Scientists Condemn Human Experiment with GE Food
 
The use of human subjects including children as young as 6 years old, in trials of a novel GE food is being condemned by scientists internationally and by GE Free NZ (in food and environment).
 
GE 'golden rice' has been promoted as a solution to malnutrition, despite other readily-available sources of vitamin A. Deficiencies of the vitamin are a cause of blindness amongst the poor.
 
The experimental rice has been highly contentious and now scientists are condemning feeding experiments being undertaken with human subjects by other researchers at Tufts University. The plans include testing the food on children. One report states:
"This project is to determine the vitamin A value (equivalence) of dietary provitamin A carotenes from spinach, Golden Rice, and pure ß-carotene (ß-C) in oil. These experiments will be conducted in children (ages 6-8) with/without adequate (marginal deficiency) vitamin A nutrition." *(3)
 
"Allowing human feeding trials of this experimental rice is highly concerning and  a frightening breach of human rights," says Jon Carapiet from GE-Free New Zealand.
 
"The New Zealand government must make its opposition clear and be a voice in the international community for the ethical use of science, just as we are for nuclear weapons."
 
Alarm about the experiments comes just days after the US authorities approved the first drug produced in GE animals following human clinical trials. The decision will increase commercial pressure for unethical experiments that are premature or exploit people in human trials. The predicted gold-rush to 'pharm' animals for medicines will impact New Zealand.
 
It threatens to transform Fonterra and New Zealand's reputation for the worse, as New Zealand is targetted for the production of pharmaceuticals in GE cows, sheep and other animals.
 
'Pharming' will blur the distinction between food and chemicals, disrupting our brand image far more significantly than the recent melamine contamination in milk powder in China.
 
"John Key and the National government must protect ethical standards in commercialised science at home and internationally," says Jon Carapiet. "It is morally right and in the national interest to speak out in opposition to unethical human experimentation whether it's for GE food or for GE medicine."  
ENDS
 
References
TUFTS UNIVERSITY INVOLVEMENT IN GOLDEN RICE FEEDING TRIALS
Professor Robert Russell, Professor Emeritus, Friedman
School of Nutrition Science and Policy Tufts University
School of Medicine 711 Washington Street Boston, MA 02111-
1524
Email: rob.russell@tufts.edu

Dear Professor Russell,

TUFTS UNIVERSITY INVOLVEMENT IN GOLDEN RICE FEEDING TRIALS
**********************************************************
We are writing to express our shock and unequivocal
denunciation of the experiments being conducted by your
colleagues which involve the feeding of genetically modified
Golden Rice to human subjects (adults and children.)  We are
all senior scientists / academics with a  professional
interest in the health and environmental effects of GMOs.

We refer to three trials described on the US Clinical Trials
web site:

1.  Project NCT 00680355.(10) Bioavailability of Golden Rice
Carotenoids in Humans.
http://clinicaltrials.gov/ct2/show/record/NCT00680355?term=golden

2.  Project NCT 00082420. Retinol Equivalence of Plant
Carotenoids in Children.
http://clinicaltrials.gov/archive/NCT00082420

3.  Project NCT 00680212. Vitamin A Equivalence of Plant
Carotenoids in Children.
http://clinicaltrials.gov/ct2/show/record/NCT00680212?term=golden

We wish to remind you that the variety of Golden Rice used
in these experiments (GR2) is inadequately described in
terms of biological and biochemical characterisation on the
Clinical Trials web site and indeed anywhere else in the
publicly available literature, and has  woefully inadequate
pre-clinical evaluation.  It is a genetically
modified
product which has not been shown to be distinctive, uniform
and stable over time.  It has never been through a
regulatory /approvals process anywhere in the world.  There
is now a large body of evidence that shows that GM crop/food
production is highly prone to inadvertent and unpredictable
pleiotropic effects, which can result in health damaging
effects when GM food products are fed to animals (for
reviews see Pusztai and Bardocz , 2006; Schubert, 2008; Dona
and Arvanitoyannis, 2009).  More specifically, our greatest
concern is that this rice, which is engineered to
overproduce beta carotene, has never been tested in animals,
and there is an extensive medical literature showing that
retinoids that can be derived from beta carotene are both
toxic and cause birth defects.

In these circumstances the use of human subjects (including
children who are already suffering illness as a
result of
Vitamin A deficiency) for GM feeding experiments is
completely unacceptable.  The three Projects listed breach
the Nuremberg Code / medical ethics code on a number of
counts, and we urge you to call them to a halt immediately.
They should not be resumed unless and until the researchers
can demonstrate that a full range of laboratory and animal
feeding trials have been completed and published for the
Golden Rice strain being used, and unless and until
appropriate regulatory bodies have had an opportunity to
come to a view on the health and safety issues about which
we are very concerned.

We can assure you that such trials would not have been
approved within the European Union in the absence of safety
information, which highlights yet again the flaw of the USDA
and FDA regulatory system in considering GM crops/foods as
hypothetically “generally recognised as safe – GRAS” in
the
absence of hard experimental data.

References:
***********

(1)     Pusztai A. and Bardocz S. (2006). GMO in animal
nutrition: potential benefits and risks. In: Biology of
Nutrition in Growing  Animals, eds. R. Mosenthin, J. Zentek
and T. Zebrowska, Elsevier  Limited, pp. 513-540.

(2)     Schubert D.R. (2008) The problem with nutritionally
enhanced  plants. J Med Food. 11: 601-605.

(3)     Dona A. and Arvanitoyannis I.S. (2009) Health Risks
of Genetically Modified Foods. Crit Rev Food Sci Nutr., 49:
164–175.

These unethical and potentially dangerous trials MUST be
stopped, and we ask you to undertake a thorough review of
why and how they were approved and funded in the first
place.  Please accept this letter as a formal protest, and
please forward it to the relevant authorities at USDA, FDA,
NIDDK, NIH and the US State Department.

ends