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PHS SHOULD ISSUE REGS RESTRICTING RESEARCH FUNDING ARRANGEMENTS

Executive Summary

PHS SHOULD ISSUE REGS RESTRICTING RESEARCH FUNDING ARRANGEMENTS that could create a conflict of interest for federal health research grantees, a congressional report recommended to HHS Secretary Sullivan Sept. 11. If the Public Health Service does not initiate the regs "immediately," Congress should take legislative action that would restrict the use of honoraria, consulting fees, and company stocks or equity to fund research, the three-year study concludes. According to the report, "HHS should immediately promulgate PHS regulations that clearly restrict financial ties for researchers who conduct evaluations of a product or treatment in which they have a vested interest. If PHS fails to meet this responsibility, then Congress should enact legislation to achieve that goal." The report, entitled "Are Scientific Misconduct and Conflicts of Interest Hazardous to Our Health?" was prepared by the Rep. Weiss (D-N.Y.) House Government Operations/Human Resources and Intergovernmental Relations subcommittee and released Sept. 10. The 73-page report concludes a three-year investigation by subcommittee staffers into PHS oversight of publicly funded medical research, including researcher conflicts of interest and scientific misconduct. The report's findings were adopted and approved by the full committee Aug. 2. Among the 10 case studies cited by the report, the most lengthy and costly, according to staffers, was the involvement by more than a dozen researchers who owned Genentech stock in the 1983-89 Thrombolysis in Myocardial Infarction (TIMI) trials on tissue plasminogen activator (TPA, Genentech's Activase). For FY 1990, the federal government spent about $21 bil. for basic and applied research, the report says. One-third, or $7 bil., of that total was provided through the National Institutes of Health, and another $763.7 mil. was channeled through the Alcohol, Drug Abuse and Mental Health Administration. Over half of all medical research funds were provided through colleges and universities. The report notes that NIH and ADAMHA "have no restrictions on conflicts of interest for grantees, although they must approve any outside financial arrangements for NIH employees that could pose potential conflicts of interest. However, NIH grant applications require grantees to list all sources of funding for research projects when they apply for NIH funds, and NIH regulations require all grantees to have policies for dealing with" financial conflicts of interest. Neither do "most universities have [a] limit on the amount of money their faculty may accept for research honoraria, travel, consulting fees, or gifts from drug companies or other private sources," the report notes. The report also is critical of "NIH's lax enforcement" of its own guidelines, and grant proposal requirements. The House panel recommends that "strong penalties be levied on grantees who provide misleading information regarding results or funding sources. These should include a mandatory 'debarring' from future grants for specified periods and mandatory reimbursement by both the institution and the investigator." In a statement released Sept. 7, PHS said, "Although we decry even one instance of misconduct in science, it should be noted that the NIH funds thousands of grants each year and [the committee] investigated only 10 examples of alleged scientific misconduct and conflict of interest over a three-year period." PHS said the agency currently is revising its draft regulation on scientific misconduct, proposed in August 1989.
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