Posts Tagged ‘dietary guidelines’

The  SBU (Swedish Council on Health Technology Assessment) is charged by the Swedish government with assessing health care treatments. Their recent acceptance of low-carbohydrate diets as best for weight loss is one of the signs of big changes in nutrition policy.  I am happy to reveal the next bombshell, this time from the American Diabetes Association (ADA) which will finally recognize the importance of reducing carbohydrate as the primary therapy in type 2 diabetes and as an adjunct in type 1.  Long holding to a very reactionary policy — while there were many disclaimers, the ADA has previously held 45 – 60 % carbohydrate as some kind of standard — the agency has been making slow progress. A member of the writing committee who wishes to remain anonymous has given me a copy of the 2014 nutritional guidelines due to be released next year, an excerpt from which, I reproduce below. (more…)

tarnowerhermanThe only person definitely known to have died as a consequence of an association with a low-carbohydrate diet is Dr. Herman Tarnower, author of the Scarsdale diet, although, as they used to say on the old TV detective shows, the immediate cause of death was lead poisoning. His girlfriend shot him. Not that folks haven’t been looking for other victims. The Atkins diet is still the bête noire of physicians, at least those who aren’t on it — a study published a few years ago said that physicians were more likely to follow a low carbohydrate diet when trying to lose weight themselves, while recommending a low fat diets for their patients.

(more…)

Dr. Eugene J. Fine.   Dr. Feinman invited me to contribute a guest blog on our recently published cancer research study: “Targeting insulin inhibition as a metabolic therapy in advanced cancer: A pilot safety and feasibility dietary trial in 10 patients” which has now appeared in the October issue of the Elsevier journal Nutrition, with an accompanying editorial.  Today’s post will focus on this dietary study, and its relation to the general problem of cancer and insulin inhibition. Part II, next week, will discuss in more detail, the hypothesis behind this study. Richard has already mentioned some of the important findings, but I will review them since the context of the study may shed additional light. (more…)

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.


“Despite the claims of various diet gurus, excess calorie consumption alone and not the amount of protein in an individual’s diet contributes to the accumulation of unwanted fat….” That’s the tendentious and pretty much inaccurate first line of the press release from JAMA on George Bray’s over-feeding study “Effect of Dietary Protein Content on Weight Gain, Energy Expenditure, and Body Composition During Overeating.”  “Amount of protein?”  What’s going here?  It hasn’t really been about protein.  Most of us “diet gurus” have claimed that carbohydrate, not protein, in the diet was the key macronutrient in regulating metabolism, consistent with the basic biochemistry of the glucose-insulin axis, or as Dr. Bray described Gary Taubes’s position in a review of Good Calories, Bad Calories:

“The problem is the carbohydrates in the diet, their effect on insulin secretion, and thus the hormonal regulation of homeostasis – the entire harmonic ensemble of the human body.”

Reduction in dietary carbohydrate puts increased demands on protein for gluconeogenesis and other processes but the controlling variable is the carbohydrate. The controversy in nutrition has been largely about fat vs carbohydrate.  Should we be on a low-carbohydrate diet or a low-fat diet?

The quotation in the press release says accurately that “Earlier studies in human beings suggested that diets containing either high or low [levels of] protein are less ‘metabolically efficient’ than diets with normal protein levels.”  Accurate, but written as if metabolic efficiency had always been recognized for its importance in weight loss, as if there had not been a dispute over whether the costs of processing protein were important in energy balance, indeed, written as if Bray and coworkers had not maintained that only calories count in weight gain or loss.  The idea of metabolic advantage, that one diet could be more efficient — more weight gained/calorie — has been largely resisted by the nutritional establishment.  Is this slouching toward Metabolic Advantage? (“Who knows not [the Duke] is dead?  Who knows he is?”)

The debate is also about calories.  Should you cut calories or just cut out carbs?  Is it really “excess calorie consumption” and not the effect of excess carbohydrates ? “A calorie is a calorie” or not. Many of the gurus have gone beyond “claiming” to demonstrating that when carbohydrates are low, weight loss is greater than when carbohydrate is high and that the weight loss on a low-carbohydrate diet is primarily in fat stores rather than lean mass.  In head-to-head comparisons, for however long they are compared, low-carbohydrate diets generally out-perform low-fat diets on other parameters as well, glycemic control, the features of atherogenic dyslipidemia. This has been the major challenge to traditional nutrition and the general approach has been to simply ignore this data and dismiss the researchers with innuendo as above.

