Speeding Help From Lifesaving Drugs
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(FORTUNE Magazine) – When Wellcome's AZT emerged as the most promising anti-AIDS drug, patients clamored for it despite its experimental status (FORTUNE, September 15). In March the Food and Drug Administration announced a radical proposal to widen availability of experimental drugs that treat life-threatening conditions but have not yet been proved fully effective. For the first time, companies would be allowed to charge patients for some of them. The plan would help small biotechnology companies, which sometimes cannot bear the financial strain of conducting years of human tests while receiving no income from a new drug. Manufacturers and medical experts say the new policy raises troubling questions. If experimental drugs are widely available, will subjects volunteer for placebo-controlled tests? And if companies can profit from experimental drugs, will they feel compelled to quickly complete testing necessary for full FDA approval? Wellcome received permission in early March to sell AZT in Britain and France and two weeks later won full U.S. government approval.