I sometimes refer to the years since 1980 as the age of antidepressants or the age of psychopharmacology, but I would be closer to the mark if I called it the age of clinical trials. Not only were the pharmaceutical companies turning them out, the NIMH [then under Director Steven Hyman] was regularly funding them. Here are some of the big ones from that time period:
|LARGE NIMH CLINICAL TRIALS
|STEP-BD||Systematic Treatment Enhancement Program – Bipolar Disorder||NCT00012558|
|CATIE||Clinical Antipsychotic Trials of Intervention Effectiveness||NCT00014001|
|STAR*D||Sequenced Treatment Alternatives to Relieve Depression||NCT00021528|
|TORDIA||Treatment of SSRI-Resistant Depression In Adolescents||NCT00018902|
|TADS||Treatment for Adolescents with Depression Study||NCT00006286|
In the last two posts [latter day STAR*D I…, latter day STAR*D II…], I was looking at several independent studies using data from the STAR*D trial to address issues not central to the study itself. I expect that there’s a lot more mileage in that approach, plus, in some cases, a much needed re-analysis of the original research question [see significant III… for an example]. But the number of NIMH sponsored trials pales in the face of the industry run and funded clinical trials – and the same points apply in terms of both re-purposing and re-analyzing that data.
In back on track… I was arguing that it’s the legacy RCTs that actually need to be included in the Data Transparency programs because the out-of-patent drugs are going to be in use for a very long time, and much of what we think we know about them is suspect. The argument about Commercially Confidential Information obviously falls by the wayside with out-of-patent drugs. And the more I think about it, so does the argument about patient confidentiality for reasons I’ve already mentioned. I would suggest that the Institute of Medicine, the NIH, the EMA, the FDA, etc. begin to have committees and meetings looking into how to effectively anonymize the data rather than succumbing to the industry’s co-opting medical confidentiality as an excuse for continued secrecy. There’s a wealth of important medical information locked away in file drawers that needs inspecting, harvesting.
I don’t think we [psychiatrists] knew a lot about RCTs in those medicalizing days. I sure didn’t. And by the 1990s, our journals were filled with RCTs. It seems in retrospect that they quickly became the currency of the land, fitting right in with the emphasis on biomedical treatment and psychiatry’s new preoccupation with evidence-based medicine. I doubt that it ever occurred to me or many of us that they were financed by PHARMA, conducted by contract Clinical Research Organizations, or that the authors on the byline didn’t do the study, the analyses, even the writing. I only thought about those things a decade or more after the fact. I expect most of us looked at the graphs of rating scale scores like they were precise chemical measurements rather than results from subjective questionnaires or raters opinions. We looked at p rather than NNT or Effect Sizes. In the process of medicalizing, we took on the trappings of medical science too quickly without getting in up to our elbows and evaluating the instruments that were directing us. My point is that we were naive, gullible, ill-prepared to critically review what we were reading – and it showed in our performance.