Archive for the ‘Research Integrity’ Category

Stone-walling low-carbohydrate diets. Attack of the self-proclaimed ICQC

Posted: December 1, 2015 in Crisis in Nutrition, glucose, glycemic index, low-carbohydrate diet, misuse of statistics, Research Integrity
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The attack was quite sudden although it appeared to have been planned for many years. The paper was published last week (Augustin LS, Kendall CW, Jenkins DJ, Willett WC, Astrup A, Barclay AW, Bjorck I, Brand-Miller JC, Brighenti F, Buyken AE et al: Glycemic index, glycemic load and glycemic response: An International Scientific Consensus Summit from the International Carbohydrate Quality Consortium (ICQC). Nutr Metab Cardiovasc Dis 2015, 25(9):795-815.

Augustin_Stresa+Nov_27

As indicated by the title, responsibility was taken by the self-proclaimed ICQC.  It turned out to be a continuation of the long-standing attempt to use the glycemic index to co-opt the obvious benefits in control of the glucose-insulin axis while simultaneously attacking real low-carbohydrate diets. The authors participated in training in Stresa, Italy.

The operation was largely passive aggressive. While admitting the importance of dietary carbohydrate in controlling post-prandial glycemic,  low-carbohydrate diets were ignored. Well, not exactly. The authors actually had a strong attack.  The Abstract of the paper said (my emphasis):

“Background and aims: The positive and negative health effects of dietary carbohydrates are of interest to both researchers and consumers.”

Methods: International experts on carbohydrate research held a scientific summit in Stresa, Italy, in June 2013 to discuss controversies surrounding the utility of the glycemic index (GI), glycemic load (GL) and glycemic response (GR).”

So, for the record, the paper is about dietary carbohydrate and about controversies.

The Results in Augustin, et al were simply

“The outcome was a scientific consensus statement which recognized the importance of postprandial glycemia in overall health, and the GI as a valid and reproducible method of classifying carbohydrate foods for this purpose…. Diets of low GI and GL were considered particularly important in individuals with insulin resistance.”

A definition is always a reproducible way of classifying things, and the conclusion is not controversial: glycemia is important.  Low-GI diets are a weak form of low-carbohydrate diet and they are frequently described as a politically correct form of carbohydrate restriction. It is at least a subset of carbohydrate restriction and one of the “controversies” cited in the Abstract is sensibly whether it is better or worse than total carbohydrate restriction. Astoundingly, this part of the controversy was ignored by the authors.  Our recent review of carbohydrate restriction in diabetes had this comparison:

 

 

15_Th_Westman_Jenkins_Mar25-2

A question of research integrity.

It is considered normal scientific protocol that, in a scientific field, especially one that is controversial, that you consider and cite alternative or competing points of view. So how do the authors see low-carbohydrate diets fitting in? If you search the pdf of Augustin, et al on “low-carbohydrate” or “low carbohydrate,” there are only two in the text:

“Very low carbohydrate-high protein diets also have beneficial effects on weight control and some cardiovascular risk factors (not LDL-cholesterol) in the short term, but are associated with increased mortality in long term cohort studies [156],”

and

“The lowest level of postprandial glycemia is achieved using very low carbohydrate-high protein diets, but these cannot be recommended for long term use.”

There are no references for the second statement but very low carbohydrate diets can be and frequently are recommended for long term use and have good results. I am not aware of “increased mortality in long term cohort studies” as in the first statement. In fact, low-carbohydrate diets are frequently criticized for not being subjected to long-term studies. So it was important to check out the studie(s) in reference 156:

[156] Pagona L, Sven S, Marie L, Dimitrios T, Hans-Olov A, Elisabete W. Low carbohydrate-high protein diet and incidence of cardiovascular diseases in Swedish women: prospective cohort study. BMJ 2012;344.

Documenting increased mortality.

The paper is not about mortality but rather about cardiovascular disease and, oddly, the authors are listed by their first names. (Actual reference: Lagiou P, Sandin S, Lof M, Trichopoulos D, Adami HO, Weiderpass E: …. BMJ 2012, 344:e4026). This minor error probably reflects the close-knit “old boys” circle that functions on a first name basis although it may also indicate that the reference was not actually read so it was not discovered what the reference was really about.

Anyway, even though it is about cardiovascular disease, it is worth checking out. Who wants increased risk of anything. So what does Lagiou, et al say?

The Abstract of Lagiou says (my emphasis) “Main outcome measures: Association of incident cardiovascular diseases … with decreasing carbohydrate intake (in tenths), increasing protein intake (in tenths), and an additive combination of these variables (low carbohydrate-high protein score, from 2 to 20), adjusted for intake of energy, intake of saturated and unsaturated fat, and several non-dietary variables.”

Low-carbohydrate score? There were no low-carbohydrate diets. There were no diets at all. This was an analysis of “43, 396 Swedish women, aged 30-49 years at baseline, [who] completed an extensive dietary questionnaire and were followed-up for an average of 15.7 years.” The outcome variable, however, was only the “score” which the authors made up and which, as you might guess, was not seen and certainly not approved, by anybody with actual experience with low-carbohydrate diets. And, it turns out that “Among the women studied, carbohydrate intake at the low extreme of the distribution was higher and protein intake at the high extreme of the distribution was lower than the respective intakes prescribed by many weight control diets.” (In social media, this is called “face-palm”).

