方舟子鼓吹的转基因金大米：在中国湖南违规儿童人体试验被禁止 (转载)# Returnee - 海归
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发信人: smokinggun (硝烟), 信区: Military
标 题: 方舟子鼓吹的转基因金大米：在中国湖南违规儿童人体试验被禁止
发信站: BBS 未名空间站 (Sat Jan 28 09:52:16 2012, 美东)
08年美国Tufts University资助人体试验，但是没有获得中国许可就在湖南衡阳进行了
20几个6到8岁儿童的进食试验，后被中国政府叫停
http://save-our-rice.net/news/single/article/15/rice-is-life-1.
http://www.bangmfood.org/feed-the-world/17-feeding-the-world/37
GOLDEN SCARE - A NEW GENETICALLY MODIFIED RICE STRAIN IS BREEDING
CONTROVERSY
Category: GE Rice
A clinical trial was cut short in China last month when the government found
that 24 children of 6-8 years of age at a primary school in Henyang in
Hunan province were to be used as guinea pigs to test a new variety of
genetically modified rice known as golden rice.
But, ironically, in the midst of a host of controversies, India’s state-
owned research labs — Indian Agricultural Research Institute in New Delhi,
Tamil Nadu Agricultural University (TNAU) and Hyderabad-based Directorate of
Rice Research — are conducting research on golden rice.
”We are breeding golden rice with local species but we are yet to develop a
potential line that would meet our dietary requirements,” says S.R. Rao,
director at the Department of Biotechnology (DBT) of the Ministry of Science
and Technology, who coordinates the golden rice project in India. ”There
are still many issues that we need to solve before coming out of the green
house. For now, there are no proposals to carry out clinical trials in India
.”
Golden rice, created by Swiss agri products firm Syngenta, owes its pale
yellow colour to beta-carotene, which helps build vitamin A. It is not
approved for commercial use anywhere in the world and has never been tested
on humans.
The China trial, sponsored by Tufts, a private US research university, had
received approval from the US National Health Institute, but not from the
Chinese government. Authorities were alerted by Greenpeace, which was then
told that ”no foreign genetically modified rice was imported into China for
the trial”. Still, the incident could steer a new debate on genetically
modified organisms (GMOs).
Greenpeace has warned the governments in Bangladesh, India, Indonesia,
Philippines and Vietnam not to allow such risky trials. ”There is no
evidence that this rice is safe,” says Jai Krishna, a campaigner with
Greenpeace in India.
The debate over genetically-engineered crops erupted when they made their
commercial debut in the mid-1990s. European environmentalists and consumer
advocacy groups were the first to launch major protests that have since
spread worldwide. Most genetically-engineered crops introduced represent
minor variations on two themes: resistance to insect pests, and to
herbicides used to control weed growth. And they are often marketed by
multinational companies that produce and sell the very agricultural
chemicals farmers spray on their fields.
But golden rice was touted as the first example of a GMO that could help
save more than a million children who die every year weakened by vitamin-A
deficiency, and another 350,000 who go blind in Asia and Africa.
Many countries, including India, have vitamin A supplementation programmes
for children under five. Since many children rely on rice as a staple food,
the genetic modification to make rice produce vitamin A was seen as a simple
and cheaper alternative to vitamin supplements, green vegetables or animal
products.
However, over a decade after it was created in 1999 by Ingo Potrykus of the
Institute of Plant Sciences at the Swiss Federal Institute of Technology and
Peter Beyer of the University of Freiburg, golden rice is still in the labs
, and scientists remain unable to address the safety and environmental
concerns it raises.
In 2005, Syngenta produced a variety of golden rice called Golden Rice 2,
which produces 23 times more carotenoids than the original. Syngenta donated
the variety to institutions across China, India, Philippines, Indonesia,
Bangladesh and Vietnam, for research.
While Syngenta holds some patents on golden rice, it has said that farmers
who make $10,000 (about Rs 4.4 lakh) or less a year would be issued free
licences. So, it may have little commercial interest in the project. ”But
once a GMO is accepted, it will be easier for them to push for other
varieties too,” argues Krishna.
Meanwhile, scientists accuse anti-GM ”well-fed folk” of disrupting
technology that will benefit the poor. ”There is no merit in activists’
arguments against golden rice,” says S.K. Datta, chair professor at the
University of Calcutta. ”They just want to say no to GMOs.”
It remains unclear when golden rice could be launched in India. ”It is
difficult to say how much time it will take for a line to be identified and
approved,” says D. Sudhakar, who is leading the research on golden rice at
TNAU. Adds Rao: ”It may take us another two years just to take a product
out of the lab, after which pre-clinical studies on animals would be
conducted.”
India’s National Biotechnology Regulatory Bill 2008 — mooted by the DBT,
and whose draft was published earlier this year — sets the stage for the
establishment of the National Biotechnology Regulatory Authority (NBRA), an
independent body that would provide single-window clearance for GM products
and processes. ”This Bill will facilitate the approval process for GM
products,” says Datta.
