Tripartite conflicts of interest and high stakes patent extensions in the DSM-5.
BACKGROUND
The revision process for and recent publication of the DSM-5 initiated debates about the widening of diagnostic boundaries. The pharmaceutical industry had a major financial stake in the outcome of these debates. This study examines the three-part relationship among DSM panel members, principal investigators (PIs) of clinical trials for new DSM-5 diagnoses, and drug companies.


METHODS
Financial conflicts of interest (FCOI) of DSM panel members responsible for some new diagnoses in the DSM-5 and PIs of clinical trials for related drug treatments were identified. Trials were found by searching ClinicalTrials.gov. Patent and revenue information about these drugs was found using the US Food and Drug Administration's Orange Book and manufacturer Annual Reports.


RESULTS
Thirteen trials met inclusion criteria (testing drugs for some new DSM disorders). Sixty-one percent of the DSM Task Force members and 27% of Work Group members reported FCOI to the trial drug manufacturers. In 5 of the 13 trials (38%), PIs reported ties other than research funding to the drug manufacturer. In 3 of the trials (23%), a PI had financial ties to the drug manufacturer and was also a DSM panel member who had decision-making authority over the revision process.


CONCLUSIONS
These findings suggest that increased transparency (e.g., registration on ClinicalTrials.gov) and mandatory disclosure policies (e.g., the American Psychiatric Association's disclosure policy for DSM-5 panel members) alone may not be robust enough strategies to prevent the appearance of bias in both the DSM revision process as well as clinical decisions about appropriate interventions for DSM disorders.
Department of Counseling and School Psychology, University of Massachusetts Boston, Boston, Mass., USA.
Lisa
L
Cosgrove
Sheldon
S
Krimsky
Emily E
EE
Wheeler
Jenesse
J
Kaitz
Scott B
SB
Greenspan
Nicole L
NL
DiPentima
D001601:Bereavement; D002986:Clinical Trials as Topic / Q000191:economics; D016265:Conflict of Interest / Q000191:economics; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy; D039721:Diagnostic and Statistical Manual of Mental Disorders; D030881:Disclosure / Q000941:ethics; D004345:Drug Industry / Q000941:ethics; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy; D010330:Patents as Topic / Q000941:ethics*; D011619:Psychotropic Drugs / Q000627:therapeutic use; D012108:Research Personnel / Q000191:economics / Q000941:ethics*
D011619:Psychotropic Drugs