Tuesday, June 30, 2009

Will Psychiatry's DSM-V Be a Huge Growth Opportunity for Pharma?

Today's hat tip goes to our psychiatry ally Danny Carlat, aided and abetted by Doug Bremner:


Carlat, Bremner and colleagues have for some time been deeply suspicious of the process being used by the American Psychiatric Association (APA) in coming up with the current revision of its Diagnostic and Statistical Manual (DSM-V). DSM is huge--it essentially controls psychiatric diagnosis, which in turn controls insurance payments for psychiatric care. The charge from some quarters is that the process has been unduly secretive and that voices critical of some of the measures being considered are excluded.

This is the sort of in-house tiff that non-psychiatrists could be forgiven for yawning at, and who's to say who's right in this sort of back-and-forth, right? Well, Dr. Carlat tells us that the tiff has now degenerated into a brawl, and that the implications are huge for the role of the pharmaceutical industry in mental health.

The trigger for this latest round of pleasantry is an editorial in press at the Psychiatric Times by Dr. Allen Frances: http://www.beforeyoutakethatpill.com/2009/6/Frances_DSM-5.pdf. Dr. Frances was the head of the APA task force that produced the last revision of the manual, which you'll be astounded to learn is called DSM-IV. (Actually there is also a DSM-IV-R but let's not go there.) He offers a thoughtful, well-reasoned and well-documented critique of DSM-V to date. His main criticism is that the DSM-V people have been not at all shy in proclaiming that their edition will revolutionize psychiatric diagnosis, preparing the world for a sea change between the fourth and fifth editions. Dr. Frances asks: And this sea change in diagnosis will be based on exactly what new scientific discoveries? Exactly what have we learned about the nature, causes, and treatment of psychiatric disorders in the last decade that merits turning the old diagnostic categories on their heads? Well, actually, hardly anything at all.

I happen to agree with Dr. Frances that psychiatry has been afflicted with this dearth of new knowledge, which in part explains why recent generations of psychiatric drugs end up looking much worse than they were touted to be when first introduced, as we have documented ad nauseam in this blog. But of special concern to us is how Dr. Frances characterizes the unintended consequences of the announced directions DSM-V is taking. Here are some key passages from his editorial. First, he mentions that even careful preliminary field studies often underestimate how small changes in diagnostic criteria can have a huge impact on the numbers of cases diagnosed: "Thus are false 'epidemics' created.... This issue becomes especially poignant when one considers the great and skillful pressure that is likely to be applied by the pharmaceutical industry after the publication of DSM-5. It has to be assumed that they will attempt to identify every change that could conceivably lead to a marketing advantage--often in ways that will not have occurred to the DSM-5 Task Force. In order to promote drug sales, the companies may well sponsor expensive 'education' campaigns focusing on the diagnostic changes that most enhance the rate of diagnosis for those disorders that will lead to the increased writing of prescriptions."

Dr. Frances goes on: "Undoubtedly, the most reckless suggestion for DSM-V is that it include many new categories to capture the milder subthreshold versions of the existing more severe official disorders. The beneficial intended purpose is to reduce the frequency of false negative missed cases, thus improving early case finding and promoting preventive treatments. Unfortunately, however, the DSM-V Task Force has failed to adequately consider the potentially disastrous unintended consequence that DSM-V may flood the world with new false positives. ... The result would be a wholesale imperial medicalization of normality that will trivialize mental disorder and lead to a deluge of unneeded medication treatments--a bonanza for the pharmaceutical industry but at a huge cost to the new false positive 'patients' caught in the excessively wide DSM-V net."

Well, Dr. Frances' criticisms of the Task Force did not sit well in the halls of the APA, and so before the editorial was even published, an APA rebuttal was sent out over the signature of the President, the chair of the Task Force, and other worthies (http://www.scribd.com/doc/16953085/PsychTimesFrancesResponse-062909-FINAL). The rebuttal basically denies the truth of most of what Dr. Frances says, especially about the secretive and closed nature of the DSM-V process. (More on that a bit later.) But what seems quite rich, and prompted Dr. Carlat's "brawl" description, was the way that the APA leaders tore into Dr. Frances's reputation. Dr. Frances, as the above quotes indicate, leaned over backwards to avoid impugning the motives of the Task Force; he spoke over and over of "unintended" consequences, and did not accuse anyone in the Task Force of actually having conflicts of interest with the pharmaceutical industry. In reply, the APA leaders directly accused Dr. Frances of writing his editorial due to his own financial conflict--they claimed that he was about to lose income as the author of a guidebook to the old DSM-IV, and so that was what prompted both the content and the timing of his criticisms.

