NIH To Require All Employees To Report Consulting Agreements
NIH Director Elias Zerhouni will require all agency employees to report the financial details of paid consulting agreements with pharmaceutical or biotechnology companies over the past five years or face dismissal, NIH spokesperson John Burklow said on Tuesday, the Los Angeles Times reports. The "toughened approach" comes as NIH faces "increased pressure from congressional leaders to rescind policies and practices that have fostered potential conflicts of interest involving agency scientists," according to the Times (Willman, Los Angeles Times, 5/19). The House Energy and Commerce Oversight and Investigations Subcommittee has begun an investigation into the issue in response to a Times article published in December that found evidence of hundreds of consulting payments -- which often were hidden from the public -- to a number of NIH officials. In January, Zerhouni told the Senate Appropriations Subcommittee on Labor, Health and Human Services and Education that the 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 companies. However, lawmakers have criticized a report from the committee and recent ethics reforms announced by Zerhouni as inadequate (California Healthline, 5/18). According to Burklow, as many as 500 NIH employees who have paid consulting agreements with pharmaceutical or biotech companies must comply with the new requirements as a "condition of their employment." NIH will submit the financial details of such paid consulting agreements to Congress, the Times reports. Burklow said that Zerhouni informed NIH officials of the new requirements on Tuesday and will send a formal letter by Friday (Los Angeles Times, 5/19).
The House subcommittee on Tuesday held a "tense" five-hour hearing on NIH decisions to allow employees to receive consulting payments from pharmaceutical and biotech companies, the Washington Post reports (Weiss, Washington Post, 5/19). Edgar Swindell, who in 1997 served as acting director of the HHS ethics division, testified that his superiors at that time directed him to take into account only strict legalities, not potential conflicts of interest, when he made ethics decisions (Rovner, CongressDaily, 5/19). Rep. Joe Barton (R-Texas) said, "So even though this is the ethics division, you're not supposed to use any ethics." Swindell, currently the HHS associate general council for ethics, responded, "It's not a decision I look back on with fondness or pride" (Washington Post, 5/19). At the hearing, former NIH Director Harold Varmus, currently president of the Memorial Sloan-Kettering Cancer Center, testified that he relaxed ethics rules on consulting payments in 1995 to help the agency recruit more top scientists (CongressDaily, 5/19). Varmus said that when he became NIH director in 1993, the agency "had not been able to recruit the best people" (Schmid, AP/Las Vegas Sun, 5/18).
The House subcommittee also heard testimony from Lance Liotta, chief of the pathology laboratory at the National Cancer Institute, and Emanuel Petricoin, a senior microbiologist at FDA, over their paid consulting agreements with a pharmaceutical company, the Times reports (Los Angeles Times, 5/19). In late 2002, NIH and FDA allowed Liotta and Petricoin to receive consulting payments from California-based Biospect, which on Monday became Predicant Biosciences, although in April 2002, the agencies had assigned them to help Maryland-based Correlogic Systems develop an ovarian cancer test. Biospect and Correlogic are potential competitors (California Healthline, 5/18). Both Liotta and Petricoin testified that they did not consider the agreements a conflict of interest at the time they requested ethics approval from the agencies (Washington Post, 5/19). Liotta said after he learned last week that Biospect and Correlogic were potential competitors, he ended his agreement with Biospect. Petricoin said that he had "performed to the highest ethical standards" in consulting for Biospect, adding, "I certainly would never knowingly pursue or continue any outside activity which I felt was in conflict with a career spent as a scientist in the pursuit of public and patient benefit." Petricoin testified that FDA officials told him on May 7 that the agency had withdrawn his approval to consult for Biospect because FDA likely would regulate future products of the company (Los Angeles Times, 5/19).
Subcommittee members "pronounced the deal outrageous," CongressDaily reports. Subcommittee Chair Jim Greenwood (R-Pa.) said that members will ask the HHS inspector general to examine the case, adding that Correlogic "risks its government partners taking the insight, knowledge and prestige gained from the (public-private partnership agreement) to consult with the competition -- and all under the cover of an ethics approval" (CongressDaily, 5/19). "These decisions are the opposite of what people have the right to expect from their ethics officials," Rep. Henry Waxman (D-Calif.) said. According to the Post, several of the subcommittee members may introduce legislation that would ban all paid consulting agreements with pharmaceutical and biotech companies (Washington Post, 5/19). Greenwood said that the subcommittee plans to hold a hearing next month on other potential conflicts of interest at NIH (Los Angeles Times, 5/19).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.