Whatever the method, though, I wanted to know how bad it was? The 12 years or so that I have been continuously on a low-carbohydrate diet might be considered pretty long term. What is my risk of CVD?

“Results: A one tenth decrease in carbohydrate intake or increase in protein intake or a 2 unit increase in the low carbohydrate-high protein score were all statistically significantly associated with increasing incidence of cardiovascular disease overall (n=1270)—incidence rate ratio estimates 1.04 (95% confidence interval 1.00 to 1.08), 1.04 (1.02 to 1.06), and 1.05 (1.02 to 1.08).”

Rate ratio 1.04? And that’s an estimate.  That’s odds of 51:49.  That’s what I am supposed to be worried about. But that’s the relative risk. What about the absolute risk? There were 43 396 women in the study with 1270 incidents, or 2.9 % incidence overall.  So the absolute difference is about 1.48-1.42% = 0.06 % or less than 1/10 of 1 %.

Can such low numbers be meaningful? The usual answers is that if we scale them up to the whole population, we will save thousands of lives. Can we do that? Well, you can if the data are strong, that is, if we are really sure of the reliability of the independent variable. The relative risk in the Salk vaccine polio trial, for example, was in this ballpark but scaling up obviously paid off. In the Salk vaccine trial, however, we knew who got the vaccine and who didn’t. In distinction, food questionnaire’s have a bad reputation. Here is Lagiou’s description (you don’t really have to read this):

“We estimated the energy adjusted intakes of protein and carbohydrates for each woman, using the ‘residual method.’ This method allows evaluation of the “effect” of an energy generating nutrient, controlling for the energy generated by this nutrient, by using a simple regression of that nutrient on energy intake.…” and so on. I am not sure what it means but it certainly sounds like an estimate. So is the data itself any good? Well,

“After controlling for energy intake, however, distinguishing the effects of a specific energy generating nutrient is all but impossible, as a decrease in the intake of one is unavoidably linked to an increase in the intake of one or several of the others. Nevertheless, in this context, a low carbohydrate-high protein score allows the assessment of most low carbohydrate diets, which are generally high protein diets, because it integrates opposite changes of two nutrients with equivalent energy values.”

And “The long interval between exposure and outcome is a source of concern, because certain participants may change their dietary habits during the intervening period.”

Translation: we don’t really know what we did here.

In the end, Lagiou, et al admit “Our results do not answer questions concerning possible beneficial short term effects of low carbohydrate or high protein diets in the control of body weight or insulin resistance. Instead, they draw attention to the potential for considerable adverse effects on cardiovascular health of these diets….” Instead? I thought insulin resistance has an effect on CVD but if less than 1/10 of 1 % is “considerable adverse effects” what would something “almost zero” be.?

Coming back to the original paper by Augustin, et al, what about the comparison between low-GI diets and low-carbohydrate diets. The comparison in the figure above comes from Eric Westman’s lab. What do they have to say about that?

Augustin_

They missed this paper. Note: a comment I received suggested that I should have searched on “Eric” instead of “Westman.” Ha.

Overall, this is the evidence used by ICQC to tell you that low-carbohydrate diets would kill you. In the end, Augustin, et al is a hatchet-job, citing a meaningless paper at random. It is hard to understand why the journal took it. I will ask the editors to retract it.

Confronting the Crisis in Nutrition. The Office of Research Integrity Conference on Quest for Research Excellence.

Posted: March 12, 2012 in Crisis in Nutrition, low-carbohydrate diet, Research Integrity, The Nutrition Story, Volek-Westman principle
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The Office of Research Integrity is hosting a conference on the Quest for Research Excellence and, for the first time, there is session that directly confronts policy and The Crises in Nutrition. The Speakers will delineate the problem — the two worlds of establishment nutrition and the major challenge of low carbohydrate diets, the growing problems of childhood obesity and our failure to deal with it, the confusion in the popular press on scientific issues, and finally, the voice of the patient, the failure to listen to the people who are dissatisfied with official guidelines and who have found workable solutions themselves. Three specific goals are recommended: 1) open hearings in which all researchers are represented, 2) funding research in which all people in low carbohydrate research work with others and finally, 3) a new oversight agency from NSF or Office of Research and Technology Policy.

The three goals may be a useful crystallizing point for moving forward. What can you do?

  1. Contact your elected officials and copy one of the authors from the conference. Use the Abstracts below as a basis for your own version of what needs to be done. The three goals can be more narrowly focussed for your own interests.
  2. Encourage local media to cover the meeting. Information is at http://ori.hhs.gov and the speakers can be contacted directly.
  3. Publicize your version of the three goals on your blog, your facebook page or other social media.

2011 Office of Research Integrity Conference Washington DC

Quest for Research Excellence, March 15, 2012.

Session on Crisis in Nutrition.

Chair: Richard David Feinman Contact Information: feinman@mac.com (917) 554-7794

Introduction and Abstracts.

