By Mark Griffin
Last week, the American Psychiatric Association released its draft of the next Diagnostic and Statistical Manual of Mental Disorders, better known as the DSM. As The Economist astutely notes:
“Mental illness carrying the stigma that it does, and the brain being as little-understood as it is, revising the DSM is always a controversial undertaking.”
The DSM codifies sets of behaviors as pathological in order to define different mental disorders. Stated simply, it explains what human behaviors are normal to health care professionals and to their patients.
The publication of the DSM-V is a big exercise in line-drawing. When line-drawing occurs, a governing body makes a distinction between acceptable and unacceptable behaviors, when these behaviors exist on a spectrum. For example, the most recently released draft of the Diagnostic Statistical Manual of Mental Disorders, the DSM-V, suggests that the new disorder “hypersexual disorder” be added to the list of currently accepted pathological disorders. The official DSM-V website lists one set of symptoms for hypersexual disorder as:
A. Over a period of at least six months, recurrent and intense sexual fantasies, sexual urges, and sexual behavior in association with four or more of the following five criteria:
(1) A great deal of time is consumed by sexual fantasies and urges, and by planning for and engaging in sexual behavior.
(2) Repetitively engaging in these sexual fantasies, urges, and behavior in response to dysphoric mood states (e.g., anxiety, depression, boredom, irritability).
(3) Repetitively engaging in sexual fantasies, urges, and behavior in response to stressful life events.
(4) Repetitive but unsuccessful efforts to control or significantly reduce these sexual fantasies, urges, and behavior.
(5) Repetitively engaging in sexual behavior while disregarding the risk for physical or emotional harm to self or others.
note: paragraph markers removed for clarity
In the first sentence of the description, the APA is drawing a line at “six months.” Why not seven or five? For one thing, several other of the disorders listed in the same category as hypersexual disorder use six months as a benchmark for treatment. So there is a history of using 6 months as a barometer of abnormal behavior. It is curious, though, how that period of time came to be used in the first place. The line that is drawn by the DSM staff is notable, since if someone suffers these dysfunctions for five months, treatment might not be recommended. Once the half-year mark comes around, though, prescriptions begin to be disbursed.
In order to officially edit the Diagnostic Statistical Manual, the APA assembled three DSM-V committees: the “Task Force,” “Work Groups,” and “Study Groups.” The Task Force, according to the DSM-V website, includes “the 13 chairs of each diagnostic work group as well as key experts in psychiatric treatment, research, and epidemiology.” Each Work Group is split up by diagnostic category. Using our example above, the potential codification of hypersexual disorder falls into the diagnostic category of “Sexual and Gender Identity Disorders”. Presumably, the Work Group of the same name is dedicated to to examining the data, drafting language, and making recommendations to the Task Force for inclusion into the DSM-V. Finally, the Study Groups serve to examine broader issues such as “Diagnostic Spectra” and “Gender and Cross-Cultural Issues”. In the APA’s own words, “as development on DSM-5 progressed, the importance of addressing cross-cutting issues relevant to all of the disorder work groups became increasingly evident”.
The actions by the APA could ripple through the economic and political sphere. Who might benefit from such a codification of sexual dysfunction in the DSM-V? For no good reason, let’s take a look at Pfizer, one of the largest and most successful drug companies in the world. Pfizer makes Depo-Provera, a birth control shot. Depo-Provera contains the active ingredient progestin, a synthetic form of the hormone progesterone. Besides its official use as a progestin, Depo-Provera is also used as a chemical castration tool to reduce libido in sex offenders.
If hypersexual disorder is codified in the DSM, then drug companies will line up to provide prescription strength relief. Here I should note I have no expertise whatsoever in the science of pharmaceuticals, nor is this example anything but a hypothetical. However, it stands to reason that a drug similar to Depo-Provera could be modified to reduce libido in people diagnosed with hypersexual disorder if such a disorder were to be codified in the DSM-V. If a drug company already has a drug available to treat a proposed DSM-V disorder, it could skip much of the research phase of the process, thus saving it money. Pfizer could stand to gain by the codification of hypersexual disorder if it could use Depo-Provera to treat it.
