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Anatomy Of A Scandal

"It was a controversial new drug used for a sexually transmitted disease."

In 2006, pharmaceutical giant Merck & Co. launched a coordinated marketing effort for a
new vaccine against certain strains of the human papillomavirus, or HPV, a sexually
transmitted disease. According to one report,

“…hundreds of doctors and nurses in the United States were signed up as


unofficial spokesmen for Gardasil, trained by Merck, provided with a multimedia
presentation and paid $4,500 for each 50-minute talk, presented over Merck-
sponsored meals. Many were paid for attending Merck ‘advisory board’ meetings
to discuss the shots1.”

According to another report2 exposing Merck’s aggressive marketing efforts in Norway,

“Four of the experts who advised the government to vaccinate all 12-year-old
girls with the HPV vaccine Gardasil have received money for research from the
U.S. pharmaceutical giant Merck.”

As of May 31, 2010, the Centers for Disease Control and Prevention reports3 that there
were 16,140 VAERS reports of adverse events following Gardasil vaccination in the
United States, of which 8% were considered serious. Serious adverse events reports
include instances of Guillain-Barre Syndrome, blood clots, and in 53 cases, death.

While those events cannot conclusively be linked to the vaccine, a controlled study
weighing the long-term benefits against the long-term risks of the vaccine has yet to be
conducted. An editorial4 printed in the Journal of the American Medical Association
asserts,

“…the net benefit of the HPV vaccine to a woman is uncertain. Even if


persistently infected with HPV, a woman most likely will not develop cancer if she
is regularly screened.

When weighing evidence about risks and benefits, it is also appropriate to ask
who takes the risk, and who gets the benefit. Patients and the public logically
expect that only medical and scientific evidence is put on the balance. If other
matters weigh in, such as profit for a company or financial or professional
gains for physicians or groups of physicians, the balance is easily skewed.
[emphasis added]”

Following a controversy stemming from the violation of India’s procedures of informed


consent, the Indian government halted5 their HPV vaccination program.

The growing concern about the drug led one former Senior Research Analyst in the
biotechnology and genomic industries to pen an op-ed6 asking publicly, “Will Merck's
Gardasil HPV vaccine be its next Vioxx?”
Anatomy Of A Scandal
"But Perry ordered all 11 and 12 year olds in Texas to be vaccinated"

On Friday, February 2, 2007, Perry issued Executive Order RP657, “Relating to the
immunization of young women from the cancer-causing Human Papillomavirus."

In it, he mandated the “vaccination of all female children for HPV prior to admission to
the sixth grade.” Moreover, he demanded public health agencies “move expeditiously to
make the vaccine available as soon as possible.”

"A giant drug company would make billions."

Had Perry’s mandate gone into full effect, Texas would be the first state in a national
effort bankrolled by Merck to mandate use of the vaccine upon nearly all American
girls.

In Texas alone, 170,000 school-age girls8 would have been mandated to receive the
$360, three-shot vaccine, administered over a six month period. Taking into account
the full cost implications for the executive order, it would have cost the state an
additional $71,000,000 per year, adding nearly $300 million9 to Perry’s $18 billion
present-day budget shortfall.

For 2008, the full-year estimated revenue for Gardisil ranged between $1.4 billion and
$1.6 billion, five billion dollars lower than the initial projections. Expectations had to
be scaled down due to regulatory setbacks and public relations controversies such as
the one in Texas10. In the fourth quarterly earnings report of 2008, the decline in sales
of HPV vaccine Gardasil had declined 16% to $286 million11.

Less than three weeks after Perry issued the order, and following the tremendous
backlash from parents and legislators, Merck announced an end to state-level efforts to
mandate use the vaccine upon school-age girls.

"So they gave to Perry's campaign."

The donation12 came on the same day that Governor Perry's chief of staff, Deirdre
Delisi, met with his aides for a "HPV Vaccine for Children Briefing" on October 16.

Governor Perry has played down the coincidental timing13 of the donation. However,
Cathie Adams, then the president of the conservative Texas Eagle Forum, conceded
that the timing of the meeting and the donation would be too much for Texans to
swallow.
Anatomy Of A Scandal
"And paid Perry's former chief of staff big money to lobby for
it."

In advance of their effort to pass a vaccination mandate in Texas, Merck doubled its
lobby budget14 for Texas. One of the beneficiaries of that increased lobby money
was Mike Toomey, top Perry aide turned lobbyist.

The low estimate15 of Merck's payments to Mike Toomey to lobby conservatives


and Perry during their push for the Gardasil vaccine is $260,000, although he may
have been paid as much as $525,000, according to reports obtained from the Texas
Ethics Commission.

Today, Mike Toomey is avoiding16 being served with a subpoena that could expose
his role in a petition drive to qualify the Green Party for the ballot. It has been
speculated that he may be hiding out on his own private resort island, co-owned by
the governor's chief political strategist Dave Carney, who has also been linked to
the Green Party petition drive.

"Parents were outraged, and the Legislature had to overturn


Perry's order."

Perry’s statewide mandate for all Texas 11 and 12 year old girls was issued less
than only one year after the vaccine was approved for use by the Federal Drug
Agency, and weeks before an independent safety review had been completed.

Parents across Texas were stunned to learn that their young daughters were
required to take the new vaccine, unless they "opted out." Thousands of letters and
emails flooded the Governor's office. By their own count, nearly 90% of Texans
opposed the order.17

State legislators passed House Bill 109818 to overturn Perry’s executive order19.
The law passed overwhelmingly, with a bipartisan vote of 139 for and 5 against in
the House, and with 29 for and 2 against in the Senate20.

Rick Perry:

Bad Ethics…
Bad Policy…
BAD MEDICINE.
Anatomy Of A Scandal
Citations

1. "Cervical cancer vaccine is popular, but fails to cure doubts." Elisabeth Rosenthal, New York
Times. August 19, 2008. http://nyti.ms/aQnmYZ
2. "Merck Is Found To Be Paying Experts To Recommend Gardasil." Wellness Uncovered, June
30, 2010. http://bit.ly/cZ3bie
3. Adverse reports statistics of HPV vaccine from the Centers for Disease Control and
Prevention. http://bit.ly/6C07kl
Additional link to questions over Gardasil's safety: "Gardasil HPV Vaccine Faces Safety
Questions." Radha Chitale, ABCNews Report. August 19, 2009. http://bit.ly/awPp3f
4. "The Risks and Benefits of HPV Vaccination." Charlotte Haug, the Journal of the American
Medical Association. 2009. http://jama.ama-assn.org/cgi/content/full/302/7/795
5. "India Halts HPV Programme." TV Padma, April 9, 2010. http://bit.ly/aVmpWl
6. "Will Merck's Gardasil HPV Vaccine Be Its Next Vioxx?" Richard Gale, OpEdNews. May 16,
2010. http://bit.ly/99gPDM
7. Executive order RP65, mandating the vaccination of Gardasil on young girls. http://bit.ly/
as8HeW
8. "Texas Is First To Require Cancer Shots For Schoolgirls." Ralph Blumenthal, the New York
Times. February 3, 2007. http://nyti.ms/9GInn0
9. "Mandate Was Months In The Making, But Few Were In The Loop." Carrie MacLaggan,
Austin American-Statesman. February 23, 2007. http://bit.ly/9Sfbnx
10. "The Gardasil HPV Vaccine: Not the Shot in the Arm Merck Hoped For." Judith Siers-
Poisson, Center for Media and Democracy. September 16, 2008. http://bit.ly/bxYUpk
11. "Gardasil In Decline, Merck Now Increasingly Dependent on Januvia." Jim Edwards,
BNet.com. February 4, 2009. http://bit.ly/c0ai1W
12. "Rick Perry's Ties With Merck Run Deep." Associated Press. http://bit.ly/d7VI2I
13. "Texas Vaccine Meeting, Donation Coincide." Francie Grace, CBSNews.com. February 22,
2007. http://bit.ly/8Y7lnX
14. See number 8 listed above.
15. See lobbying records below from the Texas Ethics Commission, from 2007-2010. Enclosed
are additional lobbying records before 2007.
16. "Perrybunkport?" The Lone Star Project. http://bit.ly/a7VoBx
17. "Angry e-mails, letters took aim at Perry after HPV vaccine order." Kelley Shannon,
Associated Press. March 8, 2007. http://bit.ly/dCyNcH
18. House vote on HB1098. http://bit.ly/cAe38j
19. "Reluctant governor yields on HPV shots..." Janet Elliott, Houston Chronicle. May 9,
2007. http://bit.ly/9Sac6H
20. Senate vote on HB1098. http://bit.ly/ahD6X5
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#1

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to
the West's disease of the moment.

Tens of millions of girls and young women have been vaccinated against the disease in the
United States and in Europe in the two years since two vaccines were given government
approval in many countries and, often, recommended for universal use among females from
11 to 26.

One of the vaccines, Gardasil, from Merck, is paid for by the government for the poorest
girls to age 18 in the United States, at a potential cost of greater than $1 billion; proposals to
mandate the vaccine for girls in middle schools have been offered in 24 states, and one will
take effect in Virginia this fall. Even the often stingy British National Health Service will
start giving the other vaccine - Cervarix, from GlaxoSmithKline - to all 12-year-old girls at
school this September.

The lightning-fast transition from newly minted vaccine to must-have injection in the
United States and Europe represents a triumph of what the manufacturers call education
and their critics call marketing. The vaccines are far more expensive than earlier vaccines
against other diseases - Gardasil's list price is $360 for the three-dose series, and the total
cost is typically $400 to nearly $1,000 when including markup and office visits.

Award-winning advertising has promoted the vaccines. Before the film "Sex and the City,"
some American moviegoers saw ads for Gardasil. On YouTube and in advertisements during
popular shows like "Law and Order," a multi-ethnic cast of young professionals urges girls
to get vaccinated.

The vaccine makers have also brought attention to cervical cancer by providing money for
activities by patients' and women's groups, doctors and medical experts, lobbyists and
political organizations interested in the disease, sometimes in ways that skirt disclosure
requirements or obscure the companies' involvement.

In the United States, hundreds of doctors have been recruited and trained to give talks
about Gardasil - $4,500 for a lecture - and some have made hundreds of thousands of

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dollars. Politicians in Britain have been invited to receptions catered with drug company
money.

Legislators in dozens of countries willingly rallied behind a vaccine that combined two
popular, hot button issues: cancer prevention and women's health.

"There was incredible pressure from industry and politics," said Dr. Jon Abramson, a
professor of pediatrics at Wake Forest University who was chairman of the committee of the
U.S. Centers for Disease Control and Prevention that recommended the vaccine for all girls
from age 11 or 12 through 26, though he later opposed state proposals to require it.

Although cervical cancer kills close to 300,000 women a year globally, pap smears and
follow-up treatment limit the death toll in countries with good medical care: 3,600 in the
U.S., 1,000 in France and 400 in Britain annually.

Even critics of the marketing efforts recognize the benefits of the vaccines. Girls who get the
shots are less likely to have Pap tests with worrisome results that would lead to further
treatment, saving themselves anxiety and discomfort and, in those cases, saving health
budgets. When it occurs, cervical cancer is a dreadful disease; genital warts, partially
prevented by the Merck vaccine, can be a painful nuisance.

But some experts worry about the consequences of the rapid rollout of the new vaccines
without more medical evidence about how best to deploy them. They say that because of the
aggressive marketing and lobbying campaigns, even parents of girls who are far from being
sexually active may feel pressured into giving them a vaccine that is not yet needed and
whose long-term impact is still unclear.

"This big push is making people crazy - thinking they're bad moms if they don't get their
kids vaccinated," said Dr. Abby Lippman, a professor at McGill University in Montreal and
policy director of the Canadian Women's Health Network.

Merck's vaccine was studied in clinical trials for five years, and Glaxo's for nearly six and a
half, so it is not clear how long the protection will last. Some data from the clinical trials
indicate immune molecules may wane after three to five years.

Some experts are concerned about possible side effects that become apparent only after a
vaccine has been more widely tested over longer periods.

And why the sudden alarm in developed countries about cervical cancer? some experts ask.

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A major killer in the developing world, particularly Africa, where the vaccines are too
expensive for use, cervical cancer is almost always preventable through regular Pap smears
that detect precancerous cells effectively. Indeed, because the vaccines prevent only 70
percent of cervical cancers, Pap smear screening must continue anyway.

"Merck lobbied every opinion leader, women's group, medical society, politicians, and went
directly to the people - it created a sense of panic that says you have to have this vaccine
now," said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Harper
was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she
spent 2006-7 at the World Health Organization developing plans for vaccine programs
around the world.

"Because Merck was so aggressive, it went too fast," Harper said.

In receiving expedited consideration from the Food and Drug Administration in the United
States, Gardasil took six months from application to approval. Most vaccines take 3 years,
Harper said, and then 5 to 10 more for universal acceptance.

"In that time, you learn a lot about safety and side effects and how to use it," Harper said.
"Those getting it early should be the ones who really want it and willing to accept the risk."

Dr. Richard Haupt, medical director at Merck, said it was crucial to get a groundbreaking
vaccine into use as quickly as possible. "You can only study a vaccine for so long before you
license and use it in a population where it has enormous value," Haupt said. "Our hope and
belief is that this is a remarkable vaccine that will have huge impact on women."

Haupt said the vaccine had not been rushed into use, saying that five years in clinical trials
was a normal period before applying for licensing. He said Merck educated physicians,
politicians and the public about the new vaccine to "accelerate and facilitate access."

Spokesmen for Merck and Glaxo say all indications are that their vaccines are safe and
effective, and there is no evidence that a booster shot will be needed. Sarah Alspach, a
spokeswoman for Glaxo, said that its formulation produces a "stronger and longer-lasting
immune response" than conventional vaccines.

But with their high price, the vaccines are straining national and state health budgets as well
as family pocketbooks. These were the first vaccines approved for universal use in any age
group that clearly cost the health system money rather than save it.

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Health economists estimate that depending on how they are used, the two cervical cancer
vaccines will cost society $30,000 to $70,000, or higher, for each year of life they save in
developed countries - a cost commonly seen in treatments for people already suffering from
deadly cancers. That number will be far higher still if a booster is needed.

"This kind of money could be better used to solve so many other problems in women's
health," said Lippman at McGill. "I'm not against vaccines, but in Canada and the U.S.,
women are not dying in the streets of cervical cancer."

By contrast, if the vaccine were to become cheap enough to be used in the developing world,
it would revolutionize women's health. Charities like the Global Alliance for Vaccine and
Immunizations, backed by the Bill & Melinda Gates Foundation, are trying to devise a
solution.

The vaccines offer partial protection against infection from human papillomavirus, or HPV,
a common and generally benign sexually transmitted virus that can in rare cases cause
cancer after years of silent infection. The Merck vaccine also prevents some genital warts.

Dr. David Salisbury, head of the British Department of Health's Vaccine and Immunization
Committee said the government decided to vaccinate school girls because "this initiative was
seen as a good use of resources that fits with the government's health priorities and political
priorities."

But critics urge restraint. Angela Raffle, a specialist in cervical cancer screening with the
National Health Service in Britain said, "If we do this quickly and badly we could cause
more deaths," for example, from side effects or from giving girls false security that they no
longer need to be screened.

Stephanie Levi decided to give her two daughters the vaccine in late 2006 in New York, after
receiving a newsletter from their physician.

That same week, she noticed articles and ads for the vaccine, "I remember thinking I had
better do this quickly."

It is not hard to hear about Gardasil.

In ads like the "Law and Order" ones, a cast of hip 20-somethings describe why they got the
shots, in the language of liberation. "I chose to get vaccinated because my dreams don't
include cervical cancer," a bespectacled artist claims. The ads direct viewers to gardasil.com,

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which includes patients' stories, buddy icons and downloads for holding an event at a
college sorority.

