Currently browsing posts about: Conflicts-of-interest

Today, Michael Goran and his colleagues published an NIH-funded study demonstrating that the proportion of fructose in products made with high fructose corn syrup is often higher than 55%—as much as 60% to 67%.

This matters because of concerns that high intake of fructose might induce insulin resistance and other metabolic problems.

Today also, a different group of investigators published a study saying just the opposite.  Fructose in products, it says, is in close agreement with the amount expected.

Who funded this one?  The International Society of Beverage Technologists, whose executive board represents soda companies.

Really, these kinds of results are so predictable that all I have to do is see the results to guess who must have funded the study.

Coincidence?  I don’t think so.

Yesterday, Food Navigator reported that Cornell economists calculated that GMO labels would cost the average family of four a whopping $800 per year.

This seemed so improbable that I immediately wondered:  Who paid for it?

I clicked on the link to the study: Bingo!

The work on this report was supported financially by the Council for Biotechnology Information.

You won’t find the list of companies and groups that support the Council on its website, but Source Watch fills the gap.

I am increasingly alarmed by the increasing extent of industry research sponsorship—it’s become a huge issue in  studies of nutrition, diet, and health.

The influence of funding source on research outcomes is so predictable—many studies have now shown that industry-funded studies almost invariably produce results that favor the sponsor—that I’m batting nearly 100% on conflict-of-interest  checks, of which this GMO study is a particularly blatant example.

It’s not that industry pays investigators to find the desired answers to questions.  It’s more complicated than that.  It has to do with the way investigators ask and try to answer the research questions.  The industry favored biases get built into the study’s assumptions and controls, often (I think) unconsciously.

This study, for example, is based on an elaborate set of assumptions leading to the $800 per family estimate.  Other assumptions might give different results.   The authors do not discuss the limitations of their estimates, nor are they required to in this type of report.

But I’m willing to hazard a guess that independently funded studies would come to considerably lower estimates.

Moral: if a study produces surprising results that favor an industry position, look hard to see who sponsored it.

Addition, May 24:

A reader sent in further information about the Council for Biotechnology Information:

Council for Biotechnology Information

1201 Maryland Avenue, SW., Suite 900, Washington, DC 20024 USA

Phone: 202-962-9200 web site: http://gmoanswers.com

(CBI: http://www.sourcewatch.org/index.php?title=Council_for_Biotechnology_Information.

http://www.powerbase.info/index.php/Council_for_Biotechnology_Information.

Experts: http://gmoanswers.com/experts. Founding members and supporting partners:

http://gmoanswers.com/about. There are also offices in Saskatoon (SK, Canada)

(http://whybiotech.ca)  and Mexico City (AgroBio Mexico: http://agrobiomexico.org.mx.)

Skeptic of the value of dietary supplements that I am, I cannot help feeling sorry for Herbalife.

The company sells protein shakes and snacks, vitamins and dietary supplements, and energy and fitness drinks which, it says, “combined with healthy eating and exercise, can help you lead a healthy, active life.”

Yes indeed, healthy eating and exercise will do that for you every time.

But Herbalife has become the victim of a bizarre hedge fund bet and its consequences.

In what is one of the most blatant conflicts of interest besetting a food product, a hedge fund manager, William Ackman, made a billion dollar “short” bet that Herbalife’s stock would fall.

When the stock did not do so immediately, Mr. Ackman set out to destroy the company’s reputation to force its stock down.

He even got members of Congress, including Senator Edward Markey (Dem-Massachusetts) to call for an investigation of the company’s marketing practices, an action that caused a 14-point drop in the stock.

This decidedly unsavory story was the subject of a New York Times investigative report yesterday: “Staking $1 Billion That Herbalife Will Fail, Then Lobbying to Bring It Down.”

The company has grown into a global powerhouse, with a worldwide team of more than three million so-called members and distributors who operate as independent contractors through a system that rewards many of them not only based on actual sales, but also on their ability to recruit more distributors.

The sales tactic, popular with many nutritional supplement companies, has frequently been the target of criticism. In 1986, California authorities issued an order prohibiting Herbalife from making false claims about the weight-loss powers of its nutritional drinks.

Herbalife reported sales of $4 billion in 2012 and is sold in more than 90 countries by distributors who earn profits on product sales and additional commissions from a “multi-level marketing” compensation structure.

Ackman argues that this is a pyramid scheme that particularly disadvantages Hispanic distributors and customers.  Other hedge funds disagree and have placed “long” bets on Herbalife.

This is food politics at a breathtaking level of income.  The Times story is well worth a look.

The American Society of Nutrition (ASN) is not the only nutrition society raising issues of conflict of interest (see yesterday’s post).  The Academy of Nutrition and Dietetics (AND) is the subject of two recent analyses of this problem.

• The Food Ties that Bind
• And Now a Word From Our Sponsors

FoodNavigator-USA interviewed a number of people, including me, about the implications of these reports.  Opinions differ, to say the least.

But here’s what I said:

Sponsorship perverts science

However, Dr Marion Nestle, Paulette Goddard professor of nutrition, food studies, and public health at New York University, said it was wishful thinking to assume that companies that make their money selling soda and chips as well as water, juice and oatmeal could provide a “full” picture.

