Commentary: Tinkering With Genes: Time For A National Debate

At a small lab outside Vancouver, 15 ordinary-looking mice scramble around their cages. Their coats are glossy white or black, their noses soft pink, their tails aquiver. But put a few cells from their bodies under a microscope, and you'll see something amazing: All 15 carry a chromosome, made in the laboratory, that they inherited from their mother.

It is the first time a so-called artificial chromosome inserted into the cells of a mammal has been passed from one generation to the next. And if it can be done in mice, it probably can and will be tried in humans--even though the biotech company behind the breakthrough, Chromos Molecular Systems Inc., says it has no intention of testing it on people.

The technology was developed to create herds of genetically modified animals whose milk can be used as a culture for producing a vast range of drugs. But its ramifications are immense. Eventually, the technology promises medical miracles, such as eradicating genetically transmitted diseases and making the world population resistant to the virus that causes AIDS.

GENIUSES. It's also possible that the technique will be sought by those who would alter human genes to create "superior offspring"--with movie-star looks and genius IQs. This is still far in the future. The mouse results, which were published on Oct. 27 in New Scientist magazine, have not yet appeared in a scholarly journal. And no one knows the long-term effects on creatures carrying artificial genes.

Nevertheless, the advance is breathtaking. Even the most sophisticated observers expected it to take decades more before the sci-fi scenario of choosing artificial chromosomes to determine the characteristics of future generations would emerge as a reality. If this discovery proves out, however, that will not be the case. "If your head isn't spinning, you aren't paying attention," says Erik Parens, a bioethicist at the Hastings Center in Garrison, N.Y.

Should we be alarmed? Regulators in Europe think so. Germany and Britain found the technology so threatening that they banned its use even before the announcement in the New Scientist. The U.S. Food & Drug Administration also won't approve the testing of artificial chromosomes in people even for far less controversial uses, such as therapies for genetic diseases, until extensive safety tests are performed. "Before we get to clinical trials, we have to ask what are all the bad things that could happen," says Dr. Philip D. Noguchi, director of the FDA's division of cellular and gene therapies.

The time to have an informed debate about this technology is now--before it is determined to be "safe and reliable" and is on its way to market. It is imperative that we decide exactly when the use of the technology is called for. We cannot risk letting this technology simply slip into the standard repertoire of in-vitro fertilization clinics, as has happened with so many other reproductive technologies. In a society that is already poised for an auction of "supermodel" donor eggs over the Internet, it doesn't require a great leap of imagination to see how this genetic breakthrough could be hijacked for the most trivial of uses.

Before science embraces the new technology, the consequences should be fully understood. In 1993, for instance, doctors began offering intracytoplasmic sperm injection to couples in which the husband had, among other things, a low sperm count. Only limited attempts were made to research possible side effects. Then, in 1998, researchers in Belgium and Australia reported that children created by these sperm injections were twice as likely as other children to have major chromosomal abnormalities as were children naturally conceived.

Banning the technology outright is no solution: Researchers would then be unable to use artificial chromosomes to repair the lung cells of a cystic fibrosis patient or the blood cells of a leukemia patient. But the time to discuss the potential uses and misuses of artificial chromosomes is before a technology is widespread--not after we live to regret our ethical failings.

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