Re: "Statins caused my kidney failure"

"Herman Rubin" <[email hidden]> wrote in message
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In article <[email hidden]>,

Zee said:

"Bill" <[email hidden]> wrote in message

news:<[email hidden]>...

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So Bill, I read the following to say:

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1.The goal of statin therapy is to reduce the odds of dying of a heart
attack or stroke, not just lower cholesterol numbers.

Yes. The claim of the studies, not by the drug companies
to get the statins approved, is that lowering the cholesterol
numbers will do this. There is a fair amount of evidence
that lowering quite high cholesterol levels does this, at
least on the average.

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2. Despite millions spent on clinical trials, researchers could not
prove lowering cholesterol had any effect on life expectancy.

The clinical trials CANNOT be long enough for this.

Yes, they accept the proxy of lower cholesterol as being predictive of
what they want.

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3. Pharmas need only prove to FDA the drug lowers cholesterol.

This is not so; they also need to prove to their satisfaction
that the drug does not have too nasty side effects too often
during the required tests.

But as the active part, they only do need to show it lowers cholesterol
and that this is always supposed to be good.

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Once the drug is approved by the FDA for some purposes, it
can be used for any other, with few restrictions. So if
statins reduce deaths over the period of study for approval
in reducing cholesterol from 400 to 200, and does not have
too high an incidence of side effects over the same period,
they get approved. Once one statin is approved, another one
has to be compared to the ones approved.

But reducing cholesterol from 400 to 200, or reducing LDL
from 300 to 130, is not the same as reducing LDL from
130 to 100 or 70 or even lower. And it is these reductions
for which the recent claims have been made.

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Someone needs to take a big broom to the FDA. They don't seem to be
doing what you are paying them to do. Not that it's any different for
the Aussie, Kiwi or Canuck regulatory bodies.

What they are SUPPOSED to do is impossible. The mandate is
to have "safe, effective" drugs. But these do not exist.
However, essentially only they get the "full" information (an
impossibility) on safety and effectiveness, and they make the
decisions.

The result of this is that errors of both kinds are made.
With the pressures they have, they are more likely to block
something which has even a few clearly dangerous side effects
recognizable as being produced by the drug, such as the
immediate muscle problems with statins. But when the side
effects are small increases in rates of dying from other
causes, these are difficult to ascertain; an increase of
10% in dying from something would not be statistically
significant (this is not the right criterion, but is an
indication) if one observes an increase from 100 to 110.

And the issue of self-selection is very great here too. There are
zillions of people who cannot afford statins every month, and are not
interested in clinical studies and live outside the area where such studies
are done. The UK populations are probably less self-selected due to the
NHS, and those studies showd only a very slight mortality decrease. The USA
doctors are on a roll now and you will have to fight your doctor off with a
stick if you don't want to be on statins immediately.