Cholesterol-lowering statin drugs, the most prescribed pills in the world, have become a family affair.
(Kim Scafuro)Middle-aged men, many women and the elderly are routinely put on the powerful drugs to lower high cholesterol. Now the nation’s leading pediatric group says that certain high-risk children as young as 8 may also be put on statin therapy, just like Mom, Dad and Grandpa.
The new guidelines from the American Academy of Pediatrics have been sharply criticized by many pediatricians and parents. They worry about the long-term health consequences of the drugs and have raised questions about financial ties between the academy and drug companies. There is also concern that the guidelines could lead to more widespread use of the drugs among children. An estimated 13 percent of children have total cholesterol above 200 milligrams per deciliter, the threshold used in adults to determine high cholesterol.
But the doctors who wrote the guidelines say they have been largely misunderstood. They say that far from leading to widespread use of statin drugs by children, the guidelines target the small percentage of children with genetic cholesterol problems or those with several worrisome risk factors, like obesity, high blood pressure and diabetes.
“I don’t see this as a major groundswell for the indiscriminate use of lipid-lowering drugs,” said Dr. Stephen Daniels, a member of the A.A.P.’s nutrition committee and chairman of the department of pediatrics at the University of Colorado Denver School of Medicine. “That’s exactly why we need these guidelines, to say where the limits of that usage should be.”
It’s not clear how many children will be affected. About 1 in 500 have genetic cholesterol disorders, and doctors estimate that currently, about 30 percent to 60 percent of those children haven’t had a diagnosis. Over all, only about 5 percent of children have levels of LDL, or “bad” cholesterol, above 130. Drug therapy would be suggested for children with bad cholesterol of 130 only if they have diabetes. Otherwise, drugs would be recommended for those with bad cholesterol of 160 and a family history of heart disease or two other risk factors, or when bad cholesterol hits 190.
Already five statin drugs — Bristol-Myers Squibb’s Pravachol, Pfizer’s Lipitor, Merck’s Zocor and Mevacor, and Novartis’s Lescol — have been approved for use in children with genetic cholesterol disorders. But there is little data on long-term use.
“People should realize that these drugs have only been studied in children with a genetic defect that causes very high cholesterol levels,” said Dr. Dianne Murphy, director of the Food and Drug Administration’s office of pediatric therapeutics, who noted that those children were followed for only two years.
Some doctors say the short-term data on statin use in children is reassuring and mirrors long-term safety data in adults. “The concept is that prevention should start early,” said Dr. Daniels. “You already have children who have risk factor levels that would be a concern for an adult.”
But the lack of long-term data has caused concern among many pediatricians, who say children often metabolize drugs differently than adults.
Dr. Darshak Sanghavi, a pediatric cardiologist at the University of Massachusetts Medical School, said statin drugs may affect a child’s endocrine system, which regulates growth and development, among other things. “I, for one, feel unsafe simply saying children are little adults in this case,” he said.
The medical literature is filled with examples of mistakes made when medical experts extrapolated data from one group to another. For years, doctors assumed that since menopause hormones appeared to protect the hearts of middle-aged women, then older women would benefit even more. But when the issue was studied in the large Women’s Health Initiative trial, older women on hormones turned out to have a far higher risk for heart attack and stroke.
The new guidelines have raised questions about the pharmaceutical industry’s ties to both the A.A.P. and the members of the group’s nutrition committee that made the recommendations. But the A.A.P. asserted last week that “there is no involvement by any commercial entity in the development of any statement or report” it issues.
Reports filed with the Internal Revenue Service and provided by the A.A.P. show that the academy has received contributions from several companies with ties to statins, including $433,000 from Merck, $835,250 from Abbott Laboratories’ Ross Product Division and $216,000 from the Bristol-Myers Squibb company Mead Johnson Nutritionals. The biggest statin maker, Pfizer, is not listed as a contributor. The A.A.P. reported a total of $81 million in revenue in 2007.
