GOLDEN RICE FEEDING TRIALS BREACH MEDICAL ETHICS CODE

GM Experiments involved sick Chinese children

Brian John
GM Free Cymru

Material recently released on the US Clinical Trials web site confirms that Chinese children suffering from varying degrees of Vitamin A deficiency have been used in feeding trials, contrary to the Nuremberg Code (1) which underpins modern medical ethics.

In three press releases (2) (3) (4) GM Free Cymru has drawn attention to the cynical attempts by the Syngenta Foundation and the Golden Rice Project to promote this GM variety as part of a grand humanitarian gesture which will solve the apparently intractable problem of Vitamin A deficiency in many of the poorer nations. Syngenta boasts that it has donated the patents for Golden Rice to the world, whereas it has done nothing of the sort (5).

Furthermore, in the publicity surrounding Golden Rice there is, as a matter of policy, an ongoing emphasis on the pretence that Golden Rice is "just rice" -- and in most of the literature there is no admission that this is an untested and unapproved GM variety which may well harm health rather than improving it (6).  The leading figures in the Golden Rice Project are using the variety to exert emotional or moral pressure on NGOs, and as a vehicle for dismantling regulatory controls in those countries which have them.  They also intend to ensure that such controls are not introduced in other poorer states.  The Golden Rice Humanitarian Board argues, with a snake's tear in its eye, that regulatory barriers are causing great delays in bringing their wonder product onto the market,  resulting in ongoing suffering in Vitamin A deficient populations.  The Bill and Melinda Gates Foundation is heavily implicated in this despicable campaign, and it has recently given  $5.4 million to the Donald Danforth Centre which will be directly devoted to political and lobbying activites (and probably diplomatic and economic blackmail as well) designed to break down regulatory resistance to GM crops in Africa.    The Donald Danforth Centre is located in St Louis, the home of Monsanto (7). The Rockefeller Foundation is also involved in lobbying and political activity on behalf of the Golden Rice project in developing countries (8).

One of the tactics employed by the proponents of Golden Rice is to plead that because it is a "humanitarian product" driven by charitable or philanthropic instincts and "owned" by the poor and sick people of the developing nations, it would be heartless to expect those poor people to expend many thousands of dollars conducting scientific experiments to verify the safety of the product and to put together the dossiers and complex applications which might lead to regulatory approvals in the USA, the EU and elsewhere.  This is another form of emotional blackmail, and it is of course nonsense.  The Syngenta Foundation, the Golden Rice Project and the Bill and Melinda Gates Foundation could, and should,  have put together regulatory approval dossiers long ago, and they have perfectly adequate resources at their disposal to have funded a considerable research programme on health, safety and environmental effects.  But they have chosen instead to spend nothing.

Another tactic is to achieve, as rapidly as possible, cross-breeding and experimentation which would spread patented Golden Rice traits across the world's rice-growing area.  From the early days of the project, Louisiana State University  -- the guilty party in the LL rice scandal of the last couple of years -- was involved in developing Golden Rice.  The LSU researchers were apparently working under Syngenta contracts.  On the Golden Rice Project web site it says this:  "While countries adopting the technology are free to introduce the trait into their preferred varieties, there are some criteria on which strategic decisions for selection should be based. For example, receptor rice varieties should preferably be widely used by farmers. Those varieties should also be expected to maintain prominence over time and be grown by most productive farmers in vitamin A deficiency-prone regions (for local and regional supply)."  This is nothing short of an invitation to wholesale cross-
breeding
and GM contamination of the rice supply chain  -- with the emphasis on the most productive and widespread varieties.  And it should not be forgotten that the patents are still owned by the GM corporations -- who will enforce them and collect their dues if and when hybrid Golden Rice varieties enter the global food marketplace.

