For Profit Stem Cell “Clinics” Now On Regulators’ Radar

Madison Avenue’s Vision of Magic Stem Cells

I have written before about dubious stem cell clinics that are for profit, and push more doubtful stem cell fat cell “extractions” that claim to cure everything that laudanum-alcohol based patent medicines of the Old West covered in the vague disease domains of pain, arthritis, “lumbago,” (one of my favorite English words). Now finally the regulators are finally starting to crack down on these greedy, nefarious and dishonest “suck mills,” (my new name for these centers for suckers, who suck gobs of fat cells out of your belly and then inject aliquots back into wherever you hurt and hope it will relieve your pain.

I had earlier noted one of the characteristics of the bogus (at least in my biased humble, scientifically trained view/mindset) “stem cell therapy” clinics. And that is they claim to treat all kinds of vague entities and at times real live disease processes too that simply astound me with the sweeping unproven claims of success. But when you read the claims on many of these clinics and sites on the Internet, the claims are often qualified. They will state that the therapy being hawked and sold “may improve” and other such get off the hook phrases. Another characteristic is that most of these clinics do not deal with insurers right from the start; everything is as we say in the United States still: “cash and carry.” Anyway here is one list I have typed out, re-edited for insertion, etc., of entities that are claimed to be treated with your own belly fat, harvested on the spot, “stem cell” infusions:

Conditions: Knee Pain, COPD, Diabetes, Alzheimer’s, Anti-aging, Autism, Autoimmune, Arthritis, Back, Pain, ED(erectile dysfunction), Foot/Ankle Pain, Hair Loss, Hand/Wrist Pain, Heart Failure, Hip Pain, Osteoarthritis, Kidney (what: cysts, infections, tumors, stones???), Liver Disease, Lupus, Lyme Disease, MS (Multiple Sclerosis), Neurological (notice how vague this category is), Neuropathy, Parkinson’s, Spinal Cord, Stroke, TBI.

I want to just wholesale quote from the June 12, 2109 edition of MEDPAGE TODAY article written by Greg Portz. This has other investigative news about the new Esketamine drug Spravoto’s alleged corner cutting approval, leptospirosis infections in Puerto Rico, the abortion controversy in the state of Missouri as well as the pertinent part about the “stem cell” clinics operating on the fringes of American medicine.

Stem Cell Ruling: Not Enough?

To quote: “Earlier this month, a federal judge said the FDA could shut down U.S. Stem Cell, a private clinic in Florida. While many hope it will serve as a warning to others, the New York Times points out that hundreds of stem-cell clinics still operate, promoting unproven treatments for myriad maladies.

U.S. Stem Cell generated autologous body-fat extracts for injections that the company claimed would treat a wide range of disorders. There was little science to support the claims, however, and some patients had horrific outcomes — three individuals with macular degeneration went blind after extracts were injected into their eyes.

Former FDA head Scott Gottlieb, MD, gets credit for starting the crackdown on stem-cell clinics, the Times noted. Still, many clinics continue to offer similar procedures, and some have gone offshore to avoid FDA oversight

The reader familiar with my own personal history, will recall my past declaration of personal bias. I am and have been a multiple myeloma patient since 2011, and a recipient of a conventional autologous stem cell transplant/infusion at a reputable university medical center (Emory medical center of Dekalb/Atlanta GA).

The Civil Rights Judge

As a psychiatrist, I recently felt the need to update my familiarity with several of the major legal decisions affecting mental health treatment laws of decades ago that opened the gates of reform. I reviewed the first such decision of 1956, Wyatt vs. Stickney in Alabama. In reading some historical blurbs on this decision, I noticed the names of the three-judge federal panel and was struck that one judge’s name, Frank M. Johnson was noted in many of the famous post Brown vs. Board of Education Supreme Court decision of 1855 that started the USA’ s move into the years of desegregation. I then started researching this judge as I realized I knew nothing about him. And lo and behold I realized I needed to read more about him.

So I zipped off to Amazon and searched to see if there were any books or biographies about this man. And there were several so I ordered at cut-rate used book prices three of the ones that looked the best. And as they arrived in the mail over a period of weeks, I started to read about. One or two of them were quite good and informative as well as fascinating. I thought I would profile one of them here.

