Search results: research bias

This photo was just sent to me by Murray Carpenter (@Murray_journo).  I don’t know him personally but he is the author of  Caffeinated, which I blurbed and wrote about in 2014.

He wrote that ILSI, a well known front group for the food industry, must have hired someone to track media reception to my 2018 book, Unsavory Truth: How the Food Industry Skews the Science of What We Eat.  ILSI is the International Life Sciences Institute, which has since changed its name to the Institute for the Advancemement of Food and Nutrition Sciences.

Murray said that on January 19, 2019, he was in the audience for the annual ILSI conference  in Clearwater, Florida.  He sent me this account of that occasion [my emphasis in red below]:

As the conference ground on, attendance fell off. So there were plenty of empty seats when Clare Thorp took the podium. Thorp had newly assumed the position of executive director of ILSI North America. She talked about scientific integrity ad nauseam. The emphasis seemed a corrective, an effort to reinforce the message among the membership. Because for an organization that prides itself on independence and integrity, ILSI kept getting caught doing the bidding of its members, over and over again. It just couldn’t seem to rein itself in.

It wasn’t just that ILSI’s Applebaum, Hill, and Sievenpiper had become the public faces of pseudoscience [Note: scientists caught up in conflicts of interest with Coca-Cola]. Thorp also referenced the Mars situation. The corporation had first criticized ILSI-funded science, then left the group entirely.

“Our membership comes with some major challenges and opportunities,” Thorp said. “We’ve lost a major member. It happens. We keep going.”

Unwittingly, Thorp worked doggedly to prove the aforementioned axiom—the degree to which you have scientific integrity is inversely related to the number of times you claim it.

“I have a passion for sound science…I come from a family of scientists, whether practitioners or academics,” she said. The science statements came out in torrents. “Unbiased and credible research…Scientific integrity is not something we made up overnight, it’s a journey.” She displayed a slide touting the Scientific Integrity Consortium, in partnership with the USDA, which she called “a coalition of the willing.”

“We are not an advocacy or a lobbying organization. But we are actually something entirely different,” she said.

“ILSI is an industry-funded organization where these companies support research that doesn’t directly serve their private interests. They agree to be hands-off…and they bravely commit to publishing the data, no matter what it says. This is very scary. And then, why would they do it?…It’s actually altruistic. They genuinely believe it’s important. They also believe that having a collaborative forum where everyone’s voice can be heard is really necessary.”

But it wasn’t enough to just focus on the science. Thorp also considered the public perception of ILSI. She said she wanted to communicate their work more broadly, to step outside this circle of friends and take a more proactive approach.

“We need to have a better understanding of who ILSI North America is, and what we do, and how we do it.” In response, ILSI was developing more communications materials, she said, and new website graphics.

Then she displayed a slide showing an elaborate, graphically elegant word cloud. Some of the big words in the center of the cloud: “science,” “truth,” “food,” “unsavory,” “industry,” “Nestle,” “Marion.”

It turned out that the nonprofit had chosen to spend some of its money to hire a media tracker to follow the press coverage of Marion Nestle’s recent book Unsavory Truth. The book focused on corporate influence in nutrition policy. The word cloud represented an analysis of the press coverage.

And here, Thorp was actually pleased. “The themes of manipulation, deception, and conspiracy that Nestle is promoting are not coming through as main themes in the media coverage.”

Thorp said that one of ILSI’s challenges was the public perception that it’s an industry front group, and that gets onto the web. “We are working very hard to get our Wikipedia page updated, and then it gets changed again, and then we have to update it again, but it’s important,” she said.

Leading ILSI had become a tough gig. Thorp would not last a year at the helm.

Comment

Of course the word cloud did not include maniputlation, deception, or conspiracy; those words do not appear in Unsavory Truth.  The whole point of conflicts of interest induced by food industry sponsorship—which is what the book is about—is that the conflicts are almost always unintentional, unrecognized, and denied.  Researchers who take industry funding do not believe it influences their science, despite the overwhelming evidence to the contrary reviewed in my book.

What’s especially interesting to me about this is that from my perspective, Unsavory Truth had little impact.  It generated much less media coverage than most of my books, and led to few speaking invitations.  I thought it had disappeared without a trace.

Apparently not.  I am pleased and honored to learn about this incident.