Three committee members have disclosed industry ties. Dr. Daniels was a one-time consultant for Merck and has also worked for Abbott Laboratories, although not on cholesterol drugs. Dr. Nicolas Stettler of the Children’s Hospital of Philadelphia took part in clinical trials for Merck’s Mevacor and a failed Pfizer cholesterol drug. Dr. Jatinder Bhatia, chief of neonatology at the Medical College of Georgia in Augusta, couldn’t be reached for comment, but in earlier disclosure statements he listed financial relationships with Bristol-Myers Squibb’s Mead Johnson unit, Abbott’s Ross Products and Dey Laboratories, which is affiliated with Merck.
Two committee members — Dr. Frank Greer, the committee chairman and a neonatologist at the University of Wisconsin, Madison; and Dr. Marcie Schneider, a pediatrician in Norwich, Conn. — said they had no financial relationships with the drug industry. Two others could not be reached for comment.
But the notion that the A.A.P. recommendations will turn into a bonanza for the drug industry — at least in the short term — is unlikely. Because five statins have already been approved for pediatric use, and most of the drugs have already gone off patent or are nearing the end of their patents, additional growth opportunities for the existing branded drugs are limited.
Regardless, many in the pediatrics community appear ready to resist the notion of putting children on statin therapy. Dr. Barney Softness, associate professor of pediatric endocrinology at Columbia University’s College of Physicians and Surgeons, who regularly treats diabetic children, said he would be reluctant to prescribe a statin to a child. He notes that he himself stopped taking the statin Lipitor because of muscle aches.
“There’s no data yet on long-term safety and efficacy studies in children,” Dr. Softness said. “I just don’t think the drug is benign enough to take the chance on some long-term side effects.”
Healthy living doesn't happen at the doctor's office. The road to better health is paved with the small decisions we make every day. It's about the choices we make when we buy groceries, drive our cars and hang out with our kids. Join columnist Tara Parker-Pope as she sifts through medical research and expert opinions for practical advice to help readers take control of their health and live well every day. You can reach Ms. Parker-Pope at 
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From 1 to 25 of 32 Comments
It appears LDL is used as a guideline to determine which children qualify for statins.
The majority of folks do not know there is more than one type of LDL, and most doctors do not request that LDL be fractionated to determine which LDLs their patients have. Small dense LDL is considered harmful and large fluffy LDL harmless.
Both small dense LDL and triglycerides (another lipid doctors look at for diabetes and metabolic syndrome) are promoted by a high carbohydrate diet. Low or restricted carbohydrate diets are the safest approaches to correct LDL imbalances. Researchers report low carbohydrate diets can even reverse diabetes in some cases. Take a look at:
Dietary carbohydrate restriction in type 2 diabetes mellitus and metabolic syndrome: time for a critical appraisal
http://www.nutritionandmetabolism.com/content/5/1/9
My favorite low carb food pyramid can be viewed here:
http://lowcarbdiets.about.com/od/whattoeat/ig/Low-Carb-Food-Pyramid/lowcarbpyramid1-IG.htm
(Copy and paste this URL into your address bar to view)
Knowledge is power.
— Dr. CI read the guidelines and didn’t think the hoopla was warranted. If you mention medication and kids there are always people who will be against it. Most of the time, they are right.
However, I had a patient who lost most of her family before age 45 to heart attacks. Her bad cholesterol was 300, if I remember correctly. She was alive at age 47 due to cardiac procedures and cholesterol medication. She was not one ounce overweight. Perhaps, if she had had medication in childhood, she wouldn’t have had to have surgery and stents.
We don’t know the long term outcome, but in certain cases, the risk might be worth it.
— rini10FROM TPP — But we don’t know do we? Where are the data? There are likely many reasons why the patient you mentioned beat her genetic odds. Maybe it was her lifestyle and weight maintenance. Perhaps if she had medication in childhood, she might have avoided surgery? That’s just 100% speculation based on zero evidence. that is the concern. Do the controlled studies. Then make the recommendations. Not vice versa. Let’s not forget, there is little or no evidence that statins help the vast majority of people who use them. Not only is the number needed to treat extraordinarily high, but the data on statins and healthy men, all women and the elderly do not show a mortality benefit.
As I have said before, millions of Americans have “volunteered” for a big national trial on statins–for better or worse. I had a cardiologist prescribe them for me because I am overweight–he never even checked my levels first. We don’t want that to start happening to kids–all the pediatricians tell us they are slammed busy.
