THE NEW YORK TIMES
June 10, 2008
Editorial
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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St. Petersburg Times
A Times Editorial
Tuesday, June 10, 2008
"Medicine research corrupted
The pharmaceutical industry's corrupting influence on medical research has
reached a new low with a case that has stained the reputations of Harvard
University and three of its top researchers in child psychiatry. It took a
congressional investigation to uncover a conflict of interest that could
violate federal and university rules. As a result, the credibility of a
supposed breakthrough in treating childhood bipolar disease is now in doubt.
Dr. Joseph Biederman and two colleagues - who have promoted the use of
antipsychotic drugs to treat bipolar children - withheld information about
payments they were getting from drugmakers. While the Harvard faculty
members were doing their research, some of it paid for by taxpayers, they
were quietly taking millions of dollars from drug companies such as Johnson
& Johnson, Eli Lilly and others that profited from the findings, the New
York Times reported.
The researchers were supposed to report earnings in excess of $10,000 as
consultants for drug companies, but they failed to do so. Even after Senate
investigators forced Biederman to disclose his income, he reported receiving
less than the drug companies say they gave him. In all, the three
researchers accepted drug company payments of at least $2.6-million over the
past seven years.
Did such hefty inducements affect the outcome of their research? It's a
question that so far is unanswered. The doctors' findings have been
influential but controversial, with 500,000 bipolar children being
prescribed antipsychotic drugs. Some doctors say the medication saves young
lives, though the side effects can be serious. Others say it is an
experimental treatment that hasn't been proved effective over time.
There is no doubt what effect the scandal has had on the medical research
field, which relies on a voluntary honor system. "The price we pay for these
kinds of revelations is credibility, and we just can't afford to lose any
more of that in this field," said Dr. E. Fuller Torrey of the Stanley
Medical Research Institute.
Neither the pharmaceutical industry nor the medical researchers they try to
influence can be trusted under the current system. Sen. Charles Grassley,
R-Iowa, wants to create a national registry of drug research to keep track
of such payments. Maybe a new bureaucracy isn't the answer, but something
has to be done before people are injured and the public loses all trust in
medical research."
(Emphasis by Justice Lover)
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