by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Apr 8 2015

The latest supplement scandal: hidden amphetamine-like drugs

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.
Apr 7 2015

Sponsored research inevitably favors the sponsor’s vested interests

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.
Mar 31 2015

Dietitians to remove their “endorsement” from Kraft Singles

Congratulations to Sonja Connor, president of the Academy of Nutrition and Dietetics, for this decision about the Kids Eat Right partnership with Kraft (this letter was sent to me by several AND members).  Congratulations also to all of the AND members who let their disappointment with this partnership be known.

I want to update all of you on a few immediate actions we are taking on the Kids Eat Right pilot initiative with Kraft. As our Academy members, you deserve the most immediate as well as accurate information that we are able to provide.

The Academy and Kraft are in discussions to terminate the contract for our pilot program. This will take a short period of time to complete. We will continue to keep you posted as we move to finalize the termination.

Elements of the program are already in motion and cannot be changed. On April 1, Kraft Singles will begin appearing on retail shelves with the Kids Eat Right logo on the packaging. We are working with Kraft to limit the time it remains on the shelves.

The Academy deeply regrets the circumstances that have led to the pending termination of this initiative. As we have shared previously, we launched this initiative to raise consumer awareness about the importance of having vitamin D and calcium as essential nutrients in children’s diets.

This pilot initiative was never intended to be an official Academy endorsement of a particular product, which is strictly prohibited by our policy and is expressly included in all contracts.

The Board and Academy leadership are taking immediate steps to avoid a similar situation in the future. We will engage with the Academy House of Delegates and with all Academy members on future initiatives to promote healthful foods and nutrition in the most professional, ethical and transparent manner possible.

Thank you for your continued support of the Academy and your patience as we resolve this situation.

And congratulations to Andy Bellatti, founder of Dietitians for Professional Integrity, a group working to uncouple the Academy from its cozy ties to food companies (these were documented by Michele Simon a couple of years ago).  His quote in the New York Times:

Hopefully, this is the beginning of much-needed and much-overdue dialogue on the academy’s corporate sponsorships…Dietitians need to continue advocating for an organization that represents us with integrity and that we can be proud of, rather than continually have to apologize for.

Mar 18 2015

Dietitians in turmoil over conflicts of interest: it’s about time

My e-mail inbox is filled with items about the Academy of Nutrition and Dietetics (AND, formerly the American Dietetic Association).  Its “seal of approval” on Kraft cheese singles (as discussed in an earlier post) was embarrassing—so embarrassing that it was discussed by Jon Stewart: “The Academy is an Academy in the same way this [Kraft Singles] is cheese” (the clip starts at 4:37).

The Onion also had some fun with this.

But now there is even more about how food companies buy the opinions of dietitians.

Candice Choi writes about how Coca-Cola pays dietitians to promote its drinks as healthy snacks (for an example of one of the paid posts, click here).  She explains that the dietitians

wrote online posts for American Heart Month, with each including a mini-can of Coke or soda as a snack idea. The pieces — which appeared on nutrition blogs and other sites including those of major newspapers — offer a window into the many ways food companies work behind the scenes to cast their products in a positive light, often with the help of third parties who are seen as trusted authorities.

Ms. Choi quotes a Coca-Cola spokesman:

“We have a network of dietitians we work with,” said Sheidler, who declined to say how much the company pays experts. “Every big brand works with bloggers or has paid talent.”

Other companies including Kellogg and General Mills have used strategies like providing continuing education classes for dietitians, funding studies that burnish the nutritional images of their products and offering newsletters for health experts. PepsiCo Inc. has also worked with dietitians who suggest its Frito-Lay and Tostito chips in local TV segments on healthy eating.

These are individual actions.  But at last the dietetic membership is objecting to the Academy’s partnership with Kraft.

  1. They have started a Change.org petition to #RepealTheSeal.
  2. The President of the New York State AND chapter (NYSAND), Molly Morgan, sent out a note in support of the petition.