However, the Bill has been facing fierce opposition. Last month, a group of
50 farmer leaders and NGO representatives from 15 states wrote a letter to
Prime Minister Manmohan Singh, asking him to drop the Bill immediately.
Separately, Greenpeace said that ”the rationale for replacing the existing
structure with the government’s single National Biotechnology Regulatory
and an inter-ministerial group chaired by a reputed scientist is essentially
to accelerate the process of GMO approvals”.
Naturally, Rao does not agree: ”The Bill does not give a clean chit to GMOs
; it creates a very procedural and transparent system.” DBT has recently
completed a process to gather feedback on both draft documents from various
stakeholders at the Central and state levels. In an interview
earlier this month with the UK’s Daily Telegraph, the Prince of Wales
warned that the mass development of genetically modified crops could cause
the world’s worst environmental disaster. His comments may spark a new
global debate on GMOs.
But at a stage where Indian state officials have come to suggest eating rats
to reduce dependence on rice, the timing may be right for GMO advocates,
and genetically-modified crops to play a role in guaranteeing food security.
But the question remains whether it would create more problems than it
would solve.
Businessworld, India, Noemie Bisserbe (22.08.2008)
www.businessworld.in/index.php/Economy-and-Banking/Golden-Scare.html
Golden Rice: A dangerous experiment PDF Print E-mail
In February 2009 a group of 22 international scientists and experts
addressed an open letter to Prof Robert Russell at Tufts University School
of Medicine, who is in charge of clinical trials on GM Golden Rice,
protesting at clinical trials of GM Golden Rice being conducted on adults
and children.[1]
The authors say that the trials breach the Nuremberg Code, brought in at the
end of World War II to prevent any repetition of the experiments conducted
on people by Nazi scientists.
The authors say that Golden Rice:
* is inadequately described in terms of biological and biochemical makeup
* has not been shown to be stable over time – GM crops have been found to
be unstable in that their genetic makeup as revealed in tests has differed
from that described by the company and scrambling of the genome at the site
of insertion sometimes occurs[2]
* has never been through a regulatory /approvals process anywhere in the
world.
The authors’ concerns are backed by a large body of evidence showing that
GM crop/food production produces unintended effects, which can result in
damage to health when GM foods are fed to animals.[3] There is no evidence
to suggest that Golden Rice is any safer than these GM foods.
The authors of the letter to Prof Robert Russell protesting at the Golden
Rice human feeding trials conclude, “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.”
This is not the first time that clinical trials of Golden Rice have become
mired in controversy. In the summer of 2008 it was reported that a clinical
trial on Golden Rice was cut short in China in July 2008, when the
government found that 24 children 6-8 years of age at a primary school in
Henyan, Hunan, were to be used as guinea pigs.[4]
Golden Rice not proven safe to eat
When pharmaceutical drugs are tested for safety, they are first tested on
animals. Only if animal studies reveal no harmful effects is the drug
further tested on human volunteers. If animal tests with a drug were to
yield results similar to those seen in feeding studies carried out with GM
foods, the drug would most likely be disqualified for further development.
Golden Rice has never been subjected to feeding trials on animals. It is
therefore criminally irresponsible to test it on humans.
The absence of animal testing data on Golden Rice is especially worrying as
Golden Rice is engineered to overproduce beta carotene, and studies show
that some retinoids derived from beta carotene are toxic and cause birth
defects.[5][6][7][8][9] In particular, high concentrations of the retinoid
called retinol are toxic.[10]
One of the breakdown products of beta-carotene, RA, is biologically active
at much lower concentrations than retinol, and for this reason excess RA or
RA derivatives are extremely dangerous, particularly to infants and during
pregnancy.[11]
In his review of GM nutritionally enhanced plants, David R. Schubert of
Cellular Neurobiology Laboratory, The Salk Institute for Biological Studies,
La Jolla, California, argues that “rigorous, multigenerational animal
safety assessments with the hope of identifying risks to health” are needed
for all such plants before they are commercialized.[12]
Defenders of Golden Rice have claimed that as humans and not animals are the
intended consumers, animal feeding trials are unnecessary.
This argument is a common one from advocates of GM, but it is fatally flawed
. It is true that animal feeding trials on Golden Rice may not answer the
questions of how much vitamin A humans would derive from eating the rice and
how effective it would be in solving vitamin A deficiency in humans. But
when it comes to testing for toxic effects, animal feeding trials have been
found to be a valuable indicator.
It is especially important to carry out such toxicological testing on GM
foods because unexpected toxins or allergens may arise from the GM process
itself. These may result from genetic disruptions or disturbed biochemistry
arising from new enzyme activities in a place where they do not normally
occur. The same enzyme working in different plant hosts and cellular
environments, as is the case with Golden Rice, can participate in different
biochemical reactions – and produce by-products that affect health.
For these reasons, animal testing is the standard investigation performed to
assess possible toxicity both in drugs and in new GM foods. Why should
Golden Rice be an exception?
