Archive for the ‘American Diabetes Association’ Category

Our 2015 paper, Low-carbohydrate diets as the first approach in the treatment of diabetes. Review and evidence-base, summarized the clinical experience and the research results of the 26 authors. Meant to be a kind of manifesto on theory and practice, the first version of the manuscript was submitted to a couple of major journals under the title “The 15 Theses on…” harking back to Martin Luther’s 95 Theses. A critique of Church practices, particularly indulgences — for a few bucks, we get you or your loved ones out of purgatory — the Theses were supposed to have been nailed by Luther to the door of a church in Wittenberg. Our MS was rejected by BMJ and New England Journal although, like the original 95, it did not seem particularly radical — The American Diabetes Association (ADA) acknowledges that dietary carbohydrate is the major source of high blood glucose and most of our points of evidence were based on pretty solid fact.  Anyway, somebody suggested that we were, in effect, trying to nail our low-carbohydrate paper to the door of the ADA and, in the end, we changed the name to “evidence base” and it was ultimately published.

Until recently, I had not noticed the extensive parallels of the current low-carbohydrate revolution with the Protestant Reformation. The recent imperious and rather savage actions of professional organizations, notably two in Australia, the DAA (Dietitian’s Association of Australia) and AHPRA (Australian Health Practitioner Regulation Agency) in clamping down on their own members for deviation from orthodoxy brought out the similarities. Unlike Luther, who felt that the church really needed his help in getting abuses straightened out, Jennifer Elliott, a dietitian with an established practice of 30 years and Gary Fettke an orthopedic surgeon, thought that they were just doing their job and that, however, non-standard, the low-carbohydrate diets that they recommended for people with diabetes, was far from heresy. Because of the ties between government health agencies, Jennifer ultimately lost her job and Gary is under the bizarre order not to recommend diets to his patients because, as an orthopedic surgeon, there is “nothing associated with your medical training or education that makes you an expert or authority in the field of nutrition, diabetes or cancer.” (Those of us who are actively trying to upgrade the medical curriculum would question which part of the medical profession has such expertise or authority). Dr. Fettke’s training does, however, allow him to perform amputations which have diabetes as its greatest cause, second only to accidents. In any case, offering low-carbohydrate diets to patients has long been perceived as a threat by establishment medicine.  While their claims that they, and they alone, can control the epidemics of obesity and diabetes has been at the level of offering reduction of time in purgatory.  The medical establishment has been intolerant of criticism but has largely responded by delaying or preventing publication and by refusing to fund research that might get the “wrong” answer. The direct attacks on practitioners is new. There are several instances but the Australian cases distinctly represent desperation.

diet_luther_worms_vonwerner_1877crop

Luther at the Diet of Worms.

History of religion remains one of the gaps in my undergraduate liberal education and I was unfamiliar with the dramatic events surrounding Luther’s mission. The sixteenth century was a brutish time and I should have guessed how violent and oppressive would have been the response of the Catholic Church to Luther’s suggestions for improvement. After all, if you insisted on the word of the Bible rather than the word of priests, indeed, if you wanted direct access to a Bible in your own language rather than in Latin, then everybody could be their own savior. Being burnt at the stake was standard punishment for such heresy. We all know about Galileo’s brutal treatment and his being forced to recant his heliocentric theories, although at some point, he supposedly muttered, under his breath, “eppur se muove.” (It (the earth) does move anyway). That was almost a century after Luther’s protest and the danger was even greater in 1521. Luther, however, was a madman and refused to recant. Ultimately, he faced a trial at the Diet of Worms. (Contrary to popular opinion, “Diet” is an English word and means assembly; the German is Reichstag; Worms is in Germany, about 60 kilometres from Frankfurt-am-Main, and is pronounced “Vorms,” to rhyme with “norms,” but the joke is widely made, even by Shakespeare: see end of this post). At The Diet, Luther got off because a unanimous vote was required for conviction. He had an inside man, Frederick the Wise, the elector (as local political leaders were known) in his province.  Frederick seems to have thought that Luther was good for tourism (and probably helped get the Church off his own back). Of course,“not guilty,” doesn’t mean innocent and, as for sex-offenders in our day, you could get killed in the street anyway and the authorities would understand. To protect him, Frederick had Luther “kidnapped,” disguised as an aristocrat with the alias Junker Jörg and he went to the mattresses in a Castle in Wartburg for a year until it all blew over. Lucas Cranach the Elder painted a portrait of Jörg, possibly to let followers know that Luther was still alive.

575707-1449742854         Junker Jörg aka Martin Luther.