The interest in nutrition for general health and for the prevention and treatment of disease is probably greater than at any time in history. A fairly large research community has grown up to provide information on the subject but the excellence of the results and their ability to inform the general public is highly questionable. The prospect for the future quality of research is similarly discouraging. This session focusses on a crisis in nutrition: the confusion in the public’s mind and the lack of accountability of official agencies and their failure to consider minority points of view. Four areas are considered in this session: the need to consider work that has been done on carbohydrate restriction (the major alternative to current recommendations), the limitations of current media representations of research, the problem of childhood obesity, and finally, the failure to listen to the patients who have not been well served by current ideas and who have discovered alternatives for themselves. The public, athrough forums and comments to blogs and other social media, have expressed substantial dissatisfaction with the current state of medical nutrition.

Three approaches are suggested as first steps for resolving the current crises:

  1. First, we need hearings to be held by congress or HHS in which all major researchers in nutrition are represented. We have to have everybody in the game. The USDA guidelines committee, the American Health Association nutrition panels have to meet with their critics. In particular, researchers in dietary carbohydrate restriction should be able to meet and discuss issues with their critics. This is what the government can do. Better than taxation or other punitive measures, they can bring out the information. The NIH or congress should hold meaningful hearings where all sides are heard.
  1. Second, we need to fund a study in which researchers in dietary carbohydrate restriction and critics of such diets cooperate to design a long-term comparison of CRD and low-fat diets, Mediterranean diets or whatever. The groups agree on methods of procedure, make-up of the diets, how compliance will be effected, and what parameters will be measured. They “write the paper first, leaving room for the data,” that is, they agree in advance on what the possible outcomes are and what conclusions could be drawn from them. In this way, the public and other scientists will have a sense that the issues have adequately been addressed and the results reliably evaluated.
  1. Finally, what’s needed is the creation of a new oversight organization, possibly under the auspices of the National Science Foundation or the Office of Science and Technology Policy in which scientists with no personal stake in nutrition, assess bias in grant awards and publications. The scientific principles involved in nutrition are neither so technical nor so profound that accomplished scientists from other fields cannot evaluate them. Such organizations might make recommendations (or indicate the limitations in existing knowledge that prevent making recommendations) after hearing all credentialed experts.

In the end, we have to say whether there is really a problem or not. Is their really an epidemic of obesity and overweight? Is there a crisis in the incidence of diabetes, or not? Are our health problems, the rising cost, the patient suffering, real? If they’re real, we have to use everything we have. We have to have real science and we can’t continue with one expert committee after another making recommendations but taking no responsibility for outcomes and refusing to show any willingness to confront their critics.

Crisis in nutrition: I. Research Integrity and the Challenge of Carbohydrate Restriction.

Author: Richard David Feinman.

Objective: Research integrity extends beyond falsification of data and explicit misconduct. We assessed the extent to which established majority opinion recommending dietary fat and saturated fat reduction has failed to cite contradictory evidence, accepted undocumented conclusions and marginalized contributions of alternative points of view, specifically the role of dietary carbohydrate restriction, the major challenge to current recommendations..

Main points: Government and private health agencies have long recommended a reduction in dietary fat, particularly saturated fat, in the treatment or prevention of cardiovascular disease, obesity and diabetes. While there are many disclaimers, low-fat in some form remains the standard nutritional recommendation. Alternative strategies based on control of insulin fluctuations via carbohydrate restriction, while widely used by many in the community, have been discouraged if not actually attacked. This has contributed to a “two worlds” system that has increased confusion among scientists and the public. While there are many exceptions and some emerging acceptance of carbohydrate restriction — which frequently fails to cite earlier work — there is a perception of a majority opinion with pervasive control of the scientific infrastructure: editorial boards, study sections and health agency administration. Examples will be given of undocumented negative statements about low-carbohydrate diets, misrepresentation of data and extensive failure to cite relevant papers from the literature. Most troubling is the tendency to accept some of the conclusions previously demonstrated in low-carbohydrate research without, again, giving appropriate citations to that research. This has led a significant part of the population to distrust official recommendations and medical science.

There is a need to re-evaluate published data on carbohydrate restriction and to guarantee adequate peer review of future manuscripts and grant applications on macronutrient composition of the diet. More generally, better communication and cooperation between researchers and physicians with different opinions can only benefit science and society, a society that is admittedly not making good progress on obesity, diabetes and metabolic syndrome.

Conclusions & Recommendations:

Recommendations for better integration of different points of view include government-sponsored meetings where all scientific approaches can present their own opinions and address critics, representation on study sections and editorial boards of people with experience in carbohydrate restriction-insulin control diets and long term comparative trials that include PIs with experience and understanding of the role of the glucose-insulin axis in obesity, diabetes and metabolic syndrome. Agreement in advance between the “two worlds” as to the expected outcomes and interpretations would provide most benefit for the public and scientist-community interactions. Given the pervasiveness of the problem, in the end, intervention of new oversight agencies, e.g. from NSF or Office of Science and Technology, may be needed

Figure 1. Comparison of low-carbohydrate diets to low-GI diets and high cereal diets.

