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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.