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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
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
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
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
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.
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