In some sense, Bray, et al. answered a question that we weren’t asking, but protein is important if more complicated than carbohydrate and fat. So what did the study find? Bray and coworkers compared three diets of 5 %, 15 % and 25 % protein at an excess of calories, that was nominally the same in each group. The study was a random controlled study and was carried out in a metabolic ward so the results are more accurate than the usual diet study that relies on dietary records.  There is something odd about this study, though, in that if you want to say that only calories are the independent variable, you can’t keep calories constant.  What was actually done was to determine the energy requirements for weight maintenance over a run-in period of 2-3 weeks on a maintenance and then an additional 40 % of calories was added.  So although the calories are constant relative to initial energy expenditure, they are not absolutely the same and this is a study of the effect of varying calories while keeping calories constant. The figure below, re-drawn from Figure 6 of the paper comparing intake of absolute energy to protein intake makes you stop and think.

When you have a small number of subjects, a single outlier can bias the results.  If you remove the single highest point (circled in red), the correlation is likely to get much weaker and the normals and low begin to separate.  In other words, the individual variation (the relative efficiency) is sufficient to make it hard to see the effect of variable energy or, perhaps, as the authors themselves set it up, it is energy normalized for baseline that is the key variable.  Then the authors are right (at least by inspection) that the protein intake does not effect the change in body fat but you have only a single value for the energy. In this case, you cannot say “calories alone account for the increase in fat” (Conclusion in Abstract) because you have only a single point.  If you keep constant the variable (carbohydrate) that is most likely to bring out differences, you shouldn’t be surprised in there are no big differences.

Even taking the conclusions at face value, the authors found, as other diet comparison studies have, that weight loss or, in this over-feeding study, weight gain, was not dependent on calories alone: “a calorie is a calorie” not.  It is likely that this was what the study was originally trying to disprove and the results must have been a disappointment.  The way out was that, in this particular case, the differential weight loss showed up in difference in lean mass, rather than in fat mass as has been found in other studies showing variable efficiency.  Since 5 % is very low protein it is probably not surprising that the diet could not provide enough protein for an increase in lean mass this group.

So what are the other diet studies that have found variable efficiency. The reduction in weight found in studies comparing low-carbohydrate diets and low-fat diets not only shows a difference favoring carbohydrate restriction but the improved weight loss is preferentially fat over lean mass. For example, Volek, et al. compared a low fat with a VLCK and the results are as shown below.  In their study, subjects were randomized to one of two hypocaloric diets, a very low-carbohydrate ketogenic (VLCK) diet (carbohydrate <10% of energy) or a low fat (LF) diet and after 8 weeks switched to the other diet. Reported energy was slightly higher during the VLCK but the VLCK group lost more weight and as shown below predominantly in fat, total fat loss, and trunk fat loss for men (despite significantly greater energy intake). The majority of women also responded more favorably to the VLCK diet, especially in terms of trunk fat loss the ratio of trunk fat/total fat was also significantly reduced during the VLCK diet in men and women.  These studies depend on diet recall so are less accurate than the JAMA study but because of the better experimental design, the changes are bigger and with appropriate correction make a less ambiguous case than the JAMA study. The more accurate measurements in the metabolic chamber suggest that individual variation is real and not just due to random error.

So what do we know from Bray, et al.? As described above, there is some ambiguity in what constant energy means. Still, nobody questions that under many conditions, a “calorie is a calorie,” but they actually found that weight gain was different so when metabolic advantage is “claimed” it cannot be dismissed out of hand.  This is different than widely cited studies in the literature that claim macronutrients do not effect weight loss, since if weight gain depends on macronutrient, it is reasonable that weight loss does too.  Similarly, if tissue distribution affects lean mass in this case, then studies where the tissue distribution shows preferential loss of fat can’t be dismissed — again, it is certainly not surprising that a low protein diet will lead to less storage of protein; generally, while it is just as bad a generalization as “a calorie is a calorie,” there is some truth in “you are what you eat.” Also, in the JAMA study, protein was exchanged for fat so a reduction in fat did not have an effect on fat which may or may not be a surprise to many people. Tom Naughton raised a few other questions about Bray, et al. but in the end, the paper reminds me of the joke about the Polish Mafia: they make you an offer you can’t understand.