Heresy down under

So what had the Australian health professionals done to arouse the wrath of the “Church”? Not much. Jennifer Elliott has more than 30 years of experience and is the author of the excellent book, Baby Boomers, Bellies & Blood Sugars  which is distinguished by its straight-forward practical approach and does not seem to tweak anybody’s beard. In fact, she was not really accused of any specific thing although the message was clear: low-carbohydrate high fat (LCHF) diets are forbidden. Trying to help out, I sent an email message to Claire Hewat, head of DAA. I attached the twelve-points of evidence paper and I explained our position. I pointed out that “Ms. Elliott seems quite upset and genuinely puzzled since carbohydrate restriction has been a treatment for diabetes more or less forever, certainly going back to Elliott Joslin (early twentieth century physician and authority on diabetes).”

hewat_claire11474634995-300x224        Claire Hewat, head of DAA.

I mentioned an interview with a reporter from the New York Times who could not understand the resistance to an established, successful and ultimately obvious therapy — you don’t give carbohydrates to people with a disease of carbohydrate intolerance — and I made the case that the burden of proof should be on anyone who didn’t approve. I suggested a discussion, “perhaps an online webinar, in which all sides present their case. I and/or my colleagues would be glad to participate.” Claire’s answer was that I was “obviously not in possession of all the facts in this matter, nor can I apprise you of them as this is part of a confidential complaints process …nor is DAA afraid of debate but this is not the place for it.”

Not to digress too much, I loved the idea that I did not have the facts right but the facts were not available because they were confidential. It reminded me of watching a scene in one of the old Basil Rathbone Sherlock Holmes movies. Holmes is playing the violin and his arch-enemy, Professor Moriarity suddenly appears in the doorway:

Moriarity: “Holmes, I’ve come to….Well, I am sure that you can deduce why I’ve come.”

Holmes: “Yes. And I’m sure you can deduce my answer.”

Moriarity: “So that’s final?”

Holmes: “I’m afraid so.”

Most distressing remains the fact that DAA constitutes a professional dietitians’ organization which should, as in Macbeth, “against his murderer shut the door, / Not bear the knife myself.” (Is this a DAAger I see before me?)

The details of Jennifer’s case are buried in evasive legal double-talk but the precipitating events make it clear that censure derives from her recommending low-carbohydrate diets to her patients with diabetes. Claire Hewat’s defense against this obvious lack of due process was that Jennifer was invited to appear before an inquiry, set up somewhat along the lines of the Diet of Worms, but Jennifer refused to appear. In fact, it would have been worse than the Diet in that there were no formal charges and even Luther had been afforded legal representation. There would certainly be no defenders, as Luther had in Frederick, the Wise. Most important, recanting was not an option — if it wasn’t about anything real, there was nothing to recant. (Like Luther, she probably would not have felt able to recant anyway). Jennifer declined to attend telling Claire that it appeared to be “an invitation to a beheading.” The net effect is that she lost her job and and legal recourse would likely be exorbitant.

The words

In the reformation, heresy might have meant simply owning a Bible in your native language, or really owning any Bible at all. The Church held onto the Latin versions which you did not get to see directly. Somewhat like governmental nutritional guidelines in our tme, it was not in your native language, and required an “expert” priest to tell you what’s what. The first English translation was accomplished by John Wycliffe and during the English Reformation, several people were actually executed for owning a Wycliffe Bible. I found it somewhat analogous to the persistent hatred of Dr. Atkins so long after his death, that, at some point, the Church in England had Wycliffe’s body exhumed and burnt at the stake.

Ultimately, Luther succeeded because of Gutenberg and the invention of movable type. Now you did not have to make copies by hand. Now Luther could really get the word out. And he wrote the word. During his period of lying low in Wartburg, he translated the Bible into German.  And he published it. It was a big hit although the German population recognized that they had been swindled — financially as well as theologically — and history records a Peasant’s Revolt which was put down with great brutality. We recognize in all this parallels to what is really going on in the establishment’s determination to repress LCHF diets. And everybody recognizes the analog of Gutenberg’s press.

Unser Gutenberg  and the Fettke case

Our Gutenberg is, of course, the internet where technical and scientific writings, once the province of specialists, can now be viewed by many and where they can be discussed widely. Publishers of many journals try to maintain pay-walls in keeping with somebody’s observation that publishers’ function used to be to make new information available while now they work to make information unavailable.  (Many simultaneously cash in on open access which charges the authors outrageous fees). Whether the availability of scientific facts is out-weighed by proliferation of alternative facts is open to question but, on balance, we have a view, not only of the science, but of the inner workings of the health agencies that might otherwise be visible to only a few. And that’s how we have extensive access to the Fettke case and an associated Diet convened by the Australian Senate.

As reported by Marika Sboros, Fettke “cannot tell patients not to eat sugar. Why not? Because the country’s medical regulatory body, Australian Health Practitioners Regulatory Authority (AHPRA), says so….It has been investigating Fettke for more than two years now. That was after the first anonymous complaint from a DAA dietitian in 2014. Earlier this year,  AHPRA told Fettke to stop talking about nutrition until it had decided on a suitable sanction.” and — I’m not making this up — “informed Fettke that it was investigating him for ‘inappropriately reversing (a patient’s) type 2 diabetes…’”

Dr. Gary Fettke testified at an Australian Senate Inquiry on November 1. and just “by coincidence,” a few hours later, AHPRA’s 2 1/2 year investigation came to an end and Fettke was told that he would be constrained from giving nutritional advice.  In the end, this did not sit well with the Senate which undertook further hearing interrogating Martin Fletcher, the CEO of APHRA.

“Haven’t you got better things to do?”

You can see Martin Fletcher trying to defend AHPRA’s actions.  on Youtube. At 31:25, one of the Senators asked “…if a health practitionerr is advising a patient to go on a … sensible, medically-accepted diet program, why would you risk-assess that and have all guns blazing? Haven’t you got better things to do?”

One of life’s great disappointments is that when you finally corner the bad guys, they turn out to be pathetic like Saddam Hussein. They don’t break down on the stand as in the old Perry Mason episodes. It is sad but it is also hard to feel much sympathy.

diet_aphra_fletcher-1and2

Martin Fletcher, CEO of AHPRA trying to juggle the truth at the Senate hearing.

“Bread thou art…”

It was a trip to Rome, intended to deepen his faith, that ultimately contributed to Luther’s transformation. He saw corruption on a grand scale but what really freaked him out was that corruption and vice were coupled with a cynical disregard for religious practice. A priest going through the motions of giving the elements in the sacrament  muttered to himself “Bread thou art, and bread thou shalt remain; wine thou art, and wine thou shalt remain.”

That becomes the most distressing feature of this analogy. The quotation above, “There is nothing associated with your medical training or education that makes you an expert or authority in the field of nutrition, diabetes or cancer,” comes from a letter to Dr. Fettke that continued “Even if, in the future, your views on the benefits of the LCHF lifestyle become the accepted best medical practice, this does not change the fundamental fact that you are not suitably trained or educated as a medical practitioner to be providing advice or recommendations on this topic as a medical practitioner.”

This statement that treating disease is less important than loyalty to political power stands as the greatest exposition of the need for Reformation in Medicine.

Appendix. Shakespeare on the Diet of Worms.

Hamlet has been charged by his father’s Ghost with avenging the father’s murder by Claudius, the current king. Hamlet has put on an “antic disposition” to hide his motives. At one point, mistaking him for the King, Hamlet kills Polonius, a pompous court official, who is hiding behind a wall-hanging. The king hears about it and is pissed and wants to know where the body is (Act 4,Scene 3):

CLAUDIUS: Where’s Polonius?

HAMLET: At supper.

CLAUDIUS: At supper where?

HAMLET: Not where he eats, but where he is eaten. A certain convocation of politic worms are e’en [now] at him. Your worm is your only emperor for diet. We fat all creatures else to fat us, and we fat ourselves for maggots. Your fat king and your lean beggar is but variable service—two dishes, but to one table. That’s the end.

CLAUDIUS: Alas, alas!

HAMLET: A man may fish with the worm that hath eat of a king, and eat of the fish that hath fed of that worm.

CLAUDIUS: What dost thou mean by this?

HAMLET: Nothing but to show you how a king may go a progress through the guts of a beggar.

CLAUDIUS: Where is Polonius?

HAMLET: In heaven. Send hither to see. If your messenger find him not there, seek him i’ th’ other place yourself. But if indeed you find him not within this month, you shall nose him as you go up the stairs into the lobby.

CLAUDIUS (to attendants) Go seek him there.

(Exeunt some attendants)

HAMLET: He will stay till ye come.

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…)

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.

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.

“Headlines” is one of Jay Leno’s routines on The Tonight Show. While low on production values, it provides amusing typos, odd juxtapositions of text and inappropriate couplings from real notices and newspapers. The headlines are frequently very funny since, like fiction in general, authored comedy has to be plausible. There have been many other versions of the same idea including items in the New Yorker but Jay Leno’s audience rapport adds to the impact. Expert as he is, though, Jay seemed a little off guard when nobody laughed at the headline: “The Diabetes Discussion Group will meet at 10 AM right after the pancake breakfast.” It’s probably generational. After 30 or so years having the American Diabetes Association tell you that sugar is Ok as long as you “cover it with insulin” and that diabetes, a disease of carbohydrate intolerance, is best treated by adding carbohydrate and reducing fat, who knows what anybody believes.

