On September 9, Mad in America published a lengthy report on the STAR*D scandal, describing how Ed Pigott and colleagues, in a series of publications dating back to 2010, had shown that the STAR*D authors violated the protocol in numerous ways to grossly inflate the announced remission rate in that study.
This past August, Pigott and colleagues delivered a final crushing blow. Having obtained patient-level data through the Restoring Invisible and Abandoned Trials (RIAT) initiative, they reported in BMJ Open that if the study protocol had been followed, the “cumulative remission rate” in the study, at the end of four steps of treatment, would have been 35% rather than the 67% the STAR*D investigators announced in their November 2006 article.
As Pigott and colleagues deconstructed the STAR*D study over this 13-year period, the STAR*D authors never publicly defended their work. When they published their RIAT reanalysis, the BMJ Open editors solicited a response from the STAR*D authors, but “they declined” to do so, the journal reported.
In concert with our September 9 report, we set up a petition on change.org urging the American Journal of Psychiatry to retract the November 2006 article. The false 67% remission rate had been touted to the public for nearly two decades, regularly referred to in the media whenever the efficacy of antidepressants was questioned, and now that the scientific misconduct and research fraud by the STAR*D investigators had been so clearly established, our petition argued that the journal editors were obligated, under the standards for ethical science, to retract the study.
On October 10, I wrote the editor-in-chief of the American Journal of Psychiatry, Ned Kalin, notifying him of our petition, which had been signed by more than 1,800 people. Kalin did not respond to us, and so it seemed that silence—from the STAR*D investigators and from the American Journal of Psychiatry—would be their response.
However, on December 1, the American Journal of Psychiatry published a letter to the editor from John Rush and four of his STAR*D colleagues. While there is no mention of our petition, the letter clearly serves as a response to it. They titled their letter “The STAR*D Data Remain Strong: Reply to Pigott et al.”
As the title indicates, they make no admission of error or of protocol violations. Theirs is a letter that seeks to defend the integrity of their research.
As we wrote in our MIA report, there was both peril and opportunity for the psychiatric profession once the research misconduct in the STAR*D trial had been so clearly documented. The publication of the fabricated remission rate of 67% had violated the public expectation that a medical discipline will be an honest relator of research findings, and it was easy to catalog how the promotion of that false outcome had done public harm. We framed the challenge to the profession in this way:
“The harm [done] also extends to psychiatry’s reputation with the public. The STAR*D scandal, as it becomes known, fuels the public criticism of psychiatry that the field so resents.
Yet, and this may seem counterintuitive, there is now an opportunity for psychiatry to grasp. The American Psychiatric Association, and the international community of psychiatrists, could take a great step forward in regaining public trust if they spoke out about the STAR*D fraud and requested a retraction of the published articles. Doing so would be an action that told of a profession’s commitment, as it moves forward, to uphold research standards, and to provide the public with an honest accounting of the ‘evidence base’ for psychiatric drugs.
However, failing to do so will only deepen justified criticism of the field. It will be a continuance of the past 15 years, when psychiatry has shown, through its inaction, that research misconduct in this domain of medicine—misconduct that rises to the level of scientific fraud—is acceptable practice, even though it may do great harm.”
The letter to the editor by Rush and colleagues makes it clear which of these two paths that psychiatry, as a profession and as the publisher of the American Journal of Psychiatry, has chosen.