law suit against big pharma

Paper title Abstract summary Authors

Lawsuit says pharm companies conspired to x prices of generic drugs Major pharmaceutical companies are being charged with conspiring to in ate prices on a variety of generic drugs by up to 1,000 percent. J. Bendix

Drug company threatens legal action over Canadian guidelines A pharmaceutical company has threatened legal action against an adviser to the Ontario Ministry of Health after taking issue with draft prescribing guidelines that she developed. M. Shuchman

Drug Companies' Liability for the Opioid Epidemic. The U.S. government pursues civil and criminal actions against physicians and pharmacies to address inappropriate prescribing and dispensing of opioids. R. Ha ajee, M. Mello

Dozens of US states sue 20 generic drug companies over “industry wide conspiracy” to drive up prices Generic drug makers conspired to avoid competition and drive up the prices of more than a hundred common drugs. O. Dyer

Scienti c harassment by pharmaceutical companies: time to stop. The results of applied medical research are impeded by the pharmaceutical industry. D. Hailey

The Courts--A Challenge to Health Technology Assessment A drug company sued to prevent publication of a report or blocked publication, and then sued a ministry of health for releasing the data used in the research. E. Hemminki, D. Hailey, M. Koivusalo

Protecting the rights of investigators in industry-supported clinical research. Investigators should carefully review the entire contract. R. Rutherford, K. Johnston

Academic medical centers' standards for clinical-trial agreements with industry. Standards for restrictive provisions in clinical-trial agreements with industry sponsors vary among academic medical centers. M. Mello, B. Clarridge, D. Studdert

The Truth About the Drug Companies: How They Deceive Us and What to Do About It Big Pharma's rise to power and manipulative and downright devious tricks it uses to stay there are presented in The Truth About the Drug Companies. M. Angell

Public Welfare Agenda or Corporate Research Agenda? Academics should keep themselves involved right from inception of clinical trials through ultimate publication. Ajai R. Singh, Shakuntala A. Singh

Uneasy alliance--clinical investigators and the pharmaceutical industry. Most clinical studies that bring new drugs from bench to bedside are nanced by pharmaceutical companies. T. Bodenheimer

Failing the public health--rofecoxib, Merck, and the FDA. Merck withdrew the drug because of an excess risk of myocardial infarctions and strokes. E. Topol

Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry? Pharmaceutical companies and their agents shape multiple steps in the research, analysis, writing, and publication of articles. S. Sismondo

Big pharma often commits corporate crime, and this must be stopped The crimes were widespread and repetitive. P. Gøtzsche

THE ‘ACCESS TO MEDICINES’ CAMPAIGN VS. BIG PHARMA A transnational civil society campaign challenged a patent protection regime in the early 2000s. T. Owen

Big pharma and health care: unsolvable con ict of interests between private enterprise and public health. The pharmaceutical industry sets up a research agenda guided more by marketing than by clinical considerations. M. Brezis

Corporate Science and the Husbandry of Scienti c and Medical Knowledge by the Pharmaceutical Industry Pharma stamps consensus-building narratives into medical-scienti c discourse. Alastair I. Matheson

Promoting transparency in pharmaceutical industry-sponsored research. Policies that promote transparency in the clinical trial research process may address these subversive practices by improving accountability among industry and investigators. J. Ross, C. Gross, H. Krumholz

The role of litigation in de ning drug risks. Litigation can exert its e ect through the discovery process. A. Kesselheim, J. Avorn

Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents The key goal of teleconferences on epilepsy management was to increase Neurontin new prescriptions by convincing non-prescribers to begin prescribing and current prescribers to increase their new prescription behavior. M. Steinman, L. Bero, M. Chren, C. Landefeld

Deadly medicines and organised crime: How big pharma has corrupted healthcare The book is comprehensive, with worldwide examples across many countries. J. Dickinson

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14 2014 126

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 Semantic Scholar URL Abstract Takeaway suggests yes/no Study type

https://semanticscholar.org/paper/c078a3228d115922fdf1f959e3350ed6a9e702c7 Major pharmaceutical companies are being charged with conspiring to in ate prices on a variety of generic drugs by up to 1,000 percent, according to reports in the New York Times, the

https://semanticscholar.org/paper/77e583c9e5f1e9e147056da0a15eb3ecb6791189 A pharmaceutical company has threatened legal action against an adviser to the Ontario Ministry of Health after taking issue with draft prescribing guidelines that she developed Review