One of the headlines on a previous show that did get a laugh said: “To increase gas mileage, drive less.”  (If Jay only knew how much we spent to get the USDA committee to come up with the advice that if you want to lose weight, you should eat less).

“.. Have we eaten on the insane root,
That takes the reason prisoner?”
— William Shakespeare, Macbeth.

For tragic humor in the bizarre field of diabetes information, it is really hard to compete. About the same time as the headlines sequence on the Tonight Show, DiabetesHealth  an organization and website that is intended to “investigate, inform, inspire” produced an inspiring investigation from the literature. The story is entitled “Maple Syrup – A Sweet Surprise.”  You gotta’ read this:

 “Meet the latest superfood: maple syrup.  Wait a minute…maple syrup? The super-sugary stuff poured on pancakes and waffles and used to glaze hams? That maple syrup? That’s right. Researchers from the University of Rhode Island have discovered that the syrup-produced in the northeastern United States and Canada–contains numerous compounds with real health benefits.”

So how did people with diabetes fare on the maple syrup? Well, there were no people. Or animals. The researchers did not test the effect of consumed maple syrup but only chemically analyzed samples of the stuff.

“‘In our laboratory research, we found that several of these compounds possess anti-oxidant and anti-inflammatory properties, which have been shown to fight cancer, diabetes, and bacterial illnesses,’ said Navindra Seeram, an assistant professor of pharmacognosy (the study of medicines derived from natural sources) at the university and the study’s lead author”

“Pharmacognosy,” incidentally, is the only English word correctly pronounced through the nose.  The article indicates that “a paper describing their results will appear in the Journal of Functional Foods. Scientists hope that these discoveries could lead to innovative treatments as the beneficial substances are synthesized to create new kinds of medicine.”  The article, however, is nothing if not circumspect:

“You might want to pause for a moment before rushing out and buying jug after jug of Canada’s finest maple syrup, though. It still contains plenty of sugar,…” In fact, by far the major ingredient in maple syrup is sucrose which, again, only has to be “covered” with insulin. So, with all those beneficial compounds, we will need less insulin per gram of sucrose with maple syrup, right?    Would Jay Leno have gotten a laugh if the diabetes meeting followed the pancakes and maple syrup breakfast?  How about if they were whole grain pancakes?

“If you can look into the seeds of time,
And say which grain will grow, and which will not…”
— William Shakespeare, Macbeth.

Not to be outdone, the American Diabetes Association website offers the lowdown on just how good grain is. Fiber, in general, is so good for you that you should be careful not to snarf it up too fast. As they point out, it is “important that you increase your fiber intake gradually, to prevent stomach irritation, and that you increase your intake of water and other liquids, to prevent constipation.” Doesn’t really sound all that healthy but foods with fiber “have a wealth of nutrition, containing many important vitamins and minerals.” Now, vitamin deficiency has always seemed to me to be the least of our nutritional problems but there’s more: “In fact,” using fact in its non-traditional meaning, fiber “may contain nutrients that haven’t even been discovered yet!” (their exclamation point). Not to belabor all the metaphors here, the ADA, long telling us that people with diabetes deserve to have their carbs, are surely offering pie in the sky.

I don’t believe in time travel, of course, so when somebody sent me the following article that was supposed to be a chapter from a Study of the History of Diabetes published in 2018, I didn’t think about it much.  Then I read an article about a woman who had been charged with neglect in the death of her son from complications due to diabetes.  It seems she “was trying to live by faith and felt like God would heal him.”

For some reason, that made me think of the Future History, so here is a chapter from the History.

Chapter IV.  ACCORD to The Court

We have seen how, early in the history of medicine, diabetes was recognized as a disease of carbohydrate intolerance and how, until the discovery of insulin, removing carbohydrate from the diet became the major treatment (Chapters I and II).  We chronicled the shift away from this medical practice under the influence of low fat recommendations and the ascendancy of pharmacology that followed the discovery of insulin.  Nonetheless, it persisted in the popular mind that you don’t give candy to people with diabetes, even as health agencies seemed to encourage sucrose (sugar) consumption.

