to learn from superbugs -- namely, how our own over-use
of antibiotics is making it more likely that a superbug of the future could live up to this summer's hype. ¶ Alexander Fleming discovered the first
antibiotic by accident in 1928, when he left out a bacterial culture for a month while on vacation and came back to find that some of the
bacteria had been killed by a fungus named Penicillium. By the early 1940s, a commercial product, penicillin, was mass-produced to cure
bacterial infections in humans, and medical practice hasn't been the same since. ¶ These days, antibiotics are a major weapon in medicine's war
on disease, used to treat everything from life-threatening infections like meningitis to more run-of-the-mill ear infections. For more advanced
medical technologies, like chemotherapy or organ transplantation, antibiotics are needed to prevent and treat infections while patients heal.
Neither treatment would be possible without antibiotics.¶ At this point, in fact, antibiotics are suffering from their own success. They are so
engrained in the medical and social culture that over-prescription is a major problem. Recent surveys have found that 70 to 80 percent of
doctors' visits for sinus infections result in an antibiotic prescription. But most sinus infections are caused by viruses, and antibiotics don't cure
viral infections.¶ The medical sin of antibiotic overuse goes beyond mere ineffectiveness -- it actually can be harmful. Here's how it works:
Bacteria are everywhere on our bodies, even when we are not sick. When we take antibiotics for a bacterial infection, they only kill certain
bacteria (usually the ones making us sick). Then, as the body gets better, the surviving bacteria multiply and take over. Now and then a few
remaining bacteria carry special resistance to antibiotics -- which is what kept them alive in the first place. With the other bacteria out of the
way, the resistant bacteria (i.e., the superbug) can multiply and sometimes cause problems. For example, if one of those superbugs causes an
infection, some antibiotics won't work anymore, and then you have an infection that is more difficult to treat. ¶ One of the prototypical
superbugs caused by antibiotic use (and overuse) is Methicillin-Resistant Staphylococcus aureus (MRSA). MRSA is resistant to many antibiotics,
including penicillin, and causes a variety of problems in humans: mostly skin infections, but also more invasive diseases like pneumonia and
bloodstream infections.¶ Another superbug that's been around for a while but has also taken a recent media tour is Clostridium difficile (C. diff),
which can be spread when antibiotics wipe out normal intestinal bacteria that keep C. diff in check. A recent study found C. diff infection
occurred in 13 out of every 1,000 hospitalizations. C. diff causes diarrhea, and in some cases a particularly severe and sometimes lethal
infection of the colon.¶ Looking at bacteria carrying the NDM-1 gene, C. diff, and MRSA, it's not surprising that people would panic over the
possibility of these or other, even more resistant, bugs of the future making our advances in antibiotics worthless. And it's a legitimate fear.
Although there are antibiotics and other treatments that work against all known superbugs, bacteria will continue to evolve, developing
stronger antibiotic resistance in the future. It is conceivable that bacteria will someday outsmart our best medical technologies. ¶ But it
is
unlikely that it will happen any time soon. One reason is that there are many different classes of antibiotics, so
while some don't work against superbugs, there are usually others that do. Antibiotics that have been shelved
for years might even be re-introduced to fight superbugs , though obviously this would be less than ideal because of higher risk
of side effects. A better and more likely solution is for drug companies and other scientists to discover new classes of
antibiotics. The financial incentives for heading off a true superbug-led medical catastrophe would be huge -- something
that always drives medical innovation quite nicely, as it did with treatments for HIV in the 1990s.
NEG
T-Privacy
 1NC---Violation
Whistleblowers don’t have an expectation of privacy
Issa 14 (Chairman Darrel Issa- committee on oversight and government reform. “HEARING BEFORE THE COMMITTEE ON
OVERSIGHT AND GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS SECOND
SESSION”. February 26, 2014. Pg 3. http://www.gpo.gov/fdsys/pkg/CHRG-113hhrg87176/pdf/CHRG-113hhrg87176.pdf//GH)

I am here to say that the Federal

employees know that every communication they do on government
property, on government time, or using government assets, or doing government business is subject
to the Federal Government looking at it. There is no expectation of privacy.
Politics
 1NC---Dems Link
House democrats defend status quo surveillance
AP 14 [February 26, 2014 http://www.foxnews.com/politics/2014/02/26/republicans-blast-fda-for-secretly-monitoring-emails-agency-
whistleblowers/ “Republicans blast FDA for secretly monitoring emails of whistleblowers”] (Vaibhav)

House Democrats defended the surveillance, in part, pointing to the findings of the inspector general
that oversees the FDA. In a report released just ahead of the hearing, the inspector general concludes that the
surveillance had a "reasonable basis" because the employees were leaking confidential information to
the press about devices under review. The report also concluded that the surveillance was not targeted to
capture communications with Congress or any other specific parties. While finding justification for the monitoring,
the report also faults the agency for having no system to ensure that "their investigations were conducted in accordance
with laws and regulations." As a result, the program "had significant negative consequences for FDA."
 1NC---Health Link
Reform is unpopular---partisan posturing
Mukherjee 1/28/2015 (Sy- Associate Editor at Industry Dive, managing and writing content for BioPharma
Dive and occasionally contributing to sister publication Healthcare Dive. “4 things you need to know about the
sweeping FDA reform bill Congress just proposed”. http://www.biopharmadive.com/news/4-things-you-need-to-
know-about-the-sweeping-fda-reform-bill-congress-just/357481///GH)

There's bound to be controversy and partisan sniping when it comes to crafting reform of this
magnitude. And the stakes are even higher considering that the legislation would directly affect the
health and safety of millions of Americans , including some of the most sick and vulnerable people in the country. However,
21st Century Cures (or at least many of its major provisions) is the rare initiative that has enjoyed bipartisan support in an ever-gridlocked
Congress. As the draft summary takes pains to note, the reforms proposed in the bill come from top Democrats and Republicans alike, including
Sens. Michael Bennett (D-CO) and Orrin Hatch (R-UT), Rep. Joe Pitts (R-PA), Rep. Marsha Blackburn (R-TN), Rep. Diana DeGette (D-CO), and even
the White House. But an ambitious mishmash of ideas, bipartisan or not, does little to ensure comity or final
passage in today's tumultuous legislative landscape. Last minute hang-ups over controversial
provisions, or the specifics of the bill's funding mechanisms, could easily derail the whole effort (see:
every year that Congress has failed to pass a permanent "doc fix"). And then there's the fact that Congress is, for the first time during
Barack Obama's presidency, now fully controlled by Republicans. That means that Senate health committee
leadership has flipped from Democrats to the GOP, and Republican staffers are the ones who get to
write the actual language of the bill. This could lead to some chest-thumping and scuffles over turf
(not to mention legislative minutiae).
 2NC---AT: No Link
The FDA is tied to the executive and politically controversial
Cook 1 (Kate- Harvard paper. “The Presidential FDA: Politics Meet Science”. Pgs 8-9.
http://dash.harvard.edu/handle/1/8852216//GH)
In spite of the FDA’s long history, the agency was not recognized in Congressional legislation until 1988.27 Moreover, until 1988 the head of the
agency – the Commissioner of Food and Drugs – was appointed by the Secretary of Health and Human Services. Since 1988 however, the

FDA Commissioner must be appointed by the president with the advice and consent of the Senate.28 Because of
the public interest in food and drug regulations the FDA is a highly visible administrative agency . “The
potential sensitivity of its decisions always have given the Commissioner a direct line to the Secretary of
HHS and, sometimes the White House as well.”29 Formally placing the responsibility of appointing the
Commissioner of the FDA in the hands of president rather than the Secretary makes explicit the importance
of the job, exposes the inherently political nature of the job , and suggests that indeed the executive is
properly located in the executive branch of government. That is, the FDA does not have the same independence of
presidential control that “independent agencies” enjoy. Indeed, the Commissioner can be removed from her position at the will of the
president for any or no reason.30 Supreme Court doctrine has construed the president has the power to remove an employee (as designated
by Congress) as evidence of whether or not the executive has authority to control the policies of the agency in question.31 Interestingly, prior
to the statutory grant that the Commissioner shall be appointed by the president – back when the Health and Human Services Secretary
appointed this head – few administrative transitions resulted in a high level of resignations or reassignments among the agency’s middle and
upper-level managers.32 Thus, many observers have noted that unlike some of its peer agencies, the FDA has historically operated without
substantial political influence.33 Nonetheless, multiple political organizations pull the FDA in different directions
(sometimes contradictory): Congress, the president, the consumer protection lobby, the pharmaceutical lobby, and the bureaucracy in general.
To fully expose and compare the relative influence and strength of these political bodies is beyond the scope of this paper; suffice it to say

however, that every decision the FDA faces will create political results —effecting given constituencies and harming
others.
 2NC---FDA Link
The plan is unpopular---business lobbies
Smith 10 (Douglas- Senior Lecturer in Residence at Loyola University Chicago School of Law. “The criminalization
of Business”. 6/16/2010. http://spectator.org/articles/39409/criminalization-business//GH)

Under the radar, the Obama administration has exhibited a disturbing tendency to criminalize business .
Recently the administration announced that it was opening a criminal investigation into the activities of Goldman Sachs in selling securities
backed by subprime mortgage loans. Now comes word that the Food and Drug Administration is considering imposing
criminal penalties against Johnson & Johnson's McNeil Consumer Healthcare unit for a "pattern of non-
compliance" with rules governing the manufacture of pharmaceutical products. This criminalization of business represents a

dramatic expansion of government power that is unwarranted . In the case of McNeil, the FDA's action is prompted
by a series of recalls of contaminated over-the-counter children's medicines. While this is a potentially serious matter, FDA
official
Joshua Sharfstein recently acknowledged in congressional testimony that "the risk for any child in the
United States was remote" and that "[s]o far, FDA has no cases with evidence that a product quality issue contributed to a significant
adverse health outcome." Moreover, Mr. Sharfstein's testimony makes clear that the FDA was long aware of potential
problems at McNeil's facilities. As he acknowledged, "Before 2009, FDA investigators identified several problems with cGMP
compliance at facilities run by McNeil." Nonetheless, only now has the FDA suggested that criminal penalties are
warranted. Moreover, recent comments by FDA officials indicate that this latest action may be part of a wider program
to make its regulatory program more "visible" by, among other things, "strengthening…criminal enforcement of FDA's laws."

FDA reform is unpopular---economy

Smith ND (Fred- founder of the competitive enterprise institute. Pg 1. “Expectations for a New Congress The
Triumph of Hope over Experience?”. https://cei.org/pdf/5705.pdf//GH)

**I can’t find a specific date but it was written in the context of the 110 Congres so it’s from this decade I promise
Speaker Pelosi has suggested revising some of the more burdensome aspects of the Sarbanes-Oxley Act; we hope to work with her and others
on this issue. We hope to share with the new Congress our ideas on how to jump-start the stalled economic liberalization process—hampered
by botched, partial deregulations in electricity, telecommunications, airlines, and other network industries . We also hope to work with
the new Congress on Food and Drug Administration (FDA) reform, to speed the process of bringing new life-saving drugs to
market. With major change comes major risks. As a Louisianan well aware of the something-for-nothing allure of populism, I
see worrisome traces of it in the current political climate. Mistakes made in the name of “helping the
little guy” can hurt everybody in the long run, by creating long-lasting damage to the American
economy. Proposals for one-size-fits-all mandates in areas like wages and prescription drugs threaten
to undermine many of the new Democrats’ recognition of the marketplace as the best means of allocating resources. We
will happily work with lawmakers of both parties to help stop bad bills such as these.
Disease CP
 1NC---Disease CP
Text: The Department of Defense should build the military public health capacity of
countries with weak civilian emergency response and engage multilateral forces to
undertake broader disease response efforts.

DOD solves disease best---global connections

CSIS 10 (Center for Strategic and International Solutions- policy proposal institution based on coming up with
international policies for growing problems. “From Conflict to Pandemics Three Papers from the CSIS Global Health
and Security Working Group A Report of the CSIS Global Health Policy Center”. Pg 3-4. May 2010.
http://csis.org/files/publication/100506_Bonventre_FromConflictToPandemics_Web.pdf//GH)

DOD’s geographic combatant commands build and maintain relationships with militaries across the
globe through disaster responses, civic assistance missions, training exercises, and formal security cooperation programs. This network
of connections to foreign militaries gives DOD access to senior decisionmakers across the globe. In countries with
weak civilian emergency response capacity, governments often turn to their militaries for emergency responses. Focusing a portion of

military-to-military activities on building the military public health capacity of these countries could
fill important gaps in global disease detection and response . DOD also has an opportunity to engage
multilateral forces such as UN peacekeeping operations, NATO, the African Union, or other regional
military forces to undertake broader disease surveillance and response efforts . Using the World Health
Organization (WHO) or other neutral international organizations as an independent interlocutor can facilitate the building of trust and
strengthen partnerships between military and civilian health agencies and result in a fuller DOD engagement with a greater legitimacy.8 For
example, officials from NATO, WHO, and DOD’s Global Emerging Infections Surveillance and Response System (GEIS)
met with Russian counterparts in 2003 to discuss pandemic preparedness . A follow-on event on emerging disease
surveillance, communication with civilian counterparts, and compliance with the legally binding and internationally agreed upon International
Health Regulations (IHRs) is being planned for fall 2010 under the aegis of WHO and the International Congress of Military Medicine, a
consortium of military surgeons general from 104 nations. There
is an opportunity to leverage these expanding global
networks of military medical policymakers, some of whom command more health capacity than their
civilian health ministries.
 2NC---Solvency
Empirics prove the DOD is the most effective
CSIS 10 (Center for Strategic and International Solutions- policy proposal institution based on coming up with
international policies for growing problems. “From Conflict to Pandemics Three Papers from the CSIS Global Health
and Security Working Group A Report of the CSIS Global Health Policy Center”. Pg 4-5. May 2010.
http://csis.org/files/publication/100506_Bonventre_FromConflictToPandemics_Web.pdf//GH)

DOD’s domestic and overseas military laboratory network has a long and rich heritage, having contributed over
the years to many important developments in preventive medicine that not only benefit uniformed personnel, but also
contribute to improving overall global public health. The Centers for Disease Control and Prevention (CDC), for example, evolved out
of a wartime agency established to reduce malaria around military training bases in the southern United States These laboratories were
originally established for the explicit purpose of researching and developing products (e.g., yellow fever vaccine, antimalarial drugs) that would
preserve and protect the health of our uniformed personnel; these efforts continue to this day through the Military
Infectious Diseases Research Program. Although geographic locations of the laboratories have changed over time, their current
sites are in Peru, Thailand, Southeast Asia, Egypt, and Kenya, assuring broad visibility to global health risks. In 1996, after Presidential
Decision Directive 7 stated that DOD’s role should be “expanded to include support of global
surveillance, training, research, and response to emerging infectious disease threats,” the DOD Global
Emerging Infections Surveillance and Response System (GEIS) was established to implement this directive. The GEIS
program brought much needed flexibility to DOD’s laboratories by facilitating outbreak investigations,
disease surveillance, capacity building, and training that directly benefits host nation civilian
populations while simultaneously improving collaborative military-to-military relationships and
providing baseline disease-specific data to help frame future DOD research priorities .
Corruption CP
 1NC---Corruption CP
Text: The United States Federal Government should create the International Anti-
Corruption Court as proposed by Mark L. Wolf.

