Source: New York Times
Date: 10 June 2008

Hidden Drug Payments at Harvard

Three prominent psychiatrists at the Harvard Medical School and its affiliated Massachusetts General Hospital have been caught vastly underreporting their income from drug companies whose fortunes could be affected by their studies and their promotional efforts on behalf of aggressive drug treatments. Their failure to divulge their conflicts is striking proof that today’s requirements for reporting payments from industry — essentially an honor system in which researchers are supposed to reveal their outside income to their institutions — needs to be strengthened.

What makes this case particularly troublesome is that the Harvard group’s research has helped fuel an explosion in the use of powerful antipsychotic drugs to treat children, as was described in The Times on Sunday by Gardiner Harris and Benedict Carey. Although supporters praise the most prominent of the trio, Dr. Joseph Biederman, as a visionary who has saved many lives, critics complain that the Harvard studies have been too small and loosely designed to provide conclusive results. Critics say they also were subject to biased interpretation through use of a subjective rating scale.

The previously unknown payments to the researchers were pried loose by Senator Charles Grassley of Iowa, the ranking Republican on the Senate Finance Committee, whose staff reviewed what the researchers disclosed on conflict-of-interest forms at their institutions and prodded the university to verify the data as accurate. Under pressure, two of the researchers acknowledged receiving $1.6 million apiece in consulting fees from drug companies between 2000 and 2007 and the third reported earning more than $1 million. That was far more than the researchers had originally reported, a number that Mr. Grassley pegged at a couple hundred thousand dollars apiece. Even the updated numbers left out other payments that drug companies reported separately that they had made to the trio.

At this point, it is not clear whether the researchers inadvertently failed to comply with reporting rules or consciously sought to hide their sizable incomes from drug companies. But it is clear that relying on researchers to report their outside incomes and on universities and hospitals to police the disclosures won’t suffice. Senator Grassley and Senator Herb Kohl, Democrat of Wisconsin, have introduced a bill that would require drug and device makers to report annually any payments to doctors that exceed $500 a year. That is the best way to ensure that conflicts of interest are transparent to all.

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