2011-09-02 04:01:00.9 GMT
By Alex Wayne and Drew Armstrong
(Bloomberg) -- The lobby for Harvard University and
other research institutions drove the Obama administration to
weaken draft rules for scientists to disclose potential conflicts
of interest, according to U.S. records and watchdog groups.
The standards, introduced by the National Institutes of
Health on Aug. 23, give schools the option to conceal when
government-funded scientists get financial compensation from
drugmakers and other companies, said Sheldon Krimsky, a
professor at Tufts University School of Medicine in Boston and
author of “Science in the Private Interest.”
The government started developing rules last year after
incidents showed scientists had undisclosed financial stakes in
their research outcomes. The rules build on 1995 U.S. requirements
that federally funded researchers tell their institutions about
possible conflicts without mandating public disclosure.
“This is going to lead to very few decisions of
significant financial conflicts of interest because most
scientists would say, ‘My holdings would have no effect on my
objectivity,’” Krimsky said in a phone interview.
Universities objected to draft rules in a letter to NIH and
in meetings with officials at the White House Office of
Management and Budget, approver of the final version, said
Carrie Wolinetz, associate vice president for federal relations
at the Association of American Universities that represents 61
research universities.
Investigators for Senator Charles Grassley, an Iowa
Republican who’s been critical of industry ties to government-
funded scientists, turned up cases where university-based
psychiatric researchers didn’t disclose payments they accepted
from drugmakers. The incidents took place at Emory University in
Atlanta, Stanford University in Palo Alto, California, and at
Harvard in Cambridge, Massachusetts.
Emory Case
In one 2008 case cited by disclosure advocates, Charles
Nemeroff, then the chairman of Emory’s psychiatry department,
didn’t report $800,000 in payments from GlaxoSmithKline Plc for
speeches between 2000 and 2006. He had a $9.3 million NIH grant
for studies that included Glaxo products. Emory ousted Nemeroff
from his leadership position and he left the school.
“There should be direct accountability and transparency
from the universities to NIH and to the public,” said Grassley
in an e-mailed statement. “The new rules don’t seem to
accomplish this.”
Wolinetz’s group sent an Aug. 17, 2010, letter to NIH
objecting to the website disclosure requirement and also asking
for greater discretion to decide whether financial interests
amounted to a conflict. In “several” meetings with regulatory
officials at the White House, she said, her organization used
proposed rules “as an example of pending regulations that we
had some concerns about.”
‘Paucity of Evidence’
Wolinetz’s organization wrote in the letter that “there is
a paucity of evidence that the disclosure and management of
financial conflicts of interest affect objectivity and
integrity.” The letter was co-signed with the Association of
American Medical Colleges, American Council on Education and
Association of Public and Land-Grant Universities.
Scientists with corporate funding are more productive than
their academic counterparts, though results they publish are
“virtually certain to support the company’s products and
services,” said Eric Campbell, an associate professor of
medicine at Harvard Medical School who has studied the effects
of researchers’ financial interests.
The disclosure rules put universities in a position to make
judgments about the “virtue” of scientists who have investments
in drugs or devices they are studying, creating a “very high bar”
for disclosing conflicts to the public, Krimsky said.
No ‘Value Judgment’
Universities will have to evaluate the effect of a
financial interest “on the design, conduct, and reporting” of
experiments, said Sally Rockey, director of extramural research
at NIH, in Bethesda, Maryland. “It is not a value judgment of
the researcher,” she said in an e-mail.
Researchers have been lax making financial disclosures and
there’s been an absence of oversight, said Peter Pitts,
president of the Center for Medicine in the Public Interest, a
nonprofit research institute in New York. “When you don’t
properly disclose, you give the impression that you’re trying to
hide something.”
Institutes should instead disclose all financial interests
without trying to judge whether they are conflicts, Pitts said.
“Interest is okay, as long as that interest is transparent
and addressed,” he said.
About 80 percent of the NIH’s $31 billion annual budget is
used for grants to privately employed scientists, mostly at
universities. The University of Pennsylvania in Philadelphia got
$482 million from NIH in 2010. Harvard received $397 million,
and Stanford received $340 million.
Unscrupulous scientists will continue to try to evade any
disclosure rules, no matter how strict, Rockey said in an
interview. “If you have a bad apple, you have a bad apple and
there’s very little regulations are going to be able to do about
that,” she said.
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--Editors: Adriel Bettelheim, Steve Walsh
To contact the reporters on this story:
Alex Wayne in Washington at +1-202-654-4339 or
awayne3@bloomberg.net;
Drew Armstrong in Washington at +1-202-654-7385 or
Darmstrong17@bloomberg.net.
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