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Last week I did a post on the FDA’s reorganization.   I should have made one other point: the long-standing inadequacy of FDA funding.  For decades, Congress has assigned tasks to the FDA but provided inadequate funding to do those tasks adequately (hence 1% of imported foods are inspected).  Congress also assigns the funding for specific purposes.

Yes, FDA ought to be doing more, but it is not up to the agency to decide how to deploy its funds.

One more point: For long-standing historical reasons, FDA funding comes from congressional Agriculture committees, even though it is an agency of the Public Health Service.  That is one reason why USDA’s food safety programs are funded at so much higher a level than FDA’s.

With that said, the FDA has come out with some recent initiatives of interest.

I.  Front-of-Package labels.  The FDA is proposing to research a front-of-package symbol: “an easy-to-understand, standardized system that is 1) mandatory, 2) nutrient-specific, 3) includes calories, and is 4) interpretive with respect to the levels of added sugars, sodium, and saturated fat per serving.”

It is doing this in response to a petition from the Center for Science in the Public Interest.

The comments that have come in so far are here.

It is examining the use of front-of-pack symbols in other countries.

It also plans to conduct research on consumer understanding of multiple designs.  Here are the prototype packages on which the designs will be tested.

None of these is likely to be as effective as the ones used in other countries.

Here is one of the better options, in my opinion.

To file comments, go here.  It’s important to do this because the Consumer Brand Association (formerly the Grocery Manufacturers Association) and other industry groups are unlikely to accept any labeling scheme that might discourage you from buying a product.

II.  Qualified health claim: cocoa flavanols.  The FDA has approved a qualified health claim for cocoa flavanols and reduced risk of cardiovascular disease.

This was in response to a petition from the Swiss chocolate company, Barry Callebaut.

Here’s what the FDA will allow.  Yes, this is absurd (look at what the FDA has to go through to get to this), but companies must think statements like this will sell their products.

• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.”
• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. FDA has concluded that there is very limited scientific evidence for this claim.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”

III.  GRAS panels.  The FDA has issued final guidance on best practices for panels deciding which ingredients can be Generally Recognized as Safe.

This lays out the guidelines for

• Identifying GRAS panel members who have appropriate and balanced expertise.
• Steps to reduce the risk of bias, or the appearance of bias, that may affect the credibility of the GRAS panel’s report, including assessing potential GRAS panel members for conflict of interest and the appearance of conflict of interest.
• Limiting the data and information provided to a GRAS panel to publicly available information.

A lot of this is headache-inducing.  FDA rulemaking takes forever.  Can’t wait to see how all this turns out.

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Astaxanthin is the dye used by growers of farmed salmon to give the fish a pink color.  They do this by matching the desired amount of the dye to this SalmoFan template.

Astaxanthin, claim its makers, is an antioxidant and, therefore, good for you.

First the public relations: Screen shot: Astaxanthin reduces work-induced visual stress in people aged over 40 – BGG trial: Astaxanthin supplementation has been found to reduce visual display terminal (VDT) work-induced visual stress in people aged over 40, according to a new Japan trial sponsored by supplier BGG Japan. Read more

As for the actual research:

The study: Effects of diet containing astaxanthin on visual function in healthy individuals: a randomized, double-blind, placebo-controlled, parallel study.  Takahiro Sekikawa, Yuki Kizawa, Yanmei Li, Naoki Miura. J Clin Biochem Nutr.  https://doi.org/10.3164/jcbn.22-65.

Results:  In participants aged ≥40 years, corrected visual acuity of the dominant eye after visual display terminal work at 6 weeks after intake demonstrated a higher protective effect of astaxanthin in the astaxanthin group vs the control group (p<0.05). In participants aged <40 years, no significant difference was seen between the astaxanthin and control groups. Moreover, no significant difference was found in functional visual acuity and pupil constriction rate between the astaxanthin and control groups [my emphasis].

Conclusion: These results suggest astaxanthin reduces oxidative stress caused by visual display terminal work. Age-related reduction in ciliary muscle strength is likely the main detractor of visual acuity. Correspondingly, astaxanthin reduced visual display terminal work-induced visual stress in the middleaged and elderly.

Conflict of interest: This trial was sponsored by BGG Japan Co., Ltd., which provided all costs for the implementation of the trial. TS and YK are employees of BGG Japan Co., Ltd. YL is an employee of Beijing Gingko-Group Biological Technology Co., Ltd., which belongs to the same company group as BGG Japan Co., Ltd. NM received funding from BGG Japan Co., Ltd. to provide medical services to the trial participants.

