COLUMN: To your health

From Lee Bailey's "The Immaculate Perception?," Fall '96 From Lee Bailey's "The Immaculate Perception?," Fall '96Reforming the U.S. Food and DrugFrom Lee Bailey's "The Immaculate Perception?," Fall '96Reforming the U.S. Food and DrugAdministratioon is just what the doctor-From Lee Bailey's "The Immaculate Perception?," Fall '96Reforming the U.S. Food and DrugAdministratioon is just what the doctor-and thousands of desperately ill patients-From Lee Bailey's "The Immaculate Perception?," Fall '96Reforming the U.S. Food and DrugAdministratioon is just what the doctor-and thousands of desperately ill patients-ordered. From Lee Bailey's "The Immaculate Perception?," Fall '96Reforming the U.S. Food and DrugAdministratioon is just what the doctor-and thousands of desperately ill patients-ordered. If someone you love has died of congestive heart failure in the last year, it is very possible that the U.S. Food and Drug Administration was responsible. Indeed, by withholding developed technology necessary for a new cardiomyoplasty procedure, the FDA may be ultimately responsible for the deaths of 5,000 Americans each year. In just one of many attempts to halt reform, FDA supporters like Washington Post columnist Morton Mintz remind us of the thalidomide scare of the 1960s. What, they ask, would have happened had the FDA not been around to save us? The question is irrelevant, especially because the FDA may not have been responsible for the revelations about thalidomide. The intent of FDA reform is not the reckless release of untested drugs and devices to an unknowing public, but rather the expedient delivery of treatments to those who need them -- a goal the FDA has yet to achieve. Delegating the testing and clinical trials process the agency currently oversees would eliminate the delays and bureaucratic obstacles that currently plague it. In addition, independent review boards can better utilize the latest medical technology to help prevent drugs like thalidomide from reaching the market. Some critics have suggested that FDA reformers follow a model based upon Underwriters Laboratory, the private agency that has competently ensured the safety of electrical appliances in American for almost 100 years. While those against curtailing the FDA's responsibilities and powers cite a conspicuously small number of drugs gone awry, experts in favor of reform point to thousands of unreported tragedies in which the absence of already-developed pharmaceuticals has cost lives. The Wilkerson Group's study on delays in FDA approval indicates that a three-year wait for a stent graft that repairs abdominal aortic aneurysms could indirectly cause 25,000 deaths. A three-year hold on technology that reduces complications following angioplasty essentially kills 3,600 people. In a moral cost-benefit analysis, little serves to justify these vicious costs, whether the approval process takes one year or 10. Consider also a type of vascular scaffolding used to keep arteries open in patients with severe heart disease. During the seven years it took the FDA to approve this device, 25,000 Americans sought its implantation overseas. So, despite the fact that health care costs already soak Americans, we must now add a travel budget to some of our expenditures. And for those who can't afford it? The FDA may as well say, "Too bad." Such statistics and the stories behind them are legion. William O'Neill, director of the Schlafer Cardiology Center in Michigan, estimates that doctors performed some 40,000 unnecessary open-heart surgeries during the eight years it took the FDA to approve a drill that unblocks calcified arteries. The human and monetary costs of these unnecessary procedures alone should be enough to force legislators to think twice about preserving the outmoded FDA. Undoubtedly, Commissioner Kessler and the rest of the scientists at the FDA believe they are protecting Americans. Unfortunately, though, the business of saving lives is not one in which it's the thought that counts. As a physician, Kessler should recognize above all that people suffer and even die as a result of his agency's inefficiencies. He boasts that approval times have come down, and that his agency is making progress. Many critics, however, assert that his claims are overstated and inaccurate, and that the reduced time spans he cites are based only on the final stages of approval. The FDA and its supporters must chalk up the agency's problems as manifestations of the simple reality that government tends toward gridlock. The FDA's shortcomings do not lie in the quality of its scientists; most are top notch, no doubt. But even the most talented physicians can't change the immutable truths of government bureaucracy, which leaves supporters of the FDA without much ground on which to stand. Throughout this century, Americans have been engaged in a dialogue of private versus public. We have witnessed the former prevail many times. But when we're dealing with death and disease, there is no room for prolonged debate because the advantages of reform are more compelling than dollars -- they are measured in years of life.