FROM TPP — That’s amazing. Did you have a prior history of heart problems? That would be one reason to take statins regardless of cholesterol levels. But are you saying he just assumed you had high cholesterol because you are overweight and had no other heart issues? My mom for years was very overweight but she always had exceptionally low cholesterol.
— StarThere are many randomized, placebo controlled trials that do support the use of statins in adults(not zetia, however). My patient was an adult when she was treated and the statins greatly reduced her genetically elevated LDL level. In addition, she was the only family member treated, and the only one who survived into her mid forties.
Sure, the evidence was circumstantial. However, if I had to bet, I think it made a difference in her case.
— rini10FROM TPP — To be clear, the only trials that show a mortality benefit are those in middle aged men with prior history of heart attack or heart disease. But I understand your point, and you are probably right that it helped your patient, but i’d still rather see the data in kids.
Shortly after your initial blog on this topic, the NYTimes Magazine featured a long article on the growing American practice of medicating dogs and cats with psychotropic drugs. The author made the point that dogs and cats have behavioral/psychological problems because we are subjecting them to an unnatural and unhealthy way of life. According to several of the veterinarians quoted in the article, lack of exercise, boredom, isolation, and abuse lead to anxiety, OCD, uncontrolled aggression, and - you guessed it - obesity. Pet owners, however, were unable or unwilling to provide a healthier environment for their pets and preferred to rely on medication, including diet drugs and Prozac.
Now why did this article seem so hauntingly familiar?
— kalebergAs I keep bleating; I have a total cholesterol of around 460. It’s been much higher. My HDL is also very high. I haven’t a clue if my LDL type is fleecy, downy or bouncy. I have no cardiovascular disease, I’m 66. Statins were disastrous for me, and the side effects not recognized as from statins. I was over a period of eight years on every one but Crestor. I refused Zetia to great anger from the providing endocrinologist, and am now labelled as difficult because I won’t use them again, I don’t care if my cholesterol goes to 960. But this is what I want to say: when you’ve been injured by them, you’ll be a pariah to your physicians, you’ll have difficulty getting a physician because somehow they view your having had side effects as a betrayal of their excellence. This all on top of not getting help to recover from the side effects which LISTEN UP FOLKS, do not disappear the next day. In fact in a majority of persons recovery takes years. For what? If you have cardiovascular disease, and are a middle aged man, you may benefit but even then the odds at that are very slim.
So, for all the docs posting here: Yes, I have heterozygous familial hypercholesterolemia as do most of my family. Only one of us has died of heart disease and we have no idea what his cholesterol level was. He smoked, drank and raged his way through life, although was very muscular and slim.
And there is the key I believe. It’s not what we eat, and it’s not what our cholesterol level is (just around 50% of those who have heart attacks have NORMAL cholesterol).
High cholesterol and heart disease? It’s marketing.
It’s stress. May all those marketing ho’s get what they deserve.
— NRThere is a big difference between treating 1 in 500 children (”About 1 in 500 have genetic cholesterol disorders”) and treating the percentage of children “with genetic cholesterol problems or those with several worrisome risk factors, like obesity, high blood pressure and diabetes.
And the doctors say that we have misunderstood the guidelines.
I can’t say that the 0.2% of the population with a genetic cholesterol disorder will or will not receive a net benefit from the statin drugs. But to offer up this very small percentage of the population as a justification for a life long cholesterol drug policy for a large percentage of the entire population seems ludicrous.
Take a look around. What percentage of our children are obese? 10%…20%…30%…40%
It sure is a lot higher than 0.2%
Are statin drugs going to fix our diets? - http://healthhabits.wordpress.com/2008/05/10/news-flash-caveman-diet-goodyour-diet-bad/
Are they going to stop parents from setting their unborn children up for a lifelong predisposition to obesity? - http://healthhabits.wordpress.com/2008/07/01/why-is-america-so-fat-in-utero-big-macs/
Are the going to convince us to take charge of our own health & fitness?
