Currently browsing posts about: Conflicts-of-interest

I’ve been posting summaries of studies funded by food companies or trade groups, all of which come up with results that the sponsor can use for marketing purposes.

In each of these posts, I ask for examples of industry-funded studies that produce results contrary to the interests of the funder.

In response, I received this comment from Mickey Rubin, Vice President for Nutrition Research, National Dairy Council.

He gave me permission to reproduce his letter: 

Dear Marion,

By way of introduction, my name is Mickey Rubin and I am a scientist at the National Dairy Council. I understand that you know Greg Miller, and I asked him for your contact information so I could write to you directly after reading with great interest your most recent post on industry-funded nutrition research, in which you selected a sample of 5 studies/papers sponsored by industry all showing favorable outcomes. Although none of the papers you selected were sponsored by the organization I represent (although there is one dairy industry sponsored review paper in the list), what struck me is your focus on the favorable vs. unfavorable dichotomy, rather than the reality of what much nutrition science research results in: null findings.

It seems that there are fewer and fewer nutrition studies published that report the null, or find no effect. I agree with you that the reason we don’t see more of these studies in the literature has to do with bias, but I suspect that it is publication bias as much as any other bias. From my interactions with nutrition researchers, I gather it is quite difficult and sometimes impossible to get a study with no significant effects published regardless of funding source, to say nothing of allegiance bias by some researchers hesitant to publish findings that may go against their own hypotheses. Dr. Dennis Bier of Baylor College of Medicine and editor in chief of the American Journal of Clinical Nutrition has presented eloquently on this issue previously. You may also be aware of David Allison’s papers on other types of bias. So I think it is important to discuss all types of bias, and not just industry bias. You of course wouldn’t want your discussion on bias to be biased to just one type.

At National Dairy Council we have an extensive program of nutrition research that we sponsor at universities both nationally and internationally. While I can’t speak for all of industry, we strongly encourage the investigators of all of our sponsored studies to publish the findings, no matter the results. Thus, we would expect our sponsored studies to have a similar “success” rate as those sponsored by the National Institutes of Health. In fact, that is exactly what one recent analysis – not sponsored by the dairy industry – found, reporting that there was no evidence that dairy industry funded projects were more likely to support an obesity prevention benefit from dairy consumption than studies sponsored by NIH.

We feel this transparency is not only critical to the credibility of the research we sponsor, but we also feel it is important that our research contributes to nutrition science knowledge as a whole. We hope that other scientists take the findings from studies we sponsor and build upon them, and if it is by using research dollars from other sources, even better! I’ll be the first to stand up and say that one favorable study on milk, as an example, does not close the books on the subject. We need many studies in many different labs sponsored by multiple agencies in order to produce a portfolio of knowledge. I suspect that is certainly an example of where you and I are in agreement.

That all said, please allow me to provide some examples of studies the National Dairy Council has sponsored that are published and, rather than showing a clear benefit, do not refute the null hypothesis. These are all studies published within the last 4 years. It’s not meant to be comprehensive, but rather just a sample similar to what you provided. I could also provide you a list of studies we have sponsored that have shown favorable results for dairy, but you seem to have that covered, and I’ll instead wait until one of our sponsored studies appears in a subsequent blog post J.

Thanks for taking the time to read. I appreciate the dialogue.

Here’s his list of papers:

Studies with null finding:

Bendtsen et al. 2014: http://www.ncbi.nlm.nih.gov/pubmed/24168904

• No unique benefit of dairy protein over other proteins for weight maintenance

Maki et al. 2013: http://www.ncbi.nlm.nih.gov/pubmed/23901280

• No effect of three servings of dairy on blood pressure

Chale et al. 2013: http://www.ncbi.nlm.nih.gov/pubmed/23114462

• Whey protein supplementation offered no additional benefit over resistance training alone in older individuals

Lambourne et al. 2013: http://www.ncbi.nlm.nih.gov/pubmed/23239680

• No change in body weight or composition in adolescents performing resistance training and supplemented with milk, juice, or control

Van Loan et al. 2011: http://www.ncbi.nlm.nih.gov/pubmed/21941636

• Recommended dairy servings offered no additional weight loss benefit over calorie restriction without dairy servings 

Studies with mixed findings (some outcomes changed, others null):

Maki et al. 2015: http://www.ncbi.nlm.nih.gov/pubmed/25733460

• The main finding from the study was that dairy intake had no effect on glucose control whereas sugar sweetened product consumption contributed to a worsening of glucose control in at-risk adults.

Dugan et al. 2014: http://www.ncbi.nlm.nih.gov/pubmed/24236646

• Waist circumference and BMI were lower in women after consuming the dairy diet as compared to the control diet. Fasting glucose was lower in men following the dairy diet as compared to the control diet. There were no differences in blood pressure, serum lipids, fasting insulin, or insulin resistance between the treatments.

Here’s what I wrote in response:

I am familiar with charges of bias against independently funded researchers (“White-hat Bias”), which equates industry biases with biases that result from career objectives and other goals.  I do not view the biases as equivalent.  Industry-sponsored research has only one purpose: to be used in marketing to sell products.   As I have said repeatedly, it is easy to design studies that produce desired answers.

When I was in graduate school in molecular biology, we were taught—no, had beaten into us—to do everything we could to control for biases introduced by wishful thinking.  I don’t see that level of critical thinking in most studies funded by food companies.

You may be correct about the influence of publication bias with respect to dairy studies, but how do you explain the situation with sugar-sweetened beverages?  Studies funded by government and foundations typically indicate strong correlations between habitual consumption of sugary beverages and metabolic problems, whereas studies funded by the soda industry most definitely do not.   The percentages are too high to be due to chance: 90% of independently funded studies show health effects of soda consumption whereas 90% of studies funded by soda companies do not.  This is troubling.

We’ve seen the results of studies funded by tobacco and drug companies.  Are food-industry studies different?  I don’t think so.   What seems clear is that industry-induced biases are not recognized by funding recipients, a problem in itself.

That’s why I’m posting these studies as they come in and begging for examples of industry-funded studies that do not favor the interests of the donor.

Thanks to Mickey Rubin for writing and for permission to reproduce his letter.

Let the discussion continue!

I’m catching up with events I missed while offline in Cuba.  Here’s one: Michele Simon’s new report:

The American Society for Nutrition (ASN) is the leading organization for physicians and scientists who conduct nutrition research.  I’ve been a member for years and have long fretted about the ASN’s too-cozy relationships with food company sponsors (for example, see my posts on the ill-fated Smart Choices campaign and on a recent ASN annual meeting).

Simon has now done for the ASN what she previously did for the American Academy of Dietetics.

A few of her findings:

• Of the 34 scientific sessions at ASN’s annual meeting, 6 were supported by PepsiCo, and others were supported by the Egg Nutrition Center, Kellogg, DuPont Nutrition and Health, Ajinomoto, and the National Dairy Council.

• The International Life Sciences Institute (a front group for Big Food and Big Pharma) sponsored a session on low-calorie sweeteners; speakers included a scientific consultant for Ajinomoto, which produces aspartame.

• For $35,000, junk food companies can sponsor the hospitality suite at the annual meeting, where corporate executives socialize with nutrition researchers.

• ASN published an 18- page defense of processed food that consists of numerous talking points for the junk food industry, such as “There are no differences between the processing of foods at home or at a factory.”

• ASN opposes an FDA proposed policy to include added sugars on the Nutrition Facts panel, at a time when excessive sugar consumption is causing a national public health epidemic.

I’m quoted in the report:

I think it’s important that professional societies like ASN promote rigorous science and maintain the highest possible standards of scientific integrity. Research and education about food and nutrition are easily influenced by funding from food companies but such influence often goes unrecognized. This means that special efforts must be taken to avoid, account for, and counter food industry influence, and organizations like ASN should take the lead in doing so.

