Lizzy Lawrence reports for Stat News on the value of testing medical devices against a placebo. Otherwise, it’s difficult to know whether a medical device offers a benefit. Because the FDA does not require placebo trials, they are rarely performed. And, that suits the device manufacturers just fine.
For sure, plenty of medical devices on the market are unsafe or of questionable value. They have not been tested thoroughly. And, sometimes, hundreds of thousands of people get them even though they could be harmful. Some experts argue for more device testing against a placebo. The device manufacturers say that a placebo test is challenging, given that a lot of these devices require invasive procedures. But, how many people are getting medical devices that offer no benefit or, worse still, put their health at risk?
A recent Abbott study to determine whether a device to treat a heart condition was safe and effective compared a cohort of patients using the device, TriClip, with a cohort who simply received diuretics or another medical therapy for heart failure. Both groups had about the same rates of death and hospitalization for heart failure.
Without a placebo, there’s no way to know whether the device and the intervention work. The device makers don’t want to incur the expense of a placebo trial, and claim it is hard to find patients to participate. The FDA has not required placebo testing.
Rather, the FDA has allowed countless “low-to-medium risk” medical devices into the market based on nothing other than their “substantial equivalence” to a device already on the market. And, the FDA takes a liberal view of the meaning of “substantial equivalence.” It also does not appear to factor in the safety and efficacy of the device already on the market.
The FDA requires only “high-risk” medical devices to be shown to be safe and effective before approving them for use. Only one in 20 medical devices are classified as “high-risk.” And, most of these devices are not tested against a placebo for safety and efficacy.
Of course, placebo testing has risks as do medical devices that offer no benefit. Moreover, placebos are not always even possible, such as in the case of bypass surgery. What to do to ensure medical devices are safe and effective?
Here’s more from Just Care:
- Beware of faulty medical devices
- FDA hides data on medical device malfunctions and injuries
- US and European patients at risk without medical device registry
- Should you care whether doctors take money from pharmaceutical and medical device companies?
- Medical device to remove fibroids causes cancer to spread
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