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New Biotech Policy Could Aid MIT

By Karen Kaplan
Executive Editor

A new federal policy aimed at boosting the biotechnology industry could be a boon to MIT research laboratories doing pioneering work in genetic engineering.

The policy, announced by the White House last week, reflects the Bush administration's position that genetically engineered products are not inherently dangerous and therefore should not be subject to special scrutiny by federal regulators.

The new policy represents "major new ground rules for regulation of biotechnology," Bush told reporters in Washington. "This $4 billion industry should grow to $50 billion by the end of the decade," he said.

Commercial biotechnology firms, which develop and market genetically altered products ranging from medicines to disease-resistant plants, will benefit the most from the new policy, since their products are subject to the most extreme regulation. But these firms often draw upon the basic research done in university laboratories, and some MIT scientists predict that could mean more funding for their labs.

"The major effect [of the policy] will be to encourage investment by society into the biotech community," said Professor of Biology Phillip A. Sharp, who studies RNA splicing mechanisms. "That will create jobs for our students, create research resources for training students, and help research here at MIT."

A substantial amount of MIT genetics research is conducted at the Whitehead Institute for Biomedical Research. Administrative Director John Pratt said approximately $1 million of Whitehead's $20 million annual budget is funded by corporate sponsors. If the regulatory changes have the intended effect, corporate sponsorship could increase, he said.

Lita M. Nelsen '64, associate director of the MIT Technology Licensing Office, said the new policy would have little effect on research at the Institute: "Our research isn't primarily driven by how big the market for a final product is going to be, but by how useful and interesting the science is," she said.

But she said companies might license more MIT patents, which garners revenue for the Institute. MIT researchers earn between 15 and 20 biotechnology-related patents each year, Nelsen estimated.

Professor of Biology Robert A. Weinberg '64, who is involved in cancer research, said the effects at MIT will probably be minimal. "There could be a trickle-down effect if the biotech industry became much more profitable and as a consequence were able to support basic research," he said.

Biggest impact for agriculture

The new policy asserts that "although the new biotechnology processes can be used to produce risky organisms, so can traditional techniques; ... Indeed, the new technologies of molecular modification may increase the potential for safe, planned introduction" of genetically-altered organisms into the environment.

The policy change is likely to have the biggest effect on genetically-altered plant and agricultural products, since they will no longer be subject to stricter regulations than their parent organisms.

"The biggest impact will be in plant biology," Sharp said. "Release of genetically engineered organisms and plants into the environment will not be viewed as releasing a potentially dangerous plant, but as another product, a genetic variant," he said.

Nelsen agreed, saying, "I think you're going to see an effect not so much in the pharmaceutical area, but in the agricultural and environmental areas, where those regulatory barriers loom larger in proportion to the potential reward."

Some Bush critics have complained that the new policy is too lenient and does not contain sufficient measures to ensure that genetically engineered products are safe for release into the environment. Without any natural enemies, they argue, such novel organisms might reproduce unchecked and disturb the delicate balance of nature.

Supporters say these concerns are unfounded, and that this shift in thinking was long overdue.

"The singling out of biotechnology products was no longer justifiable in light of their proven record over the past years as being safe," said Weinberg.

Sharp called the change "a responsible move" in "an appropriate direction." He said, "I think the environmental safety issue has been dramatically overplayed by a number of people.

"It's not a correction in which no regulation is left in place -- a significant amount is still there," Sharp continued.