Conflicts of Interest at the NIH: No Easy Solution

Article excerpt

Editor's Note: On February 2, 2005, the National Institutes of Health changed course on conflicts of interest and prohibited its scientists from owning stock in or working as consultants with pharmaceutical or biotechnology companies. The following essay, sent to press before the new policy was announced, recommends a very different approach. The author stands by the recommendations.

A controversy over conflicts of interest in the intramural research program at the National Institute of Health erupted in December 2003 when the Los Angeles Times published several articles on consulting arrangements between administrators and senior scientists at the NIH and pharmaceutical and biotechnology companies. (1) The intramural program consists of scientists, postdoctoral students, fellows, and research staff hired by the NIH to conduct basic and applied research, as opposed to the extramural program of research grants and contracts awarded to other institutions. The articles alleged that some officials received hundreds of thousands of dollars from consulting deals that apparently did not violate any of the NIH's ethics rules pertaining to outside activities. Two of the NIH'S directors allegedly received fees or stock options worth several hundred thousand dollars. Most of the officials who had these arrangements did not make any public disclosures. The relationships were possible because Zerhouni's predecessor, Harold Varmus, had loosened the NIH's ethics rules in 1995 to encourage intramural researchers to consult with industry and to recruit and retain top biomedical scientists.

In response to the allegations, NIH Director Elias Zerhouni appointed a blue-ribbon panel to examine the charges and make recommendations for changes in NIH policies. Two Congressional subcommittees also held hearings. In May 2004, the NIH panel issued a report that called for tighter controls on relationships with industry. In July, Zerhouni proposed rules stricter than those that the panel had recommended. According to the proposed changes: no NIH staff may serve on corporate boards or as paid consultants for grantee institutions; consulting fees may not exceed 25 percent of an employee's annual salary (limits on salaries for clinicians are set by market rates); employees who are required to file financial reports are not allowed to own any stock in pharmaceutical or biotechnology companies and other employees are limited to $5,000 in stock; all outside activities by NIH staff, such as consulting arrangements, will be publicly disclosed on the Internet; limits will be imposed on the awards that NIH employees may receive; NIH scientists may serve on industry advisory boards only after review and approval; and the NIH will initiate additional training and compliance mechanisms related to outside activities, including random audits. (2)

Shortly after Zerhouni's announcement, the Office of Government Ethics, which had previously found no major problems with the NIH's consulting policies, issued a report recommending that the NIH prohibit all consulting with pharmaceutical companies. (3) Zerhouni responded by announcing a one-year moratorium on consulting with pharmaceutical or biotechnology companies for all NIH employees, to allow the NIH some time to reformulate its policies and reporting procedures. He stated that relationships with industry could continue to take place, where appropriate, only as "official duty activities," meaning that they were part of the job and could not involve compensation from outside the NIH. He also declared that the NIH would seek to prohibit all NIH senior staff from receiving money to consult with pharmaceutical or biotechnology companies. (4)

There are several reasons individuals and organizations should be wary of COIs in research. The most straightforward is that COIs can compromise scientific judgment and undermine the objectivity and integrity of research. An NIH scientist who has a financial relationship with a pharmaceutical company may deliberately, or subconsciously, analyze or interpret data in a way that favors the company's products. …