Naloxone for Chronic Pain

My trusty Google search bot fleet turned up this recent article highlighting a recent piece on NPR (radio) that I had not heard or heard tell of as we say in the South since I work and cannot listen to it as much as I would wish. It concerned a trend in utilizing naloxone in treating chronic pain.

This is somewhat significant as naloxone is about as far away from using opioids to treat pain as you can get. Naloxone is used to treat addictions and simply cannot be viewed at all in the same pejorative light as opioids.

Naloxone, without boring the reader with a brainy, academic, overly pharmacologic explanation of the in’s and out’s of this area of “medication-assisted treatment” (MAT in the new parlance of addictionology), is a blocker of effects of opioids and helps to blunt the effects by which opioids and even alcohol induce and sustain addiction. It is both a generic (not a brand name, i.e., not expensive) drug and a brand name form drug, Vivitrol (super expensive and highly promoted by its parent manufacturer.

Naloxone has been around for decades. It has a well-established place in the pantheon of tools to treat addictions, along with, of course, the cognitive therapies and my sentimental favorite the 12 Step programs that I view as all-important in the journey of anyone in recovery.

As an aside, I will never forget my first patient with alcohol addiction as a naive, dumb, unschooled psychiatry resident over 45 years ago at Duke. He was not my then biased stereotype of a problem drinker, someone who had lost almost everything, came into the hospital inpatient service in alcohol withdrawal, etc. On the contrary, he was a professional, respected in his circles, accomplished, educated and showing almost none of the physical issues or stigmata of the ravages of alcoholism. He had relapsed. His treating Duke psychiatrist, my instructing attending was wise enough to ask this man to educate me about his disease. And this was in the days when moral opprobrium still reigned supreme toward alcoholism and addictions. the concept of addiction as a disease was just making headway into the lingua franca of our world then as the new enlightened way to view and approach addictions courtesy of two of then past giants in addictions, the recently late Dr. Herbert Kleber MD then of Columbia University Dept. of Psychiatry and UNC-Chapel Hill School of Medicine’s Dr. John Ewing, a giant in alcoholism research and treatment, founder of the Center for Alcohol Studies.

My patient above told me his ‘story.’ I had the sense to listen to him for as long as he wished to talk. He took me through his life account for well over an hour. I was astonished at how open he was with me about his failings, drinking, failures, and relapses. When I intimated that I would have to digest all that he had told me, he surprised me further. He asked me if I knew about A.A., Alcoholics Anonymous. I answered honestly that I knew very little. I recounted that I remembered my parents taking in geologists and mining engineers from my father’s international mining teams when I was a kid, who had been alcoholics and helping them get back on their feet. I said I only knew that my father had helped them go to AA and that it helped them but that was about the sum total of my knowledge.

My attending’s patient then proceeded to tell me of his years’ involvement with AA and gave me an introduction I would not forget. He helped me to see it as one of the most accepting, supportive organizations ever. I kept thinking to myself while he told me of AA, why weren’t most of our social organizations more like AA? Churches, fraternal orders, etc. I marveled at the trust he felt he was able to place in persons in AA.

However, what blew me away was one of the final points he left me with. He was a traveling professional, who worked in other professional centers somewhat regularly. He told me of how AA saved him from his core internal loneliness and depression that he struggled with. He spoke of his long past pattern of drinking to salve his loneliness in hotels away from home and family in the evenings after he had completed his consultations.

AA helped him to break that many year pattern by going after supper in hotels or restaurants to local AA meetings. He told me that he knew wherever he found himself, there would be an AA fellowship of persons in which he could find acceptance, support and positive booster inoculation against drinking. He described as the western world’s largest support community. I was flabbergasted as I grasped what he was conveying. And I never lost that sense of AA.

Back to naloxone. The article that set off all this in me, “In Tiny Doses, An Addiction Medication Moonlights As A Treatment For Chronic Pain,” from just days ago (Sept. 23, 2019) is well worth the reader’s attention.

One of the issues that might not strike the reader right off is that this long generic, out of patented brand name status, money-making status, has only modest research behind it to explain its now anecdotally reported effectiveness in unrelated pain syndromes. But reports are continuing to surface in some number and frequency that this medication is making perhaps a more and more solid case for more clinical investigation of it in pain control.

But, and it is a BIG but, it has not much potential as a MONEY MAKER. No drug company appears likely to pick it up and develop it as a pain modifying medication. The company marketing Vivitrol is not going to do so as documented in this NPR article.

So this possible more desirable medicine will be left to the backbench of interventions. It is not addictive in and of itself at all, like buprenorphine can be which is also used as an “MAT” medication in the treatment of opioid addiction.

This medication has little support for its use and ‘development.’ By development, I mean good clinical, nationally coordinated research that would establish its “place” in pain control clinical practice.