The rather sudden reappearance of carbohydrate restriction, the so-called modern era in diabetes treatment, is usually dated to 2008, the precipitating event, publication of the ACCORD study in which a group undergoing  “intensive treatment” to lower blood glucose showed unexpected deaths [1].  ACCORD concluded that “These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes.” The intensive treatment turned out to be intensive pharmacologic therapy and this flawed logic lead to a popular uprising of sorts, a growing number of patients claiming that they had been hurt by intensive drug treatment and typically that they had only been able to get control of their diabetes by adherence to low carbohydrate diets. Blogs compared the ACCORD conclusion to an idea that alleviating headaches with intensive aspirin led to bleeding and we should therefore not treat headaches.

The conflict culminated in the large judgment for the plaintiff in Banting v. American Diabetes Association (ADA) in 2017, affirmed by the Supreme Court in 2018.  Dalton Banting, coincidentally a distant relative of the discoverer of insulin, was an adolescent with diabetes who took prescribed medications and followed a diet consistent with ADA recommendations.  He experienced worsening of his symptoms and ultimately had a foot amputated. At this point his parents found a physician who recommended a low carbohydrate diet which led to rapid and sustained improvement.  The parents claimed their son should have been offered carbohydrate-restriction as an option.  The case was unusual in that Banting had a mild obsessive-compulsive condition, expressed as a tendency to follow exactly any instructions from his parents or other authority figures.  Banting’s lawyers insisted that, as a consequence, one could rely on his having complied with the ADA’s recommendations.  Disputed by the defense, this was one of several issues that made Banting famous for vituperative courtroom interactions between academics.

Banting was a person with type 2 diabetes.  Unlike people with type 1 diabetes, he was able to produce insulin in response to dietary (or systemic) glucose but his pancreas was progressively dysfunctional and his body did not respond normally, that is, he was insulin-resistant.  Although most people with type 2 diabetes are at least slightly overweight, Banting was not, although he began gaining weight when treated with insulin.

The phrase “covered with insulin…” rocked the court: the president of the ADA, H. Himsworth, Jr., was asked to  read from the 2008 guidelines [2], never rescinded: “Sucrose-containing foods can be substituted for other carbohydrates in the meal plan or, if added to the meal plan, covered with insulin or other glucose lowering medications.”

Jaggers (attorney for Banting): “Are there other diseases where patients are counseled to make things worse so that they can take more drugs.”

Himsworth: “We only say ‘can be.’  We don’t necessarily recommend it.  We do say that ‘Care should be taken to avoid excess energy intake.’”

It soon became apparent that Himsworth was in trouble.  He was asked to read from the passage explaining the ADA’s opposition to low carbohydrate diets:

“Low-carbohydrate diets might seem to be a logical approach to lowering postprandial glucose. However, foods that contain carbohydrate are important sources of energy, fiber, vitamins, and minerals and are important in dietary palatability.”

Jaggers: “Important sources of energy?  I thought we wanted to avoid excess energy,” and “would you say that taking a vitamin pill is in the same category as injecting insulin?”

Finally,

Jaggers: “Dr. Himsworth, as an expert on palatability, could you explain the difference between Bordelaise sauce and Béarnaise sauce?” [laughter]

Damaging as this testimony was, the tipping point in the trial is generally considered to have been the glucometer demonstration.  Banting consumed a meal typical of that recommended by the ADA  and glucometer readings were projected on a screen for the jury, showing, on this day, so-called “spikes” in blood glucose.  The following day, Banting consumed a low carbohydrate meal and the improved glucometer readings were again projected for the jury.  Defense argued that one meal did not prove anything and that one had to look at the whole history of the lifestyle intervention but was unable to show any evidence of harm from continued maintenance of low blood sugar despite testimony of several expert witnesses.  In the end, the jury agreed that common sense overrides expert testimony and that Banting should have been offered the choice of a carbohydrate-restricted diet.

Banting was held in New York State which adheres to the Frye standard: in essence, the idea that scientific evidence is determined by “general acceptance.” The explicit inclusion of common sense was, in fact, a legal precedent [3].   The Supreme Court ultimately concurred and held that the more comprehensive standards derived from Daubert v. Merrill-Dow, could sensibly be seen to encompass common sense.

The final decision in Banting lead to numerous law suits.  The ADA and other agencies changed their tactics claiming that they never were opposed to low carbohydrate diets and, in fact, had been recommending them all along [4].  This is discussed in the next chapter.

References

1. Gerstein, H. C. et al., Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 358 (24), 2545 (2008).

2. American Diabetes Association, Nutrition Recommendations and Interventions for Diabetes–2008. Diabetes Care 31 (Suppl 1), S61 (2008).

3. Berger, M, Expert Testimony: The Supreme Court’s Rules Issues in Science and Technology (2000).

4. American Diabetes Association, Nutrition Recommendations and Interventions for Diabetes–2018. Diabetes Care 40 (Suppl 1), S12 (2018).