WHAT SHOULD BE DONE ABOUT EVIDENCE THAT STATINS MAY DELAY ALZHEIMER’S? Julie Zissimopoulos in this article on the Statnews website lays out the difficult options in assessing new possible uses for older drugs which are off-patent. Random controlled trials are very expensive. There might be no way of recovering the expense of the trial. She uses the example of her work in evaluating whether statin drugs can delay the onset of Alzheimer’s. She says:”Some trials testing whether statins could reverse Alzheimer’s failed to produce conclusive evidence. But they did not address whether taking statins decades before Alzheimer’s symptoms arise might prevent the disease.”
Dr. Zissimopoulos and two colleagues looked through Medicare claims of 400,000 men and women who used a statin but who did not have Alzheimer’s before 2009 and followed them for four years. Women with high statin use were 15 percent less likely, and men 12 percent less likely, to have been diagnosed with Alzheimer’s each year compared to individuals with little or no use of a statin.
A sample of 400,000 is a large sample, but, as Dr. Zissimopoulos points out,” because the study was not a randomized clinical trial, it does not provide the kind of cause-and-effect evidence about statins and Alzheimer’s disease the FDA needs to approve a new use for statins.”
A clinical trial would be expensive and would take a long time. And a proper random sample would be much smaller than the inadequately constructed sample of 400,000.