Thank you to the many of you that have expressed your concern and disappointment about the Academy of Nutrition and Dietetics partnership with Kraft. This issue has been reviewed carefully by the NYSAND Board of Directors and the entire board is in support of actively taking steps to share our members concerns. Below are the action steps that NYSAND is taking:

–       Last week (March 11, 2015) the NYSAND Sponsorship Task Force recommendations were received and yesterday (March 16, 2015) at the March NYSAND Board of Directors meeting the Sponsorship Task Force recommendations were reviewed. Please stay tuned for more updates and note that a motion will be forth coming this week for the board to take the next step in addressing sponsorship for NYSAND.

–       Today (March 17, 2015) a letter was sent to the Academy president and emailed to several Academy leaders expressing the views that our members have shared and that as an Affiliate we are not comfortable responding with the talking points provided by the Academy on this issue.

–       Dietitians have started a petition, “Repeal the Seal”; NYSAND will be sharing this on our Affiliate Facebook and Twitter pages and encourages all members who share the concern to sign the petition as well. CLICK HERE to sign the petition.

3.  The AND national CEO, Patricia M. Babjak, sent out this letter to members, also on March 17:

Let me begin by apologizing for the concerns caused by the education initiative with Kraft. The Academy and the Foundation are listening. As a member-driven organization, the Academy’s staff and leadership hear your concerns and welcome your input.

Unfortunately, recent news articles misstated a collaboration as a Kids Eat Right “endorsement” of Kraft Singles, and that it represents a “seal of approval” from Kids Eat Right, the Foundation, or the Academy. It is not an endorsement. It is not a seal of approval. We understand this distinction is of little consequence to many Academy members who are concerned with the perception. We are working on a solution.

In addition, we are working to establish a joint, member-driven Member Advisory Panel. This Panel will work closely with both Boards to:

  • Establish dialogue with members
  • Gather input and give feedback on member issues
  • Make specific recommendations

Recognizing sponsorship as a significant issue of concern among members, the House of Delegates leadership team, who also serve on the Board of Directors, scheduled a dialogue on sponsorship for the upcoming virtual House of Delegates meeting, May 3. We encourage all members to reach out to your delegates and share your thoughts on the benefits of, concerns about and suggestions for the sponsorship program. The Academy and Foundation Boards are looking forward to your input.

Applause to members who are speaking out.

As I said in an interview with TakePart:

The food companies have learned from tobacco and drugs and other industries like that how to play this game…Let’s confuse the science, let’s cast doubt on the science, let’s shoot the messenger, let’s sow confusion.

But since everyone has to eat, the food industry has been given a pass on its pay-to-play practices….

The capital N news…is that dietitians are fighting back at last.

I hope they join Dietitians for Professional Integrity and insist that the leadership respond to their concerns.

AdditionA dietitian sends this communication from the Executive Board of the California Dietetic Association to members about the Kraft situation:

We would like to direct your attention to what the California Dietetic Association (CDA) has done to address our own issues surrounding sponsorship. We heard your concerns regarding CDA Annual Conference sponsorship and we have listened. We voted and McDonalds was not invited as a sponsor in 2015. This decision has impacted our finances; however, we believe it was important to respond to our member feedback. In addition, an ad hoc committee approved by the CDA executive board, reevaluated the sponsorship guidelines. The new sponsorship policy will be posted soon on www.dietitian.org.

Mar 16 2015

Conflicts of interest in nutrition research: recent examples

I’ve been collecting examples of conflicted research for the past week or so.  These are studies paid for in part by food businesses or trade associations with a vested financial interest in the outcome of the research.

These almost invariably promote the financial interests of the sponsor.  To wit:

Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study—a randomized controlled trialby Daniela Mastroiacovo, Catherine Kwik-Uribe, Davide Grassi, Stefano Necozione, Angelo Raffaele, Luana Pistacchio, Roberta Righetti, Raffaella Bocale, Maria Carmela Lechiara, Carmine Marini, Claudio Ferri, and Giovambattista Desideri.  Am J Clin Nutr 2015; 101:538-548 doi:10.3945/ajcn.114.092189.

  • Conclusion: These data suggest that the habitual intake of flavanols can support healthy cognitive function with age.
  • Sponsor: Mars, Inc.

Sugar-Sweetened Product Consumption Alters Glucose Homeostasis Compared with Dairy Product Consumption in Men and Women at Risk of Type 2 Diabetes Mellitus, by Kevin C Maki, Kristin M Nieman, Arianne L Schild, Valerie N Kaden, Andrea L Lawless, Kathleen M Kelley, and Tia M Rains.  J Nutr. 2015; 145:459-466 doi:10.3945/jn.114.204503.

