Tufts Quietly Publishes Results Of GM Trials On Adults, Children In US, China, Many Without Consent


Click to enlarge... for a readable copy, visit the source links below.

Researchers at Tufts have some explaining to do, perhaps more here than hereafter -- though with precedents like those set by Baxter and their  
felonious company (also see this and this), it could very well be that only the Chinese accomplices to this crime will be punished.  

From EX-SKF:



The Chinese government says it has compensated the parents of the children with 80,000 yuan (US$12,800) each.

The director of Tufts University's Carotenoids and Health Laboratory is Chinese. Dr. Guangwen Tang has published her paper titled " Golden Rice is an effective source of vitamin A" in June 2009 issue of the American Journal of Clinical Nutrition.

What is "Golden Rice"? It's one of the projects supported by Bill and Melinda Gates Foundation.

Which multinational corporation is behind "Golden Rice"? Syngenta, of Switzerland.

Who's behind the clinical studies by this director of Carotenoids and Health Laboratory at Tufts University? The US government.

After Greenpeace busted the study in China, the Tuft University researcher continued the study using the US children. She is still at it, now using adults.

First, from China Daily (12/7/2012; emphasis is mine):
Parents of students in GM rice test win payout

by Qiu Quanlin

Parents whose children unknowingly took part in a study involving genetically modified rice in Hunan province have received compensation but said they are more worried about their youngsters' health.

Each of 25 families, whose children were fed 60 grams of the GM food "golden rice" in the study, received 80,000 yuan ($12,800) on Friday from local government authorities.

The study, which covered some 80 children then aged between 6 and 8, was conducted in a primary school in Jiangkou township, Hengnan county, in 2008.

"Compared with the compensation, I have more concerns over possible health hazards to my child," said Xie Xiaohua, whose 11-year-old daughter, Liao Ke, was included in the study.

The girl developed dizziness and fever shortly after the test, Xie said.

"We were not told before the test by relevant authorities that it was genetically modified rice. We were only asked to sign names and we thought it was a nutrition program," Xie told China Daily.

Investigations by health authorities show the research team told parents about the experiment but did not say GM rice would be used.

Xie said local authorities have not announced the names of the 25 children.

Authorities in Hengnan county have promised to take full responsibility if children suffer health problems as a result of the test.

Another mother, who gave her name only as Luo, told the Beijing News the local government will soon arrange for all children involved in the study to have medical checks.

"I signed the compensation agreement with the government on Dec 1. I would rather not have received the money. So far, I don't know how dangerous the "golden rice" will be to my child's health," said Luo, whose daughter was fed the GM food.

Three officials who approved and conducted the controversial test have been sacked, the Chinese Center for Disease Control and Prevention said on Thursday.

The officials are Yin Shi'an, from the center: Wang Yin, from the Zhejiang Academy of Medical Sciences: and Hu Yuming, from the Hunan Center for Disease Control and Prevention.

US-based Tufts University, which jointly organized the study, is aware of the announcement made by the Chinese health authorities.

"While we respect China's review process which led to the statement, it would be inappropriate to make further comments at this time as investigations are currently under way in the United States," Andrea Grossman, assistant director of public relations at the Massachusetts-based institution, was quoted as saying by Xinhua News Agency.

Grossman said the university launched a full review in August to determine if proper study procedures were followed. This was after becoming aware of questions about the "golden rice" study, raised after the test was disclosed by environmental group Greenpeace.

"We have also been cooperating with Chinese investigators engaged in their own review. We will continue to cooperate with China's authorities on this matter," Grossman said.

According to the Chinese statement, Guangwen Tang, director of the Carotenoids and Health Laboratory of Tufts University, cooked the GM rice in the United States and brought it to China on May 29, 2008, without declaring it to the Chinese authorities.

Four days later, Tang and other research participants re-cooked the rice, mixed it with ordinary rice and served it for the children's lunch.

The central government introduced a regulation in 2001 to ensure the safety of GM food, with strict provisions for research, testing, production and marketing such products, according to Xinhua.