Anne Holbrook, a pharmacist and practising physician at the Centre for the Evaluation of Medicines at McMaster University in Hamilton, Ontario, serves on several committees that make recommendations on prescribing issues. In 1997, Ontario's Ministry of Health asked her to lead a review of the drugs used …

https://semanticscholar.org/paper/03d48c3615f98f884ed 3e5e35cbf382de71 c Even as the U.S. government, among others, pursues civil and criminal actions against physicians and pharmacies to address inappropriate prescribing and dispensing of opioids, a variety of lawsuits are being led against opioid manufacturers and distributors.

https://semanticscholar.org/paper/1b8e97b2e64eb3d8632d9543580a4543938939c1 Generic drug makers conspired to avoid competition and drive up the prices of more than a hundred common drugs, sometimes by more than 1000%, according to a major lawsuit led by 43 US states and Puerto Rico.1

The “industry wide conspiracy” is the principal reason the promise of generics delivering a ordable drugs to US patients has never materialised, according to Connecticut attorney general William Tong, who is leading the suit.

https://www.semanticscholar.org/paper/71fef021c53fcfa35a24804001b7862a93e56a50 The timely and accurate synthesis of clinical trial results and of other information on new drugs and new devices is essential to informed decision-making on the appropriate use of these products. However, 2 alarming trends are already impeding such assessments. First, the results of applied medical

https://www.semanticscholar.org/paper/31a2aad76263eb4 2faf9cd7044299a13fab0ce This paper discusses the use of legal means by industry to challenge the quality and credibility of research. Two cases in which a drug company sued to prevent publication of a report or blocked publication, and then sued a ministry of health for releasing the data used in the research, are described. These two unsuccessful actions were based on national laws, but in the futur

https://www.semanticscholar.org/paper/ba94fbc548eb1966e6854740ac76c83955216215 Research contracts between a company and a clinical trial investigator often contain “non-disclosure” clauses, drawn up to protect the company against the investigator divulging proprietary information or information about the company’s business operations.
Review
Yet the research contracts that today’s investigators are asked to sign before participating in an industry-supported c

https://www.semanticscholar.org/paper/d5c30b0a05f51a5447ce1e153e3f226b6e4d2800 BACKGROUND

Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials.

METHODS

We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors.

https://www.semanticscholar.org/paper/559a0074f54bf0c09d35f35266acb111b45eb040 “What does the eight-hundred-pound gorrilla do? Anything it wants to.” These are the rst words of Chapter One, innagurating the pages of this monumental book with metaphoric clear-seeing that is beyond deniability. Indeed, America has made the drug companies (aka “Big Pharma”) a political and economic behemoth nearly incapable of stopping. A staggering $200 billion

https://www.semanticscholar.org/paper/b4dd4b7b9182c05432963dbd 2b22c744084b6a As things stand today, whether we like it or not, industry funding is on the upswing. The whole enterprise of medicine in booming, and it makes sense for industry to invest more and more of one′s millions into it. The pharmaceutical industry has become the single largest direct funding agency of medical research in countries like Canada, the United Kingdom and the United St

https://www.semanticscholar.org/paper/e235a375a5b6f27caf0dd75d5bf2c80031aabac8 Clinical practice is changing rapidly. New cardiovascular drugs, antiin ammatory drugs, cancer chemotherapy, and other pharmacologic weapons are being added to physicians' therapeutic armamentarium virtually daily. Most clinical studies that bring new drugs from bench to bedside are nanced by pharmaceutical companies. Many of these drug trials are rigorously design

https://www.semanticscholar.org/paper/7a336106dec345c6dc7bf36c3ccde3df9aaf1478 On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescri

https://www.semanticscholar.org/paper/a40ea836ef390a7c12325b4fc623bcd30eabed54 Sismondo discusses how pharmaceutical companies and their agents shape multiple steps in the research, analysis, writing, and publication of articles.

https://www.semanticscholar.org/paper/fb1645b2578f851d80d8fc316b506e9f51edbfdf When a drug company commits a serious crime, the standard response from the industry is that there are bad apples in any enterprise. Sure, but the interesting question is whether drug companies routinely break the law.

