Congress, Agencies Probe Conflicts of Interest


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-07-01-2004
Volume 11
Issue 7

FDA and NIH investigate staff relationships with industry to eliminate any outside influence on regulatory decisions and clinical trial procedures.

Congressional investigators are widening their probe of potential conflicts of interest between federal government employees and pharmaceutical and biotechnology companies. Allegations of questionable payments and cozy relationships first surfaced late last year; recently they have expanded from the National Institutes of Health (NIH) to include personnel at the Food and Drug Administration (FDA), too. Both agencies are tightening their rules governing outside consulting arrangements and are seeking more information on the extent of such activity, as additional federal watchdog agencies assess current policies and practices.

The fear is that further revelations of possibly unethical public-private relationships could lead to a ban on all outside consulting between government scientists and industry. Such a move could stymie collaboration vital to biomedical discovery and the development of new therapies, as well as deter leading scientists and clinicians from seeking government employment. Even without a total ban, heightened concerns about influence on government funding and regulatory decisions could chill interaction between sponsors and FDA and NIH staffers in the future.

At the same time, the Department of Health and Human Services (HHS) released a final guidance on how clinical trial sponsors, IRBs (investigational review boards), and investigators should deal with potential financial conflicts of interest. The policy outlines actions that should be taken to reduce the possibility that any financial interests could harm research participants [see sidebar].

Multiple probes

For the past six months, the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, along with the House Energy and Commerce Committee, have been investigating allegations of financial conflicts of interest (COI) of NIH employees. The Senate panel opened the debate with a January hearing on COI charges, which committee leaders feared could undermine public support for biomedical research and NIH funding. The House E&C panel also launched a series of hearings on NIH employee consulting activities, calling on Congress' General Accounting Office (GAO) to examine the financial relationships of NIH employees with drug companies, and also the NIH procedures for preventing conflicts. The committee recently requested that the HHS Office of the Inspector General (OIG) review FDA employee outside activity requests for the last five years.

This request to the OIG arose from a May hearing before the House E&C Oversight and Investigations subcommittee that closely examined certain industry payments to NIH and FDA scientists. The panel, chaired by Rep. James Greenwood (R-PA), questioned a $40,000 award from the University of Pittsburgh to former National Cancer Institute (NCI) Director Richard Klausner that could appear as a payoff for help in settling a researcher's lawsuit against the university (an unproven allegation).

Greenwood's panel also examined consulting arrangements of Lance Liotta, chief of the NCI pathology laboratory, and Emanuel Petricoin, a senior investigator at FDA's Office of Cellular Tissue and Gene Therapy in the Center for Biologics Evaluation and Research (CBER). Both had agency approval to work with a San Francisco-based company, Biospect. But with the spotlight intensifying on COI issues, NCI and FDA recently advised termination of the activ-ity. Petricoin also declined a previously accepted paid speaking invitation from ImClone and Bristol-Myers Squibb.

In response, FDA Acting Commissioner Lester Crawford launched an agency-wide inquiry into the extent of payments by pharmaceutical and biotech companies to FDA staffers. The review failed to unearth further questionable staff activities, but Crawford announced additional oversight procedures to ensure continued compliance. FDA will:

  • Require CBER directors to review and approve employees ' requests to participate in outside activities - instead of delegating such reviews to lower level managers

  • Expand the number of staffers required to file declarations of financial holdings

  • Conduct an annual review of outside activities and financial disclosures

  • Issue a staff guide on outside activities to clarify the rules.

NIH Director Elias Zerhouni also has requested that all NIH employees report the financial details of any paid consulting agreements with pharma or biotech firms over the past five years. This includes high-level NIH scientists who previously were exempt from public disclosure of outside income sources.

Zerhouni's action builds on the findings of a blue-ribbon Committee on Conflict of Interest Policies, which the NIH chief established in January to investigate possible COI charges due to employees receiving consulting fees and stock options from drug companies. The panel, co-chaired by National Academy of Sciences President Bruce Alberts and Lockheed Martin executive Norman Augustine, unveiled its recommendations in May. Instead of banning all consulting with industry, the panel proposed to limit such activity by senior managers and NIH officials with influence on grants and funding decisions.1 Most NIH staff scientists and clinicians could continue to engage in conflict-free collaborative research that is limited in time (under 400 hours a year) and level of compensation. Stock payments are out, as well as membership on the boards of research institutes or biotech companies.

Controls catastrophic?

The uncovered proliferation of public-private interactions between NIH and FDA employees and outside organi-zations reflects the intentional relaxation of rules in the mid-1990s under NIH Director Harold Varmus. In testimony before the House Investigations Sub-committee in May, Varmus acknowl-edged his efforts to boost pay scales for NIH scientists and to lift restrictions on outside consulting activities to attract more prominent researchers to the agency and to promote good science.

Varmus emphasized that it is important for NIH intramural researchers to interact with industry and academia in order to fully exploit new biomedical discoveries, and to recruit and retain top scientists. At the same time, Varmus acknowledged that "the rules of engagement need to be more explicit and frequently revisited." He supported "reasonable limits" on the number of hours and amount of compensation that NIH employees receive from outside activity, and curbs on such activity by senior NIH personnel responsible for awarding grants.

Zerhouni defended the "outstanding" work of his blue ribbon panel and maintained that its proposed limitations on consulting activity were "not trivial." He believes that it is important for most of NIH's 6000 scientists to be able to interact with outside researchers in order to understand the latest research developments in pharmaceutical and biotech companies, noting that a ban on all such activity would be "catastrophic in the long term."

While it appears that Congress will hold off on completely curbing all outside relationships of NIH and FDA researchers, new disclosure requirements and closer review of employee interactions with industry may make government employment less attractive for prominent researchers with attractive offers from the private sector. And higher hurdles may deter pharma and biotech companies from entering into cooperative agreements with federal agencies. Although it is important to maintain public respect for NIH and FDA research activities, excessive oversight could have a dampening effect on valuable scientific collaboration.



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