The day before yesterday a group of doctors from the nutrition committee of the American Academy of Pediatrics came out with a couple of the most absurd recommendations imaginable. Not only were these recommendations silly beyond belief, one was downright dangerous to boot. I’m talking, of course, about the recommendations that children as young as 8 years old who have LDL concentrations ≥ 190 mg/dL be prescribed statins. (The other one marinated in idiocy is the recommendation that low-fat dairy products be be used in overweight children between the ages of 12 months and 2 years. These two are among 7 recommendations published in the July issue of the journal Pediatrics. All 7 recommendations are listed below*)

Drs. Stephen R. Daniels, Frank R. Greer and the rest of those on the nutrition committee are nominees for the Reckless Award. In fact, their recommendations are so egregious that had they come before the eponymous Dr. John Reckless’s suggestion that statins be put in the drinking water the award would be named after them instead.

Why is the recommendation to give statins to children aged 8 and greater so dangerous? Because no drug therapy is without risk. When as a physician you give drugs to patients, you know there are risks involved, but you balance these risks with the rewards to the patient from taking the drug. In the case of statins, there is absolutely no evidence whatsoever that statins will reduce the incidence of early heart disease and/or death in these children as they reach adulthood. And there is no evidence whatsoever that years of statin therapy in these kids as they age won’t cause disastrous problems later on.

Why did these people recommend statins to kids?

As reported in the New York Times yesterday, Dr. Nicolas Stettler, a member of the nutrition committee that made this recommendation, says:

We extrapolate from the information we have in adults,.

We know that in adults, decreasing cholesterol and giving some of those drugs decreases risk of heart disease or death. So there’s really no reason to think that would be any different in children.

Is he out of his mind? There is no evidence that decreasing cholesterol in adults reduces the risk of heart disease or death. Show me the papers, Dr. Stettler. And there is no evidence that statin drugs prevent early death in adults except for one small subset. It has been shown that in males under the age of 65 with diagnosed heart disease – not putative risk factors, but actual diagnosed heart disease – achieve some small benefit from statin drugs. But even these benefits are so small as to make many scientists wonder if they are worth the risk of giving statins to all the people in this particular group.

Let me repeat. Double-blind, placebo-controlled studies – the only ones that really count – have shown that statin drugs provide no benefit in terms of increasing lifespan in women of all ages and in men of all ages who have not been diagnosed with heart disease. These same studies have shown that statins provide no benefit for women of any age who have been diagnosed with heart disease and no benefit for men over 65 who have been diagnosed with heart disease. And, remember. an elevated cholesterol level is not a diagnosis of heart disease. ( If you’re interested in more detail, see this long post I wrote on the subject.)

So please tell me how in God’s name drugs that don’t provide benefit for the vast majority of adults are supposed to provide benefits to kids?

And what about the side effects? Many adults have experienced muscle aches and pains (sometimes to a disabling extent) and cognitive impairment. Some have had liver problems that ended up being fatal. And the Doctors on this committee recommend that children get these same drugs that are known to have side effects yet have never been shown to be of benefit. Un-frigging-believable!

I find these recommendations absolutely pernicious for a number of reasons other than the obvious ones above.

First, these recommendations are for kids with elevated cholesterol levels during childhood. In my opinion we don’t have enough evidence on the normal changes in cholesterol level throughout childhood and adolescence to be making any kind of recommendations based on one cholesterol test. Dr. George Mann meticulously evaluated the cholesterol levels of Masai children from the ages of 2 through adolescence and found that

Children show a high (for Masai) cholesterolemia [cholesterol in the blood] in infancy which declines until about age four, to near adult levels. The babies are typically nursed to age two to three years and then fed the food available for women and elders. Cholesterolemia increases in older children until puberty and reaches levels well above those of the muran [the warrior age, typically from 12-30]. After initiation and during the 15 years of warrior life, cholesterolemia is at the lowest level.

