NIH Official Discusses New Oversight System for Outside Consulting Agreements

Details of a new oversight system for consulting agreements between NIH employees and pharmaceutical and biotechnology companies are still being determined, and NIH Deputy Director Raynard Kington said agency officials "anticipate support" for the plan from the House Energy and Commerce Oversight and Investigations Subcommittee, the Washington Post reports (Weiss, Washington Post, 8/4). The subcommittee began probing potential conflicts of interest in response to a Los Angeles 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, NIH Director Elias Zerhouni directed an NIH Blue Ribbon Committee on Conflict of Interest Policies to investigate the allegations, but lawmakers criticized the panel's recommendations and NIH ethics rules revisions as inadequate. As part of the investigation subcommittee, Chair Jim Greenwood (R-Pa.) contacted 20 pharmaceutical companies about consulting agreements that they had with NIH employees and found that of the 264 consulting agreements that they reported, about 100 were apparently unknown to NIH officials.

Zerhouni in June proposed a number of new revisions to NIH ethics rules, including:

• A ban on consulting agreements between senior NIH officials -- or any other agency employee involved in the research grant process -- and pharmaceutical companies, biotech companies and not-for-profit organizations;
  
  
• A cap on compensation for consulting equal to 25% of an NIH employee's salary;
  
  
• A time limit of 400 hours of consulting each year for employees;
  
  
• A ban on stock options as compensation for consulting;
  
  
• Limits on stock ownership;
  
  
• A measure forbidding NIH employees from serving on the boards of directors of pharmaceutical and biotech companies; and
  
  
• A requirement that NIH ethics officials determine the legitimacy of consulting payments before they are accepted (California Healthline, 6/23).

In an interview with the Post, Kington said agency officials anticipate the latest revisions will be implemented within six months. Kingston said, "What we have clearly concluded is that the system was not working." NIH auditors are investigating 100 alleged conflict-of-interest cases, and "[u]nless the vast majority of such cases prove to be erroneous or attributable to minor and unintentional bookkeeping lapses, the subcommittee may cast a fresh net for more data and hold additional hearings," according to unnamed sources, the Post reports. It also remains unclear how Rep. Joe Barton (R-Tex.) will proceed with the probe, as Greenwood recently recused himself from the issue because he is leaving the House for a job in the biotech industry. In addition, NIH's efforts to move forward might be hindered by ongoing investigations from the HHS Office of Inspector General and the Government Accountability Office, the Post reports (Washington Post, 8/4).