Crisis in nutrition: II. The popular media and research publications  

Author: Richard David Feinman.

Objective: The public relies on popular media for description of nutrition research. A major interest is the controversy over macronutrient composition of the diet and particularly the role carbohydrate-restriction, the major challenge to official recommendations. The goal is to assess the extent to which statements to the media and especially press releases from authors, author institutions and journals accurately represent the results of reported research. To determine the extent to which personal bias influences and is taken as fact by the media.

Main points: Authors of research papers should sensibly have great freedom in describing the implications of their research to the media, but it is important that the public be aware of when that opinion does or does not follow directly from the publication. Two examples are given. In one, an animal study (Foo, et al. Proc Natl Acad Sci USA 2009, 106: 15418-15423), the accompanying press release implied that it was motivated by observations of patients in a hospital which were not described, were unsubstantiated and would have been purely anecdotal. In a second example, a press release stated that carbohydrate-restricted diets (CRDs) were not included in a comparative study because of their low compliance (Sacks, et al. N Engl J Med 2009, 360: 859-873. No data were given to support this assertion and it is, in fact not true — CRDs have, on average, better compliance than other dietary interventions. The study concluded that the macronutrient composition of the diet was not important even though, as implemented, dietary intake was the same for the groups studied and, again, the CRD was not included in the study. It seems likely that that this would have an inhibiting effect on the willingness of individuals to choose a CRD, an outcome that was not justified by the published research.

Conclusions & recommendations: Practices should be evaluated and guidelines should be generated by academic societies, scientific journals and the popular media as to what constitutes appropriate press description of published research. Reasonable principle are that only those specific conclusions that derive directly from the publication. The generally accepted idea that authors make clear what is their personal opinion and what is the product of research should be the norm.

Biography: Richard David Feinman, PhD in Chemistry (University of Oregon) is Professor of Cell Biology at SUNY Downstate Medical Center. His current area of research is nutritional biochemistry and biochemical education especially as it relates to macronutrients and bioenergetics. He is founder of the Nutrition & Metabolism Society and former co-editor-in-chief of the journal Nutrition & Metabolism.

Figure 2. The world according to Reuters. Low-fat is good. It’s bad. It’s not as bad as we thought. Wait! Eat more fruits and vegetables. “The low-dat diet craze?” Is that what it’s been? Is?

Crisis in nutrition: III. Childhood Obesity: Prevention and Intervention  

Author: Wendy Knapp Pogozelski, Dept of Chemistry, SUNY Geneseo, Geneseo, NY 14454.

Objective: Almost one-third of American children aged 2-11 qualify as obese or overweight, with obesity-related diseases such as type 2 diabetes greatly on the rise in this population. Despite the labeling of the crisis as “epidemic,” funding to study childhood obesity has been limited and restricted to the traditional intervention strategies (to reduce calories, to reduce dietary fat and to exercise more) despite the fact that these efforts have been largely unsuccessful. The time has come for frank assessment of foundational beliefs about a) the causes of obesity in children and b) effective prevention and intervention strategies. This talk will discuss assumptions that are barriers to research and will compare results from traditional calorie-restriction programs with results from programs that have emphasized carbohydrate control and insulin reduction.

Main points: The current generation of children is predicted to be the first to experience a lower life expectancy than that of its parents. Children across the world are experiencing unparalleled rates of obesity, heart disease and type 2 diabetes. Relatively little formal research has addressed the causes of childhood obesity, perhaps due to an assumption that the problem is already understood. Despite reluctance to use children as subjects in studies that depart from the traditional “eat less and exercise more” philosophies, it has been noted that the current efforts, dietary recommendations, educational programs and mandates of school lunch programs could be characterized as experiments. These experiments, like the numerous interventions based on traditional strategies, have had poor results but it has been very difficult to implement or fund those approaches that focus on carbohydrate control despite demonstrable success in this area. We will examine typical meals given in schools and at home, compare data from various obesity interventions and discuss causes of obesity on a molecular level

Conclusions & recommendations: The crisis warrants policy change. 1) Funding for childhood obesity should be increased. 2) A broader range of methods and principal investigators should be instituted, with greater accountability required of funded investigators. 3) The USDA nutritional recommendations, a “one size fits all” guide for school meal programs should be reevaluated and reformulated to take into account all strategies for obesity prevention and intervention. 4) Education for physicians, dietitians and health care professionals, as well as the general public, should be altered to include an understanding of the most positive results in obesity prevention.

Biography: Wendy Pogozelski, PhD in Chemistry (Johns Hopkins University) is Professor of Chemistry at SUNY Geneseo. Her research has been in radiation effects, DNA damage, and DNA computing. Current efforts are directed toward biochemical-based nutrition education for health professionals, educators and the general public. In addition to developing teaching materials that incorporate nutrition research, Dr. Pogozelski writes and lectures on diabetes and works with local and national organizations to improve nutrition education.

Figure 3. Before and After from James Bailes’s No More Fat Kids

Crisis in nutrition: IV. Vox Populi

Authors: Tom Naughton, Jimmy Moore, Laura Dolson

Objective: Blogs and other social media provide insights into how the public views the current state of nutrition science and the official dietary recommendations. We ask what can be learned from online discussions among people who dispute and distrust the official recommendations.

