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Let’s take a look at a rare industry-funded study with results contrary to the interests of the funders.

It addresses the question: Is naturally occurring trans fat from meat and dairy products healthier than industrially produced trans fat?

The answer: not really.

The study

Vaccenic acid and trans fatty acid isomers from partially hydrogenated oil both adversely affect LDL cholesterol: a double-blind, randomized controlled trial.  Sarah K Gebauer, Frédéric Destaillats, Fabiola Dionisi, Ronald M Krauss, and David J Baer.  Am J Clin Nutr, November 11, 2015,  doi: 10.3945/ajcn.115.116129.

• Conclusions: Total cholesterol (TC), LDL cholesterol, triacylglycerol, lipoprotein(a), and apolipoprotein B were higher after VA [vaccenic acid] than after iTFA [industrial trans fatty acids]; high-density lipoprotein (HDL) cholesterol and apolipoprotein AI also were higher after VA. Compared with control, VA and iTFA both increased TC, LDL cholesterol, ratio of TC to HDL cholesterol, and apolipoprotein B…VA also increased HDL cholesterol, apolipoprotein AI, apolipoprotein B, and lipoprotein(a)…whereas iTFA did not. c9,t11-CLA [conjugated linoleic acid] lowered triacylglycerol…and had no effect on other lipoprotein risk factors.
• Funding:  Supported by USDA, Dairy Management Inc., Nestlé, and Dairy Australia. The funding organizations had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; or decision to submit the manuscript for publication.

Background

Everyone agrees that hydrogenated fats containing trans fatty acids (industrial trans fatty acids or iTFAs) raise the risk of LDL-cholesterol (the bad one) and, therefore, the risk of coronary artery disease.  But what about the naturally occurring trans fats that occur in meat and dairy products as a result of bacterial hydrogenation of fats in the rumens of ruminant animals (ruminant trans fatty acids or rTFAs)?

Some studies suggest that rTFAs do not raise the risk of coronary disease.  This study tests that hypothesis.  It found that the major rTFA, vaccenic acid, does indeed raise risk factors for coronary artery disease almost or more than do iTFAs.

To make sense of the study, you need to know:

• In iTFAs, the two major trans fats are elaidic acid 25%, and vaccenic acid 10%
• In rTFAs, the trans fats are vaccenic acid 45% and elaidic acid 5%
• Therefore, vaccenic acid is the major trans fat in rTFAs

What about Conjugated Linoleic Acid (CLA, or rumenic acid)?

The study also looked at intake of another rTFA, conjugated linoleic acid, which seems to have more benign properties but is present in such small amounts that it hardly makes a difference.  Although this study found CLA to have no effect on risk factors for coronary heart disease, a study from independently funded investigators judged it to have effects similar to that of other rTFAs.

What took so long to get this study published?

David Baer, who works for USDA, is the senior author on this paper.  I saw a slide presentation he did on this study in 2010.  Its results were already available.

In 2011, his group wrote a review of ruminant trans fats, but did not report these results (they were known, but not published).

In 2012, Dr. Baer wrote about ruminant trans fats, disclosed his dairy industry funding, but also did not report these results.  He concluded:

It is still difficult to draw definitive conclusions about the role of rTFAs in modulating risk of cardiovascular disease as mediated through changes in LDL and HDL cholesterol. Intake of these fatty acids is typically low in the diet.

I heard about this study last summer and wondered whether its funders were holding up publication.  I called Dr. Baer and asked.  He said the funders had nothing to do with the delay.  Instead, life had intervened—collaborators left, he was busy with other things, and was having trouble getting the paper published.

The bottom line

The study was done with purified vaccenic acid, not dairy fat, in amounts higher than those likely to be consumed in diets.  The authors say

Evidence…suggests that VA [vaccenic acid] consumed in amounts and foods typically found in the diet is inversely or not associated with CVD risk.

That’s one possible interpretation, but check the title of the editorial accompanying the paper: “In equal amounts, the major ruminant trans fatty acid is as bad for LDL cholesterol as industrially produced trans fatty acids, but the latter are easier to remove from foods.”

The funders of this study must be disappointed.  It was undoubtedly difficult and expensive to do, since it involved synthesis of pure vaccenic acid and a clinical trial of more than 100 subjects.

The funders must have hoped the study would show vaccenic acid to be as benign or even healthier than conjugated linoleic acid.  They bet wrong on this one.

This brings the score to 80:7 (sponsored studies with results favorable to the sponsor vs. those unfavorable).

