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 

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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.

Trump Is Not Hitler

Once again the Liberal press is echoing the sentiment that President Trump is our version of Adolf Hitler, ready to take over the Republic in all manner of malevolent ways and totally destroy our democratic experiment in the USA. [Disclaimer: I am a centrist Liberal to be sure. My sentiments and beliefs are mostly on the Liberal side. As a physician, I have long favored, for instance, a single-payer healthcare system. But I am pro-military, and come from a largely a military family. I believe in civil rights, women’s rights and personal responsibility, accountability and not graft etc. I could go on but I am sort of political melange based on fairness and education among other values.]

The name of Hitler could very well be a flashpoint type stimulus for me. I am a Jewish convert which is a long story but arises from my experiences as a youth in Israel due to my father’s work which took our family there for several years. I also inherited the anti-nazi view of a family who served in World War II through multiple past relatives of my parents’ generation including female members, and which sustained losses in WWII.

As a psychiatrist, I ruefully witness the hair on fire reactions that I still consider and hope are overreactions on the part of the very Liberal media for instance, to President Trump and which continue to decry many of his misplaced, goofy and erratic social and political actions in the light of an evil dictator such as Hitler. We have had a few published efforts by psychiatric authors to publicly demonstrate by diagnostic exercises in print that President Trump is our own Hitler. The most notable book that has established this pattern and line of thought is the collected essay book by Bandy Lee MD a lady psychiatrist at Yale, The Dangerous Case of Donald Trump: 27 Psychiatrists and Mental Health Experts Assess a President.

dangerous Case of Donald Trump

 This volume became a very good seller and has been quoted and referred to by many commentators since it came out over a year ago. The primary author and editor of the multi-author book has continued to pronounce Trump in the media and meetings as an extreme threat by virtue of her now very well publicized view of him as an extremely disturbed person unfit for the Presidency. And this has had the predictable effect of giving the truly anti-Trump crowd,  intellectual justification for labeling him as now fully diagnosed as mentally dangerous to the country.

The controversy in the mental health professions, especially psychiatry, has spawned almost a new cottage industry of psychologizing and diagnosing by anyone who has enough nerve and/or a widely enough recognized name in popular American culture. This is my mind is the greatest danger that the “Goldwater Rule” of the American Psychiatric Association spoke to in making diagnosing public figures a forbidden ethical transgression for the psychiatrist.

Trump Dr Decker book

We now have a few books that take on this seductive and publicity garnering foray under the authorship of anonymous writers. The first book I came across in this genre is Another intriguing book has been the small almost pamphlet-sized book by an anonymous “Dr. Decker:” Trump’s Brain (Paperback): An FBI Profile of Donald Trump: Predicting Trump’s Actions and Presidency.

I am old enough to have lived through the late 1960’s and 1970’s as a young student. I saw all the civil unrest of those times. The Liberal segment of the nation and the more publicized ultra-radical Left saw President Nixon and his administration and political as the intellectual and political AntiChrist. Their reactions to him and vilifications of him were extreme, to say the least. Nixon was portrayed as a fascist, and dictator in the making. It turned out that Nixon did have at least some antisemitic views which were not well known at the time. But Nixon did not make the degree and depth of threats to American institutions such as the press and the Courts that President Trump has carried out so far in his Presidency. But it is history now well established that Nixon started many of the right-wing tactics such as the Southern Strategy, coded [hidden linguistically] racism intentions and ways of speaking politically, dirty tricks of campaigning, attempts at intimidating the press, etc. Back then in the Nixon era, the Left screamed constantly that the end of the Republic was at hand and it did not turn out that way. Even in my youth, I was buttressed with an international view of despots and knew that Nixon was not such. I had lived in a few such countries overseas and had my father’s wise WWII based perspective on what a dictator was. Somehow I knew that the Nixon crowd would totally self-destruct. It helped on a personal note that my father was an Eisenhower Republican and had a dim view of Nixon and had him ‘pegged’ all along.

In those days watching Nixon and the Watergate hearings the last year of his Presidency, I had the view that such character disorders, caused their own destruction. I saw the seeds of Nixon’s political demise and was relatively untouched by the near political hysteria that engulfed me at that time. I lived in one of the most Liberal areas of the country and most of my friends were far more liberal than I was. Now I live and have basically since I left that area in 1974, in a thoroughly and historically very conservative area, locally and regionally. Liberals are few and far between hereabouts. I do not see conservatives as the personification of the Devil. I was exposed to the conservative working class all my youth in different parts of the country due to my father’s migratory profession that did not take us to bastions of Liberalism…

Now to the diagnoses that have been popularly [n both senses of the word I might add somewhat tongue in cheek] assigned to President Trump:

malignant narcissistic personality disorder

antisocial personality disorder

sociopath [the nonscientific term for the above term]

sexual predatory [not really a diagnostic term]

megalomaniac [also not a real term but a literary, descriptive one]

borderline personality disorder

attention deficit disordered

And of course, all the words denoting a dictator: despot, tyrant, etc.

