“To date, embryonic stem cell research has not produced a single medical treatment, where ethical, adult stem cell research has produced some 67 medical miracles.” Vice President – Mike Pence
There is a war raging over adult (nonembryonic) stem cell use by licensed physicians right here in the USA…
It basically pits self-styled dogmatic skeptics, federally funded university researchers & research centers, the FDA, various medical groups and organizations, and some individual mainstream practitioners against hundreds of licensed MDs and DOs (and thousands of patients) who want to use the patient’s own stem cells to treat various afflictions, most being chronic in nature.
For those of us in the trenches doing stem cell medicine (Stem Cell Warriors), today’s tug-of-war is not only not news, but we saw the clouds gathering on the horizon back at the dawn of the new millennia.
It is a familiar story in the evolution of medicine: genuine innovation carries some low risk unknowns which prompts regulators and guardians of the status quo to seek to control and contain it, ostensibly to protect patients from harm.
Not surprisingly, the most strident voices advocating regulating innovation (progress) in adult stem cell use has invariably included federally funded laboratory scientists, ivory tower bioethicists, and others who have blinders on when it comes to how to effectively deliver low risk new therapies to the clinic.
Most display an arrogant disregard for suffering patients who have few or no treatment options, or else yammer on about how they are really protecting them from the horrors of “Wild West stem cell doctors” who just do whatever they want and this for the money involved – Never mind the fact they leave many of these suffering people no recourse but to rely on ineffective or marginally effective treatments by mainstream doctors, most of which have side or adverse effects that one never sees in patients given properly done in-office adult stem cell therapies).
I challenge you to look up the incidence of side effects that the average FDA approved drug has and to compare that number with the number of side effects and deaths that have occurred with the use of stem cells derived from the same patient’s body (autologous)!
The Reality of Drugs…
June 27, 2014
Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options, and have the need to do so.
Few know that systematic reviews of hospital charts found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients are given drugs that cause serious adverse reactions for a total of 2.74 million serious adverse drug reactions. About 128,000 people die from drugs prescribed to them. This makes prescription drugs a major health risk, ranking 4th with stroke as a leading cause of death. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the U.S. and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.
At this point you may be asking…
“What exactly makes you, Dr. Steenblock, qualified to sound off on behalf of private doctors doing adult stem cell therapies? What have you learned that argues for the use of adult stem cells as a part of the practice of medicine and not a ‘new drug’ that requires FDA approval and regulation?”
When it comes to stem cells, I am actually in an “old timer”. In fact, I first learned about the use of bone marrow stem cells in 1969 as a young physician extern in the University of Washington’s Department of Hematology and Oncology. The program I was part of was headed up by Edward Donnall (“Don”) Thomas, MD, who won the Nobel Prize in Physiology or Medicine with another physician, Joseph E. Murray, in 1990, for the development of cell and organ transplantation. It was Dr. Thomas who developed bone marrow transplantation as a treatment for leukemia. He and his team ultimately did over 4000 human marrow transplants.
Of course, with stem cell therapy restricted for decades (to mostly cancer and leukemia patients), I was unable to do much in the field as a private practitioner whose clinical work did not focus on cancer. However, by the late 1990s into the early 2000s adult stem cells in the form of umbilical cord blood and stem cells was being used experimentally to treat not only cancer (leukemia), but many other human ills as well.
The evidence indicated these cells are safe (i.e., did not form tumors as was the case with embryonic stem cells) and expressed special biochemicals (e.g., growth factors, chemokines, and cytokines) that promote healing and restoration in all kinds of organs and tissues.
In addition, fears expressed by (mostly lab) researchers that even HLA (immune) matched umbilical cord stem cells could provoke profound rejection reactions in people proved untrue. Not only this, but even HLA mismatched umbilical cord stem cells seldom caused more than a mild reaction in patients that was easily managed.
In the US, of course, the use of pure umbilical cord stem cells is treated by the FDA as a drug and is thus highly regulated.
The story was different in Mexico where the use of umbilical cord blood and stem cells was deemed something largely within the scope of an MD’s practice of medicine.
After making inquiries among my physician contacts in Tijuana, Fernando Ramirez Del Rio, a highly credentialed orthopedic surgeon who possessed a decree issued by the Mexican Parliament allowing him to work with adult stem cells, signaled that he was interested in having me collaborate on the use of pure umbilical cord stem cells in his country.
