NIH Director Elias Zerhouni Proposes New Agency Ethics Rules at House Subcommittee Hearing

NIH Director Elias Zerhouni on Tuesday proposed additional revisions to ethics rules related to consulting agreements between agency employees and pharmaceutical and biotechnology companies to help avoid potential conflicts of interest, the Washington Post reports (Weiss, Washington Post, 6/23). "I have reached the regrettable conclusion that some NIH employees may have violated these (existing) rules and that the agency's ethics system does not adequately guard against these violations," Zerhouni told members of the House Energy and Commerce Oversight and Investigations Subcommittee during a six-hour hearing (Willman, Los Angeles Times, 6/23).

The subcommittee began an investigation into the conflict-of-interest issue in response to a Times article published in December that found evidence of hundreds of consulting payments -- often hidden from the public -- from pharmaceutical and biotech companies to a number of NIH employees. In January, Zerhouni told the Senate Appropriations Subcommittee on Labor, Health and Human Services and Education that an NIH Blue Ribbon Committee on Conflict of Interest Policies would investigate allegations of conflicts of interest among agency employees who received consulting payments and stock options from pharmaceutical and biotech companies. However, lawmakers have criticized as inadequate recommendations from the blue ribbon committee and recent revisions to NIH ethics rules announced by Zerhouni. Last month, Zerhouni announced that NIH will require all agency employees to report the financial details of consulting agreements with pharmaceutical or biotech companies over the past five years or face dismissal (California Healthline, 6/22).

As part of the subcommittee investigation, Chair Jim Greenwood (R-Pa.) contacted 20 pharmaceutical companies and asked them to reveal all consulting agreements that they had with NIH employees. He found that of the 264 consulting agreements that they reported, about 100 were "apparently unknown to NIH officials," the Post reports. For example, Greenwood found that Pfizer paid National Institute of Mental Health researcher Trey Sunderland $517,000 in fees, honoraria and expense reimbursements for consulting agreements, none of which appear on his NIH financial disclosure reports. In addition, Greenwood presented canceled checks dated through May 1 issued by Biospect to Dr. Lance Liotta, a researcher at the National Cancer Institute, that likely were issued as part of a consulting agreement (Washington Post, 6/23). In May, Liotta testified that he had ended consulting work with the company as of February to comply with a directive from Zerhouni (Carey, CQ Today, 6/22). Rep. Joe Barton (R-Texas) said, "If our suspicions are confirmed, these unapproved, compensated activities would represent a very serious breach of NIH policies, federal ethics regulations, and possibly, in a few cases, criminal laws" (Los Angeles Times, 6/23).

In response, Zerhouni proposed a number of revisions to NIH ethics rules, concluding that "drastic changes are needed" (Washington Post, 6/23). The proposal includes:

• A ban on consulting agreements between senior NIH officials -- which include directors, deputy directors, scientific directors and research directors - and pharmaceutical and biotech companies. In addition, senior NIH officials could not take consulting or speaking fees from not-for-profit organizations (Los Angeles Times, 6/23);
  


• A ban on consulting agreements for NIH employees involved with the agency research grant process (AP/Houston Chronicle, 6/22);
  


• Limits on the consulting agreements that NIH employees can accept, such as a compensation limit equal to 25% of their agency salaries and a time limit of 400 hours each per year;
  


• A ban on stock options as compensation for NIH employees as part of consulting agreements;
  


• A ban on ownership of stock in pharmaceutical and biotech companies for more than 5,000 NIH employees (Los Angeles Times, 6/23). Other agency employees could own only $5,000 of stock in such companies (AP/Houston Chronicle, 6/22);
  


• A provision under which NIH employees could not serve on the boards of directors of pharmaceutical and biotech companies;
  


• A ban on any form of compensation from universities and other institutions that receive NIH research grants; and
  


• A provision that would require NIH employees to refuse consulting payments until agency ethics officials can determine their legitimacy (Los Angeles Times, 6/23).

Zerhouni said that he and his staff would "move diligently to completely change the system of ethics at NIH" by "working aggressively" with HHS and the Office of Government Ethics to implement the proposal. He added, "It's very painful to me that the actions of a few may have tainted the good work of thousands of scientists who have not participated in any of these actions and who work daily at NIH to solve the mysteries of disease and to advance treatments and cures for these diseases (Los Angeles Times, 6/23). Subcommittee members praised the proposal, but said that they remained concerned about potential conflicts of interest. "We are still learning how far and wide the problem of outside payment goes. What else is out there?" Rep. John Dingell (D-Mich.) said (CQ Today, 6/22).