Currently browsing posts about: Sponsored-research

Here’s the latest collection of 5 studies funded by food companies or trade associations, all with results that favor the sponsor’s interests.  I’ve just reviewed them and found a couple of duplicates, so this is a corrected score.  The correct score is 55 industry-funded studies with positive results vs. 3 with results unfavorable to industry—since mid-March.

I’m particularly interested in the unfavorable category.  If you run across any, please send.

Jejunal Casein Feeding Is Followed by More Rapid Protein Digestion and Amino Acid Absorption When Compared with Gastric Feeding in Healthy Young Men. Joanna Luttikhold, Klaske van Norren, Nikki Buijs, Marjolein Ankersmit, Annemieke C Heijboer, Jeannette Gootjes, Herman Rijna, Paul AM van Leeuwen, and Luc JC van Loon. J. Nutr. 2015; 145:2033-2038 doi:10.3945/jn.115.211615.

• Conclusions: Jejunal feeding of intact casein is followed by more rapid protein digestion and AA absorption when compared with gastric feeding in healthy young men. The greater postprandial increase in circulating EAA concentrations may allow a more robust increase in muscle protein synthesis rate after jejunal vs. gastric casein feeding.
• Funding: Supported by Nutricia Research, Utrecht, Netherlands. J Luttikhold was employed by Nutricia Research; K van Norren is a guest employee of Nutricia Research; and LJC van Loon has served as a consultant for Nutricia Research.  [Note: Nutricia Research is a subsidiary of Danone].

Higher Total Protein Intake and Change in Total Protein Intake Affect Body Composition but Not Metabolic Syndrome Indexes in Middle-Aged Overweight and Obese Adults Who Perform Resistance and Aerobic Exercise for 36 Weeks. Wayne W Campbell, Jung Eun Kim, Akua F Amankwaah, Susannah L Gordon, and Eileen M Weinheimer-Haus. J. Nutr. 2015; 145:2076-2083 doi:10.3945/jn.115.213595.

• Conclusions: In conjunction with exercise training, higher TPro [total protein] promoted positive changes in BC [body composition] but not in MetS [metabolic syndrome] indexes in overweight and obese middle-aged adults. Changes in TPro from before to during the intervention also influenced BC responses and should be considered in future research when different TPro is achieved via diet or supplements.
• Funding:  Supported by the US Whey Protein Research Consortium (to WWC) among others.  WW Campbell was a member of the National Dairy Council Whey Protein Advisory Panel while the research was being conducted.

Intense Sweeteners, Appetite for the Sweet Taste, and Relationship to Weight Management.  France Bellisle.  Current Obesity Reports March 2015, Volume 4, Issue 1, pp 106-110 10.1007/s13679-014-0133-8

• Conclusion: While many of the existing studies cannot identify any causal links between use of LES [artificial, low-energy sweeteners] and appetite for sweetness, randomized trials in children and adults suggest that use of LES tends to reduce rather than increase the intake of sugar-containing foods and to facilitate, rather than impair, weight loss.
• Conflict: Parts of [this study] are extracted from a non-published document for which the author received an honorarium from the International Sweeteners Association (ISA).  France Bellisle is a member of the Scientific Advisory Board for General Mills and has received travel reimbursement and honoraria for contributions in scientific congresses from Mondelez, ISA, and General Mills.

Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial.  Christian Heiss & Roberto Sansone & Hakima Karimi & Moritz Krabbe & Dominik Schuler & Ana Rodriguez-Mateos & Thomas Kraemer & Miriam Margherita Cortese-Krott & Gunter G. C. Kuhnle & Jeremy P. E. Spencer & Hagen Schroeter & Marc W. Merx & Malte Kelm & for the FLAVIOLA Consortium, European Union 7th Framework Program.  AGE (2015) 37: 56 DOI 10.1007/s11357-015-9794-9

• Conclusion: CF [cocoa flavanol] intake reverses age-related burden of cardiovascular risk in healthy elderly, highlighting the potential of dietary flavanols to maintain cardiovascular health.
• Funding: …Additional funding was provided by an unrestricted grant by MARS, Inc…MARS, Inc. provided the standardized test drinks used in this investigation. HS is employed by MARS, Inc., a member of the FLAVIOLA research consortium and a company engaged in flavanol research and flavanol-related commercial activities.

Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study.  Roberto Sansone, Ana Rodriguez-Mateos , Jan Heuel, David Falk, Dominik Schuler, Rabea Wagstaff, Gunter G. C. Kuhnle, Jeremy P. E. Spencer, Hagen Schroeter, Marc W. Merx, Malte Kelm and Christian Heiss for the Flaviola Consortium, European Union 7th Framework Program.  British Journal of Nutrition, September 9, 2015. doi:10.1017/S0007114515002822.

• Conclusion: In healthy individuals, regular CF [cocoa flavanol] intake improved accredited cardiovascular surrogates of cardiovascular risk, demonstrating that dietary flavanols have the potential to maintain cardiovascular health even in low-risk subjects.
• Funding: Additional funding was provided…through an unrestricted grant by MARS Inc. MARS Inc. also provided the standardised test drinks used in this investigation… H. S. provided test drinks on behalf of Mars Inc… H. S. is employed by MARS Inc., a member of the Flaviola research consortium and a company engaged in flavanol research and flavanol-related commercial activities. [The conflict statement also discloses that MARS employee H.S. shared responsibility for designing the study, writing the paper, and approving the final content].
• Comment: Lest the implicit (but never stated directly) “eat more chocolate” message of these studies be missed, Mars sent out a press release: “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.”

Since mid-March, I’ve been collecting research studies funded by food companies or trade associations, and dividing them into those that come out with results favorable to the sponsor (50 so far–this is a corrected number) and those that do not (as of today, 3).

As always, if you run across others, please send.

A reader, Cole Adam, sent me this study on dark chocolate funded by a Finnish company that makes chocolate products.

Dark chocolate and reduced snack consumption in mildly hypertensive adults: an intervention study.  Raika Koli, Klaus Köhler, Elina Tonteri, Juha Peltonen, Heikki Tikkanen and Mikael Fogelholm.  Nutrition Journal 2015, 14:84  doi:10.1186/s12937-015-0075-3

• Results: Daily consumption of dark chocolate had no effects on 24 h blood pressure, resting blood pressure…or arterial stiffness.  Weight was reduced by 1.0 ± 2.2 kg during the control (reduced snack only) period, but was unchanged while eating chocolate (p < 0.027 between the treatments).
• Conclusion:  …inclusion of 49 g dark chocolate daily as part of a diet of mildly hypertensive participants had no significant effects on cardiovascular risk factors during 8 wks.  Apart from a small effect on body weight (dark chocolate seemingly prevented a slight decrease in body weight during the control period), no other negative effects were observed.
• Funding:  This work was funded by Oy Karl Fazer Ab. Authors declare no competing interests regarding this study.  [Oy Karl Fazer Ab sells bakery, biscuit, and confectionery products in Finland, Sweden, Estonia, Latvia, Lithuania, Norway, Denmark, Russia, and internationally]

Several points to note about this study:

• Eating 49 grams (just under 2 ounces) of dark chocolate a day may be fun, but it is not going to reduce your blood pressure.
• Eating 49 grams of dark chocolate a day makes weight loss more difficult.
• The authors do not view corporate funding as introducing competing interests.  OK.  Maybe not in this case, but this is a rare exception.

Another reader, who prefers to remain anonymous, sent this one:

Milk intake is not associated with low risk of diabetes or overweight-obesity: a Mendelian randomization study in 97,811 Danish individuals.  Helle KM Bergholdt, Børge G Nordestgaard, and Christina Ellervik.  Am J Clin Nutr 2015;102:487–96. 

