Thursday, December 27, 2012

Just What is the APA Thinking These Days?

This is a little story about the American Psychiatric Association, based on a recent article by Peter Whoriskey in the Washington Post:

Whoriskey tells us how this past month, an APA committee writing a guideline--I assume as part of the revisions for the forthcoming DSM-V--decided to eliminate an old provision that urged psychiatrists to be wary of prescribing antidepressants for patients having grief reactions. The vast majority of the psychiatrists writing the guideline had financial ties to the drug industry. Since grief is very common, and most grieving people have at least some depressive symptoms, this could be viewed as an invitation to prescribe antidepressants much more widely, which wouldn be hard to do since today, almost everybody and his duck is already taking them.

Still following Whoriskey, the APA guideline panel appealed to a few studies of antidepressants in grief, and indeed the author of one such study (funded by GlaxoWellcome) was selected by the panel to write the scientific rationale for the new guidelines. Now, if I wanted to, I could challenge the science on which the guidelines are supposedly based. For example, the study by guideline writer Sidney Zisook was an open-label, uncontrolled study of bupropion (Wellbutrin). Only 22 subjects were followed for 8 weeks. Now, when I was a young lad in training, I was told that the main reason you did not want to treat grief with medicines was that grief had to work itself out normally, and if you medicated the patient all you did was produce a prolonged grief reaction later on. That may be valid or it may be nonsense, but the fact is that an 8-week follow-up period is far too short to see if there are any negative long-term consequences of treating grief with an antidepressant. Plus we've seen a lot of evidence lately of the serious adverse effects of these drugs, including addiction-like syndromes, and 8 weeks may also be much too short to detect those adverse consequences. In short, a study of 22 subjects for 8 weeks, with no control group, unblinded, is nothing but a scientifically worthless infomercial for Wellbutrin, and anyone who publishes such a paper should be ashamed to pose as a member of a scientific guideline writing committee.

So if I wanted to I cound write about the shaky science, but I won't. I am perfectly willing at this point to make a generous assumption that there may be some evidence to support using antidepressants in at least some patients. Grief and depression are both very common conditions and there has to be a wide area of overlap, so saying as dogma that no patient with grief should ever, ever be treated with medication is surely silly.

Since I am not going to challenge the science, what I want to challenge instead is the APA's posture of choosing a bunch of docs with obvious conflicts of interest to write such a guideline. Assuming that the guideline is indeed scientifically valid, why would you choose such a strongly conflicted panel and imagine that the general public and other phyicians are going to believe a word they say? Whoriskey talked to the chair of the panel, Dr. Jan Fawcett of the University of New Mexico. Here is what Dr. Fawcett told the Post reporter:

“In choosing people, I wanted some people who see patients, not just academics,” Fawcett said. “I wanted some people who were visionary and some people who are conservative and data-driven.”

Their financial ties to the industry were not a consideration, he said.
“I wanted them for their quality,” he said. “I knew whether they had integrity or not.”
Long ago, when he was serving his residency as a doctor, he recalls being a “rebel” for believing in medications — at the time, counseling was more in vogue. But then came the revolution in psychopharmacology, which made clear to him that there was a place for drugs as well as psychotherapy.
“I’m still working at 78 because I love to watch patients who have been depressed for years come to life again,” Fawcett said. “You need those medicines to do that.”
In recruiting panelists, Fawcett said he had to inform candidates that they would have to disclose their industry ties and give up any industry income over $10,000 a year. He likened the financial restrictions to “a financial colonoscopy.”
Some DSM panel members had to give up “significant” income in order to serve, he said.
Fawcett, for example, who testifies on behalf of pharmaceutical companies in suicide lawsuits, had to give up three cases, he said.
He was skeptical of efforts to reduce the financial ties to industry.
“It has gotten to be a witch hunt,” he said.
“Most academics have taken money from pharma if they’re successful,” he explained, noting the limits on government research funding. “If you want to get any studies funded, where are you going to go? How are you going to do it?”
For example, in one of his disclosures filed with the courts in 2007, when the committee’s work was beginning, Fawcett indicated that he had served as an investigator for Bristol Myers, Eli Lilly and Abbott Laboratories. His 2011 disclosure with the APA indicated that he was working for Merck on its diagnosis manual....
“I don’t think these connections create any bias at all,” Fawcett said. “People can say we were biased. But it assumes we have no intelligence of our own.
“There has to be some cooperation between academia and pharma if you want to make any progress. People need to realize that.”

