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?

1 comment:

Daniel Haszard said...

Well said,i applaud your blog, mental health consumers are the least capable of self advocacy,my doctors made me take zyprexa for 4 years which was ineffective for my symptoms.I now have a victims support page against Eli Lilly for it's Zyprexa product causing my diabetes.--Daniel Haszard