Letters

From the August/September 1995 issue

(Page 3 of 3)

Saul Kent's proposal, which would allow consumer choice, is a good one. I wouldn't lay the blame for the antiarrhythmic drug deaths, though, on the FDA. Until we become all-knowing, science will be tricky and intelligent folks will disagree. Given this, the true public health policy is not to ban things that don't work, but to empower people to choose what they think might work and to take the risks that may save their lives.

I agree with David Anast that we should be concerned about the survival of the device-manufacturing industry. I wouldn't be too concerned, though, about the number of companies that are actually inside the United States. If, regulation aside, it's really cheaper to do the same work in India, then we may be better off if companies go there. And if mom-and-pop plants go under but a multinational acquires them, then we consumers may not lose anything.

As to my statistics, I refer the reader to Sam Kazman's "Deadly Overcaution: FDA's Drug Approval Process" (Journal of Regulation and Social Costs, August 1990). Here's how they work. In 1988, the FDA approved the ulcer drug, misoprostol. The FDA estimated that gastric ulcers caused 10,000 to 20,000 deaths a year, and misoprostol was reportedly 94 percent effective. FDA review took 9.5 months (.79 years), which makes a death toll of about 7,500 (10,000x.94x.79) to 15,000 (20,000x.94x.79).

Naturally, these are just crude approximations. Of course, if the FDA had approved misoprostol immediately, not everyone would have used it. There are methodological questions--do we count FDA delay from the moment of the application or from the moment the drug is sold anywhere? But the FDA hasn't admitted that the FDA could be responsible for any deaths. If we can start arguing over the numbers, the FDA debate will have made a great leap forward.

Alicia Oakley and Eric Tellefsen claim that such numbers are useless and that I should have focused on FDA-approved drugs and devices that killed people anyway. I disagree. The "simple fact that the FDA disallows our citizens and their selected health care providers freedom of choice" is a powerful fact for libertarians, but isn't enough for most people. When people die from bad drugs and devices, they already make headlines. Folks like Sid Wolfe of Public Citizen latch onto such examples and use them to advocate vastly expanding the FDA. But drug-lag victims, even when there are thousands of them, are invisible. We need to put faces on the victims.

Regulation Blues

"Slash and Burn" by Rick Henderson (May) was a well-reasoned analysis of the frustrations that have fed the growing regulatory reform movement. The difficulties the Kahle family experienced using a well that provided fresh water cleaner than government standards required is symptomatic of the rigidity that has given the United States the most costly regulatory system of any industrialized nation.

This state of affairs could be alleviated by regulatory reform legislation containing risk assessment and cost-benefit analysis. These procedures, which the U.S. House has passed and the Senate will be considering in June, would bring about a reallocation of resources to more cost-effective programs. They "could save an additional 60,000 lives per year" at no increased cost to taxpayers or the private sector, according to the Harvard Center for Risk Analysis.
Arthur E.F. Wiese Jr.