Another Stupid Commercially Overhyped Trial – Before Prescribing Look Again By Dr. Malcolm Ken

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Friday, March 05, 2010 7:27 am Email this article
I have been aware of the ASCOT study [Anglo Scandinavian Cardiac Outcomes Trial] for some time. In fact, it seems to have been spewing out results for the past 500 years or so. Maybe not quite that long but, boy, it sometimes seems like it.

(This article was written by Malcolm Kendrick, MD, author of the wonderful, eye-opening, paradigm-shifting book The Great Cholesterol Con: The Truth About What Really Causes Heart Disease and How to Avoid It .)

First we had ASCOT–LLA (Anglo Scandinavian Cardiac Outcomes Trial – Lipid Lowering Arm). This was stopped early because of the fantastic benefits of giving people a statin. So great were the benefits that it was considered unethical for the trial to continue. The difference in overall mortality between the two arms of the study was a majestic, gigantic … zero.

But don’t be silly, overall mortality wasn’t what the study was designed to show. It had been set up just to look at cardiovascular mortality. And the benefits here were…? Listen up and stop asking difficult questions.

ASCOT–BPLA Claims Newer Blood Pressure Drugs Better

ASCOT–BPLA Claims Newer Blood Pressure Drugs Better Than Older Drugs

More recently, we had the ASCOT–BPLA. In case you didn’t know, BPLA stands for Blood Pressure Lowering Arm. This study claims to have proved that the newer, and naturally far more expensive, blood-pressure-lowering tablets are better than such older, cheaper ones as beta-blockers and diuretics.

Of course, this study, too, was stopped early due to fantastic benefits — this time in overall mortality? How they managed to work this out is an interesting question as the study was never designed — or powered — to measure this end-point. But these heroic researchers managed it, and they even gave the reduction in risk a precise statistical probability. (You may not find that funny, but I do. However, a joke explained is a joke ruined, I always say.)

 

Study’s endpoints

ASCOT study did NOT look at Total Mortality

Thus, once again, another part of the ASCOT trial has been hailed as a glittering triumph. A triumph, in my opinion, of mangled scientific methodology because the end-points that the study set out to measure were non-fatal myocardial infarction (MI) [heart attack] and fatal coronary heart disease (CHD). Not overall mortality, or stroke, or combined cardiovascular end-points — which is what all the noise has been about.

You may ask why they chose these two rather strange sounding end-points. Frankly, God knows, I have given up trying to work it out. In fact, one of the reasons I have not commented on this study before is that I have found it almost impossible to understand why they did it, or what they expected it to show. This is despite reading the protocol about 50 times. Maybe you could read it and let me know. There is an entire mind-boggling ASCOT website at the following address. http://www.ascotstudy.org/healthcare_professionals/index.htm

Anyway, back to my main point. In ASCO–BPLA, the primary end-points were non-fatal MI and fatal CHD, and the study showed no benefit on either. Somehow despite this, it has been hailed as an unrivalled success — a study that will change the face of hypertension treatment or some other such grandiose claim.

So you see, If you set your mind to it, you can get your study to prove anything you like. To hell with the facts. Decide what answer you want, then go get it. Let not science stand in your way. “Researchers, these days, do not seek; they find,” in the words of Pablo Picasso.

The reality of the ASCOT–BPLA study is that it has laid waste to scientific methodology. You may care to read some of the criticism of the study on the British Medical Journal’s rapid response pages. 

 

Opinion Leaders Linked to the Drug Industry

New drugs claimed to be better because they are more profitable for the drug companies

But, in the end, you can criticize all you like. You will never stand in the way of the new drugs. Resistance is useless. For it has been decreed by the hypertension opinion leaders, whose future earnings and prestige are closely linked to their buddies in the pharmaceutical industry, that newer (costly, still-in-patent) blood-pressure-lowering drugs are to be used. Several major trials, such as ALLHAT, (Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial) proved this was not true. So they were remorselessly attacked, their methodology shredded, and then ignored.

Now we have a trial that showed almost nothing — with a methodology so twisted you could use the trial protocol to pull corks out of wine bottles — and it is hailed as marking a sea change in the treatment of high blood pressure.

 

Negative Studies are Buried

Protocols changed mid-study

Nothing, it seems, can stop the drive toward more expensive blood-pressure-lowering drugs. Negative trials are pulverized and left for dead. Studies like ASCOT–BPLA have their protocols altered mid-stream (I kid you not) and are then subject to wild post-hoc speculation. Somehow, I am reminded of a film starring Arnold Schwarzenegger.

Listen! And understand. That pharmaceutical industry is out there! It can’t be bargained with. It can’t be reasoned with. It doesn’t feel pity, or remorse, or fear, and it absolutely will not stop! Ever! Until you are dead!

Keep taking the tablets.

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Article Previous Published on THINCS.org

This article was previously published on THINCS.org

This article was previously published on THINCS.org (The International Network of Cholesterol Skeptics).

I republished the article here with Dr. Kendrick’s permission.

 

Malcolm Kendrick’s Contact Info

Malcolm Kendrick’s Email Address—.(JavaScript must be enabled to view this email address)

Dr. Malcolm Kendrick can be reached at .(JavaScript must be enabled to view this email address).

Malcolm Kendrick, MD is the author of the wonderful, eye-opening, paradigm-shifting book book The Great Cholesterol Con: The Truth About What Really Causes Heart Disease and How to Avoid It .)

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Articles on the same subject can be found here:

• Blood Pressure Drugs

• Doctor - Malcolm Kendrick, MD author of "The Great Cholesterol Con"