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Drug Trials

Posted by alexandra_k on January 20, 2005, at 1:08:21

>Drugmakers have cherry-picked their trial data for FDA consideration for decades, defending the practice in the name of protecting proprietary information; only about 50 percent of all drug trials over the past half a century were reported or published, according to a 2003 study of clinical trials in the Journal of the American Medical Association (JAMA). As a result, the FDA routinely approves drugs based on partial and often highly unrepresentative data - thereby forcing physicians to rely on the same skewed information.

>Given the vast and growing role that medications play in our medical system, critics say that more lives could be in jeopardy. At issue is whether the "science" underlying much of our health care deserves that name. As University of California at San Francisco School of Medicine professor and JAMA Deputy editor Drummond Rennie puts it, "If a company does 10 trials on a drug, and two show it helps but eight show it works no better than Rice Krispies, I'm not exactly getting a scientific view if they publish only the two positive studies. And this affects me as a patient. I've got a good doctor, and I watch his prescribing hand closely. We like to think we're sophisticated. But how can we practice sophisticated medicine if the drug companies are hiding their results? That's not science. That's marketing."

>The solution, Rennie and other expert observers say, lies in establishing a system that makes all drug trials, not just successful ones, part of the public record.

Dobbs, David 'Antidepressants: Good Drugs or Good Marketing? in Scientific American Mind 2004 (14) 5, pp. 12-13.

OMG. I didn't know that they weren't required to make ALL their experimental findings available. That is a disgrace, indeed.

 

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