With regard to testing for efficacy and assimilation of the beta-carotene in
Golden Rice, defenders of the product say that beta-carotene is broken down
differently in animals than in humans and so animal testing is irrelevant.
But ferrets have been identified by researchers as animals that break down
beta-carotene in a similar way to humans.[13] Why has efficacy and
assimilation not been tested on them?
Golden Rice appears to have escaped animal testing because of the pervasive
attitude to GM in the USA, which was initiated and perpetuated by industry
in partnership with government. Under the US system, GM crops and foods are
classed as "GRAS" (Generally Recognised As Safe). This is a completely
theoretical evaluation which means that industry can do no safety testing at
all and still get products approved.
Tellingly, on the Golden Rice Humanitarian Board website (www.goldenrice.org
), the header for the section "Tests performed on Golden Rice" reads, "It's
just rice". The unnamed authors claim, "Detailed molecular analyses have
failed to find new allergens showing up as a consequence of having
introduced a new gene into a plant, and determination of the expression
levels of ten-thousands of genes have also shown that the only changes
encountered are related to the introduced genes and those involved in
related metabolic pathways." But no data have been published to enable
independent scientists and the public to evaluate these claims. As one
scientist told GMWatch, "If data isn't published, it doesn't exist."
Bizarrely, the "Research on Health Effects" section of the Golden Rice
website lists publications NOT on Golden Rice but on general research on the
health effects of vitamin A. Even more bizarrely, the main publications
listed are by the United Nations (UN) and the World Health Organisation (WHO
). The UN and WHO report success from their long-running programmes to
combat vitamin A deficiency (VAD) in those places where they have been
implemented. These tried-and-tested programmes involve cheap, traditional,
and readily available solutions such as vitamin A supplements and
encouraging home growing of vitamin A-rich leafy green vegetables. Golden
Rice has never been a part of these programmes. Yet in a sleight-of-hand
that has become all too typical in the GM industry, the Golden Rice
Humanitarian Board is using data from those programmes to promote its risky,
heavily patented, and expensive technological 'solution' to VAD!
Golden Rice not proven safe for the environment
No data have been published on the environmental risks of Golden Rice. These
may include the possibility that the rice will cross-pollinate with other
cultivated rice and wild rice.
Golden Rice not proven effective
No data have been published on how much beta-carotene is in the rice after
four weeks of storage and 20 minutes of cooking.
It’s important to note that Golden Rice does not contain vitamin A, but a
vitamin A precursor, beta-carotene, that needs to be converted by the body
into usable vitamin A.
No data have been published on the bioavailability and conversion into
vitamin A of the beta-carotene in Golden Rice – how much is actually taken
up and converted into a useful nutrient by the body.
No data have been published on the bioavailability and conversion into
vitamin A of the beta-carotene in Golden Rice in people who are deficient in
other nutrients. The target consumers of Golden Rice are the malnourished,
but these people are lacking in many nutrients, some of which (e.g. fats and
iron) are necessary for the uptake and use of beta-carotene. This fact
undermines the entire “single nutrient” assumption behind the Golden Rice
project.
Better alternatives are available
"GE rice could, if introduced on a large scale, exacerbate malnutrition and
undermine food security because it encourages a diet based on a single
industrial staple food rather than upon the reintroduction of the many
vitamin-rich food plants with high nutritional value that are cheap and
already available." – Professor Klaus Becker, University of Hohenheim,
Germany
“Real-world studies [on Golden Rice] are still lacking, says WHO
malnutrition expert Francesco Branca, noting that it’s unclear how many
people will plant, buy, and eat golden rice. He says giving out supplements,
fortifying existing foods with vitamin A, and teaching people to grow
carrots or certain leafy vegetables are, for now, more promising ways to
fight the problem.” [14]
WHO launched its strategy to combat vitamin A deficiency (VAD) in 1998. It
describes the strategy as follows: [15]
*promoting breastfeeding, as breast milk is a natural source of vitamin A
and protects babies from VAD
*supplying high-dose vitamin A supplements for deficient children. This has
proven a simple and low-cost intervention that has produced remarkable
results, reducing mortality by 23% overall and by up to 50% for acute
measles sufferers
*food fortification, which takes over where supplementation leaves off.
Sugar fortified with vitamin A in Guatemala maintains vitamin A status,
especially for high-risk groups and needy families.
*cultivating the garden is the next phase necessary to achieve long-term
results. For vulnerable rural families, for instance in Africa and South-
East Asia, growing fruits and vegetables in home gardens enables a diverse
diet and contributes to better lifelong health. This is backed by research
in South Africa. A home-gardening program that was integrated with nutrition
education, and focused on the production of yellow and dark-green leafy
vegetables, significantly improved the vitamin A status of 2-5-year-old
children in a rural village in South Africa. [16]
Changing agricultural models have contributed to vitamin A deficiency
Interestingly, WHO’s recommended practice of growing beta-carotene-rich
leafy vegetables in home gardens was common in developing countries before
the arrival of World Bank, IMF and other Western-backed programmes that
forced farmers into growing cash crops for export. This fact is recognized
in a World Bank report, which notes, “Cash crops are useful for generating
income but export vegetables may not be meeting local demand for
micronutrient-rich foods.”
