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It’s the gold standard in medicine: taking a treatment, and putting it head-to-head against a placebo to confidently declare whether it actually works. But for most medical devices, placebo trials have never been done.

The most basic argument for this, put forth by medical device makers and regulators, is that mimicking an invasive procedure is far more difficult than handing patients a sugar pill. But a growing, vocal contingent of doctors claim this argument lets device makers off the hook and pushes devices that haven’t been thoroughly tested into the bodies of unsuspecting patients. Their goal is to convince the Food and Drug Administration, which has largely steered clear of the subject, to require more device studies to have placebo controls.


“There is the possibility that you could unleash a procedure that’s potentially not beneficial on hundreds of thousands of people,” said John Mandrola, a cardiac electrophysiologist. “If you’re going to unleash something into the public space, I think it’s morally and ethically crucial to know it works.”

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