In short, why should physicians and the public trust what this panel says?  Because the chair of the panel, who also has his hand deep in the drug company till, says they are all people of integrity. Besides, everyone does it, at least everyone with any brains, and if you oppose it, you're engaged in a witch hunt.

I am sure reporter Whoriskey thinks he wrote a totally factual story, but I think I discern in his piece the narrative of a sort of morality play, with the APA arrayed on one side and the Institute of Medicine on the other--the IOM being the source of recent strict guidelines on avoiding conflicts of interest in medical education and research. (Full disclosure--I am an IOM member though I had nothing to do with writing the COI guidelines.) When Whoriskey has to cite an expert calling for eliminating COI from clinical guidelines, he usually cites an IOM source.

So, given the fact that the IOM guidelines on COI are widely known and have been out now for some time, what can you say about Dr. Fawcett and his protestations on behalf of his panel? I must be frank and say that this sort of commentary is increasingly Neanderthal in this day and age. It ought to be pretty embarrassing to the APA that one of their main spokespersons should talk to the press in this fashion.

So now I come to what I mainly want to say, which is to offer several hypotheses as to how to explain this behavior on the part of the APA.
  • The not-too-bad is the enemy of the better: As I have covered in previous posts, the APA has actually taken important steps to free itself from drug money influence. Whoriskey reports that they currently take about 14 percent of their operating revenue from drug firms, when the figure used to be around a third--that's a significant change. Whoriskey quotes the APA's CEO, James H. Scully Jr., several times expressing pride in the organization's progress away from COI. So I wonder if part of this is that they legitimately feel good about what they have done so far, and so are much less inclined to look themselves in the mirror and realize they still need to come a lot farther. (After all these panelists, says Dr. Fawcett, had to give up a lot of income just to sit on the panel in accord with current APA rules--even if the result fell far short of what the IOM calls for.)
  • They just don't get it: If, after all the ink spilled and voices raised about COI, Dr. Fawcett can say all the things he said and still keep a straight face, then maybe the bottom line is that he, and by extension much of the APA leadership, remains clueless about the real issues here. They have accepted all these new COI rules, but in their heart of hearts they see no reason for doing so and think the whole thing is ridiculous. The idea that this has anything seriously to do with science and public trust has never penetrated. After all, they know that they are people of integrity; how could anyone else doubt that was true? And they know that they are rational, objective scientists and so mere money could never sway their opinions.
  • The corporate culture of entitlement: Here I'll channel our good friend Dr. Roy Poses at Health Care Renewal blog. Dr. Poses, I am guessing, would point to the sort of culture that exists today in corporate board rooms across the USA. Execs feel as if they are a breed apart, superior to all other humans. They can run their companies into the dirt and still expect a multi-million-dollar end-of-year bonus, plus the golden parachute when they leave. Right-of-center commentators commonly bemoan our entitlement society and entitlement culture, but they have it quite wrong about who that consists of; it's not the poor but the rich who are prone to act entitled. Now, as corporate money has flowed into big medical societies and health care firms, this same corporate mentality is now to be found among execs in health care and organized medicine. As Dr. Poses has documented thoroughly, one commonly sees the same people on the board of the corporations and on the boards of the local hospital. So no surprise that this gang sees the world in the peculiar way that they do, that corporate COI is no problem and that anyone who claims it is is some sort of out-of-touch whiner.

I'll just lay out the options this time; you can take your pick.

Zisook S, Shuchter SR, Pedrelli P, et al. Buproprion sustained release for bereavement: results of an open trial. Journal of Clinical Psychiatry 62:227-30, 2001.


Mickey Nardo said...

Well said. I really couldn't think of anything to say about Jan Fawcett's remarks. I felt embarrassed by their contents and incensed by his arrogance.

“It has gotten to be a witch hunt,” he said. “Most academics have taken money from pharma if they’re successful,” he explained, noting the limits on government research funding. If you want to get any studies funded, where are you going to go? How are you going to do it?”...

“I don’t think these connections create any bias at all,” Fawcett said. “People can say we were biased. But it assumes we have no intelligence of our own. There has to be some cooperation between academia and pharma if you want to make any progress. People need to realize that.”

I think your word, clueless must be close to correct. They've created a closed society in which they mostly talk to each other and have no clue how they sound to the public at large.

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