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.,1,2677921.story?ctrack=1&cset=true  (must register to view original article)

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 said:

"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 medical products.

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 previously maintained.

"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 "second-class citizens."

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."