Family history and adoption in the UK: Conflicts of interest in medical disclosure

摘要

The Food and Drug Administration (FDA) relies upon adverse event data collected during pharmaceutical trials to evaluate the safety of medications, but these trials often fail to permit an adequate assessment of safety. The FDA usually recommends that at least 1500 patients be exposed to a new drug. Such relatively small samples stand little chance of detecting serious safety risks. In addition, if pharmaceutical manufacturers conduct trials on relatively young and healthy subjects, the likelihood of identifying serious risks is lessened even more. Further exacerbating the problem, the FDA accepts surrogate markers, rather than morbidity and mortality data, for some drug approvals.