Teaming The Storm: The Life and Times Of Judge Frank M. Johnson, Jr., And The South’s Fight Over Civil Rights

This book was a gem in that it delved into appropriate civil rights history that surprised me. Much of the background to the many cases this courageous judge handled, was entirely new to me. I was brought up short reading in every case’s deeply historical treatment as much history I never knew came alive. For instance, I learned that sixteen-year-old black teen preceded by a few months Rosa Parks in starting the original bus seating revolution by sitting in a white’s only section on a Montgomery AL bus. The book was full of these new historical events that I had never known. And I am a typical liberal who has tried to read through the years many books on this era. I have done this not only because of my political beliefs but also because I lived through desegregation in my early teens for a year when our family happened to live in a southern state that desegregated the high school I attended for a year. It was a tense time and thankfully our area did not have riots, violence, National Guard troops that made tv news the eye into history as the cable news networks have done since the founding of CNN two and a half decades ago. But I and my family knew we were in and through really important history.

Another feature made this book special. The author Jack Bass wrote extensively and authoritatively about the Judge’s family, his growing up years and very formative experiences that prepared him to be an impartial and incredibly fair and nonpartisan, i.e., not a typical Southern political segregationist racist. He even detailed this man’s college and law school relationship with the late George C. Wallace, the famous segregationist Governor of Alabama who publicly fought desegregation after the decision Brown vs. Board of Education. This accessory story, though brief, was nonetheless, fascinating beyond words.

Yet another aspect to this book was that the author interviewed many many persons who knew the Judge, covered his career, opposed and fought him, etc. In fact, the author interviewed the Judge himself for dozens of hours, covering his life, and decisions. The author dutifully recorded these interviewed manually and buttressed many issues and events with pertinent quotes from Judge Johnson throughout the book. These quotes were like a magical eye into the history and made it all come alive as few historical books I have read have done.

The level of such detail documented the supreme bravery this Judge exhibited throughout his legal career. The Judge and his family endured years of harassment, death threats, cross burnings, and disavowal by some of his friends. This book could have also been titled “Profiles in Courage.” This man was appropriately recognized and honored for his legal achievements and bravery the last years of his life as he so richly deserved. Bout outside certain circles, he was not as well known as he should have been. His story has also fallen into relative obscurity in the decades since his demise. Likely only historians, well versed legal scholars, attorneys, persons well acquainted with black and civil rights and American black history, and law students, know Judge Johnson’s story and important legacy.

So, students of history, take heed and note. Add items about Judge Frank M. Johnson Jr., to your self-education menu. His is a story worth learning about and knowing and passing to your children.

Book Review: The First Detective Postal Inspector

Great read for history !

To my readers: it is time for another book review which I hope to do on a regular basis every month or two. I will let the readers know that my selections of books are dictated strictly by my own reading interests and I hope they will be varied enough to interest at least a portion of my readers.

The book I have selected for this post, Inspector Oldfield and the Black Hand Society: America’s Original Gangsters and the U.S. Postal Detective who Brought Them to Justice highlighted above in the image of its book cover is one that I stumbled upon accidentally while searching in another subject area entirely this caught my eye and I knew I had to have it in hard copy form since I found that this was a volume I wish to keep in its physical form and not as an electronic, virtual book. Although the central character in this book, is named Mr. J. Frank Oldfield, he was not related to the famous racecar driver at the turn of the 20th century Mr. Barney Oldfield. This gentleman came from fairly humble roots and interestingly enough came to his profession and occupation as one of the country’s first investigative postal inspectors through the political patronage system where he grew up in the state of Pennsylvania and through his biological father who was somewhat of a political power in the area they grew up in. It makes for interesting reading as to how this process tended to work decades ago. Nowadays we would probably look on the influence peddling and political wrangling that help this gentleman come to into his appointment as a political inspector, as outright nepotism. What further makes the story engaging is that this gentleman aspired in a properly motivated professional manner to become a true postal inspector devoted to the service of protection of the public.

Overall the book traces his development into a supremely dogged, determined and very talented self-taught investigator who truly rivaled in his own way the sharpest investigative techniques of the day. As I’ve hinted in the sentence above, he was a remarkable individual because he really had no formal training in law enforcement, investigative techniques etc. He was truly self-taught. He also existed in an age in which there was no other national police force. He worked toward the end of the 1800s and early end to the 1900s which meant that the Federal Bureau of investigation or FBI, did not exist. Inspector Oldfield also operated before the era of prohibition and famous law enforcers such as Eliot Ness and others. The postal service was the largest national organization in the country outside of the national military organizations such as the US Army. This book also in its early chapters, gives a fascinating history and exposition of the development of the U.S. Postal Service from the eras of the Revolutionary war onward. This piece of history is no idle intellectual exercise as some of its most important early organizational features lent themselves to the ability of the U.S. Postal Service to be turned into a true investigative law enforcement mechanism as implemented by the central figure in this book inspector J Frank Oldfield.

