Over the past six years, ten FDA approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for measures of improvement.
On June 20, 2006, the New York Times reported that "two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States."
The Senators behind the proposal are Michael Enzi (R-Wy), chairman of the Health, Education, Labor and Pensions Committee, and Ted Kennedy (D-MA), the ranking Democrat on the committee.
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Monday, January 29, 2007
Glaxo faces drug fraud lawsuit
David Teather in New York and Sarah Boseley
Thursday June 3, 2004
The Guardian
Britain's biggest drug company, GlaxoSmithKline, is facing fraud charges in the United States for allegedly concealing information that its leading antidepressant caused suicidal behaviour among children and teenagers during clinical trials.
The civil lawsuit, filed by the combative and popular New York State attorney general Eliot Spitzer, claims that the company suppressed the results of at least four different studies that showed the drug, called Paxil in the US and Seroxat in the UK, at best was no more effective than a placebo and at worst was harmful. At the same time the company was said to be promoting the drug heavily to American doctors boasting of its efficacy and safety.
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Thursday June 3, 2004
The Guardian
Britain's biggest drug company, GlaxoSmithKline, is facing fraud charges in the United States for allegedly concealing information that its leading antidepressant caused suicidal behaviour among children and teenagers during clinical trials.
The civil lawsuit, filed by the combative and popular New York State attorney general Eliot Spitzer, claims that the company suppressed the results of at least four different studies that showed the drug, called Paxil in the US and Seroxat in the UK, at best was no more effective than a placebo and at worst was harmful. At the same time the company was said to be promoting the drug heavily to American doctors boasting of its efficacy and safety.
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The Pharmaceutical Drug Racket
The sordid behaviour of today's pharmaceutical corporations has been further demonstrated by Dr John Braithwaite, now a Trade Practices Commissioner, in his devastating expose, CORPORATE CRIME IN THE PHARMACEUTICAL INDUSTRY (1) (1984).
International bribery and corruption, fraud in the testing of drugs, criminal negligence in the unsafe manufacture of drugs - the pharmaceutical industry has a worse record of law-breaking than any other industry. Describing many examples of corporate crime, which shows the depth and seriousness of the crime problem in the pharmaceutical industry, Dr Braithwaite's revealing study is based on extensive international research, including interviews of 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala.
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International bribery and corruption, fraud in the testing of drugs, criminal negligence in the unsafe manufacture of drugs - the pharmaceutical industry has a worse record of law-breaking than any other industry. Describing many examples of corporate crime, which shows the depth and seriousness of the crime problem in the pharmaceutical industry, Dr Braithwaite's revealing study is based on extensive international research, including interviews of 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala.
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Hawaii sues drug makers for price fraud
The state is suing 44 drug companies for allegedly defrauding Hawaii taxpayers and Medicare beneficiaries out of tens of millions of dollars with inflated prices for prescription drugs.
The lawsuit was filed yesterday in state court. It is similar to lawsuits filed by at least 20 other states in the past few years, including California, Texas, Illinois and New York.
State Attorney General Mark Bennett said the companies overstate their average wholesale prices on which the state bases its Medicaid and Medicare drug reimbursement. They then charge pharmacies, hospitals and doctors who dispense and administer the drugs at a much lower price, to give them windfall profits and incentive to continue using their drugs over those of competitors.
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The lawsuit was filed yesterday in state court. It is similar to lawsuits filed by at least 20 other states in the past few years, including California, Texas, Illinois and New York.
State Attorney General Mark Bennett said the companies overstate their average wholesale prices on which the state bases its Medicaid and Medicare drug reimbursement. They then charge pharmacies, hospitals and doctors who dispense and administer the drugs at a much lower price, to give them windfall profits and incentive to continue using their drugs over those of competitors.
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Pharmaceutical Scandal or not?,
In today's media much attention is given to corporate scandals, and the misdeeds and misdealings of large corporations are a consistent source of news. Pharmaceutical companies in particular seem to have been involved in more than their share of scandals. But, not all corporate scandals are the same, and important distinctions need to be made. For example, we should distinguish between "normal" financial or public perception corporate scandals, which have plagued such corporations as Enron, and true corporate drug scandals, which companies such as Merck & Co. have been involved in. Two questions should arise when we look at a scandal involving a pharmaceutical company:
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Behind the Paxil Scandals
In June 2004 New York State Attorney General Eliot Spitzer brought suit against Glaxo, alleging that it had engaged in repeated and persistent fraud with respect to Paxil (a $3.1 billion grossing drug in 2003). Spitzer had evidence that the giant pharmaceutical corporation Glaxo had suppressed the results of studies on children and adolescents that showed Paxil to be ineffective and to increase the risk of suicidal thinking and behavior. When he first announced the suit, Spitzer stated, “By concealing critically important scientific studies on Paxil, GlaxoSmithKline impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety.” Spitzer had an internal Glaxo memo from 1998 stating that the company intended to “manage the dissemination of the data in order to minimize any potential negative commercial impact.”
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Scientific Fraud and Vaccines
The Thinktwice Global Vaccine Institute occasionally receives email from drug company insiders -- people who truly know what goes on behind closed doors. We also receive undisclosed information from CDC, FDA and other government insiders, ethical people who wish to speak out against the scientific fraud that they observed or were forced to participate in. Usually they request anonymity and that their information not be made public for fear of legal retaliation -- or worse. Here are a few of the letters we received indicating scientific fraud with regard to vaccine safety and efficacy. (Be sure to read the eye-opening interview with a pharmaceutical/vaccine company insider as well.)
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