Solves the corruption advantage and doesn’t link to politics---wide domestic support
Biron 14 (Carey- Washington correspondent for IPS. “Proposal for International Anti-Corruption Court Seeing
“Significant” Momentum”. 11/21/2014. http://www.ipsnews.net/2014/11/proposal-for-international-anti-
corruption-court-seeing-significant-momentum///GH)

The key U.S. advocate of a proposal to create a multilateral body mandated to investigate allegations
of political corruption says the idea is receiving significant interest from civil society, politicians and major
business leaders. Mark L. Wolf, a U.S. federal judge, first proposed the idea of an International Anti-Corruption

Court (IACC) in two articles this summer (available here and here). Since that time, Wolf told a recent briefing at the U.S. Congress, the proposal
has seen “remarkable progress”. “There are, of course, challenges to refining the concept of an IACC,”
Wolf told a House of Representatives committee last week. “However, since July 2014 significant support has developed for meeting

these challenges.” Wolf reported ongoing meetings with U.S. officials and the World Bank, and
reported that the new United Nations high commissioner for human rights, Zeid Ra’ad Hussein, has
made the IACC proposal a “personal priority”. Hussein was a key force in the creation of the International Criminal Court, a potential
model for the IACC. This week, Wolf is addressing representatives of major global companies. “ American companies generally want to behave ethically

and, in addition, are significantly deterred by the threat of prosecution,” Wolf stated. “They k now they would benefit from the more level

playing field an IACC would provide.” Indeed, many say the speed with which the congressional committee
moved to hold last week’s briefing is remarkable. It underscores a uniquely broad consensus, both
domestically and internationally, around the need to crack down on what is referred to as “grand
corruption” – the abuse of political office for personal gain. Increasingly, this issue is being seen as less one of theft than of basic human rights. “ Today’s
briefing seeks to foster an understanding that human rights and anti-corruption efforts are
inseparable,” James McGovern, the member of Congress who chaired the committee’s discussions, stated in opening remarks. “Currently, there is a lack of
reference to human rights in international anti-corruption commitments and, conversely, the lack of reference to corruption in international human rights
instruments.” 140,000 children a year Grand corruption is today thought to eat up more than five percent of global gross domestic product. According to estimates
cited by Judge Wolf, illicit financial flows out of developing countries are 10 times larger than the foreign assistance those countries receive – losses that have direct
human consequences. “In the developed world we can make the mistake of seeing corruption as merely stealing money, but in fact political corruption kills more
people than war and famine put together – 140,000 children a year, by our estimates,” Akaash Maharaj, the executive director of the Global Organization of
Parliamentarians Against Corruption (GOPAC), told IPS. “If a political actor were to kill that many people, there would be very few people who wouldn’t say that we
have to deal with this problem. But those who bring about human suffering through political corruption are no less guilty.” GOPAC,
which includes
legislators from almost every country, has been mobilising around the need for concerted
international action against corruption for the past three years . Maharaj says that his organization’s membership has lost faith
in the ability of many countries to deal with political corruption at the national level. While there are international mechanisms that

threaten penalties for egregious human rights abuse, for the most part corruption continues to fall
into a nebulous zone of national responsibility . Existing multilateral agreements, including the United Nations Convention Against
Corruption, which came into effect in 2003, lack substantive enforcement mechanisms. Yet while anti-corruption legislation exists in almost every country,
advocates note that many of the most corrupt officials are often able to use their wealth and power to subvert these laws. These figures are typically the least likely
to face domestic justice, and thus can come to expect impunity. “There are certain crimes so beyond the pale and beyond state
capacity to prosecute that it becomes appropriate for the international community and for
international law to become engaged. Certainly the harm grand corruption causes in many developing countries is enormous,” Zorka Milin, a
legal adviser with Global Witness, a watchdog group, told IPS. “ An international court would be a good mechanism for trying

to translate that momentum into meaningful accountability, which we haven’t really seen so far. It’s
important to frame the discussion in terms of ending impunity , and this court would be one piece of that, together with other
legal anticorruption tools at the domestic level.” Under Wolf’s proposal, an IACC would be mandated to investigate and prosecute officials from countries that are
unable or unwilling to undertake such actions on their own. He suggests making acceptance of the proposed court’s jurisdiction a pre-condition for membership
under the Convention Against Corruption or at the World Trade Organisation, or for obtaining loans from multilateral banks. Inevitable, unclear action The global
discussion today is increasingly conducive to some sort of concerted global action against political corruption. In part, this trend is driven by strengthened concern
around the effects that tax evasion is having on public coffers in both developed and developing countries. “ Unquestionably,
there is today
more momentum and awareness on the issue of grand corruption, and that’s the major reason these
issues are rising on the international agenda,” Milin says. GOPAC’s Maharaj agrees. “I’m struck by the extraordinary level of consensus
across the world,” he says. “This is absolutely inevitable. It’s not a matter of if, but when.” Exactly what should be done about the issue, however, remains highly
contentious. There are multiple potential options, after all, with an international court being just one. Others include expanding the purview of the International
Criminal Court or other regional human rights courts. Likewise, the jurisdiction of national judicial systems could be enlarged to be able to deal with allegations of
corruption in other countries. Another possibility could be to coordinate national legislation – and priority – in developed countries, aimed at seizing the assets of or
denying visas to corrupt officials. While this would not result in jail time, it would make it harder to spend ill-gotten wealth while simultaneously emphasising
international disapproval. Importantly, some countries have become increasingly aggressive in this regard in recent years, particularly the United States and
Switzerland. Watchdog groups say these nascent initiatives are important and already having impact. “ Over
the last eight years there’s been
growing official action against kleptocracy in the U.S. and elsewhere,” Arvind Ganesan, the head of the business and
human rights programme at Human Rights Watch, told IPS. “Strengthening those efforts now – meaning fully resourcing and

expanding them, and pushing other countries to put in place similar policies – will build momentum
towards an International Anti-Corruption Court.”
 2NC---Solvency
IAAC solves corruption
Wolf 14 (Mark L- senior united states district judge. “The Case for an International Anti-Corruption Court”. July
23, 2014. Pg 1. http://www.brookings.edu/research/papers/2014/07/international-anti-corruption-court-
wolf//GH)
International efforts to combat grand corruption have been inadequate and ineffective. Similar circumstances concerning genocide and other
egregious abuses of human rights led to the creation of the International Criminal Court (“ICC”) in 2002. An
International Anti-
Corruption Court (“IACC”), similar to the ICC or as part of it, should now be established to provide a
forum for the criminal enforcement of the laws prohibiting grand corruption that exist in virtually
every country, and the undertakings that are requirements of various treaties and international organizations. Staffed by elite
investigators and prosecutors as well as impartial judges, an IACC would have the potential to erode
the widespread culture of impunity , contribute to creating conditions conducive to the democratic
election of honest officials in countries which have long histories of grand corruption, and honor the
courageous efforts of the many people, particularly young people, who are increasingly exposing and opposing corruption at
great personal peril.
Biotech Turn
 1NC---Biotech Turn
Biotech is in a bubble now because of FDA approvals---plan bursts it
Zuckerman 3/26 (Gregory, Wall Street Journal, 3/26/15, “Biotech stocks inflate fears of Nasdaq
bubble”, http://www.theaustralian.com.au/business/wall-street-journal/biotech-stocks-inflate-fears-of-
nasdaq-bubble/story-fnay3ubk-1227278542038, Accessed 7/26/15)//LD

Nasdaq bubble fears are back. But this time around, the biggest dangers may not involve technology stocks.
Instead, some investors are looking askance at biotech stocks, a sector that wasn’t nearly as developed when the Nasdaq Composite
Index set its record close in 2000 of 5048.62. The Nasdaq Biotech Index is up about 240 per cent since the
beginning of 2012. That dwarfs the 82 per cent gain logged by the Nasdaq-100 tech index of the largest technology companies listed on
the exchange operated by Nasdaq OMX Group. Giant biotech firms have surged in value: both Gilead Sciences, valued
at $US152 billion ($192bn), and Amgen, at $US127bn, have risen 40 per cent over the past year. Biogen, valued at
$US108bn, has climbed 47 per cent. Celgene, valued at $US99bn, is up 75 per cent. “If any part of the
market reminds me of the go-go tech years, it’s biotech ,” said Jack Ablin, chief investment officer at
BMO Private Bank. “It’s an expensive sector.” Companies developing biotech drugs — often upstarts that can be
acquisition targets for larger pharmaceutical companies — comprise 13 per cent of the Nasdaq Composite Index by
market value but have accounted for 27 per cent of the index’s gain over the past year , according to Birinyi
Associates. Biotech firms generally seek to develop medicines using living cells rather than chemicals. Nasdaq biotech shares have advanced
27.4 per cent over the past six months and roughly 17 per cent so far this year, compared with gains of 7.3 per cent for Nasdaq-100 Technology
Sector Index shares over the past six months and 1.4 per cent this year. Behind the surge are heady earnings growth,
more approvals from the Food and Drug Administration and investor enthusiasm for a range of new
biotech drugs and potential treatments . However, biotech stocks often are viewed as a gamble for investors: high-risk and high-
reward propositions that can drop like a rock if a drug trial fails or funding runs out. Biotech shares have been hammered en
masse several times, notably in 1990, 1993 and 2000 . “To us, shares of biotech companies find
themselves entering bubble territory ,” said Darren Pollock, portfolio manager at Cheviot Value Management. “We think
investors are applying too high a success rate on biotech molecules. ” For all the sector’s recent successes, some
see recent excitement for biotech shares as the latest sign that low interest rates are encouraging
investor to take excessive risks. If the economy slows, or rates start climbing, investors could turn more conservative and shy away
from these companies, which often offer little in the way of earnings. A burst of IPOs of biotech companies over the past few years raises other
concerns that these companies and selling insiders may be cashing in on investor excitement at the expense of public shareholders. That is why
some investors are becoming wary. Biotech
shares in the Nasdaq now trade at almost 50 times their earnings
over the past year, compared with a price/earnings ratio of 27.5 for the overall Nasdaq Composite .
Nasdaq biotech shares trade at 31.5 times their expected earnings over the next 12 months, above the 21 ratio for the overall Nasdaq market,
according to FactSet.

The impact is economic collapse – pharma supports resilience

Sullivan 11 (Thomas Sullivan, founder of Rockpointe Inc., former political consultant, “Study Shows
Importance of Biopharmaceutical Jobs For US Economy,” Policy and Medicine, July 12, 2011,
http://www.policymed.com/2011/07/study-shows-importance-of-biopharmaceutical-jobs-for-us-
economy-for-every-20-billion-loss-in-revenue.html)

pharmaceutical research companies produce the highest-value jobs, the types of jobs Americans want in the 21st century economy, the
Bio

kinds of jobs that can drive future economic growth. No other sector has the ability to drive
innovation, create high-quality jobs and provide new life-saving medicines for patients. According to a recent report from the Battelle Technology Partnership Practice (TPP),
 pharmaceutical sector supported a total of 4 million jobs in 2009, including nearly 675,000 direct jobs. Battelle is the world’s largest non‐profit independent
“nationwide, the bio

research and development organization, providing innovative solutions to the world’s most pressing needs through its four

global businesses. TPP has an established reputation in state‐by‐state assessment of the biopharmaceutical sector, and has recently undertaken major impact assessment
projects for the Human Genome Project, the nation’s biotechnology sector, and major bioscience organizations such as Mayo Clinic. TPP has also been active in provision of analysis to industry
organizations, including the Council for American Medical Innovation, PhRMA and BIO‐the Biotechnology Industry Organization. Each job in a biopharmaceutical research company supported
almost 6 additional jobs in other sectors, ranging from manufacturing jobs to construction and other building service jobs to contract researchers and child care providers. Together, this
biopharmaceutical sector‐related workforce received $258 billion in wages and benefits in 2009. “Battelle also found that across all occupations involved in the biopharmaceutical sector, the
average wage is higher than across all other private sector industries, due to the sector’s role as a ‘high value-added sector.” Specifically, the annual average personal income of a

biopharmaceutical worker was $118,690 in 2009 as compared to $64,278 in the overall economy. Additionally, the biopharmaceutical sector’s total
economic output (including direct, indirect and induced impacts) was $918 billion in 2009. The sector generated an estimated $85 billion tax revenues in 2009—
$33 billion in state and local and more than $52 billion in federal. This impact comprises $382 billion in direct impact of biopharmaceutical businesses and $535 billion in indirect and induced
impacts (an output multiplier of 2.4—meaning that every $1 dollar in output generated by the biopharmaceutical sector generates another $1.4 in output in other sectors of the economy). To
put this export volume into perspective, 2010’s total biopharmaceutical exports of $46.7 billion compares favorably to other major U.S. exports including: automobiles ($38.4 billion in 2010
exports); plastics and rubber products ($25.9 billion); communications equipment ($27 billion) and computers ($12.5 billion). In addition, the U.S. Congressional Budget Office noted that, “the
pharmaceutical industry is one of the most research‐intensive industries in the United States and that pharmaceutical firms invest as much as five times more in research and development,
relative to their sales, than the average U.S. manufacturing firm.” At over $105,000 in biopharmaceutical R&D per employee, the sector is way ahead of the average across all U.S.
manufacturing which stands at about $10,000 per employee—and is far ahead of the second and third ranked sectors of “communications equipment” and “semiconductors, which
respectively spend $63,000 and $40,000 per employee in R&D annually. PhRMA Statement on Battelle Report Consequently, Pharmaceutical Research and Manufacturers of America (PhRMA)

