Sins of omission still cause real lives to be lost.

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THE WALL STREET JOURNAL REVIEW & OUTLOOK EUROPE
SEPTEMBER 21, 2010
The FDA Versus Africa
Henry Miller

Hysteria over genetically modified crops hampers solutions to diarrhea mortality.

Since May, cholera has killed nearly 800 people in Nigeria and Cameroon alone, and the World Health Organization has recorded nearly 4,000 cases in the Lake Chad Basin. Inadequate access to clean water means that waterborne diseases like cholera spread rapidly, causing extreme diarrhea and deadly dehydration if left untreated. The U.N. estimates that diarrheal diseases kill 1.8 million people every year.

So you might take it as good news that American company Ventria Bioscience says it has hit on an improvement to existing rehydration therapies, which could mean another tool in the fight against diarrhea deaths. Ventria’s product consists of a genetically modified rice strain from which it cheaply extracts two proteins also found in human breast milk. After a panel of food, medicine, immunology, child nutrition and health experts had declared its product safe, Ventria in 2004 submitted it as a food supplement to the U.S. Food and Drug Administration.

The company waited, and heard nothing. Ventria re-submitted the product with still more data on its safety and efficacy, and then waited some more. Ventria CEO Scott Deeter tells us that in March this year, “when it became clear that the final approval letter was not forthcoming,” the company withdrew its submission.

Technically, Ventria doesn’t need the FDA’s approval to market its product as a food supplement. In the real world, however, it does. “The first question we get from potential partners and customers in the U.S. and around the world is ‘has the FDA responded to your product’s submission with a ‘no further questions’ letter?'” Mr. Deeter explains. Without that letter, the financial risks of producing and marketing the product become prohibitive. Nor has the FDA been of much further assistance. “The FDA never gave us any kind of roadmap,” Mr. Deeter adds, saying his company is now “trying to determine the best approach.”

Reported here in full in the public Interest

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David Tribe is an applied geneticist, teaching graduate/undergrad courses in food science, food safety, biotechnology and microbiology at the University of Melbourne.