Statin Studies the Raw Data

The discussion of the Linus Pauling vitamin C/lysine invention for chronic scurvy

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ofonorow
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Statin Studies the Raw Data

Post Number:#1  Post by ofonorow » Sun Mar 01, 2009 8:41 am

godsilove wrote:So you have seen raw data from some statin studies? I'm just curious - what does this "raw data" consist of?

It should be noted that ten-year studies of statin use have shown a benefit; many trials are stopped based on predetermined criteria - if there is evidence of clear harm or benefit in the treatment arm, the study is stopped after this preplanned interim analysis since it is not considered ethical to subject the treatment group to further harm or to deny the control group of a treatment that could benefit them.

The following web site is a little hard to follow, I admit, but it is important and constitutes a great deal of work - analyzing the raw data for statin studies. I have relied heavily on the author of the health-heart.org (Canadian web site) Eddie Vos. Mr Vos not only supplied us with the NEJM advertisements (previous post), he has analyzed all the statin studies, and among other useful information, he was the first to point out that the Oxford "Heart Protection Study" had not and has not released its data. The following page summarizes his findings.
http://www.health-heart.org/cholesterol.pdf
Owen R. Fonorow
HeartCURE.Info
American Scientist's Invention Could Prevent 350,000 Heart Bypass Operations a year

godsilove

Re: Statin Studies the Raw Data

Post Number:#2  Post by godsilove » Mon Mar 02, 2009 6:22 pm

ofonorow wrote:
godsilove wrote:So you have seen raw data from some statin studies? I'm just curious - what does this "raw data" consist of?

It should be noted that ten-year studies of statin use have shown a benefit; many trials are stopped based on predetermined criteria - if there is evidence of clear harm or benefit in the treatment arm, the study is stopped after this preplanned interim analysis since it is not considered ethical to subject the treatment group to further harm or to deny the control group of a treatment that could benefit them.

The following web site is a little hard to follow, I admit, but it is important and constitutes a great deal of work - analyzing the raw data for statin studies. I have relied heavily on the author of the health-heart.org (Canadian web site) Eddie Vos. Mr Vos not only supplied us with the NEJM advertisements (previous post), he has analyzed all the statin studies, and among other useful information, he was the first to point out that the Oxford "Heart Protection Study" had not and has not released its data. The following page summarizes his findings.
http://www.health-heart.org/cholesterol.pdf


You're right - it is a little hard to follow. There seems to be a lot of information cherry-picked from various sources, so it's quite a task to trudge through. I'm sure he makes some valid points about statins, but I'm cautious whenever someone does a "hit job" on something in this manner.

One thing that strikes me is the misleading way in which he cites nonsignificant differences between the treatment group and control group e.g. 3 more deaths in the treatment group than the control group, when the p values are nowhere near significance.

With regards to the "raw data", it seems his beef with the Oxford HPS is that they didn't release mortality curves (rather than raw data) for women in their trial.

ofonorow
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Re: Statin Studies the Raw Data

Post Number:#3  Post by ofonorow » Wed Mar 04, 2009 9:00 am

I haven't read the HPS paper for some time, but my "beef" from memory was that they had four groups, placebo only, statin only, vitamin only, statin-vitamin, and that a large part of the paper was discussion of "statins versus placebo", without clarifying whether this discussion was of the two groups on statins, or limited to the group on statins-only versus placebo.

If you have a link that this comparison, which led to claims allowed by the FDA regarding the prevention of heart disease, was of the statin-only group and placebo, I would appreciate it.
Owen R. Fonorow
HeartCURE.Info
American Scientist's Invention Could Prevent 350,000 Heart Bypass Operations a year

godsilove

Re: Statin Studies the Raw Data

Post Number:#4  Post by godsilove » Wed Mar 04, 2009 2:02 pm

ofonorow wrote:I haven't read the HPS paper for some time, but my "beef" from memory was that they had four groups, placebo only, statin only, vitamin only, statin-vitamin, and that a large part of the paper was discussion of "statins versus placebo", without clarifying whether this discussion was of the two groups on statins, or limited to the group on statins-only versus placebo.


Since it was a factorial design, any statements talking about statins vs. placebo would have included both groups (those taking vitamins and those not taking them).

If you have a link that this comparison, which led to claims allowed by the FDA regarding the prevention of heart disease, was of the statin-only group and placebo, I would appreciate it.


http://www.ctsu.ox.ac.uk/~hps/slidesfin ... /frame.htm

The relevant information with respect to your question about the benefit of vitamins is on slide 42. Simvastatin led to a 24% reduction in major vascular events in both patients who were receiving vitamins and those who were not.


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