Ethics Concerns over Undisclosed Conflicts in Psychiatric Guidelines
March 1, 2024
By Stacey Kusterbeck
For six years, Brian J. Piper, PhD, has conducted studies on conflict of interest disclosures in the textbooks used to train physicians, pharmacists, and other allied healthcare providers. Piper and colleagues have examined point-of-care databases including UpToDate, Dynamed, and Medscape and influential journals like Journal of the American Medical Association and The New England Journal of Medicine, using the Centers for Medicare & Medicaid Services’ Open Payments database.
“As the Diagnostic and Statistical Manual of Mental Disorders (DSM) is considered the ‘bible’ of psychiatry, we thought it would be important to examine disclosures in the DSM Fifth Edition, Text Revision (DSM-5-TR) published in 2022,” says Piper, an assistant professor of neuroscience at Geisinger College of Health Sciences in Scranton, PA, and assistant professor at Geisinger’s Center for Pharmacy Innovation & Outcomes.
The researchers discovered that the American Psychiatric Association (APA) did not include any disclosure information in the DSM-5-TR. The APA’s American Journal of Psychiatry, like most biomedical journals, requires authors to self-report their conflicts of interest for three years.1 “As the DSM-5-TR is at least as influential as a journal article, we decided we would help them correct for this omission,” says Piper.
The researchers analyzed the type and amount of compensation paid to 86 physicians who were panel members and six physicians who were task force members of the DSM-5-TR.2 The study period started in 2016, the year that the development of DSM-5-TR began, and covered the subsequent three years. “We found a total of $14.2 million in undisclosed conflicts of interest. At least three-quarters of the members of five panels and 100% on one panel had received payments from industry,” reports Piper.
One member of the task force who contributed to the Medication Induced Movement Disorders section of the manual, received a striking number of industry payments. In a single year, the physician received 24 payments for speaking, 51 payments for consulting, 122 payments categorized as “other,” 213 payments for meals, and 308 payments for travel and lodging. “This works out to 6.3 payments per week from pharmaceutical companies, just for travel,” notes Piper.
The study’s findings point to some clear ethical concerns involving undisclosed payments. “When the authors of any influential medical publication do not clearly disclose their conflicts and how they were managed, this shows a lack of respect for their audience,” asserts Piper.
If healthcare providers (or anyone else reading the DSM-5-TR) have information on financial conflicts, people can draw their own inferences about what it means. “Inclusion of persons with conflicts of interest on the DSM working groups could lead to the broadening of diagnostic criteria, over-diagnoses, and over-treatment,” warns Piper. In turn, this increases the risk of harm from adverse effects or medication errors.
The Institute of Medicine (now the National Academy of Medicine) recommended that “whenever possible, clinical practice guideline writers should not have conflicts of interest.”3
“This would not be a challenging requirement to meet for the DSM-6, as about half of U.S. physicians have not received money from industry. Organizations like the National Institutes of Health require that their faculty do not have conflicts of interest, which would also provide a pool of potential working-group members with deep expertise,” offers Piper.
The study authors recommend that healthcare providers should provide the link to their Open Payments report, which is listed in all their publications. “In our experience, there is a subset of people, particularly males, that under-report their conflicts of interest. Self-reporting of conflicts of interest is inadequate — particularly when there is a database that takes less than two minutes to look up a physician, nurse practitioner, or physician assistant,” concludes Piper.
REFERENCES
- American Psychiatric Association. The American Journal of Psychiatry. Information for Contributors. https://ajp.psychiatryonline.org/ajp_ifora
- Davis LC, Diianni AT, Drumheller SR, et al. Undisclosed financial conflicts of interest in DSM-5-TR: Cross sectional analysis. BMJ 2024;384:e076902.
- Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Graham R, Mancher M, Miller et al, editors. Clinical Practice Guidelines We Can Trust. Washington (DC): National Academies Press (US); 2011.