Given the comprehensive abandonment of ethical behaviour by all of the key players in the Golden Rice Project, it comes as no surprise that medical ethics have now also been abandoned by the corporations and vested interests which are driving the project forward.  GM Free Cymru, and a number of journalists and researchers, have been attempting to discover whether any animal feeding experiments have ever been conducted in order to establish the safety (or otherwise) of Golden Rice.  There is no mention of any such tests on the Golden Rice Project web site or in any of the other literature about the rice breeding programme.  On being pressed, Syngenta finally admitted to one of the journalists that NO animal feeding experiments had been done.    In spite of that, the Project directors have initiated a series of feeding experiments with human beings used as the guinea-pigs (9).  The organization responsible for these experiments is the Golden Rice Humanitarian Board, supported by the
technology owners including Syngenta, Bayer AG, Monsanto Co, Orynova BV, and Zeneca Mogen BV. As indicated above, the Board is also supported by the Syngenta Foundation, the Rockefeller Foundation and by the Bill and Melinda Gates Foundation.  The work thus far has been channelled through the Laboratory for Human Nutrition at Tufts University, Boston in the United States, with the personal involvement of Prof Rob Russell (a member of the Golden Rice Humanitarian Board) and under the supervision of researcher Dr Guangwen Tang.  Prof Russell is also editor of the journal "Nutrition Reviews" and he is Vice-Chair of the Food and Nutrition Board of the US Institute of Medicine. Two projects have been completed so far, and one is on-going.  The details are as follows:

1.  Project NCT 00680355.(10) Bioavailability of Golden Rice Carotenoids in Humans.  This study, at Tufts University, involved feeding an "acute dose" of Golden Rice to 3 male and 3 female adults with normal Vitamin A status.  The location was registered as the USDA Human Nutrition Research Center on Aging at Tufts University, Boston, Massachusetts, USA. This study, under the direction of Dr Guangwen Tang, started in August 2004 and is no longer recruiting participants.  It is therefore presumably completed, and is being written up.  On the Clinical Trials web site there is a mention of the fact that Golden Rice is a GM variety.  There is no indication on the web site about the source of funds for this study.

2.  Project NCT 00082420. Retinol Equivalence of Plant Carotenoids in Children.  It has now been confirmed in information posted (16th January 2009) on the US Government's official clinical trials web-site that 24 children (aged between 7 and 10 years old) were fed two meals of Golden Rice per day over a period of seven days -- probably in 2004-2005.  The children were from Hang Zhou in Zhejiang Province, China.  Note that the only children excluded here were children with parasitic infections.  Some of them will certainly have been sick to some degree. Indeed, there can be no other rationale for conducting the experiments in China rather than the USA.  The sponsor for the research was the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (11).   In the feeding trial, one third of the trial group of 72 children received Golden Rice and the other two groups received either spinach or beta carotene oil capsules. (NB. This trial did not specify "healthy children
only"; on the trial web site there is no mention of the fact that Golden Rice is a GM variety; and there is no mention on the key project pages of the fact that the experiments were conducted in China.)

3.  Project NCT 00680212. Vitamin A Equivalence of Plant Carotenoids in Children.  We infer that the earlier trial with children was inconclusive, causing the managers of the Golden Rice Project to engineer so-called "improvements" in  later varieties of Golden Rice -- and to press on with another round of trials using children.  24 children of 6-8 years of age at the Center Primary School in Hengyang in Hunan province were to be used as guinea pigs.    Zhejiang Academy of Medical Sciences, Hang Zhou, China was initially shown as a project sponsor.  However, when Greenpeace alerted the Chinese authorities to the fact that Golden Rice is an unauthorised GM variety,    they refused to sanction the experiments (12) and pulled out of the project. Undeterred, the Tufts University team has now decided to press ahead.  On 6th February 2009 the US Clinical Trials web site posted news that the trial will now be conducted in the USA, not China. The study is currently recruiting participants; 24
children with and without Vitamin A deficiency will be fed on Golden Rice for an unspecified number of days.  Again, the source of funding is unspecified.
http://clinicaltrials.gov/ct2/show?term=golden+rice&rank=3

