For some time now, the medical community—and to a certain extent, the general public—has understood that the reports in the medical literature of industry-funded trials of psychiatric drugs do not provide an accurate representation of the drugs’ merits. The trials of the second-generation psychotropics were often biased by design; published results were spun; adverse events were minimized; negative studies went unpublished. The studies published in the medical literature really tell of a marketing exercise, as opposed to a scientific one.
However, the medical community and the public have long thought—or at least hoped— that psychiatric drug studies funded by the National Institute of Mental Health are not similarly tainted. Here, at least, the published reports would tell of studies that were not biased by design, with the results honestly reported. At least that is the expectation. And this is why the NIMH’s STAR*D study is such a disappointment, and why it is so important that the full details of that scandal be made known.
As Maryland psychologist Ed Pigott explained last week, in his blog on this site, he is now asking that two journals, the Journal of Clinical Psychopharmacology and Psychological Medicine, retract two STAR*D articles they published.
By doing so, Pigott is continuing to put a spotlight on this scandal, which I believe needs to be thoroughly investigated by the NIH, or other governmental investigative body. We need to know all of the scientific sins that were committed, and we need an accounting of the investigators’ financial conflicts of interest. STAR*D was hailed as the largest trial of antidepressants ever conducted, at a cost of $35 million to the American taxpayers, and we deserve to know why the results weren’t honestly reported.
His request to the two journals that they retract the two articles raises a larger question: Should the medical literature be cleansed of all STAR*D reports?
As the British Medical Journal has noted, The Committee on Publication Ethics recommends retraction of an article if the journal has “clear evidence that the findings are unreliable.” This is necessary to “correct the literature and ensure its integrity.” So let’s apply that standard to the STAR*D literature.
The STAR*D investigators have now published more than 100 papers, and the bottom-line message, one touted to the medical community, is that if antidepressants are tried and tried again, most people will see their symptoms “vanish.” In this trial, 67% of the 4,041 patients were said to have seen their depression remit in this robust way. More than half of those who got well in this trial were then said to stay well during the year-long followup (or about 40% if you do the relevant math for the various groups of remitted groups.) Those are the published results. But as best as I can calculate, in truth, fewer than 40% the protocol-eligible patients ever remitted, even for a brief period, and it is now clear that only 3% of the 4,041 patients remitted and then stayed well and in the trial throughout the maintenance period.
When I give talks, I often hear psychiatrists and others respond by quoting the fake STAR*D results. That study is touted as evidence that antidepressants—if you just keep trying them—work for most people. They help people get well and stay well. In short, the falsely-reported results are driving prescribing practices and instilling a medical delusion about the effectiveness of these drugs.
So hear’s my question: Shouldn’t the NIMH, in an effort to clean up this scandal, ask for the retraction of all 100-plus STAR*D articles? If the purpose of retracting articles it to “correct the literature and ensure its integrity,” isn’t that is what is now needed?
Thursday, May 5, 2011