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WP-95-17

Using Benefit/Cost Methods in
Prevention Research: The Case of Vitamin E

David Dranove

Abstract

Two recent cohort studies suggest that supplementation with vitamin E can reduce the incidence of heart disease by 20% or more. If so, then a 25% increase in vitamin E consumption by the U.S adult population could generate annual savings of nearly $60 billion in reduced medical costs and increased productivity. If we add on the enormous intrinsic value of improved heatlh outcomes, the effective savings increase fourfold. The Food and Drug Administration does not currently permit firms to promote the potential health benefits of nutritional supplements such as vitamin E, however, unless and until there is proof of safety and efficacy from randomized clinical trials.

There are several clinical trials underway, but results will not be known for at least five years. Even then, the trials may be inconclusive because they may not detect small improvements in health status. Because of the enormous benefits of reducing heart disease, however, even small improvements in health status would generate savings well in excess of the cost of vitamin E supplementation. Using Bayesian statistics, I show that the benefits of conducting two or more additional trials exceed the costs by a factor of eight or more. Because vitamin E is nonproprietary, the private sector cannot be expected to conduct these studies. Instead, they must be funded by goverment agencies like the National Institutes of Health.

Even if the ongoing trials fail to find a significant effect of vitamin E, the analysis shows that it might still be cost-effecive to supplement. If so, a critical issue is whether there are downside heatlh risks. Given the potential benefits of reducing heart disease, the relatively low cost of supplementation, and the difficulty of detecting small improvements in outcomes, the FDA should consider only requiring proof of safety, rather than safety and efficacy.

David Dranove, Kellogg Graduate School of Management, Northwestern University



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