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Policy

Ethics Regulations

Federal agencies follow same basic ethics rules, yet NIH appears alone in conflict-of-interest woes

by BY SUSAN MORRISSEY
February 21, 2005 | A version of this story appeared in Volume 83, Issue 8

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Credit: PHOTO BY SUSAN MORRISSEY
Credit: PHOTO BY SUSAN MORRISSEY

On Feb. 1, officials at the National Institutes of Health announced a new regulation that bans or significantly limits the outside activities, financial holdings, and awards possible for all agency employees. The regulation comes in response to a yearlong congressional investigation into whether the outside activities of agency employees--specifically outside consulting arrangements with pharmaceutical and biotech companies--have compromised employees' credibility.

Concerns about agency employees' outside activities were raised more than a year ago following an article in the Los Angeles Times. The allegations raised in that story prompted hearings in both the House and the Senate, with the House Energy & Commerce Committee launching a thorough investigation.

As Congress moved along with its inquiries, NIH did its own investigation, including setting up a blue-ribbon panel to help determine what policies the agency should implement to avoid even the appearance of conflict of interest by its employees (C&EN, May 17, 2004, page 11).

Then, at a June hearing that was part of the House investigation, NIH officials were ambushed with data on a number of consulting agreements between its intramural scientists and pharmaceutical and biotech companies for which the agency had no record (C&EN, June 28, 2004, page 30). NIH, embarrassed by the committee's findings, admitted that action was needed but maintained that a ban on consulting was not the answer.

That view changed after NIH officials took a closer look at the cases presented by the House committee. NIH Director Elias A. Zerhouni had to face the fact that the number of instances where NIH scientists were engaged in outside activities without agency knowledge, coupled with the type of activity itself, warranted strong action.

The action that resulted from such introspection came earlier this month in the form of an interim final regulation--meaning that it goes into effect once it's published in the Federal Register and remains in effect until changed by subsequent rules.

Under the new rule, NIH employees are barred from participating in paid or unpaid outside activities with pharmaceutical or biotech companies, health care providers, health insurers, trade and professional organizations, and higher education or research institutions that hold or are applying for agency grants. Employees are also restricted from owning more than $15,000 in pharmaceutical, biotech, or related company stock, with senior-level employees prohibited from holding any such stock. The policy also limits the value of awards employees may accept to $200.

These new rules supplement the current Standards of Ethical Conduct issued by the Office of Government Ethics (OGE), in place since 1993 to deal with conflict of interest for all executive branch employees. Each agency has the right to work with OGE to add supplemental rules to these general ethics standards--as NIH did in this case. The additions, however, must meet the minimum standards of the general regulation.

This means that, as a rule, scientists employed by NIH have always had to follow the same basic level of ethics standards as scientists employed by other federal agencies such as the National Institute of Standards & Technology or National Aeronautics & Space Administration. So why, if all of these scientists have to follow the same basic regulations, do scientists at NIH appear to be the only ones facing problems?

When asked this question, Zerhouni tells C&EN that he believes the cause is rooted in a 1995 relaxation of the agency's ethics rules. That relaxation came in response to an OGE audit, which found that NIH's policies were more stringent than other executive branch regulations. The agency had to decide whether to change its policies to conform to the executive-branch-wide standards reissued in 1993 or apply for supplemental regulations from OGE.

At that time, the agency believed that its tough conflict-of-interest policies put it at a disadvantage with respect to attracting top scientists, so then-NIH director Harold E. Varmus decided to change the ethics policies. The relaxation allowed intramural scientists, including high-level employees, to be involved in outside activities that did not conflict with their official duties, and it removed financial and time limitations on such activities.

Another explanation for NIH's plight is simply that a few scientists chose to just ignore the rules. "The situation at NIH is that a number of scientists who had an obligation to report consulting arrangements that they had with pharmaceutical and biotech companies simply failed to report them," explains Stephen D. Potts, chairman of the Board of Directors at the Ethics Resource Center and former head of OGE. "There wasn't anything sophisticated about it; they just didn't do what they were required to do," he says.

"The rules are perfectly clear, and the vast majority of scientists file their information, which is reviewed by the ethics office and either approved or disapproved," Potts says. But if someone chooses to be deceptive by not disclosing their activities, he notes, the agency would not directly know about it.

In the end, then, the responsibility for the tough rule that NIH has had to put on consulting activities lies with those scientists who abused the system. Now, nearly 6,000 intramural scientist employees will have to pay for the poor choices of those few individuals.


Views expressed on this page are those of the author and not necessarily those of ACS.

 

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