I shall offer a generic list of the popularly ascribed traits of the sociopathic personality disorder since that confluence of personality entities seems to be the leading ‘consensus’ of all the recent Trumpian pseudo psychiatric ascriptions:

  • Ignoring social norms
  • criminal behavior and problems with the law
  • arrogance
  • deceitfulness such as repeated lying or using aliases
  • conning others for personal profit and pleasure
  • impulsivity and failure to plan ahead
  • irritability hostility agitation
  • aggressiveness such as repeated physical fights
  • abusive relationships
  • inability to learn from negative consequences and past experience
  • reckless disregard for the safety of self and/or others
  • failure to hold down a job or honor financial obligations
  • lack of remorse
  • lack of empathy
  • exploitative relationships

All I can say at this point in this post is that for those who accept and believe Trump, he is none of these things, while for those who do not endorse or accept him as he is, he comes close to conforming to many of the above kinds of behaviors and is supremely dangerous to the Nation. But to me, the task is to keep my head from being overwhelmed with the emotion that swamps critical thinking around the figure of Trump, and state the kernel of this post: However Trump’s personality traits define him, he is not Hitler.

Let me offer an off the top of my head list of what I think of when I consider the person and political career of Adolf Hitler and compare the history of Hitler to the political career of Trump so far.

  • Hitler formulated one of the world’s most murderous social theories of race and ethnicity resulting in true mass murder and organized ethnic cleansing. Trump has done nothing that even hints at this.
  • Hitler rose to power through sustained and calculated political assassinations of political opponents, and early on even in his own early Brown Shirt movement. Trump has not done so.
  • Hitler had a large band of ruthless killers as an independent political and private military force at his command long before he assumed political office. To replicate that, Trump would have had to have organized, say, extremist militias nationwide into a force that intimidated the country in all its regions [states].
  • Hitler took over the military especially early in his rise to power, replacing his country’s top military leaders with his own henchmen. It would be as if Trump would have replaced the Joint Chiefs with extremist political hacks loyal to him after being elected.
  • Hitler systematically suppressed and took over the free press in Germany. Trump’s fight with the press and media who have opposed him has given testimony to how hard this would be even if Trump wished to do so.
  • Hitler took over the entire educational system in Germany from kindergarten to the universities to carry out his mission to brainwash and subjugate the nation’s entire population. This has not happened in the US.
  • Hitler abolished civilian control of Germany’s military.
  • Hitler assumed both the primary leadership offices of Germany unto himself. He was both Prime Minister and Chancellor. His political party took over the entire legislative body, the Bundestag.
  • Hitler abolished the popular voting electoral process in Germany. Hitler instituted a racist pseudo-genetic phenotype of the “true German” in the myth of the purse Aryan to divide the population into genetic have’s and have not’s. This was part and parcel of the basis for the mass murder of Jews, Gypsies [the Roman people’s, persons with birth defects, disabilities, etc.].

I know, and can hear through the WiFi ‘wires’ the protests of the readers who think Trump has already started these kinds of heinous anti-democratic and ‘diabolical’ maneuvers, but I think our extremely well established political and social institutions in this country are already pushing back in their stolidly resistant to change properties to oppose such. I feel confident that the military’s leaders have been quietly channeling Trump’s hairbrained ideas away from all-out calamitous consequences all along. This is not to say Trump has not goofed already in such circles. My point is that I do not think Trump is Hitler, nor will he be able to destroy our country and its institutions the ways my hair on fire very Liberal friends do.

I could be wrong but I do not think so.

 

 

Possible New Class of Antidepressants?

To give the reader some context in order to grasp the significance of the issue of a possible new class of antidepressant medications, I would offer the following points of information.

First, in spite of 30 years of hype and advertising by the pharmaceutical industry and especially the companies who have one by one introduced and advertised the so-called modern, or serotonin-based antidepressants, not much progress has been made in the actual efficacy of treating major depressive disorders with these medications. When the serotonin-based antidepressant medications started to emerge in the marketplace, the armamentarium of the psychiatrist and family physician, in the realm of novel pharmaceutical based advertising on Western television, the mode of action on a supposedly new neurotransmitter system was greatly hailed as a modern breakthrough. Serotonin actually is been known since the 1950s and the neuroscience circles in general.

Second, the only advance that was basically made was a reduction in the anticholinergic side effects of the previous generation of antidepressant medications. These the side effects are largely antihistamine. This means that they make nearly all mucous membranes and dry. This accounts for their marketed value in treating and controlling the symptoms of runny noses and watery eyes of viral colds and pollen allergies. These side effects present in the antihistamine medications and “try cyclic” antidepressant medications also cause decreased propulsion in the gastrointestinal tract, meaning the longer transit time for food and waste material through the small and large intestines. The longer that the foodstuffs and wastes stay especially in the large intestine, the more time there is for reabsorption of water from the stool. This makes for hard stool and consequently the long known constipation with all these medications. These same anticholinergic side effects can also affect heart rate and decrease blood pressure. The latter side effect is very problematic in the elderly and can cause lowered blood pressure upon standing and consequently falls in the elderly with alarming frequency and subsequent injuries such as hip fractures.

