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General News    H1'ed 6/17/12

Has the Drug Industry's Grip On Health Care Become a Pharmageddon?

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Rosenberg: There have been reports of risks to human subjects in overseas trials as well as bribes and protocol irregularities. Who oversees the ethics of outsourced trials and the quality of their data?

 

Healy: Clinical trials are overseen by private Institutional Review Boards, which are funded by the organizations they regulate--

 

Rosenberg: Like Moody's and Standard & Poor's are funded by their clients?

 

Healy: Yes. A recent large trial for the antipsychotic Abilify demonstrates the danger with outsourced clinical trials. On the basis of about 28 trials in the US, Abilify did not prophylactically stabilize mood as the manufacturer wants to claim. But when data from just two trials from Mexico were mixed in, it did.

 

Rosenberg: Most of Pharma's power to mislead and harm comes from such opaque and distorted data, you charge in Pharmageddon.

 

Healy: Without access to the raw drug data, medical professionals cannot practice responsible medicine and guidelines cannot be written. Yet Pharma, with very few exceptions, refuses to publish the data and share them with practitioners. This result is guidelines that are fictions and doctors who lack critical information they need to prescribe and treat.

 

Rosenberg: Pharma's stonewalling of data and use of ghostwriters has resulted in articles in major medical journals that made Vioxx,   hormone therapy and Neurontin look safe when they weren't. Another example you give is a paper in the Journal of the American Association of Child and Adolescent Psychiatry in which GlaxoSmithKline (GSK) has made the antidepressant Paxil look safe by hiding raw data. Then editor, Mina Dulcan, says about the missing data, which hid Paxil's suicidal side effect in children, "I can't control the authors. No, I don't have regrets."

 

Healy: If we were getting our drug information from the New York Times instead of medical journals, we would all be a lot safer. When the Times reporter Jayson Blair was found to have fabricated stories, he was history. But the editors and writers involved with journal fraud still have their jobs and the articles are not even retracted. In fact, Liz Wager, the chair of the Committee on Publication Ethics (COPE) is herself Pharma linked.

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Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)
 

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