A Safe Trade

It’s too early to assess what impact, if any the recent report from Public Citizen criticizing FDA oversight of the SCS industry will have on future regulatory policy [see article p1]. But unlike previous attacks coming from news organizations, this report may carry some weight with regulatory agencies or legislative bodies because of the participation of Victor Krauthamer, a former division director at the Center for Devices and Radiological Health.

Krauthamer is known and respected by many neuromodulation industry professionals and researchers. And while we can take issue with some of the recommendations in the report, the historical account of device approvals in the report appears to be factually correct. One observation in the report that seems hard to dispute is that the rate of adverse events in SCS is far too high. Neuromodulation vendors need to do much more to ensure that leads don’t migrate and that potential harmful effects like infection are minimized.

But the report fails to take into consideration several key factors. Whether or not one agrees with the pace of PMA and PMA supplement approvals, the SCS devices in use today are much more effective than the first generation of devices 20 years ago. This steady improvement in device quality would not have been possible without the number of patient-years worth of experience gained as a result of those approvals.

Also, professional organizations like NANS have encouraged their members to produce Class I evidence to support their claims, even when not required to do so. The FDA does not require a solid explanation of the mechanism of action for a device therapy—or for a drug intervention for that matter. As we advocated last month [NBR May20 p2], there should be incentives for trial sponsors who take the time to develop robust computational models.

The report also fails to recognize the burden placed on SCS clinical trial sponsors who are forced to incorporate a sham stimulation “control” arm. As we saw with the recent Mainstay ReActiv8 trial [see article p3], not only is this protocol difficult to administer, it often leads to an unwarranted trial failure when the sham stimulation arm receives unexpected clinical benefit. As we have said in the past, a far better way to achieve a controlled trial is to allow sponsors to conduct a noninferiority trial of neuromodulation therapy vis a vis a pharmaceutical therapy. This approach would not only preserve any differential placebo response between the two therapies, but it would also enable device therapies to address the disease population as a whole, rather than just the refractory population.

We suspect that the neuromodulation industry would accept tighter FDA controls looking at device safety in exchange for this concession on efficacy.

James Cavuoto
Editor and Publisher