Nominees for the Reckless Award
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.