The report has been well covered by the media:

• Leading U.S. Nutrition Scientists Forge Cozy Relationships With Major Food Companies and Lobbying Groups, Report Charges, International Business Times
• Is the Leading Nutrition Science Group in Big Food’s Pocket? Mother Jones
• Do big food companies have too much sway over nutrition research? WBEZ Radio
• Report Questions Nutrition Group’s Ties to Food Companies, Food Manufacturing
• Food companies, nutrition researchers getting too friendly: report, FoodDive
• And see the lengthy online rebuttal

Relations between nutrition scientists and food companies worry me.  Here’s another example: Portuguese nutritionists have produced an e-book extolling the virtues of cereal-based drinks.  The book is sponsored by Nestlé (the company, not me).  Nestlé, no surprise, is the market leader for these products in Portugal.  I thank Vladimir Pekic of BeverageDaily.com for finding this one.

Here is my latest roundup of industry-sponsored research producing results or opinions that favor the sponsor’s commercial interests.

Sugars and obesity: Is it the sugars or the calories?  Choo FL, Ha V, Sievenpiper JL.  Nutrition Bulletin, May 19, 2015.  DOI: 10.1111/nbu.12137

Conclusion: The higher level evidence reviewed in this report does not support concerns linking fructose-containing sugars with overweight and obesity.

Conflicts of interest: All three authors report scholarship or research support from such entities as the Canadian
Sugar Institute, PepsiCo, Coca-Cola, Dr Pepper Sapple, Corn Refiners Association, World Sugar Research Organization.

Cranberry Juice Consumption Lowers Markers of Cardiometabolic Risk, Including Blood Pressure and Circulating C-Reactive Protein, Triglyceride, and Glucose Concentrations in Adults.  Janet A Novotny, David J Baer, Christina Khoo, Sarah K Gebauer, and Craig S Charron. J. Nutr. 2015; 145:1185-1193 doi:10.3945/jn.114.203190.

Conclusion: LCCJ [low-calorie cranberry juice] can improve several risk factors of CVD [cardiovascular disease] in adults, including circulating TGs [triglycerides], CRP (c-reactive protein], and glucose, insulin resistance, and diastolic BP [blood pressure].

Sponsor: Ocean Spray Cranberries, Inc. and the USDA.  JA Novotny received funding from  and C Khoo is employed by Ocean Spray Cranberries, Inc.

Effect of cheese consumption on blood lipids: a systematic review and meta-analysis of randomized controlled trials. Janette de Goede, Johanna M. Geleijnse, Eric L. Ding, and Sabita S. Soedamah-Muthu

Conclusion: Despite the similar P/S ratios of hard cheese and butter, consumption of hard cheese lowers LDL-C and HDL-C when compared with consumption of butter.

Funding. The senior author received unrestricted research grants from the Global Dairy Platform, the Dairy Research Institute, and Dairy Australia for the present meta-analysis. One other author, E.L.D., has consulted for the Dairy Research Institute.

Protein Summit 2.0: Evaluating the Role of Protein in Public Health: Proceedings of a conference held in Washington, DC, October 2, 2013.  American Journal of Clinical Nutrition, June 2015 Supplement.

Program organizer: Shalene McNeill, National Cattlemen’s Beef Association, and a Contractor to The Beef Checkoff.

Sponsors: The Beef Checkoff, Dairy Research Institute, Egg Nutrition Center, Global Dairy Platform, Hillshire Brands, National Pork Board

My comment: Journal supplements are typically paid for by outside parties—government agencies, foundations, private organizations, or food companies.  The papers in this supplement discuss various aspects of protein and health.  All emphasize the benefits of animal protein in human diets, as might be expected, given the sponsors.

