- The Washington Times - Monday, July 5, 2004

Want safer, cheaper drugs? Don’t we all. Well, biotechnology applied in an ingenious new way might be the answer — if activists and regulators don’t get in the way.

Gene-splicing techniques are increasingly used to program common crop plants such as rice, barley, corn and tobacco to synthesize high-value-added pharmaceuticals, a process dubbed “biopharming.” The plants are harvested and the drug is then extracted and purified.

The concept is not new. Many common medicines, such as codeine, the laxative Metamucil and the anti-cancer drug Taxol are purified from plants, to say nothing of scores of herbal nostrums. But biopharming’s great promise lies in using gene-splicing techniques to make old plants do radical new things.

There is also great potential for cost-cutting in the process: The energy for product synthesis comes from the sun, and the primary raw materials are water and carbon dioxide. An important collateral advantage is the opportunity for farmers to grow new, high-value-added crops. (Think, for example, of putting tobacco to work improving health.)

However, regulators have created storm clouds over biopharming. They recently denied a request from Sacramento, Calif.-based Ventria Bioscience to scale up the cultivation of rice varieties modified with gene-splicing techniques to synthesize either of two medically important proteins, lactoferrin or lysozyme. Lactoferrin, a protein present in bodily secretions such as saliva, tears and breast milk, has direct antibacterial properties and also stimulates the immune system; it is thought to have a role in protecting breastfed babies from infections. Lysozyme, an enzyme found in egg whites, tears and other sources, damages bacterial cell walls and thereby inactivates the bacteria.

Even to get to its current early stage of development, Ventria has run a seemingly endless gantlet of redundant, dubious regulatory reviews. The U.S. Department of Agriculture regulates biopharmed plants by issuing permits for planting in the field, and federal permits issued in California also require approval by the state’s Department of Food and Agriculture.

To scale up cultivation of its rice varieties, Ventria also needed permission from a kind of bureaucratic fifth wheel called the California Rice Commission (CRC). The company negotiated its cultivation protocol with the CRC for more than a year, during which there were five public meetings that allowed public comment as well as feedback from the commission. After an overly thorough evaluation by a scientific subcommittee, the CRC approved the protocol in March.

But the USDA declined to give Ventria permission to grow its rice varieties, saying the company planned to cultivate them too close to varieties intended for food. California regulators followed suit, citing the USDA action and also the need for still more public discussion.

However, the health and environmental risks of such rice varieties are negligible — rice is self-pollinating, so genes are not readily transferred from one plant to another, and the newly introduced proteins are natural and completely benign.

The regulatory hoops confronted by Ventria far exceed those required for non-gene-spliced rice varieties, which are crafted with far less precise and predictable techniques.

There was no reason to delay approval of Ventria’s expanded field trials. Biopharming is in no way fundamentally new or mysterious. Gene-spliced plants for food and fiber have for almost a decade been grown worldwide on more than 100 million acres annually, and more than three-quarters of processed foods in the United States contain ingredients derived from gene-spliced organisms (mostly from corn and soybeans). There has not been a single mishap that resulted in injury to a single person or ecosystem.

Although the USDA and the California Department of Food and Agriculture finally relented and approved a scaled-down proposal, Ventria has lost a growing season and important momentum toward producing valuable pharmaceuticals. Moreover, regulatory uncertainty is hardly conducive to attracting investors or retaining employees.

Excessive, ill-considered and capricious regulation already has destroyed entire sectors of promising biotech applications, among them “biorational” pesticides (by the U.S. Environmental Protection Agency) and human gene therapy for genetic diseases and cancer (by the U.S. Food and Drug Administration). In the long run, if we are to reap what biopharming sows, we need more reasonable, science-based regulation. But that’s as likely as rice paddies in North Dakota.

Henry I. Miller is a fellow at the Hoover Institution and the Competitive Enterprise Institute. From 1989 to 1993, he was director of the FDA’s Office of Biotechnology. His next book, “The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution,” will be published later this year. This article was distributed by Scripps Howard News Service.

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