1 Boring Old Man

There’s another traditional agency that has let us down in recent years – our psychiatric journals. The literature is filled with ghost-written articles, articles that obscure data rather than make it clear, articles that reach conclusions that overstate trivial significant differences, articles that use statistical tests inappropriately that cannot be checked by the reader, articles with blatant conflicts of interest sometimes unacknowledged – in short, articles that shouldn’t have been published. Things like huge dropout rates or striking improvements with placebo are regularly seen in clinical trials and largely ignored in the conclusions. There is a predominance of articles with multiple authors who have had little to do with the study being reported [STAR*D is a paradigmatic example]. Frankly, the term "peer-reviewed" journal seems to have lost its traditional meaning judged by the quality of many articles in those journals today. And even when an article has been thoroughly debunked, it hasn’t been retracted. In addition, there are so many industry funded articles that are blatant advertisements that one is advised to read the funding source before reading the article. Separating the "wheat from the chaff" is an imposing task.

One thing I realized reflecting back on the recent years is that I feel like I lost something personally. In previous times in all my "careers" [Internal Medicine, Psychiatry, Psychoanalysis], I have always been an avid journal reader. I enjoy clear scientific thinking and so I even read articles that weren’t pertinent to my area just because I enjoyed them. Journal reading has been my preferred form of "Continuing Medical Education." But I’ve essentially stopped reading or even taking the psychiatry journals because so many of the articles are formulaic or "sales jobs." Research is more that study design or data collection. Careful analysis is a thing of beauty, and in the modern journals, it’s in the range of a lost art. Many of the articles in our journals feel to me like they’re "conclusions in search of logic," and I find that both boring and insulting. Skilled researchers write as if writing to colleagues – giving the data in a form that engages the reader in the research itself. Many of today’s articles are written to customers, not colleagues – and I find that off-putting. I think I’ve come to feel that any article written in that way must be jury-rigged. So unless I’m reading it for inclusion in this blog, I rarely finish articles in that format. They feel like "tricks."

Doctors don’t just "know" things. We learn things continuously from articles, textbooks, medical meetings, CME courses, and our own experience in practice. In psychiatry, all of the first four methods have been heavily invaded by the pharmaceutical industry, so the loss is more than just the enjoyment of reading good science, it’s like the water supply has been contaminated. That’s what I found when I decided to "bone up" on psychopharmacology. I knew a lot about the newer antidepressants, but virtually nothing about the Atypical Antipsychotics. The literature was no help. The premier textbook [edited by Nemeroff and Schatzberg] was no help. I didn’t feel like I even knew about those drugs until I’d read the studies submitted  to the FDA and a jillion blog posts. That’s a huge expenditure of effort to learn something that used to be available without that much work, much more time-investment than the everyday practitioner has to expend.

I think about that when I read some of the criticisms leveled at psychiatrists as a group. "Psychiatrists think…" might be valid for the subset that are on drug-maker’s payroll as speakers, or making money running a clinical research center, but the rest of us are in the position of having our usual conduits of learning corrupted. Many psychiatrists and primary care physicians are as much on the victim side of this equation as the patients they treat. Practicing physicans are the interface between medical science and patients. The pharmaceutical companies have found ways to poison the well. Long ago, the drug companies gave out pens and other doo-dads. The detail men came and went with their prepared speeches. I never thought much about that, because the context was clear. The new forms of stealth advertising are way more virulent because the former bedrock is now suspect, and it’s hard to know where to turn for the scientific state of the art in a modern world.

I’m less critical of the FDA than most. I see the FDA’s job as primarily responsible for safety and not a resource for efficacy. I don’t particularly want the government involved in directing prescription. Clinical efficacy in the job of medicine. The kinds of studies required by the FDA are almost by definition short term. It’s the great clinical trial of practice that has alway called the therapeutic efficacy shots. I wrankle when I see those ads that say, "Now FDA approved as adjunct therapy for treatment resistant depression." Seroquel is now bombarding us with ads for Seroquel XR as augmentation for antidepressants. You heard it here. It’s malarky, a way to extend their patent since the XR form is still patent protected. If you want to prove to yourself that Atypical Antipsychotics don’t much help people who weren’t helped by antidepressants, do yourself and your patients a favor, fail with a cheaper drug like generic Seroquel.

But I do feel critical of the National Institute of Mental Health. The director, Tom Insel, is a member of the club. I don’t question that he’s a smart guy, but he’s not directing the function of the NIMH. He’s choosing the directions of the NIMH. When he writes, he talks about where things are going in the same ways that the fraternity of pseudoscientists talk. His words are upbeat and aiming at the glowing future of psychopharmacology. He’s in love with Translational Science and Personalized Medicine. And when his favorites don’t bring home the bacon, he sends them off to the store with more money. My index case is Trivedi. His outing with John Rush gave us over a hundred papers from STAR*D but never gave us the actual results of the funded study. The follow-up, CO-MED was a predictable flop. His highly touted study of computerized algorithms never even met its recruitment goals and died on the vine. And yet, Trivedi’s back with a personalized medicine study that  can’t possibly produce useful information – dead in the design. All of this running in place has been financed by Insel’s NIMH. Right now, the NIMH is knowingly funding insiders along the lines of a specific agenda that sits on a beyond shaky foundation. We need a director that supports the proposals of creative researchers, not one who creates proposals for researchers to support. And his defining psychiatry as "clinical neuroscience" is way outside his area of authority. Neuroscience is a part of psychiatry, not the other way around. It’s the National Institute of Mental Health, not the National Institute of Neuroscience.

In my reflections [on a beach in Maui], I did have some positive thoughts. The clamor for honesty and transparency is getting louder and louder. Grassley’s investigations produced some results and it’s exciting to see he’s still in the game. The settlements in the cases against the pharmaceutical companies have been large [they’re not large enough] and they’re coming at an increasing pace. Why the government almost punished one of the corporate executives [Forest Laboratories]. The watchdog groups and bloggers have been making increasingly good use of the documents from these settlements. Even if the NIH backs down on its COI policies, the Sunshine Law in the Affordable Health Care Act holds promise. And the "pipeline" of new psychiatric drugs to worry about is finally emptying. Psychopharmacology is in it’s time of "paradigm exhaustion." That doesn’t mean that it’s going away. It means that it’s time for it to find its proper place.