0

votes

Deceptive statin studies ?

Answered on August 19, 2014
Created March 05, 2011 at 12:26 AM

We know that statins have the ability to reduce total cholesterol and some studies have shown that the reduction of cholesterol combined with their positive effect on CRP may reduce the number of cardiac events: http://www.webmd.com/heart-disease/news/20081110/crestor-faq-new-benefits-for-statins?page=2

Nevertheless other studies show that there is no significant effect of statins on total mortality (deaths) http://archinte.ama-assn.org/cgi/content/short/170/12/1024

http://www.spacedoc.net/crestor_omega3_heart_failure

my question is whether those that design the studies for new drugs are (or should be) required under scientific norms, to look for total mortality rather than ONLY mortality from a specific cause, because in the latter case they may well hide the negative effect of a drug on other parts or functions of the body, such as the liver function for statins. Although I am using statins as the example I know, of course my question is general, about the drug testing procedures that are (or should be) used.

21fd060d0796fdb8a4a990441e08eae7

(24543)

on March 05, 2011
at 06:09 AM

Eva-- Out of curiosity, do you know what the law was called and what it said? I'm a newbie working with the NIH on trial reviews, and all CVD drug trials going back as far as I can remember included total mortality data. But then again, I haven't been looking at very old trials.

62ed65f3596aa2f62fa1d58a0c09f8c3

(20807)

on March 05, 2011
at 04:08 AM

They didn't use to have to look at total mortality but a recent law changed that rule. Now they are required to look at total mortality. And they are required to publish studies even if they are not supportive of the drug. The end result has been that recent published research has been less supportive of statins. And then there was that one big study which they mysteriously ended the study early, perhaps due to the fact that the study group was developing diabetes at a statistically significantly higher rate and the rate of mortality in that group had taken a turn for the worse..

Ed71ab1c75c6a9bd217a599db0a3e117

(25482)

on March 05, 2011
at 03:52 AM

The issue that SAD docs are advocating to the US population is the the lower your LDL is the better your chances are of avoiding a cardiac death.......that is their theory that has never been proven even once. Now they are advocating the use of CETP drugs in trials even after the first one was an epic failure. They have just regrouped with big pharma and now are trying to study subgroups instead of realizing that you will die early if you use them at all so who cares if you did not die of heart disease using these drugs. Youre still dead and dead fast mind you.

21fd060d0796fdb8a4a990441e08eae7

(24543)

on March 05, 2011
at 01:36 AM

Late phase drug trials are required to look at total mortality. A valid reseasrch study does not have to isolate variables if it is a randomized controlled trial of sufficient statistical power, as confounders are spread between the groups. You are confusing the necessary nature of cholesterol with the dose-response relationship of any biological product and disease. No one said we don't need cholesterol, not even the SAD doctors. Thus your last paragraph is a strawman.

Ed71ab1c75c6a9bd217a599db0a3e117

(25482)

on March 05, 2011
at 01:22 AM

They are designer drugs being touted by anyone who believes in the lipid hypothesis that goal is to lower LDL but specifically sdLDL without getting rid of carbs which cause the sdLDL in the first place. If you take the drugs you tend to die. Here is hyperlipids post on them in Dec. I think his analysis mirrors mine. http://high-fat-nutrition.blogspot.com/search/label/Anacetrapib%20and%20phytotoxins

Ac1e55cf06c2180f4008ff01953d10dd

(3524)

on March 05, 2011
at 01:13 AM

What is CETP inhibitor, do you have any source or reference on that?

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2 Answers

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Ed71ab1c75c6a9bd217a599db0a3e117

(25482)

on March 05, 2011
at 01:07 AM

Read the great cholesterol con by anthony colpo. Excellent review of all the data on statin trials. None of the trials really showed much help but it was spun quite differently. The real big thing you need to know is from the Framingham Heart Study that spanned 50 yrs. Its data was published in 99. The final data said those with the lowest cholesterol levels died the soonest and usually from cancer and those with the highest levels died later and not from cancer. When I read that in 99 I became an anti statin doc. The new trials with CETP inhibitors just came back with even more alarming results and it had to be stopped by the pharma company because people were dying left and right from CETP inhibition. It still amazes me that cardiologists still think that using CETP inhibition to lower LDL as low as possible is a good way to fight heart disease. It is a phenomenal way to die early. I will pass on that all day long.

