Currently browsing posts about: Sponsored-research

I’ve just started getting a new Science and Research newsletter from William Reed: Informing Business Growth.

Some of the listings focus on dietary patterns or emerging microbiome research:

But most of them focus on single nutrients, ingredients, or foods—suggesting that they are about marketing those ingredients, not necessary health (people don’t eat single foods exclusively; we eat meals and mixtures).

These are a lot of fun.  They raise the possibility of magic bullets (if only).

But watch out for the weasel words “may,” “could,” “might”.  These mean “may or may not,” “could or could not,” “might or might not.”

• Long-term multivitamin use linked to fewer heart problems: Harvard study: A daily multivitamin may protect men from cardiovascular events such as heart attack and stroke in the long-term, says a new study… Read
• Eating black raspberries may decrease heart disease risk: Study: An extract found in black raspberries can significantly lower arterial stiffness, a key measure of cardiovascular disease, according to data from a Korean study… Read
• New forum showcases the benefits of pulses: A networking forum to help manufacturers understand the nutritional value of pulses has been created by McGill University in Montreal, Canada… Read
• Fish oil, cocoa & plant sterols: The winning combination against heart disease?: Combining fish oil, cocoa extract and plant sterols food supplements could offer an effective defence against heart disease, a new study suggests.  .. Read
• Plant-derived bacteria shows anti-obesity effects: RCT: Heat-killed Pediococcus pentosaceus LP28 derived from the longan fruit may help trim waist lines and reduce body fat, say results from a double-blind, randomized, placebo-controlled study… Read
• Olive-sourced hydroxytyrosol effective in biscuits: Study: Olive oil phenol hydroxytyrosol has been shown to be highly bioavailable and to lower oxidised LDL (low density lipoprotein) levels when incorporated into biscuits, suggesting functional food applications could be on the horizon for this EFSA-backed polyphenol. .. Read
• Study shows Calanus oil may benefit blood pressure and heart health: Supplements containing Calanus oil may support cardiovascular health via anti-inflammatory effects in blood vessel walls, says a new study… Read
• Review supports immune health potential of larch arabinogalactan: Supplements of Larch arabinogalactan may support immune health and help reduce the incidence of common cold infections, says a new review… Read
• Insights into banana carotenoids could hold key to fighting blindness: Insights into how bananas make and store carotenoids could help in the future development of banana varieties to combat vitamin A deficiency and blindness, say researchers… Read
• Niagen to be researched for neuroprotective effect among football players: Thorne Research and ChromaDex Corp. are partnering with the Mayo Clinic and the University of Minnesota on a study to assess the effect of nicotinamide riboside (NR) on the brains of football players… Read
• Dark chocolate rivals beetroot juice in boosting athletic performance, study shows: Dark chocolate provides similar benefits to beetroot juice consumed already by elite athletes to improve exercise endurance, a study revealing similar levels of flavanol content has suggested… Read

Wouldn’t you rather eat chocolate than beets?  That’s what such studies are about.  And I wonder how many of them are funded by the makers of the products.  Want to take a look?

The USDA has just done a write up on a study it funded in collaboration with the National Honey Board:  Consumption of Honey, Sucrose, and High-Fructose Corn Syrup Produces Similar Metabolic Effects in Glucose-Tolerant and -Intolerant Individuals.

This was one of the 12 industry-negative studies I posted to my collection of 168 industry-funded studies from March 2015 to March 2016.

The USDA article explains:

Controversy exists over whether all sweeteners produce the same metabolic effects in consumers despite the sweeteners’ chemical similarities. A study conducted by U.S. Department of Agriculture (USDA) researchers indicates that consuming lower amounts of added sugars is a more effective approach to health than finding a sugar that is more neutral in terms of its health effects…Volunteers [consuming honey, white cane sugar, or HFCS] did not show any differences in blood sugar levels based on the dietary sugar source. In addition, blood levels of triglyceride, an indicator of blood fat concentrations (a marker for heart disease risk), increased in response to all three sugars tested.

