Great summary of the past couple years of prescription drug disasters Posted by Rob Schneider at 05/24/06 09:43 AM

Dr. Marcia Angell, who wrote "The Truth About Drug Companies," has written an essay in the NY Review of Books that looks at the major books that have appeared over the last couple of years examining the failure of the prescription drug marketplace.

The essay talks about the different books that have come out over the past couple of years touching on different aspects of marketplace and regulatory failure:

Much of what is wrong with the industry is explained in several recent books. They include Merrill Goozner's The $800 Million Pill, which shows that most innovative research on serious diseases like cancer and HIV/AIDS is done not by drug companies but in government and university labs. Jerry Avorn's Powerful Medicines discusses the risks and benefits of the drugs themselves, and shows that many of them fall far short of their marketing promises. John Abramson's Overdosed America presents a clinician's view of the misinformation that leads doctors to prescribe unnecessary and possibly harmful drugs. Jerome Kassirer's On the Take explains how the medical profession has allowed itself to be seduced by the billions of dollars lavished on it by the drug companies (for example in subsidizing medical meetings of all types). Sharna Olfman's No Child Left Different takes a critical look at the promotion and overuse of psychoactive drugs in children. Selling Sickness, by Ray Moynihan and Alan Cassels, explains how the pharmaceutical industry increases sales by convincing essentially normal people that they have chronic conditions (such as erectile dysfunction) that require lifelong drug treatment. Although each of these books emphasizes different parts of the system, they are remarkably consistent when they overlap, and together they make a damning case, not just against the industry but against our entire system for developing, testing, and using prescription drugs.

Her piece is a comprehensive examination of the failure of the FDA to live up to its responsibilities:

We have an FDA precisely because we know that drug companies, given their inherent conflict of interest, should not be left to decide on their own whether their products are safe. Caveat emptor may be a reasonable approach for many consumer products, but not for prescription drugs. But the Vioxx story underscores the extent to which the FDA has come to see itself as representing the drug companies, not the public.

(Not surprisingly, polling out today shows the public's confidence in FDA has substantially eroded.)

Dr. Angell makes two recommendations:

Two reforms are necessary. First, the conflicts of interest that pervade the agency should be eliminated. The Prescription Drug User Fee Act (PDUFA) that authorized drug companies to pay user fees in return for quick approval of their drugs comes up for renewal in 2007. Congress should let it die, and instead appropriate adequate support from public funds for this vitally important agency. The FDA should also prohibit experts who consult for drug companies from sitting on its advisory panels. No one's expertise is indispensable, contrary to the current practice of granting virtually automatic waivers on those grounds.

Second, the FDA should be made much more transparent. Drug companies are required to inform the agency about all the clinical trials they sponsor on drugs for which they are seeking FDA approval. But the agency does not make the studies public without permission of the sponsor, and drug companies naturally publish only the most favorable results. By allowing less favorable results to remain buried, the agency puts proprietary interests ahead of the public interest, and doctors and the public come to believe prescription drugs are better than they are. That should stop. All studies involving human subjects should be registered at inception in a publicly available, central database, and the salient results added at completion.

She concludes:

These reforms will require congressional legislation—an uphill battle, in view of the power of the pharmaceutical lobby in Washington. That power will need to be offset by concentrated pressure from citizen and advocacy groups with an interest in regulating prescription drugs, something that has so far been lacking. But the spotlight does belong squarely on the FDA. That, after all, is where the public's protection should lie, not with juries after the damage is done.

comments (2)

1 Posted by Averyl at 06/05/08 05:12 AM

Let's hope the FDA comes with a solution as soon as possible.People are addicted to drugs a lot these days. It's high time something is done about this. We should all stand up for the cause and let drug abuse be minimized as much as possible.

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Averyl
Addiction treatment and recovery resources for the addict and their families.
http://www.addictiontreatment.net

2 Posted by Alcohol Abuse at 06/12/08 10:08 AM

The best option I see here is to choose naturist products that are 100% natural and probably less harmful. That is the choice of the future: the return to nature.