For a variety of reasons, vaccines and other critical pharmaceutical products have become increasingly scarce in the last few years, and persistent shortages involving dozens of essential drugs may imperil the public health. Pressures emanating from regulatory agencies, the courts, and insurers have conspired to make some lines of the pharmaceutical business less than attractive. Although concerns about unpredictable tort liability received most of the blame in the past, two other factors may help to account for the latest round of drug shortages: stringent federal control of manufacturing facilities and aggressive cost-containment efforts that further erode profit margins. Whatever the cause, scarce supplies necessitate efforts at rationing that pose their own difficulties for health care providers. Policymakers could avoid putting physicians to such tough choices regarding patients by focusing on ways to ensure the production of adequate quantities of these highly costeffective medical technologies. Some commentators have called for greater public sector involvement, but this Article concludes that, in addition to bolstering its emergency stockpiles, the federal government instead needs to take steps designed to encourage private manufacturers to continue supplying
A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.
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