A U.S. Food and Drug Administration ( FDA ) advisory panel has overwhelmingly recommended that rosuvastatin (Crestor®) be approved for use in patients with no history of heart disease as long as the patients have an elevated level of the inflammatory marker, C-reactive protein ( CRP ) ( December 12, 2009 ).
I doubt that many of you remember this but back in 2001 I warned it was going to happen. My exact words then were, "They are going to slip cholesterol out and inflammation in and never miss a statin sale."
Ora Shovman published in 2001 his surprising work, "The anti-inflammatory and immunomodulatory effects of statin drugs."
In this remarkable challenge to the accepted understanding of the mechanism of action of statins, Doctor Shovman dropped this bomb. For 40 years doctors had been told cholesterol was the cause of atherosclerosis and cholesterol reduction was its cure!
Statins were designed specifically to inhibit the synthesis of cholesterol. Naturally when at the beginning of their use cholesterol levels went down, we assumed any benefit observed to be due to cholesterol reduction when all the time it was apparently inflammation reduction.
Atherosclerosis many now believe, is really an inflammatory response. Multiple triggers to this inflammatory process are involved including transfats, smoking, hidden infections and homocysteine elevation but not cholesterol.
In this topsy-turvy world of shifting truths and relationships, white is black and black is white. Meanwhile drug makers are smiling for now they can sell us CRP kits in addition to statins without even bothering to admit a serious mistake has been made. Not only are our children afraid of cholesterol but doctors are rightfully miffed over being the last to know the truth.
When Ora Shovman's paper first came out in a relatively obscure medical journal, there was no significant medical response to this dramatic news. So successful had been the prior 20 years of cholesterol causation brainwashing, combined with the general mood of delight among doctors to finally have an effective club for cholesterol control, doctors asked no picky questions and really did not want to hear anything bad or discomforting about their pet statins. Everything went ahead as if nothing had happened.
The next thing we knew, several years later, was news that CRP made a far better marker of underlying atherosclerotic disease than cholesterol and a statin would give good results even if a person's cholesterol was "normal".
Obviously an even larger potential market was looming, for is there anyone in the world entirely free from arterial damage? Autopsies of U.S. soldiers killed during the Korean and Vietnam wars showed 20 year olds with dramatic arterial changes, some with up to 40% blockage. Drug company marketers could foresee a market for statins far greater than the market identified by cholesterol elevation.
Now the FDA has given this endorsement to proceed - take an expensive drug for the rest of your life. The equivalent of a daily aspirin except for the cost and side effect potential that has disabled tens of thousands in every way possible - intellectual, emotional and neuromuscular and all mediated by CoQ10 inhibition contributing to mitochondrial damage.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor