An FDA Fable

info@reason.com (Robert Higgs) — Sat, 01 Oct 1994 00:00:00 EDT

The FDA Follies, by Herbert Burkholz, New York: Basic Books, 228 pages, $23.00

Why was the U.S. Food and Drug Administration so fouled up during the 1980s? Herbert Burkholz in his book falls back on the familiar left-liberal litany: It was Reagan's fault. In doing so, he ignores the long-standing problems inherent in bureaucratic attempts to achieve "safety" at any cost.

Burkholz views the FDA fiascoes of the 1980s as anomalous because he has a starry-eyed view of the agency in earlier days. He says nothing about the tens of thousands who died prematurely in the '50s, '60s, and '70s because the FDA would not permit sellers to tell consumers about the health benefits of lowering dietary fat; nor does he mention that the agency dallied for nearly a decade before approving new beta blocker drugs being used to treat heart disease with great success in other countries. In Burkholz's eyes, before the Reagan administration arrived to ruin everything with its "cold-blooded business-as-usual attitude," the agency epitomized "the best that there was in public service: high, but attainable, scientific goals...sought by dedicated professionals." It enjoyed "worldwide respect" and was "a proud place" animated by a "laudatory purpose." In those days, heroic bureaucrats busied themselves holding in check "avaricious" capitalists who strained to peddle poisonous products to an unwitting public.

Then, with the arrival of the Reaganauts, who held the budget in check and insisted that the FDA go easy on business, the agency hit the skids. In a succession of incidents ranging from the farcical Chilean grape scare to the exposed bribery of FDA examiners, the bureaucrats dropped the ball or ran the wrong way with it. But can the "Reagan did it" explanation really account for this sorry succession of screw-ups? Evidently even Burkholz has doubts, as he opines that "the workings of the FDA during the 1980s seem to defy understanding."

For those aware of public-choice theory, the events of the 1980s present no mystery. The FDA's follies are precisely the sort of actions that one expects a powerful government bureaucracy to take--self-serving, irresponsible, heedless of the injuries it causes so long as they are ignored by the news media, and vindictive against whistle-blowers. Burkholz's ideology prevents him from presenting a coherent interpretation, but the facts he relates tell a sufficiently woeful tale in spite of the author's obtuseness.

Consider the generic drug scandal that climaxed in 1989. Under legislation enacted in 1984 to expedite the availability of generic drugs, producers are required only to establish bioequivalency between their product and the brand-name product; they need not repeat all the tests originally required. Some applications to market generic drugs did receive quick approval, but others languished in the bowels of the FDA. Stymied in their attempts to break through the official barrier, executives of three companies--Mylar, Barre-National, and Barr Laboratories--undertook investigations and then testified before Congress about the corruption they had discovered. Several FDA reviewers were accepting bribes to hasten the approval of certain companies' applications and derail those submitted by competing companies. Eventually 42 persons and 10 companies were found guilty of criminal acts.

How did the FDA respond? Of course the agency made the usual gestures to demonstrate that it had thoroughly cleansed itself--most regrettably, Dr. David Kessler was appointed to lead the agency out of the bog--but beyond the range of the TV lights the bureaucrats set about getting revenge against those who had exposed the FDA's malfeasance. Barr Laboratories, in particular, bore the brunt of the agency's wrath. As Burkholz says, "For the next three years the FDA never stopped trying to put the company out of business" by repeatedly inspecting its facilities and delaying approvals of its products.

Naturally the agency got away with this vengeful conduct; it virtually always does. Few people outside the industries subject to its regulation appreciate the extent to which the FDA acts as lawmaker, police officer, judge, jury, and executioner. Companies that want to remain in business have no effective recourse. Even if one were to win a case in court, one would certainly be crushed by the regulators somewhere down the line. As Mylar's CEO Roy McKnight testified before Congress, "It was well known throughout the industry that so-called complainers could expect to receive the harshest of treatment, including direct retaliation." Indeed, even companies that do not make waves may be attacked, because from time to time the FDA bludgeons a busi-ness merely to set an example and terrify others.

With regard to the FDA's regulation of medical devices, Burkholz considers three important episodes, each with significant consequences. The first involves the Dalkon Shield manufactured in the early '70s by the A.H. Robins Company and used by some 3.6 million women worldwide. It turned out that the device raised the risk of pelvic inflammatory disease and spontaneous septic abortion. When Robins stopped selling the product in 1975, users had reported 260 septic abortions, 15 of them fatal. Bad publicity about the device led Congress to pass the Medical Device Amendments in 1976, granting the FDA authority to require that manufacturers get permission from the FDA before marketing any new or substantially altered medical device.

The second episode had to do with the Bjork-Shiley heart valve approved by the FDA in 1979, manufactured by Pfizer, and eventually implanted in 55,000 patients. The valves failed, usually with fatal results, in seven of every 10,000 users per year. Bad publicity and mounting lawsuits led Pfizer to stop selling the product in 1986. The company later consented to set aside $375 million for research on detecting cracks in implanted valves, surgery to replace defective ones, and compensation of sufferers. With the Bjork-Shiley valve foremost in their minds, lawmakers passed the Safe Medical Devices Act of 1990, greatly enlarging the FDA's authority to regulate manufacturers of medical devices.

Burkholz treats the Dalkon Shield and the Bjork-Shiley heart valve as unmitigated disasters. He scoffs at the manufacturers' defense of their products in public statements and before the courts. This reveals his general approach, which resembles that of the FDA and most of the news media. He presumes that a risky product ought to be banned without considering the risks of such a ban.

For example, suppose the Dalkon Shield caused many more deaths than reported, say, 36 per year. That amounts to one death per 100,000 users, which is a small risk in comparison with the risk entailed by pregnancy and childbearing. In the United States between 1970 and 1975, when the Dalkon Shield was being sold, the maternal death rate averaged 17 per 100,000 live births, so one could argue that each 100,000 Dalkon Shield IUDs used, by preventing pregnancies and subsequent births, saved 16 lives a year on balance. The Bjork- Shiley heart valve is an even more extreme case. As Pfizer's chief executive observed in a statement unfairly mocked by Burkholz, "These people [bringing lawsuits] were going to die anyway, and they are alive today because of the valve."

The third episode Burkholz discusses involves silicone-breast implants. These created an enormous furor that prompted the FDA to reduce drastically the number of medical devices approved during the past three years. The implant manufacturers have ponied up $4.3 billion for potential claimants. Sheriff Science then rode in, unfortunately after the legal rustlers had made off with the horses. According to a Mayo Clinic study of 749 implant recipients and 1,498 controls between 1964 and 1991, there is no evidence that the implants cause connective-tissue diseases and other disorders that many women, loudly supported by the news media, have attributed to them. Recent studies by researchers at Yale University, the University of Michigan, and the University of Maryland--as well as a similar study in Australia--found no connection between implants and scleroderma. Indeed, no study has provided a firm scientific foundation for the numerous claims of injury. But the FDA, which pulled the silicone implants off the market in 1992 except for reconstructive surgery, indicates that it will not remove the ban until the evidence that implants are safe becomes overwhelming.

As usual the wishes of potential users and their physicians receive no weight whatever as the agency makes sure that it will not be exposed by the news media for having approved an "unsafe" device. For the media and the FDA the world is black and white. A product is either safe or unsafe. Bureaucrats reject the notion of balancing risks against expected benefits, particularly if individual users and their physicians do the balancing. Hardly ever is the FDA held responsible for the deaths of those who perish awaiting its belated approval of new drugs and devices--not to speak of all the beneficial products that never even get produced because of the costs and uncertainties the FDA places in the way of the potential innovators.

Burkholz devotes two chapters to the FDA's misguided regulation of AIDS drugs and one chapter to its flawed oversight of HIV-tainted blood supplies. He concludes that AIDS ultimately brought about "a historic move by the FDA toward a more sensitive and flexible approach to drug approval." Wrong again. Under pressure from courageous and politically savvy AIDS activists and their media friends, the FDA made exceptions for AIDS drugs alone. Victims of other maladies still must wait, their remedies unexpedited, for want of comparable political clout.

With the appointment of Kessler, a "dedicated activist," as commissioner of the FDA in December 1990, "the retreat from folly had begun"--or so Burkholz would have us believe. (In his acknowledgments, he informs us that Kessler "was at all times open and forthcoming" with him.) In reality, the new commissioner quickly turned the agency into a fearsome police force. In his first two months he "added a hundred new criminal investigators to the enforcement staff, many of them formerly with the Secret Service and the Drug Enforcement Agency." Then followed a series of armed raids on alternative health clinics, vitamin factories, and dealers in dietary supplements as well as greatly increased numbers of warning letters, product seizures, forced factory shutdowns, and criminal prosecutions in the drug and device industries.

Kessler has proven himself a Machiavellian manipulator of the media and a clever cultivator of congressional patrons. Under his direction an agency already responsible for countless thousands of premature deaths and unimaginable amounts of needless suffering has come increasingly to resemble the Gestapo. With our fate in such hands, the FDA follies of the 1980s may come to be regarded as the good old days.

Reason Magazine - Staff

An FDA Fable