• Conclusions: High milk intake is not associated with a low risk of type 2 diabetes or overweight-obesity, observationally or genetically via lactase persistence.  The higher risk of type 2 diabetes in   individuals without milk intake likely is explained by collider stratification bias.
• Conflict: HKMB’s PhD project was partly funded by the Research Unit at Naestved Hospital, the Danish Dairy Research Foundation, and the Regional Research Unit in Region Zealand. [The population studies were funded by a long list of government agencies, health organizations, and foundations].
• Comment: This study says that high milk intake is associated with a higher risk of type 2 diabetes, although it explains it away.  The Danish dairy industry paid for part of the first author’s dissertation research.  It looks like most of the funding came from independent sources, so this one is a bit of a stretch, but to be super scrupulous let’s count it as industry-funded.

NOTE: All three “negative” studies I’ve posted since March were funded by international food companies (the previous one was funded by the Danish Dairy Research Foundation).

Sunday’s New York Times story on academic conflicts of interest focused on scientists with financial ties to Monsanto.  The ties were revealed by open-records requests for e-mails and other information.

The Times was not the only one to make these requests.  U.S. Right to Know, a group devoted to investigating Big Food and its front groups had already done so.  U.S. Right to Know is funded primarily by the Organic Consumers Association, a national grassroots network advocating for organics, sustainability, and food safety—but against GMOs.

U.S. Right to Know rightfully takes credit for establishing the basis of the Times’ story.  It sent open-records requests to scientists working for public institutions who seemed likely to have financial ties to Monsanto.  Bingo.  Some of the e-mails revealed such ties.*

But should government-funded scientists be subjected to open records requests?  Couldn’t these requests amount to open season on academics—a modern-day version of witchhunts?  This question is now under active debate (and see comments on my previous post).

While these debates are raging, here is one aspect of this story that the New York Times did not tell.

Earlier this month, Paul Thacker and my NYU colleague Charles Seife, wrote a piece for PLoS [Public Library of Science] Blogs arguing that Freedom of Information Act (FOIA) requests “for personal correspondence are not just appropriate, but crucial to ensuring transparency.”   They argue that the benefits of transparency outweigh the costs.

But transparency laws remain a fundamental tool for monitoring possible scientific misbehavior. And it would be a mistake to believe that scientists should not be subject to a high level of outside scrutiny. So long as scientists receive government money, they are subject to government oversight; so long as their work affects the public, journalists and other watchdogs are simply doing their jobs when they seek out possible misconduct and questionable practices that could threaten the public interest.

Thacker and Seife explain:

Last week, Nature reported that the University of Florida had provided them with emails that U.S. Right to Know had FOIA’d on one of their researchers…the [Nature] story noted that the researcher has received money from Monsanto to fund expenses incurred while giving educational talks on GMOs.  The article also noted that the PR Firm Ketchum had provided the scientist with canned answers to respond to GMO critics, although it is unclear if he used them [the Times story says he did but now regrets it].

The article does not report that the scientist has repeatedly denied having a financial relationship with Monsanto. The article also does not report on an email titled “CONFIDENTIAL: Coalition Update” from the researcher to Monsanto in which the scientist advised Monsanto on ways to defeat a political campaign in California to require labeling of GMO products.

Some readers of PLoS were outraged that this online journal would publish an article supporting open-records requests of scientists (see, for example, this from the American Council on Science and Health).

Here’s where things get interesting.

PLoS responded to the criticism by, of all things, retracting the article.

Seife and Thacker explained their views in an op-ed in the Los Angeles Times.

If the public pays your salary, citizens have the right — within limits — to see what you’re doing. That’s the principle at the core of the federal Freedom of Information Act and of the many similar state freedom of information laws… “snooping” on scientists’ inboxes by journalists, watchdogs and government officials has revealed significant problems that would never have come to light via other means.

That, of course, is the basis of the New York Times’ exposé of Monsanto’s funding of scientists to testify on the company’s behalf to reporters, Congress, and the public.

Bottom line: Because industry-funded science and scientists almost invariably provide data and testimony that favors the sponsors interests, the press and public need to know about sponsorship.

