I wish I could afford AstraZeneca’s public relations firm. They had the media hook, line and sinker last week with the release of its Crestor study results. Even the Wall Street Journal gave AstraZeneca top billing on page B1 with what appeared to be a replay of AstraZeneca’s press release. “Crestor sharply lowered risk of heart attacks among apparently healthy patients in a major study that challenges long-standing heart-disease prevention strategies," the WSJ reported in its first paragraph. It wasn’t until the end of the article (on page B4) that the WSJ revealed that AstraZenece was the sponsor of the study and that Crestor users demonstrated a 25% increase in the incidence of diabetes.
Yes, much has been reported on the Crestor group experiencing 54% fewer heart attacks than the placebo subjects, as well as 48% fewer strokes, and 20% fewer deaths. But what do all these percentages really mean? There were 83 cardiac events of all types in the Crestor group, an 0.9% actual risk, compared with 157, or 1.8%, in the placebo group. The study actually showed that physicians would have to treat 180 people for two years to prevent one death.
Is this big news? Will this study “reshape cholesterol-treatment guidelines used for more than a decade to fight cardiovascular disease, the world’s leading killer”? (from the second paragraph of the same WSJ article) I hope not. This study calls to mind the cautions of Dr. Norton Hadler of the University of North Carolina. Dr. Hadler has proposed that Medicare and other plan sponsors consider adopting a simple “number needed to treat” rule (NNT) in determining the eligibility of new medicines and procedures. For a hard outcome (death, heart attack, stroke, etc.), the NNT should be no larger than twenty (20), meaning for every twenty patients treated, at least one would avoid the event. For a soft outcome (feel better, function better, etc.), the NNT should be no larger than five (5). These seem like reasonable thresholds – and ones that AstraZeneca’s Crestor study results would easily fail.
You can see Dr. Hadler’s own reaction to the Crestor study at ABCnews.com:
http://abcnews.go.com/Health/HeartDiseaseNews/story?id=6207285&page=1
By the way, Dr. Hadler’s thresholds would be measured by independent studies, not those funded by the manufacturers. As pointed out in a New York Times editorial today, the lead investigator in the study also stands to benefit from a patent involving the use of C-reactive protein (or CRP) to evaluate the risk of cardiovascular disease.
So, let’s take a pass on more medication and focus our attention on better diets and more physical activity.