'Pharma crop' interest grows; so does concern
By Terri Somers
UNION-TRIBUNE STAFF WRITER
June 2, 2004 (source: SignOnSanDiego.com)
Biotechnology companies quietly returned to the business of planting crops engineered to grow pharmaceutical products just 18 months after an errant crop nearly contaminated the food supply and put the brakes on the industry, according to a report yesterday from a national public interest group.
In the past 12 months, the U.S. Department of Agriculture received 16 applications to grow what are known as "pharma crops." Seven of them, including two to grow engineered rice and mustard in California, have been approved, according to the Center for Science in the Public Interest, based in Washington, D.C.
Pharma crops are corn, rice, barley, tobacco and other plants that have had foreign genes spliced into them so the plants can act as factories for producing proteins and enzymes that can be used in pharmaceutical products. To date, none of the products from these plants has been approved for commercialization.
Many of the details of the plans for growing these crops – such as where they will be planted, what is being spliced into them, and what commercial product they will be used for – have been shielded from public view because companies contend they include proprietary information, the CSPI said.
"It is impossible to know whether these biopharmed crops present any food safety or environmental risk," said Gregory Jaffe, director of the CSPI's biotechnology project and the author of the report. "What is clear is that the biopharming industry has been given a big green light by federal regulators, even though there is great concern among food producers and consumers about using food crops to produce drugs."
Pushing this science ahead is the biotechnology industry's need to find alternative and less expensive routes to bring new drugs to market. It takes more than $250 million and five to 10 years to get manufacturing rolling through current conventional methods, said Lisa Dry, communications director for the Biotechnology Industry Organization, or BIO.
"Plants are a more affordable alternative for doing similar work that's done in a manufacturing plant or for developing products that couldn't even be created in the traditional fermentation process," Dry said.
Potential products include insulin from safflower, a blood replacement from corn, hepatitis B vaccine from tobacco, cholera and Norwalk virus vaccines from potatoes and a human immune-system booster from rice.
At Stanford University, 16 lymphoma patients last year were treated with an experimental cancer drug extracted from a genetically engineered tobacco created by Large Scale Biology Corp., the first human use of a pharmaceutical derived from a plant.
Between 1995 and 2002, the USDA authorized the planting for pharma crops at more than 300 test field sites.
But the industry was dealt a hobbling blow in 2002. College Station, Texas-based ProdiGene revealed that corn it had been growing in Nebraska, which was engineered to create a pig vaccine, had mixed with conventionally grown soy headed for the food supply. The company was fined $500,000 and ordered to pay $3 million to buy and destroy the contaminated soy.
The incident was the general public's introduction to biopharming, Jaffe wrote in his report.
At the time, giant food manufacturers called for tighter regulation of such experiments, and biotech titan Monsanto Co. announced it was pulling out of the field. Last month, San Diego-based Epicyte, a startup involved in biopharming, closed its doors and sold its assets.
The USDA strengthened its rules for companies that wanted to biopharm.
Only four permits for biopharming were allowed between July 2002 and the end of June 2003. And last month, the CSPI decided to look at the USDA's public records to determine if the requests and approvals for pharmaceutical crops were dying out.
It found the contrary.
Half of the 16 permit applications to the USDA in the past year were filed in the last three months, according to the CSPI. The applications came from 10 institutions, including public research institutions and seven private companies, including ProdiGene.
More regulations urged
Two-thirds of the applications involved the use of crops typically used for food to grow pharmaceuticals. After the ProdiGene incident, critics of biopharming had pushed for the biotechnology industry to use non-food plants, such as tobacco.
It was impossible to determine from the public records how many acres of these crops would be planted and where specifically they would be located, the report states. The application simply names the states in which the planting would occur, including California.
The CSPI report urges the USDA to strengthen regulations on biopharming. The agency made some changes in the wake of the ProdiGene mishap, but they did not go far enough, Jaffe said.
The CSPI wants federal regulators to open up aspects of the regulatory approval process to the public and strengthen measures meant to ensure the crops do not get into the food supply.
Before a permit is issued, the public should have an opportunity to review the application and risk assessment and provide comments to the USDA, the report says.
Food industry groups agree there's a need for more stringent controls and public accountability.
"We oppose the use of food or feed crops to product plant-made pharmaceuticals unless there is a system in place to completely prevent an unintentional contamination of the food supply," said Tim Willard, a spokesman for the National Food Processors Association. The organization, whose focus includes food safety, also wants the USDA to take further steps to make its approval process more transparent, so that the public knows what the agency is doing to protect the safety of its food supply, he said.
The biotech industry does not object to making more information public – once the approval process is complete, said Dry, of BIO. But the location of the experimental growing plots is best left confidential so that the expensive science does not fall victim to opponents, she said, recalling an incident last year in France in which fields were destroyed.
The Grocery Manufacturers of America, which represents the Coca-Cola Co., Nestle and dozens of others in the $500 billion food industry, supports biotech crops approved for consumption. But it has called on the USDA to tighten regulation of pharma crops and for biotech companies to experiment exclusively with non-food crops.
"The current system in place with the Food and Drug Administration and the USDA is too piecemeal to ensure the purity of the food supply," said Stephanie Childs, a spokeswoman for the agency.
Review process changes
The USDA currently reviews permits for field trials of the plants. The FDA's oversight is limited to assessing the drug that can be produced from the plant's products and not whether the presence of the protein or enzyme in the plant has any food-safety implications, Childs said.
"There needs to be a comprehensive regulatory system in place to address the new advances in biotechnology," she said.
In response to the growing concern, the USDA plans to unveil a revised review process in the next three weeks that would make public more information on pharma applications and, for the first time since 1998, require detailed environmental assessments on large-scale projects near commercialization, said Cindy Smith, deputy administrator of biotech regulation for the department.
Smith said ProdiGene will be the first company to undergo the more stringent environmental review on the two applications it has pending to grow pharmaceutical corn in Texas this year.
The Associated Press contributed to this report.
Terri Somers: (619) 293-2028; email@example.com