The marketing has helped make Gardasil one of Merck's best sellers, with a projected $1.4 to
$1.6 billion outside Europe this year, and more from sales in Europe, where Merck sells the
vaccine through a joint venture with Sanofi Aventis.

Aggressive pharmaceutical advertising is nothing new, but the campaign was a revolution
for a vaccine cheap and not particularly profitable.

In 2006, hundreds of doctors and nurses in the United States were signed up as unofficial
spokesmen for Gardasil, trained by Merck, provided with a multimedia presentation and
paid $4,500 for each 50-minute talk, presented over Merck-sponsored meals. Many were
paid for attending Merck "advisory board" meetings to discuss the shots.

Merck said it provided assistance to speakers "to make sure they are providing accurate
information in accordance with FDA-approved labeling and to make sure dissemination of
information is always appropriate," said Amy Rose, a spokeswoman.

Promotion and marketing for Cervarix, the Glaxo version of the vaccine, has been far less
visible, in part because it is not yet approved for use in the United States, and consumer
advertising of medicines is prohibited in much of Europe.

But on both continents, there has been a proliferation of cervical cancer awareness
campaigns, sponsored by new or newly energized scientific and patient groups financed
with the assistance of Merck and Glaxo.

In some cases, the financial support has often been indirect, so that patients are unaware
that expert advice has been at last partly financed by the vaccine makers.

Dr. Gregory Poland, a vaccine expert at the Mayo Clinic, was a nonvoting member on the
CDC panel that recommended Gardasil in 2006 and has been a frequent defender in the
media. Records show that Poland received at least $27,420 in expenses and consulting fees
from Merck between 1999 and 2007.

To encourage vaccination on campuses, Merck provided the American College Health


Association with an unrestricted grant to train its officers to speak about the new vaccine
and to create kits to for college health services. "You, the female students sitting in your
class, your sorority sisters, your teammates and your best girlfriends could all be at risk," a

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sample message reads.

The association now recommends the shot for all female college students, even though
many in that age group will already have HPV, rendering the vaccine less effective or even
useless.

Dr. James Turner, incoming president of the association, said it undertook the campaign
because "HPV is a very important issue for college students" and the association "is a very
small organization and we don't have funds."

In Britain, Jo's Trust, a longstanding cervical cancer charity with a staff of one held a series
of breakfasts that introduced cervical cancer and the vaccine to parliamentarians. The food
bills went to Merck's European Joint Venture. Pamela Morton, executive director said: "I'm
a one man band, so I was grateful for their support and to be able to do this for women."

Haupt, said that Merck did its best to "respond" to requests.

In country after country, Merck and Glaxo also appealed to politicians. "We support policy
leaders and try to educate legislators," Haupt said

In the United States, 41 states have passed or begun considering legislation on cervical
cancer, according to the National Conference of State Legislatures, and 24 have considered
proposals to mandate the vaccine for girls, generally in middle school.

In Italy, parents of 10-year-olds have received letters from the Ministry of Health
encouraging them to get the vaccine.

One bill to require the vaccine for school entry has been passed, in Virginia; it will first apply
in 2009.

In December 2006, Merck announced it would invest $57 million to expand its Elkton,
Virginia, plant to make Gardasil, helped by a $700,000 grant from a state economic
development agency.

Two months later, Governor Tim Kaine signed legislation requiring Gardasil for schoolgirls.
Four months after that, Merck pledged to invest $193 million more in the plant.

Delacey Skinner, spokeswoman for the governor, said the Virginia vaccination program
includes an unusually broad freedom to decline the shot.

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"Without hesitation or question," the decisions about the plant and about the mandate
legislation "were completely separate," she added.

However, as in many American states where cervical cancer legislation has been considered,
there were ties between drug makers and members of government.

In Britain, drug makers visited the nurses and family practitioners who are the backbone of
the National Health Service urging them to offer the vaccine privately, if the NHS turned it
down, Dr. Raffle said. "The people who understood the issues, with black belt cancer
screening experience, were left out. "

In Belgium, the health minister approved the vaccine before the country's health technology
evaluation committee had finished deliberating. "We have a case that's about cancer, so its
very emotional. And we talk about prevention, which is also seen as good," said Ralph Crott,
a economist who was on the committee. "In my opinion it was oversold."

Many questions about the vaccines remain unanswered, including how long immunity will
last. Even commercials for Gardasil say - in small print -- "The duration of protection has
not been established."

Harper said that in the data from Merck's clinical trials, which she helped conduct, the
vaccine was no longer protective after just three years in some girls. "The immunity of
Gardasil will not last - that is dangerous to assume," she said.

She believes that at least one booster shot, and probably more, will be needed over the
course of a lifetime.

Other independent experts have worried that eliminating the two cancer-causing HPV
strains covered by Gardasil and Cervarix might actually allow the other cancer-causing
strains of HPV to increase in frequency, reducing the vaccine's effect.

But Haupt said these were "theoretical possibilities" that should not deter rapid distribution
of an important vaccine. "We'll worry about whether boosters are needed down the road,"
he said.

The Centers for Disease Control asks health care centers to report side effects through its
Vaccine Adverse Events Reporting System; reporting is voluntary. There have been 9,749
reports, almost all from doctors and nurses, of post-vaccine adverse effects, the agency
announced in a joint report with the food and Drug Administration at the end of June.

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Ninety-four percent of them were not serious, ranging from arm pain to fainting, and 6
percent were classified as serious, including blood clots, paralysis and deaths. There have
been 20 deaths.

But 16 million doses of the drug have been distributed by Merck in the United States, and in
a population so large, "by chance alone some serious adverse effects and deaths" will occur,
the FDA said.

It said there was no indication that the deaths or serious side effects were caused by the
shot, concluding that "Gardasil continues to be safe and effective and its benefits continue to
outweigh its risks."

Both the agencies and Merck acknowledge that there does appear to be a high rate of
fainting, so doctors are now advised to have patients stay in the office for 15 minutes after
receiving a shot.

Cervical cancer is the second-leading cause of cancer death in women, with 500,000 new
cases worldwide each year. But more than 90 percent are in developing countries, according
to the World Health Organization; 274,000 women died of this cancer in 2006, nearly 95
percent of them in developing countries. Where there are Pap smear programs, few women
die of cervical cancer.

Meanwhile, the vaccine's proponents are moving to the next frontier: older women and
boys.

One rationale for inoculating boys is that entire populations should be vaccinated to achieve
what is called herd immunity.

Said Raffle, the British Cervical Cancer specialist: "Oh dear. If we give it to boys, then all
pretense of scientific worth and cost analysis goes out the window."

"This big push is making people crazy - thinking they're bad moms if they don't get their
kids vaccinated,"

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#2
Merck is Found to be Paying Experts to Recommend Gardasil
Written by Christina England, Vac Truth
Wednesday, 30 June 2010 02:20

If you dangle a nice juicy carrot in front of many of the world’s leading experts
advising the governments on vaccine policies, they will accept the carrot like any
other ‘ass’. This has been proven over and over, however, agreeing to use little girls
in experiments for the HPV vaccine Gardasil, is stooping about as low as anyone
could go. This, however, is exactly what one group of experts from Norway have
done. According to the Norwegian newspaper the VG NETT in their report Fikk
betalt av vaksineprodusent – VG Nett om Helse og medisin the Norwegian experts received money from
Merck and then advised their government on the HPV vaccine Gardasil, which at the time was only in it’s
experimental stages, thus putting their own financial gain above the lives of the innocent children of
Norway.

The report reads:-

“Four of the experts who advised the government to vaccinate all 12-year-old girls with the HPV vaccine
Gardasil have received money for research from the U.S. pharmaceutical giant Merck.

A fifth expert, senior research worker Ellen Nilsen, went directly from the group which gave Health
Minister Sylvia Brustad advice, to a position with the company that markets the vaccine in Norway.

There are 13 persons in the expert group.

The newspaper VG revealed that all 12-year-old girls will in fact be research test persons for Merck, if the
Norwegian experts get their will.”

To be fair the experts, did rather weakly (in my opinion) try to defend their position.

“- In small countries it is a problem to find people who are both competent and who have not had any
commitments related to the products for which there should be given advice, or companies that have
produced the products” says director Geir Stene-Larsen at the Norwegian Institute of Public Health
(NIPH) to VG.

The report continues:-

“Clear advice
In April NIPH gave clear advice to the government: HPV vaccination should be implemented in the
national vaccination program for girls 11-12 years of age.

The advice was based on the expert group’s assessment.

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Professor Ole-Erik Iversen at the women’s clinic at Haukeland Hospital has participated in several
clinical trials and has been the national coordinator in Norway for studies of the two vaccines against
HPV viruses that currently exist. He has also served on Merck’s steering committee, and has, according to
Innovest received 120 000 kroner plus 35 000 kroner in travel expenses for this work since 2000.”

The rest of the article is in the same vein:-

“- Should I count the hours I would have earned more doing extra shifts at the hospital. I have done this
because I think it’s important work which can be of great significance for women all over the world. This
is contract research which is supported by the university and the hospital”, says Iversen to VG. He
emphasizes that he does not have shares, options or receive bonuses for vaccine sales.

My heart bleeds:-

“Professor Harald Moi at the Olafia Clinic leads a research project in which vaccine efficacy in young men
is investigated.

“- This is mission-based research and it is Merck who is funding this study. The funds go to the Research
Forum, I receive no extra remuneration for this work” said Moi.

Aud Berstad at the pediatric clinic at Haukeland Hospital has participated in clinical trials for Merck’s
vaccine.

“- I have not received any personal compensation, the money has gone to the Merck research company
Innovest at Haukeland Hospital. I do not remember the exact totals, but there is not much money” she
said.

Lecture
Agnes Kathrine Lie, chief physician at the Cancer Registry of Norway, has held two lectures for Merck
and received payment for them.

“- She received just under 5000 kroner for these lectures. This is not lectures she made for Merck, but
which she has held previously. It is also important to emphasize that Lie has not taken active part in
connection with the development of the vaccine or in carrying out the studies” says Lie’s director at the
Cancer Registry, Rita Steen.

Senior Ellen Nilsen participated in the group until 1.November last year. Then she left because she took a
position at Sanofi Pasterur MSD, where Merck is one of part owners, and who markets the vaccine in
Norway.

Eivind Smith, law professor, said Ellen Nilsen should not have been in the group:

“- This is an obvious argument against her participation, even though she left when she signed the
contract with her new employer ” says Smith.

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Ellen Nilsen emphasizes that her role in the group was as an observer for her former employer, the
Norwegian Knowledge Centre for the Health Services

“I had therefore no influence on the work. The employment process with my current employer took place
in the usual way in which I, as one of several were contacted by a recruitment agency in the beginning of
September. I had two interviews with people in the management of the company, one mid-September,
and one in October. I received an offer 31. October and accepted 1.November. The Knowledge Center was
notified on the same day, and I left my observer role in the group,” writes Nilsen in an e-mail to VG.

Full openness

“- In this case, I have been very interested in receiving impartial advice. I sent a letter to the National
Institute of Public Health in January”, Health Minister Sylvia Brustad writes in an

e-mail to VG.

Beyond that, she was unavailable yesterday to comment on the impartiality issue.

“- It is very important is that there is full openness about the commitments one has. So we will consider
in each case how strong the commitment is and how strongly one can expect that it affects the attitudes of
the person. In this case we have found that the question of impartiality is acceptable” says Geir Stene-
Larsen at the NIPH.

The article was kindly translated from Norwegian for me by my colleague Sandy Lunoe whom I thank.

Another report Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine … confirms that as
usual these experts did indeed persuade Norway to sign up for the experiment and on Google the write
up for this article says -

“the Nordic Region (Sweden, Norway, Iceland, and Denmark) to assess long-term outcomes following
administration of GARDASIL in approximately 5500 subjects”

The consequences which we have since learned from Janny Stokvia, an activist from Denmark and a
member of the TruthAboutGardasil http://truthaboutgardasil.org/ have been far from pleasant and she
has helped demonstrate this as part of a power point presentation accompanied with documents that a
group of six women presented to the FDA in March.

Even more disturbing is that some months earlier, in another article - Honorar til forskningssjef er
korrupsjon – Stavanger Aftenblad which translated means – Fees to research director is corruption, we
see another expert, this time the research director Steinar Ø. Thoresen from the Cancer Registry, also
accepting large sums of money totalling 233,900 dollars from Merck, which the Christian Demoncrate
party leader and the former Minister of Health to NRK, calls corruption.

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The article states:-

“The U.S. company also Thoresen cover travel expenses. Money transfers, a total of 233,900 dollars,
started two years before Thoresen ensured that Merck had one million agreement with the Cancer
Registry for the development of a vaccine against cervical cancer”

This shows that Mr Thoresen and the other experts advising their Government had massive and rather
lucrative conflicts of interests which were in their interest to keep quiet about.

Mr Dagfinn Høybråten the former Minister of Health to NRK however calls their silence and dirty
dealings corruption and states in the report that “Such remittances have a name, and there is
corruption,”.

The report continues:-

“He has asked the health minister to get involved in the case that there is unhealthy links between the
pharmaceutical industry and physicians in Norway is no secret. But this case is so special that it can not
be called common practice, “he said.

Thoresen and a subordinate at the Cancer Registry according to VG signed personal contracts with
pharmaceutical giant in 2002 without informing the management.The agreements took place in violation
of the guidelines that applied for medical managers.

Auditor General should investigate. Even Thoresen says that he has not done anything wrong.”

However, these experts are not alone in their misdemeanour’s by a long way. Reports show that Indian
experts also had some hidden conflicts of interests, revealing that these to, had links with Merck when
they advised their government on this vaccine. In April I revealed these conflicts of interest when I wrote
the article Are panel chosen to investigate Gardasil in India fit for purpose? I spoke at this time of a press
release released by the organisation the TruthAboutGardasil. http://truthaboutgardasil.org/ which said:-

“North Hollywood, CA. Members of TruthAboutGardasil.org and women around the world are
disappointed with the panel of investigators selected to examine alleged violations of guidelines for
conducting ‘clinical trials’, inadequate research, false advertising, along with various moral and ethical
concerns in connection with a recent health ‘demonstration project’ involving HPV vaccines amongst
disadvantaged women in India.

With apparent disregard for the women and organizations that brought these injustices to the attention
of the world, the government of India has chosen S. P., Agarwal former Director-General of Health
Services; Sunita Mittal, head of the Department of Obstetrics and Gynecology at the All-India Institute of
Medical Sciences; and Pharmacologist, Ranjit Roy to serve as the primary investigators. Now the world is
wondering if these three men; a retired government official, a practicing physician and a practicing
pharmacist are capable – or willing – to impartially review their peers and/or supervisors conduct and
the trial reports without bias.”

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‘Capable’, is possible, ‘willing’, is doubtful and to be ‘impartial’, now that is the one that is really
questionable especially as one of the panel of investigators appears to have a secret that he just
conveniently forgot to mention. The secret, well you guessed it, he is connected to the manufacturer of
the Gardasil vaccine Merck.

On the front page of the The Hindu on the 14th April 2010 in a letter to Azad it read-

“Another issue which unfortunately has not been addressed in your letter is the conflict of interest
involved in the PATH project. This NGO is a partner of the manufacturing company MERCK in other
projects.

As a partner, it can be easily understood that the conflict arises from the interests of the subjects of the
project, in this case children, on the one hand, and the vaccine manufacturer, on the other.

If there is not to be a cover-up of what appears prima facie to be a case of connivance with a vaccine
manufacturing company in violation of set guidelines, I would once again request you to kindly look into
the aspect of the inquiry, both in its terms of reference and in its composition.”

