The International Academy of Life Sciences (IALS) claims that the "academic community" supports the idea of producing pharmaceuticals in food crops (item 1).

How far that is from the truth is demonstrated by an editorial from earlier this year from the normally aggressively pro-GM science jounal Nature Biotechnology: "we should be concerned about the presence of a potentially toxic substance in food plants. After all, is this really so different from a conventional pharmaceutical or biopharmaceutical manufacturer packaging its pills in candy wrappers or flour bags or storing its compounds or production batches untended outside the perimeter fence?" (item 2)

1.THE CENTER FOR FOOD SAFETY REFUTES CRITICISMS OF ITS GM RICE REPORT
2.EXCERPT from: Drugs in crops - the unpalatable truth
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1.THE CENTER FOR FOOD SAFETY REFUTES CRITICISMS OF ITS GM RICE REPORT
Phillip BC Jones
ISB News Reports, November 2004
http://www.isb.vt.edu/news/2004/news04.nov.html#nov0406

As detailed in last month's ISB News Report ("Plant-made pharmaceuticals: progress and protests"), Sacramento-based Ventria Bioscience sparked a controversy with its plan to cultivate rice engineered to synthesize pharmaceutical proteins.

In July, the Friends of the Earth, Center for Food Safety, Consumers Union, and Environment California sent copies of a 22-page report, "Pharmaceutical Rice in California," to California's Department of Food and Agriculture, Department of Health Services, and Environmental Protection Agency. After describing concerns about the genetically modified rice, the groups urged a moratorium on pharmaceutical-producing crops until state agencies have investigated potential impacts on human health and the environment.

A few weeks after the release of the report, representatives of the International Academy of Life Sciences (IALS) published its views. In a letter to the same three Californian agencies, Drs. Hilmar Stolte (Hannover Medical School, Germany) and Robert Rich (University of Illinois, Urbana-Champaign) countered that the report does not present an objective or accurate perspective of the risks. Stolte and Rich went further by concluding that "the authors of this report have intentionally confused ‘risk’ with ‘hazard,’ presenting the hazards as if they were risk."

The Center for Food Safety responded to the IALS allegations in a letter sent to the Californian health, agriculture, and environment agencies. At the outset, Dr. Doug Gurian-Sherman (Center for Food Safety) and Bill Freese (Friends of the Earth) targeted the IALS claim that the "academic community" supports the idea of producing pharmaceuticals in food crops. They pointed to recent studies from the National Research Council as evidence that this strategy for synthesizing drugs does not benefit from a consensus of the scientific community.

Gurian-Sherman and Freese tackled the IALS contention that their report confuses risk and hazard. Their report to the Californian agencies, they stressed, highlights that their concerns represent potential risks, or hazards that might occur. They explained that the groups called for the state’s agencies to perform an independent risk assessment to cure a deficiency in federal regulation. "Federal regulatory agencies," they asserted, "have not performed risk assessments to determine either how serious the identified hazards are, the levels of exposure that may cause harm, or the likelihood that they may occur." In their view, a responsible risk assessment process must find that a hazard does not exist, or, if the hazard does exist, that exposure to the hazard either does not occur or is too low to cause significant harm.

The Center’s response also contends that the IALS exaggerated the feasibility of producing pharmaceuticals from crops. Gurian-Sherman and Freese noted that the U.S. Food and Drug Administration has approved over 100 biopharmaceuticals produced in controlled fermentation facilities, whereas biopharming has not yielded an FDA-approved pharmaceutical despite 14 years of outdoor field trials. Since no plant-made pharmaceutical has reached the market, they argue, there’s no reason for a commitment to food crops to produce drugs; alternative plants should be considered.

Copies of the Center for Food Safety/Friends of the Earth response and the "Pharmaceutical Rice in California" report are available at the Center’s website (http://www.centerforfoodsafety.org/policy_com.cfm).

Phillip B.C. Jones, PhD., J.D.
Spokane, Washington
This email address is being protected from spambots. You need JavaScript enabled to view it.
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2.EXCERPT from: Drugs in crops - the unpalatable truth
Editorial, Nature Biotechnology
doi:10.1038/nbt0204-133
February 2004 Volume 22 Number 2 p 133
http://www.nature.com/cgi-taf/DynaPage.taf?file=/nbt/journal/v22/n2/full/nbt0204-133.html
or
http://www.lobbywatch.org/archive2.asp?arcid=2621

...One might expect - and some in the industry obviously do - that drug production in plants could be good for the image of GM crops. After all, new/cheaper medicines are the sort of thing that consumers want.

The problem is - as anti-GM lobbyists have argued already - that the production of drugs or drug intermediates in food or feed crop species bears the potential danger that pharmaceutical substances could find their way into the food chain through grain admixture, or pollen-borne gene flow (in maize, at least) or some other accidental mix-up because of the excusably human inability to distinguish between crops for food and crops for drugs. The 'contamination' of soybeans and non-GM corn in 2002 with a corn engineered by Prodigene to produce an experimental pig vaccine shows just how plausible this is (Nat. Biotechnol. 21, 3, 2003).

This position is not anti-GM (something industry should appreciate) - we should be concerned about the presence of a potentially toxic substance in food plants. After all, is this really so different from a conventional pharmaceutical or biopharmaceutical manufacturer packaging its pills in candy wrappers or flour bags or storing its compounds or production batches untended outside the perimeter fence?