Why Sunshine Act isn't enough

No one has been more effective than Sen. Chuck Grassley (R-Iowa) in promoting transparency in medicine. From 2004 to 2010, he investigated undisclosed conflicts of interest between physicians and pharmaceutical and device companies. His findings helped lead to the Physician Payments Sunshine Act. Beginning March 31, 2014, companies must report to HHS all payments over $10 to physicians; the payment information will be made publicly available the following September.

The Sunshine Act will bring unprecedented transparency to physician-industry ties, but will it resolve the problems Grassley uncovered? To answer this question, we analyzed five cases Grassley highlighted for Congress. All revealed physicians significantly underreporting company payments to their academic medical centers and the National Institutes of Health. What were the consequences of exposure? Did sunlight disinfect?

Grassley took his lead from newspaper exposés. His first case began with a New York Times report on Dr. Melissa DelBello, a University of Cincinnati psychiatrist. After publishing a study supporting atypical antipsychotic use in children, DelBello became a consultant and speaker for AstraZeneca, which manufactures quetiapine, an atypical antipsychotic. DelBello declined to tell the Times how much industry funding she received.

Troubled, Grassley asked UC for DelBello's conflict-of-interest disclosures. He also asked AstraZeneca to report her earnings. Discrepancies emerged: AstraZeneca paid DelBello $238,000 in 2003, but she disclosed only $100,000 to UC. Her underreporting violated NIH guidelines.

What came of this? The consequences were minimal. The university entered the lapses in DelBello's personnel file but did nothing more. The NIH took no action, and DelBello still receives government funding.

Grassley's next case was Dr. Joseph Biederman, a psychiatrist at Harvard Medical School. As the Boston Globe reported, Biederman had NIH funding to study attention deficit disorder and Eli Lilly and Co.'s medication atomoxetine. Biederman would not divulge his payments from Lilly.

Grassley again investigated, learning Biederman had underreported his Lilly earnings to Harvard in 2000, when he studied atomoxetine with NIH funds. Harvard promised an investigation. The NIH pledged “appropriate actions.”

Yet little happened. Harvard imposed minor penalties on Biederman: no industry activities for one year; prospective approval of activities for two additional years; and unspecified “training.” The NIH never commented, continuing Biederman's funding through March 2010.

Grassley's third case was Dr. Alan Schatzberg, Stanford University's psychiatry chair. As the San Jose Mercury News reported, Schatzberg co-founded Corcept Therapeutics to license mifepristone for treating depression. Schatzberg sat on Corcept's board of directors and held stock worth $12 million while leading NIH-funded research on Corcept's product.

Grassley's investigation uncovered inaccuracies in Schatzberg's disclosures to Stanford and a lucrative licensing agreement between Stanford and Corcept. How could Stanford manage Schatzberg's conflicts, Grassley asked the NIH, while maintaining a financial interest in the company and the research outcome? In response, Stanford sought a new psychiatry chair and removed Schatzberg from the NIH grant—although it later reinstated him as principal investigator. Schatzberg still receives NIH funding and recently served as president of the American Psychiatric Association.

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.