Dying for Regulation

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Flawed government regulation discourages innovation and delays lifesaving products. Yet as the nation's population ages, Americans are becoming more dependent on medical progress to provide innovative treatments for diseases ranging from Alzheimer's and stroke to cancer.

A chilling example of this tension is the delay of an injectable antibiotic called Tigecycline for infections caused by "resistant pathogens" bacteria that are immune to standard antibiotics.

The manufacturer, Wyeth-Ayerst Laboratories, had done two human studies to show the drug is safe and effective and was planning a third and final one. However, last year the Food and Drug Administration changed the rules for measuring the efficacy in trials of antibiotics, which would have required the company to double the number of patients in the trials from 4,000 to 8,000. That would make the investment required by Wyeth much greater, and would make the trial take longer and possibly require the enrollment of patients outside the United States. The company responded by placing the last trial on hold and is considering whether to proceed with development.

Another egregious example is FDA's denial of approval for a vaccine to prevent meningitis C, a bacterial illness that infects thousands of persons and kills hundreds in this country annually. At present no conjugated vaccine one comprised of linked components against this infectious disease is approved for use in the United States, although three excellent products are available in Canada and Europe.

The safety and efficacy of these vaccines have been demonstrated in both pre-licensing testing and in large-scale immunization programs, with more than 20 million doses of the vaccines administered. But jealous of its prerogatives, the FDA refuses to recognize the foreign approvals, although such "reciprocity" is supposed to be a goal of discussions among international regulators. (When asked about the extent of the FDA's cooperation on this issue, a senior European regulator responded, "It's like discussing the Thanksgiving dinner menu with the turkeys.")

Another example pertains to a weapon against the nation's worsening epidemic of obesity, which now kills 300,000 people a year, almost as many as tobacco. At the same time that government public health officials tell us to eat less and exercise more, it is restricting an excellent tool for controlling the intake of fat and calories.

In 1996, following an eight-year review, the FDA approved a cooking oil called olestra, which adds no fat or calories to food. (It is simply a molecule of table sugar linked to soybean or cottonseed oil and is too large for the body to absorb or digest.) But they only allowed its use in chips, crackers, and other "savory snacks." Since then, Americans have bought more than 3 billion servings of snacks cooked with olestra. If they had eaten regular, full-fat chips instead, they would have consumed an additional 245 billion calories and 36,000 tons of fat.

Olestra is a boon to public health in this country, where diets are high in fat, and three of the top four biggest health concerns heart disease, cancer, and elevated blood cholesterol are related to fat intake. Research shows that people who eat olestra snacks actually consume lower levels of both total fat and saturated fat.

FDA regulators have been far too cautious about this substance that benefits public health. They granted only limited approval, although olestra is uniquely versatile and can be used as a replacement for margarine, lard, butter, and oils in frying, baking, and sauteing.

What's going on here? Don't regulators care about public health?

The short answer is that the system is biased against innovation. To see why, imagine the two types of errors possible under this system: A regulator can commit an error by permitting something bad to happen (approving a harmful product), or by preventing something good from becoming available (not approving a beneficial product). Both outcomes are bad for the public, but the consequences for the regulator are very different. The first kind of error is highly visible, and the regulators are attacked by the media and patient groups and investigated by Congress. But the second kind of error keeping a potentially important product out of consumers' hands is usually a non-event.

The bottom line is that regulators make decisions defensively that is, they avoid approvals of harmful products at any cost. As a result, they tend to delay or reject new products of all sorts, from fat substitutes to vaccines and painkillers. That's bad for public health and for consumers' freedom to choose. Americans are, literally, dying for better regulation.

Henry Miller, a physician, is a fellow at the Hoover Institution and an ACSH Director. He was an official at the Food and Drug Administration from 1979 to 1994.