We then hammered out a suitable agreement which included my setting up a nonprofit research institute (Steenblock Research Institute [SRI]) in southern California for the purpose, in part, of helping educate and track patient coming from the US and elsewhere for umbilical cord stem cell treatments in Mexico. This was in March 2003.
What followed was over 1000 treatments in both adults and children whose responses were collected and analyzed by the staff at SRI.
In addition, in 2004 I participated in the design and execution of an open-label pilot study in which eight (8) children with cerebral palsy were treated with a subcutaneous injection of 1.5 million pure umbilical cord stem cells by Dr. Ramirez. This study revealed statistically significant improvements in a number of bodily functions in the majority of those treated, and also the partial resolution of cortical blindness in a five (5) year old boy with optic nerve hypoplasia (In short, the neural circuitry that connected the boy’s eyes with the visual part of his brain, which had previously failed to function, began working sufficiently for him to begin tracking objects).
In 2006 a book I coauthored which documented some of these clinical successes titled “Umbilical Cord Stem Cell Therapy: The Gift of Healing from Newborns” was published by Basic Health Publishing, becoming the first lay level book on the subject ever written in the English language.
Prior to the publication of my book, I looked into what forms of adult stem cell therapy I might be able to do in the US without violating FDA regulations.
What I learned was that although there was no FDA approved stem cell products on the market at the time (This changed in 2011 when the FDA approved an hematopoietic progenitor cells-cord (HPC-C) cell therapy “drug” called Hemacord for treating certain diseases and medical conditions affecting the blood forming system), the agency appeared to allow doctors to harvest and infuse stem cell rich bone marrow aspirate concentrate (BMAC) so long as the marrow they used was not processed beyond a certain point (“Minimum manipulation”).
What I Found…
I asked my attorney, Richard Jaffe (JD, Columbia University School of Law) to check with the FDA and insure this was indeed the case. Jaffe received reassurances that BMAC was not regulated and fell within the scope of the practice of medicine (Which means its use by licensed physicians is treated like any medical procedure or treatment, which is to say problems or issues fall under the purview of each doctor’s state medical board).
After determining the Osteopathic Medical Board of California had no regulations barring use of BMAC, my medical team and I began cautiously, methodically using BMAC (2005 on) in conjunction with FDA approved pharmaceutical stem cell mobilizers and activators to treat a handful of conditions, most being intractable and not responsive to standard treatments.
What We Treated…
In time, and with a steady stream of clinical successes, this program was expanded to include the treatment of osteoarthritis, multiple sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), osteoporosis, spinal cord injury (SCI), Parkinson’s disease, chronic stroke and COPD (Emphysema).
To-date (2017) my clinic has administered well over 2000 BMAC treatments.
What happened during this almost fourteen (14) year period of clinical stem cell work was predictable: ever increasing numbers of MDs in Mexico began using umbilical cord blood and umbilical cord stem cells in patients with a wide variety of medical diseases and conditions. And within a few years of my work with BMAC in the US, licensed physicians (MDs and DOs) began using it in the USA,.
Stories, case histories and even some private physician clinical studies began appearing in magazines and even peer reviewed journals detailing patient responses to various forms of adult stem cell treatments. The orthopedic successes (including clinical studies) were especially compelling.
The skeptical response…
The response among academic (mostly lab) researchers, mainstream stem cell societies and organizations, dogmatic skeptics and other “medical consumer advocates” was equally as predictable: The findings and reports of myself and many other physicians was discounted as “worthless” or “nearly worthless anecdotes”; dire warnings of adverse & side effects were used to scare the public; dedicated physicians using adult stem cells in Mexico and elsewhere were depicted as money grubbing souls who could care less about outcomes; and patient accounts of experiencing impressive physical improvements were largely dismissed as wishful or mistaken thinking, or placebo effects (I use “effects” because there are more than one exerted by placebos).
The full weight of the scientific community’s negative regard for private practice doctors using adult stem cells was felt by me when I gave a review of the use of Bone Marrow Aspirate Concentrate to a group of scientists at a “SENS” conference in Cambridge, England in 2008. This was a group of scientists who were supposed to be “open minded”. To my amazement, my simple lecture was met with verbal and even physical abuse complete with profanity, in which I was told in no uncertain terms to go home and take this type of “quackery” with me. As I left the meeting I was peppered with disparaging remarks and rhetorical questions like, “Why did you present such garbage? Everyone knows what you are describing is impossible!” And then some of the attendees underscored their distain by actually throwing objects at me! This was and will always be the best example of a “PARADIGM SHIFT” that I personally have ever winessed and experienced.