So if The Hindu’s research is correct and this is so, he can hardly be impartial now can he?”

I have since found other links proving that India foster many alliances with Merck that they would hardly
want to surrender as Merck also offer to adopt talented students in India and prevent them from
dropping out of education due to lack of resources. POSTER 2010_final_for print

This clearly shows how Merck gives chosen students scholarships of a fixed amount per year upon the
submission of authentic invoices/bills to be utilised towards payment of academic and tuition fees and
stationary expenses. Very commendable, however with these sort of grants, is it any wonder that India
appear to be in favour of vaccines manufactured by Merck?

In fact after researching I found that Merck are very noble and offer a considerable amount of money to
various causes worldwide. This article Colloidal Silver Secrets: Big Drug Companies Fund Groups Behind
…written by Tony Issacs is fascinating as it reveals detailed information on an organisation called the
‘John Merck Fund’. The John Merck Fund was set up by Serena Merck who was the widow of Merck
Pharmaceuticals CEO George W Merck in honor of their short lived son John.

This fund is responsible for funding groups from Greenpeace to the American Corn Growers Association.
A small sample of some of their activities have been listed on the website John Merck Fund the full extent
of the actual funding is huge.

The world cannot get away from the fact that Merck is huge and holds power and influence over many of
our countries experts. With their cash rewards and our experts being the weak individuals they are, most
cannot resist the nice juicy carrots that are held out in front of them even if this means sacrificing our
children in experiments involving vaccines. After all when counting the cash it is easy to kid yourself that

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it is for good of mankind, especially if it does not affect you personally.

I have written this in memory of those that have died after receiving the vaccine Gardasil. Especially
Megan my friend Karen’s daughter.

Source: Vac Truth

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CDC - Health Concerns Following HPV - Vaccine Safety http://www.cdc.gov/vaccinesafety/Vaccines/HPV/gardasil.html

#3

Vaccine Safety

Reports of Health Concerns Following HPV Vaccination


HPV Vaccine Safety
There are two HPV vaccines, Gardasil and Cervarix, available to protect against the types of
HPV that cause most cervical cancers.

The safety of the HPV vaccine was studied in clinical trials before it was licensed. For Gardasil,
over 29,000 males and females participated in these trials. Cervarix was studied in over
30,000 females participating in several clinical trials performed all over the world. Cervarix
has also been in use in other countries such as England and Europe prior to licensing from the
Food and Drug Administration (FDA).

CDC and FDA have been closely monitoring the safety of HPV vaccines. There are 3 systems
used to monitor the safety of vaccines after they are licensed and being used in the U.S. These
systems can monitor adverse events already known to be caused by vaccines, as well as detect
rare adverse events that were not identified during a vaccine's clinical trials. The 3 systems are:

The Vaccine Adverse Event Reporting System (VAERS)--a useful early warning public
health system that helps CDC and FDA detect possible side effects or adverse events
following vaccination.
The Vaccine Safety Datalink (VSD) Project--a project between CDC and 8 health
organizations evaluate and monitor adverse events following vaccination.
The Clinical Immunization Safety Assessment (CISA) Network--a project between 6
academic centers in the U.S. which conduct research on adverse events that might be
caused by vaccines.

VAERS Limitation
A major limitation of VAERS data is that there is no proven causal association between the
vaccine and the adverse event. The only association is in time, meaning that the adverse event
occurred sometime after vaccination. Therefore, we cannot conclude that the events reported
to VAERS were caused by the vaccine.

Reports to VAERS Following HPV Vaccination


Since licensed in October 2009, VAERS has received 3 adverse event reports occurring in the
U.S. following Cervarix.

As of May 31, 2010, approximately 29.5 million doses of Gardasil were distributed in the
United States.

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As of May 31, 2010, there were 16,140 VAERS reports of adverse events following Gardasil
vaccination in the United States. Of these reports, 92% were reports of events considered to be
non-serious, and 8% were reports of events considered serious.

Based on all of the information we have today, CDC recommends HPV vaccination for the
prevention of most types of cervical cancer. As with all approved vaccines, CDC and FDA will
continue to closely monitor the safety of both HPV vaccines. Any problems detected with this
vaccine will be reported to health officials, healthcare providers, and the public, and needed
action will be taken to ensure the public's health and safety.

Non-serious adverse event reports


VAERS defines non-serious adverse events as those other than hospitalization, death,
permanent disability, and life threatening illness.

The vast majority (92%) of the adverse events reports following Gardasil vaccination have
included fainting, pain, and swelling at the injection site (the arm), headache, nausea, and
fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls
after fainting may sometimes cause serious injuries, such as head injuries, which can be
prevented by closely observing the vaccinated person for 15 minutes after vaccination.

Serious adverse event reports


VAERS defines serious adverse events as adverse events that involve hospitalization,
permanent disability, life-threatening illness, and death. As with all VAERS reports, serious
events may or may not have been caused by the vaccine.

All serious reports (8%) for Gardasil have been carefully analyzed by medical experts. Experts
have not found a common medical pattern to the reports of serious adverse events reported for
Gardasil that would suggest that they were caused by the vaccine. The following is a summary
of selected serious adverse event reports that were submitted to VAERS between June 8, 2006
and May 31, 2010.

Guillain-Barré Syndrome (GBS)

Guillain-Barré Syndrome (GBS) has been reported after vaccination with Gardasil. GBS is a
rare disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their
teens. A number of infections can cause GBS. There has been no indication that Gardasil
increases the rate of GBS in girls and women above the rate expected in the general population,
whether or not they were vaccinated.

Blood Clots

There have been some reports of blood clots after receiving Gardasil. These clots have occurred
in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as
taking oral contraceptives (the birth control pill), smoking, obesity, and other risk factors.

Deaths

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As of May 31, 2010, there have been 53 U.S. reports of death among females who have received
Gardasil. Twenty nine of these reports have been confirmed and 24 remain unconfirmed due to
no identifiable patient information in the report such as a name and contact information to
confirm the report. Confirmed reports are those that scientists have followed up on and have
verified the claim. In the 29 reports confirmed, there was no unusual pattern or clustering to
the deaths that would suggest that they were caused by the vaccine.

More information is available at:

http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-archive/min-oct08.pdf
[PDF - 2.37 MB] (/vaccines/recs/ACIP/downloads/min-archive/min-oct08.pdf)

Summary of HPV Adverse Event Reports Published in JAMA (/vaccinesafety/Vaccines


/HPV/jama.html)

Reports of adverse events after getting a vaccine can be submitted to VAERS by fax at
1-877-721-0366, online at https://secure.vaers.org/VAERSDataEntryintro.htm,
(https://secure.vaers.org/VaersDataEntryintro.htm) or by mail to Vaccine Adverse Event Reporting
System, P.O. Box 1100, Rockville, MD 20849-1100.
Page last modified: June 21, 2010
Page last reviewed: June 21, 2010
Content source: Centers for Disease Control and Prevention

Centers for Disease Control and Prevention 1600 Clifton Rd. Atlanta, GA
30333, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, 24 Hours/Every Day -
cdcinfo@cdc.gov

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#3--continued

CDC Report Stirs Controversy For Merck's Gardasil


Vaccine
Cervical Cancer Vaccine Linked to Deaths, Incidents of Fainting and Blood Clots

By RADHA CHITALE
ABC News Medical Unit

August 19, 2009 —

A government report released Tuesday raises new questions about the safety of the cervical cancer
vaccine Gardasil. The vaccine has been linked to 32 unconfirmed deaths and shows higher incidences
of fainting and blood clots than other vaccines.

But while some physicians expressed concern over the findings, other doctors viewed the report as
reassuring, showing that the vaccine was not associated with any more unusual and serious side
effects as other vaccines.

The results of the report appeared along with an accompanying editorial discussing whether the
potential benefit of the HPV vaccine is worth its potential risks in the Journal of the American
Medical Association. The editorial, in particular, could give pause to many parents faced with the
decision of whether or not to have their 11- and 12-year-old daughters vaccinated against the certain
strains of the human papillomavirus, or HPV.

On Wednesday morning, ABC News Chief Medical Editor Dr. Timothy Johnson said that he, too,
would encourage parents to learn more about the shot before getting their daughters vaccinated.

"I am very much in favor of childhood vaccines," Johnson told Chris Cuomo on Wednesday's "Good
Morning America," adding that there is little doubt that the vaccine does have its benefits.

"We know it does what it says it prevents HPV infections," he said.

But he added that when it comes to comparing the benefits of the HPV vaccine against its potential
risks, he believes there simply is not enough evidence to recommend to all parents that they have their
daughters vaccinated.

"I don't think we yet know the long term benefits or risks," Johnson said. "I'm taking a pass on this
one and saying to parents, 'Study the issue, read the editorial... talk to your doctor.'"

Those who search for more information on the vaccine may also find stories from other parents who

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say the vaccine had ill effects on their daughters. One of these parents, Emily Tarsell, started her
daughter Christina on Gardasil -- a vaccine that protects against four of the most common cancer-
causing strains of the human papilloma virus (HPV) -- after her first visit to a gynecologist and at the
doctor's recommendation.

Eighteen days after Christina received her final vaccine shot, she died.

"I know it was the Gardasil," Tarsell said, although the official cause of death was undetermined.
"They were really recommending it, saying that there weren't any side effects, that it was safe. So I
kind of went against my better instinct [and let her] get the shot."

Deaths like Christina's are one of several types of complications reported to the U.S. Vaccine Adverse
Event Reporting System (VAERS) following Gardasil distribution in 2006. Some of these adverse
events were serious, including blood clots and neurological disorders, and some were non-life
threatening side effects from the vaccine, including fainting, nausea and fever.

Although experts agree that the accuracy of data from VAERS reports -- which can be made by
anyone and are not verified or controlled for quality -- is questionable, they remain divided as to
whether extreme adverse events, which are serious but rare, are cause enough to stop recommending
and administering the Gardasil vaccine without further investigation.

Report Shows Rare But Serious Side Effects May Result From Gardasil Vaccine

"Although the number of serious adverse events is small and rare, they are real and cannot be
overlooked or dismissed without disclosing the possibility to all other possible vaccine recipients,"
said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University
of Missouri. "The rate of serious adverse events is greater than the incidence rate of cervical cancer."

As of June 1, 2009, the CDC reported that over 25 million doses of Gardasil, which is recommended
for women between ages 9-26, have been distributed in the U.S. and there was an average of 53.9
VAERS reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination,
and 6.2 percent were serious, including 32 reports of death.

In a statement yesterday from Merck, the pharmaceutical company that manufactures Gardasil, the
company backed the vaccine's efficacy and said they encourage further research on its safety.

"We are pleased that the study published by JAMA [yesterday] further reinforces the safety profile of
Gardasil," said Dr. Richard M. Haupt, head of the clinical program for Gardasil at Merck. "We
welcome continued study and discussion about the safety of this important vaccine."

But some clinicians are not ready to accept wide use of the drug based on the available safety data.

Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital, said he would not offer
the Gardasil vaccine to patients when good cervical cancer screening techniques and treatments exist.
He has also chosen not to have his 11-year-old daughter get the HPV shot because of his concerns.

"I'm pro preventing cervical cancer and HPV," Moritz said. "I'm not pro that the physicians don't

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know the risks and side effects."

VAERS Report Is No Measuring Stick For Gardasil Side Effects

But clinicians on both sides of the vaccination debate agree that data provided by the VAERS report is
limited because it lacks any baseline comparison for the adverse events reported. This makes it
difficult to draw cause and effect relationships when a death, for example, occurs soon after
administering the Gardasil vaccine.

In fact, the JAMA study authors showed that 90 percent of those with blood clots had typical risk
factors for clots, outside of having received the vaccine -- using oral contraceptives, for example, or
smoking.

"The problem is that there is a difference between an adverse reaction caused by the vaccine, as
opposed to an adverse event reported in association with the vaccine," said Dr. Lauren Streicher, an
obstetrician-gynecologist at Northwestern Medical School, who supports use of the vaccine. "Patients
need to understand the true risk of the vaccine, as well as the risks of not getting the vaccine."

Understanding Risks and Side Effects Essential For Recommending Gardasil

The overwhelming consensus regarding Gardasil use is that physicians who are not well versed in the
risks of HPV and cervical cancer and the side effects of the vaccine cannot adequately counsel
patients whether or not to be vaccinated.

Dr. Joseph Zanga, chief of pediatrics at the Columbus Regional Healthcare System in Columbus, Ga.,
pointed out that Gardasil does not prevent women from contracting HPV in every instance, that many
people who are infected will spontaneously rid themselves of the virus, and that routine pap smears
are still the best prevention against cervical cancer.

"Perhaps the most important, currently missing 'warning' is that the vaccine may not be forever,"
Zanga said. "We know that it protects for 5-7 years so that a girl getting the series at [age] 11-12 will
enter the time of her most likely sexual debut unprotected but believing herself to be."

Many Doctors Will Continue to Provide Gardasil

Dr. L. Stewart Massad, the Practice and Ethics Committees chair for the American Society for
Colposcopy and Cervical Pathology, said his organization has educated thousands of clinicians about
the risks of HPV and the Gardasil vaccine.

"We based our education [program] criteria on data from the CDC's risk assessment," he said.
"Certainly there are differences of opinion when it comes to how adverse events are, you have to
balance the risk for each patient."

Massad also noted that the ASCCP was unable to secure government or other non-profit funding for
education outreach programs when the vaccine was first introduced and turned instead to private
companies, including Merck, which manufactures Gardasil.

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Further Investigation of Adverse Reports Needed

Harper said that the next step in determining the severity of the risks associated with the Gardasil
vaccine would be for the CDC to investigate the reported adverse events and verify a causal
relationship. But this may prove a difficult task, she said, because many of those events were reported
by Merck and did not include sufficient information to perform an investigation.

Still, the report is unlikely to prevent most doctors from continuing to provide the vaccine to patients.

"There are 772 serious problems identified in 23 million doses of vaccine," said Dr. Kevin Ault,
associate professor of Gynecology and Obstetrics at Emory University. "I usually tell my patients that
these serious events are tragic, rare and likely unrelated to the vaccine."

ABC News' Tyeese Gaines-Reid contributed to this report.

Copyright © 2010 ABC News Internet Ventures

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JAMA -- The Risks and Benefits of HPV Vaccination, August 19... http://jama.ama-assn.org/cgi/content/full/302/7/795

#4

Vol. 302 No. 7, August 19, 2009 JAMA


• Online Features
Editorial
This Article
The Risks and Benefits of HPV Vaccination
• PDF
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Charlotte Haug, MD, PhD, MSc • Save to citation manager
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JAMA. 2009;302(7):795-796.
Citing Articles
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When do physicians know enough about the beneficial effects of a new medical • Citing articles on
intervention to start recommending or using it? When is the available information about HighWire
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harmful adverse effects sufficient to conclude that the risks outweigh the potential Science (7)
benefits? If in doubt, should physicians err on the side of caution or on the side of hope? • Contact me when this
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disease in the future, particularly when these drugs are given to otherwise healthy
individuals. Vaccines are examples of such drugs, and the human papillomavirus (HPV) Topic Collections
• Oncology
vaccine is a case in point.
• Cervical Cancer
• Public Health
zur Hausen, winner of the Nobel Prize in Physiology or Medicine in 2008, discovered that • Immunization
1-4 • Quality of Care
oncogenic HPV causes cervical cancer. His discovery led to characterization of the
• Patient Safety/ Medical
natural history of HPV infection, an understanding of mechanisms of HPV-induced Error
• Women's Health
carcinogenesis, and eventually to the development of prophylactic vaccines against HPV
• Women's Health, Other
infection. • Alert me on articles by
topic
The theory behind the vaccine is sound: If HPV infection can be prevented, cancer will Social
not occur. But in practice the issue is more complex. First, there are more than 100 Bookmarking
different types of HPV and at least 15 of them are oncogenic. The current vaccines
target only 2 oncogenic strains: HPV-16 and HPV-18. Second, the relationship between What's this?

infection at a young age and development of cancer 20 to 40 years later is not known.
HPV is the most prevalent sexually transmitted infection, with an estimated 79% infection rate over a
5-6
lifetime The virus does not appear to be very harmful because almost all HPV infections are cleared by the
7-8
immune system. In a few women, infection persists and some women may develop precancerous cervical
lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and
why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have
on the incidence of cervical cancer 20 to 40 years from now. The true effect of the vaccine can be determined
only through clinical trials and long-term follow-up.

