Whitney Palmer

Healthcare. Politics. Family.

NIH Tightens Policy on Outside Income

Published in the March 2005 AAMC Reporter

Under the new regulations announced in February by NIH Director Elias Zerhouni, M.D., all NIH employees, including its 5,000 scientists, must abandon any paid or unpaid work with pharmaceutical, biotechnology or healthcare companies, with certain exceptions. They are also prohibited from speaking, teaching or writing for academic institutions that are or recently were NIH applicants, grantees, contractors or CRADA partners.

The regulations are in response to congressional pressure to rein in  unapproved outside activities that some NIH employees engaged in, unbeknownst to agency administrators. In addition, they are an attempt to restore the agency’s integrity as an institution of scientific objectivity. The Department of Health and Human Services will review the limitations to determine whether they are sufficient.

“We wanted to break with the past and start with a clean slate,” Zerhouni said. “There’s nothing more important to the

Elias Zerhouni, M.D., former director of the National Institutes of Health. Courtesy: National Institutes of Health.

NIH than putting the public first and clearing the way to provide health advice with no taint or appearance of conflict of interest.”

Scientists will also be affected in terms of personal financial holdings. Any employee with financial interests such as stock in a biotechnology, pharmaceutical or medical company is subject to a cap of $15,000 on such holdings. The limitations also apply to their immediate family members. Certain high-level officials are prohibited from holding any such interests. The agency also prohibits senior employees from receiving gifts equal to or greater than $200 in value if the award is given because of their official position or from a prohibited source.

Many of the researchers initially cited for failure to report outside income were later absolved, according to recent media reports. These reports suggest that in many cases researchers were mistakenly accused, because of discrepancies in methods of reporting to Congress to names of scientists who received permission to perform outside work and the dates of that work.

The AAMC endorsed the new NIH policy regulating the outside activities of its employees because trust in NIH’s integrity was threatened, as well as Congressional support for the NIH and beyond.

However, the AAMC also expressed support for the NIH’s plan to assess the impact of these new rules, especially on recruitment and retention, within one year. Given the sweeping changes being made and the possibility of unintended consequences, modifications may be necessary.

Tighter restrictions will help the NIH regain its stature in the eyes of federal lawmakers and could help the agency  move past the revelations of employee misconduct, according to David Blumenthal, M.D., professor of medicine and healthcare policy at Harvard University Medical School.

“The regulations will get the heat off the NIH from Congress and other groups,” Blumenthal said. “It will enable Zerhouni to go to the Hill and speak with other groups and not work under the cloud of suspicion associated with previous practices.”

Over the past 14 months, media reports unearthed details about some NIH scientists who were reportedly abusing the former policy by accepting sizable monetary sums for their efforts. The overwhelming majority of NIH employees, however, followed the rules. But all employees are still subject to the changes, and many of the more stringent measures sound too draconian for some academics.

“These regulations are too strict,” said James Siedow, Ph.D., vice provost for research and biology professor at Duke University. “With all the furor and revelations over the past year and a half, the NIH has been put in a box, and the pendulum has been forced too far in one direction.”

Siedow served on a blue ribbon panel last summer that was charged with drafting preliminary conflict of interest regulations for the agency.

Science flourishes best when its practitioners have free, face-to-face contact, and scientists and researchers who are not allowed to interact with their peers regularly tend to become insular, Siedow said. The agency might struggle to attract and keep the nation’s top scientists because they will not be subject to restrictions elsewhere.

Zerhouni acknowledged that the agency may encounter problems in recruiting and retaining quality scientists, but he said rehabilitating the NIH’s reputation on the national stage was his primary concern.

According to Philip Pizzo, M.D., dean of the Stanford University School of Medicine who also served on the blue ribbon panel, banning too many outside activities on employees who have done nothing wrong or who have no control over NIH granting decisions could further deteriorate employee satisfaction.

“Such a ban is likely to create even further demoralization among the NIH community, especially those individuals who are in the large majority, who appear to have followed the rules and to have not engaged in prohibited activities,” Pizzo said.

Pizzo hopes the ban will be lifted, especially for scientists with no granting authority, once NIH administrators have a clear picture of employee activities.

Other activities are still permitted under some circumstances. Scientists can teach college courses as part of an established curriculum, and they can also teach or write for a continuing professional education program. If a pharmaceutical or other prohibited company funds the program, the money must be an unrestricted educational grant.

In addition, NIH employees are free to write articles, chapters or textbooks that will be peer-reviewed. such direct ties between academic medicine and the agency are important to support and foster, Pizzo said.

“Interactions between academia and NIH scientists are both desirable and mutually beneficial, and I hope that the current restrictions do not further limit those interactions or collaborations,” he said. “That would not serve the nation’s science mission.”

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March 25, 2010 - Posted by | Healthcare, Politics | , , , ,

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