Researchers Divided Over NIH Stance on Consulting

A new policy prohibiting all researchers and scientists at the National Institutes of Health (NIH) from consulting activities for the next year met with approval from most in academic medicine, but some observers believe the lasting effects could be detrimental to the agency.

In September, the NIH announced a yearlong moratorium on all consulting arrangements between its 5,000 scientists and the pharmaceutical industry, going a step beyond a recommendation made by a panel of academics and industry officials that is advising the agency regarding conflict of interest policies. The moratorium only affects individuals employed at the NIH.

After news reports revealed that several NIH researchers worked with pharmaceutical companies without the agency’s knowledge and often received financial compensation, the panel suggested banning only scientists who work with outside institutions and centers through grants from consulting. Even though some in academic medicine believe the moratorium is overdue, others argue the restriction could create a recruitment problem for the agency. Supporters contend that the announcement could prompt universities to draft the same policy.

However, the moratorium has yet to become official. The NIH must first receive permission from the Office of Government Ethics before it can impose the restriction. NIH officials did not have an exact date for when permission will be granted but consider the step a formality.

In addition to the actual clash between NIH responsibilities and consulting activities, the panel applied what it called conflicts of commitment or the “shower question,” to any suspect situation, said panel member Thomas Murray, Ph.D., president and CEO of the Hastings Center, an independent institution focusing on ethical and science issues.

“There’s a fundamental difference between conflict of interest and conflict of commitment,” Dr. Murray said. “In deciding if a relationship was a problem, we considered what the individual was thinking about in the shower. The NIH should want it to be NIH work, not outside consulting.”

According to an NIH spokesperson who requested anonymity, the agency decided to extend the sanction to all of its scientists in an effort to treat each employee equally and to accelerate the process of refining conflict of interest policies and regulations. During this time, the NIH will create computer, training, oversight and auditing methods designed to prevent any future consulting agreements from conflicting with NIH duties.

Congressional investigations and national media reports unearthed only 66 NIH-approved consulting arrangements, but the agency does not know how many of these relationships with pharmaceutical companies actually existed, the NIH spokesperson said. The most widely publicized incident involved an NIH researcher who allegedly received $500,000 over a five-year period for unapproved consulting services with Pfizer, Inc.

While Jim Siedow, Ph.D., vice provost for research and biology professor at Duke University, agreed that the consulting ban should be imposed on all NIH scientists, he said the agency could suffer some long-term losses. Dr. Siedow was also a blue ribbon panel member.

“In light of all that’s come out, I would now be in favor of looking at everything that’s happening. Too many people have been doing too many things,” Dr. Siedow said. “But for the NIH, this measure may not be in the best interest of attracting and retaining the best scientists in the world.”

Many individuals could rule out an NIH career because they do not want to voluntarily submit to such strenuous restrictions on their outside activities, he said. Dr. Siedow expressed hope that the NIH would be able to craft a workable consulting policy as soon as possible.

The NIH confirmed the agency expects to lose at least a few scientists although it has no estimate as to how many may leave.

Despite the potential loss of scientists, the ban on outside consulting activities should be permanent, said Sheldon Krimsky, a science and policy specialist at Tufts University. Krimsky said that the NIH’s reputation has been damaged by the actions of some employees.

“This shouldn’t be a temporary ban,” Krimsky said. “I don’t see why higher ranking officials should be selected out. If you have a policy, it should apply to everybody.”

Mildred Cho, Ph.D., senior research scholar and associate director of Stanford University’s Center for Biomedical Ethics, said academic medical centers could feel the impact, as well. The intense attention given to the agency’s conflict of interest policies could prompt other schools to evaluate their own regulations.

“Universities are probably going to start reviewing their own policies,” Dr. Cho said. “They might retain stricter limits on the amount of money that can be received from consulting or the amount of time spent consulting per year.”

Dr. Siedow agreed, saying revising these policies could fill in the gaps in several schools’ conflict of interest procedures and could prevent similar problems in the future.

—Whitney L.J. Howell

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