The report also says, “Home gardens can be both a major household food
resource and a source of income. It recognizes that the role of home gardens
in solving nutrient deficiencies have been ignored by policy makers because
they lack the status of marketed crops (and often do not appear on any
economic balance sheet). Home gardens are also frequently the domain of
women, which further reduces their status.[17]
It is ironic that Golden Rice is a “solution” promoted by Western
interests to a problem that was arguably generated by Western interests in
the first place.
Notes
1. Tufts University Involvement in Golden Rice Feeding Trials. Letter from
scientists and experts to Professor Robert Russell, Professor Emeritus,
Friedman School of Nutrition Science and Policy, Tufts University School of
Medicine, February 2009, archived at http://www.i-sis.org.uk/SPUCTGM.php
2. Collonnier C, Berthier G, Boyer F, Duplan M-N, Fernandez S, Kebdani N,
Kobilinsky A, Romanuk M, Bertheau Y (2003). Characterization of commercial
GMO inserts: a source of useful material to study genome fluidity. www.crii-
gen.org
3. Reviews include: 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; Schubert D.R. (2008) The problem with nutritionally enhanced
plants. J Med Food., 11: 601-605; Dona A. and Arvanitoyannis I.S. (2009)
Health Risks of Genetically Modified Foods. Crit Rev Food Sci Nutr., 49: 164
–175.
4. Noemie Bisserbe, “Golden scare: A new genetically modified rice strain
is breeding controversy”, Businessworld, 22 August 2008, http://www.businessworld.in/index.php/Economy-and-Banking/Golden-Scare.html
5. McCaffery PJ, Adams J, Maden M, Rosa-Molinar E: Too much of a good thing:
retinoic acid as an endogenous regulator of neural differentiation and
exogenous teratogen. Eur J Neurosci 2003;18: 457–472.
6. Adams J, Holson RR: The neurobehavioral teratology of vitamin A analogs.
In: Handbook of Developmental Neurotoxicology (Slikker W, Chang LW, eds.).
Academic Press, San Diego, CA, 1998, pp. 631–642.
7. Marcus R, Coulston AM: Fat-soluble vitamins. In: The Pharmacological
Basis of Therapeutics, 10th ed. (Hardman JG, Limbird LE, Gilman AG, eds.).
McGraw Hill, New York, 2001, pp. 1773–1791.
8. Teelmann K: Retinoids: toxicology and teratogenicity to date. Pharmacol
Ther 1989;40:29–43.
9. Wyatt EL, Sutter SH, Drake LA: Dermatological pharmacology. The
Pharmacological Basis of Therapeutics, 10th edition (Hardman JG, Limbird LE,
Gilman AG, eds.). McGraw Hill, New York, 2001, pp. 1795–1818.
10. Adams J, Holson RR: The neurobehavioral teratology of vitamin A analogs.
In: Handbook of Developmental Neurotoxicology (Slikker W, Chang LW, eds.).
Academic Press, San Diego, CA, 1998, pp. 631–642.
11. Marcus R, Coulston AM: Fat-soluble vitamins. In: The Pharmacological
Basis of Therapeutics, 10th ed. (Hardman JG, Limbird LE, Gilman AG, eds.).
McGraw Hill, New York, 2001, pp. 1773–1791.
12. David R. Schubert, “Perspective: The Problem with Nutritionally
Enhanced Plants”, J Med Food 11 (4) 2008, DOI: 10.1089/jmf.2008.0094.
13. Morphology of ferret subcutaneous adipose tissue after 6-month daily
supplementation with oral beta-carotene. Incoronata Muranoa, Manrico
Morronia, Maria Cristina Zingarettia, Paula Oliverb, Juana Sánchezb,
Antonia Fusterb, Catalina Picób, Andreu Paloub and Saverio Cinti.
Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease, Volume
1740, Issue 2, 30 May 2005, pp. 305-312
14. Enserink, M. 2008. Tough Lessons From Golden Rice. Science, 230, 468-471.
15. Vitamin A deficiency, World Health Organisation website, http://www.who.int/nutrition/topics/vad/en/index.html
16. Faber Mieke; Phungula Michael A S; Venter Sonja L; Dhansay Muhammad A;
Benadé A J Spinnler (2002). Home gardens focusing on the production of
yellow and dark-green leafy vegetables increase the serum retinol
concentrations of 2-5-y-old children in South Africa. The American journal
of clinical nutrition 2002;76(5):1048-54.