I find this interesting on a couple of levels. Masai consume a diet composed primarily of meat and milk. There entire subsistence revolves around their cattle. If these Masai children were evaluated at age 8 as per the recommendation of the people on this nutrition committee, they would be found to have elevated cholesterol and would probably be started on statins. If left alone, however, their cholesterol levels would drop naturally to a much lower level. How do the people who made these recommendations know that an elevated cholesterol level in a kid aged 8 won’t spontaneously drop as the kid ages, just like it did in the Masai kids. The answer is: they don’t.

Second, we don’t have a clue what the long term effects might be of children having a lower cholesterol. Cholesterol is a structural lipid. What happens if it is artificially lowered during the growth years? Who knows? I don’t. The people on the nutrition committee of the American Academy of Pediatrics don’t. I certainly wouldn’t recommend it for my own children or grandchildren.

Third, we’ve all seen kids who were fat in school who lost their weight and became thin as they got older. And we’ve all seen skinny kids who got fat as they got older (I’m a case in point). How can we be so sure we can reliably predict what’s going to happen as a kid ages that we can with good conscience put that kid on a drug that is designed to be taken daily for life? And a drug not without the potential for serious side effects. It beggars belief.

Fourth, statin drugs have been around only since the mid 1980s and haven’t been in total widespread use until the last decade. We don’t have a clue as to the long-term problems – if any – with statin use in adults. How can we possibly inflict them on kids?

Finally, as far as I’m concerned, the most pernicious part of this whole fiasco is that the recommendations were made by the American Academy of Pediatrics (AAP), the ultimate authority as to what is the standard of care for pediatric patients. Why is this so bad? Because when pediatricians treat kids, they accept the liability for their treatment until the kid is 18. In other words, they’re liable for medical malpractice for a long, long time. As a consequence, pediatricians are attuned to what the standards of care are, and can’t really be faulted for adhering to whatever the AAP deems is correct. If pediatricians follow these standards – no matter how misguided – they then can’t be held accountable if the standards turn out to be totally misguided and the kids who get the medications have bad outcomes years later. If pediatrician don’t hold to these standards, i.e., they don’t give kids with elevated LDL levels statins, then should one of their patients develop problems later the doc could get hammered with a big malpractice suit. And it’s tough trying to defend yourself when the governing body of your specialty has made recommendations and you haven’t followed them and your patients suffer. So, pediatricians will be giving statins to protect themselves.

I believe these recommendations to be far, far out of line. Already some pediatricians have gone on the attack against them. My hope is that good sense will ultimately prevail here and these recommendations will be ditched. But with all the money involved in this fiasco, I’m not holding my breath.

* The recommendations in full are below:

1. The population approach to a healthful diet should be recommended to all children older than 2 years according to Dietary Guidelines for Americans. This approach includes the use of low-fat dairy products. For children between 12 months and 2 years of age for whom overweight or obesity is a concern or who have a family history of obesity, dyslipidemia, or CVD, the use of reduced-fat milk would be appropriate.
2. The individual approach for children and adolescents at higher risk for CVD and with a high concentration of LDL includes recommended changes in diet with nutritional counseling and other lifestyle interventions such as increased physical activity.
3. The most current recommendation is to screen children and adolescents with a positive family history of dyslipidemia or premature (≤ 55 years of age for men and ≤ 65 years of age for women) CVD or dyslipidemia. It is also recommended that pediatric patients for whom family history is not known or those with other CVD risk factors, such as overweight (BMI ≥ 85th percentile, < 95th percentile), obesity (BMI ≥ 95th percentile), hypertension (blood pressure ≥ 95th percentile), cigarette smoking, or diabetes mellitus, be screened with a fasting lipid profile.
4. For these children, the first screening should take place after 2 years of age but no later than 10 years of age. Screening before 2 years of age is not recommended.
5. A fasting lipid profile is the recommended approach to screening, because there is no currently available noninvasive method to assess atherosclerotic CVD in children. This screening should occur in the context of well-child and health maintenance visits. If values are within the reference range on initial screening, the patient should be retested in 3 to 5 years.
6. For pediatric patients who are overweight or obese and have a high triglyceride concentration or low HDL concentration, weight management is the primary treatment, which includes improvement of diet with nutritional counseling and increased physical activity to produce improved energy balance.
7. For patients 8 years and older with an LDL concentration of ≥190 mg/dL (or ≥ 160 mg/dL with a family history of early heart disease or ≥ 2 additional risk factors present or ≥ 130 mg/dL if diabetes mellitus is present), pharmacologic intervention should be considered. The initial goal is to lower LDL concentration to < 160 mg/dL. However, targets as low as 130 mg/dL or even 110 mg/dL may be warranted when there is a strong family history of CVD, especially with other risk factors including obesity, diabetes mellitus, the metabolic syndrome, and other higher-risk situations.

