Conflicts of Interest Recent Cases & Discussion

Conflicts of Interest Recent Cases & Discussion Feb. 19, 2009 CTELS Tom Field, MSEd, MHSA Interim Associate Vice Chancellor for Compliance Agenda

Defining conflict of interest Regulatory requirements Current cases Penalties Discussion Defining Conflict of Interest A conflict between private interests and the official

responsibilities of a person in a position of trust Merriam-Webster a divergence between an individuals private, personal relationships or interests and his/her professional obligations to the university such that an independent observer might reasonably question whether the individuals professional actions or decisions are determined by considerations of personal benefit, gain or advantage KS Board of Regents Policy Manual

Defining Conflict of Interest when the Institutions designated official(s) reasonably determines that a Significant Financial Interestcould directly and significantly affect the design, conduct, or reporting of NIH-funded research - National Institutes of Health Financial relationships are not necessarily inappropriate or bad. Its when they are not reported and managed that problems arise.

Regulatory Requirements Written, enforced policies Institutional official to solicit & review COI Annual reporting, ad hoc updates Management requirements Manage, reduce, eliminate

From disclosure to divestiture Disclosure requirements Consent forms to publications to conventions Regulatory Environment Chuck Grassley (R-Iowa), ranking Republican on Senate Finance Committee, investigating medical COI nationally Physician Payment Sunshine Act Industry disclose payments > $500 to physicians

AAMC/AAU Zero-dollar threshold recommendation Current Case: Emory/Nemeroff* Dr. Charles Nemeroff, former chair of Emory psychiatry department $3.9 million NIH study of 5 GSK drugs $2.8 million in consulting; reported $1.2M 2000-06, paid $960K from GSK; reported $35K

Emory required fees from GSK to be <$10K Continued to earn > the $10K limit from GSK Funding frozen; enrollment halted; voluntarily resigned from Emory NIH grants New Emory office for COI oversight created New Emory regulations for COI reporting *Neuropsychopharmacology: resigned as editor over Cyberonics implant review Current Case: NIH/Sunderland Dr. Pearson Sunderland, III, sr. scientist at

National Institute of Mental Health Supervised NIMHs geriatric research Collaborative biomarker research with Pfizer $300,000 for consulting from Pfizer; did not report it Was required to report arrangements >$260 2 years probation, forfeit $300K, 400 hours of community service Current Case: UT/Wagner Dr. Karen Wagner, child psychiatrist at UT

Medical Branch at Galveston Served on the universitys COI committee GSK Paxil study for teenage depression Wagner was one of GSKs opinion leaders Co-author on study that overstated Paxils safety $160,000 from Pfizer over 6 years; $76,241 of the total was related to Paxil consulting Penalties Wide variety of enforcement/penalty

mechanisms Whole or partial suspension of funding Forfeiture of funds Debarment Community Service Probation Prison Discussion