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Mental Health Point/ Counterpoint


Background:

To diagnose mental illness psychiatrists, and other mental health professionals, question patients about their symptoms and make observations about their appearance and interaction. They use the Diagnostic and Statistical Manual of Mental Disorders (DSM) to identify disorders based on the specific set of symptoms listed in the manual. The DSM, compiled by experts in the field of psychiatric medicine, provides diagnostic parameters for widely recognized mental disorders, but also sets standards for new illnesses (examples: historic expansion from 66 to over 400 disorders; removing homosexuality from DSM as a mental illness.)

Over the years, this influential diagnostic tool has raised a number of ethical questions. Most recently, a study by researchers in Boston concluded that over half of the mental health experts who helped compile the most recent edition of the DSM had financial ties to companies that make drugs designed to treat mental illnesses. The study’s findings ignited a public debate on the ethical implications of scientists receiving monetary support from pharmaceutical companies.


Experts:

Lisa Cosgrove, Ph.D. is a clinical and research psychologist and an Assistant Professor in the Department of Counseling and School Psychology at the University of Massachusetts at Boston. She has published numerous articles and book chapters on critical psychology, research methods, feminist therapy, and theoretical and philosophical issues related to clinical practice. Her scholarship includes work in the areas of community psychology, social policy, women and homelessness, and the aftermath of trauma. Dr. Cosgrove’s research has been supported through grants from NIMH (to the Murray Center of the Radcliffe Institute, Harvard University) and from the University of Massachusetts. She is currently a Fellow in the William Jointer Center for the Study of War and Social Consequences where she is conducting research on the intergenerational impact of war-related PTSD. In addition to her teaching and research she also has a private practice in Natick, Massachusetts.

Cosgrove authored the study “Financial Ties between DSM-IV Panel Members and the Pharmaceutical Industry, published in the journal Psychotherapy and Psychosomatics.

John Kane, M.D. is Vice President for Behavioral Health Services of the North Shore-Long Island Jewish Health System and Chairman of Psychiatry at The Zucker Hillside Hospital. He is Professor of Psychiatry, Neurology and Neuroscience and holds the Dr. E. Richard Feinberg Chair in Schizophrenia Research at the Albert Einstein College of Medicine.

Dr. Kane received his B.A. from Cornell University and his M.D. from the New York University School of Medicine. He currently directs the NIMH-funded Intervention Research Center for the Study of Schizophrenia at The Zucker Hillside Hospital. He has been a member of the Board of Scientific Counselors for NIMH, and he has served on the council of the American College of Neuropsychopharmacology. He has chaired the NIMH Psychopathology and Psychobiology Review Committee as well as the Psychopharmacologic Drugs Advisory Committee of the Food and Drug Administration. Dr. Kane also sat on the schizophrenia DSM-IV panel.

Dr. Kane is a recipient of the Arthur P. Noyes Award in Schizophrenia, the NAPPH Presidential Award for Research, the American Psychiatric Association Foundations' Fund Prize for Research, the Kempf Fund Award for Research Development in Psychobiological Psychiatry, the Lieber Prize for Outstanding Research in Schizophrenia, the Heinz E. Lehmann Research Award from New York State, and the Dean Award from the American College of Psychiatrists.

 


It is assumed by those using the DSM for diagnosing mental disorders, that the Manual is based on objective evidence from rigorous science. Given this assumption and its ramifications for individuals and their families, mental health practitioners, and insurers:

To what degree do you think that values, beliefs, and ideologies – rather than objective science – play a role in the way a psychiatric disorder is defined in the DSM?

Dr. Kane: There are at times social, cultural and political (in the broadest sense) factors which influence the way any disorder (including psychiatric) is defined. These effects can be subtle, but objective science often does not provide all of the evidence required to make the necessary judgments regarding the boundaries or characteristics of specific disorders.

