Posted by Colin Rose on March 31, 2007
Intravascular ultrasound is a sensitive method for measuring the size of atherosclerotic plaques in the arterial wall. When testing a drug to see if it will have an effect on plaque volume, this technique is the gold standard.
ILLUSTRATE set out to show that adding torcetrapib, a drug that increases HDL, the “good” cholesterol, to Lipitor, that decreases, LDL, “bad” cholesterol would reverse plaque or at least stop its progression.
Here are the baseline characteristics of the subjects. Note that the average BMI was 30. Overweight is defined as a BMI over 25 and obesity over 30. So, all of them were overweight or obese. 20% were diabetic, most likely Type 2, related to obesity, and 75% were hypertensive. 18% smoked. All of those factors are risk factors for atherosclerosis related to lifestyle. Therefore, unless one intends to first completely eliminate these lifestyle risk factors, it was unethical to even conceive such a trial particularly since it is proven that atherosclerosis can be reversed by lifestyle change alone. The trialists probably rationalized that atherosclerosis, like pneumonia, must be treatable by drugs and Pfizer, who funded the trial, has a slogan, “Working for a Healthier World” it is ethical to do such a trial. Besides the money helps to keep one’s IVUS lab going and one is promoting the notion that the technique will some day lead to the cure for atherosclerosis.
The typical ILLUSTRATE patient
Here are the reported results. What was not mentioned in the abstract above is that plaque actually INCREASED in both the the Lipitor only group and the Lipitor plus torcetrapib group. Now, before actually starting the trial, the subjects were given enough Lipitor to adhere to the guidelines written by doctors paid by Pfizer and other statin dealers. So, following the guidelines for blood cholesterol lowering with Lipitor does not slow progression of plaque. The obsession with blood cholesterol is completely futile.
The conclusions of the authors shows their blinkered view of atherosclerosis. While Dr. Nissen donates his personal drug money to charity (how much is paid to run his IVUS lab, if any, is not stated), all the other authors have major financial connections to drug dealers. Revkin, Shear and Duggan are employees of Pfizer and own stock. Naturally this group would ignore non-drug methods for reversing atherosclerosis
We have known how to reverse the atherosclerotic process very easily since the revolutionary work of Dean Ornish the final report of which was published in 1998. No drugs are necessary, only a change in lifestyle which was not seriously attempted in this study. There is even no reference to Ornish’s work in the paper, a major oversight of the reviewers. So, why don’t the IVUS groups do a study of plaque volume after significant lifestyle change? Who would fund it? If Pfizer is really “Working for a Healthier World” and not just making a profit, Pfizer should be funding an IVUS lifestyle trial.
Posted in atherosclerosis, cholesterol, coronary artery disease, professionalism, statins | Tagged: atheroma volume, atherosclerosis, atorvastatin, CAD, cholesterol, cigarette, dean ornish, E. Murat Tuzcu, HDL, intravascular ultrasound, Jean-Claude Tardif, LDL, lifestyle, lifestyle diseases, lipids, Lipitor, obesity, Pfizer, plaque, Stephen Nicholls, tobacco, torcetrapib | Leave a Comment »
Posted by Colin Rose on March 26, 2007
For 30 years since the development of a balloon-tipped catheter to dilate coronary arteries, now known as PCI (percutaneous coronary intervention), it has been revealed truth from “experts”, most of whom paid their mortgages by doing PCI’s, that all significant coronary narrowings should be dilated to prevent a heart attack. In spite of overwhelming evidence that heart attacks are caused by rupture or early, unstable, non-obstructive plaques, most cardiologists still believe that heart attacks (sudden complete blockage of a coronary artery) occur at the site of the largest plaques. Patients are shown angiograms and told they have a “widow maker” or are “sitting on a time bomb”. I refused to do angioplasties until there was some proof for this superficial but very lucrative theory. Again, it turns out I was right. Even in patients with major narrowings and symptoms, PCI does not prolong life or prevent heart attacks. Chronic symptoms were slightly more improved in the PCI group but most medically-treated patients had symptom improvement just with pills.
The COURAGE type subject
All cardiologists give lip service to the necessity for lifestyle change as the ultimate cure for atherosclerosis, but in this study there was no attempt at lifestyle change. Most patients were overweight or obese, gained weight over the five year study. 20% smoked and did not stop. While the authors claim to using “optimal” medical therapy, they did not even try significantly changing lifestyle, the obvious cause of the patients’ atherosclerosis. No doubt even better results that could have been obtained with just lifestyle change, without pills or PCI, as Dean Ornish showed many years ago.
If you want an explanation for why, except for a feeble attempt to raise HDL by exercise, NO attempt was made to change lifestyle meaningfully before using statins or PCI you need look no further than the source of funding and the disclosure statements of the authors. Those who recieve substantial income from drug dealers are not keen on proving that cost-free lifestyle change alone will do the same or better than expensive drugs.
Now, why has it taken 30 years to finally prove the futility of PCI in patients with stable or stabilized coronary disease? Unlike new drugs, there are no rules and no government agency mandating that surgical procedures have to undergo clinical trials before being done on the general population. Any surgeon can develop some operation that seems superfically rational and he and his colleagues can do many thousands of those operations, costing millions or billions of dollars and risking many lives until someone gets around to actually testing it to see if the outcome is really as advertised.
Doctors profess to want to practice “evidence-based medicine” but when change negatively affects bank accounts habits change very slowly if at all. Angioplasty in stable CAD can always be rationalized by the classic, “my patient is different than those in the controlled trial”. We can predict that angioplasties in patients with stable CAD will not decline significantly until most of those trained in the procedure have retired. The system could save a lot of money by giving each of them $one million and a house in Mexico to retire to.
Posted in angioplasty, atherosclerosis, coronary artery disease, diet, drugs, professionalism, statins | Tagged: Abbot Laboratories, Amgen, angina, angiogram, angioplasty, AstraZeneca, atherosclerosis, Bayer, Boehringer Ingelheim, Bristol-Myers, Bristol-Myers Squibb, CAD, cardiology, cigarette, coronary artery, COURAGE, diet, GlaxoSmithKline, heart attack, King Pharmaceuticals, Lilly, Merck, mortality, obesity, PCI, Pfizer, plaque, sanofi-aventis, tobacco | 1 Comment »