“In the land of the blind, the snake oil salesman is king.”
~ Anonymous
Often in this column, we examine a particular study in depth to separate the wheat from the chaff. This week is no exception, but the difference today is that we take a broader view of the forest in which this particular tree was planted. Today’s focus is less on the specific study, but rather on how the information is delivered and the potential for bias.
Like most physicians, I receive numerous email updates regarding medical updates, news, and the latest research information. Generally, these consist of short synopses and links to more detailed articles, information, or even the original source materials themselves. Physicians are generally quite busy people and often take the neutrality of the news and information presented as a given. This is particularly true when the sender is a medical professional organization or the equivalent.
Such a brief recently landed in my inbox, and a quick perusal caught my eye:
It caught my eye for several reasons, not the least of which is that it looks like an advertisement. Taking the time to look more closely, one can see the small disclaimer in the right upper-hand corner. The fact that this advertisement was subtly layered into a scientific newsletter for which I pay a substantial yearly membership fee was concerning enough.
But here is where the tale takes an even darker turn.
The link takes you to a clearly commercial site with the URL almonds.com. From there, you follow a link to the latest “consensus paper,” in which “a group of the world’s leading health and nutrition experts reviewed nearly 30 years of research to conclude unanimously that eating almonds daily is a proven strategy to support overall heart health, weight management, and the gut microbiome – all of which are components of cardiometabolic health.”
Wow. That sounds pretty powerful. Group consensus of the “world’s leading health and nutrition experts” and almost 30 years of research data. Well, who am I to disagree?
The paper referred to Perspective: Current Scientific Evidence and Research Strategies in the Role of Almonds in Cardiometabolic Health, which appears in the most recent issue of Current Developments in Nutrition. A publication that proudly displays the American Society for Nutrition logo and tagline in the banner. All of which is to lead the reader, in this case, a cardiologist, to the conclusion that the findings of this expert panel are legitimate, unbiased, and scientifically valid. The implication being that a responsible physician and certainly any respectable cardiologist, particularly given the touted heart health benefits, would recommend eating almonds to their patients.
This, of course, raises the question: Is this true?
- The paper itself makes a relatively modest claims that “The most current meta-analyses on almond consumption and various health-related endpoints suggest that almond consumption does not result in weight gain and results in small [italics mine] reductions in LDL cholesterol and diastolic blood pressure, as well as improved glycemic responses in certain [italics mine] populations (i.e. Asian Indians).”
- The fact that the information and study are part of an advertising campaign does not mean that the data is not valid.
- However, it certainly requires a much higher degree of scrutiny given the obvious vulnerability of the information presented and the source documentation itself (the paper published in Current Developments in Nutrition) to a number of different biases:
- Funding Bias, which can affect everything from study design and outcome selection to the interpretation of findings and a subsequent emphasis on positive findings with minimization of any negative or null results.
- Publication Bias, with findings based on a meta-analysis that may selectively draw from studies with positive results, which are themselves more likely to be published.
- Population Specific Bias, this study touts improved glycemic responses with diets including almonds in South Asian Indian populations, a finding that may not be generalizable to other populations. There is also the possibility of a “cherry-picking bias,” which refers to studying populations most likely to show positive responses.
- Measurement and Detection Bias, which includes a confirmation bias in which the group of experts may favor interpretations supporting almond benefits, and a duration bias in which any short-term metabolic improvements may not translate into long-term benefits.
- Confounding Bias, in which the benefits seen are actually the result of other lifestyle variables, because people who were willing to consume almonds may have other healthy habits or behaviors that were not recorded in the data. Additionally, there is a dietary replacement effect in which the benefit is not due to eating almonds, but the fact that people were no longer consuming the foods that the almonds replaced.
The Caveat:
It is important to focus less on this particular study and more on the process that it is emblematic of. One should not fault advertisers for taking advantage of an opportunity to reach a desirable target audience. Newsletters from professional organizations that charge significant fees to their members to receive those newsletters should refrain from “double dipping.” If advertisements are accepted, they should clearly and obviously be labeled as such and located at the beginning, the end, or in a designated section; not sandwiched between legitimate paragraphs of information.
Advertisers and other groups should also not be faulted for taking advantage of the systems that currently exist. The publication this research appeared in, Current Developments in Nutrition (which is peer-reviewed), currently charges an Article Publishing Charge (APC) payable by authors, their institution, or funders to The American Society for Nutrition (ASN), which owns Current Developments in Nutrition. All four journals owned by ASN, The American Journal of Clinical Nutrition, The Journal of Nutrition, Advances in Nutrition, and Current Developments in Nutrition, accept direct advertising. And if you execute a successful “pay to publish” original research paper in such a journal, following up with some direct advertising dollars is “just good business.”
Of concern with papers and practices like those discussed is the fact that published data like this often becomes embedded into the public conventional wisdom with overly simple sound bites like “Eat almonds because they’re good for your heart.” Phrases like that ignore facts, such as the fact that more pesticides are used on almonds than on any other crop in California, and that one of the most widely used pesticides is glyphosate (e.g., Roundup), a known endocrine disruptor. According to EPA documents from October 5th, 2015, 85% of (nonorganic) almonds are treated with glyphosate. In 2018, more than 1 million kg of glyphosate and nearly 300,000 kg of glufosinate-ammonium (e.g., Basta) were applied in California almond orchards.
With that being said, the study authors in the publication should be commended for disclosing the funding and (rather extensive) conflicts of interest (see additional references below). Many such publications often disclose neither, although upon deeper investigation, extensive funding conflicts and other conflicts of interest often exist. In the ongoing effort to improve the quality of research and resources involved in our food-health relationship, these types of loopholes also need to be addressed.
