OPHS provides advice, policy and program coordination, and leadership in the implementation, management, and development of HHS public health and science activities. Several major OPHS-supported evaluations were completed in fiscal 1995 on the following: blood supply safety; HHS standards for methadone programs; clinical trials for the experimental drug fialuridine and its parent drug fiacitabine; Healthy People 2000 baseline data for disease prevention activities; measuring State and local public health expenditures; HIV/AIDS prevention within minority communities; breast and reproductive cancer prevention efforts at community and migrant health centers; hepatitis B virus education and outreach efforts; competitive health plans and academic medical centers; and the supply, training, and distribution of primary care providers. Evaluations and policy studies in progress include dietary supplement labels; framework for Healthy People 2010; school health programs; public health infrastructure; cost-effectiveness methodology; and public health performance measures.
A third report examined the clinical background for trials involving the experimental drug fialuridine (FIAU) and its parent drug fiacitabine to determine whether any rules governing the trial process should be changed, and if so, what burdens or costs these changes might place on future clinical trials. The study followed up on an NIH clinical drug trial in which several hepatitis B virus (HBV) outpatients who had been administered FIAU were hospitalized with liver failure; five patients died and two were saved only by liver transplantation. The report finds that the entire set of trials reviewed was an ethically sound clinical research project designed and carried out by highly competent investigators who frequently exceeded regulation requirements imposed by institutional review boards. The report discusses conclusions and recommendations issued by FDA and concurred with them without ascribing blame for the tragedy to any party.
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ABSTRACT: In June 1993, 1 of 15 HBV outpatients taking part in an NIH clinical drug trial was hospitalized with liver failure. Shortly thereafter, six more patients also developed severe toxicity. Five patients eventually died, and two more were saved from death only by a liver transplant. All of these patients were taking the experimental drug fialuridine (FIAU). The Institute of Medicine (IOM) examined the clinical trials involving FIAU and its parent drug, fiacitabine, to determine whether any rules governing the trials process should be changed, and what burdens or costs these changes might place on future clinical trials. Their report presents the history of clinical trials of the drugs, beginning with trials that showed promise in the treatment of HBV and ending with the trial in which several people died from toxic effects of FIAU. It also carefully examines the clinical background for the trials, the informed consent process, and the conduct of the investigators. The IOM found that the entire set of trials reviewed was an ethically sound clinical research project designed and carried out by highly competent investigators who frequently exceeded requirements of regulations imposed by institutional review boards. Furthermore, the IOM report discusses conclusions and recommendations issued by the FDA. The IOM generally concurs with the recommendations without ascribing blame for the tragedy to any party. 2ff7e9595c
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