These experiments raise major ethical issues.  Very young children suffering from varying degrees of Vitamin A deficiency have been fed on an unauthorised and untested GM variety.  According to the Nuremberg Code, which underpins modern medical ethics, there are three principles which have been breached (13).    First, children under the age of ten do not have the legal capacity to give informed consent prior to being used in these experiments.    Second, it has in no case been demonstrated by Tufts University or the other participants that the results desired could not be obtained by other means of study.  And third, the studies were not preceded by animal experiments which might have shown up hazards for the trial subjects.  There has been a cavalier disregard for the safety of the vulnerable persons used in these tests, driven by the ideological conviction that Golden Rice is "just another rice."  It is most definitely NOT just another rice, as indicated in a number of studies (14).
And it is not just the genetic manipulation of the plant that causes concern, since studies have shown that in certain circumstances high doses of Vitamin A can in themselves be very damaging when fed to patients / normal consumers who are not suffering from Vitamin A deficiency. (15)

It is clear that there is more than a little sensitivity in the research community about the three Golden Rice feeding experiments.  The lead researcher, Dr Guangwen Tang, refuses to respond to Email messages, and when a journalist reached her by telephone she refused point-blank to answer any questions about the research.  It was only after persistent questioning of key Golden Rice promoters that the same journalist obtained an admission from Syngenta that there had been no animal feeding studies.

Culpability for this very severe ethical breach should not only be laid at the door of the primary research personnel (Prof Rob Russell and Dr Guangwen Tang) but also at the door of the sponsoring organizations (Tufts University and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)).  The studies have also been sanctioned by the Institutional Review Boards at both Tufts University and the Chinese Academy of Preventive Medicine.  Funding came from the National Institutes of Health, after internal review, and approval has also come from the US State Dept, the USDA and the FDA.  This means that whatever ethical concerns there might have been about this work, it has been approved in the United States at the highest level (16).  We should perhaps not be surprised by this, since there is no legal requirement in the U.S. for this kind of genetically engineered crop to receive any FDA safety review or to have any form of approval.  This is a result of successful
lobbying by the GM corporations over many years on a compliant and complacent US administration.

However, as far as we know, no GM food has ever been fed to people in the USA without voluntary data submission relating to the product for review by FDA.  The Golden Rice feeding experiments therefore clearly violate the spirit, if not the letter of the regulations, and demonstrate that there is no food safety regulatory system in the USA.    If this precedent is followed, companies which develop GM crops in the future could feed them to US citizens without any testing for safety, so long as they label them as "nutritionally enhanced."

GM researchers have reacted with horror to the news that sick Chinese children have been used as Golden Rice feeding guinea-pigs.  Dr Arpad Pusztai responded by saying:  "I am aghast! There is no ethics left even in the medical fraternity. Everything is for sale as in Gounod's Faust Lucifer sings: the whole world is for sale".  Dr David Schubert said:  "It is completely immoral to feed this rice to children without proper safety testing, and I can not believe that they are actually doing it!  It's like putting a new drug on the market with no toxicology or safety trials."    Dr Michael Antoniou (17) said: "....... it is of course completely unethical to conduct a feeding study with normal let alone weak Vit A deficient children with Golden Rice 2 (GR2). .........No animal feeding study data have been made available....... Without this biochemical and animal feeding testing it is completely unethical to plough ahead with human trials especially using children who will be far more
sensitive to toxic effects than adults."  In another comment Prof Malcolm Hooper said:    “This type of experimentation is frightening - children as lab rats - it is not on!”

It is worth reminding ourselves that the Nuremberg Code, which has been widely incorporated into international law, was drawn up in response to the inhumane Nazi human experimentation carried out during the war by individuals such as Dr. Josef Mengele.  The experiments on children, when they were revealed, caused revulsion throughout the world.  They happened because the perpetrators had lost all respect for human dignity, believed that they were above the law, and argued that in the cause of science the suffering imposed on the patients used in experiments was justifiable.  There are echoes of a current US court case in which the US drug company Pfizer is being sued on the basis that it violated international law banning involuntary medical experimentation when it tested a new drug on infants and children in Nigeria (18).  The plaintiffs have cited the Nuremberg Code, arguing that Pfizer, working with the Nigerian government, failed to secure the informed consent of either the
children or their guardians and failed to disclose or explain the experimental nature of the study or the serious risks involved.

