APA Partial Disclosure - Conflicts of Interest in Writing DSM-V

Via The Alliance for Human Research Protection website, a report from the health section of US News and World Report:

In what is arguably the most important mental-health development since the early 1990s, the American Psychiatric Association will spend the next five years producing a new edition of the psychiatrist's "bible," the official guidebook for diagnosing mental problems. The Diagnostic and Statistical Manual of Mental Disorders, as it is known, is hugely influential because it determines what is and is not a mental disorder. In turn, it is responsible for much of the sales growth in prescription drugs.

The most recent edition of the DSM, published in 1994, drew controversy because it turned what had once been a thin guidebook into an 886-page tome that significantly expanded the definition of mental illness. Traits once associated with shyness, for example, became symptoms of "social anxiety disorder." And drug companies went on to spend millions promoting medicines for those problems. Eyebrows were further raised in 2006 when a study showed that more than half of the researchers who worked on the manual had at least one financial tie to the drug industry.

Transparency. This time around, pledging to avoid even the appearance of conflicts, the APA has instituted screening procedures for the 27 members of its DSM task force, asking them for detailed financial information about stocks, honoraria, and consulting fees from drug interests. It calls the effort the "most transparent" in the medical industry.

Yet the summaries of the disclosure statements that were recently released to the public are remarkably spare; they show only the existence of corporate connections, not their dollar amount or their duration. The result is a document that even an APA board member suggested is not very revealing. In a 2006 memo to the board obtained by U.S. News, William Carpenter wrote: "Simple listing of all relationships is not very informative and does not identify potential conflicts that may need to be resolved."

Critics say the limited information violates the spirit of disclosure. "There is disclosure, and then there is disclosure," says Daniel Carlat, a psychiatrist and former consultant to drug companies. "There is a big difference between $500,000 and $500. It is one thing to disclose in a generic way, to say that a psychiatrist has had some consulting with a company, but that doesn't tell you a number of things."

Documents reviewed by U.S. News, including sec filings and patent requests, also show connections between doctors and drug companies that don't necessarily turn up in the disclosures. In general, the disclosures paint an incomplete picture of the degree to which the corporate and clinical worlds are increasingly enmeshed. In other cases, they simply reflect mistakes.

For example, Dilip Jeste, a professor of psychiatry at the University of California-San Diego, had consulting ties that did not appear on his disclosure form. Yet during the reporting year of 2003, he was a consultant to Pfizer and AstraZeneca and received honoraria from Pfizer, according to documents. Jeste called the error "unintentional," saying he had relied on memory. The APA said that Jeste would submit a new disclosure. APA President Carolyn Robinowitz said that task force nominees "were on the honor system" and acknowledged that the association had made no effort to check their accuracy.

The APA itself erred in its public summary for Jan Fawcett, a professor of psychiatry at the University of New Mexico and chair of the DSM's mood disorders work group. The summary lists no directorships or corporate positions for Fawcett. But a 2005 sec filing shows that he was a member of the board of directors for Berman Health and Media, a company that is poised to "exploit opportunities in the female sexual medicine industry." [He has since resigned from the board.] The APA said that Fawcett had disclosed the connections in private filings but that its staffers accidentally omitted them from the public disclosure form.

Critics say the APA's disclosures are inadequate in other ways. Carpenter, for instance, is listed as a "co-inventor" on two patents filed in the past three years for "methods for screening, diagnosing and treating schizophrenia." The applications list pharmaceutical giant Novartis as the holder of at least one of the patents. The APA said, and Carpenter confirmed, that Carpenter did not need to disclose the connection because he has pledged to receive no financial benefit from the patents at any time.

Likewise, David Kupfer, the task force chair, reported multiple consulting arrangements with communications companies that "sponsored pharmaceutical meetings & editorial work." His public form, however, does not reveal that income from two of these companies, Prescott Communications and Innovative Medical Education, came from work for Forrest Pharmaceuticals and Pfizer, respectively. The APA said Kupfer did not need to disclose the ties because he was not paid directly by drug companies.

Industry support. The existence of drug company links does not necessarily mean the individuals reporting them are biased. In most instances, the APA says, the relationships merely underscore a simple truth: that in the absence of adequate government support, more than two thirds of all medical research funding comes from pharmaceutical companies.

Yet studies have repeatedly shown a connection between authors who received income from drug companies and published papers favoring the firms' products. The papers also tend to underreport negative side effects.

In acknowledgment of such problems, the APA's vetting procedures are stronger than those of other medical organizations. And the sacrifices required of task force members are hardly insignificant: Before being appointed, members pledged to limit their aggregate income from pharmaceutical sources to $10,000 a year. If their income exceeded that amount, they were required to reduce it or sever ties.

But critics say that loopholes weaken the policy. One is that task force members can undertake new financial arrangements after being appointed. Second, task force members are not asked to disclose "unrestricted research grants," which often go straight to one's department or institution. Lisa Cosgrove, a clinical psychologist at the University of Massachusetts-Boston, describes such grants as a "hollow open-door policy" giving pharmaceutical companies strong influence. "If your department has a $500,000 unrestricted grant from a drug company, with the potential of getting $2 million, it is disingenuous to assume that there are no potential conflicts."

Some APA members have asked association officials to strip voting privileges from all DSM committee members with industry ties. "If someone's expertise is deemed necessary, they can serve as consultant but not as a voting member," says Amy Brodkey, a professor of psychiatry at the University of Pennsylvania. Of the 27 task force members, eight had no ties to the industry.

APA officials say such changes are unnecessary since several APA groups have to approve the DSM before it's published. "What you've got is several layers of protection," says APA Medical Director James Scully. One layer to watch: the more than 150 people who will fill out the DSM work groups. Scully said the appointments should be complete by early 2008. And they will be asked to disclose ties.