Main points: A growing share of the population no longer trusts the dietary advice offered by private and government health agencies. They believe the supposed benefits of the low-fat, grain-based diets promoted by those agencies are not based on solid science and that benefits of low-carbohydrate diets have been deliberately squelched. The following is typical of comments the authors (whose websites draw a combined 1.5 million visitors monthly) receive daily:

“The medical and pharmaceutical companies have no interest in us becoming healthy through nutrition. It is in their financial interest to keep us where we are so they can sell us medications.”

Similar distrust of the government’s dietary recommendations has been expressed by doctors and academics. The following comments, left by a physician on one of the authors’ blogs, are not unusual:

“You and Denise Minger should collaborate on a book about the shoddy analysis put out by hacks like the Dietary Guidelines Advisory Committee.”

“Sometimes I wonder if people making these statements even took a basic course in biochemistry and physiology.”

Many patients have given up on their health care professionals and turn to Internet sites for advice they trust. This is particularly true of people with diabetes who find that a low-fat, high-carbohydrate diet is not helping them control their blood glucose. As one woman wrote about her experience with a diabetes center:

“I was so frustrated, I quit going to the center for check ups.”

The data suggest a serious problem in science-community interactions which needs to be

explored.

Conclusions & recommendations: Our findings document a large number of such cases pointing to the need for public hearings and or conference. The community is not well served by an establishment that refuses to address its critics from within the general population as well as health professionals.

Figure 4. Some comments from the Active Low-Carber Forums (140, 660 members on March 12, 2012).

Biographies:

Tom Naughton is a former writer for a health magazine, a contributor to the Encylopedia Britannica’s Health and Medical Annual, a documentary filmmaker, and popular blogger who specializes in health and nutrition issues.

Jimmy Moore’s top-rated “Livin’ La Vida Low-Carb” blog has drawn more than 6 million visitors since 2005. His podcast show, “The Livin’ La Vida Low-Carb Show with Jimmy Moore” has featured interviews with hundreds of respected doctors and researcher. He has also authored two books.

Laura Dolson, MS is a writer and cancer support provider at Mediconsult.com, and hastaught health and nutrition classes at a junior high charter school in California. Her About.com nutrition website draws hundreds of thousands of visitors monthly.


Slouching toward Low-Carb. “We Thought of This First.”

Posted: January 3, 2012 in American Diabetes Association, low-carbohydrate diet, Research Integrity, The Nutrition Story
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The joke in academic circles is that there are three responses to a new idea. First, “This is wrong,” second, “There’s nothing new in this,” and third, the sub-title of this post. Priority in a scientific discovery is fundamental in science, however, and “we thought of this first” is not always that funny.  Getting “scooped” can have serous practical consequences like jeopardizing your grant renewal and, if nothing else, most of us are motivated by a desire to solve the problem and don’t like the feeling that, by analogy, somebody came along and filled in our crossword puzzle.  In dietary carbohydrate, all three of the responses co-exist.  While an army of dietitians is still claiming that people with diabetes need ever more carbohydrate, in the background the low-fat paradigm crumbles and, somewhat along the lines of the predictions in A Future History of Diabetes , the old guard are coming forward to tell us that they have been recommending low-carb all along.

The latest discoverer of the need to reduce dietary carbohydrate is David Jenkins whose recent paper is entitled “Nuts as a Replacement for Carbohydrates in the Diabetic Diet.” [1] The title is crazy enough, following the tradition of getting away from nutrients, that is, well-defined variables, and replacing it with “food,” that is, mixtures of everything. It is, in fact, not really a low carbohydrate study but the experimental design is not the problem.  It is the background and rationale for the study which recognizes the disintegration of the low-fat diet paradigm but, at the same time, fails to cite any of the low-carbohydrate studies that have been instrumental in showing the need to replace carbohydrates in the diabetic diet. Given forty years of studies showing the benefits of low carbohydrate diets and forty years of unrestrained attacks on the method, it will be interesting to see how Jenkins shows that it is actually the nutritional establishment that invented carbohydrate restriction.

Disputes over priority are well known in the history of science. Newton’s frequently quoted statement that he had seen farther than others because he had “stood on the shoulders of giants” has been interpreted by some historians as a sarcastic comment aimed at Robert Hooke  with whom he had, among other things, a dispute over the priority for the inverse square law (force of gravity varies as the inverse of the square of the distance: F = GmM/g2). Hooke was short and suffered from kyphosis and is assumed not to have shoulders you would profitably stand on.

Even Einstein had trouble.  His dispute with the mathematician David Hilbert about priority for the field equations of general relativity (also about gravity) is still going on, a dispute that I prefer to stay out of. Cited by his biographer, Abraham Pais, Einstein had apparently made up the  verb to nostracize (nostrazieren) which he accused Hilbert of doing. (He meant that Hilbert had made Einstein’s idea community knowledge.  Googling the word gives you only “ostracize” and “Cosa Nostra.”)