17. “Best Practices in Addressing Micronutrient Malnutrition” by Judith
McGuire, The World Bank, 1818 H Street NW, Washington DC, 20433, http://www.unscn.org/archives/scnnews09/ch2.htm
GMWatch May 2009
发信人: smokinggun (硝烟), 信区: Military
标 题: 方舟子鼓吹的转基因金大米：在中国湖南违规儿童人体试验被禁止
发信站: BBS 未名空间站 (Sat Jan 28 09:52:16 2012, 美东)
08年美国Tufts University资助人体试验，但是没有获得中国许可就在湖南衡阳进行了
20几个6到8岁儿童的进食试验，后被中国政府叫停
http://save-our-rice.net/news/single/article/15/rice-is-life-1.
http://www.bangmfood.org/feed-the-world/17-feeding-the-world/37
GOLDEN SCARE - A NEW GENETICALLY MODIFIED RICE STRAIN IS BREEDING
CONTROVERSY
Category: GE Rice
A clinical trial was cut short in China last month when the government found
that 24 children of 6-8 years of age at a primary school in Henyang in
Hunan province were to be used as guinea pigs to test a new variety of
genetically modified rice known as golden rice.
But, ironically, in the midst of a host of controversies, India’s state-
owned research labs — Indian Agricultural Research Institute in New Delhi,
Tamil Nadu Agricultural University (TNAU) and Hyderabad-based Directorate of
Rice Research — are conducting research on golden rice.
”We are breeding golden rice with local species but we are yet to develop a
potential line that would meet our dietary requirements,” says S.R. Rao,
director at the Department of Biotechnology (DBT) of the Ministry of Science
and Technology, who coordinates the golden rice project in India. ”There
are still many issues that we need to solve before coming out of the green
house. For now, there are no proposals to carry out clinical trials in India
.”
Golden rice, created by Swiss agri products firm Syngenta, owes its pale
yellow colour to beta-carotene, which helps build vitamin A. It is not
approved for commercial use anywhere in the world and has never been tested
on humans.
The China trial, sponsored by Tufts, a private US research university, had
received approval from the US National Health Institute, but not from the
Chinese government. Authorities were alerted by Greenpeace, which was then
told that ”no foreign genetically modified rice was imported into China for
the trial”. Still, the incident could steer a new debate on genetically
modified organisms (GMOs).
Greenpeace has warned the governments in Bangladesh, India, Indonesia,
Philippines and Vietnam not to allow such risky trials. ”There is no
evidence that this rice is safe,” says Jai Krishna, a campaigner with
Greenpeace in India.
The debate over genetically-engineered crops erupted when they made their
commercial debut in the mid-1990s. European environmentalists and consumer
advocacy groups were the first to launch major protests that have since
spread worldwide. Most genetically-engineered crops introduced represent
minor variations on two themes: resistance to insect pests, and to
herbicides used to control weed growth. And they are often marketed by
multinational companies that produce and sell the very agricultural
chemicals farmers spray on their fields.
But golden rice was touted as the first example of a GMO that could help
save more than a million children who die every year weakened by vitamin-A
deficiency, and another 350,000 who go blind in Asia and Africa.
Many countries, including India, have vitamin A supplementation programmes
for children under five. Since many children rely on rice as a staple food,
the genetic modification to make rice produce vitamin A was seen as a simple
and cheaper alternative to vitamin supplements, green vegetables or animal
products.
However, over a decade after it was created in 1999 by Ingo Potrykus of the
Institute of Plant Sciences at the Swiss Federal Institute of Technology and
Peter Beyer of the University of Freiburg, golden rice is still in the labs
, and scientists remain unable to address the safety and environmental
concerns it raises.
In 2005, Syngenta produced a variety of golden rice called Golden Rice 2,
which produces 23 times more carotenoids than the original. Syngenta donated
the variety to institutions across China, India, Philippines, Indonesia,
Bangladesh and Vietnam, for research.
While Syngenta holds some patents on golden rice, it has said that farmers
who make $10,000 (about Rs 4.4 lakh) or less a year would be issued free
licences. So, it may have little commercial interest in the project. ”But
once a GMO is accepted, it will be easier for them to push for other
varieties too,” argues Krishna.
Meanwhile, scientists accuse anti-GM ”well-fed folk” of disrupting
technology that will benefit the poor. ”There is no merit in activists’
arguments against golden rice,” says S.K. Datta, chair professor at the
University of Calcutta. ”They just want to say no to GMOs.”
It remains unclear when golden rice could be launched in India. ”It is
difficult to say how much time it will take for a line to be identified and
approved,” says D. Sudhakar, who is leading the research on golden rice at
TNAU. Adds Rao: ”It may take us another two years just to take a product
out of the lab, after which pre-clinical studies on animals would be
conducted.”
India’s National Biotechnology Regulatory Bill 2008 — mooted by the DBT,
and whose draft was published earlier this year — sets the stage for the
establishment of the National Biotechnology Regulatory Authority (NBRA), an
independent body that would provide single-window clearance for GM products
and processes. ”This Bill will facilitate the approval process for GM
products,” says Datta.