The issue, she said, was not whether FNCE delegates were capable of distinguishing facts from sponsored spin in conference handouts.

She told us: “That’s not the right question. Most people are unaware of how such things influence their opinions. Substantial research on sponsorship by tobacco, drug, and chemical companies provides such evidence. There is not yet as much research on the effects of food industry sponsorship but the few studies that exist are completely consistent with research on other industries.”

It’s stunningly easy to design studies that accomplish these goals

Asked whether it was unfair to automatically dismiss industry-funded research and information rather than judging it on its merits, Nestle said: “In my opinion, agriculture, food, nutrition, and health professionals should dismiss industry-sponsored research out of hand, and journals should not accept industry-sponsored papers. 

“There is only one reason for food companies to sponsor research—so they can use the results in their own interests. 

“Sponsorship perverts science.  Sponsored research is not about seeking truth or adding to public knowledge.  It is about obtaining evidence to defend or sell the sponsor’s product, to undermine research that might suggest that a product is unhealthy, to head off regulation, and to allow the product to be marketed with health claims. 

“It’s stunningly easy to design studies that accomplish these goals and to conduct them in ways that meet the scientific criteria of peer-reviewers.”

She added: “Peer reviewers, journal editors, and readers ought to be asking: Why did the sponsor fund this study?  Was the research question designed to permit an answer that might not meet the sponsor’s goal?  Was the study conducted in a way that permitted an answer against the sponsor’s interest?  Sponsored studies almost always fail these tests of independence.”

I think corporate sponsorship poses huge problems for the credibility of nutrition researchers and nutritionists in general.  The issue requires much more discussion than it has received to date.

Let the debates begin!

I am a member of the American Society for Nutrition (ASN), the organization that publishes the American Journal of Clinical Nutrition (AJCN) and the Journal of Nutrition.

I’ve become increasingly worried about food company influence on ASN.  Food companies fund sessions at ASN annual meetings.

But I’m even more concerned about food company sponsorship of scientific studies published in AJCN.

The results of sponsored studies almost invariably benefit the sponsor.  Exceptions are scarce.

The conflicts are so blatant that I can often guess from reading an abstract who the study’s sponsor must be.

A look at the conflicts of interest disclosed by the editorial board of AJCN suggests why this problem is occurring.

Of the 12 members of the editorial board, only 3 disclose no corporate conflicts of interest, and 2 others disclose minor conflicts.

But the majority—7 of the 12—list major corporate affiliations.  The list of food companies for which they consult or advise is too long to reproduce but it includes Coca-Cola, PepsiCo, The Sugar Association, The National Restaurant Association, ConAgra, McDonald’s, Kellogg, Mars, and many others.

This raises uncomfortable questions: How does this editorial board deal with papers suggesting harm to health from consuming products from these companies?  How does it deal with sponsored papers suggesting benefits of the products?

Affiliations with food companies may or may not lead to publication bias, but at the very least they give the appearance of serious conflicted interest.  This affects opinion not only of sponsored studies, but also of the overall credibility of research published in the journal.

For the results of papers published in the AJCN to be considered credible, the editorial board should:

• List the editor responsible for review of published papers in the conflict disclosures.
• Recuse individual members with conflicts from reviewing papers in their area of conflict.
• Phase out conflicted editors as quickly as possible.
• Appoint editors who have minimal or no conflicts.
• Give special editorial scrutiny to papers sponsored by food and beverage companies.

ASN is not the only nutrition society raising doubts about its conflicts of interest with food company sponsorship.  The Academy of Nutrition and Dietetics (AND) is the subject of two recent reports analyzing its conflicts of interest.

• The Food Ties that Bind
• And Now a Word From Our Sponsors

I will say more about these reports tomorrow, but it looks like a similar report could be written about ASN, alas.

I was invited to write the editorial to accompany a study published today in JAMA Internal Medicine looking at the highly conflicted process used to decide whether food additives are Generally Recognized as Safe (GRAS).

Here’s the study.

Here’s my editorial.

I know this sounds completely crazy, but here’s what the study found:

• Manufacturers get to decide whether food additives are safe or not.
• Manufacturers get to decide whether to bother to tell the FDA the additives are in the food supply.

And if they do volunteer to inform the FDA (and many do),

• Manufacturers get to decide who sits on the panels that review the evidence for safety.

In reading the study, it seemed to me that:

• As long as not too many people roll over dead after eating foods with new additives, nobody will ever have a clue whether the additive is safe.
• The regulatory gap has spawned an entire enterprise of GRAS consultants and GRAS consulting firms who are in the business—presumably lucrative—of providing the scientific documentation the FDA needs to determine additive safety.

Some of the consultants need to do a better job.  The FDA raises enough questions that about 15% (my estimate) of the requests would be denied.

The good news: If the FDA sees the safety documentation, it does its job.

But what happens to the rejected additives?  Or the ones that don’t get voluntarily sent to FDA?

Nobody really knows (think: caffeine in alcohol drinks–the FDA had no idea).