Some news outlets, including The Washington Post have articulated generic concerns by the public that drug companies could influence the process:
Even before being made public, the proposed changes have been the subject of sometimes bitter debate over whether the process was based on solid scientific evidence and was adequately shielded from influence by the pharmaceutical industry, and whether some critics were driven by financial interests in maintaining the old diagnostic criteria.
Rob Stein, author of the Post article quoted above, does not go into any more detail about how those concerns might manifest, but the message is simple: money exchanged between pharmaceutical companies and doctors could influence how disorders are codified. And as in the case of Pfizer with Depo-Provera, some companies could benefit from an APA decision one way or another on a new disorder.
As it turns out, doctors often have side projects with pharmaceutical companies performing research, testing new drugs, and carrying out other miscellaneous consulting duties. The APA, having full understanding of the possible conflicts of interest that may arise, required that committee members abide by the following criteria:
• Serve without remuneration for their services with the exception of the DSM-5 Task Force Chair.
• Not serve on a work group with a spouse, domestic partner, or first-degree family member.
• Receive no more than $10,000 annually in the aggregate from pharmaceutical companies/device makers/ biotechnology companies and similar industry entities for direct services, such as consultancies, advisory committee positions, forensic assistance, speakers’ bureau services, etc. (These “industry entities” do not include clinical practices, hospitals, nonprofit organizations, managed care organizations, university-based lectures, and similar activities.)
• Not hold stock or shares worth more than $50,000 in the aggregate in pharmaceutical companies/device makers/biotechnology companies and similar health-care related commercial ventures or receive more than $10,000 annually in the aggregate in dividends from such sources. Stock and shares held in mutual funds, pension or retirement funds, blind trusts, and similar arrangements do not count toward these limits.
• Abstain from participating in any capacity in Industry Sponsored Symposia at an APA Annual Meeting during their task force and/or work group tenure after 2007.
In addition, the APA has posted “conflict of interest” pages detailing work performed by each doctor involved in the process for pharmaceutical companies in conjunction with the above rules. It should be noted that the APA did not do self-disclose for the release of the DSM-IV. Below is a chart of the make-up of the over-arching task force and another of the make-up of the Sexual and Gender Identity Disorder work group. In each chart I have placed the committee member’s name in the first column. In the second column, I have noted whether the individual has any disclosed financial interest in Pfizer. In the third column I have indicated whether the group member has had financial interest in any pharmaceutical company within the reporting date-range (8 years). Members with “No*” are those who have indicated a potential conflict of interest not related to the pharmaceutical industry (For example, William Narrow disclosed that he is employed by the American Psychiatric Association, which I do not count as related to the pharmaceutical industry). I count these cases equally as those who disclosed no ties whatsoever with the pharmaceutical industry. I have omitted charts on the status of members of the cross-cutting study groups, since it is not immediately clear what influence each of those groups has over final revisions.
| DSM-V Task Force | ||
|---|---|---|
| Name | Financial interest in Pfizer | Financial interest in any Pharma |
| Kupfer, David J., M.D. | Yes | Yes |
| Regier, Darrel A., M.D., M.P.H. | No | Yes |
| Burke, Jack D., Jr., M.D., M.P.H. | No | No |
| Carpenter, William T., Jr., M.D. | Yes | Yes |
| Castellanos, F. Xavier, M.D. | No | Yes |
| Compton, Wilson M., M.D., M.P.E. | Yes | Yes |
| Dimsdale, Joel E., M.D. | No | Yes |
| Escobar, Javier I., M.D., M.Sc. | Yes | Yes |
| Fawcett, Jan A., M.D. | No | Yes |
| Grant, Bridget, Ph.D., Ph.D. | No | No |
| Hyman, Steven E., M.D. | No | Yes |
| Jeste, Dilip V., M.D. | Yes | Yes |
| Kraemer, Helena C., Ph.D. | No | Yes |
| Mamah, Daniel T., M.D., M.P.E. | No | Yes |
| McNulty, James P., A.B., Sc.B. | No | No |
| Narrow, William E., M.D., M.P.H. | No | No* |
| O’Brien, Charles, M.D., Ph.D. | Yes | Yes |
| Peele, Roger, M.D., D.L.F.A.P.A. | No | No* |
| Phillips, Katharine A., M.D. | Yes | Yes |
| Pine, Daniel S., M.D. | No | No* |
| Reynolds III, Charles F., M.D. | Yes | Yes |
| Rubio-Stipec, Maritza, Sc.D. | No | No* |
| Skodol, Andrew E., M.D. | Yes | Yes |
| Swedo, Susan, M.D. | No | No |
| Walsh, Timothy B., M.D. | No | Yes |
| Wang, Philip, M.D., Dr. P.H. | No | Yes |
| Womack, William, M.D. | No | No* |
| Yonkers, Kimberly A., M.D. | Yes | Yes |
| Zucker, Kenneth J., Ph.D. | No | No* |
10 of 29 (34.5%) of the members of the DSM-V Task Force, have benefited monetarily from a professional relationship or investment with Pfizer in the last eight years. 20 of 29 (69.0%) of the members of the DSM-V Task Force have had some ties with the Pharmaceutical Industry in the last eight years.