How to do it.

But  I told George how to do it. A couple of years ago, he and I had a brief correspondence. I made the following proposal. I suggested we could apply for a joint grant and publication to get the answer.  The following is from my email to him in 2008  (I have added some highlights):

 “A modest proposal

 Proponents of carbohydrate-restricted diets (CRD) and critics of such diets cooperate to design a long-term comparison of CRD and low-fat diets.  The groups agree on methods of procedure, make-up of the diets, how compliance will be effected, and what parameters will be measured.

We write the paper first, leaving room for the data, that is, we agree in advance on what the possible outcomes are and what conclusions could be drawn from them.  The final MS can only be edited for language usage. There are no disclaimers, no Monday-morning-quarterbacking, no excuses.

The paper could be submitted while the grant application is being written and would have to be accepted because any objections could be incorporated in the plan.  The grant itself would surely be funded since it incorporates everybody’s specific aims.”

 George hasn’t answered and he obviously has a different approach to the problem but my offer still stands.

In the end, that is what it will take to solve the problem.  Unless we agree on what the question is, how it can be tested and work together to do the experiment, the lipophobes will ignore the low-carbohydrate studies and we will criticize their studies. The real losers, of course, will be the people suffering from obesity and diabetes.  The question everybody always asks me, is why can’t there be a meeting of the minds?  In the current case, why was the JAMA study done?

Why was this study done? 

 Dr Bray discussed the results with news@JAMA via e-mail.

news@JAMA: What are the practical implications of these findings for patients trying to lose weight or for the physicians trying to counsel them?

 Dr Bray: The first practical implication is an old one: calories count. We showed very clearly that the increase in body fat was due to the increased intake of calories and that the amount of protein in the diet did not change it.

 To avoid that slow weight gain that many adults experience in their middle years, people need to watch their weight and increase activity, decrease food intake, or both; changing the diet alone will not do it.”

This sounds like the the same recommendations we’ve had for years.  Writing this, I suddenly realized that, as they say in German: that’s where the dog is buried.  It is about recommendations.  This research is following the recommendations.  It used to be (should be? assume it must be?) that recommendations follow from the research. Now, it’s the other way around.  Committees make recommendations and then research (sometimes by members of the committee) tries to support the recommendations. Something about this bothers me.

Doctor:  Therein the patient must minister to himself.

Macbeth: Throw physic [medicine] to the dogs; I’ll none of it.

— William Shakespeare, Macbeth

The epidemic of diabetes, if it can be contained at all, will probably fall to the efforts of the collective voice of patients and individual dedicated physicians. The complete abdication of responsibility by the American Diabetes Association (sugar is okay if you “cover it with insulin”) and by other agencies and individual experts, and the media’s need to keep market share with each day’s meaningless new epidemiologic breakthrough leaves the problem of explanation of the disease and its treatment in the hands of  individuals.

Jeff O’Connell’s recently published Sugar Nation  provides the most compelling introduction to what diabetes really means to a patient, and the latest edition of Dr. Bernstein’s encyclopedic Diabetes Solution  is the state-of-the art treatment from the patient-turned-physician.  Although the nutritional establishment has been able to resist these individual efforts — the ADA wouldn’t even accept ads for Dr. Bernstein’s book in the early editions — practicing physicians are primarily interested in their patients and may not know or care what the expert nutritional panels say.  You can send your diabetes story to Michael Turchiano (MTurchiano.PVP@gmail.com)  and Jimmy Moore (livinlowcarbman@charter.net) at The Patient’s Voice Project.

The Patient’s Voice Project

The Patient’s Voice Project, which began soliciting input on Friday, is a research study whose results will be presented at the Office of Research Integrity (ORI) conference on Quest for Research Excellence, March 15-16 in Washington, D.C. The conference was originally scheduled for the end of August but there was a conflict with Hurricane Irene.

