Unauthorized Human Experiments Using Children in China

Guangwen Tang of Tufts University published a study on benefits of a genetically modified rice, 'Golden Rice', in the American Journal of Clinical Nutrition: β-Carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children, Am J Clin Nutr 2012;96:658-664. Scientific value and long-term effect of genetically engineered agricultural produce is a very sensitive topic, and up to debate by experts in the research community. However, the paper drew public outcry in the way these experiments were executed. Allegedly, ethic protocols in human research were not properly applied and quite a few laws and regulations were broken in the mean time.

There are a minor issue and a big problem surrounding the study, commented by the Greenpeace, that it 'could not have taken place without a serious breach of scientific and medical ethics, and goes against a Chinese government decision to abort plans for the trail.'

The minor issue was the experiment had not been performed on animals. Skipping animal tests itself did not violate any law or regulations, but some experts believe it is a calculated step to hide inheritable long term effects of consuming GE products, which will be discussed in a moment without making a distraction from the big problem.

The big problem is that it was halted and banned in China moments after the experiments started in 2008. Zou Ping of the GE Safety Office of the Ministry of Agriculture of China stated on July 24, 2008, that the research group told Chinese authorities they had not started the experiments, and had not imported the GE 'Golden Rice'. The research group was subsequently ordered to abort the experiment effective immediately by the Department of Agriculture of the Zhejiang Province.

The American researchers originally applied a permit from the Agriculture Department of Zhejiang Province, which was rescinded almost immediately, but the experiments were carried out in Hunan Province. The equivalent would be seeking permit for State of California to conduct an experiment with human as subjects in West Virginia. A permit from Zhejiang was pursued initially because the P.I.'s connections with a joint position at the Zhejiang Academy of Medicine Science. Hunan was selected as the testing field probably for reasons can't be discussed in public.

Both the Ministry of Agriculture of China and the Department of Agriculture of Zhejiang Province where the original permit were granted ordered the experiments to be stopped immediately, and banned the import of 'Golden Rice' for experimental purpose of this very study.

Nevertheless, seventy-two 6-8 year old kids in an elementary school in Hengyang of Hunan Province participated in this multi-year experiments. On paper, Hunan is probably a better place for the subject of this study on nutrition, because it is a poor area. Children with malnutrition are good subjects to respond to any compliments. However, the real reason might rest on the nationally infamous corrupted government officials in the region. With a strong anti-GM sentiment in China, which may not be rational or scientific but that's another story for another day, there is less than a slim chance to find a group of parents in any classroom to agree to feed their children with GM produce. Although the 'elementary school' was not revealed by Tufts University, more likely than not and unsurprisingly, it will turn out to be a government run orphanage. Although relatively lagging behind in China, ordinary residents of Hunam, in particular Hengyang, consumed multiple times of meat products than the average of European countries. It is not a deprived place as described in the report of this study. India, or perhaps France would be a better place for this study sponsored by the USDA. Where-else but a government-run orphanage can they find a group of children in one school suffering nutrition deficiency?

In 2005, twenty-seven members of a children trafficking gang were arrested by Guangdong police. They confessed they had stolen or purchased secondhand over 1,000 children from Guangdong Province. The children were sold at price between $400 and $538 per head to some government run orphanages in Hengyang, Hunan. These children were then sold by the local government to adoptive families from overseas, mostly from the US at about $3,000 each. Hengyang government forged entire set of documentations from police report, birth certificate to medical history as proof that these children were indeed orphans from Hunan. Ten suspects were sentenced to jail time between 1 to 15 years after a trail at a court in Qidong County.

Government run orphanages in Hunan Province had a history of making profits on human trafficking. Using them as guinea pigs is probably a lesser guilt, after all.

After the story went viral on Weibo on an alarm message from the Greenpeace, Hengyang government along with the Party Committee vowed to jointly launch a thorough investigation into this scandal.

Although China has never approved any GM produce for commercial production, many major yields were already contaminated with GM plants. Since January 2012, within half year, the EU had issued 19 emergent warnings against Chinese agricultural produce after imports from China were found GM positive.

Dr. Guangwen Tang is Director of Carotenoids and Health Laboratory of Jean Mayer USDA HNRCA at Tufts University in Boston, Massachusetts. She holds a visiting professorship at the Zhejiang Academy of Medical Sciences in Hangzhou, China. Unlike an adjunct professorship, a visiting professor is a full time job in academia. Although we do not have details of the arrangement between Tufts University and Zhejiang Academy of Medical Sciences, it could be a narrow space between a misdemeanor and a felony to claim benefits of a visiting professor while not staying in China in a full time capacity.

Tang has a Master's Degree in Chemistry from Nanjing University and a PhD in Chemistry from Rutgers University.

