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Executive Summary

NIH DIRECTOR-IN-WAITING HEALY HAS HARD-LINE STANCE on conflict of interest issues for clinical investigators. Cleveland Clinic Research Director Bernadine Healy, MD, is emerging after a year as the probable nominee for the top National Institutes of Health job. Healy has an established, hard-line position on the issue of the proper relationship between federally supported researchers and the private sector. HHS Secretary Sullivan soon is expected to forward Healy's name to the White House for a review of her qualifications for director of NIH. In 1989, chairing the steering committee of a NIH-supported post-coronary artery bypass graft clinical trial, Healy and her co-investigators adopted stringent conflict of interest guidelines barring investments by researchers in companies affected by the outcome of the study. "Recognizing the potential commercial implications of the trial's results," the policy states that "the Post-CABG investigators believe that researchers participating in this seven-year study should have no real or perceived conflict of interest with regard to its outcome. Even the perception that the study results could be influenced by financial gain is to be avoided." At the same time, the investigators further suggested that institutional and safety monitoring boards should develop conflict of interest guidelines. At an NIH conference on conflict of interest policy in July 1989, Healy went even further and declared against consultantships as well as equity holdings. "I have no doubt," Healy stated, "that consultantships are a conflict of interest when an investigator is testing a drug for the same company ("The Pink Sheet," July 10, 1989, p. 4)." Healy's conflict of interest position is politically astute for a potential NIH director but may be stricter than NIH or the research community is ready to accept. There continue to be rumblings from Capitol Hill on the subject of the objectivity and reliability of biomedical research studies. Rep. Weiss (D-N.Y.) issued a report on scientific misconduct as recently as Sept. 11 (see next T&G). Healy's own affiliation with some of the early clinical research on Genentech's Activase (TPA) makes her tough policy notable. In his report, Weiss raises issues about stock option holdings by a handful of researchers in one of the TPA trials. As the first woman director of NIH, Healy would also avoid the recent spate of criticism of the research community for not including enough women in clinical trials. Sen. Mikulski (D-Md.) told an NIH conference on women in clinical trials on Sept. 10 that "we hope to meet with Dr. Healy as soon as the White House sends up her nomination." * Healy, 46, has a gilded resume for the NIH position, including a number of years of service and affiliation with the government research operation. One of her first professional appointments, in fact, was as a staff fellow in pathology with the National Heart and Lung Institute (1972-74). Since then, she has maintained contact with NIH through consultant positions and through service on numerous NIH committees and advisory bodies. Among the committee memberships she has held at NIH are the NIH Advisory Committee to the Director, the Human Fetal Tissue Transplantation Research Panel, the National Heart, Lung and Blood Institute Council, and the National Cancer Institute's National Cancer Advisory Board. Along with her NIH background, Healy has experience in Washington health policy, including a stint at the White House in the Reagan Administration as deputy director of the Office of Science and Technology Policy (1984-85). Healy also has worked with Congress as Chairman of the Office of Technology Assessment's Advisory Panel for New Developments in Biotechnology. Healy's long list of professional society affiliations includes a year as president of the American Heart Association in 1989 and one as president of the American Federation for Clinical Research in 1983-84. She is a member of several corporate boards: Nova Pharmaceutical, Medtronic and the Bayer Fund for Cardiovascular Research (Sterling Drug).



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