— DRMany people still have heart attacks even while taking statins, my own husband included (47 yrs old). Statins are not a panacea.(BTW, his cholesterol was normal, probably from the statin Lipitor, lord knows his diet wasn’t perfect and he had a genetic disposition. However, it did not prevent his MI. Interestingly, and you MD’s should comment on this, his triglycerides were elevated and he had a slightly higher than normal A1c. His fractionalized cholesterol levels were also normal) He may have had high cholesterol as a youth. Would it have made a difference if he had started statins as a youth? Or not? The hundred thousand dollar question.
Many years ago when I was a young nurse, a patient came into the ER saying that he didn’t feel well, with some chest tightness. After it was determined that he was not having a cardiac event determined by serial EKG’s and serial cardiac enzymes, the ER MD still suggested he stay in the hospital overnight for observation, even though the patient had no complaints by this time. He did not require any nitro, either. BTW, his record was pulled (yes, we ‘pulled’ them then) and his cholesterol was normal, as well as his other lab values. He never smoked, was fit and of normal weight and had never had any real medical problems. He stated he went to his MD for physicals and followed all of the advice given to him at those appointments and lived a healthy lifestyle (he did not have significant family history, nor was he employed in any field where he was exposed to anything toxic, he was a school teacher). He decided he wanted to go home after spending many hours with us in the ER. Since he came by ambulance and lived alone, we called him a cab. (He was about 52, divorced). We placed him in the cab with specific instructions to return with any new symptoms, though we really thought he was fine. A few moments later, the cab driver came back in and said the patient had “passed out” in his cab. We ran out and rushed him back in. He was in full cardiac arrest. We worked on him for a very long time to no avail. The ER MD was so upset. He sat and reviewed his chart for hours. The autopsy showed no heart disease. He probably had an arrythmia that was lethal, but we will never know why (his toxicology reports were negative). We had started CPR immediately and defibrillated him within 4 minutes. He died anyway. So, the moral to my story is that you can do everything right, and still die. This story has nothing to do with children, but even when we do what we think is best for our kids, they may still die young for reasons we do not understand.
Medicine is as much an art as a science and I really think all the fuss about statins in children is overblown and that MD’s are just trying to help, not harm, and that all of them are not in big pharma’s pocket and this is not a vast right wing conspiracy, et cetera and so forth. It is a new guideline from a group from the AAP that have studied this in children and think this may help certain, specific children with specific issues. The jury will always be out on this, like in so many other areas of research. Time will tell, and it may never tell the whole story either, as I have just pointed out. The parent will be the final decision maker in the end, anyway. My answer, quite firmly, for my child, would be no. But that doesn’t make me right. I would have to have more information. Luckily, my husband did survive his heart attack and since he has a Ph.D in medicinal chemistry, would be intrumental in helping make this important decision, if we were ever faced with it.
I also think poster #1 is absolutely correct, very smart, the kind of doc you want. Do you practice in Boston?
— Janice NelsonRN#5 is absolutely right, all these things lead to anxiety and stress in pets. I have too many cats (7) and I have a problem with “inappropriate elimination” which I have read is the reason 70% of cats go to the shelter. I have addressed the litter box problems (numbers and types) and am working on behavioral issues. I use pheromones both in spray and in the wall release form. And in 2 of the cats I use Prozac, it works quickly and efficiently and has saved their lives. Better Prozac than two more euthanized stray cats that I got from the SPCA.
— RichIf we look at the global picture we see that much of medicine has reduced health to a question of a number.
When we consider the complexity of the human body and brain, and ask ourselves how much we know really know, intellectual honesty dictates that we admit to the fact that we know almost nothing. Note, additionally, that this doesn’t even include the subject of what is mind.
Where did we get off track when we decided that the whole of a person is immaterial to health, that rather it is only a question of blood chemistry? And even here, of the nearly uncountable number of possible chemical quantities we could measure, who decided that the list we have today is the most important, and everything else is of no consequence?
The enormous strides in physics in the last century lulled us into thinking that we were on the threshold of total knowledge about how it all works.
From this success, everyone wanted to get in on the act. Everyone declared themselves a scientist, and every area of study was science because the “scientific method” was applied. So here we have the idea that doctors are “medical scientists” and therefore have the same imprimatur of super knowledge and success that the physicists had.