However, the Bill has been facing fierce opposition. Last month, a group of
50 farmer leaders and NGO representatives from 15 states wrote a letter to
Prime Minister Manmohan Singh, asking him to drop the Bill immediately.
Separately, Greenpeace said that ”the rationale for replacing the existing
structure with the government’s single National Biotechnology Regulatory
and an inter-ministerial group chaired by a reputed scientist is essentially
to accelerate the process of GMO approvals”.
Naturally, Rao does not agree: ”The Bill does not give a clean chit to GMOs
; it creates a very procedural and transparent system.” DBT has recently
completed a process to gather feedback on both draft documents from various
stakeholders at the Central and state levels. In an interview
earlier this month with the UK’s Daily Telegraph, the Prince of Wales
warned that the mass development of genetically modified crops could cause
the world’s worst environmental disaster. His comments may spark a new
global debate on GMOs.
But at a stage where Indian state officials have come to suggest eating rats
to reduce dependence on rice, the timing may be right for GMO advocates,
and genetically-modified crops to play a role in guaranteeing food security.
But the question remains whether it would create more problems than it
would solve.
Businessworld, India, Noemie Bisserbe (22.08.2008)
www.businessworld.in/index.php/Economy-and-Banking/Golden-Scare.html
Golden Rice: A dangerous experiment PDF Print E-mail
In February 2009 a group of 22 international scientists and experts
addressed an open letter to Prof Robert Russell at Tufts University School
of Medicine, who is in charge of clinical trials on GM Golden Rice,
protesting at clinical trials of GM Golden Rice being conducted on adults
and children.[1]
The authors say that the trials breach the Nuremberg Code, brought in at the
end of World War II to prevent any repetition of the experiments conducted
on people by Nazi scientists.
The authors say that Golden Rice:
* is inadequately described in terms of biological and biochemical makeup
* has not been shown to be stable over time – GM crops have been found to
be unstable in that their genetic makeup as revealed in tests has differed
from that described by the company and scrambling of the genome at the site
of insertion sometimes occurs[2]
* has never been through a regulatory /approvals process anywhere in the
world.
The authors’ concerns are backed by a large body of evidence showing that
GM crop/food production produces unintended effects, which can result in
damage to health when GM foods are fed to animals.[3] There is no evidence
to suggest that Golden Rice is any safer than these GM foods.
The authors of the letter to Prof Robert Russell protesting at the Golden
Rice human feeding trials conclude, “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.”
This is not the first time that clinical trials of Golden Rice have become
mired in controversy. In the summer of 2008 it was reported that a clinical
trial on Golden Rice was cut short in China in July 2008, when the
government found that 24 children 6-8 years of age at a primary school in
Henyan, Hunan, were to be used as guinea pigs.[4]
Golden Rice not proven safe to eat
When pharmaceutical drugs are tested for safety, they are first tested on
animals. Only if animal studies reveal no harmful effects is the drug
further tested on human volunteers. If animal tests with a drug were to
yield results similar to those seen in feeding studies carried out with GM
foods, the drug would most likely be disqualified for further development.
Golden Rice has never been subjected to feeding trials on animals. It is
therefore criminally irresponsible to test it on humans.
The absence of animal testing data on Golden Rice is especially worrying as
Golden Rice is engineered to overproduce beta carotene, and studies show
that some retinoids derived from beta carotene are toxic and cause birth
defects.[5][6][7][8][9] In particular, high concentrations of the retinoid
called retinol are toxic.[10]
One of the breakdown products of beta-carotene, RA, is biologically active
at much lower concentrations than retinol, and for this reason excess RA or
RA derivatives are extremely dangerous, particularly to infants and during
pregnancy.[11]
In his review of GM nutritionally enhanced plants, David R. Schubert of
Cellular Neurobiology Laboratory, The Salk Institute for Biological Studies,
La Jolla, California, argues that “rigorous, multigenerational animal
safety assessments with the hope of identifying risks to health” are needed
for all such plants before they are commercialized.[12]
Defenders of Golden Rice have claimed that as humans and not animals are the
intended consumers, animal feeding trials are unnecessary.
This argument is a common one from advocates of GM, but it is fatally flawed
. It is true that animal feeding trials on Golden Rice may not answer the
questions of how much vitamin A humans would derive from eating the rice and
how effective it would be in solving vitamin A deficiency in humans. But
when it comes to testing for toxic effects, animal feeding trials have been
found to be a valuable indicator.
It is especially important to carry out such toxicological testing on GM
foods because unexpected toxins or allergens may arise from the GM process
itself. These may result from genetic disruptions or disturbed biochemistry
arising from new enzyme activities in a place where they do not normally
occur. The same enzyme working in different plant hosts and cellular
environments, as is the case with Golden Rice, can participate in different
biochemical reactions – and produce by-products that affect health.
For these reasons, animal testing is the standard investigation performed to
assess possible toxicity both in drugs and in new GM foods. Why should
Golden Rice be an exception?
