Are conflict of interest policies in clinical psychiatry credible?
May 2009 — Would you trust the world’s most influential text on psychiatric diagnosis and therapy if you knew the majority of its authors had pharmaceutical industry ties?
That is the question raised in Conflicts of Interest and Disclosure in the American Psychiatric Association's Clinical Practice Guidelines, published this month in the journal Psychotherapy and Psychosomatics.
Lead author Lisa Cosgrove, a clinical psychologist and associate professor in the Department of Counseling and School Psychology at the University of Massachusetts Boston, says that most patients assume that when they're prescribed a drug, the decision is made on the basis of an objective review of the scientific evidence. But her study raises the question: Is that decision based in science, or is there a financial incentive behind it?
Clinical practice guidelines are developed, endorsed, and disseminated through professional medical organizations such as the American Psychiatric Association (APA) as the standard of care for health care providers. Cosgrove’s study examined the degree and type of financial ties to the pharmaceutical industry held by authors of three major clinical practice guidelines.
To find financial ties, which include categories, such as consulting, research grants, speaking fees, or stock ownership, Cosgrove and her colleagues, who included Sheldon Krimsky of Tufts University and Dr. Harold Bursztajn of Harvard Medical School, searched publicly accessible databases such as Medline and the records of the Federal Patent Office.
Their conclusion? Ninety percent of the authors of three major clinical practice guidelines had financial ties to companies that manufacture drugs that were explicitly or implicitly identified in the guidelines as recommended therapies for the respective mental illnesses. None of the financial associations of the authors were disclosed in the clinical practice guidelines.
Her study is the first to examine potential conflicts of interest in the APA panels that write the treatment guidelines widely used by practitioners, the paper's authors said.
The guidelines focus heavily on medications and give relatively little attention to non-drug treatments and how and when to phase out drugs prescribed for mentally ill patients, the authors wrote. They said three common diagnoses generate some $25 billion in drug sales per year.
In an article about the study in The Boston Globe, the psychiatric association responded that its guidelines, which sum up research and real-world experiences with treatments, go through a long and elaborate vetting process and that people who receive significant portions of their income from drug companies are excluded from the guideline panels.
"We work very hard to ensure that the guidelines that we develop and publish are free of bias to the greatest possible extent," said Dr. John S. McIntyre, chairman of the guideline steering committee.
Following the publication of Cosgrove’s study on financial ties between upcoming Diagnostic and Statistical Manual panel members and pharmaceutical companies, and amidst growing scrutiny of APA’s industry relationships, U.S. Senator Chuck Grassley sent a letter to the APA requesting full disclosure of the organization’s financial relationships with pharmaceutical companies. By instituting a disclosure policy for the upcoming Diagnostic and Statistical Manual of Mental Disorders (expected to be published in May 2012), the APA took a “ halting first step” in restoring public trust in the most influential text on psychiatric taxonomy in the world, according to Cosgrove in a Point/Counterpoint published in January 2009 by Psychiatric Times.
According to Cosgrove, the need for more safeguards was evidenced when the APA reported that of the 27 task force members of the Diagnostic and Statistical Manual of Mental Disorders, only 8 reported no industry relationships.
She recommends that the APA review the composition of these newly identified work groups and institute a policy that ensures that no panel has a majority of members with ties to the pharmaceutical industry.
The pharmaceutical industry defends its practice of paying "thought leaders" in various specialties to lend their expertise to drug development and marketing, saying that their input benefits both colleagues and patients and that they must be paid for their work.
But there is a growing backlash against conflicts of interest in medicine, centered in Boston. Advocates include Drs. Marcia Angell and Jerome Kassirer, former editors of the New England Journal of Medicine, and researchers such as Cosgrove and Krimsky. They contend that financial ties introduce the potential for bias, and at the very least, all such ties must be disclosed.
"What we're saying," said Krimsky in the Globe article, is that guideline writers "should be totally transparent about their relationships with the drug companies so people reading a guideline might ratchet up the skepticism they might have about the use of drugs as the first line of therapy."
In the Psychiatric Times’ Counterpoint, Dr David Kuper, chair of the Diagnostic and Statistical Manual of Mental Disorders Task Force and professor in the psychiatry department at the University of Pittsburgh School of Medicine, and Dr. Darrel Regier, vice chair, say that Cosgrove and her colleagues assume that the public sees all connections between academic psychiatry and the pharmaceutical industry as inappropriate. “They seem not to appreciate or understand how the collaborative relationships among government, academia, and industry are vital to the current and future development of pharmacological treatments for mental disorders.”
By William Brah, Executive Director, UMass Boston Venture Development Center
[Contact: William Brah; william.brah@umb.edu or Lisa Cosgrove; lisa.cosgrove@umb.edu]