Since news of this clinical trial’s success became public, people from all over the U.S. stricken with rheumatoid arthritis have emailed, called and sent letters pressing for their shot at potentially effective—but not yet FDA-approved—treatments. Most wrote that they would gladly travel to Europe if it meant they could get access to the device.

That’s exactly the point: Some patients are very willing to take a calculated risk, but misaligned incentives in the industry are driving potential stakeholders with new solutions out of the business.

While the FDA does a commendable job, there is no reason it should have the sole responsibility for access to lifesaving treatment. Institutional review boards and human-subject research protocols provide extremely high levels of protection overseeing clinical trials in the U.S. and Europe. These bodies have weeded out the charlatans in the industry, and the ultimate determinant of success will be patient satisfaction.