President and CEO John J. Castellani issued a statement discussing the results from this report and the bio pharmaceutical research sector’s impact on jobs
and the American economy. Castellani asserted that, “at a time when the U.S. is facing a jobs crisis, evidenced by the terrible employment numbers from last Friday, it
is critical that our policymakers embrace dynamic and innovative business sectors such as the biopharmaceutical
research sector and refrain from stifling job growth through shortsighted proposals such as government-mandated price controls in Medicare Part
D.” Specifically, the PhRMA CEO pointed to a new paper from the Battelle Technology Partnership Practice, which underscored the pharmaceutical sector’s tremendous contribution to
America’s economy. Castellani recognized that, “startling potential job losses would result from undermining the business foundations of biopharmaceutical companies.” He noted that the
Battelle report estimated “that a $20 billion per year reduction in biopharmaceutical sector revenue would result in 260,000 job losses across the U.S. economy” and a $59 billion reduction in
U.S. economic activity. As a result, Castellani recognized that, “as the President and Congressional leaders negotiate an important agreement on the debt ceiling and the future of the nation’s
economy, it is critical that the jobs crisis is not exacerbated.” For example, Castellani noted how “the President and some in Congress have proposed including government-mandated rebates
in Medicare Part D as part of a debt ceiling agreement.” However, he recognized that “such a provision would have a dramatic negative effect on the economy and patients, and could
undermine the success of the Part D program, which has very high beneficiary satisfaction and has cost far less than original government projections.” He pointed to the “Battelle numbers,
which clearly demonstrated that reducing the biopharmaceutical sector’s annual revenue by $20 billion would be a serious blow to employment.” Castellani added that, “while the research is
not specific to any one policy or event, proposals being considered, such as government-mandated Part D rebates, would be expected to have revenue impact of this magnitude.” Moreover,
he noted that, “Part D is an unparalleled success, providing unprecedented access to life-saving medicines for seniors.” Accordingly, Castellani asserted that PhRMA does not “believe policies
that discourage R&D and cutting-edge science and that will inevitably slow the development of needed new medicines are fair for seniors waiting for new treatments against our most
challenging and costly diseases.” Battelle Report The Battelle Report quantifies the economic impact of the biopharmaceutical sector on the U.S. economy and jobs using input/output analysis,
measures the direct and indirect impacts of the biopharmaceutical sector, and quantifies the economic impacts that would occur if biopharmaceutical revenues increase or decrease from
significant changes in the business operating environment. The report also highlights some of the functional impacts of the sector—the wide‐ranging benefits provided through the

biopharmaceutical sector’s contributions to enhancing human health, improving life spans and sustaining the high quality‐of‐life that Americans enjoy—and
assesses the contributions of the biopharmaceutical sector to key areas of importance to our economy—
innovation, product exports and quality of jobs produced. The Battelle Report starts by recognizing that the biopharmaceutical sector has all of the
characteristics for an ideal industry for economic growth and sustainability in the U.S. Specifically, the biopharmaceutical sector: Grows in output and employment even in tough

economic times Provides high wage, good quality jobs Is innovative and deploys high‐technology to generate comparative advantage for U.S. companies Generates

significant exports that boost the U.S. economy Has a strong supply chain that drives further economic growth across the economy through “multiplier effects” Builds on

America’s long‐standing strengths and investment in fundamental and applied research Encourages capital flows to sustain growth, and is

profitable to provide funds for reinvestment into the research and development (R&D) cycle; Generates federal, state and local taxes and
other economic contributions that support public services Is sustainable and not a major drain on global resources Is geographically dispersed, providing opportunities for job creation and
economic growth across many areas of the nation, not just a few selected places Produces a product of value to society, something that improves the quality of life for humankind, including

Improved productivity resulting from prevention and effective management of

Improved life spans (personal longevity)

disease and chronic conditions; and Reductions in unnecessary hospitalizations resulting in potential cost‐offsets elsewhere in the health care system.
Fundamental to major progress in human longevity, reducing the marginalization of individuals from disease and disability, and generally improving our quality ‐of‐life, biopharmaceuticals are a
unique contributor to societal and individual well‐being. Moreover, the output of the biopharmaceutical sector is highly valued by society because the sector develops and manufactures a
broad‐range of unique products to treat disorders and diseases that, were they to go untreated, can ruin individual quality of life, personal abilities and productivity. In many instances,

pharmaceuticals are central to helping to prevent and treat a range of public health issues , address pandemic risk
bio

and thereby support national economic security. For example, innovation in the biopharmaceutical sector, combined with the diagnostic and treatment skills
of U.S. healthcare professionals, has contributed to a lengthening of the average life span of Americans. In 1900, the expected life span of an American at birth was just 47.3 years. With the
advent of more modern medicines and advanced medical knowledge, life expectancy at birth has seen a steady increase rising to 69.7 years in 1960, and 77.9 years in 2007. In fact, the
National Bureau of Economic Research reports that “there is a highly statistically significant relationship between the number of new molecular entities [drugs] approved by the FDA and
increased longevity.” Furthermore, Lichtenberg found in a study of FDA data that "approval of priority‐review drugs—those considered by the FDA to offer significant improvements in the
treatment, diagnosis, or prevention of a disease—has a significant positive impact on longevity.” Additionally, the American Hospital Association (AHA) notes that “advances in medicine
contribute to national economic growth by helping Americans recover more quickly from injury and illness, avoid lost or ineffective work time due to flare ‐ups of chronic conditions, and live

Without effective medicines and treatments for illnesses, injuries, pain and chronic conditions, the productivity of
longer with higher quality of life.”

the U.S. economy would clearly be greatly impaired . Biopharmaceuticals are a key contributor to a
more productive and healthy America and U.S. economy. Beyond direct employment in biopharmaceutical companies, the biopharmaceutical sector is the
foundation upon which one of the United States’ most dynamic innovation and business ecosystems is built. A large part of the modern biomedical economy is built upon a robust foundation
of biopharmaceutical companies that perform and support advanced biomedical and technological R&D, and act as the funnel and distribution engine for getting life ‐saving and quality‐of‐life‐
sustaining therapeutics to the marketplace. Providing R&D impetus and funding, capital resources, technology licensing opportunities, and a sophisticated market access and distribution
system, the biopharmaceutical sector is of central importance to the much broader biomedical and life sciences economy. Fueled by private investment capital, venture capital investments,
and public/private collaborations, and enabled by the U.S. open market system, the nation has been able to advance biomedical innovation, which in turn has led to new start ‐up companies,
business growth and exports across the world. Conclusion Despite the tremendous success in the biopharmaceutical industry, emerging infectious diseases continue to present new challenges
and a substantial volume of long‐standing diseases such as cancer, diabetes, neurodegenerative diseases, psychiatric diseases, immunological diseases, etc. continue to demand novel

treatments and improved therapeutics. There are millions of people suffering from diseases and disorders for which a therapy has yet to be found. The need for ongoing
biopharmaceutical research and development is simply enormous. The only way the U.S. economy can stay ahead
of international competition is by using advanced R&D and innovation to drive the growth of high value‐added industries. By
leveraging investment in federal lab, university and industry R&D, our nation is able to produce high‐value, typically technologically advanced products that the rest of the world values highly.
In recent decades, life sciences have come to the fore as a leading driver of U.S. technological innovation and competitive advantage, and the biopharmaceutical sector is a key foundation of
the life sciences innovation ecosystem. The Unites States’ biopharmaceutical industry produces products that save, sustain and improve lives, and the sector has a large and significant

Gains or losses in biopharmaceutical sector revenues will be

economic impact, affecting many other key areas of the U.S. economy.

reflected in gains and losses across a broad range of additionally important U.S. economic sectors that
have robust supply chain relationships with the biopharmaceutical sector .

Econ decline causes nuclear war

Hutchinson 14 (Martin, Business and Economics Editor at United Press International, MBA from
Harvard Business School, former international merchant banker, 1-3-14, “The chilling echoes of 1914, a
century on” Wall Street Journal) http://online.wsj.com/articles/william-galston-secular-stagnation-may-
be-for-real-1409095263,

The years before 1914 saw the formation of trade blocs separated by high tariff barriers. Back then, the world was
dominated by several roughly equivalent powers, albeit with different strengths and weaknesses. Today, the world is similarly multi-polar. The
United States is in a position of clear leadership, but China is coming up fast. Europe is weaker than it was, but is still a force to be reckoned
with. Japan, Russia, Brazil, India are also too powerful to ignore. A hundred years ago, big international infrastructure projects such as the
Berlin-Baghdad Railway, and before it the Suez Canal, were built to protect favored trading. Today’s equivalent may be the bilateral mining
partnerships forged between, for instance, China and mineral-rich African states. Today, the World Trade Organization offers some defence
against tariffs. But protectionism could be become entrenched if prolonged economic stagnation leads countries to pursue their own narrow
interests. Germany, Austria, Russia and France lost between 20 and 35 percent of national output between 1913 and 1918, according to Angus
Maddison’s data used in Stephen Broadberry’s “The Economics of World War One: A Comparative Analysis”. British GDP declined in 1914 and
1915, but grew 15 percent over the four years, as did the U.S. economy. The 37 million military and civilian casualties may tell a more accurate
story but if
history were to repeat itself, the global conflict could be both more universal and more destructive.
Nuclear weapons proliferate. Warped diplomatic anger could lead to the deployment of chemical and
biological devices. Electromagnetic pulses could wipe out our fragile electronic networks. Like the assassination of
Archduke Ferdinand that sparked World War One, the catalyst for cataclysm might be something quite surprising. A global run on bank and
other investment assets or an outbreak of hyperinflation, maybe? These threats get more serious the more policymakers pump up equity,
bond, property and banking bubbles. If global
wealth evaporates, or is proven to be an illusion, today’s largely cordial global
entente could be smashed with precipitous speed.
 2NC---Ext. Yes Biotech Bubble
Yes biotech bubble---stock prices have risen 88%
Sarich 7/18 (Christina, Collective Evolution, 7/18/15, “Biotech Stock Bubble About To Pop & Here’s
Why”, http://www.collective-evolution.com/2015/07/18/biotech-stock-bubble-about-to-pop/, Accessed
7/26/15)//LD

Remember the dot.com bubble? How about the housing bubble? If you are old enough you can probably even remember gas
rationing. In the increasingly more transparent manipulation of markets, the biotech bubble is now set to
pop. The dot.com bubble may not have affected you, but if you made it through that one unscathed, then you may have been bruised and battered by the housing
bubble – even if you weren’t part of the mortgage scam, which mainly targeted the poor but affected the entire nation, since bank bailouts were largely funded with
the idea of ‘people’s inability to pay’ used as a scapegoat, though big bank fraud was really to blame. Pump and Dump These scams can be hard to keep track of, let
alone understand, but they are all based on a single premise – pump and dump. An
industry is inflated as the next best thing – and
puffed up to such a degree, even the most level headed among us think we’re missing out if we don’t invest, also called the pump.
Then prices are manipulated, the one percent that run the entire world push a few buttons, and everything is devalued –
that’s the dump. If you haven’t noticed, the biotech industry has been heavily pumped lately . We’ve been inundated with
press about genetically modified this, and gene-edited that. From GM wheat trials that fail to the tune of several million dollars, to GM corn being refused by China,
the writing has been on the wall that the biotechnology dump is just around the corner . In fact, the Zero
Hedge website pointed out many months ago that one of the sectors which was “substantially
stretched” in this country was biotech: Nevertheless, valuation metrics in some sectors do appear substantially stretched—particularly those
for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year… Equity valuations of
smaller firms as well as social media and biotechnology firms appear to be stretched, with ratios of prices to forward earnings remaining high relative to historical

norms. Even with this news, however, biotech stock prices have skyrocketed over 88 percent . Matt Taibbi, one of my
favorite journalists for Rolling Stone, talks about this phenomenon with great acumen in an article titled, The Great American Bubble Machine. As he so eloquently
points out, “Goldman Sachs is everywhere.” He continues: The world’s most powerful investment bank is a great vampire squid wrapped around
the face of humanity, relentlessly jamming its blood funnel into anything that smells like money. In fact, the history of the recent financial crisis, which doubles as a
history of the rapid decline and fall of the suddenly swindled dry American empire, reads like a Who’s Who of Goldman Sachs graduates. Though
the
banks did it with another type of ‘investment,’ biotech companies take advantage of the same
strategy. They sell GM food and the chemicals required to grow them to farmers throughout the
world, causing them to become dependant upon patented seed and proprietary chemical cocktails . Since
many farmers initially bought the propaganda that they were “helping to feed the world” and could “increase yields” or “fight weeds,”

they bought in. They put their investment in GM goods. We all bought in, and when I say we, I mean the world in general, though some of us did it kicking
and screaming. Then, the stock prices start to go up – this is the bubble . Though he’s talking about mortgages, he could be talking

about anything – from barrels of oil to GM soy. Taibbi explains: The formula is relatively simple: Goldman positions itself in the middle of a

