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[SANET-MG] why allow pharming in the open environment?

The article below shows how basically goofy the USDA approval has been. USDA simply ignored the alternative production of lactoferrin in their review of the GM rice. I understand that the Agennix product is produced using fermentors cultivating the fungus, Aspergillus, bearing a human gene for lactoferrin. The product is as human as the human lactoferrin produced in rice. There is a number of publications on production of human lactoferrin in plant cell culture and these to have been ignored by USDA. The industry and academic public relations machinery has tried to promote a myth that pharm crops need to be grown in the open where they will pollute other crops and weeds such as red rice.The motive of industry and academe is clearly the drive to turn a quick buck. The motive of USDA is murky but seems to reflect their control by industry.

Competition grows in the biopharming market

Thursday, May 5, 2005

By Nancy Cole

The bad news for Ventria Bioscience, the California based biopharmaceutical company that drew rice-industry opposition for plans to produce human proteins in Missouri Bootheel fields, may not be over yet.

A Houston-based biotechnology firm claims it already manufactures pharmaceutical-grade human lactoferrin at costs similar to those estimated by Ventria. Rick Barsky, the chief executive officer of Agennix Inc., said the small, private company also holds dozens of patents worldwide for its lead product, talactoferrin alfa, which already is in human clinical trials for the treatment of cancer and diabetic ulcers. "Our actual costs are comparable to [Ventria’s] best guess of their projected costs," Barsky said. Ventria sought permits from the U.S. Department of Agriculture’s Biotechnology Regulatory Services to grow up to 200 acres this year in Missouri of rice genetically engineered with human lactoferrin and lysozyme, which it plans to use in an oral rehydration solution for treating children with acute diarrhea. Ventria’s plans drew opposition from Missouri rice farmers, who say that pharmaceutical rice poses an economic threat to their $93 million industry. Anheuser-Busch Cos. also threatened to boycott the state’s rice because of contamination fears, until Ventria agreed to plant 120 miles away from commercial fields. Last week Ventria’s president and chief executive officer, Scott Deeter, said the company was shelving plans to grow genetically modified rice this year in Missouri because the USDA permits were unlikely to be approved in time for planting. Instead, Ventria has applied for two permits to grow rice in North Carolina — a state with no commercial rice production — where the company already has a permit to grow its rice on 2.5 acres. Deeter said Ventria still plans to plant pharmaceutical rice next year in Missouri and to follow through on plans to relocate the company from Sacramento to Northwest Missouri State University in Maryville. Deeter did not return calls seeking a comment on Ventria’s production costs for human lactoferrin. "Biopharming" proponents argue that food crops offer a low-cost way to produce large volumes of pharmaceuticals. "It’s important to allow this work to go forward so that we can have new treatments for diseases," said Lisa Dry, a spokesman for the Biotechnology Industry Organization.

"The whole concept is that by using plants — instead of building a fermentation facility, which can cost from $500 [million] to $700 million and take five to seven years to build — you can produce drugs that might be too expensive... to produce otherwise," Dry said. Ventria’s vice president of research and development, Ning Huang, estimated his company’s cost of producing recombinant proteins using transgenic rice in a January 2004 article in the journal BioProcess International. Agennix’s Barsky said he suspected that such estimates often fail to include the cost of "meeting the ‘current Good Manufacturing Practice’ requirements for a pharmaceutical drug" that is regulated by the Food and Drug Administration. Plant-made pharmaceutical companies might have to spend even more money than Agennix to "show the level of purity and consistency and all of the safeguards that we show in our closed system," he said. Regardless of cost, Barsky said Ventria may have trouble selling human lactoferrin for a number of other reasons, including Agennix’s head start. "We’ve been developing it as a drug and we’re in human clinical trials with our recombinant human lactoferrin, which is not produced by genetically modified crops," he said. "We produce it in a pharmaceutical manufacturing facility." Since September 2002, Agennix has contracted the Dutch company DSM Pharma Products to manufacture more than 200 kilograms of human lactoferrin at DSM’s factory in Capua, Italy. Barsky said Agennix holds "over 75 issued patents and more than 50 pending patents" that give the company "broad protection on the composition of matter as well as on clinical applications," which could make it difficult for Ventria to sell human lactoferrin.

Arkansas Democrat-Gazette

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