Healthy Skepticism Library item: 7
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Publication type: news
Blumenstyk G.
2 Congressmen Take Aim at NIH Officials' Consulting Deals With Drug Companies
The Chronicle of Higher Education 2003 Dec 10
Full text:
Two members of Congress are demanding that the National Institutes of Health turn over financial records and related information about NIH scientists who receive consulting fees, stock options, and other compensation from drug companies.
The lawmakers say the proliferation of such arrangements, and the growing tendency at the NIH to allow its researchers to keep the details of their outside consulting secret, “raise concerns about whether the integrity of NIH clinical research has been affected.”
The arrangements were disclosed in an article published on Sunday in the Los Angeles Times.
The newspaper said hundreds of such arrangements exist, including many involving senior NIH officials.
Among other examples, the newspaper cited Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who was a paid consultant to a drug company at the same time the institute he supervises was testing one of the company’s drugs on patients. In June 1999, one of the patients died from the experimental treatment.
The newspaper questioned whether Dr. Katz’s “dual role” had influenced his decision not to halt the study immediately or to warn other doctors about potential dangers. Dr. Katz told the Times that his consulting arrangement had not been a factor in his decision.
In a letter sent to the NIH on Monday, Reps. James C. Greenwood and W.J. (Billy) Tauzin requested copies of all consulting arrangements between NIH employees and drug companies since January 1999, as well as a list of all NIH grants made to companies holding such arrangements with NIH employees.
They also requested information about a 1995 memorandum from the NIH’s director at the time, Harold E. Varmus, that rescinded the institutes’ prior policy of barring NIH scientists from receiving payments from companies, according to the Times.
Representative Tauzin, a Republican from Louisiana, is chairman of the House Energy and Commerce Committee; Representative Greenwood, a Republican from Pennsylvania, heads that committee’s Oversight and Investigations Subcommittee. Since June, the committee has also been investigating the NIH’s practice of allowing its scientists to receive cash payments for lectures from companies that do business with the institutes.
Congressional scrutiny of the NIH has picked up in 2003, the final year of a five-year effort to double the agency’s budget. Members of Congress have criticized some NIH officials for appearing to steer grants to favored recipients, and have questioned whether the huge influx of funds has been well managed and well spent.
An NIH spokesman, John Burklow, said on Tuesday that the agency’s director, Elias A. Zerhouni, had ordered an immediate review of all consulting relationships, dating back five years, to ensure that all rules were followed and “that the activities are in the best interest of the public.” Mr. Burklow said that questions raised about the NIH’s management of conflicts of interest were a concern and that allegations raised in the article would be “vigorously investigated.”
In addition, he said Dr. Zerhouni would soon convene a committee of outside experts to advise him on managing outside consulting relationships of NIH employees.
Mr. Burklow said officials believed that NIH employees had been abiding by all current rules but that “it is clear” that some changes in policy might be called for “after a thoughtful analysis of the issues.”
The Times, which began investigating conflicts of interest at the NIH in late 1998, found several examples involving top NIH officials who received payment from companies while also overseeing institute research that involved those companies.
The newspaper also found that many NIH scientists were able to keep the details of their arrangements secret because of how the agency interprets a disclosure policy. Under U.S. law, all federal employees earning more than $102,168 are required to file detailed disclosure forms on their outside income. The Times said that only 6 percent of the NIH’s 2,259 employees who earned that much had filed the required form.
Most file a different disclosure form, which can be kept confidential, because the institutes follow a 1998 legal opinion from the U.S. Office of Government Ethics that says the threshold for public disclosure is not an employee’s actual salary but the low end of his or her pay scale. According to the Times, “The NIH has shifted many of its high-salaried employees into pay plans that dip below the threshold.” The newspaper said that from 1997 to 2002, the number of NIH employees who filed public reports on their outside income dropped by about 64 percent.
Representatives Greenwood and Tauzin have also said they plan to scrutinize that legal opinion.
