Los Angeles Times Examines Private-Sector Payments to NIH Researchers
The Los Angeles Times on Sunday examined the "increasingly common" practice of NIH scientists serving as paid consultants to private industry and receiving outside paychecks and stock options from pharmaceutical companies. The newspaper's investigations into the scientists' roles as NIH employees and drug industry consultants began in late 1998, and the resulting report is based on corporate and federal records -- including 13,784 pages of NIH documents detailing annual financial disclosure reports, memos and internal e-mails -- and interviews. The Times found evidence of "hundreds of consulting payments to ranking NIH officials." The Times profiles Dr. Stephen Katz, director of the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases, who received between $476,369 and $616,365 in private fees during the last 10 years, including more than $140,000 in consulting fees from a company that won $1.7 million in grants from his institute before going bankrupt last year. Such payments are often hidden from public view because a 1998 legal opinion from the Office of Government Ethics allows more than 94% of NIH's top-paid employees to keep their consulting income confidential. In a poll of NIH and 34 other federal agencies on the percentage of eligible employees filing public reports on outside income, the Times found that NIH had the lowest percentage of filings, making it "one of the most secretive agencies in the federal government when it comes to financial disclosures." The "wide embrace of private consulting" within the agency may be the result of lawmakers' requests that basic federal research be more quickly translated into improved treatments for patients, the Times reports. In addition, the agency responded to a "[l]oosening" of restrictions on government employees' outside pursuits in the mid-1990s by rescinding policies that prohibited NIH employees from accepting consulting fees and stock payments, limited outside income to $25,000 annually and capped outside work to 500 hours a year, according to the Times.
Private-sector payments to NIH scientists raise questions of whether patient safety is being compromised by commercial interests; whether experimental treatments are chosen on merit or because of scientists' personal financial interests; whether study results are interpreted by NIH employees to favor outside clients; and whether officials favor their companies over others that seek NIH grants and collaborations, according to medical ethicists, the Times reports. Dr. Curt Furberg, former head of clinical trials at the National Heart, Lung and Blood Institute, called the reports of paid consulting at NIH "very disturbing," adding, "Science should be for the sake of gaining knowledge and looking for the truth. There should be no other factors involved that can introduce bias on decision-making." However, Dr. Ruth Kirschstein, who has approved many of the top officials' consulting arrangements as the deputy director or acting director of the NIH since 1993, said that the consulting arrangements have not compromised the public interest. She said, "I think NIH scientists, NIH directors and all the staff are highly ethical people with enormous integrity." Kirschstein added that based on the Times' findings, she would consider whether administrators should require more information about company ties to the NIH before approving consulting arrangements, adding, "Systems can always be tightened up." NIH Director Elias Zerhouni on Nov. 20 told NIH leaders that he would form a committee to "determine the appropriateness" of employees' outside arrangements with the private sector (Willman, Los Angeles Times, 12/7).
The Times also published case studies several researchers who have received outside payments. The following are summaries.
- The Times looks at NIH diabetes researcher Dr. Richard Eastman's work on diabetes drug Rezulin and his employment by the drug's maker, Warner-Lambert. In 1997, while Eastman was supervising a $150 million NIH study of the drug's potential to prevent diabetes, the FDA inquired about reports of liver injury among patients taking the drug, but Eastman said that the drug was safe. The drug was pulled from the U.S. market in 2000 after being cited as a potential cause of 556 deaths, including 68 that involved liver failure (Willman, Los Angeles Times, 12/7).
- The Times examines how NIH Clinical Center Director Dr. John Gallin's investments in eight biotechnology and pharmaceutical companies, along with consulting-related stock payouts and fees, have made it a "challenge" for him to avoid participating in government decisions affecting those companies in which he has disclosed a financial interest (Willman, Los Angeles Times, 12/7).
- The Times looks at NIH Laboratory of Immunology Deputy Director Dr. Ronald Germain's consulting income, which Germain says has totaled more than $1.4 million in fees over the last 11 years, with company stock options valued at $865,000. The income -- which has often come from companies that have had grants or research agreements with the NIH or have collaborated with Germain or his laboratory -- surpassed his government salary of $179,900 in one recent year and nearly matched it another (Willman, Los Angeles Times, 12/7).
- The Times examines the relationship between Jeffrey Schlom, a National Cancer Institute laboratory manager, with Cytoclonal Pharmaceuticals, which paid him $127,000 while he helped lead two NIH-funded studies on Cytoclonal's drug Taxol. Schlom also co-wrote two medical journal articles that reported positive research results on the drug, which may have helped generate more demand for Taxol (Willman, Los Angeles Times, 12/7).
- The Times looks at an endorsement made by Jeffrey Trent, former scientific director of the National Human Genome Research Institute, for RHeoGene. The company "billed itself as a cutting-edge player in gene therapy technology" in part by posting a statement by Trent on its Web site that stated, "[W]e need to focus on how nature regulates itself, which begins with genes. RHeoGene has technology to address key questions in these areas." Such endorsements are prohibited under NIH rules (Willman, Los Angeles Times, 12/7).