I googled the names of the 10 largest drug companies in combination with the term “fraud” and looked for o ences on the rst page for each company. The most common recent crimes were illegal marketing by recommending drugs for non-approved (o label) uses, misrepresentation of research results, hiding data on harms, and Medicaid and Medicare fraud.1 All cases we

https://www.semanticscholar.org/paper/d8379a891c3a2a089281f3646c713a5f299d40fa This paper deploys Laclau and Mou e's discourse theory to examine the dispute over intellectual property protection and global HIV/AIDS medicines access. Over the 1980s and 1990s, major pharmaceutical companies and minority world governments successfully crafted a strong patent protection regime, institutionalized in the World Trade Organization's intellectual propert

https://www.semanticscholar.org/paper/39435f292abd904af6d21b1ec956c2fb556e742e A landmark paper on Game Theory showed that individual maximization of pro t necessarily endangers the public good, and since the problem has no technical solution, "it requires a fundamental extension in morality" (1). We propose here that public health, as a public good, now emerges as a grave example of this problem. Recent events and reports increasingly suggest m

https://www.semanticscholar.org/paper/ca67fcee17fb3a1528f3d9a33e43d446ac7c365d This article analyses the role of the pharmaceutical and medical device industries (‘pharma’) in the construction of scienti c and medical knowledge. Pharma's activities are part of the broader dispositif of institutions, enterprises, regulations and constituencies within which medical-scienti c knowledge is generated, but pharma's contributions exhibit a speci c character re ec

https://www.semanticscholar.org/paper/b37fa26520614da24bc6cfaa6c028e0d54850937 Strong, evidence-based practice requires that objective, unbiased research be available to inform individual clinical decisions, systematic reviews, meta-analyses, and expert guideline recommendations. Industry has used seeding trials, publication planning,
Review
messaging, ghostwriting, and selective publication and reporting of trial outcomes to distort the medical literature and u

https://www.semanticscholar.org/paper/9e1d634ee9be050c20d1d3c1db0f1822e94bb0bf IN THE PAST DECADE, SEVERAL WIDELY USED PRESCRIPTION medications have been observed to cause lifethreatening adverse e ects, and some have been removed from the market. When an approved medication is found to be unsafe, the courts are sometimes called on to determine fault and allocate remedies for injured parties. But in modern prescription drug cases

https://www.semanticscholar.org/paper/61a25d03ac34713b1c19d1a1129adc4135a5dfe1 Key Summary Points Industry promoted gabapentin for on- and o -label uses as part of a comprehensive marketing plan. Frequent prescribers of anticonvulsant agents, opinion leaders, and local champions of gabapentin were specially targeted for promotion. ReviewGabapentin was promoted by using education and research, activities not typically recognized as promotional. Indep
and directors of academic clinical programs or divisions (24, 27). Of these 40 leaders, 35 participated in at least 1 Parke-Davissponsored activity, including 14 who requested or were allocated $10250 to $158250 in honoraria, research grants, or educational grants between 1993 and 1997 (11). Parke-Davis also targeted residents; planning documents for the 1998 advertising a

https://www.semanticscholar.org/paper/88b 75a6a1ead9d7e4aa796a35d915a43be72e2 AUTHOR Peter C. Gotzsche PUBLISHER Radcli e Publishing, St Mark’s House, Shepherdess Walk, London, N17LH, United Kingdom TELEPHONE 0844 887 1380 WEBSITE [www.radcli ehealth.com][1] PUBLISHED 2013/310 pp/$50.50 OVERALL RATING Excellent STRENGTHS Comprehensive, with worldwide examples across many

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 Detailed abstract summary

**Major pharmaceutical companies are being charged with conspiring to in ate prices on a variety of generic drugs by up to 1,000 percent.**

A **pharmaceutical company** has threatened legal action against an adviser to the Ontario Ministry of Health after taking issue with draft prescribing guidelines that she developed.

This paper discusses the **various lawsuits being led against opioid manufacturers and distributors**.

