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EnGENEering the future

Biotech revolution spawns vocal opposition, as science enters brave new world - with ethical debate trailing far behind.

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Some industry voices are encouraging "ever-greater engagement with the public." Eric Lander, director of the Whitehead Institute at the Massachusetts Institute of Technology in Cambridge, told his colleagues, "There has been an explosion of issues in the past year, and we don't have the trust of the public." Ticking off issues such as gene patenting, diagnostic testing, and therapies that could produce "designer children," Dr. Lander emphasized the need to engage in thoughtful discussion, and to be seen to have that discussion "in good faith."

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Biotech agriculture has become a lesson in how not to do this. The intense public backlash in Europe and Japan - and some in the US - against genetically modified (GM) crops and foods has had such impact that farmers are expected to reduce their plantings by as much as 25 percent this year. Worldwatch Institute says: "Stock prices for companies are falling, exports ... are tumbling, and questions are mounting about the liability for what is turning into a major debacle for farmers."

A class-action suit on the part of farmers has been filed against Monsanto, charging inadequate testing and an attempt to monopolize the seed industry. Another suit has been filed against the Food and Drug Administration by the Iowa-based Alliance for Bio-Integrity, charging misrepresentation of risks and a violation of federal law that requires demonstrated safety before marketing.

Industry representatives throw up their hands in disbelief, saying they've tested their products for years. Mr. Feldbaum says, "They're trying to make a case based on people's fears, not on a shred of evidence. Can people point to a single instance of even an allergic reaction" to such foods, he asks. One illustration to the contrary, he adds, is that 90 percent of today's cheeses are actually made purer by using a GM enzyme rather than the scrapings from calves' stomachs.

Still, the extent of testing has become an issue. Studies showing potential dangers to monarch butterflies and to soil organisms from transgenic corn have led the Environmental Protection Agency to consider broader testing. The FDA held a set of public meetings at the end of 1999 on whether its policy for ensuring safety of bioengineered foods should be modified. A bill introduced in the House of Representatives would put foods through a premarket approval process. And bills to mandate labeling have been proposed in Congress and 14 state legislatures.

Mr. Eramian acknowledges that in terms of public perception, the industry's "most important challenge is the development of trust." The question of trust is most challenging when it comes to human genetics, where the use of fetal tissue in research and the patenting of life forms have already outraged many.

The death last year of Jesse Gelsinger, a young participant in a gene-therapy experiment, revealed lax procedures on the part of researchers. Soon after, it was learned that more than 650 "serious adverse events" had occurred in other experiments which had not been reported as required.

Some critics say gene therapy is being hyped for commercial reasons, that the relation between DNA and observable traits is much more complex. Ruth Hubbard, of the Council on Responsible Genetics, in Cambridge, Mass., speaks of the "fallacies of genetic determinism - that genes are causes and their malfunction the basis of disease. Nothing depends on the function of a single gene," she says. "Genes are not autonomous."

Most troubling to many, along with cloning, is the capability that now exists for "germ-line interventions," in which genetic modifications would be passed on to children. It is now being done with animals, but a voluntary moratorium exists on human germ-line research. "While I'm not willing to rule it out forever," Lander says, "I'd like to ban it now. I wouldn't want some cowboy to do it in the next five to 10 years." Others, however, have begun to describe future scenarios that include it, along with clear societal divisions between the "GenRich" and the "Naturals."

Using genetics for human enhancement rather than therapeutics poses huge ethical dilemmas. Eric Parens, an associate at the Hastings Center in Garrison, N.Y., says no institution in the US today is constituted as a forum for discussing such big-picture issues. The center hopes to begin a project that would help fill that vacuum.

"The risks are huge," Dr. Parens says. "I'm surprised by how little attention these developments have received.... Nobody is educating people, and it's crucially important that we have a public conversation."

(c) Copyright 2000. The Christian Science Publishing Society