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rpautrey2 · Guest

Harvard Doctors Failed to Disclose Fees, Senator Says (Update2)
June 8, 2008 15:43 EDT
By Rob Waters

June 8 (Bloomberg) -- Harvard Medical School doctors who helped
pioneer the use of psychiatric drugs in children violated U.S.
government and school rules by failing to properly disclose at least
$3.2 million from drugmakers led by Johnson & Johnson and Eli Lilly &
Co., a U.S. senator said.

Joseph Biederman, Timothy Wilens and Thomas Spencer conducted studies
on how kids are affected by drugs such as Lilly's attention deficit
treatment Strattera. They filed yearly disclosure forms with the
Boston school showing they got a total of $120,000 from several
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 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.

Bipolar Disorder

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, 74, also wasn't immediately
available for comment.

`Examining Policies'

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.

`Important Step'

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.

Limited Disclosure?

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.

All three researchers have received support from the NIH, including
funding to study Lilly's Strattera, Grassley said. In his letter to
NIH, Grassley said he had become ``increasingly concerned about the
lack of oversight'' in its grant process.

``Every year, the NIH hands out almost $24 billion in grants,'' he
said. ``But nobody is watching.''

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.

To contact the reporter on this story: Rob Waters in San Francisco at
rwaters5@bloomberg.net.

Last Updated: June 8, 2008 15:43 EDT

Article Link:
http://www.bloomberg.com/apps/news?pid=20601087&sid=aqt7HpbgvtPk&refer=home

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