FDA's Compassion for Desperate Drug Companies

FDA's Compassion for Desperate Drug Companies The twentieth century opened with an expose of the meat packing industry that prompted almost immediate action to establish the Food and Drug Administration (FDA) to protect consumers from unconscionable industrial practices. Although Upton Sinclair's The Jungle (1906) was meant as a rallying cry for socialism to replace a rigid class system based on "wage slavery," it was the ten pages on meat packing practices in Chicago of the 300-plus page book that attracted worldwide attention and indignation, rather than the story of how Jurgis Rudkus and his family and friends were ruthlessly exploited in the stockyards. As Sinclair wrote about the response, "I aimed at the public's heart and by accident I hit it in the stomach." As the twentieth century closes, attention is again being focused on the FDA, but this time free enterprise is being given a boost by clamors to "deregulate" the drug approval process, and concern about the food supply has been manifest mainly in hysterical stories such as the poisoning of two grapes from Chile. It is often alleged that AIDS is driving the FDA to modify and even reverse safety and efficacy standards that have been in place since the thalidomide disaster of the early 1960s. But neither the Reagan nor the Bush administrations have shown much concern for the suffering of people with AIDS and even less for gays, IV drug users, and minorities. AIDS is the cover story, the real story is the drug industry. The anti-regulation Reagan and Bush administrations and the gay rights community probably have only one interest in common: deregulating the drug approval process. The gay community had adopted the administration's position as summed up in ACT UP's (AIDS Coalition to Unleash Power) slogan: "A Drug Trial is Health Care Too." The truth is otherwise: a drug trial is research designed to test a hypothesis, not to help individual patients. This strange alliance has little to do with shared love for those suffering with AIDS, but rather is attributable to federal administrations composed largely of free market advocates, and the deregulation lobbying of drug companies that see the AIDS epidemic as an opportunity to further their own interests. The Administration's position is that drugs should be permitted to go on the market faster and that dropping approval and licensing prerequisites for marketing would help accomplish this. While still Vice-President, George Bush urged the FDA to develop procedures to expedite the marketing of new drugs intended to treat AIDS and other life-threatening illnesses. In his first debate with Democratic nominee Michael Dukakis, Bush said that in response to his efforts the FDA has "speed up bringing drugs to market that can help." However, he did caution that "you've got to be careful here because there's a safety factor." The policy question is whether the safety factor should be ignored or radically lessened when the research subjects have a fatal illness for which there is no cure. Although the AIDS epidemic is new, the question is not. The FDA has faced it squarely before. The Laetrile Precedent In the 1970s, thousands of cancer victims travelled to Mexico and Canada to obtain laetrile, a substance derived from apricot pits. The drug was not available in the United States and was not even studied in experimental trials. In 1975, a group of terminally ill cancer patients and their spouses sued the federal government to enjoin it from interfering with the interstate shipment and sale of laetrile. The FDA vigorously opposed making laetrile available in the United States, even to terminally ill cancer patients, because "there were no adequate well-controlled scientific studies of laetrile's safety or effectiveness." In 1979, the United States Supreme Court, in United States v. Rutherford,[1] upheld the FDA's position, noting, among other things, that " [1] implementing the statutory scheme, the FDA has never made exception for drugs used by the terminally ill. …