And then, again…
Thankfully, from then on, things began to change (for the better)..
Now let’s look at the issue of anecdotes. As mentioned, critics have dismissed this sort of evidence as worthless or close to it. However, this does not square with the historic role of anecdotes insofar as they sometimes pointed to things worthy of a formal “look, see” (research).
Interestingly, some dogmatic skeptics have written and said as much. In an article titled “Science vs. Alternativism”, writer Gregory L. Smith, MD states that:
“Testimonials can be great places to start looking for answers, but they should not be considered the end of the journey. Many scientific discoveries start with an observation that leads to a hypothesis that eventually can be tested with a randomized controlled trial. However, people who use testimonials probably have little better to offer. After all, it is possible to get a testimonial from someone for nearly anything. In the 19th century, quack doctors sold medicines that were radioactive or gave patients bits of radioactive metal to wear near their skin. Many patients gave enthusiastic testimonials. They may have sincerely felt they were better, but experience showed that it wasn’t doing them any favors—it ultimately made them much worse”.
Steven Novella, MD, an academic clinical neurologist at Yale University School of Medicine, ably captures this in an article he penned titled “The Role of Anecdotes in Science-Based Medicine”:
“But should anecdotes play any role in medical evidence? Yes, but a very minor and clearly defined one. Anecdotes, with all their weaknesses, are real life experience. It is possible that a treatment does in fact work and personal experience may be the first indication that there is a meaningful biological effect in play. But here are two limiting factors in how anecdotes should be incorporated into medical evidence:
The first is that anecdotes should be documented as carefully as possible. This is a common practice in scientific medicine, where anecdotes are called case reports (when reported individually) or a case series (when a few related anecdotes are reported). Case reports are anecdotal because they are retrospective and not controlled. But it can be helpful to relay a case where all the relevant information is carefully documented – the timeline of events, all treatments that were given, test results, exam findings, etc. This at least locks this information into place and prevents further distortion by memory. It also attempts to document as many confounding variables as possible.”
Dogmatic skeptics including some MDs (most who do not practice medicine or never did with respect to anything connected to stem cell use) love to tell licensed physicians who use adult stem cells that they need to carry out carefully designed and executed clinical studies.
Although I doubt there is a single doctor who disputes the fact clinical studies help in sorting out treatment wheat from chaff, few practicing physicians have the staff and other resources needed to pay for randomized clinical studies out of their pockets and fewer still would be able to obtain grant money to do this.
So, what we generate is anecdotes or, with respect to my use of bone marrow, a case series. But what seems lost on skeptics and others is that progress in medicine has for centuries been driven by doctors doing in-office experiments and discovering something unexpected such as off-label drug combinations that produce better results in patients with a specific disease than standard-of-care treatments.
Their alternative is to place pretty much all experimentation under the aegis of university research centers and major pharmaceutical companies. Of course, what this will do is undermine a traditional historic source of innovation and replace it with drugs or biologics that often cost patient’s a fortune and create more health issues than the conditions or diseases they are supposed to help manage or remediate.
And what of adverse effects?
Yes, there have been instances in which a patient who was treated in the USA or abroad experienced a complication or worse.
However, what emerges when a doctor such as myself who has training and experience in both pathology and stem cell therapies looks at these, are instances that beg for a medical board remedy and not some kind of “throw the baby out with the dirty bath water” legislative initiative or new set of FDA restrictions.
Embryonic Stem Cells, Not Adult, Are the Problem…
What I discovered were instances in which a very small number of patients from (mainly) the US or Canada went abroad, most to clinics in the Ukraine, got fetal and/or embryonic stem cells and developed benign tumors called teratomas or mixed cell type tumors.
No one but a truly reckless doctor would ever use embryonic stem cells outside of approved clinical studies, because these stem cells form teratomas when injected or infused into nonembryonic (or fully developed/differentiated) tissues. There are scores of papers and newspaper articles concerning this property of embryonic stem cells. Frankly, anyone with a laptop can find this out in seconds by just using “embryonic stem cells” as a search term.
Adult stem cells such as those from umbilical cord blood and a patient’s own bone marrow do not cause the formation of teratomas.
There was also a case in which a Florida-based doctor injected bone marrow material which allegedly contain bone particles into an elderly lady who then had a stroke and ultimately died.
This MD’s governing medical board ultimately revoked his license to practice medicine. If true in all its specifics, this would seem an instance in which a physician did not adequately process the bone marrow specimen and perhaps used poor clinical judgment to boot (You don’t inject biomaterial that might clump together internally and then block a blood vessel, at least not without taking measures to prevent this).