Two examples:

Commonly consumed protein foods contribute to nutrient intake, diet quality, and nutrient adequacy.  Stuart M Phillips, Victor L Fulgoni III, Robert P Heaney, Theresa A Nicklas, Joanne L Slavin, and Connie M Weaver.  Am J Clin Nutr June 2015 vol. 101 no. 6 1346S-1352S.

Conclusion: dietary recommendations to reduce intakes of saturated fat and solid fats may result in dietary guidance to reduce intakes of commonly consumed food sources of protein, in particular animal-based protein.

The role of protein in weight loss and maintenance.  Heather J Leidy, Peter M Clifton, Arne Astrup, Thomas P Wycherley, Margriet S Westerterp-Plantenga, Natalie D Luscombe-Marsh, Stephen C Woods, and Richard D Mattes.

Conclusion:  Collectively, these data suggest that higher-protein diets…provide improvements in appetite, body weight management, cardiometabolic risk factors, or all of these health outcomes.

For the record: Industry sponsorship does not necessarily mean that the reported conclusions are wrong.  It just means that the papers require even more than the usual level of critical analysis.

I am happy to post industry-sponsored studies that do not produce results that can be used to market the sponsor’s products.  Please send if you find any.

Every time I collect five, I’m posting studies sponsored by food companies or trade associations that show benefits of the sponsor’s products.

I would love to be able to post industry-sponsored studies with results contrary to the sponsor’s interest, but I’m just not finding any.  If you run across some, please send.

Here’s this week’s batch, with comments on the last two:

Probiotic supplementation prevents high-fat, overfeeding-induced insulin resistance in human subjects. Carl J. Hulston, Amelia A. Churnside and Michelle C. Venables British Journal of Nutrition (2015), 113, 596–602 doi:10.1017/S0007114514004097.

• Conclusion: These results suggest that probiotic supplementation may be useful in the prevention of diet-induced metabolic diseases such as type 2 diabetes.
• Sponsor: The present study…was financially supported by industry funds. The cost of consumables for the study was covered by an educational grant from Yakult UK Limited.

Dairy Foods and Dairy Proteins in the Management of Type 2 Diabetes: A   Systematic Review of the Clinical Evidence.   Gonca Pasin and Kevin B Comerford.    Adv Nutr 2015; 6:245-259. doi:10.3945/an.114.007690.

• Conclusion: Given cultured dairy products’ long history of safe use, and whey protein’s overall efficacy in clinical studies so far, these dairy products appear to have great potential to assist with the management of T2DM in millions of people worldwide, in an inexpensive and easily implementable manner.
• Sponsor: California Dairy Research Foundation. G Pasin is the executive director of the California Dairy Research Foundation. KB Comerford is a paid consultant for the California Dairy Research Foundation.

One Egg per Day Improves Inflammation when Compared to an Oatmeal-Based Breakfast without Increasing Other Cardiometabolic Risk Factors in Diabetic Patients.  Martha Nydia Ballesteros , Fabrizio Valenzuela, Alma E. Robles, Elizabeth Artalejo, David Aguilar, Catherine J. Andersen, Herlindo Valdez  and Maria Luz Fernandez.   Nutrients 2015, 7(5), 3449-3463; doi:10.3390/nu7053449

• Conclusions:  When compared to an oatmeal breakfast, one egg per day did not result in changes in plasma glucose, our primary end point…[and other markers] indicating that eggs can be consumed without any detrimental changes in lipoprotein or glucose metabolism in this population. The most interesting finding, however, was that eggs—possibly due to their content of highly bioavailable lutein and zeaxanthin—reduced inflammation in diabetic subjects when compared to oatmeal intake.
• Sponsor: Egg Nutrition Center

The Acute Electrocortical and Blood Pressure Effects of Chocolate.  M. Montopoli, L. C. Stevens, C. Smith, G. Montopoli, S. Passino, S, Brown, L. Camou, K. Carson, S. Maaske, K. Knights, W. Gibson, J. Wu.  NeuroRegulation 2015;2(1):3-28.  doi: 10.15540/nr.2.1.3.