9
The first HPV vaccine was licensed for use in the United States in June 2006, and the Advisory Committee on
Immunization Practices recommended routine vaccination of girls aged 11 to 12 years later that same
10
month. However, the first phase 3 trials of the HPV vaccine with clinically relevant end points—cervical

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11
intraepithelial neoplasias grades 2 and 3 (CIN 2/3)—were not reported until May 2007. Previously only
reduction in the prevalence of persistent infection and CIN from the 2 virus strains included in the vaccine had
been reported. The results were promising, but serious questions regarding the overall effectiveness of the
vaccine for protection against cervical cancer remained to be answered, and more long-term studies were
12
called for. However, no longer-term results from such studies have been published since then.

So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young
girls a vaccine that partly prevents infection caused by a sexually transmitted disease (HPV infection), an
13-14
infection that in a few cases will cause cancer 20 to 40 years from now? Two articles in this issue of JAMA
present important data that may influence, and probably already have influenced, such decisions about HPV
vaccination.

13
The report by Rothman and Rothman demonstrates how the vaccine manufacturer funded educational
programs sponsored by professional medical associations in the United States. The article illustrates how the
Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, and American
College Health Association helped market the vaccine and influenced decisions about vaccine policy with the
help of ready-made presentations, slide sets, e-mails, and letters. It is of course reasonable for professional
medical associations to promote medical interventions they believe in. But did these associations provide
members with unbiased educational material and balanced recommendations? Did they ensure that marketing
strategies did not compromise clinical recommendations? These educational programs strongly promoting
HPV vaccination began in 2006, more than a year before the trials with clinically important end points were
published. How could anyone be so certain about the effect of the vaccine? This matters because the voices of
experts such as the professional medical associations are especially important with a complex issue such as
this.

14
In another article, Slade and colleagues from the US Centers for Disease Control and Prevention and the US
Food and Drug Administration describe the adverse events that occurred 2.5 years following the receipt of
quadrivalent HPV vaccine that were reported through the US Vaccine Adverse Events Reporting System
(VAERS). Even though most of the reported adverse events were not serious, there were some reports of
hypersensitivity reactions including anaphylaxis, Guillain-Barré syndrome, transverse myelitis, pancreatitis,
and venous thromboembolic events. VAERS is a passive, voluntary reporting system, and the authors call
attention to its limitations. They point out that only systematic, prospective, controlled studies will be able to
distinguish the true harmful effects of the HPV vaccine. These limitations work both ways: it is also difficult to
conclude that a serious event is not caused by the vaccine.

Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the
potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be
willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently
15
infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she
should be willing to accept only a small risk of harmful effects from the vaccine.

When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who
gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the
balance. If other matters weigh in, such as profit for a company or financial or professional gains for
physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse
events are not calculated correctly.

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AUTHOR INFORMATION

Corresponding Author: Charlotte Haug, MD, PhD, MSc, The Journal of the Norwegian Medical Association,
Akersgata 2, Oslo 0107, Norway (charlotte.haug@legeforeningen.no).

Financial Disclosures: None reported.

Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.

Author Affiliation: The Journal of the Norwegian Medical Association, Oslo, Norway.

REFERENCES

1. zur Hausen H. Human papillomaviruses and their possible role in squamous cell carcinomas. Curr Top
Microbiol Immunol. 1977;78:1-30. PUBMED
2. Tsunokawa Y, Takebe N, Nozawa S; et al. Presence of human papillomavirus type-16 and type-18 DNA
sequences and their expression in cervical cancers and cell lines from Japanese patients. Int J Cancer.
1986;37(4):499-503. WEB OF SCIENCE | PUBMED
3. zur Hausen H. Papillomaviruses and cancer: from basic studies to clinical application. Nat Rev Cancer.
2002;2(5):342-350. FULL TEXT | WEB OF SCIENCE | PUBMED
4. Nobelförsamlingen 2008: the discoveries of human papilloma viruses that cause cervical cancer and of
human immunodeficiency virus. http://nobelprize.org/nobel_prizes/medicine/laureates/2008/adv.pdf.
Accessed July 16, 2009.
5. Woodman CB, Collins SI, Young LS. The natural history of cervical HPV infection: unresolved issues. Nat
Rev Cancer. 2007;7(1):11-22. FULL TEXT | WEB OF SCIENCE | PUBMED
6. Woodman CB, Collins S, Winter H; et al. Natural history of cervical human papillomavirus infection in
young women: a longitudinal cohort study. Lancet. 2001;357(9271):1831-1836. FULL TEXT | WEB OF SCIENCE |
PUBMED

7. Syrjänen K, Hakama M, Saarikoski S; et al. Prevalence, incidence, and estimated life-time risk of cervical
human papillomavirus infections in a nonselected Finnish female population. Sex Transm Dis.
1990;17(1):15-19. WEB OF SCIENCE | PUBMED
8. Human papillomavirus (HPV) natural history. http://www.asccp.org/hpv_history.shtml. Accessed July 16,
2009.
9. FDA. June 8, 2006 approval letter: human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine,
recombinant. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111283.htm.
Accessed July 24, 2009.
10. Markowitz LE, Dunne EF, Saraiya M; et al, Advisory Committee on Immunization Practices (ACIP).
Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR Recomm Rep. 2007;56(RR-2):1-24. PUBMED
11. FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade
cervical lesions. N Engl J Med. 2007;356(19):1915-1927. FREE FULL TEXT
12. Sawaya GF, Smith-McCune K. HPV vaccination: more answers, more questions. N Engl J Med.
2007;356(19):1991-1993. FREE FULL TEXT
13. Rothman SM, Rothman DJ. Marketing HPV vaccine: implications for adolescent health and medical
professionalism. JAMA. 2009;302(7):781-786. FREE FULL TEXT
14. Slade BA, Leidel L, Vellozzi C; et al. Postlicensure safety surveillance for quadrivalent human
papillomavirus recombinant vaccine. JAMA. 2009;302(7):750-757. FREE FULL TEXT
15. Sawaya GF, Brown AD, Washington AE, Garber AM. Current approaches to cervical-cancer screening. N
Engl J Med. 2001;344(21):1603-1607. FREE FULL TEXT

3 of 5 7/19/10 12:45 PM
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4 of 5 7/19/10 12:45 PM
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5 of 5 7/19/10 12:45 PM
India halts HPV programme - SciDev.Net http://www.scidev.net/en/news/india-halts-hpv-programme.html

#5
Science and Development Network
News, views and information about science,
technology and the developing world

Home > News

NEWS

India halts HPV programme


T. V. Padma
9 April 2010 | EN

[NEW DELHI] The Indian Council of Medical Research (ICMR) has advised two
state governments to suspend a vaccination programme against cervical cancer
following controversy over violation of guidelines during trials.

ICMR director-general Vishwa Mohan Katoch confirmed to The Hindu this week (7
April) that the council had received "complaints of violation of guidelines and
exploitation of people from civil society groups some months ago, following the
death of four girls who were given this vaccine". The human papillomavirus
Flickr/AJC1
Cancer of the cervix (the lower narrow portion of the uterus) is caused by the
sexually transmitted human papillomavirus (HPV) and affects nearly 500,000 women each year, mostly in
developing countries. Two international pharmaceutical firms, Merck and GlaxoSmithKline, have developed
vaccines against HPV that were introduced in the United States in 2009.

That year India launched a two-year 'demonstration' project on the vaccines — run by the ICMR, the state
governments of Andhra Pradesh and Gujarat, and US-based non-governmental organisation PATH
International — involving about 32,000 girls aged ten to 14 years old.

During this time, India's drug regulatory authority cleared the vaccines for commercial marketing and Indian
TV channels broadcasted advertisements urging young girls to use anti-HPV vaccines.

But the trials came under the spotlight after the deaths of four girls were reported last month (March).
Andhra Pradesh's state health minister denied charges by women activist groups linking the deaths to HPV
vaccination.

At a press conference this week (7 April), groups including Saheli, Sama and the All India Women's
Democratic Association also said some of the vaccinated girls developed complications such as headache,
stomach disorders and early onset of menstruation.

They said the study did not follow procedures for informed consent from trial participants, violated Indian
rules that state drugs and vaccines should be tested in children only after testing on adults, and used
economically and socially disadvantaged sections of society as subjects. The groups submitted a letter to

1 of 2 7/19/10 10:58 PM
India halts HPV programme - SciDev.Net http://www.scidev.net/en/news/india-halts-hpv-programme.html

India's health minister Ghulam Nabi Azad last week (4 April).

"The Indian government licensed the vaccines with no evidence for the [cervical cancer] disease burden in
the country; or for the vaccine efficacy, or whether it offered protection against all types of cervical cancer in
India," said Madhavi Yennappu, a vaccine specialist at the National Institute for Science, Technology and
Development Studies in Delhi.

"In such post-licensing studies, the government assumes the vaccine is safe, effective and useful. But there
is no national data on prevalence of cervical cancer, how many of these cases are due to HPV, and how
many of the HPV strains in India are covered by the vaccine," said Ritu Priya, associate professor at the
Centre for Social Medicine and Community Health at the Jawaharlal Nehru University, Delhi.

"Such observation studies help circumvent some of the rigorous procedures of clinical trials," she added.

COMMENTS

R Vaidya ( India )
12 April 2010
PATH has been one of the most malicious organisations to have worked in the developing world, especially
India. It has dubious track record in the field, and has broekred unethical deals on behalf of big pharma with
corrupt bureaucrats. The Vajpayee Government should have barred organisations like PATH from India
rather than some good bliteral donors who were asked to leave the country.

http://www.scidev.net/en/news/india-halts-hpv-programme.html
Printed on: Tuesday, July 20, 2010 06:00
© 2010 SciDev.Net

2 of 2 7/19/10 10:58 PM
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Next Vioxx?
By Richard Gale (about the author) Page 1 of 4 page(s)

opednews.com
premium rt. liberal
For OpEdNews: Richard Gale - Writer blogad info

Do you find something seriously wrong with this


scenario?

Reports of faulty gas pedals, obstructive floor


carpets, and failing breaks in Toyota and Lexus
vehicles generated uproar across major media
networks. For the 4-year period starting in 2006,
the National Highway Traffic Safety
Administration (NHTSA) had reported 5 deaths,
17 injuries and 13 crashes, and an additional 29
deaths between 2000 and 2005. There was no
hesitation among the networks and federal
officials to demonize Toyota for knowingly risking US court frees Conrad Black on
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the lives of people solely to empty its dealership
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lots. Even Congress quickly called for a Congressional investigation, and Toyota took upon itself With Sergio Mendes And Brasil
the responsibility to recall over 8 million vehicles. '66
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During the same four year period while NHTSA was collecting crash data on Toyota's lemons, the
Defeat from the jaws of victory?
Centers for Disease Control's (CDC) Vaccine Adverse Events Reporting System (VAERS) database
Reactionaries don’t suicide
was gathering casualty data following vaccinations with Merck's human papilloma virus (HPV) bomb; they drive-by
vaccine, Gardasil. And it was clear that Merck was far ahead and winning its race against Toyota God Doesn’t Want Me to Get
for the Lemon of the Decade Award. Since Gardasil's launch in 2006, the vaccine has been Tenure…
responsible for 66 deaths and over 17,700 medical injuries of young girls, some as young as 11 Beijing Weather Alert: The View
from My Window
years old. Six percent of reported events, or 1,100 girls, were serious enough to require
emergency hospitalization.
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Unfortunately, vaccine injuries are not reported immediately and thoroughly as are automobile
accidents and deaths. There are no vaccine police rushing to the scene of vaccine accidents to
investigate the incidents and to record injuries and fatalities accurately. Consequently, only a
fraction of vaccine adverse events are reported by pediatricians, physicians, medical clinics and
hospitals, and make their way eventually into the VAERS database. Few parents even know such
a reporting system exists.

Cindy Bevington has investigated and reported about Gardasil extensively. During a Progressive
Radio Network interview, she reported on the hundreds and hundreds of emails she receives
from girls, mothers and doctors around the US and other countries complaining about the HPV
vaccines. Often she receives parents' requests "begging" for help because their pediatricians and
physicians refuse to report their daughters' adverse events as vaccine related.

1 of 4 7/19/10 11:00 PM
OpEdNews - Article: Will Merck's Gardasil HPV Vaccine be its... http://www.opednews.com/articles/Will-Merck-s-Gardasil-HPV...

By the CDC's own admission, only 10 percent of


Austin Coupons adverse events get listed on VAERS. Even this Most Popular
1 ridiculously huge coupon a day. Get very conservative figure has been refuted by Articles
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for any given vaccine. It is therefore realistic to
Paid Clinical Trials suspect that Gardasil is associated with between Want To Find the Worst
Get paid for clinical research trials in Anti-Semitism? Ugly
177,000 and 1.7 million adverse effects among Anti-Women's Rights
Austin, TX. Join today! vaccinated American girls and young women. Policies? Go to Israel by Rob
www.benchmarkresearch.net
Kall
Cervical Cancer Vaccine Medalerts.org reports that a young woman
vaccinated with Gardasil is ten times more likely Tea Parties are Unmasked
HPV & Cervical Cancer Vaccine - What as Republican attempt at
You Need To Know! to file a VAERS report compared to an influenza
Rebranding says Gallup by
Livesfit.net/--Cervical-Cancer vaccination. HPV vaccines now account for 20 Steven Leser
percent of all vaccine side effects aside from the
H1N1 swine flu vaccine. America's daughters are BP-Halliburton-
twice as likely to have an emergency room visit. They are four times more likely to have a death Transocean-Well is loosing
sentence, five times more likely to receive a report of "did not recover," and seven times more 60% or 9824psi of oil and
gas pressure to the
likely be pronounced "disabled."
strata.Chris
Landau(geologist) by Chris
Besides the 66 deaths, Gardasil's serious side effects now include Guillain-Barre syndrome, Landau
lupus, seizures, anaphylactic shock, chronic fatigue, paralysis, blood clots, brain inflammation,
blurred vision and blindness, convulsions, demyelinating encephalomyelitis, multiple sclerosis, Thad Allen Tells BP Seabed
pancreatitis and various digestive disorders. Last autumn a case of amyotrophic lateral sclerosis, "Seeping" and Demands
More Monitoring by
better known as Lou Gehrig's disease, was reported. And a recent 2010 issue of the Journal of
Georgianne Nienaber
Child Neurology investigated the case of a 16-year old girl going blind following vaccination, a
secondary symptom to multiple sclerosis. Iranian Scientist Would Not
Play Curveball by Ray
In her January 2010 article on Vactruth.com, "Website Documents Over 300 Gardasil Horror McGovern
Stories," Christina England, a journalist monitoring the politics and science of the HPV vaccines,
Glenn Beck a Christian? by
relates the case of an employee at a large hospital who commented on the 1,000-plus girls who
Ed Decker
are manifesting psychotic symptoms for no apparent reason other than being vaccinated with
Gardasil. Nevertheless, federal health agencies remain mute and dumb, and the CDC and the PRESSURE At The Wellhead
FDA continue to stand by their masters at Merck and preach their faith in Gardasil as "safe and And What It Really Means
effective and the benefits outweigh the risks." by Dr. Tom Termotto

The Cerebral Ecstasy of


One would expect that vaccine makers would undertake special precautionary measures when
Inception by Kevin Gosztola
conducting clinical trials for women who are undergoing hormonal changes, such as premenstrual
changes during puberty and during various stages of pregnancy. The effects that Gardasil has on WellPoint's White Knight
young girls entering sexual maturity remain unknown. The principle investigator for Gardasil's Rides Again by Jerry Policoff
clinical trials, Dr. Diane Harper, has publicly stated that no efficacy and safety trials for any of the
Pentagon Robot Culture
HPV vaccines were conducted on girls under the age of 15 years. Neither were trials conducted to
Ominous Development by
determine Gardasil's safety on pregnant women. Sherwood Ross

Dr. Suzanne Garland at the Royal Women's Hospital in Melbourne published a study in 2009 issue
of Obstetrics and Gynecology showing a "higher rate of congenital abnormalities in infants were Go To Top 50 Most
Popular
noted in pregnant women who received the vaccine." A second study, according to Christina
England, found that there were slightly higher fetal deaths and rare cases of central nervous
system malformations and neural tube defects in vaccinated pregnant women. Yet these kinds of
studies only convince us of the seriously flawed and limited clinical trials conducted by Merck,
and further confirms growing criticisms of the systemic failure in the FDA's approval process
because of the millions of dollars the agency receives from the pharmaceutical cartel to expedite
vaccine and drug launches and to require only the minimum of efficacy and safety information
for approval.

