For the longest time, the field of psychiatry remained silent about the STAR*D scandal. Ed Pigott and colleagues first published a deconstruction of the study in 2010, detailing the protocol violations that the STAR*D investigators had employed to inflate the cumulative remission rate, and even after Pigott and collaborators published a RIAT reanalysis of the study findings this past July, there was silence from psychiatry regarding this scandal.
Now that silence has finally been broken, and in a powerful way.
The first crack in that code of silence occurred on December 1, when the STAR*D investigators, in a letter published by the American Journal of Psychiatry, sought to defend their actions. They did so with a claim—that Pigott and colleagues had created “post-hoc” criteria in order to remove good responders from their analysis—that was easily shown to be a lie. As such, it simply served to deepen the scandal, and further impugn the credibility of the American Journal of Psychiatry, and by extension, the American Psychiatric Association, which is the publisher of the journal.
But then the Psychiatric Times reported on Pigott’s RIAT re-analysis in its December issue, and this was a report of a very different kind. The article, written by John Miller, editor-in-chief of Psychiatric Times, prompted readers to consider the possible extraordinary harm done.
Here is the cover from that issue:
In his essay, Miller repeatedly stressed that ever since 2006, the STAR*D study had stood “out as a beacon guiding treatment decisions.” And while he didn’t conclude that Pigott’s reanalysis was proof the STAR*D results were grossly inflated, he described the paper as a “well-researched publication,” and he reviewed several of the protocol violations that Pigott and colleagues had identified.
Most important, he emphasized that psychiatry needed to turn its attention to the Pigott paper:
“In my clinical opinion, it is urgent for the field of psychiatry to reconcile the significant differences in remission rates for patients with MDD as published in the original STAR*D article in 2006 with the reanalysis just published in the BMJ article this year.”
And he succinctly identified what was now at stake:
“For us in psychiatry, if the BMJ authors are correct, this is a huge setback, as all of the publications and policy decisions based on the STAR*D findings that became clinical dogma since 2006 will need to be reviewed, revisited, and possibly retracted.”
That sentence tells of how the STAR*D study was a pivotal moment in American medical history. The published findings told of drug treatment that led to two-thirds of all patients getting well, their symptoms having vanished by the end of the four stages of treatment. This was evidence that the treatment “worked,” and worked well, at least for the majority of patients.
Pigott’s reanalysis tells of drug treatment that failed to help two-thirds of patients, even after multiple drugs and drug combinations had been tried. Equally important, his work tells of how the study failed to provide evidence that such treatment helped patients stay well.
That is the narrative clash at stake here. The published findings supported the public understanding that antidepressants are an effective treatment. Pigott’s reanalysis told of a failed paradigm of care. Thus, the question ultimately posed by Miller’s thoughtful essay: What if the STAR*D authors had told the truth? How might psychiatric care—and societal use of these drugs—have changed?