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BLOG: July 2008

Children cholesterol and big business

(Cholesterol kids continued)

It could be said that results of these several small short-term studies indicate that statins have similar effects on young patients, as they do on adults. But what these effects actually are, and do they support American Academy of Pediatricians' move to hand "solving" the children cholesterol problem over to pharmaceutical companies. There are a few critically important questions to ask.

Where is the sense of urgency to attack cholesterol coming from? The scientific community is overwhelmingly in favor of the view that cholesterol levels alone

are not the major risk factor for developing cardiovascular disease.

Moreover, the very long-term government studies cited by the Committee actually indicate that cholesterol level in adolescents was nearly stagnant in the 1988-2000 period (with triglyceride level dropping), while in the 1988-1994 vs. 1966-70 period, total cholesterol has actually decreased by 7mg/dL. On top of that, despite the obesity epidemic, the rate of heart-related deaths in the U.S. is in steady decline, now being less than half the rate in 1950.

In order to justify opening door to widespread drug treatment of children and adolescent, at least one large, comprehensive, well controlled long-term study with convincingly positive results is a must. None of the studies cited in the new AAP guidelines comes even close to fulfill such a minimum requirement.

Most of these several small short-term studies were on children/adolescents with inherent dyslipidemia, mainly familial hypercholesterolemia. As such, they do not provide any type of direct insight of how statins would affect children whose dyslipidemia is caused by poor diet choices, low level of physical activity, metabolic disturbance, or some other possible factor (for instance, hypothyroidism), alone or combined - which amounts for the majority of children and adolescents cases.

Why is the importance of diet and lifestyle downgraded and ignored, despite being the major cause of dislypidemia in those without an inherent factor - a group that makes the overwhelming majority of affected children and adolescents?

With the "obesity epidemic" mainly being blamed for the cholesterol problem, why there is not a single word on the importance of reviving physical activity in schools, and better organizing at the community level?

Why are statins pharmaceutical agent of choice, when it is well known that there are effective, safer, less expensive natural alternatives? In adults, statins are also effective in reducing LDL cholesterol and triglycerides but this, according to studies (with most large clinical trials funded by the makers, and meta studies mainly based on that data, so take those results with a grain of salt), translates into benefit of reduction incidence of heart attacks and cardiovascular system related mortality

only in secondary prevention, specifically, in male patients
who already had heart attack.

Is it by accident that this move comes at the time when the patents on original statin brands are either expiring, or about to expire soon (are new "children statin" brands in the making?)

Finally, can any organization, or individual, with significant financial ties to pharmaceutical industry be

trusted to put public interest before their own,
and financial interest of pharmaceutical companies?

On AAP's web site, statin makers AstraZeneca, Sanofi-Aventis and Merck are in the Presidents Circle of donors (and so is, ironically, McDonald, one of the big contributors to the epidemic of children obesity).

Moreover, at least two AAP Committee members, Dr. Daniels and Dr. Bhatia have direct financial and professional ties with pharmaceutical industry (consultant, speaker, and/or company advisory board member, research grants, etc.).

Does it come as a surprise that the American Hearth Association, who preceded the AAP in calling for more aggressive use of statins in children, lists Merck (also other pharmaceutical companies) as a 2007 donor in the $1-$5 million range, and that its president, Dr. Jones, has worked as company's consultant?

We can only guess about specific longer-term effects of statins on children, but side-effects that are well evidenced with adults give pretty good clues. We are talking about possible damage inflicted to the liver, muscle and brain function. And, in large numbers, it is not a question of "if", rather when and who. This is why the Committee proposes periodic monitoring of liver transaminase and creatine kinase enzymes (for indications of liver, or muscle/brain dysfunction, respectively).

Is this a chance really worth of taking? Dr. Bhatia states that "the risk is less than the benefit", but the fact is,

there is not a single study, small or large, indicating that statin use in children will reduce rate of heart attack and/or related mortality later in life.

At present, all that we have for certain is the risk; actual benefit is a complete unknown.

Just look at how the Committee concludes that statins are safe for children - for unspecified treatment length - based on the cited children statin studies:

"Although these studies have generally been short-term, they have shown statins to be safe and effective in lowering cholesterol concentrations.".

Wishful thinking, or snake-oil sales pitch? That is probably as good a way as any of talking to an idiot. One adult study (Muldoon) has found that after only 6 months of statin therapy

100% of the participants had
measurable decline in cognition.