White cane sugar is 50% glucose and 50% fructose, linked together (but quickly separated in the body).  Honey and High Fructose Corn Syrup are glucose and fructose, already separated, but with slightly higher percentages of fructose.  Biochemically, they are not all that different.

So the results of this study, disappointing as they may have been to the Honey Board, were predictable on the basis of basic sugar biochemistry.

Last week, StatNews.com revealed that the Walt Disney company tried to withdraw a research study it had funded because its University of Colorado authors, Jim Hill and John Peters, were behind the Global Energy Balance Network, the group funded by Coca-Cola to minimize the role of sugary drinks in obesity.

The headline: “Disney, fearing a scandal, tried to press journal to withdraw research paper.”

StatNews.com based the story on e-mails obtained from the University of Colorado by Gary Ruskin of US Right to Know through open records requests.

An e-mail from John Peters to a Disney representative says “could I ask you to look this [draft press release] over and edit as you see fit.”

But the authors’ conflict-of-interest disclosure statement says:

This work was supported by the Walt Disney Company and by the National Institutes of Health (grant no. DK48520). The Walt Disney Company and the National Institutes of Health had no role in the design, analysis, or writing of this article.

This may be strictly true, but the authors were asking Disney to approve their press release, which is not exactly “no role.”

Readers: does any of this sound familiar?  In February, I wrote a blog post about precisely this article for which I wrote an invited Commentary, accepted by the journal but not published.  I said:

The paper turned out to be by a group of authors, among them John Peters and Jim Hill, both members of the ill-fated Global Energy Balance Network, the subject of an investigation by the New York Times last August…I thought Disney’s sponsorship of this research and its withholding of critical baseline and sales data on kids’ meals that the company considered proprietary did indeed deserve comment, and wrote my piece accordingly.  Brian Wansink [the journal editor] soon accepted it for publication but to my surprise, gave it to Peters et al. for rebuttal.  They filed a lengthy response.  I was then given the opportunity to respond, and did so, briefly.

My Commentary—and the back-and-forth—were omitted (although they are online and will be published in a later issue, apparently).

Brian Wansink wrote colleagues who are editing the next issue of the journal that the back-and-forth debate over the article “was heated, and it also dragged on (because of Disney approvals) and – as we feared – it missed the deadline of our issue.”

This suggests that Disney had even more of an involvement, but when I asked Wansink if Disney approvals were responsible for his having dropped my Commentary, he said no, they just ran out of room.

We now know that Disney was more involved than disclosed.  How involved?  We dont know but perhaps other e-mails will surface to answer that question.

In their Rebuttal to my Commentary, Hill and Peters said

We were disappointed by Dr. Nestle’s assertion that Disney’s decision to not allow publication of kid’s park attendance numbers or raw kid’s meal sales numbers (because of their proprietary nature in the competitive business of theme parks) and the fact that Disney funded the study raises “red flags” about the veracity of the data presented…While we believe caution and transparency are always key ingredients when working with industry we also believe that solving the obesity problem will require finding a productive model for working together that can channel everyone’s energy toward finding solutions.  The Disney study is a good example of why partnering with industry can help move the field forward.

I am sorry I disappointed them, but I disagree.

The e-mails demonstrate even more forcefully that the Disney study is a good example of why partnering with industry should raise acres of red flags.

To repeat my response:

The response from Peters and Hill still fails to acknowledge the severity of the problems posed by Disney’s sponsorship of their research—the company’s failure to produce data essential for proper interpretation of study results, and the level to which sponsorship by food companies biases such interpretations.  At one point, Disney boasted of the results of this research, confirming its benefit to marketing goals.  The threat of industry sponsorship to research credibility has received considerable press attention in recent months, as must surely be known to these authors. [References one and two]. 

Because of Disney’s funding, the company must have thought it had the right to determine whether and how its funded study would be published.  And, as these e-mails reveal, therein lies the problem.