Another fascinating piece of historical circumstance is that this Iinspector Oldfield was stationed in the Midwest out of the way of major crime centers, in central Ohio. It turns out that inspector Oldfield stumbled upon the phenomenon of criminal families in different locales, specifically and importantly located in different states. The historical account of how Inspector Oldfield discovered the existence of ties between criminal families in different states is nothing short of fascinating. This was not an over night discovery but a process that took many months and incredibly persistent mundane effort to sketch outI the existence of cooperation among criminal familiesI that had never been realized in this country before. The reader begins to discover that figures like Inspector Oldfield, and the US postal services inspector capabilities were the only law enforcement body capable of mounting investigations that crossed state lines.

Inspector Oldfield discovered odd use of the Postal Service in a small town outside Cincinnati Ohio. He was astute enough to focus his attention on this criminally appearing anomaly in which a family of Italian fruit vendors and distributors sent money overseas to Italian relatives and also so to other Italian families in other states notably Pennsylvania.

This led to his fateful discovery of the then unknown Black Hand Society, the forerunner in Italian – Sicilian organized crime that evolved in decades to come, especially during and after the Prohibition era to the Mafia, or La Cosa Nostra. As a bit of a spoiler I will reveal one of the fascinating elements of this story which was that at the time Inspector Oldfield discovered and mapped out the existence and structure of this new organized criminal organization, no national state or regional law enforcement body believed even in the concept of organized crime. It was felt that all crime was local and that criminals did not coordinate their efforts across state lines at all. So Inspector Oldfield was fighting against the prevailing notions in law enforcement about the magnitude of criminal activity that was evolving in young modern America.

The authors of this book did a masterful job of constructing the narrative. It reads like the best mystery novel as the plot line unfolds and one witnesses every step along the way of the incredible investigation. It is also extremely interesting as one realizes that the efforts of one man, tucked away in middle Ohio, discovers the existence of ethnic organized crime that served to form the institutions on a national level of law enforcement investigation, namely the Federal Bureau of Investigation under the redoubtable J Edgar Hoover. The authors also researched this book incredibly well. Their references and citations also furnish incredible material for the curious. The narrative of this book is completely supported by the research efforts of the authors. A telling example is that the authors even located a turn-of-the-century photograph of one of the original black hand Society criminal families who look incredibly ordinary like new immigrant workers.

All in all this is a diamond in the rough, a gym of a book regarding little-known history of the U.S. Postal Service, the evolution of its core of postal inspectors into top-flight investigators who paved the way for the decades long war against the Mafia by the U.S. Congress and the Federal Bureau of investigation in modern times.

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 

Fessing Up: I’m a Myeloma Patient

I have occasionally intimated that I have had a Chronic medical illness that has interfered with and interrupted my blogging. I have had another one of those unwelcome hiatuses. So it is time to be more explicit about the reason and that is O have had multiple myeloma since 2011 or so. I have had a stem cell transplant done at the Winship Cancer Center in Atlanta at Emory Medical School where I was referred by my local oncologist.

In the last year since Labor Day weekend of 2017, I have had the ‘privilege ‘ of having two shoulder and humerus surgeries due to what are called ‘pathological fractures. ” The recovery and rehabilitation time took over 8 months before I was able to return to work. That absence affected my blogging ability in that I could even write or type until the last of that interval at home.

Now I am back on track and hope to be more frequent in blogging and also to get my next big deal Internet based Mental Health Reform project underway in YouTube, having had time to work out You Tube compatible technologies figured out after a fashion from thumbnail art, to the not so easy arcane mysteries of audio video home recording. I like just everyone from whom I have begged advice, have struggled to find equipment that I could master and that “worked for me.”

So look for more reliable postings as I happily resume opinionating.

My next post oddly enough will be to cast some acerbic thoughts upon the waters of opinion concerning the phenomenon of for profit stem cell transplant clinics for all kinds of non cancer conditions.