I think that generic medications such as this with a clearly very valuable social medical potential should be ‘adopted’ by the national research and clinical research arms that be. Monies to support and drive the clinical research that should be devoted to a medication such as this, ought to be easily devoted to its cause. A new mechanism of initiating, driving, funding and sustaining the R&D of such a lowly generic medication ought to exist. I would even propose a policy of supporting monetarily pharmaceutical companies to jointly share somehow monetarily in the sale of a naloxone category of medicine so that the use of naloxone or medicines like it, would not be a marginal effort but part of mainstream medical practice to benefit the huge cohort of pain patients who need an effective non-addicting medication intervention.

Just because a medication would never make BILLIONS for companies as the Oxycontins of this world have done, does not mean it should not be developed in a way that paves the way for its mainstream use and establishes its scientifically based modes of action in the mysterious world of pain.

The “Off Label” Stem Cell Therapy Industry

In my last post I stated that I would be writing my thoughts as myeloma stem cell transplant patient. This is a disclaimer I should expand upon a bit.

First, I had a serious life threatening cancer condition, namely myeloma. Second, this process occurred in the fully traditional alloplastic world of medicine. What I am about to write about below is in the opposite world of lifestyle medicine, nontraditional and even chiropractic medicine to some extent. This world of treatment is outside mainstream medicine to say the least. It is primarily yet another treatment enterprise that serves to make money; it also has generally the characteristic of intentionally positioning itself outside nearly all consumer protections, peer and medical review from what I can tell.

I first noticed these enterprises after I underwent my stem cell transplant autologous (meaning the stem cells utilized in my transplant were harvested from me over time and not from a donor making for a lower risk as far as rejection etc.). I had a lot of time on my hands being out of work for several weeks at home before returning to work  The Internet had become my supplement to my information gathering self education efforts in conjunction with my oncologist who actively and non-defensively encouraged such “inquiries.” What actually put me on to the existence of these clinics was the appearance of full page ads appearing in our the regional large national level newspaper for such a clinic in Charlotte NC. I was startled by the ad, and it claims.

This all occurred way back in 2011. I had  a dubious, medical-moralistic reaction (as I call it since it is honestly a product of my training, medical views, etc., as a pretty science based physician). Consequently, I hopped over the FDA website and found back then nothing on this phenomenon which I already had a dim view of. In the years since, the FDA had begun to pick up the regulatory slack nationally responding to states’ complaints and actions, medical boards and an unknown megnitude of patient complaints. For the last  year or two, the FDA has posted increasingly more pointed warnings about these clinic enterprises and regulatory sanctions and actions are starting around the country which in my humble is long overdue.

A number of months ago, I started my own “secret shopper” type inquiry effort to get some direct  information about and from these clinics. I resurrected one of my old ancient slider burner phones activating its phone minutes without identigying data of mine, no name, email, credit card etc. so I could call these clinics and hopefully not be able to be identified easily. I gave one of my nome de plumes that really exists and if researced, would not reveal I was actually an M.D. I selected several clinics. Over several months I called and spent quite some  time on the phone with each clinic. I began to refine my techniques of inquiry and started with a preset list of what I thought were appropriate and reasonable quiestions. With each information gathering session, I added topics of inquiry and set questions during and after each foray into the workings of each clinic. With the last two clinics I began to  reveal my more full extent of knowledge regarding stem cell transplant therapy. I would represent my knowledge as largely coming my oncologist aided online researches which I felt was quite honest on the face of it, but stopped short of revealing I had multiple myeloma and was the recipient of a traditional full blown stem cell transplant. I ended up selecting such clinics in my home state of North Carolina but only one, the rest were in Midwestern states, and southern larger more populated states.

And I have decided not to publicly name these entities as I do not have complimentary thoughts and observations concerning any of these entities. And I do not wish to be at risk of legal action, i.e., getting threatened with libel actions or some such. I have no idea how likely any such action could be but that is how I wish to proceed.

All of these clinics have websites for inspection. This is not saying anything earth shattering as even my trusty local car repair shop that I trust my family’s conveyance to, has a splendid website…The websites for these clinics all have knock your eyes out furniture and decor. There are testimonials that are glowing. Staff rosters show a hierarchy of staff,ranging from non medical extenders that do the intakes and information gathering/initial patient intakes, to nurses that might be standard RNs or naturopathing nurse type staff with credentials I was not familiar with. These are medical directors that seemed to be of almost exclusively two professional bachgrounds, chiropractors or naturopathic non MD “docotors,” or MD plastic surgeons. These figures always looked very ‘successful,’ dressed better than I even do (but I am a non fashion clothes donkey at best and partially color blind etc.). Some of the more glitzy medical directors dressed like Miami Vice characters, slicked back hair, pastel suits etc. I guess this was their self image of success but it looked ludicrous to me, and did not inspire potential patient confidence in me at all!

