Currently browsing posts about: Ethics

Despite my long interest in and dubious opinion about the benefits of Golden Rice (genetically modified to contain the beta-carotene precursor of vitamin A), I somehow completely missed the huge and highly embarrassing uproar over a study demonstrating the effectiveness of this rice in raising vitamin A levels in young children.

This particular uproar began with publication of the study in the American Journal of Clinical Nutrition in 2012.  Last week the journal announced that it has retracted the study—on ethical, not scientific, grounds.

To explain:  Dr. Guangwen Tang, a long-time researcher at Tufts University, and her colleagues at Tufts, in China, and at Baylor and the NIH, compared the effectiveness of vitamin A capsules, Golden Rice, and spinach in raising vitamin A levels in the blood of Chinese schoolchildren.  They reported that Golden Rice proved just as effective as capsules, and somewhat better than spinach, in inducing higher vitamin A levels, just as it is supposed to do.

Golden Rice, of course, is the poster child for the benefits of GMOs, extolled by many as the solution to the developing world’s high prevalence of vitamin A deficiency (I’m dubious because I view vitamin A deficiency as a social problem requiring policy and cultural shifts).

Soon after, Greenpeace, which is decidedly anti-GMO, challenged the ethics of the study, charging that the children were being used as “guinea pigs.”

As reported in Nature,

none of the children, their parents or school teachers was aware that Golden Rice was involved, according to a 45-minute investigative news programme broadcast on 8 December on CCTV, China’s state television channel.  The informed-consent form said that the rice contained β-carotene, but not that it was genetically modified or that it was Golden Rice. Nor did it highlight uncertainty around any potential risks of ingesting such rice…Moreover, Wang didn’t apply for ethical evaluation of the trial, instead fabricating the approval documents, according to CDC. And Tang brought Golden Rice from the United States to China illegally, without due declaration to the relevant Chinese authorities, it said.

According to a report on NPR, Tufts University did a year-long investigation and agreed that ethical standards had been violated:

the study was not “conducted in full compliance with … policy or federal regulations”… the researchers did not adequately explain the nature of golden rice and made some changes in the study without getting approval from the committee at Tufts that is supposed to review all research involving human subjects.  Guangwen Tang will be banned from conducting research on human subjects for two years. For two years after that, any research that she conducts will be under the direct supervision of another investigator.

A report on the case in ScienceInsider explains the ethical problem raised by the study’s informed consent form :

U.S. guidelines stipulate that such forms use plain language understandable to lay people, and the IRB [the Tufts Institutional Review Board] agreed to let Tang say that “Golden Rice is a new rice which makes beta-carotene,” without using the loaded words “genetically modified.” (The consent form for a very similar study by Tang among adults in Boston, published in 2009, didn’t use that term either.) Given the sensitivities over transgenic food, which existed in China as well, that was the wrong decision, according to the external panel.

In 2014,  Dr. Tang sued the ASN:

ASN twice asked Tang and her six co-authors to withdraw the paper voluntarily, which they declined to do. The society recently decided to retract the paper on its own…but it has agreed to a 90-day stay after Tang filed her lawsuit, to see if the matter can be settled out of court.

But the court ruled in favor of ASN.  Hence, the retraction.  ASN issued a press release:

In a ruling by the Massachusetts Superior Court, Judge Salinger…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”…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.

In its online retraction notice, ASN states the 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….
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.

Last week, Retraction Watch published a lengthy summary of this case that includes a long statement from Tufts University:

No questions were raised about the integrity of the study data, accuracy of the research results or safety of the research subjects…Tufts University has always been and remains deeply committed to the highest ethical and scientific standards in research.  In September 2012, w …convened an external review committee to interview those involved and to review documentation of 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.

The retraction is a huge embarrassment, not only for the researchers involved but also for Tufts University’s Friedman School of Nutrition Science and Policy, Tufts’ Institutional Review Board, the American Journal of Clinical Nutrition, and the American Society for Clinical Nutrition.

The study was funded by NIH, USDA, as well as a program in China.  NIH takes research ethics very seriously and expects the researchers it funds to adhere to the highest possible standards for research on human subjects.  Because the study did not follow standard ethical guidelines, especially with regard to research on children, Tufts had no choice but to investigate and impose sanctions, and the journal had no choice but to retract the paper.

This case reinforces my views about GMOs in general and Golden Rice in particular.

The controversies are not (or not usually) about the science.  They are very much about ethics and other questions of values.

Paul Thompson.  From Field to Fork: Food Ethics for Everyone.  Oxford University Press, 2015.

I was pleased to be asked to blurb this one:

From Field to Fork makes it clear that every food choice has ethical implications and that sorting out these implications from the science and politics of food is anything but simple.   The ethical issues discussed in this book are fascinatingly complex and deserve the serious debates they are sure to stimulate.  If ever a book provided food for thought, it’s this one.