Oh, just to mention, statins are also on the very top among approved drugs with respect to cancer-causing capability in laboratory animals. Statins rodent carcinogenicity is so high, that many wonder how such drugs could have been approved for the general public in the first place.

Well, turns out, it can be quite simple when it comes to the FDA. For lovastatin, which is carcinogenic in rodents at concentrations 3-4 times higher than human concentration at the maximum recommended dose, it took a single recorded FDA advisory committee meeting, back in 1987, when Merck's representative presented their unchallenged, downplayed version of the importance of that fact. The board bought it.

And with gemfibrozil (not a statin, but on the AAP Committee's list of possible pharmacological agents for cholesterol treatment in children/adolescents), which is carcinogenic in rodent at concentrations as low as 1.3 times that in human patients, the FDA bosses, back in 1988, simply

overruled the "no approval" recommendation of their
advisory committee

By the way, the AAP also reversed its stand against reduced-fat milk for children up to the age of 2 years. For a long time, AAP was arguing that saturated fats are needed for normal brain development. Now, it says that babies are getting more than enough saturated fats from other sources, hence reduced-fat milk is O.K.

Cited basis for this turnaround is the ongoing Finnish Turku study, in which children older than 12 months had total fat intake of nearly 30% of calories, 1/3 of which were saturated fats. The Committee states that, as a part of the regime, 1.5% reduced-fat cow milk was used, and "no adverse effects of the intervention diet were observed on growth or neurologic outcomes".

Is it possible that the Committee is so sloppy and incompetent? In the study, all attempts have being made to keep near even proportions between saturated (S), polyunsaturated (P) and monounsaturated (M) fats, within the 30% fat calories level. Since the skim (cow) milk S:P:M proportion, in percentage points, is approximately 67:3:30, it was recommended to the study participants to replace the missing fat with vegetable oil - usually low–erucic-acid rapeseed oil, with the S:P:M proportion of 7:33:60. Assuming approximately 50% greater intake of these surrogate lipids vs. milk lipids, the total lipid proportion would come to about 30:22:48.

Obviously, it does matter what types of fat, and in which proportion babies consume - monounsaturated and polyunsaturated fats are

not less important than saturated fats, and likely more so.

In the study, they had on average an excess of monounsaturated, while insufficient polyunsaturated oil intake, if measured against the desired near-even S:P:M proportion. However, if measured against mother milk's average lipid proportion of about 50:15:35, saturated fats were also deficient.

Nevertheless, there was no adverse effect on growth observed in the study, up to the age of 3 years. However, if the complementary fat intake is random, as it is in the real life, the proportion can be quite different, significantly farther away from what can be reasonably deemed to be desirable one, and the consequences can be serious. Skim milk already has the excess of saturated fats, while lacking polyunsaturated, when compared to human milk; to state that small children will be O.K. if fed skim milk since they will "get saturated fats from other sources" is

intolerable disregard, or unawareness of these obvious facts.

No responsible individual, or organization can allow such conduct, especially not when sending out recommendation that can have significant impact on dietary choices and, consequently, health of many small children.

As for no negative "neurological outcome" in the study, there is no word about it in its description by study authors; could be, the AAP Committee considers it to be the "head circumference gain" monitored, among other physical growth categories, in the study?

According to its paper, the Committee doesn't have the insight into the specifics of typical fat sources other than milk in the diet of 6m old, and older children in the U.S. To recommend skim-milk (1.5%) as safe and appropriate without this knowledge is no better than a shot in the dark. Cow milk has much lower level of essential fatty acids than breast milk;

nothing guarantees that babies are getting needed EFA's -

or, for that matter, monounsaturated or saturated fats - from "other sources". Aside different lipid structure, skim-milk has about 1/3 less carbohydrates, over three times more protein and some eight time less cholesterol than breast milk8.

How these disproportions, as well as other differences in cow vs. breast milk, affect cholesterol metabolism - and general health - in this earliest stage of child development?

So, let's sum it all up. Childhood obesity is a major risk factor for developing cardiovascular disease later in life, and it stems from poor food choices and physical inactivity. Any solution to the obesity problem has to address its causes. Lowering/balancing cholesterol would be the beneficial side-effect of this approach. Cholesterol-lowering medications should be used only after everything else - diet and lifestyle change, safe natural treatments - fails, or in emergency cases (which is how the medications should be used in principle).

If it would look beyond its partnership with pharmaceutical companies, the American Academy of Pediatricians could actually help alleviate children cholesterol problem by asking the right questions, giving the right answers, and promoting the right causes.