A recent post on Behaviorism and Mental Health, Psychiatry’s Over Reliance On Pharma, took a meta-look at Dr. Lieberman’s The NIMH-CATIE Schizophrenia Study: What Did We Learn? Dr. Hickey pointed to Dr. Lieberman’s blaming pharma for their distorted messages, rather than holding psychiatrists responsible for listening to those messages, and continuing to listen even now after all the scandal. Fair point, well made. But there was a discussion in the comments about clinical trials that brought back some old memories. They have to do with calling clinical trials of drugs research. I don’t think of clinical drug trials as research. I think of them as product testing.
In my case, the DSM-III revolution arrived in the form of a person, a new chairman, and he spoke of nothing except research. At first, I thought he was interested in building the department into a more academic place, and maybe that was right. But as I listened, what he primarily meant was clinical drug research. For that and a thousand other reasons, I began to look for other work. That’s a long story that’s not pertinent here. What is pertinent is that I had left a research tract in an earlier time of life, not in psychiatry, and I had a fairly solid idea what research was. Drug trials were an aside, something reasonably important, but not research. At some point, part of this department building thing was to institute a monthly Grand Rounds with outside speakers. The first one was a presentation by someone who gave a drug talk about Mellaril, paid for by Sandoz [that speaker was later the first author on the primo Seroquel clinical trial and even later spent ten years in prison for fraud]. I was gone into private practice not too long after that Grand Rounds.
By any right-thinking that I know, a clinical drug trial is essentially composed of two parts: the design, which specifies all the details in a protocol about how it is to be conducted and analyzed; and the trial itself, which is carried out according to that protocol including the result analysis at the end [predefined]. The whole point of the pre·definition is to curb the temptation to play with the data once it is in hand. I would see that not as a research endeavor, but as administrative enterprise – something important to do well, but more in the range of robotic than creative. I hate to use the term assembly line because it has negative connotations and I don’t mean that, but I can’t think of something else – so "good assembly line" is the point here. And one needs to be paid well to do it, because it’s a pain in the ass to do. Part of the drill is to treat all subjects the same, and that’s hard to do in clinical medicine with sick people.
Everything about a clinical drug trial design is an attempt to eliminate bias, human and otherwise: randomization, blinding, standardized instruments, placebo control, active comparators, an a priori protocol, etc. Creativity, following hunches, making outside observations, anything that branches from the straight line is verboten – antithetical to the point of the trial. If something interesting happens along the way, apply for another grant because it doesn’t belong in this one. Research is something else. Research has branches. A hypothesis or a question is where it starts, but it’s refined, or redirected, or even abandoned along the way. It’s more about immersion in a question that’s unanswered and looking all around for a way out, like a spot of mold on the petri dish. In a clinical trial, that’s a contaminated sample, missing data. In research, it’s the discovery of penicillin.
At least in psychiatry, those invested in the outcome of a clinical trial have found a number of ways to lean the results. Sometimes it’s in the design e.g. an active comparator given in the wrong dose. But usually it’s by adding a third part – playing with the results to see if they lend themselves to presentation enhancement techniques; or re·framing adverse effects; or putting the whole thing in a file drawer to grow old alone. A lot of the KOLs who sign these things really don’t involve themselves in that process it turns out. They’re just tickets into an academic journal or window dressing for the author’s byline. Five or six years ago, I didn’t actually know that. They’re called researchers, but they aren’t, and many aren’t even trialists. They’re more like trophy·wives or front·men. They know a lot and present well, but they’re something other than researchers or trialists.
So back to Phil’s point. Why have psychiatrists continued to listen? Why psychiatry’s over·reliance on pharma? Part of the real answer is that they didn’t know it was just pharma. Another part is that there was no other place to listen. Another part is that their patients watch too much television. Another part is that’s what they get paid to do. Another part is that’s what they get referred patients for – "med consults." Another part is it’s easy. And the worst part is that they don’t put the time and effort into swimming upstream and figuring things out for themselves. I actually liked the CATIE study even if I’m not so taken with Dr. Lieberman. Maybe the overly-positive messages about the Atypical Antipsychotics did ultimately come from pharma, but they came out of the mouths of academic psychiatrists and flowed into algorithms and guidelines certified by same that were everywhere.
Back to the beginning and my memories. I have been reassured by many who were there to know that I trust that the pharmaceutical invasion of academic/practicing psychiatry came after the DSM-III revolution and did not have a finger in causing it. I have to take that on faith, because in my microcosm, they came at the same time. And there were a number of young psychiatrists who came to Atlanta [from Saint Louis] who opened clinical research centers in that same time frame [that are still going strong]. For that matter, John Feighner, the Saint Louis psychiatry resident whose criteria formed the nucleous of the DSM-III went on to have a successful and lucrative career running a clinical research center. So, at the least, the synergy between a segment of psychiatry and pharmaceutical industry funded clinical drug trials came early on in the days of the DSM-III, certainly in my neck of the woods.
From my perspective, the entire point of the Data Transparency movement is to eliminate that third part I mentioned above – playing with the results. The trials themselves are well regulated, but as we’ve seen, the end of the trial is often the beginning of the manipulation phase. If the raw data is there, there are plenty of people poised to analyze it correctly. It’s a profession in its own right – vetting these studies. If psychiatrists, physicians, other mental health types, and patients have access to the truth, it’s a different game. The fate of psychiatry as defined by its critics, or the majority of practitioners, or by yours truly isn’t really any of my business. That’s for a future clinical trial played out in the sunlight…
