So, while Americans can expect to see more drugs and devices sped to those who need them, they should also expect the problem of therapies based on flimsy evidence to accelerate. In a recent Stat op-ed, two Johns Hopkins University physician-researchers wrote that the new 21st Century Cures Act will turn the label "FDA approved" into "a shadow of its former self." In 1962, Congress famously raised the evidentiary bar for drug approvals after thousands of babies were born with malformed limbs to mothers who had taken the sleep aid thalidomide. Steven Galson, a retired rear admiral and former acting surgeon general under both President George W. Bush and President Barack Obama, has called the strengthened approval process created in 1962 the FDA's "biggest contribution to health." Before that, he said, "many marketed drugs were ineffective for their labeled uses."
Striking the right balance between innovation and regulation is incredibly difficult, but once remedies are in use—even in the face of contrary evidence—they tend to persist. A 2007 Journal of the American Medical Association paper coauthored by John Ioannidis—a Stanford University medical researcher and statistician who rose to prominence exposing poor-quality medical science—found that it took 10 years for large swaths of the medical community to stop referencing popular practices after their efficacy was unequivocally vanquished by science.
According to Vinay Prasad, an oncologist and one of the authors of the Mayo Clinic Proceedings paper, medicine is quick to adopt practices based on shaky evidence but slow to drop them once they've been blown up by solid proof. As a young doctor, Prasad had an experience that left him determined to banish ineffective procedures. He was the medical resident on a team caring for a middle-aged woman with stable chest pain. She underwent a stent procedure and suffered a stroke, resulting in brain damage. Prasad, now at the Oregon Health and Sciences University, still winces slightly when he talks about it.
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