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Biotech's Public Image: How to Provoke Regulation

Genetic engineering is never far from the headlines and the evening news. But most of the recent news has been dismaying for those who keep hoping that biotechnology will start learning from its own history that it has an image problem. Earlier this year, three different U.S. government agencies rebuked biotechnologists for conducting product testing outside the existing regulatory framework, sometimes in secret. In a separate incident, it was revealed that the Pan American Health Organization,

By | December 15, 1986

Genetic engineering is never far from the headlines and the evening news. But most of the recent news has been dismaying for those who keep hoping that biotechnology will start learning from its own history that it has an image problem.

Earlier this year, three different U.S. government agencies rebuked biotechnologists for conducting product testing outside the existing regulatory framework, sometimes in secret. In a separate incident, it was revealed that the Pan American Health Organization, in collaboration with the venerable Wistar Institute, has been testing a new genetically engineered rabies vaccine on cows in Argentina—without, alas, informing the Argentine government.

The vaccine shows enormous promise in controlling rabies, a major disease of wildlife and livestock. Because the vaccine uses a gene for a cell-surface protein of the rabies virus to trigger the immune response, it is also likely to be quite safe. But now a cloud hangs over this important new vaccine. The Argentine government is upset that it was not told that the tests were going on. The tests were stopped, and a government commission there issued an angry report.

The Argentine business raises a number of issues. First, of course, is the perennial question of the safety of the products of genetic engineering. Another is an ethical/political issue: is it appropriate for researchers to bypass U.S. regulatory procedures and test such products in places where regulation may be less stringent, particularly in Third World countries?

Let's focus, though, on a third issue, and that is the continuing insensitivity of some biotechnologists to what, baldly put, is simple public relations. The public relations problem has been dogging genetic engineering's footsteps since the archaic pre-Asilomar days of the early 1970s. There has been ample time for scientists to learn that this topic requires careful handling.

Sometimes they have used their knowledge well. In the United States, restrictive legislation was proposed but beaten back in the mid-'70s by lobbying scientists. A few years later, when Martin Cline tested his new gene therapy for thalassemia outside the United States, he was roundly criticized by NIH, and lost his government funding, a serious punishment indeed. But he also incurred the displeasure of his peers, who were concerned that his actions might harm other work in genetic engineering. Sometimes, though, the genetic engineers have not paid sufficient attention to appearances, which in part is why this year has been so hard on biotechnology.

It doesn't have to be that way. Researchers at Oregon State this year conducted foreign field trials of another genetically engineered animal vaccine, but they appear to have done all the right things. The testing, financed by the Department of Agriculture, was approved by their own institution and by two government agencies in New Zealand, where the testing took place. Jumping through all those hoops was doubtless an enormous nuisance for the researchers, but they did it anyway. The result appears to be an entirely successful test, and—perhaps even more important—no furor.

In the Argentine case, the researchers pointed out that they weren't really required to keep the government informed. But of course that's beside the point. Although it may not be required, sharing such information is the neighborly thing to do, and it's also canny.

Even David Kingsbury, biotechnology's good friend in the Reagan administration, pronounced himself appalled that the Argentine government was left in the dark. The New York Times quoted him as saying, “Given the volatility and concern on this issue, you just don't do things like that.”

Good advice—and it comes from someone who has done his best to reduce the regulatory apparatus genetic engineers face. But the regulatory future is not bright as long as researchers—however good and decent their intentions, however urgent the medical need—engage in behavior that gives even the appearance of side-stepping regulations or doing things in secret. Such behavior can actually stimulate the very thing they are seeking to avoid: more regulation.

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