Here’s the secret. Psychopharmacology for the practicing Psychiatrist who is mainly a psychoanalytic psychotherapist treating cases with failed previous psychotherapies is easy – a bit of antianxiety medication here and there; some SSRIs; ADHD medications for the adults who were undiagnosed as kids. That’s about it. I probably wrote more prescriptions for antihistamines [Atlanta is a pollen nightmare] than psychoactive drugs. Now I’m doing some general psychiatry as a volunteer, and I got interested in all this drug business when I started reading to catch up [and found the current literature to be what it is – unhelpful]. Catching up on the psychopharmacology wasn’t that hard. Catching up on what happened to Psychiatry while I was asleep has been more of a challenge.
In looking at this Zyprexa material, I ran across a narrative in a legal brief, and thought it was a fine summary for a Rip Van Winkle like myself. It starts a little before the time I went to sleep. It’s part of "looking up" what "I don’t know." I expect most of you already know it all, but the numbers are instructive:
|ZYPREXA PRODUCTS LIABILITY LITIGATION
Clinical Trials: Before 1980, the National Institute of Health funded most clinical trials. During the 1980s, its budget was slashed; in response, drug industry funding went up six-fold from 1977 to 1990. By 1991, drug companies funded 70% of all clinical trials, though 80% of commercially funded trials were still performed at universities. By 2004, only 26% of commercially funded trials took place at universities. Today 80% to 90% of all trials are commercially funded; between 66% and 75% of the clinical studies published in the most prestigious medical journals are commercially funded. Study design and control are increasingly in the hands of drug companies. Published studies often do not reflect their commercial ties or authorship; they may be "ghostwritten" by company employees, use proprietary data not accessible to the scientific community, or simply fail to acknowledge their authors’ financial ties to drugmakers.
Journal Articles: Research articles describe individual primary clinical trials; review articles summarize results from multiple trials on the same subject. Both are subject to systemic industry bias. Because of the increase in commercially-funded trials, the number of commercially funded journal publications has likewise dramatically increased. Today, two-thirds to three-quarters of trials published in the four most respected medical journals are commercially funded. Several editors of preeminent medical journals have gone so far as to say that their publications "have devolved into information-laundering operations for the pharmaceutical industry."For example, by April 16, 2002, the Zyprexa product team had published 125 full manuscripts and submitted an additional 100 for publication.
Drug Detailing: But company-controlled and produced information has great potential to mislead: one Journal of General Internal Medicine article "shows that nearly half (forty-two percent) of the material given to doctors by drug reps made claims in violations of FDA regulations. And only thirty-nine percent of the material provided by drug reps provided scientific evidence to back up claims." Pharmaceutical sales representatives are prohibited from promoting off-label uses; they may legally only provide information about off-label uses if a physician specifically requests the information.
CME Course and "Thought Leaders": Required to maintain medical licenses and to stay current with new developments to give patients the best medical care, many CME courses provide expert syntheses of clinical trial information. Like clinical trials themselves, the percentage of CMEs that are commercially funded has increased sharply, from 48% in 1998 to 58% in 2002. Sixty percent of CMEs have direct commercial sponsorship; indirect sponsorship (e.g., via non-profits funded by company money) accounts for a large portion of the remainder. Total industry contributions towards continuing medical education is estimated to be 70% or higher and in the hundreds of millions of dollars (noting that commercial sponsorship grew from $ 400 million in 1998 to $ 700 million in 2002). Lecture fees are used to recruit recognized clinical experts, well-known and respected in their field and referred to as "thought leaders" or "key opinion leaders," to join company "speakers bureaus" and conduct CMEs. "One recent study indicates that at least 25 percent of all doctors in the United States [approximately 200,000 physicians] receive drug money for lecturing to physicians or for helping to market the drugs in other ways."
I think, in retrospect, that I thought my reason for hibernation was regional. I was in Atlanta Georgia, affiliated with Emory University. In 1983, we got a new Chairman, and it all became about drugs and drug research. Not long after I fled, he replaced himself with Charlie Nemeroff. The Psychoanalytic Institute, part of the Department of Psychiatry, essentially became autonomous – affiliated more with the academic departments of the Graduate School than Psychiatry. We townies had almost nothing to do with the Psychiatry Department [and vice versa]. My point here is that I didn’t know that the things I read in that narrative were trends in Psychiatry in general. I thought it was local, "Charlie’s World" – something to be avoided [which I did].
As things turned out, Charlie Nemeroff was the worst of it, but it was happening everywhere. I look back on it sadly. Neuroscience is interesting to me. It was back then. It still is. But what happened didn’t feel like neuroscience to me, at least not in Atlanta Georgia. It felt like rookie roundsmanship – making big out of not very much. It wasn’t basic science. It was about specific drugs, and the advertising subtext was painfully obvious. Everything was oriented towards "breakthroughs" or "blockbusters" or "emerging novel this-and-thats." I felt guilty being there in most of those talks, so I stopped going.
When I read the narrative ["One recent study indicates that at least 25 percent of all doctors in the United States … receive drug money for lecturing to physicians or for helping to market the drugs in other ways"], it felt a little like watching one of those post-apocalyptic movies like "Road Warrior" – the trappings of a former world being used by people desperate to survive after the holocaust. I liked it better when I thought it was just "Charlie’s World" instead of everywhere.