Comment: BGG makes astaxanthin products.  This is a company-sponsored study conducted by researchers employed or paid by the company.  It is an excellent example of interpretation bias—putting a positive spin on results that are marginally significant in some groups but not others, or null.

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Happy new year to all.!

And now, back to my Monday postings of industry-funded studies.  Today’s is about the popular herbal supplement, ashwagandha.   This is typically taken to reduce stress and improve a wide variety of health problems, but little science backs up those contentions.  Hence, this study, which I learned about from reading an account of it: Single ashwagandha dose may exert cognitive performance: Study.  That headline was all it took to get me to ask my usual question: Who paid for this?

The study: Effects of Acute Ashwagandha Ingestion on Cognitive Function. Int. J. Environ. Res. Public Health 2022, 19(19), 11852; https://doi.org/10.3390/ijerph191911852

Methods: The study assessed performance on the Berg–Wisconsin Card Sorting (BCST), Go/No-Go (GNG), Sternberg Task (STT), and Psychomotor Vigilance Task (PVTT) tests.   Participants took a placebo or ashwagandha (ASH) extract (NooGandha^®, Specnova Inc., Boca Raton, FL, USA).

Conclusions: Acute supplementation with 400 mg of ashwagandha improved selected measures of executive function, helped sustain attention, and increased short-term/working memory.

Funding: “This study was funded as a fee-for-service project awarded to the Human Clinical Research Facility at Texas A&M University from Specnova, Inc. (Boca Raton, FL, USA)…Specnova was not involved in any way in data collection, analysis of the data, or the writing of the manuscript.”

Comment: Specnova, you will not be surprised to learn, is a supplier of supplement ingredients.  The company ordered the study to its specifications.  It got the result it wanted, as funders almost invariably do.  Despite booming sales of ashwagandha, so little is known about its properties that the National Center for Complementary and Integrative Medicine does not even have a fact sheet for it among its reviews of herbal supplements.  Industry-sponsored research to the rescue!  And of course it “was not involved in any way…”  It didn’t have to be.  Funding is usually enough to induce unconscious bias on its own.

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I haven’t posted anything about pistachio industry conflicts of interest since 2019 so it’s time for another one.

Here’s a press release sent to me by a reader, Matthew Kadey:

NEW STUDY REVEALS PISTACHIOS ARE AN ANTIOXIDANT POWERHOUSE…Antioxidant-rich foods are regularly encouraged as part of a healthy lifestyle, and research suggests that a diet high in antioxidants may even help to reduce the risk of death.¹ While certain fruits and vegetables are often thought of as high-antioxidant foods, a new study conducted by Cornell University and published in the journal, Nutrients, produced surprising results². Pistachios have a very high antioxidant capacity, among the highest when compared to values reported in research of many foods commonly known for their antioxidant capacity, such as blueberries, pomegranates, cherries, and beets.^3,4,5  (I’ve posted the references at the end).

My first question, as always when I see a press release like this: Who paid for it?

The study: uan, Wang, Bisheng Zheng, Tong Li, and Rui Hai Liu. 2022. Quantification of Phytochemicals, Cellular Antioxidant Activities and Antiproliferative Activities of Raw and Roasted American Pistachios (Pistacia vera L). Nutrients 14, no. 15: 3002. https://doi.org/10.3390/nu14153002

Conclusion:  It is shown that the roasting of pistachios could produce a series of beneficial phytochemical changes, leading to enhanced biological activity. Pistachios are a nutrient-dense food containing a unique profile of good-quality protein, fats, minerals, vitamins, and antioxidants, such as carotenoids and polyphenols, with cellular antioxidant activity. Dietary Guidelines for Americans 2020–2025 suggested including nuts as a health dietary pattern. Further research on antiproliferative activity and mechanisms of action of free-form extracts of roasted pistachios, and more biological activities related cellular antioxidant activity and oxidative stress, are worthy of further investigation.

Funding: This study was partially supported by Innovative Leading Talents Project of Guangzhou Development Zone and 111 Project: B17018, Cornell China Center, and American Pistachio Growers: 2021-09.

Conflicts of Interest: The authors declare no conflict of interest.