In case you haven’t been following this saga, I’ve been collecting studies funded by food companies since last March and posting them according to whether the results do or do not favor the sponsor’s interests.  So far, I’ve reported 80 that do, versus 6 that don’t (although I have a couple more saved up for posting soon).

The point of this exercise is to demonstrate that sponsored studies are far more likely to favor the interests of the sponsor than are studies funded by government agencies or foundations, and to argue for more independent funding of food and nutrition research (see my recent Viewpoint on this topic in JAMA Internal Medicine).

Here are five more examples.

Is consuming yoghurt associated with weight management outcomes? Results from a systematic review. J Eales, I Lenoir-Wijnkoop, S King, H Wood, F J Kok, R Shamir, A Prentice, M Edwards, J Glanville, R L Atkinson. Int’l J Obesity 2015 ahead of print.

• Conclusions: Yoghurt consumption is associated with lower BMI, lower body weight/weight gain, smaller waist circumference and lower body fat in epidemiological studies. RCTs [randomized controlled trials] suggest weight reduction effects, but do not permit determination of a cause/effect relationship. Well-controlled, adequately powered trials in research and community settings appear likely to identify a modest but beneficial effect of yoghurt consumption for prevention of weight gain and management of obesity. The ready availability of yoghurt (a nutrient dense food) and its ease of introduction to most diets, suggests that educating the public to eat yoghurt as part of a balanced and healthy diet may potentially contribute to improved public health.
• Funding: This project was funded by Danone Institute International.
• Conflict of interest statement: York Health Economics Consortium received funding from Danone Institute International to conduct this review. York Health Economics Consortium has received funding from the Global Alliance for Probiotics, Danone and the European Food Safety Agency for projects involving food and health topics. FJK is member of the Scientific Advisory Board Global Dairy Platform, Chicago USA RS is President of Danone Institute International ILW is employed by the Danone Company, France.

Red Meat and Colorectal Cancer: A Quantitative Update on the State of the Epidemiologic Science.  Dominik D. Alexander PhD, MSPHab*, Douglas L. Weed MD, PhDc, Paula E. Miller MPHb & Muhima A. Mohamed M PHd. J Am College Nutrition 2015;34: 521-43.  DOI:10.1080/07315724.2014.992553

• Conclusion:  The state of the epidemiologic science on red meat consumption and CRC [colorectal cancer] is best described in terms of weak associations, heterogeneity, an inability to disentangle effects from other dietary and lifestyle factors, lack of a clear dose-response effect, and weakening evidence over time.
• Funding: This manuscript was partially funded by Meat & Livestock Australia (MLA). MLA did not contribute to the writing, analysis, or interpretation of study findings.
• Comment: The conclusion of this industry-funded study contradicts the findings of the WHO International Agency for Research on Cancer, which finds processed meats to be carcinogenic, and red meat to be a probable carcinogen.

The challenges of nutrition policymaking. Joanne Slavin.  Nutrition Journal (2015) 14:15 DOI 10.1186/s12937-015-0001-8.

• Thrust of paper: As every DGAC [Dietary Guidelines Advisory Committee] wants to be bold and set new direction, nutrition science would support that first we must do no harm with our dietary guidance. Moderation and variety must be kept front and center…A suggestion that all Americans should reduce sodium intakes is not sound and is potentially dangerous. Targeting certain foods and beverages, including chocolate milk, processed meats, added sugars, and even the noble potato as villains in the nutrition wars is not a science-based strategy and may need to be countered on the political front if appointed scientific review committees continue to take this approach.
• Competing interests: In the past 5 years Dr. Slavin has received research grants from Minnesota Beef Council, Minnesota Cultivated Wild Rice Council, Novartis Consumer Health, USA Rice, Nestle Nutrition, Tate and Lyle, General Mills, Inc., USA Pears and American Pulse Association. In the past 5 years Dr. Slavin has received speaking fees from food companies and commodity groups with interests in processed foods, dairy products, meat, pulses, fruits, vegetables, fiber, grains, and carbohydrates. Dr. Slavin has participated in scientific panels and advisory boards that are funded by food companies, ingredient companies, commodity groups, scientific societies, and trade groups. She holds a third interest in the Slavin Sisters LLC, a 119-acre farm in Southern Wisconsin.

Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies PJ Rogers, PS Hogenkam , C de Graaf, S Higgs, A Lluch, AR Ness, C Penfold, R Perry, P Putz, MR Yeomansand DJ Mela.International Journal of Obesity (2015), 1–14 10 November 2015; doi:10.1038/ijo.2015.177

• Conclusions: Overall, the balance of evidence indicates that use of LES [low-energy sweeteners] in place of sugar, in children and adults, leads to reduced EI [energy intake] and BW [body weight], and possibly also when compared with water.
• Conflict of interest: Peter J Rogers has received grants from Sugar Nutrition, UK in support of research on the effects of sugar on human appetite. Cees de Graaf has received grants from the Dutch Sugar Bureau in support of a study on brain responses to sugars and low energy sweeteners. Suzanne Higgs has received a grant from Canderel in support of research on the effects of low-energy sweeteners on human appetite. Anne Lluch and David J Mela are employees and shareholders of companies that manufacture products containing sugars and low-energy sweeteners. Peter Putz is an employee of ILSI Europe.

Walnut ingestion in adults at risk for diabetes: effects on body composition, diet quality, and cardiac risk measures Valentine Yanchou Njike, Rockiy Ayettey, Paul Petraro, Judith A Treu, David L Katz.  . BMJ Open Diabetes Research and Care 2015;3:e000115. doi:10.1136/bmjdrc-2015- 000115.

• Conclusions: The inclusion of walnuts in an ad libitum diet for 6 months, with or without dietary counseling to adjust calorie intake, significantly improved diet quality, endothelial function, total and LDL cholesterol, but had no effects on anthropometric measures, blood glucose level, and blood pressure.
• Funding: Funding for this study has been provided by the California Walnut Commission.
• Competing interests. DLK has been compensated for public speaking by the California Walnut Commission.

The CDC’s latest update on the food safety problems at Chipotle says whatever food or ingredient caused 45 people to become ill with E. coli is still unknown.

Bill Marler, the food safety attorney who tracks such things, offers a history of previous Chipotle outbreaks from 2008-2015; these involved Norovirus, Salmonella, hepatitis A, campylobacter, and now an STEC (Shiga Toxin-Producing E. coli).

Chipotle closed some of its outlets in the Northwest, but then reopened.

Steve Ells, Chipotle’s CEO, placed an ad in the New York Times, promising to do everything possible to prevent this from happening again.

This got Bill Marler to ask: Is this Chipotle’s 2-b-4 moment?

We only make dramatic changes when we’ve been hit in the head with a 2-by-4 once or twice. Hopefully for Chipotle, this is their 2-by-4 moment.

The presence of E. coli indicates fecal contamination of some ingredient or food that was not cooked or not cooked sufficiently (cooking kills bacteria).  But from what animal,where, and when?

Chipotle needs to check every ingredient it sources, as well as every process involved in preparing and serving the foods.  If standard safety procedures aren’t already in place, this is a big job.

Let’s hope the CDC finds out what caused this outbreak, and soon.

The Journal of Public Health Policy (JPHP) will soon announce the retraction of a Viewpoint—an opinion piece—I co-authored with a Guatemalan physician, Dr. Joaquin Barnoya, “The food industry and conflicts of interest in nutrition research: A Latin American perspective.” Because of factual errors in the piece, and in response to valid objections about the errors from its subjects, they and we requested its retraction and JPHP is doing so.

I believe it is useful to explain how this happened.  In late summer, Dr. Barnoya brought to my attention an advertorial, a sponsored news account, published in el Periódico and other Guatemalan newspapers announcing an alliance among the Central American Bottling Corporation (cbc), the largest beverage distributor in Guatemala and bottler for PepsiCo; the Guatemala-based Institute of Nutrition of Central America and Panama (INCAP); and the U.S.-based Shalom Christian Foundation to distribute a supplemental food product, Mani+, to chronically malnourished children in rural areas (here is a translation of the advertorial).  Mani+ is a sweetened, peanut-based, nutrient-fortified supplemental food made from local ingredients in Guatemala, used to prevent malnutrition in young children.  The advertorial displayed a photograph of the directors of the three organizations holding the agreement.  It also displayed statements from all three directors emphasizing the alliance’s importance in addressing childhood malnutrition.

As readers of this blog should know, I have long been concerned about the conflicts of interest that arise when food companies—especially soda companies—enter into alliances with public health organizations.   The New York Times made the consequences of such alliances clear in its recent revelations of Coca-Cola sponsorship of the Global Energy Balance Network and the fallout from those revelations.  The announced alliance between cbc and INCAP raises similar concerns, particularly in the light of more general food industry partnerships with research and health institutions in Latin America.  Our intention in writing the Viewpoint was to question the appropriateness of this alliance, as well as of other such partnerships and alliances.

