Three researchers affiliated with Harvard Medical School failed to properly report income, a possible violation of federal law, according to Sen. Charles Grassley (R-IA). The allegations were first reported on the front page of the Sunday New York Times.
The Times story revealed that two influential psychiatrists and another colleague may have violated federal and university conflict of interest research rules by inaccurately reporting incomes received from drug companies.
According to Sen. Grassley's comments in The Congressional Record, Harvard and Mass General Hospital – the institution administering grants to Drs. Joseph Biederman and Timothy Wilens – provided conflict of interest forms to Grassley for Dr. Biederman, Dr. Thomas Spencer and Dr. Wilens last October. Based on the forms Grassley received, “anyone would be led to believe that these doctors were not taking much money. Over the last seven years, it looked like they had taken a couple hundred thousand dollars,” said Grassley in comments. After Harvard and Mass General asked the doctors to review their financial disclosures in March, the three doctors admitted receiving drug industry money ranging from $1 million to $1.6 million, according to Grassley's comments.
Additionally, Grassley requested payment records from pharmaceutical companies for the three doctors, revealing further discrepancies. “Eli Lilly has reported to me that they paid tens of thousands of dollars to Dr. Biederman that he has still not accounted for. And the same thing goes for Drs. Spencer and Wilens,” wrote Grassley.
According to Grassley, both Harvard and Mass General have established an income de minimus that forbids researchers from “conducting clinical trials with a drug or technology if they receive payments over $20,000 from the company that manufactures the drug or technology.” Additionally, the National Institutes of Health (NIH) requires universities and hospitals whose researchers apply for NIH grants to provide “significant financial interest” that could affect the results of a study. “NIH interprets ‘significant financial interest' to mean at least $10,000 in value or 5% ownership in a single entity. The three researchers' March disclosures appear to exceed the $10,000 cap.
Grassley sought financial information pertaining to the three doctors from several pharmaceutical companies, including GlaxoSmithKline, Johnson & Johnson, Thomson Physicians World and Pfizer.