This morning, I received a query from a scientist:

I have been following your documentation of industry-funded research on health benefits. I’ve been thinking about this issue from the perspective of fruits and vegetables. We know that they are good in general, but how does one fund research to demonstrate that clinically? In particular, how does one get specific about the form and amount that his helpful for specific health benefits?  You may be interested in this press release from the raspberry industry telling about the papers at the Society for Experimental Biology meetings that are relevant to the health benefits of eating raspberries. This seems to be approaching what a good model might look like. I’m interested in your perspective. Furthermore, are the results relevant to nutritionists?

Here’s how I answered it:

Thanks for sending.  I guess my question would be something along the lines of why getting specific about form and amount of specific fruits and vegetables is important for public health.  People don’t eat just raspberries.  They put them in cereal or on desserts.  Raspberries are expensive.  Wealthy, educated and, therefore, healthy people are likely to consume them.  So this looks like marketing research to me—selling raspberries as a superfood.  If you think there is a special benefit to raspberries and that it would be good to quantify it, the best strategy would be to get the research funded by an independent agency.  Otherwise, it’s clearly marketing research (hence the press release).   At least that’s how I see it.

This, of course, gets us back to the question of sponsored research which, as my collection of sponsored studies has shown, almost inevitably produce results favorable to the sponsor.  I love raspberries and don’t doubt for a minute that they are healthy, but a superfood?  I don’t think so.

I’m still working on the descriptive analysis of the year’s collection of sponsored studies.  I will also be giving more thought to such questions, so send them along.

Since March 16, 2015, I’ve been collecting research studies funded by industry or conducted by investigators with food industry connections.  These are studies that I’ve either run across in the course of my reading or that were sent to me by readers (thanks especially to Cole Adams).

It has now been a year since I started doing this.  If I have counted correctly, this somewhat haphazard collection comes to a grand total of 168 funded studies, 156 of them with results favorable to the sponsor’s interests, but only 12 industry-funded studies with unfavorable results.

That’s more than enough to make this point: it’s a lot easier to find industry-funded studies with results favorable to the sponsor’s interest than against it.

I will do a more accurate count and see what other conclusions, if any, can be drawn from this collection as soon as I can get to its analysis.

In the meantime, I’m stopping the collection.  From now on, I will only post sponsored studies that raise particular issues or that I find particularly amusing.

Here’s the last bunch:

Missing Lunch Is Associated with Lower Intakes of Micronutrients from Foods and Beverages among Children and Adolescents in the United States.  Kevin C. Mathias, PhD, Emma Jacquier, MMedSci, Alison L. Eldridge, PhD, RD.  DOI: http://dx.doi.org/10.1016/j.jand.2015.12.021.

• Conclusions: This study identifies potential concerns for children missing lunch with respect to micronutrient intakes and shows that the lunches consumed by children in the United States are an important source of essential nutrients, but also less healthful dietary components.
• Disclosures: All authors are employed by the Nestlé Research Center, Lausanne Switzerland (Nestec Ltd). Funding was provided by Nestec Ltd (Vevey, Switzerland) 

Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials.  Jing Zhou, Jung Eun Kim, Cheryl LH Armstrong, Ningning Chen, and Wayne W Campbell.   Am J Clin Nutr March 2016;vol. 103 no. 3 766-774. doi: 10.3945/​ajcn.115.124669.

• Conclusion: The consumption of a greater proportion of energy from protein while dieting may improve sleep in overweight and obese adults.
• Disclosures: WWC was a member of the National Dairy Council Whey Protein Advisory Panel while the research was being conducted. The other authors reported no conflicts of interest related to the study.

A randomized trial of high-dairy-protein, variable-carbohydrate diets and exercise on body composition in adults with obesity.  Evelyn B. Parr, Vernon G. Coffey, Louise E. Cato, Stuart M. Phillips, Louise M. Burke andJohn A. Hawley. Obesity.  Article first published online: 2 MAR 2016.  DOI: 10.1002/oby.21451

• Conclusions: Compared to a healthy control diet, energy-restricted high-protein diets containing different proportions of fat and CHO confer no advantage to weight loss or change in body composition in the presence of an appropriate exercise stimulus.
• Funding agencies: Supported by a grant from the Dairy Health and Nutrition Consortium, Dairy Innovation Australia Ltd…to JAH, VGC, SMP, and LMB).  Disclosure: The authors declared no conflict of interest.

Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial.  Betsy Foxman, PhD; Anna E. W. Cronenwett, BA; Cathie Spino, DSc; Mitchell B. Berger, MD, PhD; Daniel M. Morgan, MD.  Am J Obstet Gynecol 2015;213:194.e1-8.

• Conclusion: Among women undergoing elective benign gynecological surgery involving urinary catheterization, the use of cranberry extract capsules during the postoperative period reduced the rate of UTI by half.
• Disclosure: The authors report no conflicts of interest… We also thank Theralogix, LLC (Rockville, MD) for providing cranberry juice capsules and placebo for use in this study.
• Comment: With respect to herbal medications, JAMA says “Only the use of cranberry for prevention of recurrent urinary tract infections in women is supported by some scientific evidence.”  It does not say whether that evidence was obtained by cranberry or cranberry supplement producers.

Coffee Consumption Increases the Antioxidant Capacity of Plasma and Has No Effect on the Lipid Profile or Vascular Function in Healthy Adults in a Randomized Controlled Trial. Gloria M Agudelo-Ochoa, Isabel C Pulgar´ın-Zapata, Claudia M Velasquez-Rodriguez, ´  Mauricio Duque-Ramirez, Mauricio Naranjo-Cano, Monica M Quintero-Ortiz, Oscar J Lara-Guzman, and Katalina Munoz-Durango.  J Nutr 2016;146:524–31.

• Conclusions: Both coffees, which contained CGAs [chlorogenic acids] and were low in diterpenes and caffeine, provided bioavailable CGAs and had a positive acute effect on the plasma AC [antioxidant capacity] in healthy adults and no effect on blood lipids or vascular function. The group that did not drink coffee showed no improvement in serum lipid profile, FMD [flow-mediated dilatation], BP [blood pressure], or NO [nitrous oxide] plasma metabolites.
• Funding: Supported by Vidarium, Nutrition, Health and Wellness Research Center, Nutresa Business Group; CES University; and the University of Antioquia.
• Author disclosures: GM Agudelo-Ochoa, IC Pulgarın-Zapata, OJ Lara-Guzman, ´ and K Munoz-Durango are researchers at Vidarium, Nutrition, Health and Wellness Research Center, Nutresa Business Group. M Naranjo-Cano and M Quintero-Ortiz are researchers at the Colcafe Research Coffee Group, Colcafe S.A.S. CM Velasquez-Rodrıguez and M Duque-Ramırez, no conflicts of interest.

Consumption of Fish Oil Providing Amounts of Eicosapentaenoic Acid and Docosahexaenoic Acid That Can Be Obtained from the Diet Reduces Blood Pressure in Adults with Systolic Hypertension: A Retrospective Analysis. Anne M Minihane, Christopher K Armah, Elizabeth A Miles, Jacqueline M Madden, Allan B Clark, Muriel J Caslake, Chris J Packard, Bettina M Kofler, Georg Lietz, Peter J Curtis, John C Mathers, Christine M Williams, and Philip C Calder.  J. Nutr. March 1, 2016 vol. 146 no. 3 516-523

• Conclusions: These findings indicate that in adults with isolated systolic hypertension, daily doses of EPA+DHA as low as 0.7 g show clinically meaningful BP reductions, which, at a population level, could be associated with lower cardiovascular disease risk. Confirmation of findings in an RCT in which participants are prospectively recruited on the basis of BP status is required to draw definite conclusions.
• Author disclosures: CK Armah, EA Miles, JM Madden, AB Clark, MJ Caslake, CJ Packard, BM Kofler, G Lietz, PJ Curtis, JC Mathers, and CM Williams, no conflicts of interest. AM Minihane is academic advisor for International Life Sciences Institute (ILSI) Europe Obesity and Diabetes Task Force and receives funding from Abbott Nutrition, USA. PC Calder serves on advisory boards of Pronova BioPharma, Aker Biomarine, Danone/Nutricia, Smartfish, Sancilio, DSM, Solutex, and ILSI Europe.

