Are Medical Devices Studied on “Whites Only?” Do We Know What Works for Which Patients?

Stephanie Fox-Rawlings, PhD and Diana Zuckerman, PhD, National Center for Health Research.

For many years, Congress (especially women in Congress) criticized the FDA for not requiring companies applying for approval to include enough women, people of color, and people over 65 in clinical trials.  As a result, many drugs and devices were approved on the basis of studies primarily of relatively young, mostly white males.  This was true even for treatments for diseases where large percentages of the patients were women, people of color, and people over 65.  As part of a 2012 FDA law, Congress urged the FDA to do a better job and ever since the FDA has proudly stated that they have succeeded.

This ground-breaking study is the first independent study of high-risk medical devices approved since the 2012 law, and we found that although the studies often include some women, people of color, and people over 65, there are too few of them to determine if the product is safe or effective for those groups.  In fact, companies often don’t even try to determine safety or effectiveness for those groups.  And even when they do analyze the data that way, they often don’t include that information in the label or any other widely available public document.

  • For example, Lutonix, a drug-coated balloon catheter used to open a blocked artery, was found to be beneficial for men but not women.  Women do better with other types of balloon catheters, and yet the drug-coated one is approved for all adults.   But because it is approved for all adults, women patients are likely to be treated with a device that is worse for them.
  • In another example, the Cologuard test for colorectal cancer was more likely to identify a patient as having cancer if they were male or White compared to patients that were female or Black.
  • Another colorectal cancer test, Epi proColon was approved for all adults, even though it was less accurate for patients older than 69 years of age than patients less than 60 years old. It was also less accurate for patients who were Black compared to White.

The lack of information about safety and effectiveness for people over 65 has enormous implications for Medicare.  Medicare is going broke but at the same time is constantly asked to cover the cost of devices that had not been studied on more than a few patients over 65.  And yet, the risk to benefit ratio is often very different for older patients than for younger ones, because the risks tend to be higher and the benefits tend to be lower.

As a result, potentially life-saving medical implants are being put in the bodies of patients who are more likely to be harmed by them than to be helped.   Should devices that haven’t been tested on people over 65 be approved for “Adults Under 65 Only”?  Should devices that haven’t been tested on more than a dozen people of color be approved for “Whites Only”?  Such a designation would be very inappropriate for a federal agency to make, but the study shows that in many cases it is the only way to warn patients that they might not benefit.


This summary is based on our article in published in September 2018 in Milbank Quarterly, Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?  by Stephanie R. Fox-Rawlings, Laura B. Gottschalk, Laurén A. Doamekpor, and Diana M. Zuckerman.