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
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.
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.
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
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
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
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
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).
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
100% of the
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
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
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,
overruled the "no approval" recommendation of their
By the way, the AAP also reversed its stand against
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,
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
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 lowerucic-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
not less important than saturated
fats, and likely more so.
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
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.
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
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
developing cardiovascular disease later in life, and it stems from
poor food choices and physical inactivity. Any solution to the
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