Higher compared with lower dietary protein during an energy deficit combined with intense exercise promotes greater lean mass gain and fat mass loss: a randomized trial.  Thomas M Longland, Sara Y Oikawa, Cameron J Mitchell, Michaela C Devries, and Stuart M Phillips.  Am J Clin Nutr  March 2016  vol. 103 no. 3 738-746. doi: 10.3945/​ajcn.115.119339

• Conclusion: Our results showed that, during a marked energy deficit, consumption of a diet containing 2.4 g protein · kg⁻¹ · d⁻¹ was more effective than consumption of a diet containing 1.2 g protein · kg⁻¹ · d⁻¹ in promoting increases in LBM [lean body mass] and losses of fat mass when combined with a high volume of resistance and anaerobic exercise.
• Conflicts of interest: SMP has received research funding, travel allowances, and honoraria from the US National Dairy Council and Dairy Farmers of Canada. None of the other authors reported a conflict of interest related to the study.
• Comment: Dairy, of course, is a source of protein.

Consumption of dairy foods and diabetes incidence: a dose-response meta-analysis of observational studies. Gijsbers L, Ding EL, Malik VS, de Goede J, Geleijnse JM, Soedamah-Muthu SS. Am J Clin Nutr. 2016 Feb 24. pii: ajcn123216. [Epub ahead of print]

• Conclusion: This dose-response meta-analysis of observational studies suggests a possible role for dairy foods, particularly yogurt, in the prevention of T2D. Results should be considered in the context of the observed heterogeneity.
• Funding: This meta-analysis project on dairy products and incident diabetes was funded by Wageningen University.  SSS-M previously received funding from Global Dairy Platform, Dairy Research Institute, and Dairy Australia for projects related to dairy effects on lipoproteins and mortality; JMG previously received funding from the Global Dairy Platform and Dutch Dairy Association for projects related to dairy and cardiovascular diseases; and ELD previously consulted for the Dairy Research Institute. LG, VSM, and JdG reported no conflicts of interest related to the study. Any prior sponsors had no role in the design and conduct of the study, data collection and analysis, interpretation of the data, decision to publish, or preparation of this manuscript. The current funder had no role in design and conduct of the study, data collection and analysis, interpretation of the data, or decision to publish.
• Comment: The conclusions put a positive spin on results that can also be considered equivocal.

Plenary Lecture 2: Milk and dairy produce and CVD: new perspectives on dairy and cardiovascular health. Julie A. Lovegrove* and Ditte A. Hobbs.  Proceedings of the Nutrition Society, Page 1 of 12 doi:10.1017/S002966511600001X.

• Conclusion: These apparent benefits of milk and dairy foods have been attributed to their unique nutritional composition, and suggest that the elimination of milk and dairy may not be the optimum strategy for CVD risk reduction.
• Conflicts of Interest: The authors have previously received funding for research from AHDB Dairy. J. A. L. has acted as an advisor to the Dairy Council. J. A. L. has received funding for research from Volac for BBSRC case studentship and ‘in kind’ foods from Arla for an MRC funded study.

Multivitamin/mineral supplements: rationale and safety – A systematic review. Hans K. Biesalski, Jana Tinz.  Nutrition, in press 2016.  doi:10.1016/j.nut.2016.02.013

• Conclusion: Taken together, these findings indicate that MVM can be safe for long-term use (more than 10 years).
• Funding: Editorial support was provided by Peloton Advantage and funded by Pfizer.