• Conclusions: This is the first known study to investigate acute EEG effects of consuming chocolate and suggests a potential attention-enhancing effect… there is clearly the possibility of an application of this combination of L-theanine and cacao in the treatment of hypertension.
• Sponsor: “Chocolate products for this study were provided by a generous grant in supplies from The Hershey Company…Grateful appreciation is expressed to Dr. Debra Miller and to the staff at The Hershey Company for their guidance and support throughout this project and for their careful review of this manuscript prior to submission.”

Comment: I learned about this study from FoodNavigator, which deserves highest praise for this headline: “Step aside energy drinks: Chocolate has a stimulating effect on human brains, says Hershey-backed study.”  Bravo!

Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from 174 000 participants in 27 randomised trials.   Cholesterol Treatment Trialists’ (CTT) Collaboration.  Lancet 2015:385:1397-1405.

• Conclusion: “In men and women at an equivalent risk of cardiovascular disease, statin therapy is of similar effectiveness for the prevention of major vascular events.”
• Conflicts reported: The CTT Collaboration reports funding by various British and Australian research councils and foundations, “and not by the pharmaceutical industry.” But, it says, most of trials covered by its analysis were supported by the drug industry, and numerous members of the CTT report fees, grants, consultancies, or honoraria from various companies making cholesterol-lowering drugs.

Note:  drug companies have a vested interest in promoting drug, rather than dietary, approaches to LDL-lowering.

Comment: Conflicts of interest do not necessarily mean that the results of the study were manipulated or wrong.  They do mean that the methods and results require more than the usual level of scrutiny.  Sponsored studies almost invariably produce results consistent with the sponsor’s economic or marketing interests.

It’s likely that some industry-sponsored studies produce conclusions contrary to the sponsor’s interest.  If you know of any, please send.

As promised, I am posting examples of industry-sponsored research every time I collect five.  These, like the others, produce results favorable to the sponsor’s interests.

I am happy to post examples of sponsored studies that do not favor the sponsor’s interests, and this first one comes closest.  This Unilever-sponsored study found that consuming the product had no effect on blood flow in people with high blood cholesterol levels, although it did lower their levels of LDL (the “bad” cholesterol).

The effect of a low-fat spread with added plant sterols on vascular function markers: results of the Investigating Vascular Function Effects of Plant Sterols (INVEST) study. By Rouyanne T Ras, Dagmar Fuchs, Wieneke P Koppenol, Ursula Garczarek, Arno Greyling, Christian Keicher, Carole Verhoeven, Hakim Bouzamondo, Frank Wagner, and Elke A Trautwein.  Am J Clin Nutr 2015; 101:733-741 doi:10.3945/ajcn.114.102053.

• Conclusion: The intake of a low-fat spread with added PSs [plant sterols] neither improved nor worsened FMD [flow-mediated dilation]or other vascular function markers in hypercholesterolemic men and women. As expected, serum LDL cholesterol decreased, whereas plasma PSs increased after PS intake.
• Sponsor: Unilever Research and Development

The next four are more typical:

Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. By Mette Bohl, Ann Bjørnshave, Kia V Rasmussen, Anne Grethe Schioldan, Bashar Amer, Mette K Larsen, Trine K Dalsgaard, Jens J Holst, Annkatrin Herrmann, Sadhbh O’Neill, Lorraine O’Driscoll, Lydia Afman, Erik Jensen, Merete M Christensen, Søren Gregersen, and Kjeld Hermansen.  Am J Clin Nutr 2015; 101:870-878 doi:10.3945/ajcn.114.097923

• Conclusion:  We found that a whey protein supplement decreased the postprandial chylomicron response compared with casein in persons with abdominal obesity, thereby indicating a beneficial impact on CVD risk.
• Sponsor: Arla Foods Ingredients Group P/S, and the Danish Dairy Research Foundation, among some independent sources.