The feeding of Golden Rice to sick children may or may not carry equivalent risks.  We just do not know -- and in its obsession with forcing Golden Rice onto poor people who do not really need it the Golden Rice Humanitarian Board, aided and abetted by scientists and regulators, has abandoned the ethical and humanitarian principles which it claims to hold in high regard.  These irresponsible and dangerous trials must be stopped immediately, and the Golden Rice Project team must put its much-vaunted product through a full and transparent testing process before it is allowed to pass the lips of any other human being.


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NOTES

(1)  http://ohsr.od.nih.gov/guidelines/nuremberg.html
http://en.wikipedia.org/wiki/Nuremberg_Code
http://www.hhs.gov/ohrp/irb/irb_appendices.htm
In the United States, parents may not authorize a child's participation in nontherapeutic research that entails more than minimal risk, although they may volunteer for such research themselves so long as they are fully informed as to risks and benefits.

(2)  Sick children used as GM feeding trial guinea-pigs
Press Release -- 8th January 2009
http://www.gmfreecymru.org/news/Press_Notice08Jan2009.htm

(3)  OPEN LETTER from GM Free Cymru
Gates Foundation awards Funds for pro-GM political lobbying and removal of regulatory obstacles
http://www.gmfreecymru.org/open_letters/Open_letter10Jan2009.html

(4) Golden Rice "Panacea" exposed as a con
http://www.gmfreecymru.org/
"The campaign for genetically modified rice is at the crossroads: A critical look at Golden Rice after nearly 10 years of development." By Christoph Then, January 2009 Commissioned by foodwatch in Germany
See: http://www.scouting-biotechnology.net http://www.foodwatch.de/foodwatch/content/e6380/e23456/e23458/ GoldenRice_english_final_ger.pdf

(5)  www.goldenrice.org/
Syngenta owns the patents and the commercial rights in Golden Rice.  It is not "giving away" the technology but sub-licensing it with very specific conditions.  The only farmers entitled to use the technology without charge are those earning less than $10,000 per year from farming.  Any larger farmers, and any trading of the Golden Rice or cross-bred varieties containing the Golden Rice traits, would be subject to agreements, conditions and royalties levied by Syngenta.  Syngenta gives no warranties relating to safety or nutritional quality, and expressly states it will accept no liabilities or costs arising from the breeding, growing or consumption of the rice crop.  So Syngenta keeps ownership, spreads the financial risk, accepts no liability, undermines the regulatory system, puts moral pressure on those who stand in the way of its ambitions, and still stands to make a killing if anybody (other than a small farmer) grows any Golden Rice hybrid in the future.

(6)  http://www.goldenrice.org/Content2-How/how8_tests.html
http://www.goldenrice.org/Content2-How/how4_regul.html

(7)  http://www.truthabouttrade.org/content/view/13106/54/
Gates grant will help Danforth Center fight hunger
Posted by Truth About Trade & Technology, Thursday, 08 January 2009,  St. Louis Post Dispatch

(8)  Rockefeller Foundation to helpGolden Rice obtain regulatory approval.
During her keynote speech at the World Food Prize's "Borlaug Dialogue" on 17 October 2008, the Foundation's president Judith Rodin announced that the Foundation would be providing funding to the International Rice Research Institute to shepherd Golden Rice through national, regulatory approval processes in Bangladesh, India, Indonesia, and the Philippines.
http://www.goldenrice.org/index.html

(9)  A planned trial in Germany involving mice was abandoned when it was discovered that the Golden Rice sample provided had less than 1% of the carotene anticipated, and that even that minute amount was reduced by 50% on cooking.
Golden Scare
http://www.businessworld.in/index.php/Economy-and-Banking/Golden-Scare.html
A new genetically modified rice strain is breeding controversy, by Noemie Bisserbe,  22 Aug 2008

(10)  http://clinicaltrials.gov/ct2/show/record/NCT00680355?term=golden+rice&rank=1
Nat Biotechnol. 2007 Jun; 25(6):623; author reply 624. Comment on:. Nat Biotechnol. 2006 Oct;24(10):1200-1.
What we know and don't know about Golden Rice. ...
www.ncbi.nlm.nih.gov/pubmed/17557091
by MB Krawinkel - 2006
Small-scale feeding trials carried out at Tufts University (Medford, MA, USA) in the United States indicate that the beta -carotene produced in Golden Rice ...
www.nature.com/nbt/journal/v25/n6/full/nbt0607-624a.html

