The American Journal of Clinical Nutrition is retracting a paper that showed genetically engineered rice serves as an effective vitamin A supplement after a Massachusetts judge denied the first author’s motion for an injunction against the publisher.
The journal announced plans to retract the paper last year following allegations that the paper contained ethical mis-steps, such as not getting informed consent from the parents of children eating the rice, and faking ethics approval documents.
Last July, first author Guangwen Tang at Tufts University filed a complaint and motion for preliminary injunction against the journal’s publisher, the American Society for Nutrition, to stop the retraction.
According to the ASN, on July 17, a Massachusetts Superior Court “cleared the way” for the publisher to retract the paper. So they have, as of July 29. Here’s more from the retraction notice:
The article cited above, which was originally published in the September 2012 issue and prepublished on 1 August 2012, has been retracted by the publisher for the following reasons:
1. The authors are unable to provide sufficient evidence that the study had been reviewed and approved by a local ethics committee in China in a manner fully consistent with NIH guidelines. Furthermore, the engaged institutions in China did not have US Federal Wide Assurances and had not registered their Institutional Review Board (or Ethics Review Committee).
2. The authors are unable to substantiate through documentary evidence that all parents or children involved in the study were provided with the full consent form for the study.
3. Specific eligibility issues were identified in regard to 2 subjects in the study.
In an unusual move, the publisher issued a press release about the retraction, which presents more information about the case:
A ruling by the Massachusetts Superior Court, Judge Salinger, on July 17, 2015 has cleared the way for the American Society for Nutrition (ASN) to retract the article “β-Carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children” which was published in the September 2012 issue of The American Journal of Clinical Nutrition (Am J Clin Nutr 2012 96:658–66). The article was retracted by the American Society for Nutrition on July 29, 2015.
In July 2014, Dr. Guangwen Tang filed a complaint and a motion for preliminary injunction against ASN. A hearing on Dr. Tang’s motion for preliminary injunction was ultimately held on July 17, 2015. After oral argument, the Court denied Dr. Tang’s motion, ruling that the injunction would constitute an unconstitutional prior restraint on speech as well as an unconstitutional order compelling speech. ASN is very pleased that the Massachusetts courts have upheld the organization’s First Amendment rights and have allowed ASN to move forward with the retraction of the article.
A retraction notice was published online ahead of print on July 29, 2015 and will be published in print and online in the September 2015 issue of The American Journal of Clinical Nutrition.
A clerk’s notice about the case lists the plaintiff’s motion for a Preliminary Injunction as “DENIED”:
The requested order would be an unconstitutional Prior restraint on speech as well as an unconstitutional order compelling speech.
A spokesperson for ASN declined to comment further:
We do not have an additional statement at this time. There is still an active lawsuit associated with the retraction and we have been advised by legal counsel not to comment further on this matter.
According to ScienceInsider, initial objections to the study were raised by Greenpeace, who alleged the children eating the rice were being used as “guinea pigs.”
After a year-long investigation, Tufts concluded that Tang had indeed breached ethical regulations, and banned her from conducting human research for two years. In addition, she would have to be supervised in order to conduct any future research.
We’ve contacted Tang (as well as her lawyer), Tufts, last author Robert Russell, and the journal’s editor for comment. We’ve also asked the Massachusetts Superior Court for any additional court documents, and will update with any information we receive.
Update 7/30/15 3:23 p.m. eastern: Tang declined to comment:
We do not comment on pending litigation.
Update 7/31/15 8:41 a.m. eastern: We’ve heard from a spokesperson at Tufts:
We are aware that the American Journal of Clinical Nutrition has retracted the paper “β-carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children”, published in its September 2012 issue by a team led by a Tufts researcher. The journal indicated that its retraction was based on the fact that the authors were unable to provide sufficient evidence that the study had been reviewed and approved by a local ethics committee in China and that parents and children involved in the study had been provided the full informed consent form as well as eligibility issues identified in regard to two subjects in the study. No questions were raised about the integrity of the study data, accuracy of the research results or safety of the research subjects. The decision to retract a paper is ultimately a matter between the journal and the authors, and we must respect an academic journal’s editorial process and decisions.
Tufts University has always been and remains deeply committed to the highest ethical and scientific standards in research. In September 2012, we became aware, from the Chinese Center for Disease Control and Prevention, of various concerns relating to this study, which had been conducted under an approval issued by the Tufts Institutional Review Board (IRB). Tufts convened an external review committee to interview those involved and to review documentation of the study. The Tufts IRB also reviewed the study. There was no evidence found of falsification or fabrication of the data that underlie the study’s primary findings. Those reviews did, however, determine that the research had not been conducted in full compliance with Tufts research policies and federal research regulations.
Tufts has not been served with any complaint from Dr. Tang’s attorneys relating to these issues.
