A Doctor's Dilemma: When Crucial New-Drug Data Is Hidden
Key Excerpts from Article on Website of Time Magazine
Posted: October 2nd, 2012
Dr. Ben Goldacre is no slouch when it comes to rooting out the flaws in scientific studies, analyzing clinical trial data and recognizing when it's been manipulated or fudged. But even Goldacre has been fooled by bad science. In ... his forthcoming book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, ... Goldacre describes how he ended up prescribing the antidepressant reboxetine to his patients based on insufficient data. The research overwhelmingly finds the drug to be ineffective, but it was still approved in the U.K. In order to get approval of the drug in Europe, the manufacturer had simply not published its negative data. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed. It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients' worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs.
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