Policy Statement: Snacks, Sweetened Beverages, Added Sugars, and Schools. Council on School Health, Committee on Nutrition, American Academy of Pediatrics.  Pediatrics Volume 135, number 3, March 2015.

• Conclusion: A positive emphasis on nutritional value, variety, appropriate portion, and encouragement for a steady improvement in quality will be a more effective approach for improving nutrition and health than simply advocating for the elimination of added sugars.
• Conflicts reported: One of the members of the committee writing this statement is supported by the National Dairy Council and the American Dairy Association.  Another receives support from the Nestle Nutrition Institute.

Maternal long chain polyunsaturated fatty acid [omega-3] supplementation in infancy increases length- and weight-for-age but not BMI to 6 years when controlling for effects of maternal smoking. L.M. Currie, E.A. Tolley, J.M. Thodosoff, E.H. Kerling, D.K. Sullivan, J. Colombo, and S.E. Carlson . Prostaglandins, Leukotrienes and Essential Fatty Acids, 2015.  http://dx.doi.org/10.1016/j. plefa.2015.04.001

• Conclusion: Our results… suggest that LCPUFA [omega-3s] could have positive effects on stature without negative effects on weight status; and that LCPUFA could mitigate lower stature and higher BMI associated with maternal smoking, particularly in boys.
• Sponsor: Mead Johnson Nutrition, the maker of the LCPUFA omega-3 supplement

Mediterranean Diet and Age-Related Cognitive Decline:  A randomized Clinical Trial. Cinta Valls-Pedret, MSc; Aleix Sala-Vila, DPharm, PhD; Mercè Serra-Mir, RD; et al.  JAMA Intern Med. Published online May 11, 2015. doi:10.1001/jamainternmed.2015.1668.

• Conclusion: In an older population, a Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function.
• Conflicts reported: Dr Salas-Salvado reports receiving research funding and is a nonpaid member of the scientific advisory committee of the International Nut Council. Dr Ros also reports receiving research funding and is a nonpaid member of the scientific advisory committee of the California Walnut Commission.

Let me comment on this last one, which may seem like pushing things, given that the study itself was funded by the agency for biomedical research of the Spanish government.  I would have left it off this list had I not read an article about it in the Wall Street Journal.

The Journal interviewed Dr. Ros, the lead author:

The diminished decline in cognitive function likely stems from the abundance of antioxidants and anti-inflammatory agents found in the supplemental foods…He recommends that, to decrease age-related cognitive delay, people should add 5 tablespoons of olive oil as a well as a handful of nuts a day into their diet.

But the Journal also interviewed a clinical neuropsychologist who was not involved in the study:

The changes observed in cognition were very small and didn’t actually show that those diets improved cognition, they just showed less decline. Based on the research…people shouldn’t rush out to buy lots of olive oil and nuts.

My point here is that the sole purpose of this study was to prove the health benefits of olive oil and nuts.  Yes, these are healthy foods, but so are many others.  Like virtually all such studies, this one seems designed to produce the desired answer.

On his Weighty Matters blog, Dr. Yoni Freedhoff explains how biases play out in supposedly unbiased research journals, in this case, the British Journal of Sports Medicine.  Dr. Freedhoff talks about the journal’s temporary withdrawal of a paper arguing that diet is more important than physical activity in weight loss on the grounds that the authors did not disclose conflicts of interest.  In contrast, an editorial arguing the opposite, by authors who also did not disclose conflicts, went unchallenged and was not withdrawn.

Dr. Freedhoff asks: “Are these sorts of conflicts important to disclose?”

On the basis of today’s and many other examples, my answer is an unqualified yes.

I’ve been collecting items on sugars.  Here are the first two.  Two more will come later this week.

1.  The American Academy of Pediatrics Council on Nutrition has new guidance on sugars in schools.

Although access to junk foods remains an issue in schools, the Council blames the problem on students, parents, and staff.  It advises:

A positive emphasis on nutritional value, variety,appropriate portion, and encouragement for a steady improvement in quality will be a more effective approach for improving nutrition and health than simply advocating for the elimination of added sugars.

