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Not Surprised by ACCORD Study Halt
26 March 2008
What is “surprising” about the partial halting of the ACCORD study (“Diabetes Study Partially Halted After Deaths,” Feb. 7, 2008) is that the researchers were so surprised by completely predictable results.
What is not at all surprising is that the formulation of the failed study reflects the longstanding and general ignorance of the American Diabetes Association about what constitutes good treatment of diabetes, and what “normal” blood sugar levels are.
If halting the study calls “into question how the disease, which affects 21 million Americans, should be managed” by the ADA, then that is a positive step. If it causes diabetics to become fearful of blood sugar normalization, then that is a step backwards.
I was diagnosed with diabetes at the age of 12, in 1946, and followed ADA recommendations for many years, recommendations that would have killed me had I not discovered just how toxic they were. Sadly, those recommendations have not improved the quality of life for people with diabetes in the intervening decades. In order to encourage that, I became the first diabetic ever to self-monitor his own blood sugar, and subsequently become a doctor.
The ADA maintains that a glycosylated hemoglobin (A1c) of 6 or below is “normal.” That assumption of normal was reflected in the study.
A1c is a method of measuring average blood sugar levels. But an A1c of 6 equates to blood sugar levels of about 140 milligrams per deciliter. To my way of thinking that is still very high, given that for nondiabetics, normal is about 85 mg/dl. An A1c of 6.5 corresponds to about double normal.
A Recipe for Disaster
One can only assume that if the doctors in the study were following ADA guidelines, then the patients in the trial followed the standard ADAdietary recommendations. Those recommendations are a recipe for disaster. There is a simple explanation for this: carbohydrate.
At a minimum, the ADA recommends 130 grams of carbohydrate per day for diabetics. That recommendation is as recent as last month. But as the study was proposed more than a decade ago, we can only assume that the diabetics in this study were consuming at least that much carbohydrate. In 1996, the ADA was recommending that 60-65 percent of a diabetic’s caloric intake should be in the form of carbohydrate. That is more than 10 times the amount that I recommend for my patients (I recommend 5-10 percent) because it makes blood sugar control impossible. Why?
The answer is simple: the more carbohydrate you eat, the more glucose you will have in your bloodstream. The more glucose you have in your bloodstream, the more insulin you will have to make or inject. There are three problems with this:
First is that the combination of high levels of insulin in the blood stream and large amounts of dietary carbohydrate cause weight gain. For someone who already has heart disease, this further increases the risk of premature death.
Second is that most of the complications of diabetes – heart disease, peripheral neuropathy and a legion of others – result from high levels of glucose in the blood stream. Abnormally high levels of insulin in the blood stream – common in type 2 diabetics – cause vascular damage over and above what’s caused by elevated blood sugar. It’s been repeatedly demonstrated that grossly elevated insulin levels damage the vasculature and increase vascular rigidity and leakage.
Third is that the more carbohydrate you eat, the more insulin you need. Injected insulin cannot be fine-tuned the way that a nondiabetic’s body fine-tunes insulin. A number of years ago, researchers at the University of Minnesota showed a 29 to 39 percent variability in the action of 20 units of injected insulin. Twenty units of insulin is what I would call an industrial dose, necessitated by the absolutely wrong recommendations of the ADA.
If we just take the minimum, a 29 percent variability will create a 7-unit uncertainty in that 20-unit injection. So what does this mean?
One unit of insulin will bring down blood sugar by about 40 mg/dl. Multiply that by 7, and you have a 280 mg/dl uncertainty. The only solution to this problem is to make sure that any dose of insulin is as small as possible.
This uncertainty leads to the blood sugar “rollercoaster” that many diabetics experience. For someone with preexisting heart disease, the rollercoaster is a major stressor of the cardiac system and can lead to untimely death.
The Only Way Out
The only way to keep insulin levels down and blood sugars normal, is to eliminate fast-acting carbohydrate, such as starch (bread, rice, pasta, etc.) and sugar from the diabetic diet, eat only slow-acting carbohydrate (greens and vegetables), and reduce the overall amount of carbohydrate to about 30 grams a day.
The ADA derides this approach, maintaining that diabetics are either too stupid or lazy to follow it, but it has worked fine for me and my patients for many years. If I had followed the ADA approach, I would likely have been dead about 30 years ago.