We should, however, have exercised more care.  Shortly after publication of the Viewpoint, Carolina Siu Bermúdez, the director of INCAP who appears in the advertorial, wrote to object that our piece incorrectly implied a financial relationship with cbc, and that Dr. Barnoya had failed to disclose that INCAP paid a substantial portion of his salary via a grant from yet another organization.  We also received letters from Dr. Edward Fischer, the founder of NutriPlus/Mani+, Professor of Anthropology and Director of the Center for Latin American Studies at Vanderbilt University, objecting to our statement that the alliance was responsible for manufacturing (rather than just distributing) the product.   Both asked us to retract the Viewpoint.

Upon investigation, we realized their objections had merit.  Indeed, further investigation by us and by the editors of the JPHP exposed additional errors.  Together, these include the following clarifications and corrections:

• The alliance is involved only in the distribution of Mani+, not its manufacture (as we had asserted).
• The actual nature of the alliance between cbc, INCAP, and the Shalom Christian Foundation—who does what—is, in fact, unclear. The Viewpoint should have characterized the relationship with less certainty and specified that cbc has no financial relationship with either INCAP or the Foundation.
• Dr. Barnoya should have disclosed his financial relationship with INCAP, and I should have insisted that he do so.
• The Viewpoint was triggered by the advertorial, and we should have made this connection more explicit.
• The reference in the Viewpoint to the advertorial is incorrect. It is listed as (2015) cbc co. Unidos contra la desnutricion. INCAP, cbc y Fundacion Crisitiana Shalom Firman Convenio 23(July): 9.  The correct reference is Alianza Contra la Desnutricion. elPeriódico. July 23, 2015;Advertorial: 9.

To correct and clarify these issues, we would need to revise the Viewpoint.  Doing so, however, is not possible once a paper is published.  That left us no choice but to request a retraction, which I believe is the right course of action in this situation.

In my books and other writing, I try as hard as I can to be precise and accurate.  This incident is a lapse that I regret deeply, for which I take responsibility, and for which I apologize to Carolina Siu Bermúdez, to Dr. Fischer, and to my readers.  I also apologize to Phyllis Freeman and Anthony Robbins, the editors of JPHP, and to Lucy Wheeler of Palgrave, who have set an exemplary standard of ethics and integrity throughout these investigations and discussions.

As for lessons learned: Although I fully intend to continue to write critically about alliances between food companies and public health organizations, I also intend to use this experience to recommit myself to accountability and to diligence in checking and double-checking facts and disclosures going forward.   Again, my deepest apologies.

Addition, December 14: The actual retraction notice is published here.  The discussion on Retraction Watch is here.

When I wrote my books on pet foods some years ago, Feed Your Pet Right and Pet Food Politics, I was reading a lot about veterinary practice and how it has shifted from large animals to small.  The shift is so great that hardly anyone trains to be a farm-animal veterinarian anymore.  Almost all students focus on pet dogs and cats.

Among practicing veterinarians,

• 75 % treat pets
• 6% work treat horses
• 8% treat farm animals

The USDA wants to change that, at least a little.

It announced an award program of $4.5 million to pay off the school loans of up to 49 veterinarians who promise to work for three years in rural America where veterinarians are scarce.  The maximum award is $75,000, which is expected to cover half the average school-loan debt.  Recipients may be required to devote at least 80% of their time to work on food animals.

Sounds like a great opportunity to get terrific experience.  I hope lots of recent grads apply.

I learned about the new civil and criminal actions against makers of dietary supplements from a press release from US Senator Claire McCaskill, ranking member of the US Senate Special Committee on Aging.  The dietary supplement industry, she says, “continues to resemble the Wild West.”  

The Department of Justice, Food and Drug Administration (FDA), and Federal Trade Commission (FTC) have initiated enforcement actions against USPlabs,  which makes muscle and weight loss supplements such as Jack3d and OxyElite Pro.  The charge:

USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products.  According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.

The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use.  In fact, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.

The FDA’s statement says that it has warned consumers not to use certain USPlabs products containing a synthetic alkaloid, aegeline, which is so toxic that it induces liver problems so severe that they caused several victims to need liver transplants and one died (the New York Times says more about this).

The FDA says it:

continues to warn consumers about the risks associated with some over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients. These products are most frequently marketed for sexual enhancement, weight loss, and body building.