speculative bubble, selling investments they know are crap. Then they hoover up vast sums from the
middle and lower floors of society with the aid of a crippled and corrupt state that allows it to rewrite
the rules in exchange for the relative pennies the bank throws at political patronage . Finally, when it all goes
bust, leaving millions of ordinary citizens broke and starving, they begin the entire process over again, riding in to rescue us all by lending us back our own money at
interest, selling themselves as men above greed, just a bunch of really smart guys keeping the wheels greased. Check out the evidence: MonsantoDow
Monsanto stock prices in the past five years have gone up, despite grassroots efforts to promote
divestment. So have the stock prices of Syngenta, Dow, and Bayer . Overvalued? That’s an
understatement. SyngentaBayer These companies have single handedly caused super weeds, super bugs, and farmer suicides in India. The WHO just
called one of Monsanto’s biggest selling chemicals “probably carcinogenic.” That’s the same chemical that their inaugural crops were developed for – thus the
name, Round Up Ready. There is no evidence that GM seed yields more crops, and a large part of the world, including Russia, won’t even allow their import any
longer. The biotech bubble is ripe, and its about to pop like gum gone rancid.
Biotech is a bubble---collapse in the pharma industry will cause a burst
Nisen 15 (Max, Quartz, “Forget the tech bubble. It’s the biotech bubble you should worry about,” 2-19-
15, http://qz.com/324939/biotech-valuation-bubble/, ava)
CAR T-cell therapy, for example, genetically engineers the body’s own immune cells to attack tumors. It has shown the potential to rapidly
eliminate some cancers. But the problem—besides the fact that it could cost $300,000 or more per patient for a one time treatment—is
preventing the cells from attacking healthy tissues, or releasing dangerous chemicals into the bloodstream. And the research has yet to yield a
commercially available treatment. But none of that has stopped the market going nuts on small bits of news about the therapy. In January,
Intrexon, Ziopharm and MD Andersen Cancer Center announced a licensing agreement for this kind of technology at J.P. Morgan’s biotech
conference. Intrexon’s stock almost immediately jumped $10 per share, adding a billion dollars to its market capitalization, while Ziopharm’s
stock price nearly doubled. The cause: Big
Pharma is suffering a science stagnation Momentum and market
optimism have a lot to do with these surging biotech valuations . But a more basic reason is that major
pharmaceutical companies, the ones worth hundreds of billions of dollars, badly need new drugs . A wave of patents
on blockbuster drugs have expired in the past few years, hitting the industry’s profits—the
phenomenon known as the “patent cliff.” But bringing new drugs to market has gotten more expensive.
According to a 2012 study, pharmaceutical firms spend an average of $4 billion in R&D for each drug that gets approval. For some companies
it’s as much as $12 billion. (Research sponsored by the industry puts the figure at $2.6 billion per drug, but such estimates, according to the
2012 study, don’t sufficiently account for high failure rates.) A
key reason is that it’s become harder to find promising
substances. Pharma’s traditional expertise, known as small molecule discovery (paywall)—screening large numbers of relatively simple
chemicals to find effective ones—is seeing rapidly diminishing returns. Years of investment in attempting to streamline,
speed up, and automate discovery haven’t panned out (pdf). A newer class of medicines called biologics (paywall)—made
up of giant molecules that adapt or exploit processes that already occur in the body—are more promising, but need a lot more investment.
Moreover, if companies try to research a broad portfolio of potential drugs—which might seem like a prudent way to ensure a few successes—
they risk ending up with spiraling costs and low returns, according to a recent report from Deloitte (pdf, p.4). The internal rate of return on
research and development (R&D) has fallen over the past few years, according to Deloitte’s analysis, which covers the 12 biggest R&D spenders
(see chart below). On some other measures, R&D productivity has been declining for more than a decade .
 2NC---ABR Impact
Antibiotic resistance causes extinction---new drugs are key
Davies 8 (Julian, British Columbia Microbiology and Immunology professor “Resistance redux:
Infectious disease, antibiotic resistance and the future of mankind,” EMBO Rep. Jul 2008; 9(Suppl 1):
S18–S21)

For many years, antibiotic-resistant pathogens have been recognized as one of the main threats to human
survival, as some experts predict a return to the pre-antibiotic era. So far, national efforts to exert strict control over the use of
antibiotics have had limited success and it is not yet possible to achieve worldwide concerted action to reduce the growing threat
of multi-resistant pathogens: there are too many parties involved. Furthermore, the problem has not yet really arrived on the radar screen of
many physicians and clinicians, as antimicrobials still work most of the time—apart from the occasional news headline that yet another nasty
superbug has emerged in the local hospital. Legislating the use of antibiotics for non-therapeutic applications and curtailing general public
access to them is conceivable, but legislating the medical profession is an entirely different matter. In
order to meet the growing
problem of antibiotic resistance among pathogens, the discovery and development of new antibiotics
and alternative treatments for infectious diseases, together with tools for rapid diagnosis that will ensure effective and
appropriate use of existing antibiotics, are imperative. How the health services, pharmaceutical industry and academia
respond in the coming years will determine the future of treating infectious diseases . This challenge is not to
be underestimated: microbes are formidable adversaries and , despite our best efforts, continue to exact a toll on
the human race.
Pharma Advantage Answers
 1NC---Big Pharma Down
Big pharma down now---strong dollar and patent losses
Kinahan 7/27 (JJ, 26-year trading veteran, regular CNBC guest, frequently quoted in the Wall Street Journal, Financial Times and
Reuters News, 7/27/15, “Big Pharma's Pfizer And Merck To Feel Pinch Of Strong Dollar, Patent Loss”,
http://www.forbes.com/sites/jjkinahan/2015/07/27/big-pharmas-pfizer-and-merck-to-feel-pinch-of-strong-dollar-patent-loss/, Accessed
7/28/15)//LD

Strong dollar headwinds are likely to smack pharmaceutical giants Pfizer Inc. (PFE) and Merck & Co.
(MRK) when they report earnings Tuesday ahead of the market’s opening. Both big pharma firms have a
heavy international presence—more than half of their revenues— and like other multinationals are
likely to feel the ravaging financial impact of foreign currency translations. Ahead of earnings, these
stocks tend to trade in similar fashion with volatility on both measuring in a relatively low 20th
percentile range. Pfizer Lost Celebrex, Lipitor Kingpin Pfizer (PFE), which has a 61% forex exposure, is
expected to turn in earnings of $0.52 a share on revenue of $11.42 billion, according to Thomson
Reuters. That’s below the year-ago results of $0.58 per share and $12.7 billion on the top line as the
company grapples with patent losses on blockbuster treatments including arthritis drug Celebrex and
cholesterol drug Lipitor, the best-selling drug of all time.
 2NC---Ext. Big Pharma Down
Big pharma is on a decline---3 warrants:
1. New pricing models undercut profits
Campbell 7/18 (Todd, E.B. Capital Markets, 7/18/15, “The 3 Biggest Threats to Big Pharma”,
http://www.fool.com/investing/general/2015/07/18/the-3-biggest-threats-to-big-pharma.aspx,
Accessed 7/28/15)//LD

Todd Campbell: According to the Memorial Sloan Kettering Cancer Center, drugmakers slapped prices
of nearly $10,000, or more, on eight of nine cancer drugs approved by the FDA since 2014, and last year
a new generation of hepatitis C medicines hit the market with $1,000 per pill price tags. Harvoni
SOURCE: GILEAD The soaring cost of newly approved therapies like these has payers incredibly
nervous and that's leading many of them to investigate new pricing models that could threaten Big
Pharma's payday. For example, Express Scripts has floated the idea of a pay-for-performance model
that would pay drugmakers more when their drug succeeds in a patient and less -- or nothing -- if their
drug fails. Insurers are right to be looking at new payment models given that they're likely to remain
under considerable pressure from governments to keep premiums affordable. Last month, California's
health-insurance exchange capped copays for people paying for high-priced medicine, forcing insurers
to make up the difference. This suggests that at some point the current trend in pricing will become
untenable. After all, insurers are already operating on single-digit margins, so there's not a lot of fat
for them to cut.

2. Stiff competition from generic pharma companies

Speights 7/18 (Keith, The Motley Fool, 7/18/15, “The 3 Biggest Threats to Big Pharma”,
http://www.fool.com/investing/general/2015/07/18/the-3-biggest-threats-to-big-pharma.aspx,
Accessed 7/28/15)//LD

Keith Speights: Stiff competition ranks as another huge challenge facing many Big Pharma companies.
And the biggest threats are coming from outside the ranks of the major drugmakers. Generic
pharmaceutical companies and "Little Pharma" -- the smaller up-and-coming players -- could make life
much tougher for Big Pharma in the years ahead. Lyrica SOURCE: PFIZER For example, look at Pfizer's
top-selling drug, Lyrica. Pfizer made over $5.1 billion last year from the drug, which is used to treat
several conditions, including fibromyalgia. But the company lost patent exclusivity for Lyrica in several
key European markets in July 2014. An assortment of generic drugmakers are chomping at the bit to
create their own versions of the drug. While Pfizer won a legal battle that holds off U.S. generic
competition for Lyrica until 2018, the threat from generics is significant. Meanwhile, smaller
pharmaceutical companies are hoping to dethrone Lyrica with new drugs. Theravance BioPharma is in
midstage clinical trials with TD-9855 targeting treatment of fibromyalgia, and the company thinks this
drug could wind up being "more compelling" than existing treatment options. What are Big Pharma
companies like Pfizer doing to remain competitive? Spending a lot of money. They are investing in
developing new drugs. And, in some cases, they'll buy some of those Little Pharma rivals to cover their
flanks and gain access to more new products. Those Big Pharma companies that don't spend their
money wisely could find themselves to ultimately be big losers.
3. Overestimated revenues and earnings
Budwell 7/18 (George, writing about healthcare and biotechnology companies since 2013, 7/18/15,
“The 3 Biggest Threats to Big Pharma”, http://www.fool.com/investing/general/2015/07/18/the-3-
biggest-threats-to-big-pharma.aspx, Accessed 7/28/15)//LD

George Budwell: Big Pharma's resurgence following the patent cliff has been closely tied to the advent of
multiple new classes of game-changing products, such as cancer immunotherapies and potent cholesterol-lowering drugs
known as PCSK9 inhibitors. As these groundbreaking drugs make their way to the market , though, we're learning
that their initial peak sales estimates might have been grossly overestimated for a variety of reasons. As Keith
noted, fierce competition is one factor that could cut deeply into the sales of any one new product. Last month, for example, an
advisory panel for the U.S. Food and Drug Administration recommended the approval of two PCSK9 inhibitors, Repatha and Praluent, from
Amgen and Sanofi/Regeneron, respectively, meaning that they'll now probably hit the market around the same time. And not to be left out,
Pfizer is planning on filing for regulatory approval for its own PCSK9 inhibitor within the next two years. When
the Street originally
pegged Praluent's peak sales at over $6 billion , however, the prevailing wisdom was that the drug would
enjoy a somewhat lengthy first-mover advantage -- a competitive advantage that has since evaporated
with the rapid development of Amgen's Repatha. Lymphoma SOURCE: WIKIMEDIA And then there is the problem
of how widely some of these new drug classes will be used in the real world . The cancer immunotherapy craze
had analysts suggesting that drugs based on the PD-1 and related PD-L1 proteins could generate sales in the stratosphere of $35 billion by 2020.
The clinical data, though, hints at a far leaner estimate. The basic issue is that patients
who respond to these treatments
tend to do so within three to four months , and their responses are often extremely durable. In short, there's
little reason to continue treatment beyond the four-month benchmark in most cases , and this issue
wasn't fully appreciated by the Street at first. All told, Big Pharma's revenues and earnings are likely to
continue to rise as these innovative new drugs barrel toward the market , but they probably won't
touch the sky-high peak estimates the Street was floating only a few months ago .
**TPP Scenario**
 1NC---Generic Drugs Bad
Generic drugs bad---don’t work as well and appearance changes cause confusion
Kamerow 11 (Douglas, chief scientist, RTI International, and associate editor, BMJ, 7/20/11, "The pros
and cons of generic drugs", BMJ, Vol. 343, Accessed 7/26/15)//LD

Not necessarily. Firstly, in the United States the financial incentives to use generics are not as dramatic as the cost
differences would indicate. Patients who have insurance see only the difference in copayments between generic and brand drugs, which is usually
tens rather than hundreds of dollars per prescription. Secondly, all this makes sense only if the generics are truly clinically

equivalent to brand name drugs. As Robin Ferner and colleagues point out in a recent review,5 there are lots of reasons to
expect that generic drugs may not work as well, or at least the same, as what the drug industry likes to call the “innovator”
products. Some generics use a different chemical version of the drug, such as another salt. They may use
different excipients to stabilise or flavour the drug, which can lead to different absorption properties
or adverse reactions. Although US generics must be proved to be bioequivalent to gain approval for sale by the Food and Drug Administration,
bioequivalence is required only within 90% confidenc e intervals. This may be fine for most drugs, but some conditions
may require drug levels with smaller variations. Full clinical trials are not required to approve generics —
that’s why they are so inexpensive, after all—so true clinical equivalence is never tested . There are lots of examples of

patients taking drugs requiring careful titration and close tolerances—anticonvulsants, antifungals, thyroid replacement, and others—who have
had therapeutic failures when they switch to generics . Because pharmacies constantly change which generic version they purchase,
depending on where they can get the best price, it is common for different generic versions to be dispensed each time

the prescription is refilled. I’ve seen these changes myself with my generic prescriptions for a statin and a sleeping tablet. Thirdly, and perhaps more
widespread and serious than the occasional clinical equivalence problem, is the confusion that may arise in many patients when they

find that their dependably yellow round pill is now a green oblong one after a generic is introduced or
changed. Patients, especially elderly patients, use colour to identify their pills,6 and they report great concern when

the appearance, packaging, and labelling change.7 This may lead to a paradoxical decrease in
adherence with generics that could be equal to or greater than the increased compliance seen because of lower
prices. To decrease this confusion Jeremy Greene and Aaron Kesselman have proposed that the FDA allow manufacturers of generic drugs to adopt the “trade
dress” (appearance) of the innovator drug.8
 2NC---Ext. Generic Drugs Bad
Big pharma solves disease better
Chris Lo 14, Progressive Media Reporter, "Drug prices: profits before patients?" Progressive Media, 6-9,
Lexis

A new UCL report questioning the use of off-label drugs to save money has been criticised for propping up an unfair status quo in the pharma industry. Pharma

companies charge high premiums for patented medications to recover costs, maximise profits and
help fund new R&D, but is there another way of funding high-risk research while avoiding budget-busting prices at the other end of the pipeline? The
pharmaceutical industry has been responsible for a host of medical miracles over the past century,
from disease-eradicating vaccines to revolutionary new treatments for a wide range of cancers and
long-term chronic conditions like diabetes. Research undertaken by private pharmaceutical companies and
bio-tech firms, alongside public research institutions, has improved the length and quality of millions of lives. In light of the
industry's achievements, it's natural to think of it as something of a sacred cow, a special case that should, to a certain extent, be given extra leeway to ensure it can
continue bankrolling life-saving medical innovations. That status also makes it easy to forget the price tag that comes with many of these innovations - a price tag
that has been rising steadily over time. In the US, for example, annual cancer care costs are expected to rise from $104bn in 2006 to $173bn in 2020, according to
the American Society of Clinical Oncology. A major component of that increase is the rising number of cancer diagnoses along with other factors, but with data from
the Memorial Sloan Kettering Cancer Center showing that 15 cancer treatments launched in the last five years cost more than $10,000 a month, and many existing
drugs getting pricier every year, the fact remains that the cost of innovative, patent-protected drugs is becoming increasingly difficult for patients and cash-strapped
health systems to cover.