We need a better food safety system in this country and conflicts of interests in GRAS additive approvals are a good place to start.

Here’s what USA Today has to say about this (I’m quoted).

My post yesterday about Michele Simon’s report on food company sponsorship of the Academy of Nutrition and Dietetics (AND) elicited a wealth of thoughtful comments.  These are well worth careful consideration.

Many express disappointment that I would suggest that corporate sponsorship might influence their thinking or practice, that other nutrition professionals have equal or better education, that I singled out AND when other nutrition and health organizations also accept food industry funds, or that I am unsympathetic to their plight (they are required to be AND members whether or not they agree with its policies).

Let me clarify:

On the effects of corporate sponsorship: I don’t know a single individual who thinks that taking money from food companies influences personal opinion or practice, but research on the effects of drug—and food—company sponsorship demonstrates otherwise.    At the very least, sponsorship gives the appearance of conflict of interest.  Individuals and organizations who accept sponsorship from soda companies, for example, can hardly be expected to advise the public to drink less soda.

On education: my point here is not that dietetic education is inadequate but that other nutritionists without such training may be equally qualified to advise the public about diet and health.

On other organizations:  That other nutrition and health organizations accept funds from food companies has long been a point of discussion on this blog (click on Partnerships).  I am especially concerned  about the practices of the American Society of Nutrition, to which I belong.  Its embarrassing role in the Smart Choices fiasco was an example of why nutrition professional organizations should avoid getting involved in such alliances.

On sympathy: I have plenty.  Food company sponsorships create painful dilemmas for nutrition professionals and each of us must figure out our own way to deal with them.  I have written about my own struggles with this issue in Food Politics and elsewhere.

I especially appreciate the comments from those of you engaged in your own struggles with this issue within AND.  You have your work cut out for you.  Here, for example, is the response of your president, Dr. Ethan Bergman, to Simon’s report. He writes [and see addition below]:

There is one indisputable fact in the report about the Academy’s sponsorship program: We have one. And for the record, I support the Academy’s sponsorship program, as does the Board of Directors and our members.

Let me make it clear that the Academy does not tailor our messages or programs in any way due to influence by corporate sponsors and this report does not provide evidence to the contrary.

…As members of a science-based organization, I encourage you to not take all information you see at face value, always consider the source (in this case, an advocate who has previously shown her predisposition to find fault with the Academy) and seek out the facts.

My interpretation: ignore the message because the messenger is not one of us.

As nutrition professionals, we ignore such messages at our peril.  If we want the public to trust what we say, our views cannot be perceived as compromised by financial ties to food companies.

What you can do.  If, as some of you noted, you oppose corporate sponsorship and would like to do something about it, here are a few suggestions:

• Let your voice be heard: write letters, post blogs, send tweets.
• Make it clear to colleagues and clients that you oppose current policies on corporate sponsorship.
• Provide evidence that your organization can do just fine without the money.
• Join committees and groups within your organization; say what you think.
• Organize petition campaigns.
• Run for office; run a slate for office.

If you want the policy to change, work for it.

But don’t be discouraged if nothing much happens right away.  Change takes time.  Keep at it.

Thanks to all of you for taking this issue so seriously.  Let’s keep working together to find ways to keep food company money out of our professional lives.

Addition, January 25: a reader, Craig, points out that Coca-Cola gave Dr. Bergman the opportunity to carry the torch at last summer’s Olympic games.  A news story about this event quotes Dr. Bergman on the Academy’s partnership:

I think the philosophy that Coca Cola has through its Live Positively campaign, and our philosophy at the academy, is about trying to improve the nation’s health through better nutrition and fitness so this fits in well with our cause.

 

I’m always saying that food company donations and partnerships to health and environmental Good Causes end up doing more for the companies than the recipients.  Money always talks.  Accepting corporate donations comes with strings that create conflicts of interest.

The latest evidence for these assertions comes from the Grand Canyon’s efforts to get plastic water and soda bottles out of the park.  These account for a whopping 30% of its waste.

According to the account in today’s New York Times, Coca-Cola, one of the park’s big donors, convinced the National Park Service to block the bottle ban.

Stephen P. Martin, the architect of the plan and the top parks official at the Grand Canyon, said his superiors told him two weeks before its Jan. 1 start date that Coca-Cola, which distributes water under the Dasani brand and has donated more than $13 million to the parks, had registered its concerns about the bottle ban through the foundation, and that the project was being tabled.

The Times quotes Mr. Martin:

That was upsetting news because of what I felt were ethical issues surrounding the idea of being influenced unduly by business…It was even more of a concern because we had worked with all the people who would be truly affected in their sales and bottom line, and they accepted it.

It also quotes a Coca-Cola spokeswoman, Susan Stribling:

the company would rather help address the plastic litter problem by increasing the availability of recycling programs. “Banning anything is never the right answer…If you do that, you don’t necessarily address the problem…You’re not allowing people to decide what they want to eat and drink and consume.”

And throw plastic bottles into the park, I guess.

This sordid episode explains why Coke gives millions to the Grand Canyon.  In a word, greenwashing.

Oops.

Coke needs to change its position on this one.  And so does the Park Service.