June 8 (Bloomberg) -- Harvard Medical School doctors who helped pioneer use of psychiatric drugs by children violated U.S. government and school rules by failing to properly disclose at least $3.2 million from drugmakers including Johnson & Johnson and Eli Lilly & Co., a U.S. senator said.
Joseph Biederman, Timothy Wilens and Thomas Spencer all conducted studies on how kids are affected by drugs including Lilly's attention deficit treatment Strattera. They filed yearly disclosure forms with the Boston school showing they got a total of $120,000 from drugmakers, Senator Charles Grassley said in the Congressional Record. When Grassley sought added documentation in March, they admitted getting more, he said.
Grassley, an Iowa Republican, said the ethics violations put the medical school and the affiliated Massachusetts General Hospital, where the three work, in jeopardy of losing federal funds. The hospital and school said they will investigate the researchers and review current ethics policies.
``Obviously, if a researcher is taking money from a drug company while also receiving federal dollars to research that company's product, then there is a conflict of interest,'' Grassley said in a statement he entered into the Congressional Record. He sent letters to the medical school and the U.S. National Institutes of Health last week.
Biederman directs, and Wilens and Spencer are affiliated with, a research center at Mass General that studies psychiatric medications in children. Biederman is the leading proponent of the idea that bipolar disorder, once viewed as an adult disease, can begin early in childhood and be treated with drugs.
Biederman's research helped convince many psychiatrists and pediatricians to look for and diagnose bipolar disorder in children, said Larry Diller, a behavioral pediatrician in Walnut Creek, California who has written two books on the overuse of psychiatric drugs by children.
``He single-handedly put pediatric bipolar disorder on the map,'' Diller said in a telephone interview yesterday.
The number of kids diagnosed as bipolar increased 40-fold between 1994 and 2003, according to a recent study. Sales of drugs used to treat the condition doubled from 2003 to 2006.
Grassley, a member of the Senate Finance Committee, has proposed legislation that would require disclosure of the fees physicians receive for speaking, consulting and research.
Repeated attempts yesterday to reach the three doctors by telephone and e-mail were unsuccessful. Grassley also wasn't immediately available for comment.
Arch MacInnes, a spokesman from Mass General, said in an e- mail that the hospital is investigating the doctors' disclosure and conflict of interest forms in coordination with Harvard Medical School. The hospital and its corporate parent, Partners HealthCare, have also convened a commission to ``re-examine its policies to ensure that they appropriately address all issues in the relationships between Partners institutions and its physicians and industry,'' MacInnes said.
Harvard Medical School's office of the dean has referred the case to the Standing Committee on Conflicts of Interest and Commitments, Robert Neal, a spokesman for the school, said yesterday in an e-mailed statement.
The university and hospital ban researchers from working on a company's product if they receive more than $20,000 a year from the company, Neal said. The limit was $10,000 before 2004.
Tara Ryker, a spokeswoman for Indianapolis-based Lilly, said in a phone interview yesterday that she had no information about payments to the doctors, and that the company supports Grassley's legislation.
``The bill is a really important step in trying to build public trust and confidence in the relationship between the pharmaceutical industry and physicians,'' she said.
A telephone message for Srikant Ramaswami, a Johnson & Johnson spokesman, was not immediately returned.
The National Institutes of Health, which oversees $24 billion in federal health funding, requires researchers to disclose to their institutions relationships of least $10,000 with companies whose products are involved in studies.
Biederman is currently recruiting 4- to 6-year-olds with bipolar disorder to test London-based AstraZeneca Plc's Seroquel, and 6- to 12-year-olds with the condition to test Equetro, developed by U.K.-based Shire Ltd, according to a U.S.- run registry of clinical trials.
According to Grassley, the three researchers initially disclosed receiving less than $80,000 from Lilly, the maker of Zyprexa, an antipsychotic, and Strattera, a drug used to treat attention deficit disorder. On further review, in March, they said they had received $172,198 while the company told Grassley it had paid the three a total of $259,756.
Biederman initially said he had gotten less than $10,000 from Johnson & Johnson, the maker of the antipsychotic Risperdal. In March, he said the amount was $5,500. The company told Grassley it paid Biederman $64,378.
John Burklow, a spokesman for the NIH, said in an e-mail that if the agency finds its policies were violated ``we will take the appropriate action and consider the full range of options'' including terminating grants or withholding the award of money committed for future projects.