One more comment:  A substantial body of literature exists on industry sponsorship of science, particularly on the effects of pharmaceutical industry funding of medical professionals.  Conflicts-of-interest researchers conclude that such conflicts are generally unconscious, unintentional, and unrecognized by participants.  The remedy is increased government spending for research, an unlikely possibility these days.  This means journalists will be kept busy exposing the many problems that arise when scientists take industry funding.

*The documents collected by the New York Times

• David Shaw
• Bruce Chassy
• Kevin Folta

Additions:

• Note: My previous post on organic-industry funding gives the link to the e-mails for Charles Benbrook
• Jonathan Latham provides further details on GMO public relations efforts

Today’s New York Times has another front-page (and on the inside, full-page) story on the food industry’s financial relationships with academic scientists.

The article describes how Monsanto funded scientists to lobby for GMOs in Washington (I will say more about this in a subsequent post).

But, as is clear from this report, the organic industry is doing much the same.

The Times based the story on e-mails it collected through open records law requests (the equivalent of Freedom of Information Act requests for federal documents).

And surprise!  I turn up in Charles Benbrook’s.  I learned this from checking Twitter yesterday.

I’m only on the B-list for influencing public opinion?  Alas.

It seems that Charles Benbrook, a strong proponent of organics (as am I), was working with (for?) the Organic Valley Cooperative on a public relations campaign to promote his organics-funded study demonstrating that organic milk has a healthier fatty acid profile than conventional milk.

I vaguely remember him contacting me about the study, but I didn’t write anything about it.  It appeared to be an industry-funded study with results favoring the sponsor’s interests—much as, in this case, I sympathize with those interests.

A few months later, I did write write about another conflicted organic study:

The study is not independently funded….This study is another example of how the outcome of sponsored research invariably favors the sponsor’s interests.  The paper says “the  [Sheepdrove] Trust  had  no  influence  on  the  design  and management of the  research  project  and  the  preparation  of publications  from the project,” but that’s exactly what studies funded by Coca-Cola say.  It’s an amazing coincidence how the results of sponsored studies almost invariably favor the sponsor’s interests.  And that’s true of results I like just as it is of results that I don’t like.

Benbrook has been criticized recently for not fully disclosing his ties to the organic industry.  Even if he had, disclosure is not enough.

The bottom line: Conflicted studies are conflicted, no matter who pays for them.

Documents: Charles Benbrook

Coca-Cola, in case you missed the furor over last week’s New York Times article, has a huge public relations problem.

The damage control begins today with Coke’s CEO’s op-ed in the Wall Street Journal:

Our company has been accused of shifting the debate to suggest that physical activity is the only solution to the obesity crisis. There also have been reports accusing us of deceiving the public about our support of scientific research…I am disappointed that some actions we have taken to fund scientific research and health and well-being programs have served only to create more confusion and mistrust. I know our company can do a better job engaging both the public-health and scientific communities—and we will.

By supporting research and nonprofit organizations, we seek to foster more science-based knowledge to better inform the debate about how best to deal with the obesity epidemic. We have never attempted to hide that. However, in the future we will act with even more transparency as we refocus our investments and our efforts on well-being.

He promises that the company will:

• Publish on our website a list of our efforts to reduce calories and market responsibly, along with a list of health and well-being partnerships and research activities we have funded in the past five years, which we will continue to update every six months.

• Charter and recruit an oversight committee of independent experts to advise and provide governance on company investments in academic research.

• Engage leading experts to explore future opportunities for our academic research investment and health and well-being initiatives.

Personally, I can’t wait to see the list of Coke-funded research activities.  Want to bet how many of those studies came out with results that Coca-Cola can use to claim that sugary drinks have no effect on obesity or type 2 diabetes?  I’d also like a count of the number of studies Coca-Cola has funded to cast doubt on the National Health and Nutrition Examination Survey, the country’s major dietary monitoring program, which has the annoying habit of linking sugary drinks to those conditions.

Mr. Kent ends his piece with this plea:

As we continue to learn, it is my hope that our critics will receive us with an open mind. 

Unless Coca-Cola stops pouring millions of dollars into fighting soda caps and taxes, stops targeting its marketing to minorities, and stops lobbying against public health measures to help people eat more healthfully, keeping Mr. Kent’s version of an open mind will be difficult. 

