Policy Controversy in Biotechnology: An Insider's View.

• Author: Kazman, Sam

By Henry I. Miller Austin, Tex.: R.G. Landes Company and Academic Press, 1997. Pp. x, 217. $88.95.

In the mid-1980s TPA--tissue plasminogen activor--was being hailed as a major biotechnological breakthrough. It was so effective in dissolving the coronary blood dots responsible for heart attacks that a federal institute abruptly halted a study comparing TPA to another drug. In the view of its researchers, TPA was so superior that it would have been unethical to continue administering the other drug to patients. Nonetheless, the U.S. Food and Drug Administration (FDA) did not approve TPA until late 1987, by which time it was available in eight other countries. According to some rough calculations that I published back then, the FDA's delay cost about thirty lives per day I did not realize at the time, but came to appreciate only after reading Henry Miller's Policy Controversy in Biotechnology, that in regulating biotech products the FDA was one of the better agencies!

Miller's book is a wide-ranging exploration of the interplay between regulatory policy and scientific advances. This can be an especially insidious process. Unlike taxes, whose magnitude is visible, the burdens of regulatory policies arc usually well hidden, especially With regard to new product approvals. Prior to approval, we usually don't know what we're missing; after approval, we generally don't care about how long we had to wait. And where new scientific processes arc involved, we are even more clueless.

Consider, for example, that the computer has had a far greater impact on our lives than biotechnology. Perhaps biotech has not advanced as far as computer science, or perhaps its potential is simply not as great. But Miller's book leaves the disturbing impression that the difference arises at least in part because biotech is regulated far more heavily.

Drawing on his background as both a scientist and a former regulator, Miller compares the development of biotech policy at several powerful agencies. In his view the key issue was, and continues to be, that of "product versus process": Should biotech's creations, especially those produced through recombinant DNA techniques, be regulated on the basis of the sort of products they are or on the basis of how they were produced.) The latter approach holds the greatest potential for mischief, because it opens the door to regulatory burdens based not on actual risks but on fear of the science. One result is that two identical...