Fortunately, the seriousness of HPV vaccination is becoming more apparent, via the efforts of the
National Vaccine Information Center, NaturalNews.com, Mercola.com and the Progressive Radio
Network, and concerns are being raised within the practicing medical community and among
parents. For example, the otherwise pro-Big Pharma Journal of the American Medical Association
(JAMA) printed an article in 2009 stating, "the rate of serious adverse events [of Gardasil] is
greater than the incidence rate of cervical cancer." Given the high prestige of JAMA, this alone
should be a sufficient warning to avoid HPV vaccines at any cost.

Once a vaccine is administered, the risk for potential damage cannot be recalled. It is not like
returning your Toyota to avoid the possibility of a mechanical failure in the future. And the length
of time a serious adverse effect might occur from Gardasil remains unknown. Christina Tassell, a
21-year-old National Honor Student died in her sleep a couple days after receiving Gardasil.
There was no way the vaccine could be returned to her pediatric salesman after symptomatic
complications began to surface.

Since Gardasil is administered in a series of three injections, adverse effects may occur after the
second or third vaccination, or even months afterwards. One mother shared the condition of her
15-year-old daughter who two months after receiving her second vaccination began having
seizures and complete memory loss. The mom writes, "her other symptoms were hair loss, joint
pain, severe headaches, stomach pain and insomnia. When she did sleep, she would have
seizures for hours. We have taken her to numerous doctors but they have no idea what is wrong
with her. She continues to struggle on a day to day basis and is on the 504 Disability Plan at

2 of 4 7/19/10 11:00 PM
OpEdNews - Article: Will Merck's Gardasil HPV Vaccine be its... http://www.opednews.com/articles/Will-Merck-s-Gardasil-HPV...

school."

So where is the media in reporting on this Big Pharma-created medical catastrophe? Where are
the New York Times and Rupert Murdock's media empire? Why aren't our health officials at the TOP EDITORIALS: TOP LIFE NEWS:
FDA, the CDC and Secretary Kathleen Sebelius at the HHS taking precautionary measures, and The Long War; just say "No" Update: We Need New Lyrics
why aren't our elected officials on the Hill demanding a Congressional investigation of a product by John Grant for the Battle of New Orleans
BP's Scheme to Swindle the - Well, Here Are Some!
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by David Swanson by Joan Brunwasser
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by Bruce K. Gagnon by Dean A. Banks, MCIWD,
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3 of 4 7/19/10 11:00 PM
Office of the Governor Rick Perry - Executive Orders - RP65 – ... http://governor.state.tx.us/news/executive-order/3455/

#7
You are here: News >> Executive Orders

RP65 – Relating to the immunization of young women from the


cancer-causing Human Papillomavirus.
Friday, February 02, 2007

BY THE
GOVERNOR OF THE STATE OF Related Content
Monday, July 19, 2010 | Austin, Texas | Appointment
TEXAS
Gov. Perry Appoints Matthews to Texas Council on Autism and
Executive Department Pervasive Developmental Disorders
Austin, Texas
February 2, 2007 Monday, July 12, 2010 | Austin, Texas | Appointment
Gov. Perry Appoints Three to Advisory Council on Emergency
WHEREAS,immunization from Medical Services
vaccine-preventable diseases such as
Human Papillomavirus (HPV) protects Wednesday, June 30, 2010 | Austin, Texas | Appointment
Gov. Perry Appoints Stoebner-May to Texas State Board of
individuals who receive the vaccine; Examiners of Psychologists
and
WHEREAS,HPV is the most common Friday, June 11, 2010 | Austin, Texas | Appointment

sexually transmitted infection-causing Gov. Perry Names Marx Chair of Texas Health Services Authority
Corporation
cancer in females in the United
States; and Thursday, June 10, 2010 | Austin, Texas | Press Release
WHEREAS,the United States Food Gov. Perry Announces TETF Investment in Savara Inc.
and Drug Administration estimates
there are 9,710 new cases of cervical
cancer, many of which are caused by
HPV, and 3,700 deaths from cervical cancer each year in the United States; and
WHEREAS,the Texas Cancer Registry estimates there were 1,169 new cases and 391 deaths from cervical
cancer in Texas in 2006; and
WHEREAS,research has shown that the HPV vaccine is highly effective in preventing the infections that are
the cause of many of the cervical cancers; and
WHEREAS,HPV vaccine is only effective if administered before infection occurs; and
WHEREAS,the newly approved HPV vaccine is a great advance in the protection of womenʼs health; and
WHEREAS,the Advisory Committee on Immunization Practices and Centers for Disease Control and
Prevention recommend the HPV vaccine for females who are nine years through 26 years of age;
NOW THEREFORE, I, RICK PERRY,Governor of Texas, by virtue of the power and authority vested in me by
the Constitution and laws of the State of Texas as the Chief Executive Officer, do hereby order the following:
Vaccine.The Department of State Health Services shall make the HPV vaccine available through the Texas
Vaccines for Children program for eligible young females up to age 18, and the Health and Human Services
Commission shall make the vaccine available to Medicaid-eligible young females from age 19 to 21.
Rules.The Health and Human Services Executive Commissioner shall adopt rules that mandate the age
appropriate vaccination of all female children for HPV prior to admission to the sixth grade.
Availability.The Department of State Health Services and the Health and Human Services Commission will
move expeditiously to make the vaccine available as soon as possible.

1 of 2 7/20/10 9:32 AM
Office of the Governor Rick Perry - Executive Orders - RP65 – ... http://governor.state.tx.us/news/executive-order/3455/

Public Information.The Department of State Health Services will implement a public awareness campaign to
educate the public of the importance of vaccination, the availability of the vaccine, and the subsequent
requirements under the rules that will be adopted.
Parentsʼ Rights.The Department of State Health Services will, in order to protect the right of parents to be the
final authority on their childrenʼs health care, modify the current process in order to allow parents to submit a
request for a conscientious objection affidavit form via the Internet while maintaining privacy safeguards
under current law.
This executive order supersedes all previous orders on this matter that are in conflict or inconsistent with its
terms and this order shall remain in effect and in full force until modified, amended, rescinded, or superseded
by me or by a succeeding governor.
Given under my hand this the 2nd day of February, 2007.
RICK PERRY(Signature)
Governor
Attested by:
ROGER WILLIAMS(Signature)
Secretary of State

2 of 2 7/20/10 9:32 AM
Texas Is First to Require Cancer Shots for Schoolgirls - New Yo... http://www.nytimes.com/2007/02/03/us/03texas.html?pagewan...

#8

February 3, 2007

Texas Is First to Require Cancer Shots for Schoolgirls


By RALPH BLUMENTHAL

Correction Appended

HOUSTON, Feb. 2 — Texas on Friday became the first state to require all 11- and 12-year-old girls entering
the sixth grade to be vaccinated against a sexually transmitted virus that causes cervical cancer.

Averting a potentially divisive debate in the Legislature, Gov. Rick Perry, a Republican, signed an executive
order mandating shots of the Merck vaccine Gardasil as protection against the human papillomavirus, or
HPV, starting in September 2008.

Mr. Perry’s action, praised by health advocates, caught many by surprise in a largely conservative state
where sexual politics is often a battleground.

“I had no idea; I was absolutely caught off guard,” said Representative Jessica Farrar, Democrat of Houston,
who sponsored a bill to require the vaccinations starting this September. “Normally, the governor does not
take things like this upon himself, although I’m glad he did.”

Under the order, girls and women from 9 to 21 eligible for public assistance could get free shots
immediately. The governor’s office said parents could opt out of the school program “for reasons of
conscience, including religious beliefs.”

“Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and
fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical
costs,” said Mr. Perry, who was re-elected to his second full term last November.

HPV, affecting 20 million people nationally, including one in four 15-to-24-year-olds, is the nation’s most
common sexually transmitted disease. Texas has the second-highest number of women with cervical cancer,
with nearly 400 deaths last year, the governor’s statement noted.

The vaccine, approved for ages 9 to 26, is given in three shots over six months. The shots are effective for at
least five years, and together cost $360, said Curtis Allen, a spokesman for the federal Centers for Disease
Control and Prevention.

The governor did not put a price on the effort. But, extrapolating from school figures, vaccinations for about
170,000 sixth-grade girls would come to about $60 million, with insurance covering many families’ costs,
and the federal government assisting the state in subsidizing shots for needy schoolgirls and women.

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The governor’s executive order directing his Health and Human Services Commission to adopt rules
mandating the HPV inoculations along with others required for schoolchildren saved legislators from
having to go on record for or against a bill involving child sexuality.

Some parents have voiced concern that the plan could send a message that sexual activity was condoned or
that vaccinations made it safe. On the whole, however, conservative and religious groups have not come out
strongly against the vaccinations as long as families can opt out.

The Texas Freedom Network, a nonpartisan advocacy group often critical of Mr. Perry, issued a statement
praising his move. “Today’s decision by the governor is not just a positive step forward in efforts to promote
women’s health,” said the group’s president, Kathy Miller. “It is also an important acknowledgment that
health and science should not be held hostage to politics and ideology.”

A spokesman for the governor, Robert Black, discounted news accounts that Merck’s high-powered lobbyist
in Austin, Mike Toomey — chief of staff for Mr. Perry from 2002 to 2004 as well as for a Republican
predecessor, William P. Clements — might have swayed his former boss. “I don’t put a whole lot of stock in
that talk,” Mr. Black said. The governor’s order, he said, “protects human health; it was the right thing to
do.”

Mr. Toomey did not return a call. A Merck spokesman, Raymond F. Kerins Jr., declined to discuss the
company’s lobbying efforts in Austin, part of a nationwide campaign that has enlisted women in state
legislatures to advance the program.

“Merck’s goal is to support efforts to implement policies that ensure that Gardasil is used to achieve what it
was designed to do: help reduce the burden of cervical cancer,” Mr. Kerins said.

Correction: May 1, 2007

An article on Feb. 3 about efforts by Gov. Rick Perry of Texas to require sixth-grade girls to be vaccinated
against a virus that causes cervical cancer misstated the length of time over which the vaccine’s three shots
are administered. (The error was pointed out after it was repeated in an article on Thursday.) They are given
over six months, not eight months.

Copyright 2007 The New York Times Company

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Perry surprised by backlash to HPV order


MANDATE WAS MONTHS IN THE MAKING, BUT FEW WERE IN THE LOOP.
By Corrie MacLaggan
AMERICAN-STATESMAN STAFF
Friday, February 23, 2007

In the days before his Feb. 6 State of the State address, Gov. Rick Perry dribbled out announcements of several
initiatives so they wouldn't get lost in bigger news the day of the speech. On Jan. 30, a disaster contingency fund. On
Feb. 1, higher education reforms. And on Feb. 2, the mandate that schoolgirls be vaccinated against the human
papillomavirus.

That turned out to be one of the most controversial initiatives of Perry's tenure, but the governor's office never saw the
backlash coming.

The next day, when the governor's executive clerk went to church, he was unprepared for the criticism he would
encounter.

"I got hammered in church this morning on the Merck thing — and it was just Saturday," Chief Clerk Greg Davidson
wrote in a Feb. 3 e-mail to colleagues, referring to the company that makes the vaccine. "Do we have any talking points
or stats or anything that can help me fight through Sunday. This is brutal." LATEST NEWS GALLERIES »
This e-mail and other documents obtained by the Austin American-Statesman under Texas open records laws reveal
new details about how Texas became the first state to require the vaccine that helps prevent cervical cancer. They show
that the governor's office had been talking about HPV with drug maker Merck for at least five months and that the same
state agency that the governor directed to implement the executive order actually drafted the order. And they show that,
as Davidson's experience illustrates, the governor's office had simply failed to predict the firestorm.
Photos of the Charity dog Jolly Joe
Critics have blasted the executive order, with some saying Perry overstepped his authority and others worrying about the
day, July 2010 wash, 07.18.10 Harkin,
vaccine itself: that it's too new to know about long-term effects or that getting vaccinated against the sexually transmitted
07.19.10
virus could encourage young girls to be promiscuous.

A House health panel led by state Rep. Dianne White Delisi, R-Temple, a member of Perry's own Republican Party and MOST POPULAR
the mother-in-law of the governor's chief of staff, Deirdre Delisi, this week recommended that the full chamber pass a bill
that would essentially overturn Perry's mandate. Fans who bleed orange can now drink orange

"Did we expect such an uproar?" Perry spokesman Robert Black asked during an interview. "I think it's fair to say no. Huskers don't plan to be Longhorn-friendly
Would it have changed (Perry's) mind if he would have known that? No. What people thought of his order or the fact that 94-year-old makes a different kind of Starbucks run
we were the first state in the nation — for the governor, none of that really comes into play."
Statesman college football countdown: No. 10
Rather, it is a women's health issue, Black said. Nebraska

Much of the controversy has centered on Merck, which this week suspended efforts to lobby statehouses around the
country to mandate the vaccine, Gardasil. The company had been funneling money through an advocacy group, Women
in Government. LATEST AP TEXAS NEWS »

In Texas, some had questioned Perry's Merck ties: Mike Toomey, Perry's former chief of staff, is one of Merck's lobbyists Cruz's 2-run homer ends marathon game in 14th
here, and Merck gave $6,000 to Perry's re-election campaign. Black said that Toomey and Perry have never discussed 5 mins ago
HPV and that "it's a bit of a red herring" since another drug company, GlaxoSmithKline, is also developing an HPV On the Call: Texas Instruments on use of cash
vaccine. 23 mins ago

However, documents show that on Nov. 7, the day Perry was re-elected, a gubernatorial policy adviser sent an e-mail to US official: Mexican car bomb likely used Tovex
Toomey and to Lara Keel, both of the Texas Lobby Group, with the subject "HPV numbers." The e-mail included 29 mins ago
projected costs of providing the HPV vaccine to low-income Texans.
AP NEWS: Texas | Nation | World | Sports |
In fact, the governor's office was talking with Merck representatives not long after Gardasil was approved by the FDA in Business | Entertainment
June, documents show.

