In Defense of Psychiatric Diagnoses and Treatments
The Boston Globe is out today with a story about conflicts of interest involving American Psychiatric Association guidelines for treating depression, mania, and schizophrenia – disorders for which the market in medications is said to be $25 billion annually. Conflicts abound, it seems, and the consequent implication is that industry influence has led to guidelines that “focus heavily on medications and give relatively little attention to nondrug treatments.”
The lead author of a forthcoming analysis, Lisa Cosgrove from the University of Massachusetts is quoted in the Globe as saying “…the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." Maybe so, but it’s not just psychiatry. And this new study should not be taken to invalidate psychiatric diagnoses or to undermine the efficacy of psychiatric treatments.
The existence of disease is not predicated on having a biological test. It’s nice when we do have one, but there are many disorders throughout medicine, not just in psychiatry, for which there is no conclusively defining biological test. Think migraine. Think multiple sclerosis. Think chronic pain.
There is a distinguished tradition of clinical research, going back to the late 1950s, wherein disorders like depression, mania, and schizophrenia were studied for their genetic profiles, their clinically meaningful subtypes, their biological correlates, and their responses to treatments. This bottom-up approach yielded useful theories, which in turn led to better theories and to new treatments for depression, mania, and schizophrenia. Like any other branch of science, clinical science has a self-correcting function that distinguishes it from pseudo-science and propaganda. So, we welcome new theories even though most will not survive, and we welcome new diagnostic proposals and we welcome potential new treatments. All are subject to the test of independent confirmation, and nobody is surprised when many fall away.
Since around 1990 that tradition has been corrupted by Pharma and Pharma’s money. There is no shortage of examples regularly in the news. Academic key opinion leaders lost their ethical compass and, with or without a figleaf, devolved into spokespersons for industry. One is reminded of Julien Benda’s term la trahison des clercs. Instead of moving on from undistinguished and problematic new drugs, key opinion leaders work with the marketing departments of Pharma to promote and defend the brand. Remember the PsychNetters? Of course, psychiatry is not the only medical specialty corrupted in this way. Stents, anybody? Orthopedic devices, anybody?
Lost in the marketeering and propaganda since around 1990 is the discipline of clinical therapeutics. As one commentator put it, if there is no way to confirm biologically the existence of disease, then “…we cannot confirm with much confidence that this or that treatment treats mental disease.” It actually is possible to identify effective treatments for mental disease. We did it with lithium. We did it with the early antidepressant drugs. And we did it with the early antipsychotic drugs. There was room for improvement in all of these, but make no mistake – they were dramatic positive developments. Most of the work in the past 20 years, however, put marketing first and clinical therapeutics second. Humbug aside, the goal was not to improve the management of depression or mania or schizophrenia but to jump whatever bar the FDA was setting in order to get a product on the market. Indeed, the really hard clinical research issues were studiously avoided. Along the way, the clinical research enterprise became dominated by academic and for-profit contract research organizations in which, to put it gently, standards of recruitment of patients apparently suffered, so that response rates in placebo-treated patients skyrocketed. As a result, proving that a drug does work became harder, and the overall drug advantage over placebo in treating depression came into serious question. In effect, the corruption of clinical research standards has brought us to an epistemologic quagmire about the efficacy of today’s most popular antidepressant drugs.
As for the charge that psychiatrists and primary care physicians just throw drugs at mental health problems, that is nothing new. It is a reflection of the professional pragmatism that permeates medical practice. Think back to the 1950s when the new wonder drugs called antibiotics were handed out like Pez, mostly for people who did not really need them and who would not benefit from them. The working principle was misguided simplicity and pragmatism, which minimized and discounted the risks. Even today the over-use of antibiotics remains a public health concern. Just as in the 1950s patients with nonspecific upper respiratory symptoms were “given the benefit of the doubt” and were prescribed an antibiotic on the reasoning that it might help them while probably not hurting them, so today patients with nondescript depressive or anxiety symptoms are prescribed an SSRI drug on the same reasoning. The cost of this approach in wasted money, in unnecessary side effects, and in unproductive clinical management is non-trivial.
So, the issues are more nuanced than today’s Boston Globe story would suggest. For good and for ill, psychiatry is not so very different from the rest of medicine. Corruption and compromise respect no subspecialty boundaries. We can have reliable and valid knowledge of disease without a biological test. We can show efficacy of treatments for disorders that lack a biological test. But when simplistic pragmatism and cutting corners dominate in therapeutics and in clinical trials, then we are in trouble.
Showing posts with label DSM-V. Show all posts
Showing posts with label DSM-V. Show all posts
Thursday, April 02, 2009
Friday, April 21, 2006
Financial Relationships Among Authors of the Psychiatric Diagnostic and Statistical Manual and Pharmaceutical Companies
A new study about conflicts of interest affecting the writing of important medical texts has been widely reported in the media, although the study is not yet available (as far as I can tell, on the web).
Based on New York Times and Washington Post reports, the study was a cross-sectional study of the prevalence of financial links to pharmaceutical companies among the authors of the latest (1994) full edition of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM). This text is the authoritative guide to the definitions of psychiatric diseases. Apparently, the investigators searched through publicly available data, including "legal files, patent records, conflicts-of-interest databases and journal articles," covering 1989 to 2004, according to the Times. From these records, they were not able to determine the time course of the authors financial connections to the drug companies.
They found that 95/170, 56% of authors had some financial relationship to at least one pharmaceutical company from 1989 to 2004. They found higher prevalences of such relationships among authors "who worked on sections of the manual devoted to severe mental illnesses, like schizophrenia...," according to the Times.
The Post reported that "Darrel Regier, director of the association's division of research, said that concerns over disclosure are a relatively recent phenomenon, which may be why the last edition, published in 1994, did not note them. Regier and John Kane, an expert on schizophrenia who worked on the last edition, agreed with the need for transparency but said financial ties with industry should not undermine public confidence in the conclusions of its experts. Kane has been a consultant to drug companies including Abbott Laboratories, Eli Lilly, Janssen and Pfizer Inc. 'It shouldn't be assumed there is a true conflict of interest,' said Kane, who said his panel's conclusions were driven only by science. 'To me, a conflict of interest implies that someone's judgment is going to be influenced by this relationship, and that is not necessarily the case....'
Furthermore, again per the Post, "at least one psychiatrist who worked on the current manual criticized the analysis. Nancy Andreasen of the University of Iowa, who headed the schizophrenia team, called the new analysis "very flawed" because it did not distinguish researchers who had ties to industry while serving on the panel from those who formed such ties afterward."
In summary, Sheldon Krinsky, a study author, said, "When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions."
There is reason to be concerned that the data in this study may have reflected financial relationships that did not occur at the time the authors worked on the manual. Yet no better data about the time course of these relationships may have been available from public sources. In retrospect, one could criticize the study investigators for not directly querying the DSM authors about their financial relationships. But would all the authors have answered them? And would an academic institutional review board approved such a study?
It may very well be true that DSM authors with financial ties to drug companies honestly believed that these ties did not bias their work. On the other hand, some cognitive psychologists have found that people do not believe that conflicts of interest affect their thinking, yet such effects may occur, but not be consciously acknowledged. A recent op-ed article in the New York Times summarizing this work stated, "research suggests that decision-makers don't realize just how easily and often their objectivity is compromised. The human brain knows many tricks that allow it to consider evidence, weigh facts and still reach precisely the conclusion it favors."
Finally, and again commenting without having seen the actual research paper, in thinking about conflicts of interest, one has to consider all the parties involved. This leads to questions including: Did the editors and publishers of the DSM try to limit the involvement of authors with conflicts? Were the authors under pressure from their academic institutions to develop more financial ties with pharmaceutical companies to help "support their salaries?" Did the pharmaceutical companies develop the ties to the authors because of their work with DSM, or for entirely unrelated reasons?
Based on New York Times and Washington Post reports, the study was a cross-sectional study of the prevalence of financial links to pharmaceutical companies among the authors of the latest (1994) full edition of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM). This text is the authoritative guide to the definitions of psychiatric diseases. Apparently, the investigators searched through publicly available data, including "legal files, patent records, conflicts-of-interest databases and journal articles," covering 1989 to 2004, according to the Times. From these records, they were not able to determine the time course of the authors financial connections to the drug companies.
They found that 95/170, 56% of authors had some financial relationship to at least one pharmaceutical company from 1989 to 2004. They found higher prevalences of such relationships among authors "who worked on sections of the manual devoted to severe mental illnesses, like schizophrenia...," according to the Times.
The Post reported that "Darrel Regier, director of the association's division of research, said that concerns over disclosure are a relatively recent phenomenon, which may be why the last edition, published in 1994, did not note them. Regier and John Kane, an expert on schizophrenia who worked on the last edition, agreed with the need for transparency but said financial ties with industry should not undermine public confidence in the conclusions of its experts. Kane has been a consultant to drug companies including Abbott Laboratories, Eli Lilly, Janssen and Pfizer Inc. 'It shouldn't be assumed there is a true conflict of interest,' said Kane, who said his panel's conclusions were driven only by science. 'To me, a conflict of interest implies that someone's judgment is going to be influenced by this relationship, and that is not necessarily the case....'
Furthermore, again per the Post, "at least one psychiatrist who worked on the current manual criticized the analysis. Nancy Andreasen of the University of Iowa, who headed the schizophrenia team, called the new analysis "very flawed" because it did not distinguish researchers who had ties to industry while serving on the panel from those who formed such ties afterward."
In summary, Sheldon Krinsky, a study author, said, "When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions."
There is reason to be concerned that the data in this study may have reflected financial relationships that did not occur at the time the authors worked on the manual. Yet no better data about the time course of these relationships may have been available from public sources. In retrospect, one could criticize the study investigators for not directly querying the DSM authors about their financial relationships. But would all the authors have answered them? And would an academic institutional review board approved such a study?
It may very well be true that DSM authors with financial ties to drug companies honestly believed that these ties did not bias their work. On the other hand, some cognitive psychologists have found that people do not believe that conflicts of interest affect their thinking, yet such effects may occur, but not be consciously acknowledged. A recent op-ed article in the New York Times summarizing this work stated, "research suggests that decision-makers don't realize just how easily and often their objectivity is compromised. The human brain knows many tricks that allow it to consider evidence, weigh facts and still reach precisely the conclusion it favors."
Finally, and again commenting without having seen the actual research paper, in thinking about conflicts of interest, one has to consider all the parties involved. This leads to questions including: Did the editors and publishers of the DSM try to limit the involvement of authors with conflicts? Were the authors under pressure from their academic institutions to develop more financial ties with pharmaceutical companies to help "support their salaries?" Did the pharmaceutical companies develop the ties to the authors because of their work with DSM, or for entirely unrelated reasons?
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