(11)  Further details:
http://clinicaltrials.gov/ct2/show?term=golden+rice&rank=2
http://clinicaltrials.gov/archive/NCT00082420
http://clinicaltrials.gov/archive/NCT00082420/2005_06_30/changes
(Updated 30th June 2005)
Researchers:  Shi-an Yin, MD and PhD
Yin Wang, B.S.
Supervisor:  Prof Yin Wang
The Zhejiang Academy of Medical Sciences
Hang Zhou
Zhejiang Proviance
310013
China

(12) "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."  "Greenpeace has warned the governments in Bangladesh, India, Indonesia, Philippines and Vietnam not to allow such risky trials."
http://www.businessworld.in/index.php/Economy-and-Banking/Golden-Scare.html

(13)  http://ohsr.od.nih.gov/guidelines/nuremberg.html
These are the first three principles of the Nuremberg Code:

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.  The duty and responsibility for ascertaining the
quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

(14)  The Problem with Nutritionally Enhanced Plants, by David R. Schubert
JOURNAL OF MEDICINAL FOOD
J Med Food 11 (4) 2008, published on line
http://www.liebertonline.com/doi/abs/10.1089/jmf.2008.0094? prevSearch=allfield%3A(schubert)
Quote:    "........... with golden rice there has been concern about -carotene absorption, but none about the potential for teratogenesis. Indeed, in a recent article in Science on golden rice, there was no discussion about safety, despite the fact that simple derivatives of beta-carotene are known teratogens.  NEPs are designed to make molecules that are biologically active in animals. Given that the transfection procedures used to make GM plants cause random mutations that can alter the already unpredictable plant metabolism, that there will be unforeseen pleiotropic interactions between overproduced metabolites of introduced enzymes and normal plant metabolism, and that NEPs will likely have no required safety testing, there should be significant concern about allowing the introduction of this type of GM plant product into the marketplace."

(15)  Nutritional enhancement usually involves increasing the amounts of something in the diet and thus is sold as good for those who do not get
enough of that something. But these things are also BAD for some individuals and perhaps for nearly everyone sometimes or at some
concentrations. Vitamin A overdose has long been associated with birth defects in pregnant women. The amount of Vitamin A actually contained in Golden Rice is not sufficient as such for relieving Vitamin A deficiency in the malnourished and undernourished, but could be harmful to people who are healthy and well-nourished.  See Joanna Goven's report (http://www.conversations.canterbury.ac.nz/reportspapers.htm) on nutritional foods. See also http://www.abc.net.au/rn/healthreport/stories/2007/1861068.htm.

(16)  Letter from Dr Leslie Curtis of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), dated 9th February 2009.

(17)  Comment from Dr Michael Antoniou:  "........ it is of course completely unethical to conduct a feeding study with normal let alone weak Vit A deficient children with Golden Rice 2 (GR2). This product cannot be held up as having GRAS or substantial equivalence to non-GM equivalent rice as it contains nutrients that are not normally present; i.e., GR2 is NOT compositionally equivalent to non-GM and therefore fails to be GRAS or substantially equivalent. More importantly the available data of analysis of this product is very limited. There is no published data in terms of disturbances to the plant biochemistry and composition resulting from the GM transformation process and from having engineered a new biochemical process in the seeds of this rice plant. Disturbances are very likely. Apart from extensive biochemical analysis, there also need to be animal feeding studies to assess general toxic effects before contemplating a human feeding trial. No animal feeding study data is have
been made available, if animal tests have been conducted at all. Without this biochemical and animal feeding testing it is completely unethical to plough ahead with human trials especially using children who will be far more sensitive to toxic effects than adults. Have feeding studies been conducted by Syngenta with negative outcomes, which is why we do not hear about them? This may explain why there has been NO uptake of this product since its announcement in 2005."

(18)  http://www.sott.net/articles/show/174619-Pfizer-faces-war-crimes-lawsuits-under-Nuremberg-code-over-human-medical-experimentations