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The National Institutes of Health (NIH), just outside Washington, D.C., has long represented an international gold standard in medical research. Scientists and manufacturers of medical and pharmaceutical products worldwide pay close attention to the work of NIH researchers.
When President Richard M. Nixon declared war on cancer in 1971, he asked the NIH to lead the fight. The agency led the federal government's struggle against AIDS, and, most recently, assumed a lead role in developing countermeasures against potential bioterror attacks.
Margaret Heckler, secretary of Health and Human Services under President Ronald Reagan, once described the NIH as “an island of objective and pristine research, untainted by the influences of commercialization.”
Not anymore, according to recent media and congressional investigations. Last December a well-documented exposé in the Los Angeles Times disclosed that top NIH researchers had collected hundreds of stock options and consultant's fees from drug companies, with one scientist receiving more than $1 million. The dealings have raised serious questions about possible conflicts of interest.
For example, early one morning in 1999 a patient in an NIH research clinic died following complications from an experimental treatment involving a drug made by a German company. Study participants were shocked to learn later that the doctor overseeing the study was a paid consultant of the drug company.
The doctor later said his consulting contract with the firm had not influenced any of his decisions in the study, and that top NIH officials were aware of the relationship.
Indeed, as the Times' investigation revealed, the NIH leadership has routinely approved consulting agreements between staff and outside companies, some of which stood to benefit from NIH research. But a senior official involved in the approval process says the agreements posed no conflict with or compromise of NIH on behalf of the public.
But members of Congress are not convinced. Reps. W. J. “Billy” Tauzin, R-La., and James C. Greenwood, R-Pa., — both members of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee — called for hearings last spring on the propriety of NIH researchers receiving outside compensation from drug companies, and asked NIH Director Elias A. Zerhouni to provide a full account of all compensation that institute scientists have received from drug companies. Unlike most other federal agencies, the NIH allows employees to keep the amount of their consulting fees private.
“The receipt of outside payments, even though approved, raises concerns about whether the integrity of NIH clinical research has been affected and whether the honor system used by NIH to [monitor] NIH scientists and other conflict-of-interest rules has been violated,” Tauzin and Greenwood wrote in a letter to Zerhouni.
As a result of the hearings, the NIH prevented 66 of its most senior employees from taking consulting fees and stock options from drug companies. But the NIH did not comply with the Tauzin-Greenwood request for a full accounting of compensation. (Greenwood recently announced he will retire from Congress at the end of his term to become a lobbyist for the biotech industry, at a salary of $650,000 a year.)
Instead, the agency formed an internal review panel to determine whether rules or ethics had been violated. But its final report only provoked more congressional ire.
The report recommended no more industry compensation in any form for senior NIH scientists who review grant applications. It also limited the amount of outside income scientists can make and the amount of time they can devote to outside work.
But it did not address whether any violations had occurred, leading Rep. Peter Deutsch, D-Fla., to allege NIH was trying to “excuse the inexcusable.”
“This investigation has been slow-rolled and stonewalled,” said Rep. John Dingell, D-Mich.
Rep. Joe Barton, R-Texas, declared, “We have found NIH to be less than cooperative, and that's going to change. They can cooperate cooperatively, or we will make them cooperate coercively.”
In a separate investigation, the Food and Drug Administration found that violations of federal rules had indeed occurred. For example, NIH scientists had entered into approximately 100 consulting arrangements without notifying agency managers, in violation of NIH rules. One scientist was receiving $100,000 a year. Another had allegedly lied under oath to a congressional committee, claiming he had terminated his consulting fees when he was still receiving thousands of dollars from a drug firm.
The National Institutes of Health recently came under fire because top NIH scientists were working as paid consultants to drug companies. (National Institutes of Health)
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As a result, the NIH plans to implement a new oversight system within six months that will prevent personnel with even indirect authority over NIH grants from consulting for drug or biotechnology companies, NIH Deputy Director Raynard S. Kington said on Aug. 3.
Meanwhile, observers decry the apparently growing ties between the drug industry and academic as well as government researchers. “The threat is to the objectivity of scientific research,” Sheldon Krimsky, a science policy expert at Tufts University, recently said. “It is reaching crisis proportions.”
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