September 27, 2020

The Niche

Knoepfler lab stem cell blog

The opioid crisis, pain, stem cells, & FDA

stem-cells-for-painLast year I started seeing stem cells mentioned along with the opioid crisis in a particular way, but now recently I saw an entirely different pairing of stem cells with the opioid crisis.

The first connection I saw was of a few for-profit, unproven clinic firms claiming that for pain sufferers it would be better to turn to experimental stem cells than to opioids or that such iffy stem cells would help people stop using opioids because the stem cells would make the pain go away.

I’ve covered “stem cells for pain” a few times including most recently here and, yes, I’m a skeptic about this. Whether it’s your back, your knees, or other locations giving you severe pain that would warrant opioid use, I strongly doubt that unproven stem cells are going to make a real and lasting dent in that pain. So, no, unfortunately I don’t see stem cells as a solution to the opioid crisis or even an individual’s pain situation outside the opioid context.

More recently, I saw attorney Richard Jaffe make a very different kind of stem cell connection to the opioid crisis or at least a comparison. In a recent blog post, Jaffe aimed to put the stem cell clinic problem and specifically adverse events due to unproven clinics into its “proper” context by comparing it to the massive carnage from the opioid crisis, which causes something like 40,000-60,000 deaths a year. For sure, few things are as bad as the opioid crisis and who would argue the FDA should put equal resources into that and the stem cell clinic problem? Nobody. At least, I don’t. However, it’s not quite that simple and the for-profit stem cell clinics require relatively more action from the FDA than in the past, which can be done without harming the opioid response. Here are some key points.

First, the divisions of the FDA that handles opioids and stem cells are different. As to the latter, it is the Center for Biologics Evaluation and Research or CBER. If the FDA wants to deal with both the opioid crisis and sketchy for-profit stem cell offerings, it’s not a zero sum game since these are different divisions. Admittedly, there may be some FDA resources (attorney time) that are shared and certainly the Commissioner must prioritize his time and focus over all the massive number of issues facing the agency so I acknowledge that. The FDA probably only has so much political capital too. Still, stem cell issues are mostly handled by biologics folks.

Second. With the stem cell clinic problem we have as many as nearly 800 firms marketing non-FDA approved stem cells and perhaps as many as 2/3 are selling stem cells of such a kind or in such a way that those stem cells are unapproved biological drugs. If FDA doesn’t take some proportionate steps about that then it could be seen as tolerating large-scale non-compliant use of unapproved drugs. That’s not a message the agency wants to be sending generally.

Third, most types of stem cells remain experimental and risks aren’t very well understood, particularly since it is literally a living product rather than a chemical pharmaceutical. While I agree the magnitude of known serious adverse events from stem cell clinics is not massive, knowledge of such events is growing. Also, I wouldn’t be shocked if we learn in coming decades that there are unique long-term risks ranging from residual cells causing tumors to immune problems to other issues. If as most people think tens of thousands of people are getting unproven stem cells in the U.S. alone, there’s a big experiment going on over time with them and we’ll have to see how it turns out in terms of safety. We cannot rule out larger numbers of long-term adverse events at this point in a germinal area like this.

The bottom line is that while the collective selling of unapproved stem cells is definitely not anywhere near the scope of problem of the opioid situation, the FDA needs to give the stem cell issue more action at least relative to the past. Overall, the FDA can take big actions even on things unrelated to opioids as it did with reported issuance of 40 warning letters at once to e-cig makers, which I don’t think one could argue hurt the effort on opioids. For these reasons, I’m hoping we’ll see more action from the agency soon on the stem cell clinic problem.

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