Now since we have followed a path of utter illogic, the next step was to consider the body as merely a mechanical system and therefore nearly fully understandable in the same way that Newton’s laws and quantum mechanics successfully described inanimate mechanical systems.
And so we arrive at the current time and the heart is isolated as a mechanical system wherein a pump and fluid coursing through a pipe is extracted as the “model.” If the physicists can do it, so can we!
I won’t go through the rest of the tortuous “logic” because it is so convoluted that I don’t think anyone can really retrace the steps to where we are now. But just as this process is a study in illogical thinking, so too we arrive at this simple-minded idea that a single number and a simplified description of plaque is sufficient to understand the nature of heart disease.
So when we are confronted with the fact that just as many heart attacks occur with low cholesterol values as with higher numbers, we have the “medical scientists” simply ignoring it and continuing to repeat the same false statements over and over again. To be sure a physicist, when confronted with the same facts, would conclude that we really don’t know what is going on, and that the simplified model of a pump and pipe is not an appropriate model at all.
The bottom line in all of this is that we really are quite ignorant about the nature of disease and health and healing, and advocating prematurely pumping toxic chemicals into the human body is not only illogical – because of the absence of a real scientific understanding of what is going on – but even more it may be criminal.
— Tom HuntingtonThank you Janice Nelson RN (post #8), for your post.
To answer your query I am a Child and Adolescent Psychiatrist practicing in the Pacific Northwest. I am currently writing a textbook chapter for other health care providers covering this and other nutritional aspects impacting child and adolescent mental health. What I read in the news and cases I encounter in practice keep the topic of metabolic syndrome and cholesterol on my mind.
Some of the posts here question the validity of current theories of cholesterol’s impact on health. Bravo!
Please take less than two minutes of your time to view the following video by Dr. Malcolm Kendrick (URL below). Using data from the World Health Organization’s MONICA study he shows no relationship between cholesterol levels and death from heart disease. I could not speak to his data on Aboriginals, but was able to double-check Dr. Kendrick’s data from the MONICA study (you can, too–the MONICA data is available online). In terms of the MONICA data I find Dr. Kendrick’s presentation accurate:
http://www.youtube.com/watch?v=i8SSCNaaDcE
Per the obesity statistics at Nationmaster.com, the US ranks no. 1 for obesity, while countries with some of the highest cholesterol and lowest heart disease (a Swiss paradox?) rank among the lowest in obesity:
http://www.nationmaster.com/graph/hea_obe-health-obesity
Last but not least check out the obesity maps at the Centers for Disease Control, spanning the years 1985 (five years after public health recommendations emphasized high carbohydrate, low fat diets) to 2005:
http://www.cdc.gov/nccdphp/dnpa/obesity/trend/maps/index.htm
Pharmaceuticals cannot fix this, but we can, by changing our dietary habits. The high carbohydrate/low fat approach to eating is a failed experiment. We cannot eat like marathoners and not run marathons. Like rocket fuel in a Volkswagen the carbohydrates we consume provide fuel too hot for us to burn. Human bodies are remarkably tolerant, often able to sustain these high-carb habits for two or more decades before we malfunction. Metabolic Syndrome is Mother Nature pleading with us to return to the diets of our ancestors.
— Dr. CI just wanted to ask: is an inherited condition enough reason to start a statin treatment? These inherited conditions are not new. How doctors used to deal with such problems forty years ago?
We have become extremely dependent on drugs to solve health problems. Why just do the right thing: eat nutritionally and exercice bodies? Would it be better to establish a full co-responsability between childs-parents-doctors and prevent any further consequence in our children?
FROM TPP — This isn’t just an inherited predisposition to high cholesterol. This is a serious genetic condition that leads to astronomically high cholesterol (like in the 500s) some of these kids are known to have heart attacks in their 20s and 30s….Although some of them may also be overweight, that’s not necessarily the case. A lifestyle intervention isn’t enough to help them.
— AnaIt is good that this issue is getting a lot of blog time. It is important. And this Sunday installment has plenty of new information in it.