Dr. Cosgrove: At every level—from the questions that drive our research to the conclusions we draw—the conduct of “science” reflects our values. In other words, the science/politics binary (in which science= “objective facts” and politics=values) is an untenable one. The labeling of abnormality always involves interpretation, judgment, and values.Thus, I believe that it is more accurate and honest to see the diagnoses listed in the DSM as constructs, not as ontological truths or “real” diseases. In some contexts those constructs may be useful and in other contexts they may not be as useful or they may even have deleterious effects on the individual being diagnosed. An example of the impossibility of value-free science can be seen in the way that the psychiatric community has treated homosexuality. Until the mid-1970’s, homosexuality was included in the DSM (e.g., DSM–II ), until pressure from gay rights activists forced the DSM committee members to reconsider its inclusion. Dr. Robert Spitzer (as cited in Kirk& Kutchins, 1992) wrote a controversial paper in which he argued that those individuals who were adversely affected by their sexual orientation be given a new diagnosis of Sexual Orientation Disturbance. After much debate, Sexual Orientation Disturbance was changed to homodysphilia, then to dyshomophilia. In the end, the DSM–III contained the diagnosis Ego Dystonic Homosexuality,a diagnosis for individuals who experience distress about their homosexuality (Kirk & Kutchins, 1992). Until 1994, Ego Dystonic Homosexuality appeared in the index of the DSM . Although the DSM–IV–TR (APA, 2000) no longer includes homosexuality in the index, the third example listed under the category Sexual Disorders Not Otherwise Specified is “persistent and marked distress about sexual orientation” (p. 582).


 
What are the potential implications for the diagnosis and treatment of mental illnesses when scientists and clinicians who receive funding from pharmaceutical companies work on the DSM? Can you cite examples where this has been relevant?

Dr. Kane: I do not believe that scientists participating in the development of diagnostic systems are necessarily influenced by current or past relationships with pharmaceutical companies, however, I do believe that such relationships should be disclosed.

Dr. Cosgrove: Pharmaceutical companies have a vested interest in what mental disorders are included in the DSM. Therefore, the most obvious implication is that BigPharma is influencing the inclusion of new disorders and/or influencing the expansion of symptomatology. It is also important to note that this influence is problematic regardless of the timing of the financial association. For example, even if the association occurred after work on the panel was completed, members might use their prestige to leverage lucrative consulting arrangements with the pharmaceutical industry. In this case, not only is public trust eroded, but panel members can also exert enormous influence on prescription practices through public speaking, consulting, taking part in industry-sponsored workshops, etc.

The pharmaceutical industry can exert influence on panel members during their tenure on the DSM. Here’s one example:

A professor at an Ivy League university had multiple and continuous financial associations with the pharmaceutical industry. He/she received research funding and she/he was a consultant for multiple drug companies that manufacture psychotropic medications, including Selective Serotonin Reuptake Inhibitors (SSRIs) such as Prozac (fluoxetine hydrochloride). She/he also served on the speakers or advisory boards of various pharmaceutical companies. He/she served on the Premenstrual Dysphoric Disorder (PMDD) committee for both the DSM IV (1994) and DSM IV-TR (2000). She/he had these financial associations during his/her tenure on the DSM. These financial relationships are problematic and should raise ethical concerns--they certainly erode public trust in the independence of medical science. However, these relationships are even more troubling in light of his/her participation in the process of getting the FDA to approve Eli Lilly’s drug “Sarafem” (fluoxetine hydrochloride).  
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Would other types of association between scientists and clinicians working on development of the DSM and pharmaceutical companies (e.g., consultancy work, position on a speakers bureau, etc.) be more (or less) acceptable?

Dr. Kane: As long as the type of relationship is disclosed I do not see one or another as more or less acceptable.

