The attorney general’s civil suit accuses the drug giant GlaxoSmithKline of committing fraud by concealing negative information about Paxil, a drug used to treat depression. The suit says that the company conducted five clinical trials of Paxil in adolescents and children, yet published only one study whose mixed results it deemed positive. The company sat on two major studies for up to four years, although the results of one were divulged by a whistle-blower at a medical conference in 1999 and all of the studies were submitted to the Food and Drug Administration in 2002 when the company sought approval for new uses of Paxil. At that time it became apparent that Paxil was no more effective than a placebo in treating adolescent depression and might even provoke suicidal thoughts. Read the rest of this editorial at the NY Times (via Metafilter).
Isn’t it amazing that when you’re as powerful as any of the world’s pharmaceutical companies, you can not only play the game according to your own rules, but pretend that the rules are appropriate and ethical for the hundreds (if not thousands) of researchers who’ve agreed to them over the past 3 decades worth of pharmaceutical research? That’s what you did if you wanted the research grant — you agreed that the pharmaceutical company basically had sole discretion as to whether to allow you to publish your results or not.
Of course, the American medical establishment didn’t help matters any, by limiting publication of negative findings in major peer-reviewed journals. Basically if your research doesn’t find the effect you were looking for, you had a nearly impossible time finding a reputable journal willing to publish your (non-)results.
I’m glad this is finally coming to light, and maybe, just maybe, it will start to save some additional lives… Medical research is vital and important, but doing it in an ethically- and scientifically-responsible manner is equally as important.