Crestor Helped Reverse Buildup Of Artery Plaque, Study Finds
According to a WSJ article (not linked here but see this story from the Washington Post), investigators believed it was unethical to withhold high-dose statins from the high-risk patients enrolled in this study, so the study was done without a control arm. My question to them: Is it more ethical to conduct a clinical study knowing in advance that its results will do little to advance the state of scientific knowledge significantly? But, you say, the study was published in JAMA and Steve Nissen said this was the first time a statin actually shrunk plaque and raised HDL-C significantly, so it must be a scientific/medical advance. How could it not be an advance? Because, I reply, there was no control group. I don’t care if Osler ran the study and published it in Nature. If a clinical study makes no attempt to control for the introduction of all sorts of biases by comparing the test drug to a concurrent therapy (including the test drug itself, if done properly), its results must be regarded as preliminary, speculative, and probably not very newsworthy.
The proper choice of a control group is increasingly difficult to make as therapeutic advances limit the comparator choices that provide requisite equipoise between groups. But that difficulty isn’t an excuse to abandon a control arm altogether. If readers are interested, I’ll be happy to discuss some ways of designing controlled studies in a future PCE post.
