- The Washington Times - Wednesday, November 3, 2010

The conflict-of-interest policies in the medical profession are coming under fire as too stringent and as impeding medical progress, a claim the Food and Drug Administration dismisses as a misunderstanding of its rules.

In a report published last week by the conservative-leaning Manhattan Institute, New York University law professor Richard Epstein said conflict-of-interest rules have too many restrictions that prevent informed and knowledgeable people from sitting on medical school faculty and panels that rule on drug licensing.

“If you want pure information, you get less information. There’s much less tolerance of the conflicts than there used to be,” said Mr. Epstein, whose report calls for more lenient regulations on whether medical professionals who have consulted for pharmaceutical companies can hold such posts.

However, other scholars said the conflict-of-interest laws don’t go far enough and that reports of undermanned or uninformed federal advisory panels are exaggerated.

“The kind of expertise you need in serving on a federal advising committee is not necessarily the same kind of expertise you need to help a pharmaceutical company develop a drug,” said Sheldon Krimsky, an adjunct professor in Tufts University School of Medicine’s Department of Public Health.

The 49 Food and Drug Administration advisory committees have 177 vacancies, including 10 openings on the 13-member Drug Safety and Risk Management Advisory Committee, six unfilled slots on the 14-member Nonprescription Drugs Advisory Committee and six vacancies on the 26-member Pharmaceutical Science and Clinical Pharmacology Advisory Committee.

However, Jill Hartzler Warner, the FDA’s acting commissioner for special medical programs, said the vacancies have nothing to do with conflict-of-interest rules, which she said are applied piecemeal for each particular vote. A member judged to have a conflict of interest on a specific drug or treatment is prevented from voting only on that issue. Under some circumstances, the panel member can attend the meetings on the issue and can vote on other drugs or treatments.

“We screen each member in advance of each meeting for financial interests related to the topic(s) of the meeting,” she said.

Mr. Epstein, however, said FDA policies requiring disclosures of any pharmaceutical-industry payments are enough to keep people from even applying for open postilions.

“How many people are going to sign up if they are forced to announce to everyone who they worked for and how much they’ve been paid?” he asked.

In an interview with The Washington Times, Mr. Epstein also said the scope of conflict-of-interest rules are overly broad.

He singled out the National Institutes of Health and Harvard Medical School as places where policies are too stringent. Harvard, he said, requires that medical school faculty members, their families or any “associated entity” be free from any financial interests in the medical profession outside their “responsibilities as a member of the Faculty of Medicine.”

FDA guidelines say advisory committee members “generally” cannot have a financial stake of $50,000 or more in a panel decision. Those holding financial stakes of less than $50,000 can request FDA waivers to participate and/or vote, but only if their involvement is deemed “essential” or the amount is “not so substantial as to be deemed likely to affect” the decision’s integrity.

Although Mr. Epstein agrees that physicians should not review devices or drugs to which they have contributed research, he said that serving as an adviser in research related to a particular field of medicine shouldn’t necessarily disqualify a person from serving on that field’s advisory committee.

He said people with expertise have reputations to protect as scholars and researchers. “Because committee members closely interact, they risk a rapid loss of reputation if they show bias,” he wrote in his report.

A report published last year by the Institute of Medicine of the National Academies called for standardized conflict-of-interest policies and for the federal government to require pharmaceutical, biotechnology and medical device companies to publicly disclose any payments to medical professionals who are hired to consult for them.

The report also states that “conflicts of interest threaten the integrity of scientific investigations, the objectivity of professional education, the quality of patients care and the public’s trust in medicine.”

FDA defenders could point to the case of Dr. Janet Woodcock to show that the conflict-of-interest rules don’t prevent people working with industry from serving on the panels.

Last summer, the manufacturer of one generic version of the blood-thinning drug Lovenox filed an ethics complaint against Dr. Woodcock, director of the FDA Center for Drug Evaluation, because she had co-authored research with doctors from a competing generic manufacturer. But Dr. Woodcock recused herself from that vote and the FDA later ruled that Dr. Woodcock, despite stepping aside on an abundance of caution, had no conflict based on that paper.

Mr. Krimsky said public confidence in the drug-approval process depends on tighter restrictions and that the current system rewards double- and triple-dipping.

“I happen to feel that we’ve created a system that reinforces and rewards people who are in academia, are on the advisory committees and are in the pharmaceutical industry,” Mr. Krimsky said. “It seems like the scientists who are doing all three are the ones who are most rewarded. We’re perpetuating the bias.”

These conflicts of interest have “reached a level where people want something done and the FDA is a place where the public expects to have objectivity, and even the appearance of conflicts of interest will damage the public’s trust in the agency,” he said.

Mr. Krimsky said the FDA panels lack imagination when looking for scientists to evaluate drugs and treatments, and instead habitually settle for known quantities.

“There are people out there, but they tend to be younger,” he said. “They examine the data just as well as some of the more prestigious scientists who are on these committees.”

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