Pharmaceutical profits are key to innovation against emerging disease threats

Engelhardt 8 (PhD, MD, Professor of Philosophy @ Rice (Hugo, “Innovation and the Pharmaceutical
Industry: Critical Reflections on the Virtues of Profit,” EBrary)
Many are suspicious of, or indeed jealous of, the good fortune of others. Even when profit is gained in the market without fraud and with the
consent of all buying and selling goods and services, there is a sense on the part of some that something is wrong if considerable profit is
secured. There is even a sense that good fortune in the market, especially if it is very good fortune, is unfair. One might think of such
rhetorically disparaging terms as "wind-fall profits". There is also a suspicion of the pursuit of profit because it is often embraced not just
because of the material benefits it sought, but because of the hierarchical satisfaction of being more affluent than others. The pursuit of
profit in the pharmaceutical and medical-device industries is tor many in particular morally dubious
because it is acquired from those who have the bad fortune to be diseased or disabled. Although the suspicion of
profit is not well-founded, this suspicion is a major moral and public-policy challenge. Profit in the market for the pharmaceutical and
medical-device industries is to be celebrated. This is the case, in that if one is of the view (1) that the presence

of additional resources for research and development spurs innovation in the development of
pharmaceuticals and med-ical devices (i.e., if one is of the view that the allure of profit is one of the most effective ways not only to acquire
resources but productively to direct human energies in their use), (2) that given the limits of altruism and of the willingness of persons to be
taxed, the
possibility of profits is necessary to secure such resources , (3) that the allure of profits also
tends to enhance the creative use of available resources in the pursuit of pharma ceutical and medical-device
innovation, and (4) if one judges it to be the case that such innovation is both necessary to maintain the human
species in an ever-changing and always dangerous environment in which new microbial and other
threats may at any time emerge to threaten human well-being, if not survival (i.e., that such innovation is necessary to prevent
increases in morbidity and mortality risks), as well as (5) in order generally to decrease morbidity and mortality risks in the future, it then
follows (6) that one
should be concerned regarding any policies that decrease the amount of resources and
energies available to encourage such innovation . One should indeed be of the view that the possibilities for profit, all things
being equal, should be highest in the pharmaceutical and medical-device industries. Yet, there is a suspicion regarding the pursuit of profit in
medicine and especially in the pharmaceutical and medical-device industries.
Generics don’t solve---inactive ingredients can trigger allergies
Wax 7 (Naomi, New York-based journalist and the editor of PillGirlReport.com, 12/17/7, “Generic
drugs' hidden downside”, http://articles.latimes.com/2007/dec/17/news/OE-WAX17/2, Accessed
7/26/15)//LD

Yet the true

insanity lies in the way many medical professionals, convinced by the FDA, keep pushing the myth
that "generic drugs are identical to their brand-name counterparts." Assurances of total sameness "in dosage form, safety,
strength, route of administration, quality, performance and intended use" pop up all over the FDA's website and are dutifully reprinted on the sites of health
insurers, drug makers, pharmacies and others whose interests it serves. Health
insurers, for instance, save so much on generics that a
number of them actually offer incentives to doctors and pharmacists to switch their patients off
brand-name drugs; earlier this year, Blue Care Network of Michigan was paying $100 per case. Even more widespread: insurers' practice of charging
lower co-pays for generics. Many insurers won't cover brand-name drugs at all if there's a generic available. To be sure, consumers benefit financially as well. With
an average price of $102 to fill a brand-name prescription -- compared to $29 for a generic one -- generic drugs make medication vastly more affordable. But how
advantageous is it to save $70 a month if taking a generic makes you feel like crap? I wrestled with this question a
few months ago when my doctor prescribed Sertraline, a Zoloft generic, to treat my depression. I'd done well on Zoloft in the past and had seemed to do all right
when I was switched to a generic, but I'd only taken it for a few months before I went off the medication entirely. This time, after a month, Sertraline hadn't made a
dent in my symptoms. My generics-happy insurer wouldn't cover Zoloft, so I contemplated paying the additional cost myself. And I did some research. It turns out
that hundreds of former Wellbutrin XL 300 users were facing a similar dilemma -- although under far graver conditions. The FDA-approved generic, Budeprion XL
300, had arrived on the market last December, and in the weeks and months that followed, complaints began to appear all over Internet health boards. Users who'd
been successfully treated with Wellbutrin for years said that they'd been switched to Budeprion by their doctor or pharmacist, often without being informed, and
had suffered such consequences as a return of depression (sometimes more severe than ever), suicidal thoughts, panic attacks, mood swings, anxiety, nausea and
insomnia. Those who then went back on the brand-name medication reported that their symptoms disappeared. Veteran syndicated health columnists Joe
Graedon, who holds a master's degree in pharmacology, and his wife, Terry, who earned her doctorate in medical anthropology, were so alarmed by the
unprecedented volume of reader response on their website, peoplespharmacy.com, that they notified the FDA. The FDA, in October, confirmed that it was
investigating but has yet to issue a comment or findings. The Graedons also contacted ConsumerLab.com, an independent testing organization. Budeprion users
probably found bittersweet consolation in the lab's analysis of the little yellow pills. It discovered that "generic bupropion XL released its ingredient at a very
different rate than Wellbutrin XL." While the extended-release feature is meant to keep a steady supply of medication flowing to the bloodstream throughout the
day, the generic pill released 34% of its ingredients in the first two hours, compared to the brand-name's 8%. Although both pills started out with equal amounts of
active ingredient (bupropion), according to the ConsumerLab report, the large upfront dose from the generic could account for the anxiety, irritability and nausea --
all known side effects of too high a dose of bupropion. The FDA finds it acceptable for generics to use different time-release technology than their brand-name
counterparts. Although the rate and extent of absorption must be similar enough to be deemed "medically
insignificant," lab data and/or test results from a small group (typically 24 to 36 people) of healthy volunteers (typically male) -- provided by the
manufacturer -- are considered sufficient to demonstrate this. Clinical testing -- multiphase studies done on thousands of patients to determine safety and

effectiveness, which brand-name drugs undergo -- is not required for generics . The assumption is that the innovator drug was already thoroughly

tested on humans, so if the generic can be shown to perform "in the same manner" in the lab, then it will perform similarly in patients. Yet, although

generics must have the same active ingredients as the brand-name product, they can include any
number of different inactive ingredients (colorings, flavorings, binders, diluents, fillers, etc.) that can cause differences in
how well a particular patient absorbs and tolerates a particular medication -- especially patients with
allergies, sensitivities or gastrointestinal disease. Formulas also vary from one generic manufacturer to the next. So someone who has
success with, say, Company X's Zoloft generic may have trouble if his or her pharmacist refills a prescription with Company Y's version. Which is what happened to
me. Once I'd made the rounds of neighborhood pharmacies and found one that carried my old generic brand, my symptoms improved.
 1NC---No Disease !
No impact to disease – they either burn out or don’t spread
Posner 5 – Senior Lecturer at University of Chicago (Richard A, “Catastrophe: the dozen most significant catastrophic risks
and what we can do about them.”, Winter, http://findarticles.com/p/articles/mi_kmske/is_3_11/ai_n29167514/pg_2?tag=content;col1)

Yet the fact that Homo sapiens has managed to survive every disease to assail it in the 200,000 years or
so of its existence is a source of genuine comfort , at least if the focus is on extinction events . There
have been enormously destructive plagues, such as the Black Death, smallpox, and now AIDS, but
none has come close to destroying the entire human race. There is a biological reason. Natural
selection favors germs of limited lethality; they are fitter in an evolutionary sense because their genes
are more likely to be spread if the germs do not kill their hosts too quickly . The AIDS virus is an example of a
lethal virus, wholly natural, that by lying dormant yet infectious in its host for years maximizes its spread. Yet there is no danger that AIDS will
destroy the entire human race. The likelihood of a natural pandemic that would cause the extinction of the
human race is probably even less today than in the past (except in prehistoric times, when people lived in small,
scattered bands, which would have limited the spread of disease), despite wider human contacts that make it more
difficult to localize an infectious disease. The reason is improvements in medical science. But the comfort is a
small one. Pandemics can still impose enormous losses and resist prevention and cure: the lesson of the AIDS pandemic. And there is always a
lust time.
 2NC---Ext. No Disease !
Burnout and variation check
Ian York 14, head of the Influenza Molecular Virology and Vaccines team in the Immunology and
Pathogenesis Branch of the Influenza Division at the CDC, PhD in Molecular Virology and Immunology
from McMaster University, M.Sc. in Veterinary Microbiology and Immunology from the University of
Guelph, former Assistant Prof of Microbiology & Molecular Genetics at Michigan State, “Why Don't
Diseases Completely Wipe Out Species?” 6/4/2014, http://www.quora.com/Why-dont-diseases-
completely-wipe-out-species

But mostly diseases don't drive species extinct. There are several reasons for that. For one, the most dangerous
diseases are those that spread from one individual to another. If the disease is highly lethal , then the
population drops, and it becomes less likely that individuals will contact each other during the infectious phase.

Highly contagious diseases tend to burn themselves out that way.¶ Probably the main reason is variation. Within the
host and the pathogen population there will be a wide range of variants. Some hosts may be naturally resistant. Some pathogens
will be less virulent . And either alone or in combination, you end up with infected individuals who survive .¶ We see this in
HIV, for example. There is a small fraction of humans who are naturally resistant or altogether immune to HIV, either because of their CCR5 allele or their MHC Class
I type. And there are a handful of people who were infected with defective versions of HIV that didn't progress to disease. ¶ We can see indications of this sort of

thing happening in the past, because our genomes contain many instances of pathogen resistance genes that have spread
through the whole population. Those all started off as rare mutations that conferred a strong selection advantage
to the carriers, meaning that the specific infectious diseases were serious threats to the species.

Infectious diseases can’t cause extinction – population density mitigates virulence

through resistance
Wynne Parry 11, 2/2/11, Live Science Staff Writer, “Article: Theory About Mammals and Fungus
Explains Bat Plague”, <http://www.livescience.com/11705-theory-mammals-fungus-explains-bat-
plague.html>

Even highly virulent infectious disease does not cause extinctions – because as population density
decreases, so does transmission, and the remaining individuals are more resistant. In addition, at the end
of the Cretaceous, dinosaurs weren't the only ones to be decimated. Marine animals were affected, as were many species of flowering
plant, according to Douglas Robertson, of the Cooperative Institute for Research in Environmental Sciences at the University of Colorado.

"It is not even vaguely plausible that all these extinctions , let alone just the various dinosaur species extinctions,
were all caused by some pathogen," Robertson wrote in an e-mail.

Government responses solve

Zakaria 9 - Editor of Newsweek, BA from Yale, PhD in pol sci, Harvard (Fareed, “The Sky Isn’t Falling,”
5/16/9, Newsweek, http://www.newsweek.com/id/197922)//WL
It certainly looks like another example of crying wolf. After bracing ourselves for a global pandemic, we've suffered something more like the
usual seasonal influenza. Three weeks ago the World Health Organization declared a health emergency, warning countries to "prepare for a
pandemic" and said that the only question was the extent of worldwide damage. Senior officials prophesied that millions could be infected by
the disease. But as of last week, the WHO had confirmed only 4,800 cases of swine flu, with 61 people having died of it. Obviously, these low
numbers are a pleasant surprise, but it does make one wonder, what did we get wrong? Why did the predictions of a pandemic turn out to be
so exaggerated? Some people blame an overheated media, but it would have been difficult to ignore major international health organizations
and governments when they were warning of catastrophe. I think there is a broader mistake in the way we look at the
world. Once we see a problem, we can describe it in great detail, extrapolating all its possible consequences. But we can rarely
anticipate the human response to that crisis. Take swine flu. The virus had crucial characteristics that
led researchers to worry that it could spread far and fast. They described—and the media reported—what
would happen if it went unchecked. But it did not go unchecked. In fact, swine flu was met by an
extremely vigorous response at its epicenter, Mexico. The Mexican government reacted quickly and
massively, quarantining the infected population, testing others, providing medication to those who
needed it. The noted expert on this subject, Laurie Garrett, says, "We should all stand up and scream, 'Gracias, Mexico!' because the
Mexican people and the Mexican government have sacrificed on a level that I'm not sure as Americans we would be prepared to do in the exact
same circumstances. They shut down their schools. They shut down businesses, restaurants, churches,
sporting events. They basically paralyzed their own economy. They've suffered billions of dollars in financial losses still being tallied up,
and thereby really brought transmission to a halt." Every time one of these viruses is detected, writers and officials
bring up the Spanish influenza epidemic of 1918 in which millions of people died . Indeed, during the last
pandemic scare, in 2005, President George W. Bush claimed that he had been reading a history of the Spanish flu to help him understand how
to respond. But
the world we live in today looks nothing like 1918. Public health-care systems are far
better and more widespread than anything that existed during the First World War. Even Mexico, a
developing country, has a first-rate public-health system—far better than anything Britain or France
had in the early 20th century.
**India Scenario**
 1NC---Indian Pharma Resilient
Indian medical industry is successfully resisting US big pharma push---court rulings
prove
Smedley 13 (Tim, The Guardian, 5/14/13, “Patent wars: has India taken on Big Pharma and won?”,
http://www.theguardian.com/sustainable-business/patent-wars-india-takes-on-big-pharma, Accessed
7/28/15)//LD

