At the invitation of the U.S. State Department, I presented a series of lectures and briefings in the Philippines about an exciting advance in agricultural biotechnology: "biopharming" -- the programming of plants to produce pharmaceuticals that can be purified, or that might even be delivered by eating the plant material itself.

The early-stage R&D I saw during my travels was astonishing. University of the Philippines, Manila, Professor Nina Barzaga -- "The Illustrious Nina," as she is known locally -- has introduced into banana plants the genes that express potential vaccine proteins for typhoid fever, rabies and the HIV virus. She and her collaborators intend to process the bananas sufficiently to be able to standardize the dose -- by converting them to dried banana chips, for example -- and then to carry out clinical testing.

As I met with scientists, regulators, agency heads and senior politicians, I found that while much of the science is stunning, over-regulation is a significant obstruction to progress.

The concept of biopharming is not new. Many common medicines, such as codeine, morphine, bulk laxatives and the anti-cancer drugs taxol and vincristine have long been purified from plants. But biopharming's great promise lies in using gene-splicing, or genetic modification (GM), techniques to make old plants do radical new things. Gene-splicing has been applied to plants for decades in order to improve their nutritional value and agronomic traits (yield, pest- and drought-resistance and the like). The production of high value-added substances is a logical, straightforward extension.

Biopharming offers tremendous advantages over traditional methods for producing pharmaceuticals. There is great potential for reducing the costs of production: The energy for product synthesis comes from the sun, and the primary raw materials are water and carbon dioxide. And if it becomes necessary to expand production, it is much easier to plant a few additional hectares than to build a new bricks and mortar manufacturing facility. (Think Tamiflu, the anti-influenza drug, which is in short supply.)

Finally, vaccines produced in this way will be designed to be heat-stable, so that no "refrigeration chain" from manufacturer to patient will be required -- a major advance for use in developing countries, especially in the tropics and throughout Africa.

Approximately two dozen companies worldwide are involved in biopharming, and about half have products in clinical trials. The spectrum of products is broad, ranging from the prevention of tooth decay and the common cold to treatments for cancer and cystic fibrosis. Just last month, California-based Ventria Bioscience reported favorable clinical results with two human proteins biopharmed in rice and used to treat pediatric diarrhea.

There are major, interrelated obstacles to moving these projects through to commercialization, however. Excessive, unscientific regulation, the bleating of anti-biotech NGOs, and shortfalls in funding -- all conspire against the projects. Worse still, these negative factors reinforce one another. Over-regulation makes field trials difficult and hugely expensive to carry out, which makes it hard to attract Big Pharma collaborators or funders; and the NGOs endlessly wring their hands about risks and point skeptically (and cynically) to the absence of medical breakthroughs.

Critics of the new technology have made dire predictions of contamination of the food supply, warning of "drugs in your corn flakes." However, the sophistication of modern agriculture enables us to sequester different crop varieties when necessary and to cultivate safely the same species of crops for food and for new pharmaceuticals. Having said that, one must admit that human error is inevitable, so it is reasonable to ask: What is the likelihood of consumers' sustaining injury if a few biopharmed plants find their way into the food supply?

In order for unwanted health effects to be realized, several highly improbable events would have to occur. First, the active drug substance would have to be present in the final food product -- say, corn chips or oil, if the drug were made in corn, for example -- at sufficient levels to exert an adverse effect from either direct toxicity or allergy. But there is generally a huge dilutional effect, as small amounts of biopharmed material are pooled into a much larger harvest; with few exceptions (e.g. peanuts), even an allergic reaction requires the presence of more than a minuscule exposure. Second, the active agent would need to survive milling, other processing, and cooking. Third, it would need to be orally active (usually, proteins are not because they are degraded in the gut).

The probability that all of these events would occur is extremely low.

To be sure, biopharming misused could present valid safety concerns. It would be irresponsible, for example, to produce the anti-wrinkle drug Botox in an edible plant, except under very high conditions of containment, probably in a greenhouse or screenhouse: the active ingredient in the drug is, after, all, the highly lethal botulinum toxin (which is safe when injected under the skin in tiny doses).

One constant around the world is the over-regulation of agricultural biotechnology, especially biopharming. For example, the regulations of the U.S. Department of Agriculture impose highly prescriptive standards that fail to take into account the actual risks of a given situation, but mindlessly dictate one-size-fits-all, draconian requirements. These include large buffer zones between biopharmed and other crops; the requirement to leave land used to grow biopharmed plants fallow for a year following harvest; and the setting aside of planting, storage and harvesting equipment exclusively for biopharmed crops. Moreover, USDA has imposed a zero-tolerance for any biopharmed crop in food -- which is unscientific, unrealistic and unnecessary. (Regulators seem to have forgotten about the long-established tolerance levels in grains for unwanted substances such as insect parts, rodent droppings and harmful fungal toxins.)

Countries such as the Philippines that lack large, sophisticated regulatory apparatuses often follow the lead of the United States or the United Nations, whose regulations are lethal to innovation in poorer countries. If you're running a small-scale but high-quality R&D operation that can't test its biopharmed plants in the field, it's hard to convince potential commercial collaborators that you're for real.

If we can't break this vicious circle by injecting science into public policy, biopharming's development costs will continue to be hugely inflated, only very high-value-added products will become development candidates, and consumers worldwide ultimately will see few biopharmed drugs in the pharmacy. And in the process, the impressive work of people like The Illustrious Nina will be for naught.

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Henry I. Miller (miller@hoover.stanford.edu) is a fellow at the Hoover Institution. From 1989 to 1993, he was director of the U.S. FDA's Office of Biotechnology. His most recent book, The Frankenfood Myth, was selected by Barron's as one of the 25 Best Books of 2004.