It is not the priority dispute, per se — the original low carbohydrate diet is usually attributed to William Banting who published the Letter on Corpulence in 1863, although Brillat-Savarin’s 1825 Physiologie du goût  understood the principle. He said that some people were carbophores and admitted to being one himself.  It is not just priority but that the people who are now embracing carbohydrate restriction were previously unrestrained in their attacks on the dietary approach and were adamant in denying the strategy to their patients.

David Jenkins: “Nuts.”

In trying to find an appropriate answer to the recent bit of balderdash by the redoubtable Hope Warshaw, Tom Naughton recounted the story of the Battle of the Bulge of WWII.  Towards the end of the war, Hitler launched a massive winter attack around the city of Bastogne where, at one point, American Forces were surrounded. When the Germans demanded surrender, the American General, Anthony McAuliffe, sent the one-word reply: “Nuts!”  I always thought it was a euphemism and that he actually went “Vice-presidential” as it was called in the last administration, but it turns to have been a common expression with him and he really did write “nuts” which, of course, had to be explained to the German couriers. (There is a “Nuts” Museum in Bastogne commemorating the battle which the Americans won somewhat as described in the movie Patton).

For installation in the Nutritional Nuts Museum and as an example of the current attempts to co-opt carbohydrate restriction, one can hardly beat Jenkins’s recent paper [1].

Richard:…Who knows not that the gentle duke is dead? ….

King Edward: Who knows not he is dead! Who knows he is?

Queen Elizabeth: All-seeing heaven, what a world is this!

— William Shakespeare, Richard III

The trick is to act as if the point you are making is already established. The Abstract of Jenkins study: “Fat intake, especially monounsaturated fatty acid (MUFA), has been liberalized in diabetic diets to preserve HDL cholesterol and improve glycemic control….” It has? Liberalized by whom?  Although the American Diabetes Association guidelines are traditionally all over the place, few would consider that there is any sense of substantial liberalization on replacing carbohydrate with fat from them or any health agency.

“Replacement of carbohydrate by healthy fat … has been increasingly recognized as a possible therapeutic strategy in the treatment of diabetes [2] as concerns emerge over the impact of refined carbohydrate foods in increasing postprandial glycemia and reducing HDL cholesterol.”  Reference [2] ((1) in the original) actually “emerged” in 2002 and is ambiguous at best: “Carbohydrate and monounsaturated fat together should provide 60–70% of energy intake.” (It is not my style of humor, but the behavioral therapists call this “shoulding on people.”) The paper admits that the evidence “is based on expert consensus”  and contains what might be called the theme song of the American Diabetes Association:

 “Sucrose and sucrose-containing food do not need to be restricted by people with diabetes based on a concern about aggravating hyperglycemia. However, if sucrose is included in the food/meal plan, it should be substituted for other carbohydrate sources or, if added, be adequately covered with insulin or other glucose-lowering medication.” (my italics)

In fact, one emerging piece of evidence is Jenkins 2008 study comparing a diet high in cereal with a low glycemic index diet [3].  The glycemic index is a measure of the actual effect of dietary glucose on blood glucose.  Pioneered by Jenkins and coworkers, a low-GI diet is based on the same rationale as a low-carbohydrate diet, that glycemic and insulin fluctuations pose a metabolic risk but it emphasizes “the type of carbohydrate,” that is, it is a politically correct form of low-carbohydrate diet and as stated in the 2008 study: “We selected a high–cereal fiber diet treatment for its suggested health benefits for the comparison so that the potential value of carbohydrate foods could be emphasized equally for both high–cereal fiber and low–glycemic index interventions.” (my emphasis) The Conclusion of the 24-week study was: “In patients with type 2 diabetes, 6-month treatment with a low–glycemic index diet resulted in moderately lower HbA1c levels compared with a high–cereal fiber diet.”  The figure below shows the results for HbA1c and weight loss and just looking at the figures, the results are certainly modest enough.

By coincidence, on almost the same day, Eric Westman’s group published a study that compared a low glycemic index diet with a true low carbohydrate diet [4].  The studies were comparable in duration and number of subjects and a direct comparison shows the potential of low carbohydrate diets (NOTE: in the figure, the units for the change are those of the individual parameters; an earlier version showed this as % which was an error):

 

Fad_Westman_Jenkins_FigWe thought of this first.

Oddly, neither of these papers are cited in the current study by Jenkins, et al.  In fact, according to the paper, the precedents go way back:

“Recently, there has been renewed interest in reducing carbohydrate content in the diet of diabetic patients. In 1994, on the basis of emerging evidence, the American Diabetes Association first suggested the possibility of exchanging dietary carbohydrate for MUFA in dietary recommendations for type 2 diabetes). Although not all studies have shown beneficial effects of MUFAs in diabetes, general interest has persisted, especially in the context of the Mediterranean diet.”

The ADA discovered low carbohydrate diets ? Did my blogpost see it coming, or what? But wait…

 “low carbohydrate intakes have also been achieved on the Atkins diet by increasing animal fats and proteins. This influential dietary pattern is reflectedin the relatively lower pre-study carbohydrate intakes of ~ 45% in the current study rather than the 50–60% once recommended.

The researchers in this area might not feel that 45 % carbohydrate has much to do with the Atkins diet but, in any case, it appears not to have been “influential” enough to actually get the studies supporting it cited.

Again: “Fat intake, especially monounsaturated fatty acid (MUFA), has been liberalized…” but “… the exact sources have not been clearly defined. Therefore, we assessed the effect of mixed nut consumption as a source of vegetable fat on serum lipids and HbA1c in type 2 diabetes.”  Therefore? Nuts?  That’s going to clearly define the type of MUFA?  Nuts have all kinds of nutrients.  How do we know that it is the MUFA in the nuts?  In fact, the real question is whether any benefit would not be due to the reduction in carbohydrate regardless of what it were replaced with. So what was the benefit? The figure above shows the effect on hemoglobin A1C. As described by the authors:

 “The full-nut dose reduced HbA1c by two-thirds of the reduction recognized as clinically meaningful by the U.S. Food and Drug Administration (.0.3% absolute HbA1c units) in the development of antihyperglycemic drugs…”

 In other words, almost meaningful, and

 “the number of participants who achieved an HbA1c concentration of <7% (19 pre-study participants, down to 13 post-study participants) was significantly greater on the nut treatment than on the muffin treatment (20 pre-study participants, remaining at 20 post-study participants…).”

This is some kind of accomplishment but the figure above shows that, in fact, the results were pretty poor.  The statistics do show that the “full nut dose” was significantly different from the half-nut dose or the muffin.  But is this what you want to know?  After all, nobody has an average change in HbA1c.  What most of us want to know is the betting odds. If I down all those nuts, what’s the chance that I’ll get better.  How many of the people in the full-nut study did better than those in the half-nut study (did the authors not know that this would sound funny?).  You can’t tell for sure because this information is buried in the statistics but the overlap of the error bars, highlighted in pink, suggests that not everybody gained anything — in fact, some may have gotten worse.

What kind of benefit is possible in a dietary intervention for people with diabetes?  Well, the studies discussed above from Jenkins himself and from Westman show that, with a low-GI diet, it is possible to obtain an average reduction of about 4 %, more than ten times greater than with nuts and with a real low-carbohydrate diet much greater.  I have added an inset to the Figure from Jenkins with data from a 2005 study by Yancy, et al. [5].  The red line shows the progress of the mean in Yancy’s studied.  If you had diabetes, would you opt for this approach or go for the full-nut dose?

Bibliography

1. Jenkins DJ, Kendall CW, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza R et al: Nuts as a replacement for carbohydrates in the diabetic diet. Diabetes Care 2011, 34(8):1706-1711.

2. Franz MJ, Bantle JP, Beebe CA, Brunzell JD, Chiasson JL, Garg A, Holzmeister LA, Hoogwerf B, Mayer-Davis E, Mooradian AD et al: Evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. Diabetes Care 2002, 25(1):148-198.

3. Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S et al: Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA 2008, 300(23):2742-2753.

4. Westman EC, Yancy WS, Mavropoulos JC, Marquart M, McDuffie JR: The Effect of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet on Glycemic Control in Type 2 Diabetes Mellitus. Nutr Metab (Lond) 2008, 5(36).

5. Yancy WS, Jr., Foy M, Chalecki AM, Vernon MC, Westman EC: A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Nutr Metab (Lond) 2005, 2:34.

The Office of Research Integrity Conference and the Crisis in Nutrition.

Posted: August 15, 2011 in Lipophobes, low-carbohydrate diet, Research Integrity, The Nutrition Story
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The headline in the BBC News is “Fat ‘disrupts sugar sensors causing type 2 diabetes’” The article does not attribute the quotation in the headline and the first sentence says “US researchers say they have identified how a high-fat diet can trigger type 2 diabetes, in experiments on mice and human tissue.”  Should “mice” or “tissue” have been in the headline?  Should the article itself point out the extent to which mice respond differently, sometimes, oppositely from humans, to high-fat diets?  How strong is the evidence in light of other work?  Is the article altogether prejudicing the reader against fat which is the official position of both private and government health agencies?  The article in question may have some sins of omission but it is certainly restrained if not actually circumspect. The general problem, of course, is whether we get accurate scientific information from the popular media.

Peter Farnham and I and a group of bloggers (Laura Dolszon, Tom Naughton and Jimmy Moore) will speak at the end of the month at a conference produced by the Office of Research Integrity (ORI)) where we will raise several issues in the ethical conduct of current nutritional research. The conference, in general, tries to explore a number of questions on the interaction of science and  society.  The goals are to “discuss the latest research on research integrity…education in the responsible conduct of research; responsible research practices.” While each presenter will have only 15 minutes, this is one of the first times thatd the practices in nutrition with regard to issues of integrity are being addressed.  There are four areas that we will discuss:

Crisis in Nutrition I: The Popular Media and Research Publications

Richard David Feinman, SUNY Downstate Medical Center

Crisis in Nutrition II: Research Integrity in Meeting the Challenge  of Carbohydrate Restriction

Richard David Feinman, SUNY Downstate  Medical Center

Crisis in Nutrition III:  Was the Government Standard Met by the  2010 Dietary Guidelines?

