[Aug 02, 2005]
In addressing medications' potentially dangerous side effects, FDA should err "on the side of patients' freedom to choose" rather than erring "on the side of safety," which prevents patients with "incurable or poorly treatable diseases" from "exercising their own judgment about risks and benefits," Henry Miller -- a physician, fellow at the Hoover Institution and Competitive Enterprise Institute and former director of FDA's Office of Biotechnology -- writes in a Washington Times opinion piece. Recently, criticism of the agency has focused on safety issues, and FDA's "increasing sensitivity to safety" has influenced drug manufacturers and led to the immediate and premature withdrawal of some drugs from the market, according to Miller. FDA officials should not "forget their mission: to ease the plight of patients who need new medicines," and they also should not infringe on patients' ability "to make informed decisions about possible treatment options," Miller writes. "As more breakthrough drugs come before FDA for approval, the agency must curb its paternalistic instincts and find a way to more sensibly balance safety with patients' right to assume responsibility for their own medical decisions," Miller writes, adding that patients' rights "should not be usurped by risk-averse, publicity-shy bureaucrats, anti-FDA health care activists or members of Congress" (Miller, Washington Times, 8/1).