The ADA has also maintained that low-carbohydrate diets should be avoided because there have never been any studies showing that they are safe over the long term. But there have been many studies of peoples who, when they leave their indigenous diets behind for Western high-carb diets, develop typical Western health problems: obesity, diabetes, cardiac disease, Etc. The longest running study of them all, human history, has shown that diabetes, atherosclerosis and heart disease didn’t exist until after the spread of agriculture.
There is another, institutional problem with blood sugar normalization: doctors’ fears of having a patient die from hypoglycemia, for which they could be sued. So it’s in the interest of physicians to keep their patients’ blood sugars unnaturally high. If they die of heart attacks, as in this study, or of other disease, as often happens, they can just shrug and say it was the “natural” consequence of the disease.
To that I say, nonsense.
Richard K Bernstein, MD, FACE,FACN, FACCWS
Mamaroneck, NY
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The halting of the branch of the ACCORD study which attempted to control blood glucose levels by insulin and medication alone actually does demonstrate that using only insulin and medication is dangerous to diabetics and results in increased mortality.
The obvious alternative is to limit glucose ingestion, precisely the substance which diabetics cannot metabolize normally. Then insulin and medications can be used in lower doses as necessary to address the residual problems. For this reason, the ACCORD initial results confirm that Dr. Bernstein's approach is logically advantageous, healthier and less dangerous for the diabetic patient.
It is unfortunate that press coverage obscured this conclusion by not highlighting that "industrial doses of insulin and medication" was the treatment course which lead to increased mortality. Instead, popular press commentary referenced the "label" for the subject branch of the ACCORD study -- the attempt to lower A1C levels -- and thereby did a great disservice to public health issues by suggesting lowering blood glucose levels alone is dangerous, contrary to established facts regarding the cause of diabetic damage. It is not a stretch to conclude that the ACCORD study's press release was irresponsible, deceptive and might well be the cause of a future increase in diabetic damage and early death.
Dr. Bernstein points out the safer and better way for diabetes management.
Dannee
Dr. Bernstein does the public a disservice in that he forgets that persons with diabetes are human beings.
Telling most persons to limit carbohydrate to 30 grams a day is not only unrealistic, but irresponsible for a medical professional--as it is unlivable for most patients.
Giving patients unrealistic expectations sets them up for failure and "non-compliance".
It is much better to allow reasonable amounts of carbohydrate into a persons diet and give them a meal plan that they can follow for a lifetime.
The question is what is "reasonable carbohydrate"? That question is unanswered. There is, however, a definite difference between restriction of carbohydrate and limiting of carbohydrate.
Let's hope that Dr. Bernstein and other diabetes specialists do not lose the human element of their practices by expecting the unexpectable of their patients.
Dr Bernstein- I believe everything you have said- what will it take to convince the ADA!
I support Dr. Bernstein's thoughts and recommendations with all my heart. There is a lot of common sense in these statements. In my opinion, it is especially valuable when the recommendation comes from the Doctor who suffers from Diabetes himself. But the society and doctors are not ready yet to accept this style of diabetes management.
My response is to anonymous author, who wrote " Dr. Bernstein does the public a disservice in that he forgets that persons with diabetes are human beings.
Telling most persons to limit carbohydrate to 30 grams a day is not only unrealistic, but irresponsible for a medical professional--as it is unlivable for most patients."
I am a Pediatric Endocrinologist. I myself follow low grain carb diet because of celiac disease.
I do not eat starches and sugar: my carbohydrates are fruits in a very reasonable amount and unlimited green vegetables.
Sometimes I allow myself dark chocolate, otherwise no usual sweets and snacks.
And I am a human being! And my life is full of joy! Unlike almost all my peers I did not change my dress size since high school (size 6) even after 45.
And I do not have to care about blood sugar-diet is mainly to stay fit and healthy!
I DO RECOMMEND restriction of grain and sugar carbs to all my pediatric patients with type 1 diabetes regardless of their age, not talking about obese adolescents with type 2! And I see UNBELIVABLE improvement of the control in those who follow my recomendations.