India's trailblazing patents decision Two

recent court cases in India may have changed the rules of the game. On 1
April, pharma giant Novartis lost a six-year legal battle after the Indian supreme court ruled that small
changes to its leukaemia drug Glivec did not deserve a new patent . Campaigners had long highlighted
this as a clear case of "evergreening" – making minor alterations to existing drugs in order to secure a new
patent, and so extend its monopoly (Glivec costs patients $2,600 (£1,670) a month). And only one month before,
India upheld a compulsory licence of Bayer's cancer drug Nexavar , effectively allowing generics firms to
copy a patented drug, reportedly bringing the price down from more than $5,500 (£3,540) per month to $175 (£112). Both rulings
are landmark cases, vehemently criticised by both Big Pharma and major drugs-producing countries .
Crucially, India broke no rules. Its verdicts are allowable under TRIPS – it's just that no country had
previously dared try it. "You could say," says Dr Ken Shadlen, reader at LSE and co-editor of Intellectual Property, Pharmaceuticals and
Public Health, "that the health activist community for the past five or six years has been calling Novartis all the names under the sun for
pursuing this case, but right now they are probably thanking them." Similarly, says Colin McCall, a leading pharmaceutical patent lawyer with
Taylor Wessing LLP, "I think [India] felt a little bit miffed that having entered into the WTO and taking on this obligation to allow product
patents, that these pharmaceuticals were no longer available at a publicly affordable price. So [India]
is blazing a trail by granting
compulsory licences where products aren't sold cheap enough and they are willing to say no to
[evergreening] outright."
 2NC---Ext. Indian Pharma Resilient
Court rulings block big pharma from evergreening
McCauley 14 (Lauren, staff writer, Common Dreams, 12/13/14, “Crippling Dominance of Big Pharma,
Indian Judge Blocks Bayer's Drug Monopoly Bid”,
http://www.commondreams.org/news/2014/12/13/crippling-dominance-big-pharma-indian-judge-
blocks-bayers-drug-monopoly-bid, Accessed 7/28/15)//LD

In a move that advocates are saying is a "momentous" win for public health, an Indian court on Friday
rejected a bid from multinational pharmaceutical giant Bayer to block a local generic drug company
from mimicking their costly cancer drug. Bayer had attempted to appeal a 2012 decision by India's
patent controller, who had argued the monthly $5,500-per-person cost charged by Bayer for the liver
and kidney drug Nexevar was too costly for most Indians. The Hyderabad-based Natco Pharma's
version of the drug costs roughly 97% less. Friday's court's decision highlights India's "critical role" in
"balancing intellectual property and public health," Leena Menghaney, South Asia regional head of
Medicins San Frontieres (MSF)/ Doctor's Without Borders' regional access campaign, told AFP.
Observers are saying that the decision may have far-reaching impact on the drug market because of
India's dominance in the pharmaceutical industry. AFP reports: India'a Lawyers' Collective, another
rights group, said the "momentous" judgement held wide-ranging implications for access to other
medicines.

Novartis case sets a precedent for judicial protection of generics in India

Mahr 13 (Krista, Time, 4/1/13, “The Novartis Decision: Is the Big Win for Indian Pharma Bad News for
Investment?”, http://world.time.com/2013/04/01/the-novartis-decision-is-the-big-win-for-indian-
pharma-bad-news-for-investment/, Accessed 7/28/15)//LD

In a decisive victory for India’s pharmaceutical industry, India’s Supreme Court rejected Novartis’
patent application for the cancer drug Glivec on Monday , ending a seven-year battle by the Swiss drugmaker to get a
patent in India on its powerful leukemia drug. The medication, which was approved for use in the U.S. back in 2001, has been produced
generically by Indian pharmaceuticals for years at a fraction of the Swiss drug’s cost. The
Indian drug industry’s victory,
however, is being described as a stunning defeat for intellectual-property rights and may have repercussions on
India’s attempts to attract foreign investment. Nevertheless, health activists have called the top court’s decision a win
for patients seeking cheaper treatment and against “evergreening,” the alleged practice of making minor tweaks to
an existing drug to prolong a company’s hold on a patent and protect it from being produced by other firms as a cheaper generic version once
the patent has expired. The ruling was met with enthusiasm by Indian drug manufacturers, which produce a
generic version of Glivec, or Gleevec, as it is called in the U.S. market. Patients’-rights groups, who advocate for cheaper drugs to be
available in countries like India where few can afford costly medication, also applauded the move. Advocates were concerned that
a ruling in favor of Novartis could set a precedent that would ultimately cut off India’s vast supply of
cheap generic drugs for diseases like HIV. Such medicines are exported to other developing markets. Millions of poor patients
rely on them.
 1NC---Indian SoPo High
Indian soft power high and resilient now---spiritualism, culture, principles, democracy
Ramachandran 5/29 (Sudha, The Diplomat, 5/29/15, “India’s Soft Power Potential”,
http://thediplomat.com/2015/05/indias-soft-power-potential/, Accessed 7/26/15)//LD
Yoga is among the themes that figured during the recent visit of India’s Prime Minister Narendra Modi to China, Mongolia, and South Korea.
Clearly, India is dipping into its ample soft power resources in its diplomatic engagements abroad . But
first, what is soft power and why are countries looking to it in their conduct of diplomacy? According to Harvard political scientist, who coined
the term, soft
power is the ability of a country to persuade others to do what it wants without resorting
to force or coercion. Soft power, he said, lies in a country’s attractiveness and comes from three resources: its culture (in places where
it is attractive to others), its political values (when it lives up to them at home and abroad), and its foreign policies (when they are seen as
legitimate and having moral authority). Though slower to yield results, soft power is a less expensive means than military force or economic
inducements to get others to do what we want. India boasts an amazing variety and wealth of soft power resources.
Its spiritualism , yoga, movies and television soaps, classical and popular dance and music , its
principles of non-violence , democratic institutions , plural society, and cuisine have all attracted
people across the world. Indian foreign policy analyst C Raja Mohan observed that India holds “strong cards in the
arena of soft power” to further its foreign policy goals. It is only over the past decade or so that India
has begun to play its soft power cards more systematically . Besides setting up a public diplomacy division
within the Ministry of External Affairs in 2006 and expanding the Indian Council for Cultural Relations
(ICCR) worldwide, it has roped in the Ministry of Tourism, which is behind the “Incredible India” campaign, and the
Ministry for Overseas Indians “to showcase its social, political, and cultural assets abroad,” Rohan
Mukherjee, a research scholar at the Department of Politics in Princeton University told The Diplomat. These government actors are
working to leverage India’s soft power “by using it to support larger foreign policy initiatives such as
the Look East Policy (now Act East), the Connect Central Asia policy, and developing strategic aid and trade
partnerships in Africa,” he said, adding that in each of these initiatives, “official diplomacy has been buttressed by
cultural exchange and efforts at increasing public knowledge and appreciation of India in foreign
countries.”
 1NC---No Indian SoPo !
No impact to Indian soft power---overestimation, lack of hard power, unresolved
identity
Mukherjee 14 (Rohan, Princeton University, 2014, “The False Promise of India’s Soft Power”,
Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp. 46–62, Accessed 7/27/15)//LD

Since the early 2000s, in keeping with India’s rise on the world stage, the scholarly and policy
communities in India and abroad have witnessed a steady increase in writing on India’s soft power.
Many of these assessments are optimistic, placing faith in India’s potential as a civilizational great
power with considerable resources arising from its culture, domestic ideology and diplomacy. However,
in terms of impact, Indian soft power has fallen far short of expectations . Significant sections of public
opinion in the West and in Asia are still not favorable toward India. Moreover, one is hard pressed to
identify a significant role played by soft power in India’s diplomatic gains since the early 1990s. This
paper argues that India’s inability to capitalize on its soft power resources is the result of three factors.
First, the overestimation of these resources by analysts. Second, the lack of sufficient hard power to
undergird India’s soft power ambitions. And finally, unresolved elements of India’s identity that tend
to undermine its efforts at soft power projection through public diplomacy.
 2NC---Ext. No Indian SoPo !
Indian soft power fails---empirics prove
Mukherjee 14 (Rohan, Princeton University, 2014, “The False Promise of India’s Soft Power”,
Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp. 46–62, Accessed 7/27/15)//LD

As the Cold War wore on, Nehru was succeeded eventually by his daughter Indira Gandhi, who
continued to speak the language of non-alignment and anti-imperialism but pursued policies that were
far more “realist” in substance. This had the effect of undermining some of India’s international
legitimacy, especially when India concluded a defense pact with the Soviet Union in 1971. The
following two decades were also marked by increasing Indian interventionism in the affairs of
neighboring countries, especially Sri Lanka, Nepal, and the Maldives. The end of the Cold War, according
to one scholar, marked a transition from realpolitik back to softer forms of diplomatic in- 53 tercourse
for India, largely due to the realization that hard power had failed to achieve beneficial objectives in the
preceding two decades (Wagner 2005). While this might be true in terms of grand strategy, it was
certainly not the case that any of the foreign policy gains made by India after 1990 were due to its use
of soft power. Increases in investment from and trade with developed economies, rapprochement
with the US in the mid-2000s, and improvements in bilateral relations with other South Asian states
(including Pakistan, despite setbacks) can all be traced back to the end of the Cold War and India’s
economic liberalization and rapid growth since 1991. Soft power has been a very minor aspect – if at all
– of Indian foreign policy during this period.

No impact to Indian soft power---3 warrants:

1. India has no international influence
Mukherjee 14 (Rohan, Princeton University, 2014, “The False Promise of India’s Soft Power”,
Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp. 46–62, Accessed 7/27/15)//LD

India’s shortcomings on this front are due to three factors. First, its soft power resources are not as abundant
as proponents of the idea might suggest. India’s cultural influence abroad, while significant, pales in comparison to the
cultures of the West already in circulation around the globe, and increasingly in comparison to Chinese culture in
circulation in Asia and beyond. Official and semi-official Indian modes of cultural dissemination are also relatively few . For
many decades, organizations such as the Peace Corps, Alliance Francaise, the British Council, the Goethe Institut and the Japan Foundation have been promulgating
the respective cultures of the great powers around the world. They have most recently been joined by China’s Confucius Institutes, which numbered 322 in 2011
(Na 2012). Although the Indian Council for Cultural Relations (ICCR) has been around since 1950 with the aim of conducting activities similar
to the organizations already mentioned, as of January 2013 it did not have more than 35 centers in foreign countries
(ICCR 2013). Moreover, it was only in 2004 that India established its Ministry of Overseas Indian Affairs to better

leverage the presence of millions of Indians abroad, and only in 2006 that India’s Ministry of External Affairs established a

division dedicated to public diplomacy (Suri 2011). In the realm of non-governmental cultural dissemination, Bollywood has been
a major force and yet despite producing more films than Hollywood annually, the size of the former
remains considerably smaller than that of the latter : Hollywood’s 2010 worldwide box office receipts alone were estimated at $US
31.8 billion (Verrier 2011), whereas Bollywood’s entire industry size in 2010 was estimated at $US 1.8 billion (FICCI-KPMG 2011). Moreover, Bollywood’s

international diffusion is not as strong as many analysts argue – in 2011, overseas theatrical sales
constituted only eight percent of total industry revenue (Fig. 6 in Appendix). Although Indian culture, which is based largely on
universalist and assimilationist Hindu principles, is a potent source of attraction, India’s domestic institutions and foreign policy have
mitigated this effect on the perceptions of outsiders . In the domestic realm, India has done a much poorer job
of lifting its population out of poverty when compared to China . Although 54 growth has been impressive, India’s per
capita income leaves it in the ranks of countries such as Sudan, Ghana, the Solomon Islands, and
Nigeria. Although the government has made major strides in liberalizing the economy, many sectors remain highly regulated . India’s
public institutions are rife with corruption, inefficiency, patronage and nepotism . In Transparency International’s
2012 Corruption Perceptions Index, India ranked 94 out of 174 countries, tied with Benin, Colombia, Greece, Moldova, Mongolia, and Senegal (China ranked 80). In
the words of one analyst (Malone 2011, p. 38), “ no amount of cultural promotion can undo the damage internationally
caused by spectacular corruption scandals” of the sort that India has recently been witness to, and that have given rise to
an anti-state social movement that made international front page news in 2011. In the international realm, India
has not pursued the types of cooperative and conciliatory policies required to garner soft power
resources. Particularly in the realm of global governance, India has been accused of being a spoiler on issues as diverse
as trade, nuclear nonproliferation, and humanitarian intervention . On trade, India was held responsible to
a great extent for blocking the efforts of the great powers to rescue the Doha Round in 2009 (Blustein 2009).
On nuclear non-proliferation and testing, India continues to be a non-signatory to the Non-Proliferation Treaty (NPT)

and the Comprehensive Test Ban Treaty (CTBT), despite having received official recognition as a nuclear power via the 2008 agreement
with the US on civilian nuclear cooperation. On humanitarian intervention, India’s approach to crises in Libya and Syria during its

recent term on the UN Security Council invited much criticism from the West (Kelemen 2011). As with China – which
itself is struggling to increase its stock of soft power – Western observers are frequently heard asking if India can be a “responsible stakeholder” in the international
system (Dormandy 2007). All these factors point to major obstacles in the way of India’s soft power ambitions ,
obstacles that might have been irrelevant had India been more powerful.

