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15 Biotechnology Law Report 162 (Number 2, March-April 1996)

Leaving aside the fine points of risk analysis, most of the costs ofSuperfund actually end up going to lawyers. Usually, I would find thatoutrageous, but it seems preferable to spend money on Mercedes-Benzes forlawyers than for killing bioremediation workers.

Why Regulators Act as They Do

Why do regulators adopt and retain such policies and programs? It's inthe self-interest of bureaucrats to amass bigger budgets, larger empires, andmore responsibilities. And it's in their nature — as former FDA CommissionerDr. Frank E. Young once quipped, "Dogs bark, cows moo, and regulatorsregulate." Also, who ever heard of federal regulators pulling the plug on a

major program, no matter how dumb, cost-ineffective, or destructive?

Government "services" such as EPA's Superfund cleanups and FDA'soversight of drug advertising and promotion that afford little or no protection tohuman health or the environment are not uncommon. They are costly anddivert resources from other legitimate public and private sector endeavors. Theybreed well-deserved cynicism about government's motives. They benefitprimarily one special interest: the bureaucrats themselves.

We would actually be better off without many federal policies andprograms. If EPA's Superfund program and FDA's oversight of drug advertisingand promotion were abolished tomorrow, American citizens would benefit

—

andthe US Treasury would be richer.

Congress, take notice. Reform FDA. Override the EPA veto.

Dr. Miller is the Robert Wesson Fellow ofScientific Philosophy and Public Policy at the

Hoover Institution and Consulting Professor atStanford University's Institute for International Studies.

From 1979-1994, he was an official at theFood and Drug Administration.

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CONFERENCE REPORT

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Gene enhancement no different on scientific,legal, or ethical basis from plastic surgery— Henry Miller Discusses Ethics of Gene Therapy at AAAS

BALTIMORE, MD 2/10/96 — Should laws or regulations prohibit peoplefrom using gene therapy to cure baldness or grow taller? What about adding a


gene to suppress one's appetite or to improve memory?Some ethicists have maintained that gene therapy should be used only to

cure serious diseases and that "enhancement engineering" would take societyinto new and dangerous moral territory. Henry I. Miller, M.D., formerlyresponsible for biotechnology policy at the U.S. Food and Drug Administrationand now a Fellow at the Hoover Institution at Stanford University and amember of the BLR Editorial Board, disagrees. Gene therapy is no different ona scientific, legal, or ethical basis from plastic surgery, liposuction, or the use ofdrugs to suppress appetite or age spots, he told a session today at a meeting ofthe American Association for the Advancement of Science.

Most Issues Not Unique to Gene TherapyMiller went on to say that although the prospect of altering genes to

enhance human looks or potential does raise a number of important issues, noneof them is unique to gene therapy.

Like any new drug, gene therapy introduces a foreign substance into thebody; and, as with other drugs, the inserted gene might have unintendedconsequences — it might inactivate a cancer suppresssor gene, for example,thereby triggering a cancer. However, this risk of unintended consequences isnot unique to gene therapy. Moreover, many protections are in place to avertreckless use: before any gene therapy can be tested in humans, Miller noted, itmust be reviewed by various oversight groups at research institutions and bythe FDA and the National Institutes of Health.

Gene therapy does pose one special risk because it may be irreversible.However, Miller said, the technology exists to introduce genes that can beremoved or blocked if they prove to be dangerous.

Moral and Social Questions

Genetic enhancement also poses some moral and social questions, Millercontinued. Who would have access to the treatment: those with the greatestneed, or those with the ability to pay? Would pressure be exerted for workers tohave genes inserted that would make them less susceptible to workplace toxins?Would some people seek gene therapy to change their skin color or other trait toescape discrimination? Who would decide whether a treatment is warranted?For example, would only the morbidly obese be able to obtain a "corrected" fatgene, or would the new gene be available to people who simply want to lookmore attractive on the beach?

None of these questions is unique to gene therapy, Miller pointed out.There have been numerous trials of memory-enhancing drugs and appetitesuppressants. And the people seeking enhancement do not regard the desiredeffect as trivial. "It is certainly not trivial to an adolescent boy who is sixinches shorter than anyone else in his class," Miller remarked, "or to the manypeople of either sex who suffer hair loss."


Mechanisms Already in Place

American society already has the mechanisms in place to evaluate themedical risks and benefits of gene therapy, Miller argued. Individuals can begiven the information needed to decide whether the personal benefits ofenhancement outweigh the risks.

"If society is to realize the full spectrum of benefits from human genetherapy," Miller said, "[such therapy] cannot be considered in a philosophicalvacuum. It must be judged in the broader context of what people want andwhat society permits."

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EXECUTIVE AND LEGISLATIVE ACTIONS

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Infringement-

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Technology Transfer.

SUMMARY OF PENDING PATENT-RELATED LEGISLATION

By Patricia D. Granados

A large number of bills related to the U.S. Patent system are currentlypending before the 104th Congress. This article summarizes these various billsand their relevance to U.S. Patent practice.

Pending LegislationReexamination Reform Act of 1995

H.R. 1732 (Carlos J. Moorhead, R-CA; May 25, 1995) and S. 1070 (OrrinG. Hatch, R-UT; July 25, 1995) would change U.S. reexamination procedures inthe United States by permitting greater third-party participation throughoutthe reexamination proceeding and by allowing challenges to validity based onissues other than prior art, including enablement and written description issues.Specifically, a third-party requestor could provide written comments during eachround of prosecution in the reexamination proceeding and would have a right toappeal a decision.

In order to prevent harassment of patentees, H.R. 1732 would providethat: (1) a party failing to sustain its burden of proving a patent invalid inlitigation would be barred from requesting reexamination; (2) an order forreexamination and the first office action on the merits would be combined; (3)a third party requestor electing to appeal to the Court of Appeals for theFederal Circuit would waive the right to assert invalidity of the patent in anyforum on grounds which were or could have been raised in the reexaminationproceeding; and (4) the outcome in a reexamination proceeding could not be

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