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George L. Blackburn, M.D.

A reader commented on yesterday’s post guessing that I was going after Dr. Blackburn for his advocacy of weight-loss surgery. I’m not. He gets the award named after him for much worse. Advocacy for weight-loss surgery is boneheaded to be sure, but Dr. Blackburn is a surgeon, so we can kind of forgive him his tendencies in that direction. Plus, there have been a number of papers published lately promoting bariatric surgery as a treatment for not just obesity but for diabetes as well, so he at least has some – misguided, in my view – rationale for his surgical advocacy.

No, what I am presenting here is his latest medical writing. He wrote a commentary piece for the debut of the new journal Obesity that is mind numbing in its insipidity. I have never read so many totally stupid statements in such a short (one page without references) paper in my life. It makes me wonder if there is an editorial staff for this journal, and if so, were they off the day this dreck came through.

You can read the piece in its entirety here. In fact, you can read this entire issue of the journal free. And lest you suspect that this is some throw-away journal that no one reads, let me assure you that it is not. This journal is published by the Nature Publishing Group, the same group that publishes Nature, probably the most respected scientific journal in the world. It is the replacement for the journal Obesity Research, which is the house organ of the Obesity Society, nee NAASO, the academic obesity group. So, as I say, it’s not a slouch journal.

Dr. Blackburn’s piece is short, so let’s go through it almost paragraph by paragraph just looking at the crass stupidity manifest there.

The premise of the article, title The Low-Fat Imperative, is that we (the august group of obesity ‘experts’ who read this journal) should encourage everyone to go on low-fat diets to defeat the obesity epidemic.

Oh, really? Let’s take a look.

Strangely, given how short this piece is, there is a fair amount of repetition. Dr. Blackburn starts out by mentioning two studies that he says support the idea that reduced fat consumption is a good thing. (He repeats this first sentence almost word for word three paragraphs later.) Then he comes up with his first insipid statement.

Diets with less fat (20–25%) can reduce mean energy intake by 100 kcal/day—enough to stop the growing epidemic of overweight and obesity.

Do tell. And his second.

Our task is not to debate whether low-fat diets work, but to find ways to increase adherence to them.

In other words, we’re not interested in whether or not low-fat diets are the optimal diet, we simply want to promote them. He precedes this idiotic statement by referring to two studies contained in this issue of Obesity that he contends support the idea that low-fat diets are efficacious in treating obesity. You can read the two studies he references here and here, and although the second one minimally supports his premise, the first one doesn’t at all. In fact, it concludes

Energy intake, but not percentage of energy from fat, appears responsible for the observed weight gain.

Not particularly a resounding endorsement for the low-fat diet.

After the obligatory paragraph about the extent of the obesity epidemic, he goes on to write

Cutting dietary fat is the most efficient way to stop the obesity epidemic.

How he can write this with a straight face, I don’t know. Especially since virtually every study done comparing low-carb diets to low-fat diets has proclaimed low-carb diets the winner.

Here is a chart from another journal from the Nature group published a few months ago showing the superiority of the low-carb diet as compared to the low-fat one. Did Dr. Blackburn not see this article? Has he not kept up with all the studies emerging showing the low-carb diet to be the preferred diet for weight loss?

