NIH Director To Meet With Agency Scientists To Discuss Proposed Alternative To New Conflict-of-Interest Guidelines
NIH Director Elias Zerhouni on Thursday will meet with agency scientists who are "growing increasingly disturbed" by "stringent" new conflict-of-interest guidelines and plan to introduce an "alternative set of ethics regulations," the Baltimore Sun reports (Baer, Baltimore Sun, 2/24). However, a top NIH official on Wednesday indicated that "it was unlikely that the rules would be significantly changed as a result" of the "renewed protest" from agency scientists, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 2/24).
Zerhouni on Feb. 1 announced revised ethics guidelines that will restrict the ability of NIH employees to enter outside consulting agreements with pharmaceutical companies, hospitals, health insurers and health care providers. The revised guidelines also will mandate that about 6,000 top NIH employees cannot hold stock in pharmaceutical or biotech companies and require current stockholders in the group to sell their shares.
The move followed an investigation by the House Energy and Commerce Subcommittee on Oversight and Investigations into hundreds of consulting payments from 20 pharmaceutical and biotechnology companies to a number of NIH employees. An NIH review released this week concluded that statistical and clerical errors led the agency to improperly implicate more than half and possibly as many as 80% of about 100 scientists alleged to have violated conflict-of-interest guidelines as part of the House investigation (California Healthline, 2/23).
The revised guidelines will become final in early April after a 60-day comment period (Los Angeles Times, 2/24).
Zerhouni requested the meeting on Thursday with the Assembly of Scientists, a group of 15 elected NIH researchers who represent workers throughout the agency. The group plans to present to Zerhouni alternative ethics guidelines, which would exempt NIH employees who are not institute directors, clinical directors and officials with significant authority at the agency from some restrictions on consulting agreements and stock ownership.
Under the alternative guidelines, NIH scientists could continue to receive payments for consulting and speaking at health care companies and academic institutions, provided that the agreements are not related to their specific areas of work. The alternative guidelines also would allow nonscientific NIH employees, as well as spouses and children of employees, to own unrestricted amounts of stock in any company.
Cynthia Dunbar, senior investigator at the National Heart, Lung and Blood Institute and a member of the Assembly of Scientists, said that NIH scientists could receive higher salaries in the private sector, adding, "Now, add to that the new restrictions, and the good surgeons, radiologists and clinicians are going to say, 'Sorry,'" and leave the agency (Baltimore Sun, 2/24).
The Assembly of Scientists on Thursday distributed a newsletter that said the revised ethics guidelines "substantially overreach and will severely and irreparably compromise the NIH's mission." The newsletter continues, "These new regulations will discourage talented, innovative scientists from staying at or being recruited to the NIH, and preclude scientists already at the NIH from participating as full members of the scientific community," adding that "such expansive restrictions seem unnecessary and unlinked to preventing conflicts of interest, but they will have profoundly detrimental financial impacts on individual employees and hinder recruitment and retention."
Zerhouni in an article in the newsletter wrote to NIH scientists, "You must not serve two masters. You cannot have another financial interest in the work that you do for NIH outside of your federal job." He added, "If the taxpayers have paid for your work, someone else may not pay you again for that work." According to Zerhouni, the revised guidelines will allow NIH scientists to speak, write and interact with others in their fields.
NIH Deputy Director Raynard Kington, the chief ethics officer at the agency, said in an interview, "I cannot anticipate under any circumstances changing large sections of the rule for the most senior people, who have the greatest potential -- because of their authority -- for conflicts of interest." Kington said that despite the results of the NIH review, the agency must implement the revised ethics guidelines to prevent potential conflict of interests.
"We never said we were going to base our policy on the list of names that Congress obtained" from pharmaceutical companies, Kington said, adding, "We concluded that our system of oversight was not up to the task of monitoring a wide range of complicated outside activity, and we wanted to start over with a clean slate. The preponderance of all the evidence gave us pause" (Los Angeles Times, 2/24).