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Diagnosing Us Via Our Emails?!

In a very well written, succinct article Dr. Alan Hofmann, an internist of Preventia Clinics in Saint Jerome, Canada, wrote relatively of recent but little-known efforts to use AI [Artificial Intelligence] to key in on mental illness flags in emails. As alarming as this might sound initially, the article surprises the reader by quickly informing that there have been well-intentioned efforts to help crisis clinics and services to identify potential high-risk contacts who might need urgent services.

I have to quote Dr. Hofmann’s definition of this phenomenon as he conveys the notion far better than I can: “A series of emojis, words, actions or even inactions can communicate how you feel at a given moment and when collected over time, comprise your “socionome” — a digital catalogue of your mental health that is similar to how your genome can provide a picture of your physical health.”

His article, “What happens when an algorithm labels you as mentally ill?,” appearing in this week’s WorldPost publication, a service of the Washington Post, discussed somewhat playfully [in my interpretation to be clear] extending this effort into the area of diagnosing anyone psychiatrically by running emails through an AI app or program that would flag designated codewords that could be associated with depression, suicide risk etc. Dr. Hofmann wrote that, lo and behold, this HAS been done on a larger scale than any of us would have thought…Microsoft Research and some crisis clinics have done some preliminary work trying to craft programs or apps to facilitate real-time identification of callers in distress.

The latter half of the article went on to discuss that the level of accuracy was only around 70% in associating certain words with depression. Interestingly, it emerged that even innocent words such as “ibuprofen”  could be linked with suicide or overdose risk on mental health hotlines. Seventy percent concordance sounds pretty impressive but the author helps the reader to learn that in the world of mental health, psychology and all, this does not constitute very good predictability at all, and is barely above “a coin toss.”

But I got to thinking about all this as my sneaky, weasel-like, conniving mind started inevitably whirling around the possibilities. In my personal deranged computing life, I suddenly remembered that my voice dictation software is always asking me to permit analysis of all my documents and emails! Egads! If I consented would it diagnose me? Likely not, but it certainly might gang up with my handy-dandy super trustworthy grammar correcting program and send me back to a freshman English composition course.

But this personal, in-my-computing-space reminder got me to thinking even more so about the implications.

We all take for granted that the NSA and all the mind-boggling spy networks analyze our phone calls and emails for “bad words” that have to do with the War on Terror. These words I imagine are things like bomb, blow up, kill the Infidel, and so on. When I was a kid during the Cold War, words/phrases like dirty Capitalist pig, Molotov cocktail, bourgeois and such would have brought the attention of the FBI and CIA to “Commies” and student radicals in the 1960’s and 1970’s.

Closer to home for those who are on Facebook™ [I no longer am for many reasons which I will rant about here] ‘consent’ to having posts analyzed for use by advertisers for targeting ads constantly to one’s views of posts, photos etc.

Twitter may do much the same thing, I am not sure. Tweets seem to me, in general, to be more unrestrained and loose-lipped with more gutter language and “F-bombs” than anywhere I go on the Internet. What if the ‘mental health diagnosing’ apps were set loose on twitter by enterprising wags, or hackers, or smear artists, “trolls” in today’s lingo for blackmail purposes. Or by ill-tempered political types in an effort to smear tweeters with whom they disagreed politically?

Granted this kind of idea seems ludicrous to me and bourne of ‘hair on fire’ kind of media exaggeration/hysteria that could emerge from any Right or Leftist fringe territory. Then again I thought this could be a “good thing” if we could have our own personal mental health screener app. One would purchase and install it in your browser. You could then program it yourself to screen for words or code phrases that you found distasteful or not in line with your political or social-cultural views and tag those tweets for exclusion.

But then one would further aggravate the silo’ing that we face in only reading and contemplating views consistent with our own preferences. And that is NOT a good thing in my view. It only reinforces echo chamber based discourse, further dividing us politically and “every which-a-way” from engaging and ‘building bridges’ of understanding, if that is still possible.

Or given the mudslinging, insult-driven tenor of our times, one could use such “linguistic” grading of tweets to label the posted sentiments of others as “unbalanced,” or “mentally ill” according to one’s own prejudicial scoring system. I can see it now, a genre of tweet replies along the lines of “well my app shows you score 84% on the skreptomaniac scale!”

And the cycle of anger, flame wars as they were called in the early days of “Bulletin Boards” would continue and do our national no good whatsoever.

And lastly, I am sure that opponents of our President would run their mental health scoring apps on Trump’s all too over the top tweets and move armchair, unethical, misplaced psychiatric diagnosing into new stratospheric levels of absurdity worthy of publication in my long-time favorite past journal of satire, The Wormrunner’s Digest from Dr. James V. McConnell of the University of Michigan in the days of Mort Sahl and the Golden Age of Satire.