Yesterday, the news was that antidepressants may not work as well as people think--may not, in fact, work any better than placebo in any but the most severely depressed. That assessment came out of a meta-analysis that included some previously unpublished studies. Data, in fact, that the researchers could only obtain via the Freedom of Information Act.
So it's no surprise that today, pundits are pointing fingers at drugmakers and their "long and ignoble history of secrecy." They're ticking off incidents: U.K. researchers tried to get unpublished data on antidepressants in 2004 and were refused. A recent study showed that all the FDA-registered antidepressant trials deemed "positive" by the agency were published; only a few of those the agency deemed otherwise saw the light of day. Some 38 percent of independent studies of cancer drugs reached unfavorable conclusions, while only 5 percent of company-funded research did. Flattering data is sometimes published two or three times in slightly different form as if it came from different studies. And so on.
But GlaxoSmithKline, for one, is fighting back. The U.K. drugmaker says that only 16 of 170 Paxil trials were included in the new analysis, and that all data--published and unpublished--was given to regulators before the med was approved. It's all available on the company website now. "We strongly believe that the authors' interpretation is incorrect," the company said of the new study.
Is regulation called for? Some say yes: a compulsory international trials register, for starters. "Biased under-reporting of clinical trials happens in all areas of medicine," one columnist wrote in The Guardian. "It wastes money, and it costs lives...But most damning of all, it could be fixed in a legislative trice."
- get GSK's statement on the study
- read the article in The Independent
- check out The Guardian's column
- see the coverage in the Belfast Telegraph
- find the GSK story in Pharma Times