Fifteen years after the demonstration in controlled studies of angiographic regression (lumen increase) of atherosclerotic plaque and reduction of events by cost-free lifestyle change alone there was much excitement over the demonstration of small changes in plaque volume without lumen increase using intravascular ultrasound in an uncontrolled trial of high-dose statins, the ASTEROID trial. Read the study. It’s free on the JAMA site. You will note that there is absolutely no reference to the lifestyle trials. Who reviewed this paper? Why would anyone recommend publishing an uncontrolled drug trial with no attempt at lifestyle change, with not even a mention of previous, much more impressive controlled trials, is a mystery. All of the ASTEROID patients were overweight or obese, 96% had hypertension and 13% were diabetic. Obviously these patients had major lifestyle issues to address before even considering drugs. Given the known profound effect of lifestyle change on plaque, we can say that the lack of intensive lifestyle change in the treatment of the ASTEROID patients with documented atherosclerosis is unethical. Is it any wonder that the pandemic of obesity and Type 2 diabetes is unabated? Why would any patient care about controlling his or her appetite when the doctors are fixated on “cholesterol?”
And to make matters worse JAMA allowed immediate free access to the article on its web site. In contrast the final report of the Ornish trial published in the same journal in 1998 was only available recently under a new policy allowing free access to full text in JAMA six months after publication. Does this imbalance not raise some suspicions? Could Astra-Zeneca, the maker of rosuvastatin, be paying JAMA for “reprints” to promote its drug? How else could a publsher justify giving free access to an article? We invite submission of documentation from the AMA on their financial connection to AZ.
Here are some comments on ASTEROID from “experts” that appeared in the March 30, 2006 issue of the National Review of Medicine with our reflections on them:
Dr. Steven Nissen, the lead author of ASTEROID is quoted as saying that he had never seen regression of atherosclerotic plaques in his entire career. Which planet has he been living on? All he had to do was talk to Dean Ornish many years ago. He would have shown Dr. Nissen angiographic regression of coronary plaque. Because of compensatory dilation it is a lot harder to show angiographic regression than ultrasound regression. Some good has come from the ASTEROID trial. Dr. Nissen has seen the light and now has all payments from drug companies donated directly to charity, just like we have always done.
Dr. Jacques Genest, Novartis Chair and head of cardiology at the McGill University Health Centre, is quoted as saying “Wow, they really reduced the size. That’s impressive.” Actually, the lumen of the arteries did not increase even after two years. So, Dr. Genest should be even more impressed with the Ornish trial that showed angiograhic regression (larger lumen size) in one year, but he doesn’t even mention it. And he is one of the “experts” in the “Working Group” making rules for Canadian doctors to follow. But cure of a lifestyle disease with lifestyle change only and no drugs is not profitable to anyone except the patient. Is that not a definition of professionalism?