Subject: The Orwellian FDA Date: Published: 10/8/92 (102 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. LEISURE & ARTS -- Bookshelf: The Orwellian FDA ---- By Sam Kazman Jonathan Kwitny's "Acceptable Risks" (Poseidon, 466 pages, $24) is a tale of two types of illegal border crossings. One involves the geographical line between the U. S. and Mexico, the other the bureaucratic line between terminally ill people and experimental drugs. Both lines are patrolled by government guards, but those at the latter, arrayed in the regalia of public health and correct science, are a far more insidious obstacle. Mr. Kwitny has written a saga about illicit drugs -- not cocaine and heroine, but isoprinosine, ribavirin, DDI and a host of other AIDS treatments distributed by underground activists in the face of a Food and Drug Administration committed to playing it safe. This network takes shape in the early 1980s, as patients and friends drive to Tijuana for over-the-counter drugs that are unapproved and therefore unavailable here. The trips soon extend to Europe and Asia, while at home the network's activities grow from informal drug distribution to organized clinical testing, confronting and eventually altering FDA policy. Among its achievements are the FDA's adoption of surrogate markers for gauging drug efficacy and its accelerated approval of DDI. The story is told through the eyes of Martin Delaney, a corporate training consultant who went on to co-found Project Inform, and Jim Corti, a hospital nurse turned international smuggler. Incredible scenes abound. In a Tijuana side street, Mr. Delaney unloads dozens of shopping bags containing thousands of boxed ribavirin pills, which he then tediously pulls from their bulky cartons and stuffs into every crevice of his car. In Washington, D. C., Mr. Corti addresses an FDA advisory committee, composed in part of physicians who had previously approached him for drugs: "`Here I am trying to convince you of the value of this compound, and two of you listening to this have already come to me to buy it for your patients.' They offered no signs of reaction." Mr. Kwitny avoids the cliched tack of bashing drug companies for attempting to make a profit. Mr. Delaney is a hard bargainer with uncooperative firms, but he understands the dead-end nature of mandated giveaways. Under "parallel tracking," for example, a much-touted FDA attempt to increase access to promising but unapproved therapies, companies cannot charge for their drugs. When DDI was parallel-tracked, the huge demand for it created skyrocketing costs for its manufacturer. "The worst part, Delaney felt, was that every big drug company in the country was watching. The lesson seemed to be that any gesture of charity by a drug company would only create the demand for so much more charity as to be intolerable. Free drugs for all was no way to encourage expanded access." The forces that shape the FDA have been widely described in academic literature. When the FDA mistakenly approves an unsafe drug, the consequences are quick and severe -- headline stories about highly visible victims coupled with congressional hearings bashing the agency. But when the FDA delays a needed drug, its victims are generally invisible and the political consequences are nil. As a result, the FDA's operating policy is one of deadly overcaution. The scurrying for drug sources and new importation routes; the political cowing of firms and physicians by the federal power over licensing and grants; the hopelessness that so quickly replaces moral outrage when patients find their fates delegated to distant bureaucrats -- these are features that we commonly associate with the Soviet Union. There is an Orwellian ring to such aspects of FDA logic as: "We have scientists arguing for it, and scientists arguing against it. Therefore, as regulators we cannot say this is the right thing to do. Our hands are tied if there isn't scientific consensus, and I don't see scientific consensus here." For a work of this length, there are some serious gaps. The "consumer-protection" lobby makes several appearances, opposing any loosening of FDA control. Mr. Delaney fends them off, but we never learn how; while disputes with agency officials are recounted in endless detail, there is not one description of a confrontation with Ralph Nader groups or with such "pro-consumer" congressional leaders as John Dingell, Henry Waxman or the late Ted Weiss. Since it is their philosophy that drives FDA policy, Mr. Kwitny's silence suggests a reluctance to take on certain sacred cows. Similarly, Mr. Kwitny uncritically accepts Mr. Delaney's questionable insistence on changing the FDA internally rather than by congressional action. This policy led Mr. Delaney to oppose a Republican reform bill and produced rifts among AIDS activists that go unmentioned in the book. His portrayal of FDA Commissioner David Kessler as a blossoming reformer rings false, given the agency's stance on such diseases as Alzheimer's. In the recent words of one agency official, "Gays are well organized and FDA would be hesitant to take them on; the cancer and Alzheimer's patients are not." Given the forces at work on the FDA, true reform is unlikely to come from mastering its politics or at the hands of enlightened agency officials; it requires a statutory reshaping of the agency itself. "Acceptable Risks" is an unprecedented expose of the FDA's pharmaceutical fortress, but its closing impression -- that the bad old days are over -- is unwarranted. --- Mr. Kazman is general counsel of the Competitive Enterprise Institute in Washington, D. C. [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]