The Patients Voice Project is an outgrowth of the scheduled talk “Vox Populi,” the text for which is at the end of this post.  A major stimulus was also our previous study on the Active Low-Carber Forums, an online support group. The March conference will present a session on “Crisis in Nutrition” that will include the results of the Patient’s Voice Project.

Official Notice from the Scientific Coordinator, Michael Turchiano

The Patient’s Voice Project is an effort to collect first hand accounts of the experience of people with diabetes (type 1 and type 2) with different diets.  If you are a person with diabetes and would be willing to share your experiences with diet as a therapy for diabetes, please send information to Michael Turchiano (MTurchiano.PVP@gmail.com) and a copy to Jimmy Moore (livinlowcarbman@charter.net). Please include details of your diets and duration and whether you are willing to be cited by name in any publication.

It is important to point out that, whereas we think that the benefits of carbohydrate restriction have been greatly under-appreciated and under-recommended, the goal is to find out about people’s experiences:both benefits and limitations of different diets. If you have not had good success with low-carbohydrate diets, it is equally important to share these experiences.

  • Indicate if you saw a physician or other health provider, what their attitudes were and whether you would be willing to share medical records.
  • We are particularly interested in people who have switched diets and had different outcomes.
  • Include any relevant laboratory or medical results that you think are relevant but we are primarily interested in your personal reactions to different diets and interaction with physicians and other health providers.
  • Finally, please indicate what factors influenced your choices (physician or nutritionist recommendations, information on popular diets(?) or scientific publications).

Thanks for your help.  The Patient’s Voice Project will analyze and publish conclusions in popular and scientific journals.

The Survey of the Active Low-Carber Forums

The Active Low-Carber Forums (ALCF) is an on-line support group that was started in 2000.  At the time of our survey (2006), it had 86,000 members and currently has more than 130,000.  Our original survey asked members of the forum to complete a 27-item questionnaire and to provide a narrative on any other health issues.  Some of the narrative answers included in the published paper were as follows:

“I no longer have diabetes, high blood pressure, sleep apnea, joint pain, back pain and loss of energy.”

“I started low carbing for diabetes. My 3 month blood sugar was 8.9 when diagnosed. It is now 5.4. My doctor is thrilled with my diabetes control and as a side benefit, I lost all that weight!”

 “I’m controlling my diabetes without meds or injecting insulin (with an a1c below 5), my lipid profile has improved, I’ve lost weight, I’ve gained both strength and endurance, and I’ve been able to discontinue one of my blood pressure meds.”

 “I have much more energy, fewer colds or other health problems. I was able to go completely off oral diabetes medication.”

The survey covered a number of topics.  We found that most respondents had the perception that they ate less food than before their low-carb diet, and most felt that the major change in their diet was a large increase in the consumption of green vegetables and a corresponding large decrease in fruit intake.

Physicians Attitudes in the ALCF survey

The Patient’s Voice Project is likely to tell us as much about physicians, or at least their interaction with patients, as about the patients themselves. We found in the ACLF survey that slightly more than half of the people who responded said that they had consulted a physician. We were surprised that about 55 % said that the physician or other health professional was supportive of their diet. Another 30 % or so fit the category of “did not have an opinion but was encouraging after seeing results.” Only 6 % of responders indicated that “they were discouraging even after I showed good results,” which may be a surprising result depending on your feeling about the rationality of doctors vs hostility to the Atkins diet.  Perusal of patients’ opinions on diabetes websites, however, suggests that the story on people with diabetes will not be as encouraging. 

The Survey on Sources of Information

Given the contentious nature of the debate on diet in diabetes therapy, it is not surprising that a  group following a low-carb strategy would  not put much stock in official sources. The table below shows the breakdown on sources of information from the ALCF survey.  Of the half of respondents who said that they relied on original scientific publications, 20 % felt they had generally inadequate access (important articles were not accessible) whereas 61 % felt that access was adequate and were able to see most articles that they wanted.

Voices of Dissatisfaction.