Peter Farnham, Nutrition and Metabolism  Society, Alexandria, VA

Crisis in Nutrition IV:  Vox Populi 

Tom Naughton, Jimmy Moore, Laura Dolson, Independent Writers Franklin TN

The abstract of my first talk is presented below. It is, of course, a tricky area. Within some legal limits, reporters can say what they like.  A researcher speaking in a public venue, personal blog, social media can similarly pretty much sound of as they choose.  Or can they? If they are identified as an expert or are have credentials based on a employment by a prestigious institution, don’t they have to clearly distinguish between opinion and fact? And does the headline have to say that, for example, the high-fat study was done in mice?  All of these are gray areas and motives are hard to discern.  I focussed on one area that seemed more clear cut.  If an experimental study is reported in the media or in a press release from an academic institution (sometimes the same thing), is there an obligation to be sure that any opinions attributed to the investigator derives from that research unless otherwise indicated?

 Crisis in nutrition: I. The popular media and research publications  

Objective:

The public relies on popular media for descriptions of nutrition research.  Of particular interest is carbohydrate-restricted diets, the major challenge to official recommendations.  The goal is to assess the extent to which statements to the media and press releases accurately represent the results of research.

Summary of findings or main points:

Nutrition is an area of great interest to the public but one where matters of scientific fact and policy are contentious. Authors of research papers should sensibly have great freedom in describing of the implications of their research, but have an important role in explaining to the public when that opinion does or does not follow directly from the publication.  Two examples are given of where this is a critical issue. In one, an animal study (Foo, et al. Proc Natl Acad Sci USA 2009, 106: 15418-15423), the accompanying press release implies that it was motivated by observations of patients in a hospital, observations which were purely anecdotal and unsubstantiated.  In a second example, a press release stated that carbohydrate-restricted diets (CRDs) were not included in a comparative study because of their low compliance (Sacks, et al. N Engl J Med 2009, 360: 859-873). No data were given to support this allegation and, it is, in fact not true.  The study concluded that the macronutrient composition of the diet was not important even though, as implemented, dietary intake was the same for the groups studied and, again, the CRD was not included in the study.  It seems likely that that this would have an inhibiting effect on individuals choosing a CRD and represents an important impact of research integrity issues on the community.

Conclusions & recommendations:

Practices where research directly affects the community should be evaluated and guidelines should be generated by academic societies, scientific journals and the popular media. What constitutes appropriate press description of published research should be defined. Reasonable principles are that only those specific conclusions that derive directly from the publication are relevant and authors make clear what is their personal opinion and what is the product of research data.

 Office of Research Integrity

It is important to emphasize that ORI is sponsor of this academic conference and is not related to is regulatory function.  ORI is charged with overseeing federally funded research and emphasizes its role as watchdog in detection and prevention of research misconduct, assisting the Office of the General Counsel (OGC), dealing with suspected retaliation against whistleblowers, and responding to Freedom of Information and Privacy Acts.  Its usual activity involves pinpointing specific fraud.  The website reports, for example, a final judgement against an Assistant Professor at the Boston University School of Medicine Cancer Research Center who published two papers in which he had fabricated data shown as figures in the paper.  He is required to retract the papers and not enter into contracts or sit on advisory panels for two years.

ORI, in general, has the same relation to the research community that Internal Affairs has to the police.  Of course, in research, although there are substantive rewards, blatant fraud is generally pathological: if the results you are falsifying are important, they will surely be repeated and the misbehavior discovered while, if they are not important, the rewards are not likely to be spectacular although, especially these days, keeping your job is desirable.  The suspicion about ORI is also bolstered by their behavior in the Baltimore case in which they were part of the mindless zeal and witch-hunting whose appearance in human interactions seems to have such a low activation energy.

David Baltimore, a Nobel laureate in Physiology or Medicine and, at the time, MIT professor, had co-authored a paper with an immunologist named  Thereza Imanishi-Kari who was accused by a postdoctoral fellow of fabricating data. In the end, nothing came of it but there was much sound and fury and many idiots participated in the tale including the Secret Service (who I was taught were only supposed to protect the President and prosecute counterfeiters). The details of the Baltimore case are well told in capsule form in the Wikipedia entry. Daniel Kevles wrote an outstanding book, at least judged by the first half — the content was too infuriating for me to keep reading.  In any case, after most of the furor had died down, the ORI persisted and found Imanishi-Kari guilty of research misconduct, a ruling overturned by an appeals panel of the Department of Health and Human Services (HHS) which “found that much of what ORI presented was irrelevant, had limited probative value, was internally inconsistent, lacked reliability or foundation, was not credible or not corroborated, or was based on unwarranted assumptions.”  the ORI reputation has probably not recovered from this but it remains one of the few oversight agencies which, at least in nutrition, is sorely needed.

David Baltimore wrote his own description of the events and emphasized that it raise many questions, in particular,  “Who should judge science?” and “How does one distinguish between error and fraud? And does science do an adequate job of policing itself?”  The conference and this blog will discuss these matters which the crisis in nutrition has made of critical importance.  Such philosophical questions were formerly what most of us would have preferred to simply gab about in Starbucks.