But what I don’t understand is: why feature a cartoon-style image of a young boy at the top of this blog entry who appears to be overeating, is overweight, and is clutching his heart as well?
This cartoon image implies personal and parental blame for what may be mostly a genetic disorder. The image is also needlessly sensationalizing, IMO. I would leave that sort of blogging to the NY Times columnist, Judith Warner, if I were you. In a health blog, more facts and less hype is better. My two cents.
— Rob L; N Myrtle Beach SCFROM TPP — Point taken but the issue here, really is not kids with a genetic disorder. The issue are the kids who have high cholesterol because of lifestyle and other risk factors such as obesity, diabetes and high blood pressure. Those are the kids we have zero data on and those are the kids who are now targeted by the new guidelines.
“FROM TPP — To be clear, the only trials that show a mortality benefit are those in middle aged men with prior history of heart attack or heart disease. But I understand your point, and you are probably right that it helped your patient, but i’d still rather see the data in kids.”
TPP: First, you should realize that when statins came on the market, no placebo-controlled trials were conducted in people with heterozygous familial hypercholesterolemia. It was considered unethical. When people talk about the primary prevention trials of statins, they are NOT talking about people with heterozygous FH. Based on observational data, the benefits of statins in people with heFH are very large. It is likely that if a primary prevention trial with clinical endpoints had been done in women with heFH, that there would have been a reduction in total mortality.
Can you be more specific about the kind of data would you like to see in kids? You cannot do clinical trials in kids that show a reduction in heart attacks and strokes, because kids generally do not have heart attacks and strokes. There have been trials that show statins slow the progression of atherosclerosis, as measured by carotid IMT, in kids with heFH.
I believe that only a small percentage of kids should be on statins. What I am totally against is putting kids on ezetimibe (Zetia) and bile acid sequestrants. The latter class of drugs is just not very effective, and ezetimibe has not been shown to prevent heart attacks and strokes, and in the ENHANCE trial it did not slow the growth of atherosclerosis.
— Marilyn MannFROM TPP — There are no long term data on kids. The trials we have involve a total of about 1,000 kids with the genetic disorder and lasted for 2 years or less. The new guidelines aren’t targeting only kids with a genetic disorder but other children with high cholesterol, and those kids haven’t been studied at all. According to the FDA, this constitutes an off label use, since the data we have are only for kids with the genetic condition. What bothers me about your posts is that there is so much “it is likely” and so little real evidence. The statin companies aren’t doing these studies any more because the drugs are off patent or about to get there. So we’re just going to say “oh well, it can’t be studied so this is our best guess.” ??
I think it would be helpful if people remembered that everyone’s risk of dying is 100%. You can’t reduce that risk. Even if you faithfully follow all of your doctor’s orders and regularly take your statins and all other prescription drugs you will never reduce your risk of dying. It is still 100% So it seems to me that how you live your life and use the time that you have is the most important thing.
— TheoOne more caveat:
Thyroid disorders can affect cholesterol levels. An overactive thyroid can reduce cholesterol and an under-active thyroid can increase it. Under-active thyroids increase the potential for heart disease as well. Thyroid disorders that are not obvious are called (sub)clinical thyroid disorders. Giving someone a statin rather than diagnosing and treating the underlying thyroid disorder, no matter how slight it may be, is harmful, as noted in the following text (interpretations of medical terms in brackets):
“By affecting the metabolism of lipids [cholesterol, LDL, HDL, triglycerides, e.g.], hypothyroidism [low thyroid hormone] accelerates the process of atherogenesis [“hardening of the arteries”] and increases cardiovascular [heart and blood vessel] risk… Starting treatment with lipid lowering agents (especially statins) for (sub)clinical hypothyroidism [subtle hypothyroidism] is extremely risky though due to the risk of the development or worsening of myopathy [muscle disease or damage], which is a further cogent argument for the active screening and treatment of(sub)clinical hypothyroidism for all patients with dyslipidemia [abnormal lipids].” http://lib.bioinfo.pl/pmid:17578170
— Dr. C“FROM TPP — There are no long term data on kids. The trials we have involve a total of about 1,000 kids with the genetic disorder and lasted for 2 years or less. The new guidelines aren’t targeting only kids with a genetic disorder but other children with high cholesterol, and those kids haven’t been studied at all.”