Posts on the ALCLF itself reinforced the idea that official recommendations were not only a limited source of information but that many were perceived as misleading. Typical posts cited in the paper:

“The ‘health experts’ are telling kids and parents the wrong foods to eat. Until we start beating the ‘health experts’ the kids won’t get any better. If health care costs are soaring and type 2 diabetes and its complications, as are most of these expenses why are we not putting a ‘sin’ tax on high glycemic foods to cut consumption and help pay for these cost? Beat the ‘health experts’ – not the kids!”

 While I am not a fan of sin taxes, the dissatisfaction is clear, and…

 “Until I researched it three years ago – I thought the most important thing was low fat. So I was eating the hell out of low fat products and my health continued to get worse.”

Similarly, the recent article in Diabetes Health by Hope Warshaw  http://bit.ly/mYm2O3 with its bizarre recommendation for people with diabetes to increase their carbohydrate intake elicited a number of statements of dissatisfaction:

“Respectfully, this column is not helpful to diabetics and probably dangerous. I am going on 6 years of eating 30-35 carbs/day. My A1c has been in the “non-diabetic” range ever since I went this route and I feel better than I have in years. I am not an exception among the many folks I know who live a good life on restricted carb diets.”

“…carbohydrates are a very dangerous and should be consumed with caution and knowledge. i had awful lipids and blood sugar control on a low fat/high carb diet. now that i have switched to a lower carb diet – all my numbers are superb. and the diet is easy to follow and very satisfying!”

 Summary:

The Project is intended to bring out the patient’s perspective on diet as therapy in diabetes.  The goals are to document people’s experience in finding the right diet. In particular, we are interested in whether switching to a low-carbohydrate diet provided improvement over the recommended diet typical of the ADA. Or not.  We are looking for a narrative that can bring out how people make decisions on choosing a diet and sticking with it: the influences of physicians, the media and personal experimentation. Your diabetes story.

Text of Abstract for the Original ORI Conference

 Crisis in Nutrition: IV. Vox Populi

 Authors: Tom Naughton, Jimmy Moore, Laura Dolson

Objective: Blogs and other social media provide insights into how a growing share of the population 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 diabetics 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.

The King in Hamlet says “you cannot speak of reason to the Dane and lose your voice” and most Americans do feel good about the Danes. We hold to the stereotype that they are friendly folk with a dry sense of humor like Victor Borge.  That is why Reuben and Rose Mattus, the Polish-Jewish immigrant ice-cream makers from the Bronx who tried to find an angle that would allow them to compete with Sealtest® and other big guns, picked Häagen-Dazs® as the name for their up-scale ice cream, even including a map of Denmark on the early packaging. (Never mind that there is no Scandinavian language that has the odd-ball collection of foreign-looking spelling; Danish does not have an umlaut and I don’t think any Indo-European language has the combination “zs;” there is Zsa Zsa Gabor, of course, but Hungarian is a Uralic language related only to languages that you never heard of).

Jakob Axel Nielsen

The original post here held that the Mattuses would have been very surprised to see that products like their high-butterfat ice cream are now a target of the Danish government which instituted a tax on foods containing saturated fat on October 1 of 2011. The tax, I am happy to say has since been repealed.  In a brilliant turn-around that gives a great insight into the mind of the tax man, the Times reported that ” the tax raised $216 million in new revenue. To offset the loss of that money, the Legislature plans a small increase in income taxes and the elimination of some deductions.” Get it? They are going to increase taxes to cover the money that they hoped to have, never mind, that the intention was to stop people from buying the stuff that would bring in the revenue.

The original idea for collecting taxes on a number of items including “sugar, fat and tobacco,” came from  Jakob Axel Nielsen (right), then Sundhedsminister.  A graduate of the law school at Aarhus, Nielsen is reputed to know even more about science than Hizzona’ Michael Bloomberg.  The LA Times points out, however, that “for those who may be tempted to call for Nielsen’s job, please note that he stepped down…last year.”

One of the things that is surprising about all this is that, in  2009, a combined Danish and American research group whose senior author was Dr. Marianne Jakobsen of Copenhagen University Hospital published a paper showing that there was virtually no effect of dietary saturated fatty acids (SFAs) on cardiovascular disease.  The study was a meta-analysis which means a re-evaluation of many previous studies. The authors concluded that the results “suggest that replacing SFA intake with PUFA (polyunsaturated fatty acid) intake rather than MUFA (monounsaturated fatty acids) or carbohydrate intake prevents CHD (coronary heart disease) over a wide range of intakes.”