2. Soft power is useless without sufficient hard power

Mukherjee 14 (Rohan, Princeton University, 2014, “The False Promise of India’s Soft Power”,
Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp. 46–62, Accessed 7/27/15)//LD

Which leads to the second reason: India is not sufficiently far along in terms of hard power resources for its soft
power to make a difference in its foreign policy. Although in earlier periods India had relied on soft power as a substitute for
hard power, India’s attractiveness following the end of the Cold War grew precisely because of its hard
power resources, specifically economic growth, which made India a desirable international partner. It is no coincidence that
references to India’s soft power grew in frequency only after its economic gains were consolidated and
the world could be optimistic about India’s fortunes. In this sense, India’s trajectory corroborates the argument of various
analysts that soft power is most effective when backed by hard power (Tharoor 2008, Lee 2010, Blarel 2012). Soft
power is therefore not only generated by hard power (all else being equal, other countries are drawn to success), it also
facilitates the smoother exercise of hard power by influencing the preferences of those who are the targets of a state’s
foreign 55 policy. India, however, is not at the point yet where the precepts of Joseph Nye – which were meant
largely for an American audience – might apply. Instead, India remains in a transitory phase where its hard power
is yet to become preponderant even regionally to the point where it can meaningfully project its soft
power in order to create a political environment conducive to its international goals. Although India is not in the position of China, which
wields considerable hard power but lacks the required domestic legitimacy to successfully wield soft power, it does lack many of the
ingredients that make soft power a useful tool for states such as the US and Western European countries that can rely on an
astute mix of hard and soft power to effect outcomes in world politics. Indeed, as one scholar has argued (Hanson 2012, p. 13), India’s primary
challenge lies in “gaining the attention, status, and recognition of a global power,” rather than in battling any negative perceptions that its rise
may have created in other states (as is the case with China). This recognition is
likely to come only when India addresses
its internal problems and devises a more cooperative foreign policy within the existing global order.
3. No coherent, consistent policy strategy
Mukherjee 14 (Rohan, Princeton University, 2014, “The False Promise of India’s Soft Power”,
Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp. 46–62, Accessed 7/27/15)//LD

The third and final cause of India’s underperformance with regard to soft power is the contested nature
of India’s own identity. India’s ruling elites have yet to determine what kind of power their nation will be
as it continues to rise, and this indecision contributes to a sense of incoherence in the portrayal of
India’s image to the world. On the one hand, India is the second-largest contributor to the US-led UN Democracy Fund for the
promotion of democracy around the world; on the other, it continually reiterates its unwillingness to become an
exporter of democracy, i.e. to externalize its domestic political values. Consequently, states and peoples that
look to India for leadership on democratization – such as Myanmar – are frequently frustrated by India’s
unwillingness to commit to a coherent policy on democracy promotion . In a similar vein, on the one hand, India
is increasingly a member of small groups of powerful states that determine the course of international bargaining over global issues such as
trade, climate change, and international security; on the other, it clings to its identity as a developing and non-aligned
country, remaining an active member of the Non-Aligned Movement and frequently arguing for special privileges due
to its developing-nation status (e.g. on climate change). Consequently, poorer countries in international organizations – such
as the African nations and small island states in the climate change negotiations – are often frustrated by what they perceive
to be India’s pursuit of self-interest over the interests of developing nations , and rich countries decry
India’s unwillingness to compromise on issues that might cede some ground to the developed world
(e.g. in trade negotiations). At a more basic level, India’s multiple social and political identities – Hindu, Islamic, economically
liberal, protectionist, conscientious objector to nuclear treaties, responsible nuclear power, staunch supporter of human rights, opponent of
humanitarian intervention – continue
to conflict with each other both within 56 Indian policymaking and in the
messages and images that India portrays to the world. The end result is confusion at the receiving end,
unpredictable policy shifts, and general distrust among India’s interlocutors, none of which is
conducive to the effective exercise of soft power .
**Africa Scenario**
 1NC---SQ Solves African Health
Status quo solves local African pharma production
UNAIDS 14 (Press Release, 3/29/14, “Cooperation for the local manufacturing of pharmaceuticals in
Africa intensifies”,
http://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2014/march/2014
0329ecapharmaceuticals, Accessed 7/28/15)//LD

GENEVA/ABUJA, 29 March 2014—African

leaders and key multilateral organizations are strengthening and
broadening support for the local production of essential medicines on the continent . This was one of the key
outcomes of the Seventh Joint African Union (AU) Conference of Ministers of Economy and Finance and the Economic Commission for Africa
(ECA) Conference of African Ministers of Finance, Planning and Economic Development held in Abuja, Nigeria, from 25 to 30 March. On the
sidelines of the annual conferences, the
AU, UNAIDS, UNECA and UNIDO held a high-level meeting, Local
Manufacture of Pharmaceuticals: an Untapped Opportunity for Inclusive and Sustainable Industrial
Development in Africa, with African ministers of finance and economic planning. The event highlighted the
opportunities for developing a high-quality pharmaceutical industry in Africa, which will bring important health
and economic development benefits. African Union Commission Deputy Chairperson, Erastus Mwencha stressed the benefits of the local
production of medicines. “Local
production of generic medicines promises affordability and availability of
needed drugs, employment opportunities and overall public health benefits , including shortened supply chains,
hence helping to reduce stock outs, as well as enhancing the capacity of local regulatory authorities to oversee the quality standards of
essential medicines for their countries.” The Pharmaceutical Manufacturing Plan for Africa business plan, the Action Plan for the Accelerated
Industrial Development of Africa and the AU Roadmap on Shared Responsibility and Global Solidarity for AIDS, TB and Malaria Response in
Africa have been endorsed by African Heads of State and Government as strategic continental frameworks for developing the pharmaceutical
sector from both the public health and industrial development perspectives. UNAIDS Executive Director Michel Sidibé welcomed the broader
support from financial and industrial leaders for the local manufacture of medicines. “The time for Africa to break its dependency on foreign
imports is now. The
local manufacture of pharmaceuticals in Africa is an opportunity to develop a broader
manufacturing and knowledge-based economy,” he said.
 1NC---No Africa War !
No risk of great power conflict over Africa
Barrett 5 (Robert Barrett, PhD student Centre for Military and Strategic Studies, University of Calgary,
June 1, 2005, http://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID726162_code327511.pdf?
abstractid=726162&mirid=1)
Westerners eager to promote democracy must be wary of African politicians who promise democratic reform without sincere commitment to
the process. Offering money to corrupt leaders in exchange for their taking small steps away from autocracy may in fact be a way of pushing
countries into anocracy. As such, world financial lenders and interventionists who wield leverage and influence must take responsibility in
considering the ramifications of African nations who adopt democracy in order to maintain elite political privileges. The obvious reason for this,
aside from the potential costs in human life should conflict arise from hastily constructed democratic reforms, is the fact that Western donors,
in the face of intrastate war would then be faced with channeling funds and resources away from democratization efforts and toward conflict
intervention based on issues of human security. This is a problem, as Western nations may be increasingly wary of intervening in Africa
hotspots after experiencing firsthand the unpredictable and unforgiving nature of societal warfare in both Somalia and Rwanda. On a
costbenefit basis, the West continues to be somewhat reluctant to get to get involved in Africa’s dirty wars,
evidenced by its political hesitation when discussing ongoing sanguinary grassroots conflicts in Africa. Even as the world apologizes for bearing
witness to the Rwandan genocide without having intervened, the
United States, recently using the label ‘genocide’ in the context of the
Sudanese conflict (in September of 2004), has
only proclaimed sanctions against Sudan, while dismissing any
suggestions at actual intervention (Giry, 2005). Part of the problem is that traditional military and diplomatic
approaches at separating combatants and enforcing ceasefires have yielded little in Africa. No
powerful nations want to get embroiled in conflicts they cannot win – especially those conflicts in
which the intervening nation has very little interest.
 2NC---No Africa War !
No US involvement – their ev is all hype
O’Hanlon 2/16/14 [Michael O’Hanlon, senior fellow with the Center for 21st Century Security and
Intelligence and director of research for the Foreign Policy program at the Brookings Institution, where
he specializes in U.S. defense strategy, the use of military force, and American foreign policy, February
16, 2014, “U.S. military intervention, done right, could boost African stability”,
http://articles.latimes.com/2014/feb/16/opinion/la-oe-ohanlon-troops-to-africa-20140216]

For decades, one golden rule has guided America's military involvement in Africa: Stay out .¶
Generally speaking, the reason was a sense that the strategic stakes did not justify the risk. When we
deviated from this rule, we often learned lessons the hard way that seemed to reinforce its validity, as
in Somalia in 1993. And while presidents often profess a stronger interest in Africa than their actions
would imply, they tend to say such things when not in the White House — witness Bill Clinton calling
the nonintervention in Rwanda's 1994 genocide his greatest regret as president, or Sen. Barack Obama
calling for more assertiveness in the Democratic Republic of Congo, or DRC, and Sudan six to eight years
ago.

Empirics – dozens of conflicts disprove

Docking 7 (Tim Docking, African Affairs Specialist with the United States Institute of Peace, 2007,
Taking Sides Clashing Views on African Issues, p. 372)

Nowhere was the scope and intensity of violence during the 1990s as great as in Africa. While the general
trend of armed conflict in Europe, Asia, the Americas, and the Middle East fell during the 1989-99 period, the 1990s witnessed an increase in
the number of conflicts on the African continent. During this period, 16 UN peacekeeping missions were sent to Africa. (Three countries-
Somalia, Sierra Leone, and Angola-were visited by multiple missions during this time.) Furthermore, this
period saw internal and
interstate violence in a total of 30 sub-Saharan states. In 1999 alone, the continent was plagued by 16
armed conflicts, seven of which were wars with more than 1,000 battle-related deaths (Journal of Peace Research, 37:5, 2000, p. 638). In
2000, the situation continued to deteriorate: renewed heavy fighting between Eritrea and Ethiopia claimed tens of thousands of lives in the
lead-up to a June ceasefire and ultimately the signing of a peace accord in December; continued violence in the Democratic Republic of Congo
(DRC), Sierra
Leone, Burundi, Angola, Sudan, Uganda, and Nigeria as well as the outbreak of new
violence between Guinea and Liberia, in Zimbabwe, and in the Ivory Coast have brought new hardship and
bloodshed to the continent.

No escalation – doesn’t spill over enough

Stremlau 2k – professor and the head of the Department of International Relations at the University of the
Witwatersrand in Johannesburg, South Africa (John J., “Ending Africa's Wars,” Council on Foreign Relations,
July/August 2000, <http://www.foreignaffairs.com/articles/56245/john-j-stremlau/ending-africas-wars>)//SS
Following last year's military interventions in defense of human rights in Kosovo and East Timor, Western leaders proclaimed a new
determination to stand up to similar abuses whenever they occur. On one continent, however, warfare still rages unchecked, and far too little is
being done about it. Renewed clashes in Sierra Leone and on the Ethiopian-Eritrean border are two recent
examples of deadly African conflicts that have killed and displaced millions of people. Yet despite occasional bursts
of aid and attention, the United States and Europe have remained largely disengaged . The reasons for their
lack of involvement in conflict prevention and peacekeeping there are fairly obvious. War in Africa seems to pose no clear and
present danger to U.S. interests. Furthermore, most African conflicts are fought within, not between,
states. The international norms, institutions, and political will to intervene in such hard-to-solve
conflicts remain inadequate. So do Washington's defense doctrine, bureaucracy, and budgets, all of which are still dedicated to
preventing or settling traditional conflicts between states.
Whistleblowing Advantage Answers
 1NC---Cred Turn
Whistleblowing destroys cred
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R. Allison Professor of Law,
Texas Tech University School of Law and Director, “What to Do When You Can't Hear the
Whistleblowing: A Proposal to Protect the Public's Health by Providing Whistleblower Protection for
Medical Researchers,” 2011 / 2012, lexis)//ghs-VA

Stricter laws protecting whistleblowers in the United States might also backfire by encouraging the already
prevalent practice of exporting medical research overseas . It is therefore important that any proposed
legislation close this loophole by requiring the FDA to monitor companies seeking to market drugs ,
vaccines or medical devices in the United States to make sure they have a documented program for protecting
scientists conducting basic research.
 2NC---Ext. Cred Turn
Revelations cause the FDA to lose credibility
Ting 8 (Michael, Department of Political Science and SIPA, Columbia University, “WHISTLEBLOWING,”
May 12, 2008, http://www.columbia.edu/~mmt2033/whistleblowing.pdf)//ghs-VA

Whistleblowers have historically played key roles in passing crucial information from lower levels of organizations to
higher-level officials. A casual survey of American organizations in recent years amply demonstrates that this trend has not abated. In 2002,
Federal Bureau of Investigation (FBI) staff attorney Coleen Rowley went public over the bureau’s investigation of the alleged 9/11 co-
conspirator Zacarias Moussaoui. Her account of how FBI headquarters stifled attempts to investigate his activities built support for the
reorganization of its anti-terrorism efforts. In
2004, Food and Drug Administration (FDA) researcher David Graham testified
before a Senate committee that the agency had ignored warnings about the heart disease risks posed by Vioxx prior

to its approval. These revelations caused serious damage to the FDA’s credibility , and generated demand
for both stricter drug approval procedures and improved post-approval monitoring . Such episodes have not
been confined to the public sector. In 2002, Sherron Watkins of Enron and Cynthia Cooper of WorldCom both gained acclaim for their roles in
uncovering managerial irregularities in their respective corporations.
 1NC---G20 Fails
G20 Policies are useless and ineffective more than half of the time.
ITUC 14 (International Trade Union Confederate, 12/12/14, “New Survey: Half of G20 Policies Rated as
Ineffective”, http://www.ituc-csi.org/new-survey-half-of-g20-policies?lang=en, Accessed 7/28/15)

More than half of G20 policies have failed to have a positive impact on working people with weak
action on issues that could have had an impact on workers lives such as jobs, decent wages and social
protection,” said Sharan Burrow, General Secretary, International Trade Union Confederation, on the eve of the annual Labour 20 (L20)
Summit in Brisbane, Australia. More than 200 million people were unemployed in 2013, an increase of five million compared with the year
before according to the International Labour Organisation. “Governments are prioritising policies which support the
interests of big business and not tackling the inequality of wages and rising unemployment,” said Ms Burrow. “In
Brisbane, the G20 needs to agree on a plan for jobs and growth, putting in place comprehensive measures to support aggregate demand,
reduce inequality and spur investments. This must be backed up by national job creation targets, and followed up in consultation with social
partners,” said John Evans, General Secretary of the Trade Union Advisory Committee to the OECD (TUAC). Economic modelling prepared for
the L20 shows that a co-ordinated mix of wage and investment policies in G20 countries could halve the global jobs gap and create up to 5.84
percentage points more growth in G20 countries, compared to business as usual. Labour 20 Chair and Australian Council of Trade Unions
President Ged Kearney said that effectively tackling unemployment must be a priority for the G20 Leaders’ Summit. “With Australia’s
unemployment at a twelve year high of 6.2%, and youth unemployment more than double that at 14%, the Abbott Government must shelve its
spin and set out a jobs plan,” Ms Kearney said. “Prime Minister Abbott needs to understand that empty rhetoric won’t cut it. He
needs to spell out concrete policies and initiatives for job creation based on decent wages, conditions and investment in skills.” The ITUC Global
Poll 2014 of G20 countries found that • 68 per cent of people say their government is bad at tackling unemployment; • 79 per cent of people
believe the economic system favours the wealthy, rather than being fair to most people; and • 62
per cent of people want their
governments to do more to tame corporate power. The results of the G20 tracking survey will be presented at the Labour
20 Summit in Brisbane 14 -15th November 2014.
 2NC---Ext. G20 Fails
G-20 does not solve for all it claims.
Foley 9 (Stephen, The Independent, 9/27/9, “G20 promises: 'Overhyped and ineffective'”,
http://www.independent.co.uk/news/business/news/g20-promises-overhyped-and-ineffective-
1793731.html , Accessed 7/28/15)