Tara,
I agree that the guidelines go beyond kids with heFH, and I do not endorse them. I’m sorry if I was unclear.
“What bothers me about your posts is that there is so much ‘it is likely’ and so little real evidence. The statin companies aren’t doing these studies any more because the drugs are off patent or about to get there. So we’re just going to say ‘oh well, it can’t be studied so this is our best guess.’??”
Tara, I’m sorry my posts bother you. Actually, there was a study that followed up kids for several years, I think it was 4-5 years. Perhaps the FDA does not have that data, I have no idea. I totally agree, though, we don’t have data on the effect of putting kids on statins or other cholesterol drugs for a lifetime. The points I have been trying to make, and perhaps I haven’t done a good job, are the following:
1. There are a few high risk kids where the benefits of treating with a statin may outweigh the risks. In most cases, treatment can be postponed until the child is a teenager and the child can be involved in the decision, along with his/her parents.
2. We can’t do trials with clinical endpoints (i.e., heart attacks, strokes, death) in kids, so we have to look at surrogate endpoints, such at endothelial function and carotid intima-media thickness. There are many areas of medicine where our information is not as complete as we would like, and this is one of them.
2. Any kids that are treated should be treated with a statin, not with a bile acid sequestrant, ezetimibe or plant sterols and stanols.
3. There are a lot of difficulties in doing studies in kids. You would not want to do them in kids who are not high risk because there would be no chance of benefit. However, if you do them in kids who are high risk, and the trial is placebo controlled, the participants who get the placebo are not being treated. The other obvious problem is that if the trial is anything more than short term, the kids turn into adults so you are no longer studying kids. To prove that treating kids prevents heart attacks, you would have to have a study that lasts 35 or 40 years. That will never happen in the form of a randomized controlled trial. Eventually, we will have observational data.
I’m done with this thread.
Marilyn
FROM TPP — Please let me clarify. Your posts don’t bother me at all — poor choice of words on my part in my last response. I’m thrilled you are part of the discussion and it’s clear you have much knowledge on the topic, including catching my initial error in reporting the guidelines. So no disrespect at all intended. As for the longer term studies — my point was about placebo controlled trials being short term — as you are aware, there is a difference in the quality of the data and meaning of hte data you get from a placebo controlled study vs. a followup study. My question is — is anybody collecting the observational data? I don’t know. the statin companies certainly aren’t. Thanks for detailing your points — it does help clarify your position. I recognize the concerns about how difficult it is to study this issue — which is why it seems the recommendations should be ultra cautious. I must say, a leading statin researcher who is a proponent of these drugs emailed me today and said he was quite bothered by the AAP guidelines. Anyway, thanks for taking part and sorry for my clumsy word choice earlier.
— Marilyn MannTara,
The familial hypercholesterolemia researchers in the Netherlands have been collecting observational data on their patients who have been treated with statins over the last 21 years, but I don’t know if the data involves children. I believe they are hoping to publish some of the data in the near future.
— Marilyn MannYes, in some cases I see the advantages of prescribing a statin to children - however, in severe cases only. As a new parent, I am obligated to do as much research as possible when thinking about giving my child ANY medication whatsoever. How can we completely trust the American Academy of Pediatrics when they are working hand-in-hand with the drug companies? I have taken statins in the past, but stopped due to side effects that I was not willing succumb. I can only imagine what a powerful drug can do to a little person’s body. Their endocrine systems are much too important to risk upsetting. I would love to see the government get more involved in subsidizing programs to initiate education and implement better foods in schools. In most cases, it is diet related. Children in this country eat poorly mostly because it’s cheap and their families cannot afford healthy foods. For this I am sorry and wish we all had the opportunity to eat healthy. I would love to see our country take food more seriously and produced in a way that is less toxic to our children and our environment. It might not be the answer to eliminating heart disease, but it is definitely a big contributor.
— Eric WatermanWhat bothers me about MMs posts is the “we”. And she’s not using it where it would mean her and her daughter. No. It’s her and the researchers and pharma.