This paper discusses a **lawsuit led by 43 US states and Puerto Rico against 20 generic drug companies**. The lawsuit alleges that the companies **conspired to avoid competition and drive up the prices of more than 100 common drugs**.

This paper discusses **two alarming trends** that are impeding the synthesis of clinical trial results and other information on new drugs and devices. First, **the results of applied medical research are being suppressed by pharmaceutical companies**. Second, **there is a growing trend of companies manipulating the scienti c process**.

This paper discusses the use of legal means by industry to challenge the quality and credibility of research. It describes two cases in which a drug company sued to prevent publication of a report or blocked publication, and then sued a ministry of health for releasing the data used in the research. These two unsuccessful actions were based on national laws, but in the future international treaties may be used to challenge health technology assessments.

This paper discusses the **restrictive clauses** in **research contracts** that **can create problems for investigators**. These problems may include **con icts with the scienti c goals and integrity of the investigator**, **delays or failure to report adverse events or to report negative trials**, and **restrictions on access to data**.

This paper discusses **standards for clinical-trial agreements with industry sponsors**. It nds that there is **considerable disagreement about the acceptability of some provisions**, and that **disputes are common after the agreements have been signed**.

This book is about **Big Pharma's** power and the manipulative tricks it uses to stay in control.

This paper discusses the **con icts of interest between academia and industry**. It argues that **industry funding is on the upswing** and that **industry decides which clinical research/trial gets done**. The paper concludes that **researchers should refuse to allow commercial interests to rule research reporting**.

This paper discusses how **clinical practice is changing rapidly** and how **most clinical studies that bring new drugs from bench to bedside are nanced by pharmaceutical companies**. It describes how **commercial oriented networks of contract-research organizations (CROs) and site-management organizations (SMOs)** have altered the clinical research landscape.

On September 30, 2004, **Merck withdrew rofecoxib** because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history.

This paper discusses how **pharmaceutical companies and their agents shape multiple steps in the research, analysis, writing, and publication of articles**.

This paper discusses how **big pharma companies often commit corporate crime**. The most common recent crimes are illegal marketing by recommending drugs for non-approved (o label) uses, misrepresentation of research results, hiding data on harms, and Medicaid and Medicare fraud.

This paper uses **Laclau and Mou e's discourse theory** to examine the **dispute over intellectual property protection and global HIV/AIDS medicines access**. It nds that the **2001–2003 period was a 'golden window' for expanded global HIV/AIDS medicines access**, but that this was an **un sustainable aberration** to a continuing hegemonic regime that prioritizes patent protection.

This paper discusses how the interests of the **pharmaceutical industry** are often misaligned with those of **public health**. It describes how the industry uses **marketing tactics** to promote its products and how this can be detrimental to public health.

This paper discusses how the pharmaceutical industry's construction of scienti c and medical knowledge is shaped by commercial pressures. It describes how the industry stamps consensus-building "narratives" into medical-scienti c discourse and how this mode of knowledge production can be viewed as a normative transformation of Kuhnian normal science.

This paper discusses how **industry has used seeding trials, publication planning, messaging, ghostwriting, and selective publication and reporting of trial outcomes to distort the medical literature**. It argues that **policies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data

This paper discusses the role of **litigation in uncovering new information concerning drug-induced illness and the impact of litigation on drug policy**. It looks at how litigation has helped uncover previously unavailable data on adverse e ects, questionable practices by manufacturers, and aws in drug regulatory systems.

This paper discusses how **gabapentin was promoted by using education and research, activities not typically recognized as promotional**. It describes how **independent continuing medical education, peer-to-peer selling by physician speakers, industry-funded studies, and publications in the medical literature were used to advance marketing goals for the drug**.

This book is **comprehensive**, with **worldwide examples** of how **big pharma has corrupted healthcare**.

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 Main ndings

• Major pharmaceutical companies are being charged with conspiring to in ate prices on a variety of generic drugs by up to 1,000 percent.

• The lawsuit alleges that the companies colluded to x prices and limit competition.

• A pharmaceutical company has threatened legal action against an adviser to the Ontario Ministry of Health after taking issue with draft prescribing guidelines that she developed.