In an Aug. 17 e-mail to Dr. Charles Bell, deputy executive commissioner of the Health and Human Services Commission,
gubernatorial adviser Heidi McConnell wrote: "There is a good chance that we are going to do something on the HPV
vaccine, so (a colleague) and I met with Merck representatives earlier this week to get an update on the vaccine."

Black said that conversations between the governor's office and Merck "shouldn't surprise anyone. They're the ones who
had the vaccine," he said.

When preparing to announce the executive order, Perry's staffers apparently worried about coming across as too Merck-
friendly.

On the day before the executive order was issued, in response to a draft of the news release, the governor's assistant
director of budget, planning and policy wrote: "(T)hat first line sounds almost like a Merck commercial."

The draft was not provided to the Statesman. The governor's office has asked the attorney general's office for an opinion
on whether it may keep HPV-related draft documents confidential, said Chelsea Thornton, the governor's assistant
general counsel.
1 of 3 7/19/10 11:19 PM
Austin news, sports, weather, Longhorns, business | Statesman.com http://www.statesman.com/news/content/region/legislature/stori...

While the governor's office was worrying about the wording of the announcement, key lawmakers were out of the loop.
State Sen. Jane Nelson, R-Lewisville, chairwoman of the Senate Health and Human Services Committee, told reporters
Feb. 5 that she was surprised Perry hadn't contacted her about the mandate. She called on him to rescind it, saying, "I
just don't think he thought this one through."

The same day, Brandon LeBlanc, the governor's community affairs public liaison, wrote an e-mail to colleagues with the
subject "Why the rush?" He asked for an answer to "why we didn't let HPV vaccine run its course in the Leg.? Preferably
one I can use in public."

Even some members of the governor's staff were blindsided by the executive order.

Ken Armbrister, a retired state senator who is the governor's new liaison to lawmakers, was inadvertently left off the list
of officials who were to be notified ahead of time. Because Armbrister was unaware, he was unable to alert key
lawmakers to what was coming.

Perry's support of mandating the vaccine surfaced during the gubernatorial race, though few took notice.

In September, after Democrat Chris Bell had said he favored mandating the vaccine, the Fort Worth Star-Telegram
reported that Perry spokesman Ted Royer said: "Perry supports requiring the cervical cancer vaccine, as long as parents
retain the right to opt their children out."

At the time, perhaps because Bell and Perry agreed, "no one batted an eye," Black said.

After Election Day, when Perry switched from campaigning to preparing for the 2007 legislative session, he began to
consider how to implement the mandate, Black said.

State health officials could have added the vaccine to the required list without the drama of an executive order. Diesel and Power Generator In-Shop/Field
Service T
But "after spending a lot of time thinking about it, talking to folks, not the least of which was Mrs. Perry, who feels very Cummins Southern Plai
strongly about this issue, I think the governor felt so strongly that it was the absolute right thing to do to protect life, that Austin, TX
when we had an opportunity like this to prevent a cancer in young women, that he needed to put the weight of the entire
executive branch behind it," Black said. Sales
Equipment Depot
The executive order directs the Health and Human Services Commission to adopt rules that mandate the vaccination Pflugerville, TX
against HPV for girls before starting sixth grade.
Apartment Personnel
But documents show that state health officials were the ones writing a draft of the executive order that directs their own Aspen Square
agency to write the rules. Austin, TX
On Jan. 18, Dr. Charles Bell of the commission wrote an e-mail to a gubernatorial adviser: VIEW ALL TOP JOBS | SEARCH FOR A JOB

"(A)ttached is the draft Executive Order that was requested by the Governor's Office staff. Neither my staff nor I have
ever drafted such a document so we just patterned it off the ones that we found on the Governor's website. I hope the
draft is satisfactory to edit and create the official document."

Commission spokeswoman Stephanie Goodman said it's not surprising that the agency drafted the order because "we
know the language necessary to implement the vision laid out by the governor's office."

The order says that beginning in September 2008, sixth-grade girls must be vaccinated against the four strains of HPV
that cause 70 percent of cervical cancers. The shots cost $360 for the three-dose series, and it will cost $71.7 million a
year to pay for the shots for low-income Texans, Perry spokeswoman Krista Moody said. Parents may opt not to have
their daughters vaccinated.

Three weeks after Perry issued the order, he is standing by it despite widespread opposition from lawmakers and the
social conservatives who have traditionally backed him. Perry is trying to shape the debate into one that's more about
people with cervical cancer and less about politics and money. On Monday, Perry introduced reporters to a 31-year-old
Houston woman who is dying of cervical cancer caused by HPV.

"This debate should be based on whether or not this state is going to do everything it can to prevent cervical cancer in
young women, to save women's lives," Black said. "Anything else is a distraction from the real issue."

cmaclaggan@statesman.com; 445-3548

Additional material from staff writer Laylan Copelin.

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2 of 3 MARKETING 7/19/10 11:19 PM
Community Development
The Gardasil HPV Vaccine: Not the Shot in the Arm Merck Ho... http://www.commondreams.org/print/32416

#10

Published on Tuesday, September 16, 2008 by Center for Media and Democracy

The Gardasil HPV Vaccine: Not the Shot in the Arm Merck Hoped For
by Judith Siers-Poisson

With the start of the school year, debate has heated up again about Gardasil, Merck's vaccine
against human papillomavirus. Since writing my series of four articles on The Politics and PR of
Cervical Cancer last year, I have continued to track the developments and have noticed some
interesting trends. While Gardasil has not been the financial jackpot that Merck was hoping it
would be, there is still a steady push for vaccination and even still for mandates. Even though it
has not played out as positively as Merck planned, it is too early to turn our attention away from
their efforts to sell their so-called "vaccine against cancer." Merck's obvious corporate
steamrolling has generated a public backlash and has also faced general concerns about
possible health risks from vaccinations, along with conservative opposition to the idea of
government health mandates. These reactions slowed the company's money train but didn't
bring it to a full stop.

The Drumbeat Goes On

The push for mandatory vaccination continues, and many of its supporters have received money
from Merck, including Women in Government , about whom I wrote extensively in my article,
"Women in Government: Merck's Trojan Horse ." Despite a palpable turning of the tide against
mandates, Women in Government still swims against the current. In a 2008 report titled "State of
Cervical Cancer Prevention in America ," WIG continued to push for mandates and gave higher
scores to states that have introduced or passed legislation for this purpose.

WIG reports that 27 states, plus the District of Columbia, saw legislation introduced in 2007 that
would have mandated HPV vaccination. To date, Virginia and the District of Columbia are the only
places where the mandate has passed. In Virginia, it is already the law, but because it went into
effect after the start of the current school year, the mandate's impact will not really be felt until
Fall 2009. In DC, it needs Congressional approval to take effect. In the other states, legislation
either died in committee, was referred on to the next legislation session, was withdrawn, or was
modified to focus on education and availability of funds instead of the mandate.

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Merck continues to promote Gardasil through advertising and PR. Building on the "One Less" ad
campaign, designed and implemented by the Edelman public relations company, Merck is now
pushing Gardasil in a series of "I Chose" commercials. The spots include adult women saying "I
chose to get my daughter vaccinated because I want her to be one less woman affected by
cervical cancer," while a girl intones "I chose to get vaccinated after my doctor told me Gardasil
does more than help prevent cervical cancer." Again playing on parents' desires to protect their
children and girls' needs to feel independent and empowered, the ad ends with a montage of
women and girls saying "O-n-e-l-e-s-s. One less. Gardasil." In the end, women are told " "You
have the power to choose. Ask your daughter's doctor about Gardasil."

The New Jersey Star Ledger reported on June 5, 2008 that Merck bought a 60-second ad slot
to be screened before the blockbuster film, "Sex and the City" -- a long-awaited "chick flick" that
gave Merck the perfect demographic for selling its vaccine. According to the Ledger, Merck's
"research showed 76 percent of young women between the ages of 19 and 26 described
advertising they saw before a movie as entertaining. But here's the clincher: The same young
women said they pay more attention to ads on a movie screen than on television." This age range
corresponds exactly to the target market for Gardasil, since 26 is the top age at which the U.S.
Food and Drug Administration has approved giving the shots to women.

Recent Developments

Despite its corner on the market, Merck is not making as much on Gardasil as previously
planned. Forbes reported on September 12, 2008 that "Merck has already scaled back full-year
sales estimates for Gardasil from between $1.9 billion and $2.1 billion to between $1.4 billion and
$1.6 billion, following regulatory setbacks and challenges making inroads with young adult
patients." The company also suffered another financial setback: after initially insisting that it
would never settle personal injury claims related to Vioxx deaths, Merck did just that to the tune
of $4.85 billion. People injured by the painkiller are not the only ones who want Merck to pay up.
Merck investors are also seeking class action status for a Vioxx-related suit against the company.
Merck was initially successful in getting that claim dismissed, but the Wall Street Journal
reported last week that the Third U.S. Circuit Court of Appeals has reversed that ruling.

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Despite these setbacks, Merck continues to profit from Gardasil's monopoly status as the only
FDA-approved vaccine for HPV on the market. It appears that they will have the market cornered
longer than previously expected. GlaxoSmithKline 's competing vaccine, Cervarix, was
submitted to the FDA in March 2007 but has not yet been approved. Instead, the agency sent
GSK a Complete Response Letter in December, 2007 asking for more information. GSK did not
publicize the specifics of the letter, so analysts were left to wonder what the FDA wanted, and
whether it would mean a short or long delay to approval.

In June 2008 GSK announced that they had provided follow up information to the FDA in
response to the December letter, but they also made clear that there were tests in progress
whose results they felt were critical to FDA approval. A June 30, 2008 GSK press release states
that "'Study 008 is a key study that will be completing later this year, and we expect the final
results will strengthen the U.S. label for Cervarix,' said Barbara Howe, M.D., Vice President and
Director, North American Vaccine Development, GlaxoSmithKline. 'We continue to have positive
and productive discussions with the FDA and remain confident in the vaccine's safety and
efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls
and women in the U.S.'" Those tests are scheduled to run through 2008, which means that GSK
will not submit its findings to the FDA until early 2009, after which another six months at least will
be needed before the FDA can make a decision on approval. Merck can therefore count on
having the only dog in the fight for at least one more year.

Merck would like to expand vaccination with Gardasil to much older women, but even if the FDA
approved it, there are serious cost-benefit questions.Merck has suffered a regulatory setback of
its owh this year, when the FDA rejected its application to legally extend the ages for which
Gardasil can be marketed. Currently, it is approved for girls and women between the ages of 9 to
26. Merck wanted to extend that to age 45, and initial reports said Merck had data to support the
extension that they would submit to the FDA by the end of this summer.

August, however, saw a flurry of news stories and medical journal articles that cast serious doubt
on the efficacy and cost-effectiveness of vaccinating women later in life. The August 21, 2008
issue of the New England Journal of Medicine (NEJM) carried both an editorial and a lengthy
study on HPV vaccines . The editorial was written by Dr. Charlotte J. Haug, editor of The Journal
of the Norwegian Medical Association. She directly challenged the claim that HPV vaccination is
effective at preventing cervical cancer. "Despite great expectations and promising results of
clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer," she
wrote. "With so many essential questions still unanswered, there is good reason to be cautious."

The accompanying NEJM study, "Health and Economic Implications of HPV Vaccination in the
United States," looks specifically at the cost-effectiveness of the HPV vaccine. Anytime someone
raises the question of cost-effectiveness, of course, someone is bound to object that we can't
put a price tag on human life. In reality, however, cost-benefit considerations always play a role in
health decisions. With respect to cervical cancer in particular, the high cost of Gardasil compares
poorly against simple Pap smears, which provide a time-tested, reliable and inexpensive
diagnostic tool that can detect premalignant processes early and thereby prevent cervical cancer.
It seems, therefore, that financial and public health sense should favor programs to ensure that all

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women, but especially those most at risk from cervical cancer, receive consistent and appropriate
screening.

As for Gardasil, the NEJM study concluded that while the cost benefit of vaccinating twelve-year
old girls falls within accepted guidelines for wealthy countries, the cost benefit declines rapidly as
age increases. This finding is a major blow to Merck's efforts to promote intensive "catch up"
vaccinations of girls and women who are over the age targeted by schools and proposed
mandates. The benefit drops dramatically by the time women reach the maximum approved
vaccination age of 26. In the even higher age range of 27 to 45 for which Merck is seeking
additional approval, the calculated cost benefit is far outside the accepted range.

This information might seem to suggest that it is all the more important to vaccinate girls at the
youngest age possible. Merck's Dr. Richard Haupt told the New York Times that the NEJM study
"underscores the value of vaccinating pre-adolescent girls." But there is a big hitch. The NEJM
study states clearly that its cost-benefit ratios are based on an assumption that the vaccine
provides lifetime immunity to HPV. There is no evidence that this is actually the case. In fact, a
number of indicators suggest one or more boosters will be needed during the recipients'
lifetimes.

Even in the best-case scenario, HPV vaccines would only prevent 70% of cervical cancer cases,
which means that regular and consistent screening, such as tried and true Pap smears, will
remain critical for women's protection against cervical cancer. This means that the significant
costs of the three shot initial Gardasil vaccination series (with a price tag of $450-$1,000, not
including a possible booster) will be in addition to the existing costs of screening.

The NEJM article spelled out the bottom line: "If vaccine-induced immunity lasted only ten years,
the vaccination of preadolescent girls provide only 2% marginal improvement in the reduction of
the risk of cervical cancer as compared with screening alone." Experts closely involved in drug
trials for both Cervarix and Gardasil, such as Dr. Diane Harper, feel that immunity is likely to
decline after as few as five years.

On August 21, 2008 the New York Times published an article titled "Researchers Question
Wide Use of HPV Vaccines," which quoted extensively from the NEJM. The Times article
emphasized a key point: Since cervical cancer grows slowly (often a decade from infection to
full-blown cancer), there is no hard evidence yet that an HPV vaccine will actually lower the rate
of cervical cancer. The vaccines can prevent some HPV infections that may lead eventually to
cervical cancer if not diagnosed and treated. However, the tests have not lasted long enough yet
to say definitively that the result will actually translate into a real decrease in cervical cancer.
Evidence of real benefit therefore won't be available until enough years have passed that girls
who receive the vaccine can be compaired against those who don't as they pass into adulthood
and beyond.

That is quite a bombshell, and certainly a different message than Merck's marketing blitz has
encouraged the public to embrace. Merck and its supporters would have you believe that time is
of the essence and that society must move quickly to ensure that every young girl gets
vaccinated. The main beneficiary of this hurry-up approach is Merck, not women and girls.

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Things to Watch For

There are some likely developments on the horizon that I expect to emerge. One is that on
September 12, 2008, Gardasil was approved by the FDA to carry labeling that it is also effective
in preventing vaginal and vulvar cancer. According to the National Cancer Institute , the U.S.
sees 5,670 cases of these types of cancer per year, causing 1,630 deaths. These numbers are
much smaller than the figures for cervical cancer, which itself doesn't even crack the top ten fatal
cancers for women. Nevertheless, we can expect more PR and advertising from Merck, aimed at
"educating" us about the risk that they pose, however small they are in reality compared to other
threats. (For comparison's sake, cancer of all types combined kills more than 500,000 people in
the United States each year, while heart disease claims more than two million lives. An estimated
27,000 to 55,000 people have died just from taking Merck's Vioxx.)

