NIH Chief Calls for Ethics Summit
Dr. Elias Zerhouni, who banned drug company payments to agency scientists,
wants a wider discussion on conflicts in medical research.
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By David Willman, Times Staff Writer
BETHESDA, Md. — The director of the National Institutes of Health —
describing consulting payments from drug companies as a "systemic problem"
that threatened the integrity of his agency — has called for a summit of
government and academic leaders to address conflicts of interest throughout
American medical research.
Dr. Elias A. Zerhouni last week banned all of his agency's scientists from
accepting consulting fees, stock or any other compensation from the
biomedical industry. He also instructed the scientists to divest stock
holdings in any biomedical company. The reforms, Zerhouni said in an
interview, will put the NIH ahead of universities and private physicians in
battling conflicts of interest.
Asked whether academic researchers should follow the NIH's lead, Zerhouni
"We need to have a summit discussion to say, 'Look, what is the interest of
the public?' The interest of the public is to make sure the science that's
done is not tainted…. We can't lose the public trust. Not just at NIH, but
into research in general. There is work to be done. Stay tuned."
Zerhouni stopped short of saying that he would organize such a summit. But
as the leader of an agency that will award about $21 billion in federal
grants to academic researchers this year, he is in a strong position to
demand change. Federal authority already exists, for example, to require all
recipients of NIH research grants to comply with new ethical standards.
The crackdown on conflicts of interest at the NIH, the nation's leading
agency for medical research, comes at a time when drug-industry influence on
research choices, on the practice of medicine and on the prescribing of
drugs is pervasive.
About one-fourth of biomedical researchers at universities have financial
affiliations with industry, according to an analysis published two years ago
by the Journal of the American Medical Assn. In neighborhood clinics and
hospital emergency rooms, doctors have accepted fees from drug and device
makers to enroll patients in studies aimed at promoting an array of
biomedical products. Sometimes, patients are not informed that their doctor
has a financial stake in their participation.
At the NIH, Zerhouni has transformed himself from a reluctant reformer to a
leader in setting national conflict-of-interest standards.
Zerhouni defended his staff after the Los Angeles Times reported in December
2003 that NIH scientists — including senior officials overseeing clinical
trials — had accepted stock options or industry consulting fees totaling
millions of dollars, and that more than 94% of the top-paid agency employees
were not filing public income-disclosure reports.
As recently as last summer, Zerhouni reiterated that he wanted most NIH
scientists to remain eligible to enter private, paid consulting deals with
drug companies. The freedom to enter those arrangements, Zerhouni said,
would help "translate" discoveries from government laboratories into useful
Zerhouni did not mention at the time that the NIH maintained formal,
structured collaborations with companies for the purpose of bringing to
market such discoveries. Under those formal arrangements, NIH scientists are
prohibited from taking any compensation from the participating companies.
In the interview this week, Zerhouni, 53, said that the more he learned
about the industry ties to staff scientists, the less comfortable he grew.
He realized, he said, that the potential for serious conflicts of interest
was not confined to only the most senior agency officials, as he had
"What changed my mind," Zerhouni said, was when he saw that NIH scientists
"were trading on that to be speakers for products, or whatever. That's when
I said, 'Wait a minute, I'm wrong.' "
Zerhouni said he was particularly bothered to read recently in The Times
that a senior agency scientist had participated in dozens of federal
advisory sessions without declaring publicly that he was on the payroll of
companies that stood to be affected by the panels' decisions.
Zerhouni was similarly displeased, he said, to learn that other NIH
scientists had written articles for medical journals endorsing certain drugs
— without disclosing to readers that the manufacturers had paid them.
"If you are weighing in on behalf of the public, I want you to be there on
behalf of the public," he said. "This is an absolute for me. Don't tread on
your prestige, position, in a way that pretends to be completely objective."
Although most NIH scientists were beyond reproach, Zerhouni said, he
ultimately concluded that the conflicts of interest were serious and could
not be dismissed as "just a few bad apples."
"I came to the conclusion that we have a systemic problem," Zerhouni said.
"They were not just isolated events. They reflected the complete set of
rules that had been adopted over the years, which had transformed the
culture. I said, if that's the case, let's bring back the culture to where
it needs to be: That is, public first.
"That's the hardest part," he said. "It's easy to come up with regulations.
It's not easy to change a culture."
As he spoke in his office at NIH headquarters, Zerhouni occasionally thumped
his hands on a circular table for emphasis. Outsiders, he said, may
underestimate the difficulty of achieving change within government.
Appointed in March 2002 by President Bush, Zerhouni is the first immigrant
to head the NIH.
He is a native of Algeria, where he was educated as a physician with a
specialty in radiology. He learned English after coming to the U.S. in 1975
at age 24, when he joined the staff at Johns Hopkins University medical
school in Baltimore. In 1990, he obtained U.S. citizenship.
Except for two brief stints elsewhere, Zerhouni remained at Hopkins, where
he rose to executive vice dean of the medical school and chief radiologist
before coming to the NIH.
Zerhouni said he could still summon the resolve of the competitive swimmer
that he was during his high school years in Algeria. His swim training,
Zerhouni said, provided strength amid the last year's tumult.
"The training is very long," he said. "You're going for miles on end. And
you're on your own…. I'm one to look at the information and carefully
evaluate it in great detail. No matter what the pressures are. That comes
from the swimming experience."
Asked about the sharp criticisms he had heard from some staff scientists at
the NIH, Zerhouni said he found aspects of their remarks troubling.
"What I faced here is a sort of pendulum swing that said, 'Everything is
OK,' " Zerhouni said, adding: "Not everything is OK. And I've made a very
strong stand — an internally unpopular stand."
Unpopular, particularly, with a vocal contingent of NIH scientists, some of
whom had complained in advance that tightening the rules would render them
Zerhouni said that he had "received as many e-mails on the other side too. A
lot of good e-mails."
Zerhouni questioned why the most outspoken critics of tightening the rules
did not see danger when then-NIH Director Harold E. Varmus dramatically
loosened restrictions on moonlighting for industry in 1995.
"No limits on stock. No limits on money. No limits," Zerhouni said. "Where
were all these holier-than-thou intellects? I believe in candor as an
instrument of leadership…. This issue was standing between the history of
NIH and its future."