Golden Rice trial scandal

The Golden Rice Scandal Unfolds

Dr. Mae-Wan Ho and Prof. Joe Cummins: Phase II clinical trials on children have been conducted with unapproved experimental GM rice enhanced in pro-Vitamin A that has the potential to cause birth defects and developmental abnormalities

Clinical trials of unapproved, uncharacterized GM rice on children

goldenriceMore than 30 senior scientists and academics signed an open letter condemning researchers at Tufts University (Boston) in the United States for carrying out clinical trials of genetically modified (GM) ‘Golden Rice’ on children [1] (Scientists Protest Unethical Clinical Trials of GM Golden Rice). The scientists claimed that the trials were in breach of the Nuremberg Code of Ethics brought in at the end of the Second World War to prevent any repetition of the experiments conducted by Nazi scientists including many on children.

The ‘Golden Rice’ in the trials (GR2) appears to be an experimental collection of transgenic events still in the laboratory, uncharacterised in terms of basic molecular genetics or biological and biochemical properties, not tested pre-clinically on animals, or subjected to any other safety assessment.

Of the three studies listed on the US Clinical Trials website, two involved children. The first, “Retinol Equivalence of Plant Carotenoids in Children” [2] – a phase II trial to compare the vitamin A value of b-carotene in oil capsule, spinach and Golden Rice – recruited 72 children 7 to 9 years of age, and the start and finish dates were September 2004 and November 2005 respectively. The second study, with the same title and also a phase II trial [3], recruited 72 children 6 to 8 years of age and registered start and finish dates July 2008 and January 2009 respectively. No results are available for either of the studies (as of 17 March 2009).

The third study [4], “Bioavailability of Golden Rice Carotenoids in Humans”, listed as “ongoing, but not recruiting participants”, was a phase I trial on 6 adults 40 to 70 years of age. The start date was August 2004, and estimated completion date August 2008. Again, no results are available; though an article in Science (25 April 2008) [5] mentioned “a recent, soon-to-be-published study among healthy volunteers who ate cooked golden rice, led by Robert Russell of Tufts University in Boston.”

All the studies were done in the United States, though it appears that trials were also carried out and/or intended elsewhere.

The Golden Rice Project website [6] (accessed 17 March 2009), stated that “Golden Rice has gone through many tests since it was first obtained” Nine items are listed; but no feeding trial on animals among them. The final two items

“8. Tests for beta-carotene bioavailability and bioconversion to retinol….with deuterium-labelled Golden Rice fed to adults in USA and a small group of children in China have been conducted. The former were highly successful and the latter are being evaluated at present.

9. Feeding trials with human adults in China were carried out to measure the effect of fat in the diet, on bioconversion and bioavailability.”

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