I was riveted by an article in today’s New York Times about the latest decision of an FDA drug advisory panel.

The panel voted to approve a new weight-loss drug, lorcaserin.  The vote was mixed: 18 for approval, 4 against, and 1 abstention. The majority felt that the benefits outweighed the risks and that even if there were risks, “new tools are needed to treat a major health problem.”

The benefits are worth a look.

• People taking the drug lost an average of  5.8% of their body weight in a year, compared to 2.5% for people taking a placebo.  This difference is below the FDA’s standard for approval which requires a 5% difference.
• Among those taking the drug, 47% lost at least 5 percent of their weight after a year, whereas only 23% of those taking the placebo did so.  This meets a second FDA standard for approval.

What about the risks?  The drug:

• Causes tumors in rats (although perhaps at higher doses than might be taken by people).
• Damages heart valves (in the same way the withdrawn drug, Fen-Phen, did).

Also in the Times is a piece by Dr. Danielle Ofri on her experience with patients who want weight-loss drugs.

She quotes from an essay called “Lemons for Obesity” by Dr. Michael S. Lauer, who was a minority voter on the FDA panel that approved the weight-loss drug Qnexa earlier this year.

The weight-loss field is strewn with lemons, more so than other areas of medicine, Dr. Lauer argues. Because of the enormous potential market for these drugs — two-thirds of American adults are overweight or obese — pharmaceutical companies rush new drugs to market after conducting only small clinical trials. The F.D.A. and doctors are complicit in the process, Dr. Lauer says, leaving the population at large to act essentially as guinea pigs.

Shares of the maker of the drug nearly doubled after the decision.  The Times reported that “Arguments by investors have been passionate.”

People who cannot easily lose weight are desperate for help.

But is it ethical to put them at this kind of risk?

Staunch feminist that I am, I am greatly enjoying the fuss over the all-male judging panel for the New York Times’ contest calling on “carnivores to tell us why it’s ethical to eat meat.”  The Times’ ethicist, Ariel Kaminer, announced the contest in Sunday’s magazine:

So today we announce a nationwide contest for the omnivorous readers of The New York Times. We invite you to make the strongest possible case for this most basic of daily practices.

We have assembled a veritable murderer’s row of judges — some of the most influential thinkers to question or condemn the eating of meat: Peter Singer, Michael Pollan, Mark Bittman, Jonathan Safran Foer and Andrew Light.

In the graduate course in food ethics I taught at NYU a couple of years ago, I had the class read:

• Peter Singer and Jim Mason’s The Ethics of What We Eat: Why Our Food Choices Matter
• Michael Pollan’s critique of Singer’s views in The Omnivore’s Dilemma
• Jonathan Safran Foer’s critique of Pollan in Eating Animals.  

I also had them read a scientific paper on the nutritional benefits of adding meat to the diets of children in developing countries (Whaley et al.  J Nutrition 2003;133: 3965s–3971s).

Discussions, to say the least, were lively.

As for the other two: Mark Bittman writes eloquently about ethical issues in food choice for the New York Times.  Although I am not familiar with the work of Andrew Light, a quick Google search reveals that he writes about the ethics of climate policy.

All happen to be white men.

On her blog, the “vegan-feminist intellectual” Carol Adams,  author of The Sexual Politics of Meat, says:

Here’s the crux of the problem, our culture is heavily invested in the identification of meat eating with manliness…. How could an intelligent woman miss the fact that her own panel of “ethicists” is male-dominated and that such a choice is, itself, an ethical issue?

Michele Simon writes on her blog, Appetite for Profit:

When I asked why all the judges were male, Kaminer replied that she couldn’t find one female expert in food ethics with a fraction of the name recognition of the men. She argued that the famous male judges would bring far more attention to the contest, and in turn get more people to consider the ethics of meat eating.

Full disclosure: Michele puts me first in her list of ten women who should have been considered.

You can see why I am amused, no?

If you want to enter this contest—and please do!—send written entries of no more than 600 words to ethicist@nytimes.com. Entries are due by April 8.

On December 19, Food Chemical News reported that Pascal Lamy, secretary-general of the World Trade Organization (WTO) “traded blows” with  United Nations’ Special Rapporteur on the Right to Food, Olivier De Schutter, over the role of trade in food security.

As far as I can tell, the “blows” were figurative, not literal, but the debate was real.   De Schutter had written a report questioning whether greater trade liberalization—the goal of WTO—could deliver on food security (for the basis of this debate, see below).

“Developing countries are rightly concerned that their hands will be tied by trade rules,” De Schutter said, and called for higher tariffs and targeted farm subsidies to stimulate local food production.   He labeled the “WTO’s vision as “outdated. … The right to food is not a commodity, and we must stop treating it that way.”