Really?  Evidence, please.

I ask because Kellogg could not be happier with this approach.  A little sugar, it says, may help kids eat more nutritious foods.

Surely it’s not a coincidence that one of the authors discloses receiving support from the National Dairy Council and the American Dairy Association, and the other receives support from the Nestle Nutrition Institute.

In any case, we aren’t talking about a little sugar in schools.  We are talking about candy, cupcakes, and drinks brought in for birthdays, treats, and after school celebrations.

2.  Sugar in the Trans Pacific Partnership (TPP)

This, you will of course recall, is the controversial multinational trade agreement currently under negotiation (see my previous post on this topic).

Japan wants to keep its tariff on sugar.

It now appears that the Japanese sugar industry gave a 1 million yen donation to a political group that supports Minister of Agriculture Koya Nishikawa, just before he became involved in the TPP talks in 2013.

As one commentator put it, considering Nishikawa’s central role in the TPP negotiations,

his receipt of a donation from an industry group brings his morals as a politician into question. Nishikawa stated that he returned the donation in light of his capacity as agricultural minister, but this is unlikely to resolve the situation…In March 2013, it was announced that the Japan Sugar Refiners’ Association would receive 1.3 billion yen in subsidies under a Ministry of Agriculture, Forestry and Fisheries’ project.

At the very least, this situation looks like blatant conflict of interest.

Today’s New York Times has a front-page story about how the FDA knew that certain weight-loss supplements contained unlabeled amphetamine-like substances but did nothing about it, perhaps because its head supplement official came from the industry (and has since returned to it).

Let’s start with the science.

In 2014, Pieter Cohen and his colleagues noted that several athletes had been disqualified from competition after tests found evidence of a methamphetamine analog (N,α-diethyl-phenylethylamine) in their urine.  The athletes said that the chemical must have come from their workout supplements.  Cohen et al. tested the supplements and identified the analog as one with entirely untested stimulant, addictive, or other adverse effects in humans.  They recommended its immediate removal from all dietary supplements.

Earlier that year, the FDA reported that 9 of 21 supplements containing Acacia rigidula to test positive for varying amounts of another methamphetamine analog, β-Methylphenethylamine (BMPEA).   The FDA investigators said this compound could be misidentified as amphetamine during certain kinds of analyses, but did not identify the products found to contain BMPEA.

Cohen et al. then did their own tests of the kinds of supplements the FDA had tested.  

The stimulant was present at quantities such that consumers following recommended maximum daily servings could consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements.

The New York Times explains the context:

The controversy comes at a time when the supplement industry is under increased scrutiny. Last week, 14 state attorneys general, led by Eric T. Schneiderman of New York, called on Congress to provide the F.D.A. with more power to regulate supplements. Mr. Schneiderman’s office in February accused four major retailers of selling contaminated herbal supplements, and one of the companies, GNC, has agreed to extensive new testing and quality control procedures for its store-brand herbal products.

This brings us to the politics.

The supplement industry, of course, is doing everything it can to oppose and stop Schneiderman’s work.

Recall that Congress passed the Dietary Supplement Health and Education Act in 1994, essentially deregulating the industry.  The act allowed absurd health claims for supplements and essentially removed much of the FDA’s authority to regulate these products.

The result was an increase in sales despite remarkably little evidence for efficacy.

As for conflicts of interest at FDA:

• Daniel Fabricant, the head of the FDA’s dietary supplement division at the time this was happening, came to the agency from the Natural Products Association, “Over 75 years of serving the natural products industry.” He has since left the FDA and now heads the NPA.
• The NPA spent nearly $1.5 million on lobbying in 2013 and 2014.
• The current head of the FDA’s dietary supplement division, Cara Welch, also came to FDA from the NPA.

Since DSHEA, the dietary supplement industry has gotten a pass.  Suggestions:

• Congress should rescind DSHEA and give the FDA the authority to regulate supplements as it does food.
• The FDA should appoint officials who are independent of the industries they are supposed to regulate.

