NIH Issues Revised Ethics Guidelines for Agency Employees
As expected, NIH Director Elias Zerhouni on Tuesday announced an overhaul of agency ethics guidelines that will restrict all 18,000 NIH employees' outside consulting activities for pharmaceutical companies, hospitals, insurers and health providers "in an effort to restore luster" to NIH's "tarnished reputation," the Wall Street Journal reports (Wysocki, Wall Street Journal, 2/2). The Los Angeles Times in December 2003 reported evidence of hundreds of consulting payments from pharmaceutical and biotech companies to a number of NIH employees, some of which involved potential conflicts of interest. Over the past year, a series of congressional investigations and hearings examined the financial arrangements (Baer, Baltimore Sun, 2/2).
Under the revised guidelines, about 6,000 high-ranking NIH employees will no longer be allowed to hold stock in pharmaceutical or biotechnology companies, and current stockholders in that group must sell all shares (Wall Street Journal, 2/2). Other NIH employees "with no control over purse strings or policies" will be subject to a $15,000 limit on "health-related stock holdings," the Washington Post reports (Weiss, Washington Post, 2/2).
The guidelines, which will take effect as soon as they are published, also limit awards that scientists may receive to no more than $200, with the exception of the Nobel and Lasker prizes (Baltimore Sun, 2/2). According to the AP/Raleigh News & Observer, the guidelines do not affect scientists' "official duties in turning basic research into health treatments," which typically calls for industry involvement. Scientists also will be permitted to conduct courses and lectures and write textbooks and articles related to their work (Schmid, AP/Raleigh News & Observer, 2/2). NIH Deputy Director Raynard Kington said NIH officials are reviewing previous potential conflicts of interest and will enter the "penalty phase" if violations are found (Baltimore Sun, 2/2).
According to the Post, the revisions "codify the reversal of a trend toward liberalized links between NIH researchers and drug and biotechnology companies that began in 1995," when then-NIH Director Harold Varmus eased consulting restrictions in an effort to speed medical advances to the market. Zerhouni on Tuesday "reiterated his concern" that strengthened guidelines could impair efforts to recruit top-level scientists. However, he said that "it was more important for an agency that funds grants and gives advice to hold itself to a different standard than the rest of the world." He added, "We needed to absolutely achieve the number one goal I've stated many times before: preserving the public trust" (Washington Post, 2/2).
Zerhouni also said the rules will be in effect until NIH decides to change them, and some observers said the rules are unlikely to change in the foreseeable future (Harris, New York Times, 2/2). "We will never go back to the old rules -- that's for sure," Zerhouni said.
Sen. Tom Harkin (D-Iowa) said, "I welcome (NIH's) decision today," adding, "NIH's well-deserved reputation as the world's premier biomedical research agency was in danger of being tarnished."
Rep. Joe Barton (R-Texas) said, "For [NIH] to do the complex work of thwarting disease and saving lives requires near-absolute public confidence in the people who conduct the research. If the notion that private gain is supplanting public service as the guiding light for health research, NIH's value to our nation will plummet" (Willman, Los Angeles Times, 2/2). He added, "NIH must remain a place where the nation's top researchers have the freedom, equipment and encouragement to for their best work, ... and it must be a place where the trust of the public is earned and warranted" (Heil, CongressDaily, 2/1).
Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia, voiced concern that the ban could affect NIH's ability to attract and retain scientists. He said, "Scientists can make more money right now at big research universities that allow them to work outside. But we have to keep the brains at these government agencies so they can do this basic research" (Rubin/Weise, USA Today, 2/2). A summary of the guidelines can be accessed online. Note: You will need Adobe Acrobat Reader to view the summary.
APM's "Marketplace" on Tuesday reported on the new NIH guidelines. The segment includes comments from cardiologist and former NIH director Bernadine Healy and Zerhouni (Scott, "Marketplace," APM, 2/1). The complete segment is available online in RealPlayer.
In addition, NPR's "All Things Considered" on Tuesday reported on the guidelines (Palca, "All Things Considered," NPR, 2/1). The complete segment is available online in RealPlayer.