As in many nutritional papers, it is worthwhile to actually look at the data.  The figure below, from Jakobsen’s paper shows the results from several studies in which the effect of substituting 5 % of energy from SFA with either carbohydrate (CHO) or PUFA or MUFA (not shown here) was measured.  The outcome variable is the hazard ratio for incidence of coronary events (heart attack, sudden death).  You can think of the hazard ratio as similar to an odds ratio which is what it sounds like: the comparative odds of different possible outcomes. The basic idea is that if 10 people in a group of 100 have a heart attack with saturated fat in their diet, the odds = 10 out of 100 or 1/10.  If you now replace 5 % of energy with PUFAs for a different group of 100 and find only 8 people have an event, then the odds for the second group is 8/100 and the odds ratio is 0.8 (8/100 divided by 10/100).  If the odds ratio were 1.0, then there would be no benefit either way, no difference if you keep SFAs or replace.  So in the first figure below, most of the points are to the left of the point 1.0, suggesting that PUFA is better than SFA but the figure on the right suggests that SFA is better than CHO.  But is this real?

You probably noticed that you would have the same odds ratio if the sample sizes were 1000.  In other words, a ratio gives relative values and obscures some information. If there were a large number of people and the real numbers were actually 8 and 10, you wouldn’t put much stock in the hazard ratio; decreasing your chances of a low probability event is not a big deal; you double your chances of winning the lottery by buying two tickets.  In fact, whereas heart disease is a big killer, if you study a thousand people for 5 years there will be only a small number of coronary events. I discussed this in a previous post, but giving Jakobsen the benefit of the doubt that there were really differences on outcomes, we need to know whether the hazard ratios are really reliable.  In this case, Jakobsen showed the variability in the results with “95% confidence intervals,” which are represented by the horizontal bars in the figure.

The 95% confidence interval (95% CI) is a measure of the spread of values around the average. It tells you how reliable the data is. Technically, the term means that if you calculate the size of the interval over and over, 95% of the time the interval will contain the true value. Although not technically precise, you could think of it as meaning that there is a 95% chance of the interval containing the true value.

There is one important point here. It is a statistical rule that if the 95% CI bar crosses the line for hazard ratio = 1.0 then this is taken as indiction that there is no significant difference between the two conditions, in this case, SFAs or a replacement.  Looking at the figure from Jakobsen, we are struck by the fact that, in the list of 15 different studies for two replacements, all but one cross the hazard ratio = 1.0 line; one study found that keeping SFAs in the diet provides a lower risk than replacement with carbohydrate. For all the others it was a wash.  At this point, one has to ask why a combined value was calculated.  How could 15 studies that show nothing add up to a new piece of information. Who says two wrongs, or even 15, can’t make a right?  The remarkable thing is that some of the studies in this meta-analysis are more than 20 years old. How could these have had so little impact?  Why did we keep believing that saturated fat was bad?

Taxing Saturated Fat.

Now the main thing that taxes do is bring in money.   That’s why it is not a good idea to tie it to a health strategy unless you are really sure (as in the case of cigarettes). For one thing, there is something contradictory (or pessimistic) about trying to raise money from a behavior that you want people to stop doing.   In any case, given that during the epidemic of obesity and diabetes, saturated fat intake went down (for men, the absolute amount went down by 14%), and that there was no effect on the incidence of heart disease (although survival was better due to treatment), there is every reason to consider  the possibility of unexpected negative outcomes (think margarine and trans-fat).  Although now repealed, it is worth considering possible unintended consequences (since the sugar tax is still alive).  Suppose that the Danes had reduced consumption of saturated fat but still ate enough to bring in money. And suppose that this had the opposite effect — after all, if you believe the Jakobsen study, substituting carbohydrate for saturated fat will increase cardiovascular risk.  So now there would be a revenue stream that was associated with an increase in cardiovascular disease.  What would they have done?  What would we do? Well, we’d stop it, of course.  Yeah, right.