Dr. Cosgrove: Receiving financial support from a pharmaceutical company should not automatically disqualify an individual from serving on a DSM panel. However, the public and mental health professionals have a right to know about these financial ties. Transparency is especially important when there are multiple and continuous financial relationships between panel members and the pharmaceutical industry, because of the greater likelihood that the drug industry may be exerting an undue influence on the DSM. For example, the DSM working groups that had the highest percentage of financial ties to the pharmaceutical industry were those groups working in diagnostic areas (e.g., mood disorders and psychotic disorders) where pharmacological interventions are standard treatment. In light of the extreme profitability of the psychotropic drug market, the connections found in this study between the DSM and the pharmaceutical industry are cause for concern. Anti- depressants and antipsychotics were the fourth and fifth leading therapy classes of drugs in 2004, with annual global sales totaling $20.3 and $14.1 billion dollars respectively [25]. One antidepressant alone, venlafaxine (Effexor, Wyeth), achieved $3.7 billion in sales in 2004 [26]. The antipsychotic drug market has been identified as one of main therapeutic areas for global market growth with sales of $8.5 billion in 2002 and projected sales of $18.2 billion by 2007 [27].


Do you think asking experts participating in the development of the next DSM to disclose their financial ties (as promised by the American Psychiatric Association) should be a requirement for their participation? Is that sufficient or should there be more stringent standards?

Dr. Kane: Yes, disclosure is appropriate and sufficient.

Dr. Cosgrove: Raising awareness about the real or perceived conflicts of interest of DSM panel members is an important public health issue. Based on our research, we have recommended that the APA institute a disclosure policy for panel members of the DSM who have financial ties to the drug industry. This is consistent with the trend for greater transparency in the membership of federal advisory panels. At the very least, the APA should ensure that no DSM panel has the majority of its members with ties to BigPhrama. Also, all psychiatry journals should have conflict of interest policies (currently only 42% have instituted them). Finally, the FDA should be strengthened as a truly independent agency (e.g., ideally all experts providing testimony would be free of ties).

 

 
Is it realistic to expect that doctors and scientists who are prestigious enough to sit on a DSM panel to be free of ties to pharmaceutical companies?  Is it reasonable to expect researchers to find adequate funding from sources outside the pharmaceutical industry throughout their career, especially when they are starting out?

 

Dr. Kane: No, it is not realistic to expect no ties to the pharmaceutical industry or commercial entities on the part of senior scientists.

Dr. Cosgrove: Again, receiving financial support from a pharmaceutical company should not automatically disqualify an individual from serving on a DSM panel. However, it certainly is possible to find experts without financial ties to the pharmaceutical industry and the APA should make a more concerted effort to do so. Financial conflict of interest among medical researchers has been shown to bias the outcome of studies. Thus, it is imperative that researchers be made aware of the fact that industry supported research tends to draw pro-industry conclusions. If researchers decide to use funding from the pharmaceutical industry they should avoid making any contractual agreement that may undermine their ability to publish non-pro industry findings.

 

Are there other steps you think should be taken to be sure that the DSM is, and is perceived to be, free of bias and conflicts of interest?

Dr. Kane: Having a broad representation of experts serving on the DSM committees and a thorough review process by other experts in the field is important in illuminating any potential bias (from any source).

Dr. Cosgrove: I believe that there should be greater transparency with regard to the process by which the DSM is revised. In addition, DSM panel members should not provide expert testimony to the FDA on behalf of a pharmaceutical company (e.g., testifying about the validity of a new DSM diagnosis or about the efficacy of a drug to be used for a DSM disorder) if they will profit by supporting that company.

There is also a pressing need for faculty to address the issue of bias in psychiatric diagnosis, because many programs have been remiss in this area. Indeed, the development of critical thinking remains an important issue for curricula enhancement. Especially in light of the fact that over 400,000 mental health professionals use the DSM, it is important to teach students in psychopathology courses to think critically about the socio-political context in which symptoms are manifest. For example, challenging dichotomous belief systems, especially the science/politics binary is a precondition for critical thinking and a precondition for attending to all forms of bias in psychiatric diagnosis. Faculty also need to help future clinicians appreciate the relationship between social injustice and emotional distress (see, e.g., Hare-Mustin & Mareck,1997).