Conflicts of Interest Recent Cases & Discussion

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

2. Agenda • Defining conflict of interest • Regulatory requirements • Current cases • Penalties • Discussion

3. 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 individual’s 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

4. Defining Conflict of Interest • “…when the Institution’s designated official(s) reasonably determines that a Significant Financial Interest…could 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. It’s when they are not reported and managed that problems arise.

5. 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

6. 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

7. 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

8. Current Case: NIH/Sunderland • Dr. Pearson Sunderland, III, sr. scientist at National Institute of Mental Health • Supervised NIMH’s 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

9. Current Case: UT/Wagner • Dr. Karen Wagner, child psychiatrist at UT Medical Branch at Galveston • Served on the university’s COI committee • GSK Paxil study for teenage depression • Wagner was one of GSK’s “opinion leaders” • Co-author on study that overstated Paxil’s safety • $160,000 from Pfizer over 6 years; $76,241 of the total was related to Paxil consulting

10. Penalties • Wide variety of enforcement/penalty mechanisms • Whole or partial suspension of funding • Forfeiture of funds • Debarment • Community Service • Probation • Prison

11. Discussion