| DSM-5 Sexual and Gender Identity Disorder Work Group | ||
|---|---|---|
| Name | Financial interest in Pfizer | Financial interest in Any Pharma |
| Zucker, Kenneth J., Ph.D. | No | No* |
| Binik, Irving M., Ph.D. | Yes | Yes |
| Blanchard, Ray, Ph.D. | No | No* |
| Brotto, Lori, Ph.D. | Yes | Yes |
| Cohen-Kettenis, Peggy T., Ph.D. | No | No |
| Drescher, Jack, M.D. | No | No |
| Graham, Cynthia, Ph.D. | No | Yes |
| Kafka, Martin, M.D. | No | No |
| Krueger, Richard B., M.D. | Yes | Yes |
| Långström, Niklas, M.D., Ph.D. | No | No* |
| Meyer-Bahlburg, Heino F. L., Dr. rer. nat. | No | No |
| Pfäfflin, Friedemann, M.D. | No | No |
| Segraves, Robert Taylor, M.D., Ph.D. | Yes | Yes |
4 of 13 (30.8%) members of the Sexual and Gender Identity Disorder Work Group have benefited monetarily from a professional relationship or investment with Pfizer in the last eight years. 5 of 13 (38.5%) members of this group benefited from a professional relationship with any pharmaceutical company. As previously stated, amending the DSM means creating a potential boon to some drug companies who have the resources to perform research and the luck to have already developed drugs for potential new disorders. Not including members of the omitted cross-cutting study groups, almost a third of the doctors working to amend the Sexual and Gender Identity Disorder DSM have some link to Pfizer. It is clear from the example of Depo-Provera above that a company like Pfizer could benefit from hypersexual disorder being added to the DSM.
The Task Force percentage of 69% seems a little high to me, but the sample size of 29 is a little low to claim that this percentage is representative throughout APA’s 38,000 members. However, for the sake of argument, let us assume that the Task Force percentage is representative of the Association as a whole. The DSM website claims that it represents 38,000 doctors. If it were the case that 69% of all APA members are financially involved in some way with pharmaceutical companies, then there would still be a pool of 11,780 physicians from which to choose who have had no recent financial connections to drug companies.
It is not clear whether or not a financial interest in a pharmaceutical company by DSM team members constitutes influence by the company on the DSM process. It could be the case that consulting with a big drug company gives doctors a valuable perspective on the industry for use in their capacities as DSM group members. On the other hand, it is hard to ignore the possible conflict of interest that arises when a doctor makes decisions on a DSM committee which could benefit a drug company for which she was a recent employee.