Comment: Roasted pistachios are healthy?  No surprise here.  Further research needed?  Also no surprise.  This is another example of an industry-funded study with unimpressive results but plenty of interpretation bias, along with the usual contention that industry funding does not induce conflicts of interest.  Alas, it does.

References to the press release paragraph

¹ Jayedi A, Rashidy-Pour A, Parohan M, Zargar MS, Shab-Bidar S. Dietary Antioxidants, Circulating Antioxidant Concentrations, Total Antioxidant Capacity, and Risk of All-Cause Mortality: A Systematic Review and Dose-Response Meta-Analysis of Prospective Observational Studies. Adv Nutr. 2018 Nov 1;9(6):701-716. doi: 10.1093/advances/nmy040. PMID: 30239557; PMCID: PMC6247336.
² Yuan W, Zheng B, Li T, Liu RH. Quantification of Phytochemicals, Cellular Antioxidant Activities and Antiproliferative Activities of Raw and Roasted American Pistachios (Pistacia vera L.). Nutrients. 2022; 14(15):3002. https://doi.org/10.3390/nu14153002
³ Wolfe KL, et al. Cellular Antioxidant Activity (CAA) Assay for Assessing Antioxidants, Foods, and Dietary Supplements. J Agric. Food Chem. 2007, 55, 8896–8907.
⁴ Song W, et al. Cellular Antioxidant Activity of Common Vegetables. J. Agric. Food Chem. 2010, 58, 6621–6629. DOI:10.1021/jf9035832
⁵ Wolfe, K., Kang, X., He, X., Dong, M., Zhang, Q., and Liu, R.H. Cellular antioxidant activity of common fruits. J. Agric. Food Chem. 56 (18): 8418-8426, 2008.

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The Alliance for Potato Research & Education is explicitly “Dedicated to advancing the scientific understanding of the role potatoes play in promoting the health of all people.”

As the Alliance explains:

Potatoes are a nutrient-rich vegetable and one of the top sources of potassium in Americans’ diets, yet they are often singled out as a food to limit. This recommendation is often based on misperceptions that eating potatoes is linked to increased cardiometabolic disease risk, even though potatoes contribute to overall fruit and vegetable consumption.  However, a newly published study in the Journal of Nutritional Science finds that advice may be unwarranted

Guess who sponsored that study.

• The study:  Potato consumption is not associated with cardiometabolic health outcomes in Framingham Offspring Study adults

• Conclusion: In this prospective cohort, there was no adverse association between fried or non-fried potato consumption and risks of T2DM/IFG, hypertension or elevated triglycerides.

• Funding: This work was supported by the National Heart, Lung and Blood Institute …with additional support from the Alliance for Potato Research and Education. The funders had no role in the design, analysis or writing of this article…The authors have declared that no conflict of interest.

Comment: We can argue about the effects of potatoes on insulin and blood sugar levels, a contentious issue because the ways they are cooked and prepared influence digestion of their starches to sugars and how quickly those sugars are absorbed.  But industry funding confuses the arguments, as it has a high probbility of inducing more than the usual level of bias into the results.  Much industry influence occurs at an unconscious level where it is unrecognized by rsearchers, so much so that they do not see it as a conflict of interest.  I think it is.

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Two studies of the role of nuts in health.

I.  This one comes from ObesityandEnergetics.org’s “Headline vs. Study.”

Headline: Maximum Wellness: Walnuts are a Life-Extension Food:  “Looks like your [sic] nuts not to include walnuts in your diet. For more information and to read this study…go to maxwellnutrition.com, where you can find top wellness and nutrition products made in the United States – shipped to your door.”  [Comment: Clearly, we are dealing here with marketing]

Study: Association of Self-Reported Walnut Consumption with Total and Cause-Specific Mortality and Life Expectancy in U.S. Adults. Maximum Wellness nor Causation Necessarily Established.  Liu, X.; Guasch-Ferré, M.; Tobias, D.K.; Li, Y.  Nutrients 2021, 13, 2699. https://doi.org/ 10.3390/nu13082699

Conclusion: A greater life expectancy at age 60 (1.30 years in women and 1.26 years in men) was observed among those who consumed walnuts more than 5 servings/week compared to non-consumers.  Higher walnut consumption was associated with a lower risk of total and CVD mortality and a greater gained life expectancy among U.S. elder adults.  [Comment: association, not causation, and the difference is small].

