Update on Retracting the Fraudulent STAR*D Results

After we published our report on “The STAR*D Scandal,” I submitted a “First Opinion” essay to STAT on the scandal.

My hope was that a summary of the research misconduct in that forum would attract wider public attention to the scandal, and prompt investigations by the major media, such as the New York Times, on the subject. For reasons I don’t fully understand, when Ed Pigott and others have contacted that newspaper and other media about the research misconduct and the fraudulent nature of the 67% published remission rate in that study, they have shown no interest in the story. That proved true with STAT too, as the First Opinion editor, Torie Bosch, replied that STAT would pass on my submission.

However, as part of the essay I submitted, I solicited a quote from Ed Pigott regarding Mad in America’s call for retraction of the article. Here is what he wrote:

“I started investigating STAR*D in 2006 and with colleagues have published six articles documenting significant scientific errors in the conduct and reporting of outcomes in the STAR*D trial.  STAR*D’s summary article should clearly be retracted. This is perhaps best seen by the fact that its own authors lack the courage to defend it. By rights and the norms of ethical research practice, STAR*D authors should either defend their work and point out the errors in our reanalysis or issue corrections in the American Journal of Psychiatry and New England Journal of Medicine where they published their 7 main articles. What they can’t defend must be retracted.”

This indeed is the normal expectation in scientific research. If there is a claim set forth detailing research misconduct that led to the publication of misleading results in a scientific journal, then the authors of the original research, if they are going to defend the integrity of their work, must provide a detailed response. Yet, the STAR*D investigators have never done so, and as noted in our MIA Report, when BMJ Open prepared to publish Pigott’s RIAT reanalysis of the remission rate, it contacted the STAR*D investigators to ask if they would like to respond and they “declined” to do so.

This non-response is akin to their acknowledging the accuracy of the reports by Ed Pigott and colleagues detailing their research misconduct.

I have added Pigott’s call for retraction to our petition, which now has more than 1,250 signatures. I would like to get to 1,500 signatures—and preferably 2,000 signatures—before sending the petition to Ned Kalin, M.D., editor of the American Journal of Psychiatry.

One other STAR*D update. In our report on the STAR*D Scandal, we noted the mysterious appearance of an additional 136 patients in the summary America Journal of Psychiatry article said to be “non-evaluable” because they never came back for a return visit to the clinic after their first “baseline” visit. This number hadn’t been mentioned in the earlier published reports, and its appearance served to give the remission rate one final small boost. The question we raised at the end of our report was whether this 136 number came from the 136 patients who were cited, in an earlier report, to have never entered the study for various reasons.

Ed Pigott and his collaborators are now working to solve this mystery, and so stay tuned: we will be reporting on what they find as soon as they have this information.