The forth paragraph is a virtual word for word repetition of the first with the added idiocy that low-fat diets can reduce energy intake by 100 kcal per day leading to a 10 pound weight loss over a year, which, in Blackburn’s mind, is

enough to stop the growing epidemic of overweight and obesity.

Pitiful. Dr. Blackburn has obviously never read the papers on adaptive thermogenesis.

Then he goes on to say that there is a question as to whether or not low-fat diets can be adhered to for the long haul. He references the Women’s Health Initiative (WHI) study as proof that they can. Instead of my going through the WHI myself, let me simply give you the pdf of the critique of it that came from JAMA, the journal in which it was published. I certainly wouldn’t use the WHI to prove that low-fat diets are effective for the long haul. whi-editorial.pdf

He drones on about a couple of other allegedly supportive studies then writes:

Unlike a diet high in carbohydrates and proteins, a high-fat diet works against the goals of healthy eating.

Since the goals of healthy eating have gotten us into the mess we’re in with the obesity epidemic, it would seem that working against those goals would be a good thing, not a bad thing.

He tells us that

The United States Department of Agriculture has been recommending moderate fat intake since it released its first set of nutritional guidelines in 1916.

And that

The American Dietetic Association, American Heart Association, National Heart, Lung, and Blood Institute, and the Institute of Medicine all recommend lifetime consumption of diets high in vegetables and moderately low in fat.

What he doesn’t tell us, however, is that since all these groups began recommending the low-fat diet, rates of obesity and diabetes have skyrocketed.

Then he really goes over the edge. He wades into the evolutionary aspects of diet, a place he should avoid in the future. He writes:

Evolution favors such a diet. For nearly 2 million years, our predecessors consumed lean meat, fish, vegetables, fruits, and nuts—low-fat diets high in fiber, proteins, and essential fatty acids. Retrospective models of Paleolithic diets estimate macronutrient content at 62% carbohydrates, 24% fat, and 14% protein.

To support this ludicrous statement, he references Loren Cordain’s seminal paper on the plant/animal subsistence ratios of hunter/gatherers, which shows that most hunter/gatherers got 65 percent of their calories from foods of animal origin and 35 percent from plants. Who knows where Blackburn got his numbers? As Loren emailed me when I sent him this paper

Nowhere in that paper do we give the numbers he quoted. We provided these ranges of macronutrient estimations are being most likely (protein 19-35% energy, carb 22-40% energy, and fat (28-58% energy).

Finally he comes out with one of the stupidest statements I’ve ever read. (I swear it’s true; read the article to see for yourself.)

As all macronutrient-based diets produce similar long-term weight loss, it does not matter which one people choose…

All macronutrient-based diets?!?!?! What are macronutrients? Fat, protein and carbohydrate. That’s it. Those are the macronutrients. So, what are macronutrient-based diets? As far as I can tell, they are diets composed of fat, protein and carbohydrate. And these macronutrient-based diets all produce similar weight loss? Say what?

As I say, one of the stupidest, most nonsensical statements I’ve ever read. Where were the editors who should have saved Dr. Blackburn from himself?

Finally and mercifully he ends this garbage by repeating himself yet again. Almost word for word. Where were the editors?

Our task is not to debate whether low-fat diets work, but to find ways to increase adherence to them. We need to spread the message that moderate weight loss of 10% is an acceptable, healthy option for those who want to lose weight—an option easily achieved by cutting small amounts of fat out of each meal. This is a reasonable and realistic goal, one that can be achieved as well as sustained.

We’ve had several instances of misrepresenting others’ work, a couple of examples of failing to understand the data, a few misinterpretations of what’s going on, and an outright, no question about it, idiotic statement. All in one short article. Stupidity compressed.

So now you know the rationale for the Blackburn Award, which will go to the person who makes most feckless, stupid, dogmatic, insipid nutritional statement imaginable. And whoever makes such a statement will have to go a long, long way to top that made by the man after whom the award is named.

