Secret U.S. Biopharms Growing Experimental Drugs

"Just one mistake by a biotech company and we'll be eating other people's prescription drugs in our corn flakes," said Larry Bohlen, director of health and environment programs at Friends of the Earth, a member of a coalition of consumer and environmental groups that produced the report.

The experimental application of biotechnology in which plants are genetically engineered to produce pharmaceutical proteins and chemicals they do not produce naturally has been termed "biopharming." Companies engaged in biopharming keep their activities secret, citing the secret plantings as confidential business information.

The report, entitled "Manufacturing Drugs and Chemicals in Crops: Biopharming Poses New Threats to Consumers, Farmers, Food Companies and the Environment," was produced by the Genetically Engineered Food Alert coalition and presented to Agriculture Secretary Ann Veneman.

"The USDA [U.S. Department of Agriculture] should prohibit the planting of food crops engineered with drugs and chemicals to protect the food supply from contamination," Bohlen said.

The highest number of field trials are taking place in Nebraska, Hawaii, Wisconsin and Puerto Rico. But other states, including Iowa, Florida, Illinois, Texas, California, Maryland, Kentucky and Indiana, also have numerous tests being conducted near food producing farms.

The report details the many threats that biopharm crops pose, the extent to which crops have been planted across the United States, the failure of regulatory agencies to regulate the experiments, and a set of recommendations.

The coalition proposes that the USDA permit limited cultivation of non-food plants in the same controlled environment as other drug production.

The USDA has primary authority for experimental biopharm crop cultivation. Historically, the agency has kept all drug and chemical crop sites secret from the public and neighboring farmers, and has hidden the identity of the drugs or chemicals being produced. The agency has condoned companies' preferred practice of anonymously planting biopharm crops without identification, security measures or notification of neighbors, the report claims.

Coalition members are concerned that genetically engineered traits could spread from biopharms through pollen carried by wind or insects, spilled seed, unharvested seed sprouting the next year, and biopharm seed residues carried by farm equipment to conventional fields.

"Current gene containment strategies cannot work reliably in the field, the editors of the journal "Nature Biotechnology" said. "Can we reasonably expect farmers to [clean] their agricultural equipment meticulously enough to remove all GM seed?"

In response to the report, a National Academy of Sciences spokesperson who preferred not to be identified, said, "It is possible that crops transformed to produce pharmaceutical or other industrial compounds might mate with plantations grown for human consumption, with the unanticipated result of novel chemicals in the human food supply."

Biopharm companies normally contract with selected farmers to grow their genetically engineered drug or chemical crops. The coalition contends that when one field is sown, all farmers, through their proximity to the test field, are exposed to substantial liability from the biopharming.

Neighboring farmers whose fields become contaminated with drug or chemical traits have no choice but to file expensive lawsuits against the biopharming companies.

On the other hand, biopharm companies that discover their patented drug traits in conventional farmers' contaminated fields could sue those farmers, alleging violation of the company's intellectual property rights.

The majority of engineered biopharmaceuticals and chemicals are incorporated into corn, a prolific pollinator, followed by soybeans, tobacco and rice. The engineered plants are then integrated into farmers' fields where it is impossible to detect their presence.

Contamination of farmers' corn by engineered insecticides is already widespread. Iowa farmer Laura Krouse said, "I've seen sales of open-pollinated corn drop 50-75 percent due to genetic pollution with engineered traits."

Corn is especially risky for pharmaceutical applications because it readily cross-pollinates and its pollen can travel for miles. This has been demonstrated by engineered StarLink corn, which contaminated food products and corn seed stock with a potentially allergenic protein even while companies were taking gene containment measures.

Nevertheless, two-thirds of open air biopharm field trials have been in corn. Experts have warned that current isolation standards will not prevent contamination of normal corn. According to the coalition's report, engineered viruses used to infect plants with drug genes could easily spread to related crops.

In response to one report of biopharm contamination, Chris Webster, a representative of Pfizer Pharmaceuticals said, "We've seen, on the vaccine side, where modified live seeds have wandered off and have appeared in other products."

ProdiGene, the company with the most plantings of drug and chemical producing plants, projects that 10 percent of the U.S. corn crop will be devoted to biopharm production by 2010.

Far from supporting containment strategies such as buffer areas, ProdiGene's CEO Anthony Laos is pressing for their elimination. He wrote farmers in 2001, "We will be dealing with these distances until we can gain regulatory approval to lessen or abandon these requirements altogether."

Some companies propose extracting drugs or chemicals from plants, then selling the remainder of the plant material. Incomplete extraction would mean drug and chemical residue in food or feed.

"Farmers cannot afford another contamination incident hurting sales and throwing the harvest into turmoil like StarLink did in 2000," said Matt Rand, biotechnology campaign manager at the National Environmental Trust.

The report cites indications that standard methods of pharmaceutical cultivation may be more cost effective and safer than open field testing.

Laboratories conventionally develop new drugs through extraction from animal or human tissues or production in animal, bacterial and yeast cell cultures. Newer techniques include plant cell cultures and secretion of biopharm proteins from plant roots into hydroponic media.

In contrast to open air biopharming, these methods are contained to the laboratory environment, greatly reducing contamination risks, the coalition maintains. These practices allow complete control of growth conditions where purification is easier, producing a more consistent drug quality.