Additional references:
Conflicts of interest noted per Study disclosure:
During the past 5 years, PRT has served as a consultant to General Mills, PepsiCo, Johnson & Johnson, Nestle United States, Ocean Spray, GlaxoSmithKline, Tate & Lyle, Ingredion, Bioneutra, Lantmännen, Hayashibara, MycoTechnology, Quebec Maple Syrup Producers, Colgate Palmolive, Almond Board, Constellation Brands, Kappa Biosciences, Kodiak Cakes, Bay State Milling, Intertek, The Protein Brewery, 8Greens, GRAS Associates, ILSI North America, and Institute for the Advancement of Food and Nutrition Sciences. JOH serves on an advisory board for General Mills and is a member of the McCormick Science Institute. FB serves on scientific advisory panels for General Mills and the International Sweeteners Association. RK has served on an advisory board for General Mills, Ocean Spray and the Sesame Street Workshop, as a consultant to Arla Food Ingredients and as Board Chair of the Global Child Nutrition Foundation and Project Bread, Boston, MA, and a member of the Board of Directors of the Agricultural and Food Sciences Inst., the European Biomedical Research Institute, Salerno, the Genetic Literacy Project, the David Ortiz Children’s Fund and UNICEF Regional Board, New England. AD is the original developer of the Naturally Nutrient Rich (NNR) and the Nutrient Rich Food (NRF) nutrient profiling models and is or has been a member of scientific advisory panels for BEL, Lesaffre, Nestle, FrieslandCampina, National Pork Board, and Carbohydrate Quality Panel supported by Potatoes United States. AD has worked with Ajinomoto, Ayanabio, DSM-Firmenich, FoodMinds, KraftHeinz, Meiji, MS-Nutrition, Nutrition Impact LLC, Nutrition Institute, PepsiCo, Samsung, and Soremantec on quantitative ways to assess nutrient density of foods. JA reports research support from Nestle Healthcare Nutrition, Eli Lilly, Epitomee, UnitedHealth Group, Novo Nordisk, KVK Tech, and WW and serves as a consultant for Regeneron, Brightseed, Boehringer Ingelheim, Intuitive, Novo Nordisk, Eli Lilly, and WW. JLS received research support from the Canadian Foundation for Innovation, Ontario Research Fund, Province of Ontario Ministry of Research and Innovation and Science, Canadian Institutes of Health Research (CIHR), Diabetes Canada, American Society for Nutrition (ASN), National Honey Board (U.S. Department of Agriculture [USDA] honey “Checkoff” program), Institute for the Advancement of Food and Nutrition Sciences (IAFNS), Pulse Canada, Quaker Oats Center of Excellence, INC International Nut and Dried Fruit Council Foundation, The United Soybean Board (USDA soy “Checkoff” program), Protein Industries Canada (a Government of Canada Global Innovation Cluster), Almond Board of California, European Fruit Juice Association, The Tate and Lyle Nutritional Research Fund at the University of Toronto, The Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), The Plant Protein Fund at the University of Toronto (a fund which has received contributions from IFF among other donors), The Plant Milk Fund at the University of Toronto (a fund established by the Karuna Foundation through Vegan Grants), and The Nutrition Trialists Network Fund at the University of Toronto (a fund established by donations from the Calorie Control Council, Physicians Committee for Responsible Medicine, and Login5 Foundation). He has received food donations to support randomized controlled trials from the Almond Board of California, California Walnut Commission, Danone, Nutrartis, Soylent, and Dairy Farmers of Canada. He has received travel support, speaker fees, and/or honoraria from FoodMinds LLC, Nestle, Abbott, General Mills, Nutrition Communications, International Food Information Council (IFIC), Arab Beverage Association, International Sweeteners Association, Calorie Control Council, and Phynova. He has or has had ad hoc consulting arrangements with the Almond Board of California, Perkins Coie LLP, Tate & Lyle, Ingredion, and Brightseed. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, the European Association for the Study of Diabetes (EASD), the Canadian Cardiovascular Society (CCS), and the Obesity Canada/Canadian Association of Bariatric Physicians and Surgeons. He serves as an unpaid member of the Board of Trustees of IAFNS. He is a Director at Large of the Canadian Nutrition Society (CNS), founding member of the International Carbohydrate Quality Consortium (ICQC), Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and Director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His spouse is a former employee of Nestle Health Science and AB InBev. The rest of the authors have no conflicts of interest or financial relationships relevant to the article to disclose. MT served as a consultant for Once upon a Farm, the Almond Board of California, Mycotechnology, The Protein Brewery, Bactolife, Alt Collective, Alpha Site, Benson Hill, Sound Agriculture, Umiami, Melibio, Bolder, Brain, Noblegen, Calyxt, Center for Food Integrity, Circe Bioscience, Gingko Bioworks, Culinex, Clareo, Kraft Heinz, Food Strategy Associates, Novo Nordisk, Emerald Technology Ventures, LFE Capital, DIC Corporation, Perfeggt, Eli Life, Emerid, Formo, Gosh Foods, Jack and Bry, Narayan, Eggmented, Reality, More Foods, Sokowell, and John B. Sanfilippo & Son Inc.
Funding per Study disclosure:
This work was supported by the Almond Board of California. This perspective article, in part, includes information from an Almond Cardiometabolic Roundtable held July 15 and 16, 2024, in Modesto, California, that included presentations and dialogue among academia representing various areas of nutrition and health. PRT received funding to collect scientific information, participate in the roundtable, and prepare the manuscript. MT received funding to collect scientific information, onboard relevant experts, and Chair the roundtable. FB, JA, AD, JG, JH, RK, AM, JS, and KW received travel funding and honorarium to participate in the July 2024 meeting.