For some time now, I’ve been following the De Schutter’s work, not least because he is using the office of Special Rapporteur as a bully pulpit from which to promote healthier and more sustainable and equitable food systems throughout the world.

De Schutter, among other things, is my occasional colleague at NYU.

Olivier De Schutter (LL.M., Harvard University ; Ph.D., University of Louvain (UCL)), the UN Special Rapporteur on the right to food since May 2008, is a Professor at the Catholic University of Louvain and at the College of Europe (Natolin). He is also a Member of the Global Law School Faculty at New York University and is Visiting Professor at Columbia University.

As Special Rapporteur, he is supposed to

Report both to the UN General Assembly (Third Committee) and to the Human Rights Council on the fulfillment of the mandate…In addition to addressing structural issues threatening the full enjoyment of the right to food, the Special Rapporteur may send communications to governments, called letters of allegation, in urgent cases brought to his attention by reliable sources.

Professor De Schutter has used this office to produce a remarkable succession of reports and position papers on a broad range of topics related to food, agriculture, and human and environmental health:

• Agribusiness
• Agrifood paradigms
• Climate change
• Food Aid and Development Cooperation
• Governance and the Global Food Crisis
• Intellectual property rights
• Land Rights
• National Implementation
• Trade

Take a look at the documents listed under these categories.  They are a terrific resource for anyone interested in the human right to food.

As for De Schutter vs. WTO, see:

• De Schutter’s briefing paper
• WTO Secretary Lamy’s reply
• De Schutter’s riposte
• And a previous debate between them on YouTube

My post of several days ago on the ethics of childhood obesity interventions elicited this interesting question from Megan:

I am curious as to what your thoughts are on individuals giving food to the homeless.

I used to give them a granola bar or a piece of fruit (whatever I happened to have in my lunch), but a friend of mine said she gives McDonald’s coupons for a free hamburger because she can carry the coupons with her more easily than a box of granola bars or a bag of apples.

Since I, myself, do not eat McDonald’s I find it hard to give anyone else McDonald’s food.  However, my friend argues that it’s a caloric dense meal and that makes it better than my one apple.  Any suggestions?

I’d like to see readers responses to this.  Giving food to the poor can solve the immediate problem, but is not sustainable in the long term and diverts attention from policy solutions to hunger problems (for a clear explanation of this dilemma, I highly recommend taking a look at Janet Poppendieck’s Sweet Charity).

But the homeless are a special case.   In my NYU neighborhood, many of us try to take care of a clearly deranged but charming homeless man who is very precise about what he asks for and will accept.  He becomes outraged if offered food.  He occasionally asks for a dollar and will not accept one penny more.

But other homeless people might be grateful for a McDonald’s handout.

Is it ethical to give food to the homeless that you would not eat yourself?  Is it ethical not to give food to the homeless?  How can you do the most good in this situation?

Weigh in, please.

Imagine this.  A professional journal, Preventing Chronic Disease: Public Health Research, Practice and Policy (Vol 8, Issue 5, Sep 2011) has published a series of papers on the ethics of childhood obesity interventions. 

It is about time that these kinds of ethical issues are getting focused attention.  Applause for the journal’s editors and authors!

Ethical Issues In Interventions For Childhood Obesity

A92: Protecting Children From Harmful Food Marketing: Options for Local Government to Make a Difference
  Jennifer L. Harris, Samantha K. Graff

A93: Childhood Obesity: A Framework for Policy Approaches and Ethical Considerations
  Rogan Kersh, Donna F. Stroup, Wendell C. Taylor

A94: Childhood Obesity: Issues of Weight Bias
  Reginald L. Washington

A95: Children With Special Health Care Needs: Acknowledging the Dilemma of Difference in Policy Responses to Obesity
  Paula M. Minihan, Aviva Must, Betsy Anderson, Barbara Popper, Beth Dworetzky

A96: Public Policy Versus Individual Rights in Childhood Obesity Interventions: Perspectives From the Arkansas Experience With Act 1220 of 2003
  Martha M. Phillips, Kevin Ryan, James M. Raczynski

A97: A Question of Competing Rights, Priorities, and Principles: A Postscript to the Robert Wood Johnson Foundation Symposium on the Ethics of Childhood Obesity Policy
  Shiriki K. Kumanyika

A98: The Ethical Basis for Promoting Nutritional Health in Public Schools in the United States
  Patricia B. Crawford, Wendi Gosliner, Harvey Kayman

A99: Ethical Family Interventions for Childhood Obesity
  Mandy L. Perryman

A100: Public Policy Versus Individual Rights and Responsibility: An Economist’s Perspective
  Frank J. Chaloupka

A101: State Requirements and Recommendations for School-Based Screenings for Body Mass Index or Body Composition, 2010
  Jennifer Linchey, Kristine A. Madsen

A91: Ethical Concerns Regarding Interventions to Prevent and Control Childhood Obesity
  John Govea