Merck is also eager to get Gardasil approved for vaccinating boys. Why limit your potential
market to just half of the population when you can ultimately target everyone? This may be a
harder sell than they expect, but I would be surprised if they don't give it their best shot. HPV is
implicated in some cases of penile and anal cancer, but neither is widespread in the United
States. According to the National Cancer Institute, there are 6,320 cases of these types of cancer
per year in the U.S., causing 970 deaths. These numbers do not suggest that the vaccine's
benefit to male health is much of a selling point. Merck may try to sell men on the idea of getting
vaccinated to avoid passing HPV on to their sexual partners, but altruism can be a tough sell,
especially when it involves a painful series of shots and a high price tag. Only time will tell if
Merck can successfully finesse the marketing.

Merck isn't the only company that stands to profit from continued interest in and worry about
HPV. We haven't heard much from Digene, the makers of the HPV test, but I wouldn't be
surprised if they ramped up their outreach as well. Especially with Gardasil not being approved
for older women, Digene could try to market their test as a way to protect yourself even if you are
too old to get the HPV vaccine. And of course, GSK will be hoping to get Cervarix approved in
the U.S. as it has already done in many other countries worldwide.

Conclusion

With the amount of money to be made in this area worldwide, there is no chance of this issue
disappearing anytime soon. There is no doubt that the development of an HPV vaccine could
have and should have been cause for celebration -- advances in women's health care are truly
few and far between. However, Merck's own overly aggressive PR campaign, its deceit in
pushing for mandates through a non-profit front, and its willingness to over-hype its product has
made it impossible for many of us to willingly embracing their so-called "vaccine against cancer."

If you'd like to read more on this issue, much of the material mentioned here came from a chapter
that I contributed to a forthcoming book published by Project Censored. You can learn more
about Project Censored and order the book at http://www.projectcensored.org/

The debate over Gardasil in Canada provides an interesting comparison to the debate in the

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The Gardasil HPV Vaccine: Not the Shot in the Arm Merck Ho... http://www.commondreams.org/print/32416

United States. I was one of three guests on the Canadian Broadcasting Company's Sunday
Edition program on September 7, 2008. Since Canada has a national health system, there are
some differences in how this has played out, but there are also many similarities. One that is very
reminiscent of the case in Texas in 2007 , the federal Canadian government approval CA$300
million for provinces to access in order to implement mass HPV vaccination programs. What
came out soon after was that only one short month before Stephen Harper 's government put
this plan into place, one of his former senior advisor has registered as a lobbyist for Merck. To
make it even more questionable, the federal government put a time limit on how long the pool of
money was available. In year one, three provinces bought in. In this, the second and last year of
the offer, three more joined their ranks, but not without heated debate. That interview is available
at http://www.cbc.ca/thesundayedition/ (If it has been moved from the front page, it is the
September 7, 2008 program.)

Judith Siers-Poisson is the Associate Director of the Center for Media and Democracy .

Article printed from www.CommonDreams.org

URL to article: http://www.commondreams.org/view/2008/09/16-5

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Gardasil in Decline, Merck Now Increasingly Dependent on Jan... http://industry.bnet.com/pharma/1000842/gardasil-in-decline-m...

#11
Gardasil in Decline, Merck Now
Increasingly Dependent on Januvia
By Jim Edwards | Feb 4, 2009

Merck CEO Richard Clark says he cannot “categorically rule out” an acquisition despite a
slight uptick in net income, according to the WSJ. You bet he can’t. A look at Merck’s income
statement shows that the company is increasingly dependent on a single drug — diabetes
treatment Januvia — and that its overall productivity is flatlining. The decline comes in part
due to Gardasil already faltering in sales despite legal requirements that U.S. schoolgirls
receive the drug.

Q4 2008 sales were $6 billion, down slightly from the year before. But sales and marketing
expenses were up more than $100 million over the same period. Merck now gets $3.24 in
revenues for every dollar it spends on sales reps. That’s not too bad but it has been as high as
$3.63 in recent quarters. So sales-wise, this is a company that is treading water.

It’s not clear where the growth is going to come from. Look at the individual products:

Singulair in Q4 declined 3 % to $1.1 billion


Gardasil in Q4 declined 16% to $286 million
Fosamax in FY08 lost 49 percent of its sales.
Zocor in FY08 lost 25 percent of its sales.
Merck’s hepatitis vaccine business is down 47 percent.

At the same time, the costs of the Vioxx fiasco are ruining Merck’s productivity. If it were
not for legal costs, this company would be in the pink of health. From Merck’s earnings
release:

Expenses for the full year of 2008 were $7.4 billion, 2 percent less than the
Company recorded in 2007.

The full-year 2008 amount included aggregate charges of $102 million solely for
future legal defense costs for VIOXX litigation and FOSAMAX litigation.

Marketing and administrative expenses declined 17 percent in the fourth quarter


of 2008, excluding the charge for legal defense costs in the fourth quarter of
2008 and the insurance arbitration gain in the fourth quarter of 2007.

For the full year 2008, marketing and administrative expenses declined 6
percent, excluding charges for legal defense costs in 2008 and 2007…

Which leaves Januvia, pumping out $413 million per quarter of Merck’s revenue, up 64

1 of 2 7/19/10 12:50 PM
Gardasil in Decline, Merck Now Increasingly Dependent on Jan... http://industry.bnet.com/pharma/1000842/gardasil-in-decline-m...

percent from the prior year. The drug grosses greater than $1.4 billion a year.

So you can see why Clark is so open-minded about M&A. His other options are, currently,
limited.

More:
Dissecting Merck’s Gardasil for Boys FDA Application

Tags: Merck & Co. Inc., Sales Strategy, Sales Force Management, Sales, Jim Edwards

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at
Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's
business and journalism schools. Follow him on Twitter or send him an email.

Voice your 2cents

2 of 2 7/19/10 12:50 PM
Rick Perry's Ties With Merck Run Deep http://www.kbtx.com/home/headlines/5546651.html

#12

Search Monday July 19, 2010 12:51 PM Blogs Report News Eye on You Live Stream SpotCrime

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Rick Perry's Ties With Merck Run


Deep
AUSTIN (AP) -- Gov. Rick Perry ordered Friday that schoolgirls in
Texas must be vaccinated against the sexually transmitted virus that
causes cervical cancer, making Texas the first state to require the
shots.
Reporter: Associated Press
Rick Perry's Ties With Merck Run Deep

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AUSTIN (AP) -- Gov. Rick Perry ordered Friday that schoolgirls in Texas must be vaccinated against
the sexually transmitted virus that causes cervical cancer, making Texas the first state to require the shots.

The girls will have to get Merck & Co.'s new vaccine against strains of the human papillomavirus, or HPV, that are responsible
for most cases of cervical cancer.

Merck is bankrolling efforts to pass laws in state legislatures across the country
mandating it Gardasil vaccine for girls as young as 11 or 12. It doubled its lobbying
budget in Texas and has funneled money through Women in Government, an
advocacy group made up of female state legislators around the country.

Details of the order were not immediately available, but the governor's office
confirmed to The Associated Press that he was signing the order and he would
comment Friday afternoon.

Perry has several ties to Merck and Women in Government. One of the drug
company's three lobbyists in Texas is Mike Toomey, his former chief of staff. His
current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White
Delisi, is a state director for Women in Government.

Toomey was expected to be able to woo conservative legislators concerned about


the requirement stepping on parent's rights and about signaling tacit approval of
sexual activity to young girls. Delisi, as head of the House public health committee,
which likely would have considered legislation filed by a Democratic member, also
would have helped ease conservative opposition.

Perry also received $6,000 from Merck's political action committee during his
re-election campaign.

It wasn't immediately clear how long the order would last and whether the legislation was still necessary. However it could
have been difficult to muster support from lawmakers who champion abstinence education and parents' rights.

Perry, a conservative Christian who opposes abortion rights and stem- cell research using embryonic cells, counts on the
AP Video
religious right for his political base.

But he has said the cervical cancer vaccine is no different than the one that protects children against polio.

"If there are diseases in our society that are going to cost us large amounts of money, it just makes good economic sense, not
to mention the health and well being of these individuals to have those vaccines available," he said.

Texas allows parents to opt out of inoculations by filing an affidavit stating that he or she objected to the vaccine for religious
or philosophical reasons.

Even with such provisions, however, conservative groups say mandates take away parents' rights to be the primary medical
decision maker for their children.

The federal government approved Gardasil in June, and a government advisory panel has recommended that all girls get the
shots at 11 and 12, before they are likely to be sexually active.

The New Jersey-based drug company could generate billions in sales if Gardasil _ at $360 for the three-shot regimen _ were
made mandatory across the country. Most insurance companies now cover the vaccine, which has been shown to have no Find Out What's On
serious side effects.
Find out Whats on KBTX Tonight
Merck spokeswoman Janet Skidmore would not say how much the company is spending on lobbyists or how much it has
donated to Women in Government. Susan Crosby, the group's president, also declined to specify how much the drug
company gave.
Check Out What's on the CW
A top official from Merck's vaccine division sits on Women in Government's business council, and many of the bills around the
country have been introduced by members of Women in Government.
Community Media

1 of 3 7/19/10 12:52 PM
Texas Vaccine Meeting, Donation Coincide - CBS News http://www.cbsnews.com/stories/2007/02/22/politics/main2502...

AUSTIN, Texas, Feb. 22, 2007

#13
Texas Vaccine Meeting, Donation
Coincide
Gov. Perry's Staff Discussed HPV Vaccine Same Day Drug Co. Donated
To Campaign
By Francie Grace
(AP) Texas Gov. Rick Perry's chief of staff met with
key aides about the human papillomavirus vaccine
the same day its manufacturer donated money to his
campaign, documents obtained by The Associated
Press show.

Chief of staff Deirdre Delisi's calendar shows she


met with the governor's budget director and three
members of his office for an "HPV Vaccine for
Texas Gov. Rick Perry, seen here Feb. 19,
2007, at the state Capitol in Austin, has Children Briefing" on Oct. 16.
angered some of his conservative
supporters by backing the plan to vaccinate
That same day, New Jersey-based Merck & Co.'s
sixth-grade girls against HPV. (AP)
political action committee donated $5,000 to Perry
and $5,000 total to eight state lawmakers.

An order the governor issued earlier this month directed the Texas Health and Human Services
to adopt rules requiring the shots for girls entering sixth grade as of September 2008. The
vaccine protects girls and women against the HPV strains that cause most cases of cervical
cancer.

The mandate inflamed conservatives, who say it contradicts Texas' abstinence-only sexual
education policies and intrudes too far into families' lives. They also say the shots are too new
and too costly to force on young girls.

On Wednesday, the House public health committee voted 6-to-3 in favor of a bill that would
override Perry's mandate by barring state officials from requiring the vaccine for school

1 of 4 7/19/10 12:53 PM
Texas Vaccine Meeting, Donation Coincide - CBS News http://www.cbsnews.com/stories/2007/02/22/politics/main2502...

attendance. Ninety-one state representatives - or nearly two-thirds of the House - are


co-sponsoring the bill, which now can be considered by the full House.

A calendar and other documents obtained by the AP show Perry's office began meeting with
Merck lobbyists about the vaccine as early as mid-August, months before social conservatives
helped re-elect him in November.

Perry spokesman Robert Black said Wednesday afternoon that the timing of the meeting and the
donation was a coincidence. He said Delisi had asked budget director Mike Morrissey to update
her on the cost of providing the newly FDA-approved HPV vaccine free to young women on
Medicaid.

"There was no discussion of any kind of mandates," Black said.

On Wednesday night, Black issued the following statement: "The Associated Press has tried to
create a conspiracy where none exists, and they have offered not one shred of evidence to their
baseless accusations that the governor's office has done anything wrong."

Perry has repeatedly said the vaccine's lifesaving potential far outweighs opponents' concerns.
He has declined to say whether he would veto the bill but has said he is open to changes to his
order.

The documents obtained Wednesday by The AP under Texas' open records law provide new
detail about the relationship between the governor's office and Merck, which makes the only
HPV vaccine on the market.

Critics had previously questioned Perry's ties to the company. Mike Toomey, Perry's former
chief of staff and Delisi's predecessor, lobbies for the drug company. And the governor accepted
a total of $6,000 from Merck during his re-election campaign, including $1,000 in December
2005.

According to Delisi's calendar, she met with Toomey three times in the six months before the
order was issued. One meeting happened in August, on the same day two other Perry staffers
met with a different Merck lobbyist for a "Merck HPV Vaccine update." The other meetings
came just after the November election and just before the legislative session began in January.

2 of 4 7/19/10 12:53 PM
Texas Vaccine Meeting, Donation Coincide - CBS News http://www.cbsnews.com/stories/2007/02/22/politics/main2502...

Black initially said he did not know what the two discussed but later said the November and
January meetings involved State Farm Insurance Co. He said the pair have been friends for
years and pointed out that Toomey has many clients other than Merck. He also insisted that the
governor did not decide to issue the mandate until well after the election.

Merck spokesman Ray Kerins reached after business hours said he could not immediately
comment but would look into the matter. Calls seeking comment were made to a home number
for Delisi and an office number for Toomey, but were not immediately returned.

Cathie Adams, president of the conservative Texas Eagle Forum, said Black's explanation of the
timing of the campaign contribution didn't wash.

"We have too many coincidences," she said. "I think that the voters of Texas would find that
very hard to swallow."

Merck has waged a behind-the-scenes lobbying campaign to get state legislatures to require 11-
and 12-year-old girls to get the three-dose vaccine as a requirement for school attendance. But it
announced Tuesday it was suspending those efforts.

The drug company had mainly funneled money through Women in Government, a bipartisan
group of female state lawmakers. Many of the group's members have sponsored legislation in
other states that would require the vaccine for schoolgirls.

One member of Women in Government is Texas state Rep. Dianne White Delisi, Deirdre
Delisi's mother-in-law. Despite her ties to the group, the elder Delisi has opposed Perry's order
and voted for the bill aimed at overriding it.

© MMVII The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or
redistributed.

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Style)

3 of 4 7/19/10 12:53 PM
#15

LOBBYING RECORDS FROM THE TEXAS ETHICS COMMISSION


FOR MERCK GARDASIL VACCINE CAMPAIGN (2006-present)

Toomey, Michael (00013686) (512)473-2646 919


Congress Avenue #1500 Austin, TX 78701
Merck & Co. Inc. P.O. Box 4 WP39-306 West Point, PA
19486-0004 Type of Compensation: Prospective
Amount: $10,000 - $24,999.99 Client Start Date:
01/13/2006 Client Term Date: 12/31/2006

Merck & Co. Inc. P.O. Box 4 WP39-306 West Point, PA


19486-0004 Type of Compensation: Prospective
$25,000 - $49.999.99 Client Start Date: 01/12/2007
Client Term Date: 12/31/2007

Merck & Co. Inc. P.O. Box 4 WP39-306 West Point, PA


19486-0004 Type of Compensation: Prospective
$25,000 - $49.999.99 Client Start Date: 01/08/2008
Client Term Date: 12/31/2008

Merck & Co. Inc. P.O. Box 4 WP39-306 West Point, PA


19486-0004 Type of Compensation: Prospective
$50,000 - $99,999.99 Client Start Date: 01/28/2009
Client Term Date: 12/31/2009

Merck Sharp & Dohme Corp including its affiliates-Schering


Corp and Merck Schering-Plough Pharmaceut P.O.
Box 4 WP39-306 West Point, PA 19486-0004 Type of
Compensation: Prospective $50,000 - $99,999.99
Client Start Date: 11/04/2009 Client Term Date:
12/31/2009

Merck Sharp & Dohme Corp. including its affiliates


P.O. Box 4 WP39-306 West Point, PA 19486-0004 Type of
Compensation: Prospective $50,000 - $99,999.99
Client Start Date: 11/04/2009 Client Term Date:
12/31/2009

Merck Sharp & Dohme Corp including its affiliates-Schering


Corp and Merck Schering-Plough Pharmaceut P.O.
Box 4 WP39-306 West Point, PA 19486-0004 Type of
Compensation: Prospective $50,000 - $99,999.99
Client Start Date: 01/26/2010 Client Term Date:
12/31/2010

LOBBYING RECORDS FROM THE TEXAS ETHICS COMMISSION


FOR MERCK BEFORE GARDASIL CAMPAIGN(2005-earlier)

2005: Merck & Co. Inc.