I am increasingly concerned about the proliferation of research studies sponsored and funded by food, beverage, or supplement companies with a vested interested in the outcome.  These almost invariably come to conclusions in favor of the sponsor’s food product.

You must understand that I am not searching for sponsored studies in any systematic way.  They just appear in the tables of contents of journals I typically read and are easily identified by their titles.

My plan is to post a list of sponsored research studies every time I accumulate 5 examples.  My first post in this series appeared March 16.

Recent examples

1.  Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: A double-blinded, randomized, placebo controlled study, by Adam M. Bernstein, MD, ScD, Michael F. Roizen, MD, Luis Martinez, MD, MPH.  Journal of Clinical Lipidology 2014;8:612–617.

• Conclusion: Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL.
• Sponsor: Tersus Pharmaceuticals (maker of Provinal palmitoleic acid).  Dr. Roizen is chair of the Scientific Advisory Board of Tersus Pharmaceuticals and chair of the Cleveland Clinic Wellness Institute.

2.  Whey Protein Supplementation Preserves Postprandial Myofibrillar Protein Synthesis during Short-Term Energy Restriction in Overweight and Obese Adults, by Amy J Hector, George R Marcotte, Tyler A Churchward-Venne, Caoileann H Murphy, Leigh Breen,Mark von Allmen, Steven K Baker, and Stuart M Phillips.  J Nutrition 2015;145:246–52.

• Conclusion: We conclude that whey protein supplementation attenuated the decline in postprandial rates of MPS [Myofibrillar Protein Synthesis] after weight loss, which may be of importance in the preservation of lean mass during longer-term weight loss interventions.
• Sponsor: The Dairy Research Institute through the Whey Protein Research Consortium.

3.  Natural cocoa consumption: Potential to reduce atherogenic factors? By Brian K. McFarlin, Adam S. Venable, Andrea L. Henning, Eric A. Prado, Jill N. Best Sampson, Jakob L. Vingren, David W. Hill.  J Nutritional Biochemistry 2015: in press.

• Conclusion: Collectively, these findings indicate that acute natural cocoa consumption was associated with decreased obesity-related disease risk.
• Sponsor: The Hershey Company

4.  The effect of a high-egg diet on cardiovascular risk factors in people with type 2 diabetes: the Diabetes and Egg (DIABEGG) study—a 3-mo randomized controlled trial, by Nicholas R Fuller, Ian D Caterson, Amanda Sainsbury, Gareth Denyer, Mackenzie Fong, James Gerofi, Katherine Baqleh, Kathryn H Williams, Namson S Lau, and Tania P Markovic.  Am J Clin Nutr 2015; 101:705-713.

• Conclusion: High egg consumption did not have an adverse effect on the lipid profile of people with T2D [type 2 diabetes] in the context of increased MUFA [monounsaturated fatty acid] and PUFA [polyunsaturated fatty acid] consumption. This study suggests that a high-egg diet can be included safely as part of the dietary management of T2D, and it may provide greater satiety.
• Sponsor: Australian Egg Corporation

5.  Dietary Flaxseed Independently Lowers Circulating Cholesterol and Lowers It beyond the Effects of Cholesterol-Lowering Medications Alone in Patients with Peripheral Artery Disease.  Andrea L Edel, Delfin Rodriguez-Leyva, Thane G Maddaford, Stephanie PB Caligiuri, J Alejandro Austria, Wendy Weighell, Randolph Guzman, Michel Aliani, and Grant N Pierce.  J. Nutr. 2015; 145:749-757.

• Conclusion: Milled flaxseed lowers total and LDL cholesterol in patients with PAD [peripheral artery disease] and has additional LDL-cholesterol–lowering capabilities when used in conjunction with CLMs [cholesterol-lowering medications].
• Sponsor: Flax2015, the Canola Council of Canada, and others.