The inspector general for the U.S. Department of Health and Human Services has issued a special fraud alert warning about potential financial conflicts in the world of medical devices. Specifically, the warning focuses on medical device distributorships owned by doctors and says such businesses “produce substantial fraud and abuse risk and pose dangers to patient safety.”
Doctor-owned businesses that act as middlemen between medical device makers and hospitals are “inherently suspect” and some of their practices may violate U.S. anti-kickback laws, a government inspector general said.
Daniel Levinson, the inspector general for the Health and Human Services Department, today issued an unusual “special fraud alert” about so-called physician-owned distributorships, or PODs. The companies sell medical devices that the doctor owners then use in surgical procedures on their own patients.
A new analysis by researchers at Harvard and Tufts makes a disconcerting point: The revised Diagnostic and Statistical Manual of Mental Disorders (aka, the DSM, the internationally recognized guide to classifying mental health disorders produced by the American Psychiatric Association) is riddled with conflicts of interest. And, the researchers say, this latest edition of the DSM is no better than the previous one when it comes to members’ financial conflicts.
Lisa Cosgrove of Harvard and the University of Massachusetts and Sheldon Krimsky of Tufts University write in this week’s PloS Medicine that a new disclosure policy has not led to an overall reduction in financial conflicts among the DSM-5 members:
Currently, 69% of the DSM-5 task force members report having ties to the pharmaceutical industry. This represents a relative increase of 21% over the proportion of DSM-IV task force members with such ties (57% of DSM-IV task force members had ties). This finding is congruent with emerging data from fields outside of psychiatry suggesting that transparency of funding source alone is an insufficient solution for eliminating bias…
There are 141 panel members on the 13 DSM-5 panels and 29 task force members. The members of these 13 panels are responsible for revisions to diagnostic categories and for inclusion of new disorders within a diagnostic category.
Three-fourths of the work groups continue to have a majority of their members with financial ties to the pharmaceutical industry. It is also noteworthy that, as with the DSM-IV, the most conflicted panels are those for which pharmacological treatment is the first-line intervention. For example, 67% (N = 12) of the panel for Mood Disorders, 83% (N = 12) of the panel for Psychotic Disorders, and 100% (N = 7) of the Sleep/Wake Disorders (which now includes “Restless Leg Syndrome”) have ties to the pharmaceutical companies that manufacture the medications used to treat these disorders or to companies that service the pharmaceutical industry.
Comparison of financial conflicts of interest among DSM-IV and DSM-5 task force and work group members. (Cosgrove and Krimsky 2012, PLoS Medicine, doi:10.1371/journal.pmed.1001190)