Steven Blair, one of the scientists involved in Coke-funded research, posted this statement today:

I have asked that my video addressing energy balance be taken down from the GEBN website. I regret that a statement I made in this video has been used by some to brand GEBN as a network focusing only on physical activity. This is not true and never has been true. From the beginning the mission of GEBN has been to study the science of energy balance which involves both diet and physical activity. GEBN has some of the top nutritionist experts in the world who have published research showing the importance of diet and in particular of soda consumption in causing obesity. My dismissal of diet as a cause of obesity did a disservice to their work. I hope many of you can relate to feeling so passionate about an issue that you say some things that you later regret. I believe that both diet and physical activity are important in obesity and that we must address both together to help people achieve healthy weights. I look forward to working with other GEBN researchers to do this.

James Hill, another of the scientists involved in this fiasco, also has issued a statement.  When it becomes public, I will post a link to it.

Additions, August 21

• The Global Energy Balance Network’s defense of its funding by Coca-Cola
• James Hill’s letter in response to a query from my NYU colleague Lisa Young.

When the New York Times published an article describing Coca-Cola’s financial sponsorship of university researchers who de-emphasize the role of sugary drinks in raising the risk of obesity and type 2 diabetes, it kicked up a storm.

USA Today’s editorial board said:

It isn’t that companies pay scientists to put out false research. It’s that companies fund the work of scientists who happen to be doing research that spurs consumers to look away from science that hurts corporate interests.

Soft drinks are far less dangerous than cigarettes, but GEBN’s website, tweets and videos come right out of Big Tobacco’s playbook, brought into the digital era. Its leaders have done research in the past under about $3 million in grants given to their universities.

USA Today also printed a response by a Coca-Cola spokesman:

A recent New York Times article created confusion about our support of research and non-profit organizations, stating we want people to think that only exercise matters and not diet — but nothing could be further from the truth. We have always operated under the fact that a healthy, balanced diet and regular exercise are key ingredients for a healthy lifestyle.

That said, we need to do a better job of being even more transparent about the research we fund, the non-profit organizations we support and the way we publicly share this information. And we will.

Yesterday, Senator Richard Blumenthal sent letters to the University of Colorado, West Virginia University, and the University of South Carolina urging them to  clarify the nature of the University’s relationship with projects funded by Coca-Cola and to review the academic integrity of such grant agreements.

I believe your university must determine whether this research is in effect promoting a predisposed and biased agenda, rather than reflecting the impartiality and objectively (sic) expected from a public academic institution.

Years of litigation with tobacco companies were necessary to fully expose the tragic public health consequences when companies lie about the hazards of the products they sell.  I am deeply concerned that we may force future generations to relive this history if corporate-sponsored studies devoid of scientific integrity are permitted once again to deceptively downplay and conceal the dangers of a product consumed on a mass scale.

Do not underestimate Senator Blumenthal’s ability to deal with food companies.  He, you may recall, was responsible for withdrawal in 2009 of the ill-conceived Smart Choices program during his stint as Connecticut’s attorney general.

I’m still waiting for the Global Calorie Balance Network to issue its promised statement.  Stay tuned.

Now cartoonists are producing their own interpretations of the revelations in the New York Times of Coca-Cola’s funding of scientists to argue that what you drink has far less to do with obesity than does how much you move.

In Sunday’s Times, Brian McFadden comes to this conclusion:
Here’s the entire strip

:

The Global Calorie Balance Network (GEBN) scientists say they will have a response to all the criticism (and now ridicule).

GEBN welcomes the opportunity to engage in a global debate and discussion on the science and application of energy balance to promote health and reduce chronic disease. GEBN also welcomes scrutiny and constructive criticism. We respect our critics and ask that they respect us in return. The recent media attention has raised important issues about the goal and mission of GEBN. We have taken these comments very seriously and are in the process of clarifying these issues here on our website. We will have that information available early this week.

I look forward to seeing it.