Tang can hardly claim being used as a cat's paw, when she by-passed a direct ban from Chinese authorities on this very experiment to feed a group of 6-8 years old school children a potentially dangerous product that had yet to be tested on animals. Having a PhD from Rutgers University, Tang should fully aware that a similar move in the US would without any doubt land a researcher in jail. Corrupt local government officials and lack of enforcing of existing regulations is not an excuse to knowing put children in harms way, even in name of scientific research.

Co-authors of this study include Hu Yuming of Hunan Province Center for Disease Control and Prevention, Yin Shi'an of Maternal & Child Nutrition, National Institute for Nutrition and Food Safety, Wang Yin of Zhejiang Academy of Medical Sciences, Gerard E Dallal of Tufs University, Michael A Grusak of USDA-ARS Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine and Robert M Russell of the Office of Dietary supplements of NIH.

The work is sponsored by the US Department of Agriculture (USDA) and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Health (NIH).

It is noted in the paper that the study was approved by

• the Institutional Review Board of Tufts Medical Center, and
• the Ethics Review Committee of Zhejiang Academy of Medical Sciences

The irony here is obvious: analogously, one committee in France and another committee in California approved human experiments on a group of six year old children in remote West Virginia (counting on hillbilly parents do not know better), despite specific orders to abort the experiment issued by both the US federal government and the West Virginia State government.

Tang's team was not the first case of Chinese born US researchers took advantage of Chinese people living in remote poverty areas. In late 1990s, Dr. Xiping Xu of Harvard University obtained an over $100 million funding from US based Millennium, a pharmaceutical company, to collect gene information from Auhui Province, a place known for poverty and illiterate population. Dr. Xu, with a proven aptitude for getting things done in China (uncooperative farmers were sent to face communist officials), later admitted to having stolen 16,000 serum samples used for drug development.

In response to criticisms from research communities in both China and the US, Dr. Xu employed Great Cultural Revolution tactics to write senior Chinese officials. Dr. Xu advocated censorship on any reporting in China regarding gene study for three years. Harvard's spokewoman Herman said of the Xu's letters, 'we are absolutely appalled by their tone. We are also very disappointed if any faculty member would try to suppress any discussion or criticism of their work.' After the Anhui incident, NIH forwarded a guideline drafted by the US Embassy in China to steer researchers away from poverty areas in China on such experiments because of concerns that it might be impossible to fulfill the duty to inform. Somehow, Tang and her team at Tufts University did not receive the memo, it seems.

Back to Hunan in 2008, it looks like a win-win situation for multiple parties involved: the USDA get valuable data on human experiments on six year old kids. The Tufts University and the Zhejiang Academy of Medicine Sciences got paper published. The manufacture of 'Golden Rice' obtained never before available children testing data. Unfortunately they all come at the cost of 72 children in a rural town in Hengyang, Hunan Province. The second author works at a government agency in the Hunan Province, but the research must feel it an unbearable burden to report this to his employer in Hunan.

The study claimed the 'Golden Rice' is as effective in converting beta-carotene into vitamin A. However, there are unmistakable scientific flaws:

1. The experiments should have been conducted on animals first, not only for the reason that lab mice are not human, or children in this case. Lab mice are used in biological experiments because they can be easily reproduced many generation during a shot time, thus enable observations of lasting effects over generations;

2. As mentioned earlier, the subjects in this experiments, although in a rural township in a poverty area of China, they are still healthy kids with enough nutrition intake, including abundant sources for vitamin A. On average, a Chinese consumes 60kg (132 lbs) meat each year, not as much as one in the US, but more than almost everyone else in the world. For example, that figure doubles value for a Korean (in South Korea). Hunan is right in the middle among other provinces on this measure. A study in another country, actually in any country but China and US, would be more appropriate and convincing to the goal as targeted in this study.

   A widely cited number of 11% Chinese children suffer from VDA was the result of a survey sponsored by a commercial company making vitamin D supplement in 2000. Even if that number stood, people would need to factor in the fast increase of meat consumption in China. Average meat consumption increased 13 times between 1949 to 2009. In reality, much of this improvement happened after 1980.

   It is counterintuitive to have this experiment carried out in Hunan, China. The puzzle may be easily solved, if taking into consideration that it will not be allowed to proceed in any other country in today's world.

Update:

The 'elementary school' turned out not an orphanage as we had suspected earlier. It is the Central Elementary School of Jiangkou Township in Hengnan County, Heyang Prefecture, Henan Province.

However, it is disturbing to read what a grunted parent posted on an online forum regarding this school, titled, the Central Elementary School of Jiangkou Township forced students to eat at school, even though most of its student population lives within 100 meters (109 yards) of the school in a small town. Students who do not eat at school cafeteria were denied registration. This is a direct violation of China's Compulsory Education Act.

Another parent's complaint is more specific, this school extended school time from 4:00pm to 5:30pm (a violation of regulations of the Department of Education of China), so that they could force students to eat dinner at school cafeteria.

