Scientists Protest Unethical Clinical Trials of GM Golden Rice

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.

We look forward to hearing from you.

Yours sincerely,

Prof Malcolm Hooper,
Emeritus Professor of Medicinal Chemistry,
University of Sunderland
SUNDERLAND , SR2 3SD , UK .

Prof David Schubert
Salk Institute for Biological Studies
10010 N. Torrey Pines Road,
La. Jolla, CA 92037
USA

Professor Brian Goodwin
Schumacher College,
Dartington Hall Estate,
Totnes, Devon TQ9 6EA

Dr Michael Antoniou
Head: Nuclear Biology Group
King's College London School of Medicine
Department of Medical and Molecular Genetics
8th Floor, Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT, UK

Dr Vandana Shiva Ph D
Research Foundation for Science Technology and Ecology
105 Rajpur Road
Dehra Dun, India

Stanley W.B. Ewen M.B.Ch.B., Ph.D., F.R.C.Path.
Consultant Pathologist (Locum)
Department of Pathology,
University of Aberdeen,
Foresterhill
Aberdeen AB25 2ZD
UK

Dr Mira Shiva MD
Initiative for Health and Equity
A 60 Hauz Khas
New Delhi, 110016 India

Dr Brian John
(Past Lecturer in Geography, University of Durham)
Member, Independent Science Panel
Trefelin
Cilgwyn
Newport, Pembrokeshire SA42 0QN

Dr Phil Davies
Director,
Institute of Health and Environmental Research,
PO Box 155
Kensington Park, South Australia, 5068

Dr Irina Ermakova
Institute of Higher Nervous Activity and Neurophysiology RAS (IHNA)
Russian Academy of Sciences
Butlerov str., 5a,
Moscow 117463, Russia

Dr Judy Carman BSc (Hons) PhD MPH MPHAA
Epidemiologist and Biochemist
Director
Institute of Health and Environmental Research
PO Box 155
Kensington Park, South Australia, 5068

Prof E R Orskov
IFRU
Macaulay Institute
Craigiebuckler
Aberdeen AB15 8QH

Professor Leda Raptis, Ph.D.
Department of Microbiology and Immunology
and Dept. of Pathology
Botterell Hall, Room 713
Queen's University
Kingston, Ontario
Canada, K7L 3N6

Dr Eva Novotny
Associate, Institute of Science in Society,
Member Independent Science Panel,
25 Brownlow Road, Cambridge, CB4 3NG

Professor Peter T Saunders
Professor of Applied Mahematics
Department of Mathematics
King's College London
Strand, London WC2R 2LS

Dr E. Ann Clark,
Associate Professor
Department of Plant Agriculture
University of Guelph
Guelph, Ontario, Canada N1G 2W1

Professor Carlo Leifert
Res Dev Prof of Ecological Agriculture
Newcastle University School of Agriculture,
Food and Rural Development (SAFRD)
Nafferton Farm
Stocksfield
Northumberland, NE43 7XD, UK

Dr Mae-Wan Ho
Institute of Science in Society, PO Box 51885,
London, NW2 9DH, UK.

Professor Ralph C. Martin, Ph.D., P.Ag.,
Founding Director, Organic Agriculture Centre of Canada
Department of Plant and Animal Sciences
Nova Scotia Agricultural College
Truro, Nova Scotia, Canada B2N 5E3

Prof. Joe Cummins
Prof. Emeritus of Genetics,
University of Western Ontario,
738 Wilkins Street,
London, Ontario , Canada N6C4z9

Prof David Suzuki
Professor Emeritus
Zoology Dept.
University of British Columbia
Vancouver, BC, Canada

THIS LETTER IS ALSO SIGNED BY CHILDREN'S ADVOCATE JOAN KNOX

Joan Knox
Food Service Manager -Advocate for Children
University of Guelph Child Care and Learning Centre
University of Guelph. 50 Stone Road East .
Guelph, Ontario, N1G 2W1 Canada

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Copies:

Tufts Medical Center and TUHS Institutional Review Board -- Jennifer
A. Graf, BA
IRB Administrative and Operations Manager
jgraf@tuftsmedicalcenter.org

Dr David Chelmow
Chair, Tufts University Institutional Review Board
dchelmow@tuftsmedicalcenter.org

Dr Leslie Curtis
NIDDK Office of Communications and Public Liaison
lesliecurtis@mail.nih.gov

Dr Guangwen Tang
Golden Rice Project researcher
guangwen.tang@Tufts.edu

Article first published 16/02/09

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