I wrote this piece for The Guardian in response to the New York Times article earlier this week about Coca-Cola’s funding of scientists who think obesity is more about exercise than drinking sodas:

These days, you almost have to feel sorry for soda companies. Sales of sugar-sweetened and diet drinks have been falling for a decade in the United States, and a new Gallup Poll says 60% of Americans are trying to avoid drinking soda. In attempts to reverse these trends and deflect concerns about the health effects of sugary drinks, the soda industry invokes elements of the tobacco industry’s classic playbook: cast doubt on the science, discredit critics, invoke nanny statism and attribute obesity to personal irresponsibility.

Casting doubt on the science is especially important to soda makers. Overwhelming evidence links habitual consumption of sugary drinks to poor health. So many studies have identified sodas as key contributors to chronic health conditions – most notably obesity, type-2 diabetes and coronary artery disease – that the first thing anyone trying to stay healthy should do is to stop drinking them.

Soda companies know this. For at least the last 10 years, Coca-Cola’s annual reports to the US Securities and Exchange Commission have listed obesity and its health consequences as the single greatest threat to the company profits. The industry counters this threat with intensive marketing, lobbying and millions of dollars poured into fighting campaigns to tax or cap the size of sugary drinks.

But it is also pours millions into convincing researchers and health professionals to view sodas as benign.

Just last month, the Mayo Clinic Proceedings published a study arguing that the results of national dietary surveys, such as those that link sugary drinks to type-2 diabetes, are so flawed that they constitute a major misuse of public funds. The authors report honoraria, speaking and consulting fees from Coca-Cola.

This week’s revelation of Coca-Cola’s funding of the Global Energy Balance Network is only the latest example of this strategy in action. The Network promotes the idea that to prevent obesity you don’t need to bother about eating less or drinking less soda. You just have to be more active. Never mind that most people can’t lose weight without also reducing their intake.

A reporter who looked into this group discovered that Coca-Cola had funded the research of the scientists behind it, and generously. The network’s website was registered to Coca-Cola. None of this, however, had been made explicit.

Most nutrition professional journals now require researchers to declare who funds their studies, making it possible to compare study outcomes with funding sources. Studies sponsored by Coca-Cola almost invariably report no association of sugary drinks with diabetes, they question the validity of studies that do find such associations or, as in the case of Global Energy Balance Network investigators, they find activity to be the most important determinant of body weight.

Analyses of studies funded by Coca-Cola or its trade association demonstrate that they have an 83% probability of producing results suggesting no harm from soda consumption. In contrast, the same percentage of studies funded by government agencies or independent foundations find clear linkages between sugary beverages and such conditions. Coincidence? I don’t think so.

Since March, I’ve been posting industry-funded studies with results that favor the sponsor’s interests every time I find five of them. They are easy to find. Despite pleas to readers to send me industry-funded studies that do not favor the sponsor, I hardly ever get them. Whenever I come across a study that shows no harm from sodas, I immediately look to see who paid for it.

Soda companies spend generously to convince researchers and health professionals not to worry about sodas’ health effects. But why do researchers take the money? It is too simplistic to say that they are “bought.” Industry-funded investigators say they believe the funding has no effect on the design, conduct or interpretation of their research. But research involves choices of questions, assumptions and methods. It is not difficult to carry out a study that appears to meet high scientific standards yet fails to include critical controls that might lead to alternative conclusions.

Researchers funded by Coca-Cola need to take special care to control for unconscious biases but can only do this if they recognize the possibility. Many do not. Neither do many peer reviewers or editors of scientific journals. Although food-company financial support should not necessarily bias results, it appears to do so in practice.

Industry-funded scientists resent questioning of the influence of sponsorship on the quality of their science. They charge that investigators who find adverse effects of sodas on health are equally biased by career goals, righteous zeal or anti-corporate morality. Yes, independent scientists may have biases of their own, but their overarching research goal is to improve public health. In contrast, the goal of soda companies is to use research as a marketing tool.

Disclosure is essential. If a study is funded by Coca-Cola, caveat emptor.