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Anchor lead: FDA regulators may have contributed to the prescription opioid epidemic, Elizabeth Tracey reports
Enhanced enrichment randomized withdrawal. Hmmm, not sure what that might sound like to you, but Caleb Alexander, a physician and researcher at Johns Hopkins, shows in a recent study that this is a study design that may have allowed quite a few opioids that have contributed to our current epidemic on the market.
Alexander: Using this trial design everybody is started on the drug. If you don’t respond to the drug or if you have a bad adverse effect, then you’re just removed from the pool of people. This is a fundamentally flawed method of studying the safety and effectiveness of these products. We found both when looking at effectiveness as well as when looking at safety that the FDA missed important opportunities to require manufacturers to generate more information at the time of market approval. :29
Many are observing that both the opioid and Covid-19 epidemics are continuing apace, yet the former might have had less momentum with better oversight of prescription opioid medications. At Johns Hopkins, I’m Elizabeth Tracey.