Over the past six years, ten FDA approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for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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Pharmaceutical Company to Reimburse State $152,000 in Medicaid Fraud Settlement
HELENA – Montana will receive nearly $152,000 in Medicaid restitution and penalties as part of a settlement recently negotiated between the National Association of Medicaid Fraud Control Units and pharmaceutical manufacturer Parke-Davis, a division of Warner-Lambert. The Medicaid fraud settlement is separate from a recent consumer-protection settlement with Warner-Lambert.
Warner-Lambert will pay $152 million in damages and penalties to states' Medicaid programs as part of an agreement that resolves allegations of a massive "off-label" marketing campaign for the epilepsy medication Neurontin. "Off-label" describes a use of a medication other than the use for which the drug is approved. Although doctors may prescribe drugs for off-label purposes, it is illegal for manufacturers to promote those off-label uses.
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Warner-Lambert will pay $152 million in damages and penalties to states' Medicaid programs as part of an agreement that resolves allegations of a massive "off-label" marketing campaign for the epilepsy medication Neurontin. "Off-label" describes a use of a medication other than the use for which the drug is approved. Although doctors may prescribe drugs for off-label purposes, it is illegal for manufacturers to promote those off-label uses.
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FDA Shields Drug Companies From Lawsuits
"A little-mentioned fact is that many FDA employees end up working for the pharmaceutical industry."
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Last month, the FDA revealed its latest protective policy for drug companies in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
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Last month, the FDA revealed its latest protective policy for drug companies in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
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Cancer Cure and Bad Biotech
Stem cells were supposed to be a miracle, but all that has been proven is that the South Korean researcher lied and the majority of western institutions/researchers were of such low standards they were unable to detect the flaws and lies. Worst, they seemed more than willing to accept and promote the lie if they (too) could (share in the pie) receive billions of tax dollars for themselves to fund useless research. Useless research solves nothing and people die or are crippled with false hopes. Mrs. Nancy Reagan, they would misuse your dreams and good will in order to lie to use you for money and give back nothing in return (they would steal). That is the definition of bad scientists and universities: people who give deliberate false assurances to gain money for nothing except personal gain and why institutions which give FALSE SIGNED ASSURANCES for taxpayers'/federal monies must be held ACCOUNTABLE! This is especially RELEVANT in light of proposed FLU vaccines – you could die if a bad one is produced and no one is held ACCOUNTABLE and LIABLE. We are talking about the public TRUST and SAFETY. Institutions and researchers must be held to high standards and accountability. Read More...
Florida sues drug company for Medicaid fraud
Charlie Crist, Florida's Attorney General is taking three pharmaceutical companies to court for $25 million, accusing them of illegally inflating prices on generic drugs used to treat depression, schizophrenia, seizures and angina.
The lawsuit alleges that since1994, Sandoz Inc., Ivax Pharmaceuticals Inc., and Purepac Pharmaceutical Company, along with various parent and subsidiary companies, have overstated the prices of generic drugs in statements to the Medicaid program. Under the False Claims Act triple damages could be awarded and that would increase the state's potential recovery amount to $75 million.
Patent Absurdity Ending a drug company scam
"You do not have the right to keep generic drugs off the market for frivolous reasons," President George Bush declared on Monday as he announced his administration's new effort to bust up complicated legal schemes devised to do just that. Drug manufacturers have been using loopholes in the 1984 Hatch-Waxman Act—which is aimed at promoting cheaper alternatives to brand name pharmaceuticals whose patents have expired—to prevent competition.
It's no wonder that brand name drug makers are worried. In 1984, when the law was passed, only 19 percent of prescriptions were for generic drugs; today the figure is 47 percent. That means patients have saved a lot of money. Generic drugs are just as effective as their brand name equivalents, and typically cost one-third as much.
Patent Absurdity Ending a drug company scam
"You do not have the right to keep generic drugs off the market for frivolous reasons," President George Bush declared on Monday as he announced his administration's new effort to bust up complicated legal schemes devised to do just that. Drug manufacturers have been using loopholes in the 1984 Hatch-Waxman Act—which is aimed at promoting cheaper alternatives to brand name pharmaceuticals whose patents have expired—to prevent competition.
It's no wonder that brand name drug makers are worried. In 1984, when the law was passed, only 19 percent of prescriptions were for generic drugs; today the figure is 47 percent. That means patients have saved a lot of money. Generic drugs are just as effective as their brand name equivalents, and typically cost one-third as much.
Massive medical fraud exposed: pharmaceutical company paid doctors to prescribe drugs and run sham clinical trials
Here's a must-read article for anyone interested in learning how the pharmaceutical industry really operates. It's a case of aggressive marketing gone bad, with a mixture of corrupt physicians, underhanded payola and a near-total disregard for patient health. And yet it's business as usual in the pharmaceutical industry: drug maker Schering-Plough, one of the largest drug companies in the world, has been outright bribing physicians to prescribe drugs and operate sham clinical trials.
Here's how it would work: doctors who prescribed the drug company's products and avoided competing drugs were paid "consulting fees" of tens of thousands of dollars. And what kind of consulting did these doctors do? The kind of consulting that requires nothing more than signing a blank sheet of paper and cashing the check, of course. And thousands of doctors participated in this criminal scam, collecting untold sums of money in exchange for hyping Schering-Plough's pharmaceuticals to patients. (Medical ethics, anyone?)
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Here's how it would work: doctors who prescribed the drug company's products and avoided competing drugs were paid "consulting fees" of tens of thousands of dollars. And what kind of consulting did these doctors do? The kind of consulting that requires nothing more than signing a blank sheet of paper and cashing the check, of course. And thousands of doctors participated in this criminal scam, collecting untold sums of money in exchange for hyping Schering-Plough's pharmaceuticals to patients. (Medical ethics, anyone?)
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