DSM-V Study Exposes Possible Conflict of Interest between Pharmaceutical Companies and Review Members

Posted in Dangerous Drugs on January 30, 2014

According to a recent study published in Psychotherapy and Psychosomatics (1/22/14, “Tripartite Conflicts of Interest and High Stakes Patent Extensions in the DSM-5”, http://www.karger.com/Article/FullText/357499#abstract), panel members for the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) may have financial conflicts of interest (FCOI) due to financial ties with pharmaceutical companies.

The DSM manual is published by the American Psychiatric Association (APA) and serves as a diagnostic checklist for psychiatric disorders, many of which require pharmacological treatments. The APA instituted a disclosure policy requiring panel members to disclose drug industry ties, a positive step toward transparency. According to the study, “… findings suggest that there may be a risk of industry influence on the DSM revision process. Additionally, our findings of FCOI of PIs running the clinical trials suggests that there also may be a risk of industry influence on the clinical decision-making process for identifying interventions to treat these new ‘disorders’.”

The drug industry has a sizable financial stake in the outcome of DSM disorders and treatment methods. Panel members with drug industry ties have introduced new diagnoses or propose revisions to treatment which have drawn criticism from experts arguing lack of scientific evidence. One example is a notable revision from the DSM-IV to the DSM-V of a provision known as “bereavement exclusion” — the two month grieving period following the death of a loved one where clinicians formerly were advised to refrain from diagnosing major depression in family members. The newly revised “bereavement exclusion” in DSM-V now advises clinicians to consider medicating family members who have lost a loved one in as early as two weeks after death.

In the study of 13 clinical trials, every single clinical trial except for 1 had panel members with financial conflicts of interest with drug companies manufacturing the drugs being tested to treat new disorders. Seven out of the ten patented drugs involved in the trials are or were at one point a “blockbuster drug”, meaning a drug that earns over $1 billion in a single year. The study also found that in 3 out of 13 trials (23%), principle investigators who performed the studies served as DSM-V panel members helping create or redefine disorders and treatment related to the drugs they studied.

In the end, 69% of the DSM-V task force members reported some form of financial tie to a pharmaceutical company. That’s a 21% increase from disclosures under the DSM-IV task force. Transparency is a critical first step in maintaining public and professional trust. Financial conflicts of interest in the development and treatment of disorders run the serious risk of allowing the well-respected and widely-used DSM-V manual to become a means of promoting the commercial interests of pharmaceutical companies. The Institute of Medicine’s standard provide that committee members work independently from a study’s sponsor, carrying out deliberations in private to avoid any external influence. We at RCRSD believe that the integrity of the DSM-V manual, the safety of the public and Institute of Medicines standards, support the exclusion from the DSM-V panel of any persons with financial ties to drug companies.