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Archive for March 5th, 2009

Prevention—science vs. nonsense

There are many ways in which cult medicine believers try to insinuate themselves into the health care system.  As Dr. Gorski has pointed out, “prevention” is one of their metaphorical feet in the door.  The cult medicine literature often says things like, “mainstream medicine is fine for treating acute illness, but what we do is prevention.” What they often leave out is the question of what “prevention” means, what the data on prevention is, and how to properly approach prevention.  It’s likely that one of my co-editors will touch on this topic in a bit more detail, but let me give you an introduction to the topic of prevention.

Definitions

Prevention is usually divided into three types: primary, secondary, and tertiary.

Primary prevention  refers to the prevention of diseases and conditions before their biological onset.  Examples of our most successful primary prevention interventions are clean water/sewerage and, ironically, vaccination.  I say “ironically” of course because so many of the altmed folks who talk about prevention are anti-vaccine.

Secondary prevention refers to the search for diseases that have not yet progressed to the point of causing overt disease, and intervening to prevent overt disease.  This  includes things like Pap smears, which look for early cervical cancers (which could have been primarily prevented by vaccination), mammography, which looks for early breast tumors,  and colonoscopy, which looks for early colonic neoplasms.  Secondary prevention is sometimes used synonymously with “screening”.

Tertiary prevention refers to the prevention of progression of and complications from existing disease.  For example, retinal and foot exams in diabetics prevent blindness and amputation very effectively.
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Posted in: Public Health, Science and Medicine

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Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

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Posted in: Pharmaceuticals, Politics and Regulation

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