Update 2:

The 'Golden Rice' used in this four-year long experiment was delivered in packages labeled 'Hundred Tastes Inc, Nantong, Jiangsu Province'. It is probably how the P.I. by-passed the import ban issued by the Chinese Agriculture Ministry. The Nantong company may act like a middleman to plant the rice with imported seeds locally, or repackage rice smuggled in.

In either case, authorities in Jiangsu ought to be alerted on contamination from GE rice to local rice production.

Update 3:

Hengyang Government and CCP official websites were shut down.

Update 4:

According to official registration at US government, the trail took place in the US, with no mentioning of China. The record strongly indicate an intention to cheat from the very beginning.

According the same registration, the trail was approved by an ethics review board in Zhejiang on 5/19/2008. However, this approval was removed on 7/16/2008. This information was not revealed in the paper in question which is submitted on 11/7/2011 and published on 8/1/2012.

Update 5:

Via the Institute of Science in Society (I-SIS), more than 30 senior scientist and academics signed an open letter condemning Tufts University on multiple violations of rules, protocols and laws, in conducting the research described in its recent 2012 paper, back in 2009. In the letter dated 2/16/2009, researchers accused the Tufts team's conduct a breach of the Nuremberg Code of Ethics, which was brought in at the end of WWII to prevent repetition of experiments conducted by Nazi scientists involving children. The letter also points to a detailed scientific audit on the project, and called the 'Golden Rice' project an exercise in how not to do science. Besides scientifically flawed, the trail is 'morally inexcusable'.

The open letter which was addressed to Professor Robert Russell of Tufts University and copied to Jennifer Graf, administrative manager of IRB at Tufts University, Dr. David Chelmow, Chair of the IRB at Tufts, Dr. Leslie Curtis of NIH, and Dr. Guangwen Tang, the correspondence author of the paper in question, was also delivered to the FDA. The 2012 paper indicated a serious lapse in judgement at regulatory agencies and the scientific community itself.

Update 6:

The Hengyang Prefecture government disputed the existence of the experiments the Tufts paper based upon. According to the official statements, sixty-eight students participated in an experiments to study the conversion efficiency of β-carotene to vitamin A in March 2008. All food used in the study were locally purchased. No GE rice was used, and no other GE products are used. Experts from Provincial CDC and national CDC monitored every procedure.

Parents were fully informed of the nature and risk of these experiments through two face to face meetings. All parents received a detailed documentation and signed a consent form, which did not include any GE products.

The government investigation task force contacted two researchers participated in the experiments and they all confirmed the findings by the team.

A third possible source of the 'Golden Rice' used in the experiment emerged with the government finding. Tufts University might have contacted local farmers to cultivate the GE 'Golden Rice' in Hengyang, without informing them the nature of the plant.

With the announcement, the Hengyang Government and CCP websites went back online.

Update 7:

According to a paper accused of the Tufts University team's experiment 'breach medical ethics code' on GM-Free Cymru, another experiments with same design and control were carried out in 2004-2005 on children between 7-10 year old in Hangzhou of Zhejiang Province.

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.)

Government in Zhejiang needs to answer a few questions.

The Tufts team found results obtained from the experiments in Hangzhou was 'inconclusive', and had to re-engineer the 'Golden Rice'. It is only intuitive to be curious of the nature of that inconclusiveness, and whether it had anything to do with impact on health risk.

And there is another question the Tufts team should have answered, a question reviewers and editors of the American Journal of Clinical Nutrition should have asked, that is why did the author cover up their Hangzhou experiment while mention an earlier and less relevant experiment also in China (ref No. 28)?

Update 8

New Capital Daily (Xin Jing Bao)interviewed parents of children participated in the Tufts University experiment of Golden Rice, a GE product. Because 80% of young population were migrant workers in other provinces, most children at the school are raised up by their grandparents.

Eighty one year old farmer Liu Taoying had no clue as to the 'experiment' his grandson went through 4 years old in Jiangkou Elementary School. Liu confirmed his grandson got free meals provided by the school, the only string attached was three blood tests each month. Later he worried about the frequent blood drawing and stopped having his grandson eat at school.

Liu recollected, in the second half semester in 2008, the school held a parents meeting in which the Principle He Zhongqiu said the school was sponsored by the national government on a grant to provide nutritious meals to students. The meals would make students grow taller, stronger and healthier.

Sixty-three years old Xie Juhua echoed Liu's words, 'the school requested all 6 to 8 years old to eat at (free meals) at school.' 'At the time, the school did not explain why they need to draw blood from students. Every time they did (draw blood), they gave each student a carton of milk and an apple.'

A parent Mr. Yang is also the owner of school convenient store. He testified he had never seen any consent form and never signed any document. Yang stated he would never agree (to have his child get in) had he knew it was an experiment.

Update 9

Tufts University released a written statement on September 3, in which Professor Tang said 'Golden Rice' was fed to kids in China.