Re: A Systematic Review and Meta-Analysis of Statin Therapy in Children With Familial Hypercholesterolemia

On Jun 25, 6:32 pm, David Rind <d...@xxxxxxxxxxxxxxxxxxxxx> wrote:

Actually, I strongly doubt that any drug company is very interested in
studying statins in children with FH so as to boost their profits. Some
may have decided to do so for one reason or another, but it's hard to
see how there is much upside profit benefit (not that many potential
patients), compared to the downside risk that the drugs will turn out to
be harmful in children.

So even if you want to take the position that all drug-company sponsored
research is tainted, if I were a profit-maximizing drug company I'd
rather not study this at all or I'd try to tip the results to show no
benefit in children. (I'm not such a conspiracy theorist as to think
they would actually do such a thing.)


I did not mean to say that all drug company sponsored research is
tainted. Sorry about that.

I do not think the market is limited to kids with FH. There are also
kids who are considered at risk of early cardiovascular disease due to
obesity, metabolic syndrome, diabetes, HIV infection, kidney disease,
lipid disorders other than FH, and so forth. The guidelines that have
come out are not limited to kids with FH. See McCrindle et al., Drug
Therapy of High-Risk Lipid Abnormalities in Children and
Adolescents . . . Circulation 2007;115:1948-1967. They may do the
research first in kids with FH but the potential market is bigger. I
was just trying to be realistic. Drug companies are in business to
make money, like all other companies.

I am not necessarily against using statins in kids under some
circumstances. I just think that everyone should be upfront that the
proof that you are reducing cardiovascular events by doing so is not
there yet. It may be reasonable to assume that you are, but it is not
proven. You yourself have frequently expressed skepticism about
relying on surrogate endpoints. As I noted, the authors of this meta-
analysis do say that: "Although the relation between elevated LDL-C
and CVD and the effect of lipid lowering treatment on CVD is evident,
the effect of lipid lowering treatment in childhood on CVD later in
life is not as clear."

Studies of lipid-lowering medications in kids with FH are not new.
They did them with bile acid sequestrants first, of course. They have
been doing them with statins for some years now. One of the trials
included in this meta-analysis was done in 1996. The new
recommendations are to use statins as first-line treatment.

I am not so sure that the drug companies are that worried about
adverse events, given the favorable results of the studies that have
already taken place.

Marilyn


.

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