I was hesitant to weigh in at first when I learned that Brown University’s School of Medicine had decided not to pressure a psychiatric journal to retract the seriously flawed Paxil study that I wrote about in Side Effects. After all, Brown has been covering up misconduct by the study’s principal investigator, Martin Keller, for decades; so why would it suddenly change its tune now?
What bothers me as much as Brown’s refusal to do the right thing (and provide an ethical example to its students) is the stance that the Office of Research Integrity at the Department of Health and Human Services has taken in response to the study. As I and many others have noted, researchers misrepresented data in study 329 to make Paxil look safer and more effective than it really is — see here, here and here.
The Paxil study, which was published in August 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry, purported to show that Paxil was safe and effective in treating depression in adolescents, when in fact actual data from the trial showed the opposite. Even the FDA concluded that study 329 was a negative finding — that it failed to show Paxil was more effective than a placebo.
So what reason does the federal Health and Human Services’ Office of Research Integrity give for why they won’t investigative allegations of scientific misconduct here? As Pharmalot reports, the director of that office falls back on old rhubarb: a statute of limitations. In a letter to Jon Jureidini, the Australian researcher who has led the effort to win a retraction, John Dahlberg writes: “…allegations of falsification, fabrication or plagiarism must be made within six years of the alleged misconduct…”
Yet investigators for the FDA and HHS were well aware of potential misconduct with regard to study 329 before any statute of limitations expired. Not only had I been in touch with federal officials asking questions about serious flaws in the study while I was doing research for my book in 2006 and 2007 (my book was published in June 2008), but Jureidini and Leemon McHenry published a paper in early 2008 pointing that the study 329’s researchers had changed the primary outcome measures and skewed data in other ways to make Paxil look safer and more effective than it really was. As I mentioned earlier, the FDA had decided as far back as 2004 that study 329 didn’t show efficacy despite its published claims.
So all the clues to scientific misconduct were there well before any six-year statute of limitations. This is why Dahlberg’s argument seems completely specious to me.
As for Brown University School of Medicine, its dean should be hanging his head in shame. Joel Lexchin, a professor of health policy at York University in Toronto and one of the academics who signed the letter to Brown University pressing for a retraction, says it best, according to Pharmalot:
“I find it very disturbing that a university that is suppose to be standing up for the highest academic values is unwilling to take any action when its faculty members violate those values.”