That is why I really advice the anonymous writer, whoever he is-patient with diabetes or a doctor-to look at Dr.Bernsten's article one more time with open minded attitude. May be the word of wisdom will be heard.
Sincerely,
Dr.K.
There are multiple flaws in Mr. Bernstein's article. Insulin responds differently in different people. Where Mr. Bernstein gets his number that one (1) unit of insulin reduces bg by 40 points, is beyond me. One unit of insulin knocks me me down about 150 points. The article is clearly flawed, and has functional flaws. I've had type I for almost 40 years, and I find limits on the diet to be unrealistic, cruel and plainly stupid, as diet is part of every human culture. Deprive yourself long enough, and you won't live long enough to figure out if insulin or diet is the cure. My parents were told I'd be dead by 7 when I was diagnosed, I ate everything, played every imaginable sport and game known to humankind, and have absolutely no signs of complications whatsoever. This supposed Dr. is a quack. Listen to what your body tells you. Beware the demonization of food, most medicines, and the way you live your life.
My non diabetic, grown up daughter has a near impossible diet to follow - avoiding all salicylates in food. That means virtually no fruit or vegetables or foods with added chemicals, and avoids all chemicals in her environment.
She sticks to the lifestyle quite easily because if she doesn't, she quickly gets covered in hives from head to foot, and/or her feet, throat, face etc swell up, she also gets fatigue and brain fog lasting days. She is quite happy and copes well, believing that one day things will improve.
My point is that you do get used to and enjoy any diet. It is obviously easier to stick to if cause and effect are instantaneous. It is good that people like Dr Bernstein offer a choice.
To the person who said > than 30g of carbs a day is unrealistic, it seems as though you are fooling yourself into believing diabetes is not a disease.
If your doctor told you your child was alergic to peanuts would you feed him/her any of the many, many foods containing nuts or nut oils? My guess is that you would have them on a very restricted diet.
Feeling entitled to eating every food at the expense of your health seems a little silly to me. As previously mentioned, there are many other joys in life.
Dr. Bernstein has been a diabetic for over 60 years. He has followed his own plan since 1973; I would say that's proof eating low carb for a lifetime is very attainable.
Personally, I have been eating about 20g net carbs per day for over 5 years. I have stopped taking all meds and my last A1c was 4.9. Not only is eating very low carb doable, it is enjoyable! It CAN be done if you want to do it.
Dr. Bernstein's best comment in this article is:
"The longest running study of them all, human history, has shown that diabetes, atherosclerosis and heart disease didn’t exist until after the spread of agriculture."
That is right on the money. Heart disease, hypertension, type 2 diabetes... indeed, all the symptoms and complications of Metabolic Syndrome did not appear until after the agricultural revolution.
Thankyou Dr. Bernstein for standing up to the ADA. I have type 1 diabetes, and have had the highest A1C sinse trying to "fit in" with the high carb "American" diet recomendations. I have reduced my carb intake this week and feel sooo much better in my body (as well as not having near as many high numbers). More people need to have this discourse and be open to questioning so-called "truths".
For succinct comments, how about this from the 2008 ADA Nutritional Guidelines:
"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."
I think it is reasonable to ask the ADA to include people who are familiar with low carb diets and see their potential to be included on the committees that write these guidelines. I think congress should hold hearings on the diabetes epidemic that includes the minority voice from low carb.
"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" says it all.
I think there are more options to controlling Diabetes than just Dr. B. If you are not familiar with the work of Dr. Neal Barnard & PCRM (Physician's Committee for Responsible Medicine) Dr. John McDougall you may want to check it out before you think Dr. Bernstein is the best & only way. Even I have had experiences with very high carbohydrate diets (70-80%), low fat (10-20%) & low Protein (10-20%) & have seen diabetics get off diabetes pills and even reduce or eliminate insulin (obviously Type 2s) with a low fat, low protein, high Carb plant-based diet. Of course, whole foods & especially whole grains are recommended. And anyone who has diabetes needs to understand the importance of lifestyle changes such as regular exercise, weight loss & stress management to the success in controlling diabetes. PLEASE do yourselves a favor & check out the incredible successes of those who chose to follow other programs such as: Barnard's, McDougall & others.
BTW I am an RD & CDE & I agree ADA is not always the most up to date in recommendations.
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