Cat and mouse gene game

Few of us are strangers to using chemicals to “enhance” our mental state. No, not alcohol or marijuana — just good old No-Doz caffeine tablets and coffee to stay awake while cramming for a final exam or driving late at night.

But medicine has made great advances in the use of cognition-enhancing drugs, which doctors prescribe to treat cognitive disabilities and improve quality of life for patients with neuropsychiatric disorders and brain injury. These prescription drugs are now used more widely, including by shift-workers and travelers with jet-lag. The ethical issues and risk-benefits considerations are the subject of a commentary published last week in the journal Nature.

But technology will soon offer even more extreme possibilities for enhancement. Scientists using “gene therapy” to increase the levels of a single enzyme recently announced creation of a line of “mighty mice” that run much faster and longer than their nongenetically-engineered cohorts.

“They are metabolically similar to Lance Armstrong biking up the Pyrenees,” said Richard W. Hanson, the Case Western University biochemist who directed the research. Though the mice eat 60 percent more than control-group mice, they remain fitter and trimmer and live and breed longer than the controls.

The appearance of these mice represents a sort of laboratory-created evolutionary balancing act, following by several years the enhancement of cats. (The good news for rodents is that the felines aren’t smarter or faster, only less allergenic to humans.)

These experiments have reinvigorated a long-running debate about the ethics of creating “designer humans.”

“We’re in an era when breakthroughs in biology and intelligence are outpacing the culture’s capacity to deal with the ethics,” said Joe Tsien, Princeton University molecular biologist, at the time he directed development of a “smart mouse” almost a decade ago.

“There will be issues of access and who can afford it [and] whether the social wealthy class will have the intellectual advantage over poor people.” As though attending the Massachusetts Institute of Technology instead of Florida A&M; doesn’t confer an “intellectual advantage.”

Molecular biologist Lee Silver of Princeton University has written thoughtfully about these issues. He speculates about the emergence of two biological classes, the “Gen Rich” and “Naturals.” Comprising perhaps 10 percent of the population, the Gen Rich will include businessmen, musicians, artists, athletes and intellectuals, all enhanced with specific synthetic genes that allow them to perform at levels not possible for those who have access only to Nature’s lottery. They might be thought of as the logical successors to Mark McGwire and Marion Jones, who were able to use only crude chemical means to enhance their athletic prowess.

Who, then, should dictate when and how such procedures can be used? Economist Francis Fukuyama thinks the answer is more government regulation. In “Our Posthuman Future,” he writes: “The FDA is not set up to make politically sensitive decisions concerning the point at which selection for characteristics like intelligence and height ceases to be therapeutic and becomes enhancing, or whether these characteristics can be considered therapeutic at all. The FDA can disapprove a procedure only on the grounds of effectiveness and safety, but there will be many safe and effective procedures that will nonetheless require additional regulatory scrutiny.” Therefore, Mr. Fukuyama proposes “a new agency to oversee the approval of new medicines, procedures, and technologies for human health,” which would exert broader control than current regulation, by including “other societal voices that are prepared to make judgments about the technology’s social and ethical implications.”

This additional interference with decisions that should be left to consumers and physicians smacks of anti-libertarian nanny-statism of the worst kind. Moreover, it ignores the fact that our society now affords wide latitude to those who choose to enhance their appearance or health in other ways. For example, drugs are commonly tested and commercialized for relatively trivial indications, such as modest obesity, stuffy nose, age spots and baldness. The injectable drug Botox, widely used to treat nothing more ominous than wrinkles, is one of the best-selling drugs in the United States. And there have been numerous clinical trials of appetite suppressants, memory- and performance-enhancing drugs, and human growth hormone for hormonally normal but short children.

Gene therapy is an extension of drug and surgical treatments, and part of a continuum of medical interventions that introduce or modify DNA or modulate genes’ activity. Among the therapies on the continuum are organ transplantation (for genetic-deficiency diseases); vaccination (which precipitates irreversible changes in white blood cells’ DNA, initiating the synthesis of antibodies); and drugs (to stimulate the activity of dormant genes in sickle-cell anemia).

Over a half-century, these therapies have raised many medical and ethical questions similar to those of gene therapy, and physicians, ethicists, patients and society at large have had to confront them. Issues such as whether a patient suffers from a condition that warrants treatment, the kinds and magnitude of risks, and equal access to therapy, are fundamentally no different for gene therapy than for other interventions. So, even when used for enhancement, gene therapy should not be treated differently from other medical interventions.

Arguments against testing gene therapy for enhancement should be weighed against society’s permissiveness toward experimental medical and surgical interventions in general, and those intended for nontherapeutic purposes in particular.

An array of entities, at several levels of government, regulates gene therapy. This intensive and highly duplicative oversight offers a stark contrast to the scrutiny of a radical new surgical procedure, for example, which might be completely unregulated or subject only to a hospital committee’s approval.

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