PHA-Exch> The Golden Rice Scandal Unfolds

[Claudio Schuftan]

From: Flavio Valente valente at fian.org

http://www.fian.org/

This article can be found on the I-SIS website at

http://www.i-sis.org.uk/goldenRiceScandal.php

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ISIS Press Release 18/03/09     EXCERPTS

The Golden Rice Scandal Unfolds

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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 Dr. Mae-Wan Ho and Prof. Joe

Cummins



This report has been sent to the United States Food and Drug

Administration on behalf of ISIS



Clinical trials of unapproved, uncharacterized GM rice on

children



More 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.
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