P.O. Box 4 WP39-306 West Point, PA 19486-0004

Toomey, Michael (00013686)


1122 Colorado St. #220 Austin, TX 78701
Type of Compensation: Prospective
Amount: Less Than $10,000.00
Client - Start: 01/12/2005 Term Date: 12/31/2005

2004: Merck & Co. Inc.


P.O. Box 4 WP39-306 West Point, PA 19486-0004

Toomey, Michael
1122 Colorado Street #220 Austin, TX 78701
Type of Compensation: Paid
Amount: $10,000 - $24,999.99

2002: Merck & Co. Inc.


P.O. Box 4 WP39-306 West Point, PA 19486-0004

Toomey, Michael
1122 Colorado, Suite 220 Austin, TX 78701
Type of Compensation: Prospective
Amount: $25,000 - $49.999.99
Termination Date: 11/18/02

2001: Merck & Co. Inc.


P.O. Box 4 WP39-306 West Point, PA 19486-0004

Toomey, Michael
1122 Colorado, Suite 220 Austin, TX 78701
Type of Compensation: Prospective
Amount: $25,000 - $49.999.99

2000: Merck & Co. Inc.


P.O. Box 4 WP39-306 West Point, PA 19486-0004

Toomey, Michael
1122 Colorado Street SUITE 220 Austin, TX 78701-
Type of Compensation: Prospective
Amount of Compensation: $ 25,000.00 - $49,999.99
1999: Merck & Co. Inc.
P.O. Box 4 WP39-306 West Point, PA 19486-0004

Toomey, Michael
1122 Colorado St. SUITE 220 Austin, TX 78701-
Amount of Compensation: Not Provided

1998: Merck & Co. Inc.


P.O. Box 4 WP39-306 West Point, PA 19486-0004

Toomey, Michael "Mike"


1122 Colorado St. Ste 220 Austin, TX 78701-
Type of Compensation: Prospective
Amount of Compensation: $ 10,000.00 - 24,999.99

 
Perrybunkport? http://www.lonestarproject.net/Permalink/2010-07-09.html

#16

Perrybunkport?
Is Mike Toomey avoiding a subpoena by hiding out on his privately owned island?

That’s right. Mike Toomey owns an island. Being Rick Perry’s


former Chief of Staff and close political confidant is apparently
quite lucrative. What’s more, Toomey owns the island – which is
located on Lake Winnipesaukee in New Hampshire – jointly with
top Perry political strategist, Dave Carney. (Source: New
Hampshire Secretary of State)

Efforts have been underway this week to serve Toomey with a


Court-issued subpoena demanding that he appear for questioning
Lone Star Project on under oath. Toomey is subject to questioning after a witness Parker Island
Facebook
testified under oath that he played a key role in the Rick
Like 1,493 Perry/Green Party ballot scandal. So far, Toomey has dodged the subpoena.
Lone Star Project on Facebook

Toomey beating the heat and the “Heat”


The New Hampshire shoreline is not only a good place to escape the 100-degree Texas
weather; it’s also a good place to avoid Travis County Sheriff’s Deputies with subpoenas. The
Lone Star Project has learned that Toomey has so-far ducked the process server by fleeing to
-
the New Hampshire shores and staying at his luxury island hideaway. Of course, when Toomey
returns to "mainland" Austin, the subpoena will be waiting.

Making an Impact
About Perrybunkport
“The Lone Star Project … "Parker Island is a 2.7 acre private unbridged island
hammers Republicans located just outside of Wolfeboro Bay on Lake
whenever it gets a chance, Winnipesaukee." The island, which is owned by
promoting strong local Toomey and Carney, rents for $18,000 a week when
Democratic candidates and the pair is not using it. The island includes:
even bringing lawsuits.”
(Roll Call, Stuart Rothenberg,
"Dock space for up to 14 boats, two beaches,
March 12, 2009)
a screened gazebo, water slide and swim raft,
as well as beautifully manicured lawns...
“Anyone who questions whether 4 bedroom Main House is 2,956 sq. ft, sleeps Toomey's Private Island Luxury Home
[The Lone Star Project] can 12 and has 2 1/2 bathrooms...
make life difficult for a 4 bedroom Guest House is 2,040 sq. ft, sleeps
Republican legislator should 8 and has 2 bathrooms. "
talk to former Sen. Kim Brimer.” (All information directly from Parkerisland.com)
(Austin American Statesman, February 17,
2009)

“[The Lone Star Project] is


responsible for the aggressive
stance the party has taken
toward DeLay and other Lone
Star State Republicans since
the 2004 election.”
(The Washington Post, March 6, 2006)

1 of 3 7/19/10 12:54 PM
Perrybunkport? http://www.lonestarproject.net/Permalink/2010-07-09.html

"David Dewhurst has said most


Texans don't have much
sympathy "for someone who
that can't fill out a two page
[health insurance] application
every six months".

The Democrat-supported Lone


Star Project in Washington
reported this week that
Dewhurst failed to file
necessary forms at least six
times in recent years.
(San Antonio Expres News,, 4/12/2007)

"The Justice staff memo was


obtained by the Lone Star
Project ...The story broke the
same day the U.S. Supreme Mike Toomey strolls to his private island dock
Court was considering legal
challenges to the plan brought
by Democrats and minority
groups."
(Houston Chronicle, 12/3/2005)

Like Noelle Cigarroa Bell and 2 others like this.


"The Texas chapter of the
NAACP, along with the Lone
Star Project, have analyzed the Permalink
amicus brief filed by the Justice
Department and have
concluded, justifiably, that the
Voting Rights section of the
Justice Department is now
controlled by partisan political
appointees."
(Roll Call - Donna Brazile, 2/28/2006)

2 of 3 7/19/10 12:54 PM
Angry e-mails, letters took aim at Perry after HPV vaccine order... http://www.printthis.clickability.com/pt/cpt?action=cpt&title=A...

#17

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Angry e-mails, letters took aim at Perry after


HPV vaccine order
By KELLEY SHANNON Associated Press Writer

March 8, 2007
Posted: June 10, 2008, 6:33 PM CDT

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1 of 3 7/19/10 1:00 PM
Angry e-mails, letters took aim at Perry after HPV vaccine order... http://www.printthis.clickability.com/pt/cpt?action=cpt&title=A...

State News

Recommend Be the first of your friends to recommend this.

Texans who disagreed with Gov. Rick Perry's order that girls be vaccinated against a virus that causes
cervical cancer flooded his office with angry messages in the days after he announced his decision.

More than 5,900 e-mails and printed notes have been sent to Perry about his Feb. 2 executive order
that girls entering the sixth grade in 2008 be vaccinated against the human papilloma virus, which
causes most cases of cervical cancer.

The Associated Press obtained the majority of that correspondence last month using the Texas Public
Information Act and examined a portion of it. Most of the letters voiced disapproval. Some Texans
agreed with Perry's goal of fighting cervical cancer, but said mandating the Gardasil vaccine made by
Merck & Co. wasn't the way to achieve it.

"Please, reconsider. Please, return parental choices, control, power to parents," wrote Bette D. Bittner
of Caldwell.

Ned Funnell of Longview also told Perry the decision to vaccinate belongs to the parents of young
women, not the state.

"Aside from endorsing sexual conduct in young girls, the requirement of this vaccination is an
invasion into the people's rights _ it's one big step towards big government," he said.

Perry repeatedly has noted that under state law parents can "opt out" of having their children
vaccinated.

Republican legislators are pushing to pass a bill this session that would override Perry's vaccine order.
They argue that the Merck vaccine is too new and unproven to be forced on young Texas girls.

Some of the anti-vaccine e-mail messages to Perry's office were sent from different people but
contained identical wording, indicating they were likely part of an orchestrated letter-writing
campaign. That's common with issues of widespread interest, said Ted Royer, a spokesman for Perry.

Royer said of the e-mails and letters on the vaccine received by the governor's office as of Tuesday, 89
percent opposed his order, while 11 percent favored it.

The volume of vaccine mail set no records within the governor's office. Royer said the office received
almost 31,000 pieces of correspondence regarding proposed coal-fired power plants from November
through early January. All of it opposed the power plants, and about 24,000 of the messages were
from out of state, Royer said.

"There are some issues that will generate near unanimous contact on one side of an issue," Royer said.

Most of the e-mails and letters on the cervical cancer vaccine were from Texans, with about 1,500
coming from out of state, he said.

2 of 3 7/19/10 1:00 PM
Angry e-mails, letters took aim at Perry after HPV vaccine order... http://www.printthis.clickability.com/pt/cpt?action=cpt&title=A...

The governor's office has a constituent services division that receives letters and e-mails and responds
to them. That division summarizes the trend in the mail and provides the tallies to top aides to Perry.

Occasionally, correspondence is routed directly to Perry if it's from a friend or acquaintance or is


particularly noteworthy, Royer said.

In the cervical cancer vaccine mail, some Texans said they've always been supportive of Perry, but
that this action turned them away from him or his Republican Party.

Rhonda Hess of Conroe, who signed herself "a disappointed Texan," wrote that the human papilloma
virus, or HPV, can be prevented through use of a condom.

"Why not hand out condoms to 9 year olds? Guess Merck wouldn't make much money on a
condom.... I deeply regret giving my vote to you in the last election," Hess wrote.

Charles Tucker of La Marque alluded to recent gubernatorial challenger Carole Keeton Strayhorn, an
unsuccessful independent candidate who called herself "one tough grandma."

"You have stepped in it again _ big time," he wrote to Perry. "I now regret that I didn't vote for the
Grandmaw."

Among the favorable e-mail messages to Perry came from a woman who said she has HPV and that
she wishes she could have had the vaccine. She compared it to the polio vaccine or any childhood
immunization and said administering the vaccine doesn't have "anything to do with religion or with
sending a signal for teens to have sex."

"If you can prevent 92% of women from getting Cervical Cancer then why wouldn't you do it! Thank
you!"

Find this article at:


http://www.beaumontenterprise.com/news/angry_e-
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reversing his vaccination order
JANET ELLIOTT, Austin Bureau Staff
Wed 05/09/2007 Houston Chronicle, Section A, Page 1, 3 STAR Edition Cruise specials for those 55
or older
AUSTIN - Gov. Rick Perry, at times emotional and defiant, chastised
Share One of the great perks of
lawmakers for overturning his mandate that schoolgirls be vaccinated reaching age 55 is
Share against HPV as he let the law take effect Tuesday. having... More
As Perry announced his decision to let the bill become law without his
signature, he was flanked by several woman who have been affected
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by HPV, a common sexually transmitted disease linked to most Mysterious fruits reverse aging, improve
Twitter Yahoo! Buzz health
cervical cancers. He said one woman contracted the virus from a
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Acknowledging that it would be useless to veto the bill because there New student aid you never heard of
is sufficient legislative support for an override, he continued to try and How to restore your PC to like-new
provoke his opponents at the Capitol. performance
"In the next year, more than a thousand women will likely be diagnosed with this insidious yet mostly preventable
Advertising provided by: ARALifestyle.com
disease," said Perry. "I challenge legislators to look these women in the eyes and tell them, `We could have
prevented this disease for your daughters and granddaughters, but we just didn't have the gumption to address all Bodies of two infants found in Tarrant Co.
the misguided and misleading political rhetoric.' " Man dies in crash on tollway in NW Harris Co.
Critics of Perry's order countered that it was the governor who mishandled the issue from the start by not consulting Michael Jackson's death called homicide
with senators and representatives before issuing his Feb. 2 executive order. Only three of 181 lawmakers voted Melanie Griffith checks into rehab
against the bill rescinding his order. Malaysia delays caning of woman who drank
"All the governor would have had to do is talk to us and he would have seen that we would have embraced a beer
program where there was an opt-in instead of an opt-out," said Lt. Gov. David Dewhurst.
Perry's order that all sixth-grade girls be inoculated against HPV before entering school next year would have Obama to health care critics: end 'phony
allowed parents to opt out their daughters. But the author of the bill overturning Perry's order, Rep. Dennis Bonnen, claims'(654)
R-Angleton, said it's much better to allow parents to decide what's best for their daughters. More advertisers ditch Beck after he calls
Obama racist(505)
"This drug has not been properly studied to know the impact on 11-year-olds and what the long-term impact might be Deal on jail, stadium, Dome in home
on those young girls' fertility," Bonnen said. stretch'(178)
Next review may be in 2011 Try to envision this: a world with $20-a-gallon
gas(155)
Perry said that lawmakers didn't want to hear from some cervical cancer victims, including Heather Burcham, of
County puts more heat on adult businesses(155)
Houston. The 31-year-old dying woman became exhausted and had to leave a late-night committee hearing in
February before testifying after state health officials and other invited witnesses were called first.
Perry ended his press conference by showing a video on a large screen from Burcham, who she said was too ill to
travel to Austin. Speaking from a bed, with an oxygen feed in her nostrils, Burcham said if she could save one child
from the pain and heartbreak she has suffered "it would mean the world to me."
Bonnen said he was offended at Perry's "use of cancer victims as his background for an issue that he has grossly
misjudged."
Just because he doesn't want 165,000 preteens to be "the study group" for vaccine manufacturer Merck, Bonnen
said, that doesn't mean he is uncaring about women's health.
House Bill 1098 prevents state health officials from requiring the vaccine against the human papillomavirus for
school enrollment until 2011. At that time, lawmakers can reconsider the issue, said Sen. Glenn Hegar, who
sponsored the bill in the Senate.
The Katy Republican said he hopes that there will be more HPV vaccines on the market in four years and that they
might be even more effective. Merck's Gardasil vaccine protects against four strains of HPV responsible for 70
percent of cervical cancers.
Motivations still doubted
The Texas Eagle Forum was among those who questioned whether Perry was acting to benefit pharmaceutical giant
Merck, whose Gardasil vaccine went on the market last June. Perry's former chief of staff, Mike Toomey, is a lobbyist
for Merck, and the governor had accepted $6,000 in contributions from the company's political action committee.
Within three weeks of Perry's order, Merck had abandoned its lobbying push to get states to mandate the shots. The
company said the campaign was becoming a distraction in efforts to make the vaccine widely available.
Perry said he was motivated by a desire to save the nearly 400 Texas women who die from cervical cancer each
year.
On Tuesday, he rejected arguments by some social conservatives that vaccinating girls and young women against
HPV might encourage premarital sex.
In a written message about his decision, Perry said even if they do make wrong choices, the "greater imperative is to

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protect life."
Perry also said that attempts to discredit Gardasil are "hyperbole that doesn't stand up in light of clinical data."
The Texas medical community is split on the issue. Among doctors' concerns is the high cost of the three-dose shot
regimen, which Merck sells for $360.
Texas will continue to pay for girls and young women covered by state health programs to receive the shots if they
choose to do so.
One of the few lawmakers to support Perry, Rep. Garnet Coleman, praised his message.
"The governor and I hardly ever agree, but he has shown tremendous leadership on this issue," the Houston
Democrat said. "It is my sincere hope that we can work together next session to pass legislation that puts politics
aside and does what is right for the people of Texas."

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Partnership, L.P., or its news and feature syndicates and wire services. No materials may be directly or indirectly published, posted to Internet
and intranet distribution channels, broadcast, rewritten for broadcast or publication or redistributed in any medium. Neither these materials nor
any portion thereof may be stored in a computer except for personal and non-commercial use.

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