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Obviously the researcher should be disciplined for violating ethical guidelines, but as long as the data and methods used in the paper are sound and there’s nothing wrong with the results, I don’t think that this retraction is in the best interest of the scientific community.
It is, because ethical guidelines are part of the trial. Otherwise other scientists might get tempted to not follow the ethical guidelines during other human trials, because even if the would get caught, the consequences wouldn’t be as serious and hey, they could still publish.
And in this case we are talking about ethical violations in a clinical trial on children, who cannot give informed consent themselves. That is what makes it even worse.
This article does not get that far but the result is flawed as well. It assumes additional diet requirements that are impossible for the target audience.
I am looking for a link to this but as I recall the study assumes a high level of animal fat and protein needed to absorb the Vitamin A.
http://www.theecologist.org/News/news_round_up/2970095/golden_rice_gmo_paper_retracted_after_judge_rules_for_journal.html
“Further objection – unrealistic diet would boost absorption
A further objection raised to the scientific work is that the children were fed on a diet rich in fat and protein – both of which would artificially raise the absorption of the beta-carotene, which is fat soluble. The meals comprised 20% fat by energy content and included 100g or 110g of pork meat, also eaten with egg, spinach and tomato soup.
Given that Golden rice is promoted as a means to raise the standard of nutrition among poor and malnourished children, a diet so rich in meat, fat, protein and vegetables is unrealistic and thus uninformative as far as the enhanced nutrition of the ‘target group’ is concerned.
Indeed, anyone eating so rich a diet as that given the the child subjects would be at little danger of suffering from vitamin A deficiency in the first place, since spinach, along with other green vegetables, is a good source of the necessary nutrients.
However this question was not taken into account in the AJCN’s decision to retract the paper, which was taken entirely on ethical grounds.”
and more
“Here is another : “One of the arguments used for advertising Golden Rice is that the people at risk of vitamin A deficiency have such poor diets that other sources of β-carotene and vitamin A are not accessible to them. Because diet definitely has an effect on the bioavailability of β-carotene from any β-carotene-containing food, the choice for a study diet that included meat, oil, and nuts, which does not represent a poor diet, is of concern. Therefore, the results of the study do not much help us in preventing vitamin A deficiency in populations at risk.”
http://ajcn.nutrition.org/content/90/3/695.2.short
There is a lot more going on here. The researchers can’t even keep their story straight on how much GE rice they were given. First they said they fed them GE rice everyday for 3 weeks, then they said they only fed them one meal of GE rice. There was a scientist involved who was demoted for lying on top of almost all of them demoted for unethical behavior. Not only that, but they lied and said the study had a physician but it turns out he wasn’t even in China but was only available for emergencies via telephone. There were Chinese scientists involved who said they had no idea there was any GE rice involved, they thought it was a study comparing spinach tablets to provitamin A oil since they never saw anyone eating yellow rice. It is all an unethical, unscientific exercise in biotech propaganda.
Here is a much bigger problem : “the CDC’s investigation revealed that the children ate Golden Rice just once during the study — and not lunch every day during the three-week study as the paper states.
“How much Golden Rice did the children have exactly?” asks Wang Zheng, a policy researcher at the Chinese Academy of Sciences’ Institute of Policy and Management in Beijing. “Either the researchers are lying about this now or they lied about it in their paper. It’s a serious offence either way.” http://www.nature.com/…/china-sacks-officials-over…
Basically the researchers can’t even keep their story straight on how much golden rice was used. So the data is useless since it appears to be fabricated.
“Russell, now retired, was the head of the Tufts-USDA lab at the time the study was conducted. Although he helped design the trial, Russell tells ScienceInsider that he had little to do with how it was carried out, was not present at the study site in China, and does not speak Chinese. The paper lists him as “the study physician,” but he was only available for “long-distance consultation” if problems emerged, he says.” http://news.sciencemag.org/…/golden-rice-not-so-golden…
“Under public scrutiny, the three Chinese co-authors denied their involvement in the project. Wang told People’s Daily that she was unaware of the paper. Yin said that researchers only gave the schoolchildren spinach and capsules, and he was not aware of the “golden rice” part of the project. However, Yin’s account of the event was inconsistent with those of Tang. In September, the Chinese CDC had Yin suspended. Further investigation by the Chinese CDC revealed that the Chinese scholars lied about their roles in the project.” http://www.bjreview.com.cn/…/2013-10/05/c”
Whether or not the paper should have been retracted is one question, but even if we grant that the retraction was wrong, it is clearly wrong to try to use legal action to force the journal not to retract. It’s the principle of academic freedom – an academic journal should be free to publish and retract what it wishes. Academics should be free to criticize journals, and boycott them, but there are very few circumstances in which they should sue them.