With regard to testing for efficacy and assimilation of the beta-carotene in
Golden Rice, defenders of the product say that beta-carotene is broken down
differently in animals than in humans and so animal testing is irrelevant.
But ferrets have been identified by researchers as animals that break down
beta-carotene in a similar way to humans.[13] Why has efficacy and
assimilation not been tested on them?
Golden Rice appears to have escaped animal testing because of the pervasive
attitude to GM in the USA, which was initiated and perpetuated by industry
in partnership with government. Under the US system, GM crops and foods are
classed as "GRAS" (Generally Recognised As Safe). This is a completely
theoretical evaluation which means that industry can do no safety testing at
all and still get products approved.
Tellingly, on the Golden Rice Humanitarian Board website (www.goldenrice.org
), the header for the section "Tests performed on Golden Rice" reads, "It's
just rice". The unnamed authors claim, "Detailed molecular analyses have
failed to find new allergens showing up as a consequence of having
introduced a new gene into a plant, and determination of the expression
levels of ten-thousands of genes have also shown that the only changes
encountered are related to the introduced genes and those involved in
related metabolic pathways." But no data have been published to enable
independent scientists and the public to evaluate these claims. As one
scientist told GMWatch, "If data isn't published, it doesn't exist."
Bizarrely, the "Research on Health Effects" section of the Golden Rice
website lists publications NOT on Golden Rice but on general research on the
health effects of vitamin A. Even more bizarrely, the main publications
listed are by the United Nations (UN) and the World Health Organisation (WHO
). The UN and WHO report success from their long-running programmes to
combat vitamin A deficiency (VAD) in those places where they have been
implemented. These tried-and-tested programmes involve cheap, traditional,
and readily available solutions such as vitamin A supplements and
encouraging home growing of vitamin A-rich leafy green vegetables. Golden
Rice has never been a part of these programmes. Yet in a sleight-of-hand
that has become all too typical in the GM industry, the Golden Rice
Humanitarian Board is using data from those programmes to promote its risky,
heavily patented, and expensive technological 'solution' to VAD!
Golden Rice not proven safe for the environment
No data have been published on the environmental risks of Golden Rice. These
may include the possibility that the rice will cross-pollinate with other
cultivated rice and wild rice.
Golden Rice not proven effective
No data have been published on how much beta-carotene is in the rice after
four weeks of storage and 20 minutes of cooking.
It’s important to note that Golden Rice does not contain vitamin A, but a
vitamin A precursor, beta-carotene, that needs to be converted by the body
into usable vitamin A.
No data have been published on the bioavailability and conversion into
vitamin A of the beta-carotene in Golden Rice – how much is actually taken
up and converted into a useful nutrient by the body.
No data have been published on the bioavailability and conversion into
vitamin A of the beta-carotene in Golden Rice in people who are deficient in
other nutrients. The target consumers of Golden Rice are the malnourished,
but these people are lacking in many nutrients, some of which (e.g. fats and
iron) are necessary for the uptake and use of beta-carotene. This fact
undermines the entire “single nutrient” assumption behind the Golden Rice
project.
Better alternatives are available
"GE rice could, if introduced on a large scale, exacerbate malnutrition and
undermine food security because it encourages a diet based on a single
industrial staple food rather than upon the reintroduction of the many
vitamin-rich food plants with high nutritional value that are cheap and
already available." – Professor Klaus Becker, University of Hohenheim,
Germany
“Real-world studies [on Golden Rice] are still lacking, says WHO
malnutrition expert Francesco Branca, noting that it’s unclear how many
people will plant, buy, and eat golden rice. He says giving out supplements,
fortifying existing foods with vitamin A, and teaching people to grow
carrots or certain leafy vegetables are, for now, more promising ways to
fight the problem.” [14]
WHO launched its strategy to combat vitamin A deficiency (VAD) in 1998. It
describes the strategy as follows: [15]
*promoting breastfeeding, as breast milk is a natural source of vitamin A
and protects babies from VAD
*supplying high-dose vitamin A supplements for deficient children. This has
proven a simple and low-cost intervention that has produced remarkable
results, reducing mortality by 23% overall and by up to 50% for acute
measles sufferers
*food fortification, which takes over where supplementation leaves off.
Sugar fortified with vitamin A in Guatemala maintains vitamin A status,
especially for high-risk groups and needy families.
*cultivating the garden is the next phase necessary to achieve long-term
results. For vulnerable rural families, for instance in Africa and South-
East Asia, growing fruits and vegetables in home gardens enables a diverse
diet and contributes to better lifelong health. This is backed by research
in South Africa. A home-gardening program that was integrated with nutrition
education, and focused on the production of yellow and dark-green leafy
vegetables, significantly improved the vitamin A status of 2-5-year-old
children in a rural village in South Africa. [16]
Changing agricultural models have contributed to vitamin A deficiency
Interestingly, WHO’s recommended practice of growing beta-carotene-rich
leafy vegetables in home gardens was common in developing countries before
the arrival of World Bank, IMF and other Western-backed programmes that
forced farmers into growing cash crops for export. This fact is recognized
in a World Bank report, which notes, “Cash crops are useful for generating
income but export vegetables may not be meeting local demand for
micronutrient-rich foods.”