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George L. Blackburn, M.D.

This is going to be a two-part post. Today’s post will be the history. Tomorrow’s post will be the outrage.

Last year I initiated the Reckless Award named for Dr. John Reckless, the British physician who suggested that statins should be put in the drinking water. The award goes to the person who makes the most outrageous recommendations for statin drug use. Now comes the second such award, the Blackburn Award given to the person who makes the most feckless, stupid, dogmatic nutritional statement imaginable. The award is named after Harvard associate professor George L. Blackburn, M.D. Dr. Blackburn is the Chief of the Nutritional/Metabolism Laboratory, and Director of the Center for the Study of Nutrition Medicine, which are affiliated with the Beth Israel Deaconess Medical Center in Boston, Massachusetts.

Benjamin Franklin said that “we are all born ignorant, but one must work hard to remain stupid.” George Blackburn has not just worked hard to remain stupid, he’s made it his life’s labor. Before I get to Dr. Blackburn’s latest outrage, I need to make a disclosure. I’ve had personal experience with him that probably colors my judgment a little, but tomorrow I’ll post his latest so readers can make the call themselves. But first, the personal history.

In the early to mid 1980s I was working as a family physician. I had gained a bunch of weight and stumbled into the low-carb diet by trial and error. I had started many of my own patients on my version of the low-carb diet (which later morphed into the Protein Power diet) and was in the process of moving from a general medical practice to one more specialized in the treatment of obesity and related disorders. In about 1986 or so the physician-supervised, protein-sparing, modified fasting (PSMF) programs were becoming popular. Two companies – Optifast and Medifast – were the largest promoters of these programs: the Optifast program was generally conducted through hospitals and the Medifast program through individual doctors’ offices. I sent off for the materials on Medifast looking to see if I could make it a part of my obesity-treatment practice.

When I got the materials and read through them I was struck by a couple of things. First, all the documentation for the benefits of the PSMF were the same medical papers I had found substantiating the effects I was seeing in my own patients on low-carb diets. And second, the makers of Medifast were using the PSMF to get patients down to goal weight, then switching them to standard low-fat, high-carb, reduced calorie diets for maintenance. At the time these fasting programs were much in the news, and one of the complaints was that although subjects lost weight rapidly on the PSMF part of the program, they just as rapidly regained it once they went on maintenance. To my way of thinking, it didn’t take a rocket scientist to see why.

I decided to start using the Medifast program in my clinic to help patients rapidly lose weight, but I used my own low-carb program once they reached goal weight and started maintenance. I cranked along for a couple of years using this protocol with great success.

All of the information provided me by Medifast was soaked and cloaked in the idea that the PSMF was fraught with danger and consequently required a lot of hands-on physician supervision to ensure that patients stayed out of trouble. Me experience was that it was anything but dangerous. By the time I had supervised a couple of thousand patients on the program I realized that it was really pretty safe. And I realized that it could be made even safer if one whole-food protein meal were added to the regimen. I began putting my own patients on four shakes per day and a meat and green vegetable meal instead of the five shakes and nothing else. My patients did fine on this regimen and had zero problems. It dawned on me that such a regimen could be made available to the public at large who couldn’t afford a medically-supervised program that cost a couple of thousand dollars that insurance didn’t cover.

I wrote up my idea in a proposal form, sent it to a number of publishers, and ended up with a book contract with Warner Books to write the book Thin So Fast.

As I was nearing the end of writing the first draft of the manuscript William Vitale, M.D., the founder and owner of Medifast, somehow got wind of the fact that I was writing a book on the PSMF. He came to Little Rock, and he and his very lovely wife took MD and me to dinner. He alluded to the book I was writing and said that he would love to write the foreword to it. I assumed he knew what the book was about, so I didn’t really elaborate. We had a wonderful dinner and parted the best of friends.