George Monsanto did a piece on pharma plants to consumer discussion sites. The Guardian 2002.
— NRTheo, who posted above, makes a very salient point, and I’d like to add a comment.
Over the course of my life I have had, unfortunately, the need to see a doctor on a semi-regular basis because of a medical condition diagnosed over 40 years ago.
My condition has little impact on my life except for the need to take a drug on a daily basis to replace what my body is not producing naturally, and for this I need to see a doctor for a new, yearly prescription.
I absolutely dread seeing doctors because most of those I have seen are simply incompetent and incomprehensively dense. Having said this, I have also encountered those – a nearly insignificant minority - who were extremely competent. The biggest component of this competence is the independence of thought, in contrast to the usual situation of hearing a prepared speech.
In the case of one such doctor, I had asked his thoughts about cholesterol, and he then launched into a detailed analysis which included an enumeration of some of the harmful effects of lowering cholesterol. At the end of his analysis he then stated, in effect, “when your ticket is up, it is up, and there is nothing you can do about it.”
Another observation I have made over the years is how psychologically dependent many patients are on their “condition.” In my experience, the majority of people with various ailments absolutely adore having them because they can then be the center of attention and force everyone around them to say “Oh poor so and so, how terrible it is that you have such and such.”
And so it is that they are such lovely patients who drink in and hang on every word their priestly doctor utters. And so it is that the kitchen counter gets fuller and fuller with drugs as time goes on, and more and more are added to counteract the ill effects of the other drugs in an unending cycle. And with each new added drug a whole new chapter is opened requiring everyone in sight to commiserate on this poor “patient” for having to “endure” yet more problems.
We are overly dependent on doctors, and we have incorrectly endowed them with near “priestly” importance. Their knowledge is, in reality, very meager, and their emphasis on sickness rather than wellness just reinforces this dependency.
We need to reintegrate the idea of wholeness, a gestalt, when it comes to medicine. Chopping off the brain and declaring it immaterial to health is the real quackery that is so prevalent today.
— Tom HuntingtonTo NR:
By “MM” I assume you mean me? Let me get this straight: my daughter has a serious genetic disease that if untreated could cause her to develop early heart disease. I’m allowing her to be treated with a statin. I post something about my experiences, based on research I have done (countless hours reading cardiology journals and corresponding with various researchers).
You conclude I’m a “pharma plant”? LOL.
I can’t help noticing that people who make these kind of accusations never give their names.
Marilyn
FROM TPP — yes, I think all indications are that you are a concerned and informed parent.
— Marilyn Mann# 22 and #23 are related and support a suggestion that everyone should try to get out to the “I have (name the condition or diagnosis….” as the introduction to their story and try to mention something about their life and humanity.
The suggestion’s purpose might gets everyone away from the fear, sickness, disease syndrome that almost overcomes our ability to thinka and act as something more than dependent on others, see ourselves facing a life situation with a plan to deal with it and see ourselves trying to adjust, and to live a quality life.
It also might relieve some levels of suspicion that a contributor might be making a contribution for reasons other than those mentioned (i.e. a hidden adgenda). We then can stay on topic, avoid the personal attacks and try to support each other through understanding. No doubt disagreements will exist. We might even write something that is not clear, contradictatory, perhaps something we did not intend.
But the point is that we need to get beyond, “I am sick…” and start thinking about how not to become ill, to think and act ill and to be able to consider all options, medical and others to recover when the body is unable to defend itself sucessfully.
— ed gAnyone here can post with any name. That doesn’t make it true.
I am speaking as someone who has had familial hypercholesterolemia all my life. From the time I was born. Where’s the seriousness? Where’s the *disease*? I haven’t seen it.
That would be because it’s not a disease. It’s marketing and completely regrettable that some parents are driven to hysteria over nothing.
— NRI posted earlier but wanted to add this. Most doctors don’t break down your overall cholesterol. My cholesterol top number is always over 300-350. The good thing is my HDL is over 80 and my triglycerides are under 100. The thing about having really good HDL is it helps clean out the bad. I had a cath done and my arteries were clean even tho I had cholesterol 330. Doctors should always have the labs break down your cholesterol and do the risk factor.
— Betty Miller