The report also says, “Home gardens can be both a major household food
resource and a source of income. It recognizes that the role of home gardens
in solving nutrient deficiencies have been ignored by policy makers because
they lack the status of marketed crops (and often do not appear on any
economic balance sheet). Home gardens are also frequently the domain of
women, which further reduces their status.[17]
It is ironic that Golden Rice is a “solution” promoted by Western
interests to a problem that was arguably generated by Western interests in
the first place.
Notes
1. Tufts University Involvement in Golden Rice Feeding Trials. Letter from
scientists and experts to Professor Robert Russell, Professor Emeritus,
Friedman School of Nutrition Science and Policy, Tufts University School of
Medicine, February 2009, archived at http://www.i-sis.org.uk/SPUCTGM.php
2. Collonnier C, Berthier G, Boyer F, Duplan M-N, Fernandez S, Kebdani N,
Kobilinsky A, Romanuk M, Bertheau Y (2003). Characterization of commercial
GMO inserts: a source of useful material to study genome fluidity. www.crii-
gen.org
3. Reviews include: 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; Schubert D.R. (2008) The problem with nutritionally enhanced
plants. J Med Food., 11: 601-605; Dona A. and Arvanitoyannis I.S. (2009)
Health Risks of Genetically Modified Foods. Crit Rev Food Sci Nutr., 49: 164
–175.
4. Noemie Bisserbe, “Golden scare: A new genetically modified rice strain
is breeding controversy”, Businessworld, 22 August 2008, http://www.businessworld.in/index.php/Economy-and-Banking/Golden-Scare.html
5. McCaffery PJ, Adams J, Maden M, Rosa-Molinar E: Too much of a good thing:
retinoic acid as an endogenous regulator of neural differentiation and
exogenous teratogen. Eur J Neurosci 2003;18: 457–472.
6. Adams J, Holson RR: The neurobehavioral teratology of vitamin A analogs.
In: Handbook of Developmental Neurotoxicology (Slikker W, Chang LW, eds.).
Academic Press, San Diego, CA, 1998, pp. 631–642.
7. Marcus R, Coulston AM: Fat-soluble vitamins. In: The Pharmacological
Basis of Therapeutics, 10th ed. (Hardman JG, Limbird LE, Gilman AG, eds.).
McGraw Hill, New York, 2001, pp. 1773–1791.
8. Teelmann K: Retinoids: toxicology and teratogenicity to date. Pharmacol
Ther 1989;40:29–43.
9. Wyatt EL, Sutter SH, Drake LA: Dermatological pharmacology. The
Pharmacological Basis of Therapeutics, 10th edition (Hardman JG, Limbird LE,
Gilman AG, eds.). McGraw Hill, New York, 2001, pp. 1795–1818.
10. Adams J, Holson RR: The neurobehavioral teratology of vitamin A analogs.
In: Handbook of Developmental Neurotoxicology (Slikker W, Chang LW, eds.).
Academic Press, San Diego, CA, 1998, pp. 631–642.
11. Marcus R, Coulston AM: Fat-soluble vitamins. In: The Pharmacological
Basis of Therapeutics, 10th ed. (Hardman JG, Limbird LE, Gilman AG, eds.).
McGraw Hill, New York, 2001, pp. 1773–1791.
12. David R. Schubert, “Perspective: The Problem with Nutritionally
Enhanced Plants”, J Med Food 11 (4) 2008, DOI: 10.1089/jmf.2008.0094.
13. Morphology of ferret subcutaneous adipose tissue after 6-month daily
supplementation with oral beta-carotene. Incoronata Muranoa, Manrico
Morronia, Maria Cristina Zingarettia, Paula Oliverb, Juana Sánchezb,
Antonia Fusterb, Catalina Picób, Andreu Paloub and Saverio Cinti.
Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease, Volume
1740, Issue 2, 30 May 2005, pp. 305-312
14. Enserink, M. 2008. Tough Lessons From Golden Rice. Science, 230, 468-471.
15. Vitamin A deficiency, World Health Organisation website, http://www.who.int/nutrition/topics/vad/en/index.html
16. Faber Mieke; Phungula Michael A S; Venter Sonja L; Dhansay Muhammad A;
Benadé A J Spinnler (2002). Home gardens focusing on the production of
yellow and dark-green leafy vegetables increase the serum retinol
concentrations of 2-5-y-old children in South Africa. The American journal
of clinical nutrition 2002;76(5):1048-54.
17. “Best Practices in Addressing Micronutrient Malnutrition” by Judith
McGuire, The World Bank, 1818 H Street NW, Washington DC, 20433, http://www.unscn.org/archives/scnnews09/ch2.htm
GMWatch May 2009