The FDA versus Africa

Posted: September 22nd, 2010 - 7:13am
Source: Wall Street Journal

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.


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