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BLOG:
December 2009
Rosuvastatin
indication broadened, or:
JUPITER
statin study, phase 2
It shouldn't come as a surprise to
see this news: on December 15th, FDA's advisory committee voted
overwhelmingly (12 to 4) in favor of broadening indication for
rosuvastatin - AstraZeneca's anti-cholesterol drug better known as
Crestor - to include those at low to moderate risk for
cardiovascular disease, whether their LDL
cholesterol level is
elevated, or not.
In other words, if the FDA accepts the indication -
which is very likely - it gives to doctors green light to recommend
Crestor not only to those with elevated "bad" (LDL) cholesterol, but
also to middle-aged and older persons with LDL cholesterol in the
normal range (specifically, the advisory panel talks about men over
50y and women over 60y, but it is all but certain that it will be
recommended and prescribed well outside these age groups).
The indication for broadening segment of the population to which
Crestor will be recommended is based mainly on the results of the
JUPITER statin study. While even those panel members that voted in
favor of broadening Crestor's indications express concern about the
risks associated with its use, they readily point out that drug's
benefits, shown in the study, outweigh the risks.
As for the concern, it is hard to see it as genuine. Despite
pointing out the need to set very clear guidelines specifying to
whom is Crestor supposed to be recommended and prescribed, and to
whom not, panel members have not included such guidelines, not even
in the most rudimentary form.
And what about the evidence of Crestor's benefits, supplied by
the JUPITER study? A HeathKnot
article following the conclusion - or should we say, disruption
- of this study goes through it in more details, but here are the
highlights:
● against all professional
standards, study was terminated after only 1.9 years averaged per
participant, despite being designed for 5 years, and despite (or
because of?) troubling side-effect trends clearly developing
● being early terminated, the
study not only failed to prove longer-term benefits, it also failed
to prove longer-term safety of Crestor, both a must for what is
generally intended to be a long-term preventive treatment
● deaths from all causes were
significantly higher in the treatment group (125 vs. 90 in placebo
group), with the plots for total mortality for two groups actually
merging closer together at the time the study was terminated
● competing interests are
glaringly evident: the lead author, Dr. Paul Ridker, who was also
the chairman of the steering committee,
is a co-inventor of the hs-CRP (high-sensitivity CRP) test,
licensed to AstraZeneca - a key test needed for recommending
preventive Crestor treatment; so AstraZeneca benefits doubly, from
selling the drug and the test
● oh, by the way, AstraZeneca
sponsored the study
In short, it is plainly evident that the study was heavily
manipulated for
self-serving purposes of the drug manufacturer,
disregarding the very basic professional
and ethical standards. The fact that it was greeted as
"ground-breaking" development by the official medicine only
illustrates enormous controlling power of pharmaceutical companies,
as well as pitiful servant (and occasional partner) role to which
the organized medicine has been reduced.
As if it isn't bad enough, that is not where the reach of mighty
pharmaceutical companies ends. The next and final logical step is
the government's own agency set up to protect your and mine health
and safety, the FDA. For all that we can see, it is joining the
parade of celebrating the emperor's (AstraZeneca's) "new cloths".
Again, it doesn't come as much of a surprise. It is merely the
next phase in the business plan designed to let AstraZeneca cash in
on its products. Everything else is, obviously, less important.
Not the FDA panel members that voted for widening the market for
rosuvastatin are unaware of all this. But they
opted for swimming with
the flow.
That is probably why their statements sound either as an excuse,
or nonsense, or plain politically twisted jargon. "The biggest
adverse effect is not being treated," says panel member Dr. Thomas
Bersot, which should explain why he voted "yes" despite the very
troubling factual evidence against his vote.
The point is that "not being treated" is not, and never was, the
only alternative. There are proven, safer alternative treatments for
both, elevated "bad"
cholesterol, and
C-reactive protein (i.e. internal inflammation). The only
problem is: they can't be patented, and bring in big profits. As for
the medicine, it can't serve God and Mammon; it will take a lot of
integrity, work and determination to bring it back to what it should
be: profession whose only goal is protecting people's health.
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