Promises of a new era of international co-operation to end economic imbalances, monitored by the
G20 and the International Monetary Fund, were overhyped by the leaders of the industrialised
nations, according to the Nobel prize-winning economist Joseph Stiglitz. The G20 pledged this weekend to work towards a stronger and more balanced global
economy, after years when US policymakers have blamed China for saving – rather than spending – the fruits of its export boom, leaving the American consumer to
borrow and spend to keep the global economy moving. The
post-summit communiqué described itself as "a compact that
commits us to work together to assess how our policies fit together, to evaluate whether they are
collectively consistent with more sustainable and balanced growth, and to act as necessary to meet
our common objectives". And it promised a new role for a reformed International Monetary Fund, which would help conduct a "candid,
even-handed, and balanced analysis of our policies". But Professor Stiglitz said hopes that this might mean the Chinese agreeing to international
oversight of their economy were far-fetched. "It has been accepted because at least some of the people who have signed up to it believe it won't be effective," he
said. Substantial further concessions will be required from Western nations, Professor Stiglitz said, but he welcomed the agreement to scrap the G8 as the main
body of international economic co-operation in favour of the G20, which includes more emerging nations. The move is the first step in what will be "very slow
progress towards a new financial architecture", he said. "At the G8, China and others were treated like second-class citizens, allowed only to come to the dinner
after the communiqué was issued. "So China is beginning to assert itself, and to take its rightful place. The post-colonial world order, 60 years on, is beginning to fall
apart." The G20 pledged that there will be reform of the IMF to increase the voting power of newly powerful economies, including China, but the balance of power
will shift by just 5 per cent. Bigger moves were blocked by France and the UK, which face losing seats. Professor Stiglitz said: "There is quibbling over the details, but
the bigger picture is that the US is not giving up its veto power and, until it does, the IMF as an institution cannot serve in the role of international arbiter." John
Lonski, a senior economist at Moody's Investors Service, said the economic imbalances will erode in the face of reality – not because of any international
communiqué. "Even without an accord, you would still find that countries such as the US will move away from consumption and towards production. "That's what
the weaker dollar implies, and an ageing US population means it cannot be the juggernaut of global growth any more. It behoves other countries to step up and
stimulate demand of their own."

Empirics prove transparency fails and G-20 utility is hype

Davis 13 (Alan, DevEx, 9/4/13, “Why the G20 anti-corruption drive is failing in the Philippines”,
https://www.devex.com/news/why-the-g20-anti-corruption-drive-is-failing-in-the-philippines-81736,
Accesed 7/28/15)//LD

The irony of Russia making “growth through trust and transparency” one of three “overarching
priorities” during its presidency of the G-20 is unlikely to be appreciated by those civil society groups
currently being targeted by the Kremlin. Nor is it likely to be missed by those leaders of countries which
score poorly in global transparency and corruption rankings who may take comfort in the ongoing gap
between rhetoric and reality in the West and thus see little need or pressure to undertake real reform at
home. Despite some clear gains in the G-20’s anti-corruption action plan in the areas of combating
bribery and money laundering, perhaps too much claimed progress is based on governments’ own
assessments of their performance — and too little emphasis given to external and more objective
monitoring and engagement by ordinary citizens. A similar criticism might also be made of the Open
Government Partnership, the global initiative established in 2011 to promote greater public
transparency and accountability where membership, more open than the G-20, is offered to all states
which promise to do better for their people.
 1NC---No Econ Nationalism !
No impact to economic nationalism or protectionism---institutional checks
Dadush et al 11 [Uri, senior associate and director in Carnegie’s new International Economics Program, currently focuses on trends in
the global economy and the global financial crisis, previously served as the World Bank’s director of international trade and before that as
director of economic policy. He also served as the director of the Bank’s world economy group, leading the preparation of the Bank’s flagship
reports on the international economy, Shimelse Ali, economist, Carnegie’s International Economics Program, Rachel Esplin Odell, junior fellow
in Carnegie’s Asia Program, Carnegie Endowment for International Peace, “Is Protectionism Dying?”, May,
http://www.carnegieendowment.org/files/is_protectionism_dying.pdf]

Despite a limited increase in the incidence of protectionist measures during the recent financial and economic crisis,
the effects on global trade appear small—the world, remarkably, did not resort to protectionism. In addition to
the concerted stimulus measures, financial rescues, and the strengthening of lender-of-last-resort
facilities that restricted the duration and depth of the economic downturn, the World Trade
Organization’s disciplines, enforceable through its dispute settlement mechanism, no doubt played an important role in
staving off trade protection. But this is only one part of the story. The increased resistance to protectionism is the
result of a complex, mutually reinforcing set of legal and structural changes in the world economy that
have made a return to protection more costly and disruptive and have established new vested interests in open
markets. These changes include: • National disciplines: Along with autonomous liberalization and a generally robust rule of law in
the largest trading countries—which improve the confidence of importers and exporters— national trade tribunals help prevent
protectionism by providing a mechanism whereby individual firms can contest protectionist measures
that impact their company. Many national governments have also developed explicit or implicit mechanisms for countering protectionism and
ensuring that trade policy reflects the general interest. • Regional
and bilateral agreements: In addition to codifying
further tariff reductions, regional trade agreements—now covering over half of world trade—contain
provisions establishing dispute settlement mechanisms that parties can use to contest violations of the agreement and
thereby defend against protectionism. Furthermore, such agreements have often established regular high-level
dialogues on trade disputes, treaty implementation, and further liberalization, providing a mechanism for resolving
serious violations of the agreement even if its formal juridical mechanisms are not utilized . • “Facts on the
ground”: The political resistance to backsliding on liberalization is stronger because trade has become
more prevalent and inextricably woven into production and consumption patterns . The change in the political
economy of protectionism is manifested in the increased interest of retailers and consumers in imports, the internationalization of production,
and the rise of intrafirm trade. Limiting trade in any one sector not only hurts those consumers, retailers, and firms that depend on imports for
inputs, but also has repercussions for firms that operate both vertically (within a sector) and horizontally (across sectors) that depend on
complex global production chains.
 2NC---Ext. No Econ Nationalism !
Protectionism is not relevant to war -- other factors outweigh
Hulsman et al 3 [John, PhD, Research fellow in European affairs at the Heritage Foundatiion’s Davis
Institute, Joshua Bridwell and Eric Hamilton, “The Myth of Interdependence,” August 20,
http://nationalinterest.org/article/the-myth-of-interdependence-2412]
As realization of this phenomenon increases, it is disturbingly common for analysts to develop false conclusions based upon a superficial
understanding of globalization. Perhaps the most prevalent and beguiling mirage of all is the notion of a universal "interdependence."
Implicit in the arguments of interdependence proponents is the premise that interdependence affects
all nations to roughly the same extent --that it acts as a blanket phenomenon, restraining all that are involved to the same
degree. Clearly this is not true. Consider this hypothetical. Would Australian foreign policy have been affected if it had strenuously opposed
America's efforts in Iraq? WouldCanberra have been likely to abrogate the ANZUS treaty because of its
people's opposition to the Iraq war? Hardly, as Australia undoubtedly benefits from the American
military alliance serving as life insurance in the volatile Asian region. Would it be likely to impose an embargo on the U.S.?
Nonsense, as it greatly benefits from trade with America. In fact the opposite is true: it has long been a goal of Australian foreign policy to
secure a free trade agreement (FTA) with Washington --Iraq war or no. Would Australia refuse to continue closely sharing intelligence with
America? Impossible, as the Bali bombing illustrated that Canberra is a major target of Al-Qaeda, along with the United States. Or would certain
Australian diplomats simply snub Americans at cocktail parties? For in the end, that is what "disapproval" with America often amounts to.
While interdependence does mean that there is always mutual vulnerability, in the case of the U.S.
and Australia (and indeed in every case), this is not the salient feature of the relationship. Rather,
Australia's far greater dependence on the U.S. conditions foreign policy decision-making at the highest
levels --but not necessarily the other way around. The Wilsonian habit of misunderstanding the nature of
interdependence is far from an esoteric error. For despite what many foreign policy practitioners believe, policy outputs flow naturally from
first principle intellectual assumptions. By overrating the universal impact of interdependence theory, Wilsonians
naturally see the present order as fundamentally multipolar, and devise policies to fit this ‘reality.'
Unfortunately, the real world does not correspond to their assessment, thus dooming their policy
initiatives to failure. In the turbulence of a changing world order , one particular paradigm has been almost totally
neglected. Ironically, we have abandoned realism-the one doctrine that can best navigate our role in the
uni-multipolar world we find ourselves in. For, if we hold that the attempt to remake our global history of conflict and chaos
into a hopeful future of peaceful order is but an illusion, then we must accept the anarchic nature of our world and
attempt to live in it as best we can. Specifically, we must create policies that recognize and place our national interest above all
other priorities. This reality is largely reinforced by the current nature of interdependence. The Wilsonian view suggests it binds all states with
equivalent strength, while the realist outlook allows that interdependence in the economic arena is very much part and parcel of the modern
world, but does not in fact affect all states equally. As illustrated by the U.S.-Australia hypothetical, a power hierarchy characterizes
interdependence. Countries
that possess the preponderance of power are able to significantly influence the
policy outcomes of weaker states (assuming such states do not perceive overriding
security/geopolitical concerns). Such will it ever be.
Solvency Answers
 1NC---Oversight Key
Oversight is key to agency effectiveness
Oleszek 10 (Water J- Senior Specialist in American National Government. “Congressional Oversight: An
Overview”. February 22, 2010. http://fas.org/sgp/crs/misc/R41079.pdf//GH)

Oversight is an implicit constitutional obligation of the Congress. According to Historian Arthur Schlesinger, Jr., the
framers believed it was not necessary to make specific reference to “oversight” in the Constitution. “[I]t was not considered necessary to make
an explicit grant of such authority,” wrote Schlesinger. “The power to make laws implied the power to see whether
they were faithfully executed.”15 The Constitution also granted Congress an array of formal powers—the purse strings, lawmaking,
impeachment, among others—to hold the president and the administration accountable for their actions or inactions. In short, oversight
plays a key role in our system of checks and balances . There is a large number of overlapping purposes associated with
oversight. This array can be divided into three basic types: programmatic, political, and institutional. Programmatic purposes
include such objectives as making sure agencies and programs are working in a cost-effective and efficient
manner; ensuring executive compliance with legislative intent; evaluating program performance;
improving the economy of governmental performance; investigating waste, fraud, and abuse in
governmental programs; reviewing the agency rulemaking process; acquiring information useful in
future policymaking; or determining whether agencies or programs are fulfilling their statutory
mission. There are also political purposes associated with oversight, such as generating favorable publicity for lawmakers, winning the
electoral support of constituents and outside groups, or rebutting criticisms of favorite programs or agencies. After all, oversight occurs in an
ever-present political context in which Congress’s relationship with administrative entities can range from cooperation to conflict. There are,
moreover, inherent constitutional and political tensions between Congress and the President even during periods of unified government (one
party in charge of the House, Senate, and White House). Partisan and inter-branch conflicts are not uncommon in the conduct of the legislative
review function. In addition, there
are institutional oversight purposes that merit special mention, because
they serve to protect congressional prerogatives and strengthen the American public’s ability to
evaluate and reevaluate executive activities and actions. Three institutional purposes include checking the power of the
executive branch; investigating how a law is being administered; and informing Congress and the public.
 2NC---Ext. Oversight Key
Oversight is key to FDA credibility---turns their adv
Markey 7 (Edward J- representative from Mass. “The Adequacy of FDA to assure the safety of the nations drug supply”
Pg51.https://books.google.com/books?
id=s6cBQmWJbm8C&pg=PA51&lpg=PA51&dq=FDA+whistleblowers+AND+legislative+oversight&source=bl&ots=gzO4GSXmHl&
sig=06myUJ5CuVgEXvPSDNvf1yQUeoY&hl=en&sa=X&ved=0CEoQ6AEwB2oVChMI1pLX_9P5xgIVg5aICh0acQ2z#v=onepage&q=F
DA%20whistleblowers%20AND%20legislative%20oversight&f=false//GH)

The FDA is clearly in desperate need of

Chairman Stupak, thank you for allowing me to participate in today's hearing.
oversight and reform. Like Senator Grassley, I have been working on FDA reform with whistleblowers for several years and asking the
FDA questions about Ketek since May, 2006. The FDA refused to answer my requests for information. It appears that the FDA has
finally responded to congressional oversight. It is not a coincidence that FDA finally took action to
protect the public from Ketek by making changes to the label the day before this hearing . But the FDA's
long overdue actions on Ketek do not eliminate the threat to the American people. Although the FDA has acted to warn the public about
Ketek, we have no idea exactly how many dangerous products like Ketek the FDA has allowed on the market and put our families at risk every
day. The FDA's problems are systemic and it is in dire need of reform. Today we will hear about the truly frightening problems at the FDA
including: a culture of suppression and intimidation; a lack of transparency into the review process; the inaction of FDA management in
response to serious drug risks; and a lack of scientific freedom and the inability of FDA Reviewers to have their concerns heard by senior
management, FDA advisory committees and the public. It is clear from the testimony that the FDA is a deeply troubled agency
that has failed to act in the best interest of the public. We need the FDA to be a watchdog for public health, not a lapdog
for the industry. We need to bring transparency, accountability and scientific integrity back to the FDA

through a combination of increased oversight and legislative reform . Today we begin the oversight
and later this week I will reintroduce my bill, the Swift Approval, Full Evaluation (SAFE) Drug Act to address many of these problems. We
need to act now--not only to protect the public health but also to restore the public's confidence in
the FDA . A Harris Poll conducted last year found that 80 percent of adults say they are concerned about the FDA's ability to make
We need to turn this agency
independent decisions that will ensure that patients have access to safe and effective medicines.
around now and I look forward to working with my colleagues on this committee to make the changes
necessary to ensure that the FDA can protect the public health.