Ac1e55cf06c2180f4008ff01953d10dd

(3524)

on March 05, 2011
at 01:13 AM

What is CETP inhibitor, do you have any source or reference on that?

Ed71ab1c75c6a9bd217a599db0a3e117

(25482)

on March 05, 2011
at 03:52 AM

The issue that SAD docs are advocating to the US population is the the lower your LDL is the better your chances are of avoiding a cardiac death.......that is their theory that has never been proven even once. Now they are advocating the use of CETP drugs in trials even after the first one was an epic failure. They have just regrouped with big pharma and now are trying to study subgroups instead of realizing that you will die early if you use them at all so who cares if you did not die of heart disease using these drugs. Youre still dead and dead fast mind you.

Ed71ab1c75c6a9bd217a599db0a3e117

(25482)

on March 05, 2011
at 01:22 AM

They are designer drugs being touted by anyone who believes in the lipid hypothesis that goal is to lower LDL but specifically sdLDL without getting rid of carbs which cause the sdLDL in the first place. If you take the drugs you tend to die. Here is hyperlipids post on them in Dec. I think his analysis mirrors mine. http://high-fat-nutrition.blogspot.com/search/label/Anacetrapib%20and%20phytotoxins

1
F9a0b72f38860d7601afd5a45bb53394

(3618)

on March 05, 2011
at 01:08 AM

Oh, I agree. They should be required to look at total mortality. After all, the goal of reducing heart disease is to reduce early mortality (we're all gonna die eventually, and that is just going to have to be OK). If we are not in fact reducing early mortality by putting patients on statins, the public deserves to know.

I don't think statin benefits have anything to do with reduction of cholesterol. In that WebMD article they assume cholesterol reduction is the reason statins help with heart disease risk. But if they have not looked at cholesterol reduction and inflammation reduction separately, they can't know that the benefit isn't from the inflammation reduction alone. In order to conduct a valid research study into the purported benefits of a substance, you MUST isolate your variables.

Also, that article is going on 3 years old.

If we didn't need cholesterol, every cell in the body wouldn't be making it--it's not a waste product, so that means it's necessary. If someone's that desperate to take a statin, that's on them. I ain't touching statins with a ten-foot pole, myself.

21fd060d0796fdb8a4a990441e08eae7

(24543)

on March 05, 2011
at 06:09 AM

Eva-- Out of curiosity, do you know what the law was called and what it said? I'm a newbie working with the NIH on trial reviews, and all CVD drug trials going back as far as I can remember included total mortality data. But then again, I haven't been looking at very old trials.

62ed65f3596aa2f62fa1d58a0c09f8c3

(20807)

on March 05, 2011
at 04:08 AM

They didn't use to have to look at total mortality but a recent law changed that rule. Now they are required to look at total mortality. And they are required to publish studies even if they are not supportive of the drug. The end result has been that recent published research has been less supportive of statins. And then there was that one big study which they mysteriously ended the study early, perhaps due to the fact that the study group was developing diabetes at a statistically significantly higher rate and the rate of mortality in that group had taken a turn for the worse..

21fd060d0796fdb8a4a990441e08eae7

(24543)

on March 05, 2011
at 01:36 AM

Late phase drug trials are required to look at total mortality. A valid reseasrch study does not have to isolate variables if it is a randomized controlled trial of sufficient statistical power, as confounders are spread between the groups. You are confusing the necessary nature of cholesterol with the dose-response relationship of any biological product and disease. No one said we don't need cholesterol, not even the SAD doctors. Thus your last paragraph is a strawman.

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