Dr. Karen Wagner, a University of Texas Medical Branch at Galveston psychiatrist, became Grassley's fourth case. Wagner was deposed in a 2006 lawsuit charging GlaxoSmithKline with “persistent fraud” in researching and marketing its antidepressant paroxetine. Glaxo paid Wagner to promote paroxetine while she received NIH funding to study it. In her deposition, Wagner denied knowing how much Glaxo paid her. Grassley learned that, from 2002 to 2005, Wagner disclosed to the university only $600 of $88,927 from Glaxo. The university promised to investigate. The NIH stated “they were never told of Wagner's conflicts.” Yet again, nothing happened. The NIH took no action. Wagner remains a University of Texas Medical Branch professor.
Grassley's fifth and most notorious case involved Dr. Charles Nemeroff, Emory University's psychiatry chair. The New York Times reported Nemeroff had lucrative Glaxo ties even as he used NIH funding to study the company's antidepressants. Emory told Grassley it had reprimanded Nemeroff in 2004 for violating university and NIH conflict-of-interest policies—to which Nemeroff pledged to “recommit himself.” However, Grassley's investigation revealed that, from 2004 to 2008, while conducting NIH-funded research on Glaxo products, Nemeroff failed to report to Emory receiving $500,000 from the company.
Immediately after Grassley presented the case to the Senate, Nemeroff resigned as psychiatry chair. The NIH froze his grant and imposed stringent funding conditions on Emory. Emory prohibited Nemeroff from submitting NIH grants for two years.
Yet, soon thereafter, assisted by the National Institutes of Mental Health's director, Nemeroff became chair of psychiatry at the University of Miami, where he was free to apply for federal funding. He recently received an NIMH grant.
Grassley's probes of individual malfeasance and weak institutional oversight built support for transparency. But will the Sunshine Act be sufficient to remedy conflicts of interest in medicine? Probably not. Even in the most egregious cases, the physicians escaped largely unscathed, and the NIH was reluctant to intervene.
What could make the Sunshine Act effective? Medical and governmental bodies should implement stringent conflict-of-interest policies, using Sunshine Act data to verify physicians' disclosures. They must also impose strong penalties for violations. Transparency by itself is not enough. People behave better when watched, but only if misbehavior has consequences.
Susan Chimonas, left, is associate director of research at Columbia University's Center on Medicine as a Profession; Frederica Stahl is product manager and data scientist at Meddik; and David Rothman, who has consulted for the state of Texas in its litigation against Johnson & Johnson for Medicaid fraud, is director of CMAP.