As Carlat points out, this is such obvious balderdash that it is astounding that anyone in organized medicine could imagine for one minute that this charge would win them any debating points. Like, it was only one day a week ago or so that Dr. Frances woke up and suddenly said, "Omigosh, I'm about to lose all my royalty income because once they publish DSM-V, no one will want to buy my guide to DSM-IV any more"? Like the psychiatric community has not known for years that DSM-V was coming? Plus book authors like me well know how close royalty income on even highly successful books approaches the sums that paid consultants to the drug industry routinely take home.

And just who is making this accusation of financial conflicts of interest against Dr. Frances? Lead author is the APA President, Dr. Alan F. Schatzberg. Does that name ring a bell? How about our previous posting, http://brodyhooked.blogspot.com/2008/08/how-conflicts-of-interest-poison.html? And it's this pot that is calling the kettle black?

I promised one additional comment about the secrecy issue. It turns out that one way that the DSM-V Task Force has imposed secrecy, according to the critics, is by getting members to sign nondisclosure statements. The APA rejoinder is that, "'Confidentiality Agreements' Frances and his colleagues cite as evidence of secrecy around DSM-V Task Force are in reality legal documents designed to protect intellectual property. Attorneys for the APA worked with the DSM-V Task Force and Work Groups to develop these agreements to protect the work product of these volunteers." Dr. Frances reports that at no time during the creation of DSM-IV was it found necessary to resort to such "confidentiality agreements."

My question is a simple one. When I read a statement like the above passage from the APA leaders, I would not be at all surprised if I were reading a document produced by private industry, worried about protecting its property and its profits above all else. I would, however, be a bit surprised to see the same language emanating from a professional society whose purported aim is public health and service. Am I the only one who thinks the line between these two types of enterprises has become way too blurred?


Dan said...

The Diagnostics and Statistical Manual (DSM), the Shrink's bible, has been around for over 50 years. Within this manual, there are now possibly nearly 300 mental disorders.

As a dictionary of suspected mental illnesses, many redefined diagnoses are added to this manual with each edition, and how such disorders are classified and assessed.

On occasion, a mental disorder is deleted from the DSM, such as homosexuality in the early 1970s.

Its purpose, this manual, is to assist mental health professionals to diagnose and classify mental disorders.

How a group sponsored by for profit pharmaceutical industry corporations that promote psychotropic drugs for various mental issues that may or may not fully exist make the determinations that they do while maintaining objectivity is a phenomenon.

Published and designed by the American Psychiatric Association (APA), the DSM is also used, I understand, for seeking mental diagnostic criteria to assure reimbursement.

The DSM is organized by the following:

I- Mental disorders
II- mental conditions
III- Physical disorders/syndromes, medical conditions (co-morbidity)
IV- Mental disorder suspected etiology
V- Pediatric assessments

The APA has historically directed the creation of each edition of the DSM, and assigns selected task force members to create this manual. This situation has proven to be controversial.

The next DSM involves 27 people. About 80 percent of these individuals are male, and only 4 members are not medical doctors.

Most have had relationships with the NIH, and about 25 percent of these task force members have had relationships with the WHO.

Historically, at least a third of task force members have had, or do, have often monetary pharmaceutical industry ties in some way.

This makes sense, as about one third of the APAs total financing is from the pharmaceutical industry.

The APA required this task force for the next DSM edition to sign non-disclosure agreements- which is rather absurd and pointless. Lack of transparency equals lack of credibility because of these agreements of the content of the next DSM.

It opposes any recovery model necessary regarding such disorders, I believe.

The DSM should be evaluated by another unrelated task force or a peer review of sorts to assure objectivity.

This is particularly of concern presently, as many more are diagnosed with mental dysfunctions presently at a concerning rate- with very young children in particular.

Dan Abshear

Doug Bremner said...

I had the exact same response to the legal comment. It sounds like what pharmaceutical companies do whenever they have a meeting, or start a litigation, or whatever. That is what is scary about it-- APA sounding (and looking) like a drug company. And I am glad that "book writer conflict of interest" baloney finally got shot down, since as you know writing on a blog does nothing for book sales, and it is a pittance compared to consulting, and it usually comes as an advance when the book is published and noone in our field writes a best seller that will earn more than the advance, that I know of. So lets get real people.