Conflict of interest: The last (senior?) author reports having received research support from California Walnut Commission, but states that ” The funder has no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, and in the preparation, review, or in the decision to publish the results.”  [Comment: That’s what they all say, but research often demonstrates otherwise, as I review in my book Unsavory Truth].

And now for the second:

II.  Association of nut consumption with risk of total cancer and 5 specific cancers: evidence from 3 large prospective cohort studies.  Zhe Fang, You Wu, Yanping Li, Xuehong Zhang, Walter C Willett, A Heather Eliassen,1Bernard Rosner,
Mingyang Song, Lorelei A Mucci,and Edward L Giovannucci.  The American Journal of Clinical Nutrition, Volume 114, Issue 6, December 2021, Pages 1925–1935, https://doi.org/10.1093/ajcn/nqab295

Conclusion: In 3 large prospective cohorts, frequent nut consumption was not associated with risk of total cancer and common individual cancers.  [Comment: What? An industry-funded study that finds no benefuts?]

Funding: Supported by the California Walnut Commission and Swiss Re Management Ltd (to YL),… and NIH grants U01 CA167552 (to LAM and the Health Professionals Follow-up Study), UM1 CA186107 and P01 CA87969 (to the Nurses’ Health Study), and U01 CA176726 (to AHE and the Nurses’ Health Study II). The funding sources did not participate in the study design; or
collection, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.

Here’s how the authors explain their highly unusual no-benefit result:

Given the scarcity of available high-quality data, our findings add to current evidence to more precisely determine the relation between nut consumption and cancer risk. So far, the population based evidence has not been strong enough to conclude that nut consumption is protective against total cancer and these 5 common cancers. Future studies on other cancer sites are still needed to examine the benefits of nuts on cancer development.

Really?  Why?  Do the authors not believe their own data?  Their findings ought to settle the matter and encourage the authors to move on to more significant research.  “More research needed” keeps the California Walnut Commission busy.

Research funded by food companies always requires a degree of skepticism, no matter what the results.

I first learned of this study from a headline in the newsletter, BakeryAndSnacks.com: “Swedish RyeWeight study confirms bread can actually aid weight loss.”

Swedish researchers have found that breakfasting on rye bread significantly reduces appetite, resulting in 16% fewer calories consumed at lunch. What’s more, the suppression of appetite continued well into the afternoon

This seemed worth a look.  Here’s it is.

The study: A hypocaloric diet rich in high fiber rye foods causes greater reduction in body weight and body fat than a diet rich in refined wheat: A parallel randomized controlled trial in adults with overweight and obesity (the RyeWeight study).  Clinical Nutrition ESPEN.  Volume 45, October 2021, Pages 155-169.

Methods: Subjects with overweight or obesity consumed a weight-loss diet that contained either high fiber rye products or refined wheat products for 12 weeks.

Results:  Participants in the rye group lost 1.08 kg body weight and 0.54% body fat more than the wheat group, and their C-reactive protein was 28% lower.  There were no consistent group differences on subjective appetite or on other cardiometabolic risk markers.

Conclusion:  Consumption of high fiber rye products as part of a hypocaloric diet for 12 weeks caused a greater weight loss and body fat loss, as well as reduction in C-reactive protein, compared to refined wheat. The difference in weight loss could not be linked to differences in appetite response.

Sources of support: Formas, grant no.: 2014-00542. Barilla and Lantmännen pro-vided additional funding for the study (8% of total study budget each) and provided the intervention products.

Conflict of interest: RL is the founder of the Nordic Rye Forum, which is a research and dissemination platform for research related to rye and health that includes academic institutions as well as institutes and food industry with interest in rye across the Nordic region. The forum and its activities are funded by the industrial partners. RL is the PI of several projects funded by several cereal industrial companies. Such funding is used to carry out scientific studies. RL receives no salary, honorary, or by any other means has any personal economic benefits from industrial collaborations. Remaining authors declare no conflicts of interest.

Comment: The industry-funded Nordic Rye Forum has an interest in promoting rye consumption.  Its industry partners are listed here.  Two of them helped fund the study.  They must have appreciated the results.

Once again, the issue here is the potential for unconscious bias under the influence of industry funding.

Reference: For a summary of research on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests but that recipients of industry funding typically do not recognize its influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.