The regulation states that those conducting GM agricultural experiments should have certain qualifications, and form a panel to oversee the safety of the experiments.

Contact the writer at qiuquanlin@chinadaily.com.cn

A non-profit organization in Wales in the UK called GM-Free Cymru alleges that this Golden Rice is an untested, unapproved GM variety. Further (emphasis is mine),
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.
After checking the government link on clinical trials above, the test of Golden Rice on young children in the US by Tufts University was completed in January 2009. According to the government page:
  • 72 children, aged 6 to 8, with or without adequate Vitamin A nutrition
  • Duration of the study, 21 days

It was a Phase 2 study, but GM-Free Cymru says Syngenta has admitted that there has been no animal studies. So they basically used children as lab animals.

I wonder what the incentive was for the parents of these 72 children to agree to have their children subjected to a GMO test. I wonder they knew what the test was about.

Ms. Guangwen Tang is currently recruiting participants in her Phase 1 study of "Bioavailability of Golden Rice Carotenoids in Humans":
  • A well-nourished population will be fed hydroponically grown Golden Rice
  • 15 adults, aged between 40 and 70 years

But the government data is as of April 2012. This clinical trial may have also been over.

Indeed.  Here is that ClinicalTrials.gov page, detailing that Phase 1 study of "Bioavailability of Golden Rice Carotenoids in Humans." Fifteen adults, and
click to enlarge
 even though the closing date was in August, no results provided, or link thereto, or any inkling thereof.  


But it is already December... and indeed, in the wonderful labyrinthine recessess of the NCBI database, a clue:



Lo and behold!  Golden Rice is an effective source of vitamin A!  That would, of course, hinge on the definition of 'effective.' Doubtful there is an effective effective enough to merit the sort of treatment that, quite against their wills and the will of their usually less protective Mother State, certain Chinese children were made to undergo.

There may be redress, even now. I, for one, am willing to offer what little I have towards this end, as, I am sure, are many of us.

 From one of the many figures meant to accompany that research piece we find this gem:




Experimental ethical framework 
for the Golden Rice human study. 

A three-tiered standard is used to justify the overall methodology in modern times, to progressively less compassionate stakeholders. 

The first standard or ethical protocol (upper class) is behind the actions of the sponsors of the study and the institution(s) facilitating the undertaking. 

The second standard or ethical protocol (middle class) forms the basis for the actions of the students and researchers who supported ongoing experimentation upon unsuspecting children and adults in China as well as in the United States. Each one of these individuals, considered intellectually fit by the larger society, tacitly condoned these actions, despite ethical considerations easily judged as questionable by even those the age of the unsuspecting children that became their guinea pigs. They had the chance to withdraw support, at the very least, if not blow the whistle on the whole affair, during every day on which the poison was unwittingly ingested. They did not. They were being paid but little for this. No pay should suffice.
click to enlarge;
when visiting link be sure to open in new window,
and click on header for source;  see  below for more details.


The third standard or ethical protocol (lower class) belongs to those paid even less, the janitors and common wage slaves, the security guards and undergrad part-time workers, the paralegals and assistant teachers, any of whom may have at one time or another, here or in China, become aware of what was going on. If such existed, either they chose not to rock the boat, or, having been brave enough to speak out perhaps, they lost their job as a result: no word has come to light. 

We encourage any such to come forward, anonymously if need be; see instructions here.

read more at 
http://ncbi.nlm.nih.gov/pmc/articles/PMC2682994/

Links:

Of  inestimable benefit to the Curious and Diligent, the links at:
(if you care about this topic do not fail to click this)

Source for Tufts student paper:

Guangwen Tang, Ph.D., curriculum vitae: http://hnrca.tufts.edu/people/scientists/q-z/guangwen-tang-ph-d/  

Clinical Trials, completed:

The published materials, meant to accompany
the Tufts work, available at
 http://ncbi.nlm.nih.gov/pmc/articles/PMC2682994/:  click on the header to retrieve the original study. 

And of course you should already be following EX-SKF, online and on Twitter.   (As well as me.)
Be seeing you.









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