Copyright 2001 The San Diego Union-Tribune  
The San Diego Union-Tribune
May 3, 2001, Thursday
SECTION: OPINION;Pg. B-13:7; B-7:1; B-11:2,6

LENGTH: 771 words

HEADLINE: On human cloning, federal regulators go too far

BYLINE: Henry I. Miller; Miller, a physician, is a fellow at Stanford University's Hoover Institution and the author of "To America's Health: A Proposal to Reform the FDA." He was head of the FDA's Office of Biotechnology from 1989-93.

BODY:
In response to public claims by two groups that they are attempting to produce a human baby using the cloning technology used to create the sheep Dolly and other animals, a senior FDA official threatened to shut down any such attempts.

Kathryn Zoon, director of the Center for Biologics Evaluation and Research, testified that "FDA views the use of cloning technology to clone a human being as a cause for public health concern," and assured members of a subcommittee of the House Committee on Energy and Commerce that "FDA would not permit any such investigation to proceed."

Human cloning offers thorny ethical issues, to be sure. The failure of the procedure could mean either the premature "death" of the clone, or its survival with grotesque malformations. Moreover, there is no clear medical necessity for the procedure, especially in the absence of any patients whose life or limb is at risk without it.

What does seem clear, however, is that FDA lacks the mandate to interdict such research. The agency's mandate is to regulate products -- drugs, vaccines, pacemakers, X-ray machines, foods and other items that meet certain statutory definitions -- but not processes or concepts like "human cloning." For example, the agency does license the drugs used by fertility clinics but does not license or inspect them.

Like many members of the scientific and medical communities, I am skeptical that even the most expert fertility specialists can perform human cloning successfully with current technology, but in a sense that's beside the point. Cloning does not involve the testing, use or sale of an FDA-regulated product. So why do we have Zoon pushing the regulatory envelope? There are two reasons.

First, regulators are always seeking to expand their mandates and responsibilities. Bureaucrats' power and perks are increased by larger empires and budgets. And besides, it's in their nature -- then-FDA Commissioner Frank E. Young once quipped that, "Dogs bark, cows moo, and regulators regulate."

Second, bringing the might of America's most formidable regulatory agency to bear on publicity-seeking doctors with an unpopular idea offends no powerful lobby or other group. Patients' groups and drug companies don't much care. A biotech industry spokesmen even cheered on FDA's excesses. Only a few civil libertarians and students of regulation are likely to remonstrate.

The FDA often pushes the regulatory envelope beyond what is legal or in the public interest. The agency's attempts to regulate cigarettes as a "drug delivery device" were rejected by the courts after lengthy and expensive litigation. Similarly, the FDA's attempts to interfere with constitutionally protected commercial free speech -- in the form of drug companies' distributing articles or textbooks describing not-yet-approved uses of marketed drugs -- were repeatedly struck down and condemned by the judiciary. And the FDA's requirement that companies perform drug testing in children represents a shocking attempt to arrogate the prerogatives of the private sector.

The agency's most egregious misdeed in recent decades was surely the recall of silicone breast implants. Epidemiologic and other evidence subsequently failed to show an association between the implants and connective tissue diseases (and there is actually some protection from breast cancer).

But the agency's headline-making decision to remove the implants from the market unnecessarily terrified thousands of women, fostered spurious litigation for nonexistent damages, drove Dow-Corning into bankruptcy and interrupted the availability of silicone for other essential pharmaceuticals.

The fundamental question is really what should be the threshold for the legitimate use of federal executive power. During the Clinton administration, that threshold was lower than at any time since FDR's New Deal. Whether the issue was K-12 educational standards, the provision of health care to Americans who lack it, the ability of patients to accept responsibility for trying experimental drugs -- or as in this case a publicity-seeking, would-be cloner -- government action was invariably the remedy of first resort. Any societal ill, inequity or iniquity was fair game for federal relief.

The current controversy is as much about the abuse of federal power as it is about the abuse of cloning technology. It will be instructive to see to what extent that power is reined in when the Bush administration appoints a new head of the FDA. In the meantime, if human cloning is to be proscribed, congressional action is the appropriate way to do it.



LOAD-DATE: May 5, 2001