Pharming in Peru
Take the latest research ethics controversy in Peru. The US biotech company Ventria Biosciences has been testing genetically modified rice there as a tool against childhood diarrhea, which claims the lives of millions of children in the developing world every year. Ventria is testing rice modified with synthetic human genes in order to produce lysozyme, a protein which is found in mother's milk and which aids rehydration. A Peruvian-lead study indicates that the 'genetically enhanced' rice powder speeds rehydration of babies by around 40%. So what's the problem, or problems?
One problem concerns the production of the genetically modified rice crop: there is a fear of contamination of 'normal' rice crops, and the subsequent entry of lysozyme-releasing rice into the commerical food chain. Ventria has already been booted out of Missouri and California, the boot taking the form mostly of Anheuser-Busch Inc. and other powerful rice interests, who know that their biggest consumer base (the Japanese) is not thrilled about genetically modified food. Who would want to eat Uncle Ben's thinking that mother's milk-imitating enzymes were stuck in there? Ventria's spokespersons try to point out that rice is self-pollinating, so the 'gene flow' normally associated with transgenic plants should be minimized. Maybe so. But once the spooky idea is in your head, it is hard to get out.
Another problem concerns (international) research ethics: do Ventria's Peruvian experiments involve the use of untested substances on babies in a country with lax regulations? According to Dr. Herberth Cuba, who runs the Peruvian Medical Association, that is exactly what is going on. It does not inspire confidence that Ventria has applied to the FDA to consider lysozyme "Generally Regarded as Safe" (or GRAS), a rather disquieting classification that apparently would spare Ventria the bother of running a clinical trial on its rice before children eat it in their studies. Of course, this would not be a genuine bioethics issue if opponents did not say the diametrical opposite: the untested substances in question are no more dangerous than mother's milk, the Peruvian studies have gone through stringent ethical review, and studies using Ventria's proteins are also being conducted with elderly hospitalized patients in undisclosed locations in the USA. But once the 'exploited developing world babies eating weird rice' picture gets in your head ...