• Anne Holbrook, a pharmacist and practising physician at the Centre for the Evaluation of Medicines at McMaster University in Hamilton, Ontario, serves on several committees that make recommendations on prescribing issues.

• A variety of lawsuits are being led against opioid manufacturers and distributors in response to the opioid epidemic.

• The U.S. government is pursuing civil and criminal actions against physicians and pharmacies to address inappropriate prescribing and dispensing of opioids.

• 43 US states and Puerto Rico have led a major lawsuit against 20 generic drug companies for conspiring to avoid competition and drive up the prices of more than a hundred common drugs.

• The lawsuit alleges that the generic drug makers conspired to raise prices by more than 1000%.

• Pharmaceutical companies are engaging in scienti c harassment, which is impeding the timely and accurate synthesis of clinical trial results and other information on new drugs and devices.

• This harassment is taking the form of intimidation, censorship, and manipulation of data.

• Industry has used legal means to challenge the quality and credibility of research.

• Two cases of unsuccessful legal action by a drug company to prevent publication of a report or block publication of data used in the research are described.

• Research contracts between a company and a clinical trial investigator often contain “non-disclosure” clauses that can restrict the investigator's rights to access, analyze, and report trial data.

• These clauses can con ict with the scienti c goals and integrity of the investigator, and may indirectly violate ethics regarding patient safety.

• There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications.

• There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts, draft the manuscript, and prohibit investigators from sharing data with third parties after the trial is over.

• Disputes were common after the agreements had been signed and most frequently centered on payment, intellectual property, and control of or access to data.

• Big Pharma has become a powerful political and economic force, spending $200 billion a year on prescription medication.

• Big Pharma uses manipulative and deceptive tactics to maintain its power and pro ts.

• Industry funding of medical research is on the rise.

• Con icts of interest between industry and academia are inevitable.

• Clinical practice is rapidly changing due to the introduction of new drugs.

• Most clinical studies that bring new drugs to the market are funded by pharmaceutical companies.

• Merck was granted approval by the FDA to market rofecoxib (Vioxx) in 1999.

• After 80 million patients had taken the drug and annual sales had topped $2.5 billion, the company withdrew the drug in 2004 due to an excess risk of myocardial infarctions and strokes.

• Pharmaceutical companies and their agents are involved in multiple steps of the research, analysis, writing, and publication of medical literature.

• Pharmaceutical companies and their agents can in uence the content of medical literature by providing funding, selecting authors, and providing editorial input.

• The most common corporate crimes committed by the 10 largest drug companies are illegal marketing, misrepresentation of research results, hiding data on harms, and Medicaid and Medicare fraud.

• These crimes are likely committed deliberately, as they are widespread and repetitive.

• Major pharmaceutical companies and minority world governments successfully crafted a strong patent protection regime in the 1980s and 1990s.

• In the early 2000s, a transnational civil society campaign challenged this regime, positioning patents at the centre of a highly publicized dispute.

• There is a misalignment between the interests of the pharmaceutical industry and those of public health.

• Pharmaceutical companies prioritize pro t over public health, using tactics such as ghost writing, professional guidelines, and manipulating media for disease mongering.

• Pharmaceutical and medical device industries (‘pharma’) play a signi cant role in the construction of scienti c and medical knowledge.

• Pharma's activities exhibit a speci c character re ecting commercial pressures, such as the integration of scienti c truth-claims and commercial positioning.

• Industry has used various tactics to distort the medical literature and undermine clinical trial research.

• Policies that promote transparency in the clinical trial research process can address these practices.

• Litigation can uncover previously unavailable data on adverse e ects, questionable practices by manufacturers, and aws in drug regulatory systems.

• Litigation can motivate proper disclosure of drug risks and bene ts by presenting the possibility of substantial damages in cases of misconduct.

• Industry promoted gabapentin for on- and o -label uses as part of a comprehensive marketing plan.

• Frequent prescribers of anticonvulsant agents, opinion leaders, and local champions of gabapentin were specially targeted for promotion.

• Big Pharma has corrupted healthcare by using organized crime to distribute deadly medicines.

• Pharmaceutical companies have used bribery, fraud, and other unethical practices to increase pro ts.

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