  • Conclusion: These results suggest that SSP consumption is associated with less favorable values for HOMA2–%S, LMTT disposition index, HDL cholesterol, and serum 25(OH)D in men and women at risk of T2DM vs. baseline values and values during dairy product consumption.
  • Sponsor: Dairy Research Institute/National Dairy Council

Squeezing Fact from Fiction about 100% Fruit Juice, by Roger Clemens, Adam Drewnowski, Mario G Ferruzzi, Cheryl D Toner, and Diane Welland. Adv Nutr 2015;6: 236S-243S. doi: 10.3945/​an.114.007328.

  • Conclusion:  The preponderance of evidence supports the position that 100% fruit juice delivers essential nutrients and phytonutrients, provides year-round access to a variety of fruits, and is a cost-effective way to help people meet fruit recommendations.
  • Sponsor: Juice Products Association

Can probiotic yogurt prevent diarrhoea in children on antibiotics? A double-blind, randomised, placebo-controlled study, by Michael J FoxKiran D K AhujaIain K RobertsonMadeleine J BallRajaraman D Eri.  BMJ Open 2015;5:e006474.  doi:10.1136/bmjopen-2014-006474.

  • Conclusion: A yogurt combination of LGG, La-5 and Bb-12 is an effective method for reducing the incidence of antibiotic-associated diarrhoea in children.
  • Sponsor: Parmelat Australia

Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults, by Rebecca J Kean, Daniel J Lamport, Georgina F Dodd, Jayne E Freeman, Claire M Williams, Judi A Ellis, Laurie T Butler, and Jeremy PE Spencer.  Am J Clin Nutr 2015; 101:506-514 doi:10.3945/ajcn.114.088518.

  • Conclusion: Chronic daily consumption of flavanone-rich 100% orange juice over 8 wk is beneficial for cognitive function in healthy older adults.
  • Sponsor: Partially funded by the State of Florida Government, Florida Department of Citrus.  The authors report: “Florida Citrus helped designed [sic] the research. None of the authors reported a conflict of interest related to the study.”

Dairy consumption and risk of cardiovascular disease: an updated meta-analysis of prospective cohort studies, by Li-Qiang Qin PhD, Jia-Ying Xu PhD, Shu-Fen Han PhD, Zeng-Li Zhang PhD, You-You Zhao PhD, Ignatius MY Szeto PhD.   Asia Pac J Clin Nutr. 2015 Mar;24(1):90-100. doi: 10.6133/apjcn.2015.24.1.09.

  • Conclusion This meta-analysis provided further evidence supporting the beneficial effect of dairy consumption on CVD. Low-fat dairy products and cheese may protect against stroke or CHD incidence.
  • Sponsor: Nestec Ltd. (Nestlé R&D (China) Ltd.  Two of the authors work for the company (to which I am not related).

In each of these cases, the sponsors got what they paid for.  Recent sponsored studies have not come to conclusions contrary to the interests of the sponsor.

Coincidence?

You decide.

Feb 18 2015

And now a word from our sponsors: The Dietitians Association of Australia

Michele Simon’s latest investigative report deals with sponsorship by food corporations of the Australian Dietetics Association.


cover

 

Consistent with her previous report on corporate sponsorship of the American dietetic association (now The Academy of Nutrition and Dietetics), this one finds that the Dietitians Association of Australia (DAA):

  • Is sponsored by Meat and Livestock Australia, Nestlé, Unilever, Dairy Australia, and the Egg Nutrition Council
  • Is a partner in the “Nestlé Choose Wellness Roadshow”
  • Has important members who work for Kellogg and PepsiCo
  • Has a spokesperson who is paid by Coca-Cola to present his research denying a connection between sugars and obesity
  • Displays recipes from corporate sponsors with branded products despite policies against such things
  • Is believed to have stripped a dietitian of her earned credential for speaking out against such conflicts of interest [*but see additional comments below].