The process of wending my inquiry journeys in all these clinics was much the same. First, I was transferred to an intake worker all of whom were not “medical,’ by any measure including the clinics’. These persons did the standard face sheet info gathering, name, means of contact, age, a bit of bachground, etc. Two of them asked permission and did a live simultaneous identity search on me. I was glad I had my nome de plume identity set up and was able to confirm that virtual reality as an author in NC, that I had money, health insurance etc, and my family general information. But mostly the purpose of this intake was to confirm I had a chief complaint of some kind of nonspecific but significant pain issue that I wished relief with, AND that I had liquid cash sufficient to pay out of pocket the total price. Often at this point, I as  the prospective patient would ask for ball park figure which ranged from $4,000 to more than $10,000 per treatment episode. If I showed economic hestiancy, some of the clinics would offer to have me talk with a “financial counselor,” who would help to arrange financing often with a local loan house or bank in their locale which they always extolled warmly. If I indicated at the outset of the ‘wallet biopsy’ segment or decided I did not need finanching, I was then referred to a more ‘clinical specialist’ if I had the time for a lenghty history taking segment. Otherwise a time was set when I would call back and confer with that person as the next to last step before setting a actual face to face clinic visit to then proceed to the procedure.

This history gathering portion was usually fairly well done. A detailed history of the pain complaint was taken, covering such information as its origin, duration, what approaches had been taken in the past, the effectiveness of those, what the character of the pain was that remained, all current medications I took, allergies, surgical history, other current medical diagnoses especially those thought to be influencing or contributing the pain complaint. I always offered my long present ordinary osteoarthritis as the culprit which was also easily true. My pain sites were given as hips and shoulders and wrists.

Problems always started to arise when I would start to sound out the clinical person on issues such as: 

  1. why insurance was not utilized;
  2. what follow up efficacy information was available both on a larger clinical literautre and their clinic experience
  3. typical complications, risks, adverse events were known;
  4. what clinical follow up the clinic itself offered’
  5. what liaison the clinic offered to my personal physicia I could expect’

Questions in the above areans always provoked discernible types of reactions. These ranged from quiet subtle hesitancy to outright efforts to convince me to move away from such non productive lines of inquiry. The more pointed issues concerning efficacy data, and the complications/risks queries were reserved or delayed until I would preseent for the face to face clinic visit. It was clear that anything that might contribute to my deciding against undertaking the procedure would be somehow be resolved or disappear from my horizon of doubt then. All effort with me was geared to getting to the clinic as soon as possible and undergoing the procedure.

One issue that surprised me was not all the clinics explicity stated they would forward all cllinic data to my personal physician. Even when I asked about this, two of the clinics presented their service as so non traditional that they stated medical doctors varied in their wish to have the clinics’ records of my care. I found this ‘funny,’ as in medically weird. My perhaps overactive cynicism prompted me to wonder if the clinics’ in question wish was to not be subject to outside review/scrutiny. Who knows.

Things really got interesting when I started to ask about “Where do you get the stem cells?” Answers were often vague. Sometimes the impression was given that stem cells came  from ‘costly’ (therefore medically precious and expensive) blood donor sources. If I asked about possiblities of presence of HIV, Hep B or C risks, the answer was changed to more vague realms such as pooled amniotic cord blood. If I asked about this kind of source, things got even vaguer and assurances flowed that sources were safe and had long been used. Half the time either at the outset, or as I asked uncomfortable questions about stem cell sourcing. I was tolk that blood would be drawn from me making it autologous blood and not subject to host reactions. If I asked if the hematology lab stem celll harvesting “washing machine” (my goofy lay term) I was never clear how stem cells were isolated…

The actual procedure was easy for all the clinic personnel to describe. The treatment fluid of so called stem cells of whatever origin was injected into the actual area of pain, usually one’s joint, e.g., a knee, hip, shoulder etc. Variable time courses of weeks usually were touted as necessary to await and witness results.

There were other more subjective commonalities that I noticed. Every outfit I called were over the top in their characterizations of their staff, especially the heads of the clinics. Phrases such as “nationally known figures in the field,” were liberally used. I found this off putting but realized the less educated and gullible could unduly positively influenced by such tactics.

In conclusion, you the reader will likely sense what is coming in my summary thoughts arising from my secret shopper and traditional physician belief system. These new young pseudo stem cell therapy industry is yet another medical procedure scam. It sounds poorly factually based and strictly a money grubbing enterprise world populated by those who are in it, so to speak, mostly for self enrichment. Patient buyer beware. I for one look forward to the day when this pseudo industry of ill repute and lesser intrinsic value will be largely another extinct chapter in medically cloaked greed