Dr. Vitale called a few times and dropped me a note or two asking about the book’s progress. When I was finally finished and had the manuscript turned into the publisher, I had my editor send Dr. Vitale a copy to read before he wrote the foreword. When he realized that the book wasn’t a history of the PSMF, but was a do-it-yourself manual for people to go on without physician supervision, he went ballistic.

He called me and had the company’s lawyer on the phone with him. He told me that under no circumstances should this book ever be published. He said that I would be responsible for the deaths of thousands of people. He begged me not to publish. It was all in his economic interest, of course, but he couched his plea in terms of patient safety. I refused and told him that his best bet was to write the foreword so that his company’s name would be out there. I told him that it was simply a matter of time before someone wrote such a book, and that if it weren’t me, it would be someone else. And soon. He said not just No, but Hell No to the idea of writing the foreword, and we ended the call unpleasantly.

A few days later I got an emergency call from my editor. She told me that Medifast’s lawyers had written a letter to Warner Books’ legal department pointing out that if Warner persisted in the publication of my book they would end up having the blood of thousands on their hands. The legal department wanted me to respond. Which I did. The decision was made to continue with publication.

Shortly, the folks at Warner got another letter of warning. This one came from Harvard professor Dr. George Blackburn. It was one of the most inarticulate letters I had ever seen. The letter echoed the one from Vitale’s attorneys, and stated in no uncertain terms that Warner was treading on dangerous ground with the publication of this book. Blackburn detailed all the dangers associated with the PSMF, and said that such a program absolutely required physician supervision. A book such as mine, so he said, would give people a blueprint for their own destruction.

Once again I had to write a rebuttal, and once again Warner decided to go through with the publication. The book Thin So Fast was on the shelves in December, 1988.

It’s difficult to believe now what with the plethora of ready to drink protein shake products available, but when I wrote this book there were no such products. The only ones available were the Medifast and Optifast shakes. I had to instruct readers on how to make their own protein powders out of non-fat powdered milk and a number of other products available at the time. Before my book and the ready-made protein shake products it inspired, the only way people could really do a PSMF was by using the Medifast and Optifast programs, which were out of reach cost-wise to the majority of people. Also, as an historical note, this book was the first mention anywhere of the idea of net effective carbs, although I didn’t call them that at the time. And it was the first to lay out for the layman the idea that the metabolic syndrome existed and that insulin resistance and too much insulin could be the cause of heart disease, high blood pressure, obesity and diabetes. I proposed some mechanisms that since have turned out to be pretty much correct.

Had the Blackburn letter been merely an effort by a friend to help out another friend (Blackburn and Vitale were buddies) it wouldn’t have gotten under my skin so much. But later events proved just what a snake Blackburn really is.

Thin So Fast came out in December 1988, and in September 1989 MD and I attended a NAASO conference in Bethesda, MD. In going through the book of abstracts for the various presentation, I noticed one by George Blackburn. He was giving a presentation on how he had developed a program on which patients went on a self-monitored (NOT physician-monitored) PSMF program that he ran out of Harvard. His presentation pointed out that the program was safe and that the patients made it through without problem. (And although he didn’t mention it, somewhere along the way he became affiliated with Slim Fast and even appeared in a video news release prepared by that company. Not only that, he has consulted for Novartis, the company that makes Optifast.)

So, Dr. Blackburn, who in late 1988 condemns me and my book as being potentially lethal to readers who might follow the PSMF on their own, comes out with his own similar program within a year. Which is why he’s not at the top of my list of friends, and which is why I might have a little bit of an axe to grind. But at least I’ve disclosed it.

Interestingly, now Medifast is sold as a self-monitored PSMF. You can order their meal replacements and go on it without physician supervision. And, the good folks at Medifast have published their own book showing how to use their supplements. And in a bizarre twist of fate, Medifast is recommended for use with Protein Power and other low-carb programs.

Today you get my personal history with Dr. Blackburn, tomorrow I’ll post on what he’s done (most recently) to have the Blackburn Award named after him.