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.

8 thoughts on “The opioid crisis, pain, stem cells, & FDA”

  1. I had my right knee injected with amniotic stem cells last November 2017. Before that, I had an MRI showing a torn meniscus. I dislocated both of my knees a total of 4 times that left me with a 8 or 9 out of 10 pain. 5 weeks after the injection I’ve been pain free since and the new MRI does not show a tear in the meniscus. When looking at my options, I was told there would be some “risk” with a knee replacement but never explained what the risk is and really avoided the topic. I considered the risk of surgery and that’s why I decided on stem cells. I am so happy I made the decision! You can wait for the research to come out but i personally know 6 people that had an amniotic stem cell injection before I did. None of them had any complications or side affects, and pain drastically improved which is why I decided to get it done also.

  2. I have had my own mesenchymal stem cells injected into my lumbar discs resulting in a 50% reconstruction of the discs so far. This is real. Very real. It’s game changing.

  3. You’re article seems to lump all stem cell treatments into one general category and that is problematic!

    I am a recipient of stem treatment for a neuroligical disorder called cerebellum degeneration and I can say with certainty that my first treatment is a success.

    I will return to Vancouver in Nov 2018 for a second treatment . I now have absolutely no reservations that these treatments are beneficial to the point of stopping the progression and even reversing it!

    You should do more homework before dissing this promising and revolutionery area of medicine.

    1. @Harold, I’m glad you feel you’ve had a positive experience and I appreciate patient comments. Believe me, I do a lot of homework.

      I’m curious, did you have to pay for this?

      Did you receive a stem cell injection directly into your brain or spinal cord? If instead the stem cells were injected into your blood such as through your arm vein, how did the clinic explain the cells would help your cerebellum? Did they explain risks to you?

  4. The pharmaceutical industry has certainly done a first-rate job marketing and promoting FDA-approved opioids:

    This article also raises what I consider to be the bigger problem:
    “The pharmaceutical industry’s role and influence in medical education is problematic.”

    That final point seems to be at the heart of amniotic “stem cell” industry, for instance.

    From where I look, the medical industry seems to be polluted by revolving doors: regulators-pharma, pharma-MD, research-pharma, politics-the lot… Such is the human condition. Still, so long as money is in the drivers seat, I may as well complain about a compass pointing north.

  5. As an anesthesiologist/stem cell biologist I’ve been thinking about stem cells for pain for a long time, and did some preliminary studies in a standard neuropathic pain model a decade ago (Anesth Analg 2007; 104:988; Neurosci Lett 2008; 433:188), based on the theory that stem cells could ameliorate the contribution of ischemia to pain and inflammation to pain. Unfortunately the right clinical studies have not been done yet, to determine the particular pain phenotypes (and stages of disease) amenable to stem cell therapy, and clearly the ideal anti-inflammatory cell, dose and delivery method are also unknown. One thing that can be done right now to enhance our knowledge in this space is to incorporate better (more quantitative) pain end-points into clinical trials in which anti-inflammatory stem cells (MSC or MAPC) are used for diseases that have pain as a component (critical limb ischemia, arthritis, etc.).

    Nonetheless, for a clinician to promise pain relief with stem cells is false advertising–Some patients may genuinely experience an analgesic response, some will have a placebo effect, some will be unresponsive and there is simply no way to predict a particular patient’s response–haphazard medicine. So far, there haven’t been clear reports of increased pain after stem cell injections but how would we know in the context of a disease characterized by progressive pain? Most disturbing is the advertising to people with chronic pain — who are a vulnerable population by the very nature of having chronic pain, which can take over one’s life.

    I hope recognition of the opioid crisis combined with increased understanding of the molecular mediators of pain syndromes, and advances in stem cell biology can somehow come together to invigorate much-needed rigorous investigation. An estimated 11% of the population has chronic pain–also an epidemic.

    Marie Csete MD, PhD

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