No Public Disclosure
For DSM-5, the APA instituted a new disclosure policy for contributors and reported those disclosures on its website.
This time, the association spokesperson said that DSM-5-TR chairs and the DSM Steering Committee who reviewed all proposed changes were required to have no industry-related income above $5000 and that “in fact, many had no industry income.”
Other DSM-5-TR contributors had to submit “extensive” disclosure forms and report “any relationships they or close relations had with industry (very broadly defined) and sources of income,” the spokesperson added. They were also asked to report other nonfinancial interests that they or close relatives had that could potentially bias their work.
The APA’s standing Conflict of Interest Committee reviewed all disclosure forms and flagged those with disclosures that could impact content. Text written by individuals with flagged disclosures received additional review, the spokesperson said.
“If any possible bias was noted in the text content, such as for a potential commercial advantage with a diagnostic instrument, that content was deleted,” the spokesperson said.
However, the real sticking point for medical ethicists is that unlike with the DSM-5, the APA did not share DSM-5-TR contributors’ disclosures publicly.
Commenting on the research, Bernard Lo, MD, professor emeritus of medicine and director emeritus of the Program in Medical Ethics Emeritus at University of California, San Francisco, said that the lack of public disclosure is critical.
“Part of the report should be, ‘Here are the conflicts of interest reported by the members of the panel,’” said Dr. Lo, adding that publishing disclosures is standard in all of APA’s peer-reviewed journals. “Failure to do that in the DSM-5-TR is unacceptable from an ethical and transparency point of view.”
Loss of Public Trust?
In her previous research and in this new study, Dr. Cosgrove recommends the APA follow the 2011 report Clinical Practice Guidelines We Can Trust. Published by the Institute of Medicine (IOM, now called the National Academy of Medicine), that report updated and streamlined a 2009 conflicts of interest guideline, which Dr. Lo coauthored.
“The IOM recommends that the whole guideline development group be free of industry ties,” Dr. Cosgrove said. “At a minimum, the chair should not have ties and the majority of folks should not have ties to industry.”
Some have argued that banning all contributors with industry ties would shrink the expert pool that develops the DSM and other guidelines. Dr. Cosgrove disagrees with that assertion.
“There are hundreds of experts in all medical disciplines that do not have industry ties,” Dr. Cosgrove said. “The ‘most experts have industry ties’ is a spurious and unsupported argument.”
The APA also should ban contributors who receive industry funding as key opinion leaders, known as KOLs, such as members of pharmaceutical companies’ speakers bureaus, Dr. Lo said.
“Certain types of funding relationships with industry are more fraught with ethical problems,” including KOLs, who Dr. Lo said are “basically salespeople trying to increase sales of a product.”
“It really compromises their scientific objectivity and should exclude someone from any practice guideline body,” Dr. Lo said. “This failure to adequately address conflicts of interest doesn’t promote transparency and it doesn’t promote public trust in the diagnostic criteria.”