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Executive Summary

NIH FORUM ON INDUSTRY/GOVERNMENT-SPONSORED RESEARCH AGREEMENTS will be convened Jan. 25-26 at the & National Institutes of Health, newly-appointed NIE Director Harold Varmus announced Dec. 1 at his inaugural Advisory Committee to the Director meeting in Bethesda, Md. The forum, consisting of scientists, lawyers and industry representatives, will address concerns about the scope and size of the collaborative agreements. It represents one of two responses by the new NIH director to the inherited congressional interest in collaborative deals stemming from the 1992 $300 mil. deal between Sandoz and the Scripps Research Institute. In addition to the forum, Varmus reported that an internal committee will be established to develop an NIH position paper on the "way in which agreements are negotiated and are put into effect." The committee's findings will ultimately be transmitted to Rep. Wyden (D-Ore.), who has taken particular interest in the development of commercialization agreements between government- sponsored research institutions and private industry. Discussing the status of NIH's review of the fialuridine (FIAU) trial, which resulted in the death of five hepatitis B patients being treated with the Lilly/Oclassen drug, Varmus said a nine-member "outside review panel" has been assembled "to consider all the issues that are raised by the FIAU trial." Co-chaired by advisory committee member David Challoner, MD, University of Florida, the panel will meet in December, with a report expected in the middle of January. Noting that congressional concern has contributed to the "urgency" of the review, Varmus said he anticipates that House Government Operations/Intergovernmental Relations Subcommittee Chairman Towns (D-N.Y.) will hold a hearing on the trials in the spring. Varmus also confirmed that an Institute of Medicine review of the trial will commence in January. An FDA task force already has issued a report on FIAU ("The Pink Sheet" Nov. 22, p. 15), and FDA's Division of Scientific Investigations is also looking into the matter. Updating recent progress regarding NIH's pending CDNA sequence patent applications, Varmus said that a "small group" will meet next month to determine "how far to carry the appeals process." NIH's first round of applications was rejected by the U.S. patent office ("The Pink Sheet" Sept. 28, p. 9). Also at the meeting, in his status report on the Department of Defense's $20 mil. appropriation for a gp160 vaccine Phase III trial of MicroGeneSys' VaxSyn, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD, informed the advisory committee that "as far as the NIH is concerned, we have given our final recommendation...based on scientific evidence, this trial will not go forward." An NIH-FDA letter addressed to Senate Appropriations Chairman Byrd (D-W.V.) and House Appropriations Chairman Natcher (D-Ky.) is currently being cleared at the Public Health Service, and according to Fauci, "we've been given strong indication that it will go through." If the letter is approved, Fauci indicated that DoD has stated its intention "not to proceed with therapeutic trials of gp160...[but instead will] utilize the funds for science related to basic and clinical research on vaccines" ("The Pink Sheet" Nov. 22, In Brief).

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