By allowing APA members with financial ties to drug companies, the APA is making clear that the organization does not believe financial interest suggests future influence. In other words, the APA does not believe that doctors receiving money for services by Pfizer means that these same doctors are being paid off to make decisions benefiting Pfizer in the DSM committees. Conversely, excluding allmembers with potential conflicts of interest would have been a clear sign that the APA believed that doctors with financial ties to drug companies could not make unbiased decisions about how to codify disorders. In fact, the APA may have made a conscious decision to have mixed groups with some members with pharmaceutical industry ties, and some without. As Cogrove et al. note in their paper Financial Ties between DSM-IV Panel Members and the Pharmaceutical Industry,
“One hundred percent of the members of the [DSM-IV] panels on ‘Mood Disorders’ and ‘Schizophrenia and Other Psychotic Disorders’ had financial ties to drug companies.”
This time around, there are several members of each work group who have disclosed no pharmaceutical industry ties. Whether this was mere luck of the draw, or an organizational directive remains unclear.
By disclosing those ties that do exist between panel members and pharmaceutical companies, the APA seeks legitimacy. Instead of hiding any financial connections between DSM team members and pharmaceutical companies, the APA placed basic guidelines on its team regarding financial interest in drug companies, published the information on its website, and asked the public to judge for themselves.
One basic way the public can assert its approval or disapproval over the legitimacy of the process is by voting for representatives who advocate for transparency and rules similar to those the APA itself instituted. In fact, the APA’s guidelines mirror several federal and state laws already in place. On a national level, theFederal “anti-kickback” laws prohibit any doctor from receiving money in excess of fair-market value for their services. This means that a doctor cannot receive $18,000,000 for a 15 minute consult unless other doctors making similar consultations have received the same. Presumably, this law serves to make the act of bribery of doctors by drug companies a more difficult task.
As noted, several states have taken the law a step further and added “anti-gift” laws requiring disclosure. Massachusetts has instituted ThePharmaceutical and Medical Device Manufacturer Code of Conduct. It states:
In all speaker and commercial consultant contracts, pharmaceutical manufacturing companies shall require any health care practitioner who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the nature and existence of his or her relationship with the company. This disclosure requirement must extend for at least two years beyond the termination of any speaker or consultant arrangement.
Similar to the DSM committee guidelines, the Massachusetts law focuses on disclosure of pharmaceutical company ties. Going into effect in June, 2010, the law also outlaws some kinds of gifts from drug companies to doctors, including meals, airline tickets, and tchotchkes like pens and notepads.
The Pharmaceutical Research and Manufacturers of America (PhRMA) was not pleased when the legislation passed in 2009. Immediately following passage, PhRMA released a statement containing the following:
Public disclosure of a pharmaceutical company’s arrangements with principal investigators of its clinical trials also could reveal sensitive, proprietary business information to a company’s competitors. This could erode the independent decision-making of companies trying to bring science from research facilities to patient care settings.
PhRMA argues that the public will be less likely to go to doctors who work for pharmaceutical companies. Thus, doctors will be less likely to work for the companies in the first place, in order to have a “clean” record. The premise put forward by PhRMA is that the general public views ties between doctors and drug companies in a negative light. In other words, PhRMA assumes that the public’s decision to use a doctor is influenced by how much that doctor works for a pharmaceutical company.
PhrMA may have good reason for its poor self-image. A poll conducted in June 2009 by Gallup showed that only “Repulican leaders in Congress” and “Health Insurance Companies” were trusted less than pharmaceutical companies when it came to healthcare policy.*
The difference between approaches by the APA and PhRMA is stark. Seeing value in the ties between pharmaceutical companies and doctors (or at least value in admitting they exist), the APA advocates for transparency and openness in the process. In doing so, the DSM committees via the APA trust the public to affirm its legitimacy, regardless of pharmaceutical industry ties. PhRMA, on the other hand, does not have the problem of having to prove legitimacy in the public sphere. Instead, this group must advocate for laws that would make their member companies the most money, thereby pleasing shareholders. In the meantime, companies it represents still have to adhere to whatever local and federal laws currently exist. Thus, in advocating against disclosure laws, PhRMA, and by extension its member companies, would rather keep ties between doctors and its member companies secret. In the end, it will be the public’s support or disapproval of future federal and state regulations on the matter that will determine which of these approaches is the best for patients, doctors, and pharmaceutical companies.
* It appears Gallup has not followed up on this poll since then.