Earlier this year, Senator McCaskill:

sent letters to 15 retailers inquiring about their policies concerning dietary supplements and what they do to prevent the sale of harmful or fraudulently marketed products in their stores and on their websites and shows. This inquiry was in response to the discovery of products such as Brain Armor, which was recently removed from the Amazon website, that made false claims about their ability to enhance memory and treat dementia.

She also  

wrote FDA Acting Administrator Stephen Ostroff to request that the FDA take appropriate action to suspend sales of any supplement containing picamilon, a product that FDA has determined is not a dietary ingredient. McCaskill also asked for any documents submitted to the FDA as a part of the New Dietary Ingredient notification process that confirm the ingredient’s safety, and for any cases in which picamilon had caused ‘adverse events’ in consumers. After the FDA failed to respond, McCaskill asked retailers to voluntarily remove products containing picamilon from their shelves—an action that many took.

As past Chairman of the Senate’s Consumer Protection Subcommittee, McCaskill has also examined misleading and false claims made by makers of weight-loss products. 

Wild West indeed.  The supplement industry brought this on itself when it convinced Congress that its products were so safe and so much more effective than prescription drugs that regulations were unnecessary.  In 1994, Congress agreed and passed the Dietary Supplement Health and Education Act, which essentially deregulated dietary supplements and, except for egregious instances like this one, forced the FDA to leave supplements pretty much alone.

The industry argues that there are just a few bad apples like these.  But how would we know?

I went yesterday to the press conference for the release of the Food Policy Action 2015 Scorecard.

This was outdoors at Campos Community Garden in Manhattan’s East Village, attended by classes of schoolkids.  The speakers:

• Tom Colicchio: co-founder of Food Policy Action (FPA) and owner of Crafted Hospitality
• Bill Telepan: executive chef of Wellness in the Schools (WITS) and chef/owner of Telepan
• Ken Cook: co-founder of Food Policy Action and president of Environmental Working Group (EWG)

Food Policy Action aims to improve national discussions of food policy issues by informing the public about how elected officials vote on these issues.  Hence: the Scorecard.

As I discussed last year, points are awarded for votes on bills introduced or co-sponsored that deal with:

• Domestic and international hunger
• Food safety
• Food access
• Farm subsidies
• Animal welfare
• Food and farm labor
• Nutrition
• Food additives
• Food transparency
• Local and regional food production
• The environmental effects of food production

In the Senate, for example, there were just 5 bills to be voted on an 10 that were co-sponsored (but not voted on).  In the House, there were votes on 10 bills and 12 that were co-sponsored (no vote).  This leaves lots of room for improvement, even among the best.

The speakers explained to the kids that the Scorecard gave grades to members of Congress, just like they get, and took them through a discussion of thumbs up and thumbs down appraisals of legislators’ votes on key food issues.  Congress is doing a little better this year than last, they said, but still has a long way to go.

Those of us in New York are lucky.  Both of our Senators, Kirsten Gillbrand and Charles Schumer scored 100.

Here are my reports on the Scorecards from 2013 and 2014.  The Scorecard is a great first step in holding legislators accountable.

I’m always indebted to Food-Navigator-USA for spot-on commentary on current food politics.  Here, for example, is Elaine Watson on the FDA’s amazing decision to take comments on the meaning of “natural” on food labels.

Having studiously avoided this food labeling minefield for years, the Food and Drug Administration (FDA) has surprised many in the trade by seeking comments on the definition of a word that has launched a thousand class action lawsuits (well almost): ‘natural’.

Her piece is worth reading for its excellent reporting and interviews with industry stakeholders.

About “natural,” the FDA has said:

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

Now petitions have induced the FDA to seek comments, the first step in its standard rulemaking processes.

Specifically, the FDA asks for information and public comment on questions such as:

—Whether it is appropriate to define the term “natural,”

—If so, how the agency should define “natural,” and

—How the agency should determine appropriate use of the term on food labels.

“Appropriate” in this context translates as:  Should high fructose corn syrup be considered “natural?” (The FDA said yes in 2008).   How about GMOs? (the FDA’s position on GMOs is that they are not materially different from any other kind of food).

To file comments on these and other questions,

• For electronic submissions, go to Regulations.gov and search for docket number FDA-2014-N-1207.
• For submissions by mail, use the following address. Be sure to include docket number FDA-2014-N-1207 on each page of your written comments.  Division of Dockets Management, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852