The DAA offers its corporate sponsors the following benefits:

  • Credible, independent, expert partner for nutrition communications
  • Unparalleled opportunity to inform the Australian public through members and the DAA profile
  • Access to members and interest groups for advice
  • Information and expert advice on all nutrition and health issues
  • Opportunities to sponsor DAA programs

This is a good deal for food and beverage corporate sponsors.

It’s not such a good deal for DAA members.  At best:

  • They appear in conflict of interest.
  • Their advice appears bought.
  • They lose credibility.

As Simon concludes:

The health of all Australians depends upon the independence of the nutrition profession and its leadership’s ability to operate free of conflicts of interest and be the nutrition leaders they claim to be, free from sponsorship money.

*Additions:

February 19:  Dr. Sara Grafenauer APD PhD of the DAA wrote me an e-mail detailing charges of error in this account.  She also wrote to Michele Simon.   Food company sponsorship of nutrition professional societies deserves far more critical attention than it usually gets and I am glad to see this debate.

February 20: Dr. Grafenauer writes again: “Thank you for considering our concerns however, with all due respect, the following statement is factually incorrect and should be removed:

  • Is believed to have stripped a dietitian of her earned credential for speaking out against such conflicts of interest.

DAA’s credential, Accredited Practising Dietitian (APD) is very important to the association and its members. It has rigorous processes around its maintenance and integrity and would never be used for purposes other than it is designed (for such as ‘gagging’ a member as is suggested here). There is no basis for this potentially defamatory statement and DAA will take whatever steps are necessary to defend the credential.”

Feb 13 2015

Sugar politics: The BMJ’s series “Spinning a web of influence”

BMJ (formerly the British Medical Journal) has just released an editorial and four papers on ties between the sugar industry and public health scientists who advise the government on health policy.  Some health policies involve recommendations about intake of sugars.

The BMJ press release explains

Recipients of research funding from sugar and other related industries include members of the Scientific Advisory Committee on Nutrition (SACN), which is currently updating official advice on carbohydrates consumption, and researchers working for the Medical Research Council’s Human Nutrition Research unit (HNR).  HNR scientists have received research funding and funding in kinds from companies including Coca-Cola, Mars, Nestlé, Sainsbury’s, the Institute of Brewing and Distilling, Weight Watchers International and others…Of the 40 scientists affiliated with SACN between 2001 and 2012, only 13 have had no interests to declare.

This, of course, is no different than what we see here.  Food and beverage companies support food and nutrition research as well as professional societies, and conflicts of interest are rampant.

Even so, these well documented studies are alarming and worth serious attention.  And be sure to look at the map.

MedPage has a nice summary (I’m quoted).

The furor over these articles

Jan 26 2015

Some thoughts about the Revolving Door

Joel Leftwich has left his job as senior director for PepsiCo’s public policy and government affairs team (since March 2013) to become staff director for the Senate Agriculture Committee now led by Pat Roberts (R-Kansas).

In some ways, it’s a perfectly logical appointment.  Before joining PepsiCo, Leftwich worked for Roberts as a legislative aide from 2005 to 2010 and as deputy staff director for the Ag Committee from 2011 to 2013.

But his connection to PepsiCo raises concerns.  The Ag committee will be dealing with several issues involving sodas and snack foods opposed by some members of Congress:

  • Reauthorization of WIC, the Women, Infants and Children nutrition program (its requirements for healthy foods are always under pressure).
  • Preservation of the school nutrition standards authorized by the Healthy, Hunger-Free Kids Act (under attack by the food industry and its friends in Congress).
  • SNAP nutrition standards (there is a movement to make sodas ineligible for SNAP-EBT purchases).
  • Issuance of the 2015 dietary guidelines, always under pressure not to say anything direct about not drinking sodas.
  • Issuance of the new food labels.  The soda industry opposes putting in “added sugars.”   While this is FDA’s purview, not USDA’s, the Ag Appropriations Committee governs FDA’s appropriations.

And on the state level, it’s worth taking a look at what the Texas Commissioner of Agriculture is up to, courtesy of Bettina Siegel’s The Lunch Tray: “cupcake amnesty.”

Clearly, agricultural policies affect public health in highly prominent ways.

That’s why we need to do a much better job of connecting food policy to health policy.

And that’s why having a leading PepsiCo lobbyist in charge of agricultural committee staff raises serious concerns about conflict of interest.

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