The challenges of vitamin and mineral supplementation in children with inherited metabolic disorders: a prospective trial.  A. Daly, S. Evans, S. Chahal, I. Surplice, S. Vijay, S. Santra and A. MacDonald.  J Human Nutrition and Dietetics.  Article first published online: 18 JAN 2016. DOI: 10.1111/jhn.12354 (thanks to Cole Adams for sending).

• Conclusions: Despite improvements in some nutritional markers, overall use of the vitamin and mineral supplement was less than prescribed. New methods are needed to guarantee delivery of micronutrients in children at risk of deficiencies as a result of an essential manipulation of diet in inborn disorders of metabolism.
• Funding: Anita MacDonald has received research funding from Merck Serono, Vitaflo Ltd and Nutricia. She is on Advisory Boards for Arla, Merck Serono and Nutricia. Anne Daly and Sharon Evans have received research funding from Vitaflo Ltd, and Nutricia. Research funding was obtained from Vitaflo International for the funding of this project.

The Australian Broadcasting Corporation’s Sarah Whyte of ABC 7:30 interviewed me and others for a 6-minute segment on Coca-Cola’s funding of health researchers.  Here’s an excerpt from the transcript:

TIM OLDS, UNI. OF SOUTH AUSTRALIA: I’ve got about $26 million worth of funding, and of that, probably less than $2 million would have come from industry sources. Most of it comes from government schemes such as the NHMRC and the ARC, a lot from government departments.

SARAH WHYTE: So when you take that funding, do you get other academics saying you shouldn’t be taking funding from that?

TIM OLDS: We get a lot of academics saying that.

SARAH WHYTE: He disagrees with people like Marion Nestle who says his work is compromised.

TIM OLDS: I think frankly this is an example old-style, superannuated chardonnay socialism.

Oh.

Here’s what he’s referring to (the dates are Australian).

February 17  Marcus Strom, a business reporter with the Sydney Morning Herald, invites me to lunch to discuss issues related to Soda Politics.

February 24  Strom publishes an article based on our conversation: “What Coca-Cola isn’t telling you about its health funding in Australia” (the video tells the story).

February 26  The Sydney Morning Herald publishes Strom’s account of our lunch interview.

March 1  I give a lecture on Soda Politics at the University of Sydney.

March 3  In response to my remarks, the director of Coca-Cola Amatil makes this statement: “one can [of soda] a week not unhealthy.”

March 10  Coca-Cola publishes a preliminary version of its “commitment to transparency,” listing some of the community organizations it funds.

March 10  Strom writes an analysis of the transparency list—$1.7 million in support of research over five years—noting several key omissions.

March 10  ABC 7:30 runs its video (and see transcript).

March 10  A blogger publishes a list of individuals funded by Coca-Cola during that period.

March 11  Coca-Cola releases the complete version of its transparency list, including the names of individuals.

March 11  I receive an e-mail message from a Coca-Cola official stating the company’s commitment to transparency.

We are continuing to progress on our commitment to enhance our transparency in markets across the globe. Today, in Australia and New Zealand, we launched country-specific websites listing our health and well-being partnerships, research and health professionals and scientific experts that have received financial support from Coca-Cola from 2010-2015. In December 2015, we launched sites with this information in Great Britain, Germany, France, Ireland, Denmark, Finland, Belgium, Sweden, Norway and the Netherlands.  We will publish the six-month update for the U.S. later this month.

March 11  Strom attempts to interview the 14 health experts on Coca-Cola’s list; most don’t return his calls.

Coca-Cola deserves much praise for following through on its transparency commitments.  The aftermath continues.

Additions: New Zealand transparency and more from Australia

March 3: Coke: One can a week ‘not unhealthy’

March 11:  Coca-Cola cash went to NZ health organisations and research

March 11: Coca-Cola funds research in NZ, NZ Herald

March 13: Three Kiwi health professionals took money from Coca-Cola

March 14:  Gary Moorhead, past CEO of Sports Medicine Australia argues that shaming researchers does no good

March 15: NZ Dominion Post editorial says dentists should not take money from Coca-Cola

March 16: The Press, New Zealand, editorial on whether Coca-Cola should be paying scientists