And another case worth mentioning is one in which three (3) patients were given fat derived stem cells by nurse practitioners and then went blind. When fat stem cells or stem cell rich fat is used at all it is typically employed by plastic surgeons doing breast or facial reconstruction or enhancement work.
What happened with the three (3) now blind patients prompted this comment from healthcare lawyer Richard Jaffe in his blog at http://rickjaffeesq.com/: “What idiot decided that was a good idea? Still, the remedy to that kind of problem is or could be a combination of civil actions by the patients, criminal prosecution, professional licensure proceedings, or state action to shut the place down.”
Some of these cases were included in presentations by academic researchers and others who argued for more restrictive FDA regulations on a doctor’s use of a patient’s own cells during a two (2) day public workshop (“Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products”) held on September 12 and 13 at the National Institutes of Health’s Bethesda, Maryland campus.
The Good Old Internet…
The Internet abounds with articles that clearly favor greater FDA restrictions on what a doctor may do with a patient’s own cells including autologous (from self) stem cells. There are also many others that are highly critical of this, some by patient advocates, and others by physicians and other professionals. One of the best article series along this line is this one by attorney Rick Jaffe:
“THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures” (September 16, 2016):
Want to read more of lawyer Jaffe’s learned opinions on stem cell regulation?
Physicians Getting Rich?
As for private physicians growing incredibly wealthy doing BMAC and other adult stem cell based treatments, this is hard to determine. One would have to survey those doing this — which means contacting over 600 clinics in the US — and have the docs tease out the income generated by these kinds of treatments from the many others they do. Not impossible but daunting to be sure.
I suspect few are sitting on a mountain of gold thanks to their clinical adult stem cell work. In my own practice, a series of BMAC treatments can run as little as $1000.00-3000.00. The older you are, the more stem cell stimulating agents must be used to get good results which does bump up the cost. In general, young people who are active and on their feet do not need anything other than a simple BMAC treatment.
Mice and Rats…
This brings me to how academic researchers (mostly lab people working with mice and rats) and journalists have dismissed patient accounts of impressive physical improvements as wishful thinking or placebo effects. It is actually mindboggling that scientists, in particular, would call physiological, neurological and other turnarounds “wishful thinking” or the end result of “placebo effects”.
Do they really believe, for instance, that a young boy who is cortically blind from birth and then recovers some of his ability to see following a stem cell treatment (in Mexico) experienced this due to wishful thinking, placebo effects or coincidental betterment (This case is cited in paragraph 10 above)?
And what of a female pediatric patient with a hereditary “brain meltdown” condition called metachromatic leukodystrophy, who was not expected to live very much longer, who received an infusion of genetically modified umbilical cord stem cells (again, in Mexico) and went on not only to live far beyond what was expected, but who experienced significant mental and other bodily improvements to boot?
It is important to keep in mind that placebo effects have not been shown to indisputably cure a dire illness or medical condition. They can lessen a patient’s perception of pain or nausea and other symptoms, but not pull off the “miraculous” reversal of a progressive, terminal illness or condition.
And while a patient, parent or caregiver might indulge in “wishful thinking” in the sense of inflating a minor improvement into something else, what of those who document changes of a magnitude not seen in those with a given disease or medical condition? And yet some dogmatic skeptics and naysayers invoke this to explain away something that is anything but wishful thinking.
Now having tried to address the most common objections I’ve heard skeptics and others raise about physicians such as myself doing adult stem cell therapies, I would like to shine a light on something many critics of what I do conveniently ignore: the sheer hypocrisy that abounds in the worlds of science and medicine with respect to adult stem cell use by private physicians (Not to mention pervasive hypocrisy when it comes to many other promising nonstandard medical practices or procedures).
Consider this blatant example:
Back in 2003-6 stem cell experts, mostly academics who worked with cell cultures and lab animals and not humans, characterized Dr. Fernando Ramirez’s use of cord blood stem cells to treat cerebral palsy in children (in Mexico) just so much “smoke and mirrors”, and then turned around and pursued funding to test the use of cord blood or cord blood derived stem cells in animals and humans. Some even sent patients to Dr. Ramirez on the sly.
Here Comes the Media…
On January 8, 2012 60 Minutes aired an investigative segment titled “Stem Cell Fraud: A 60 Minutes” investigation that focused on a doctor who allegedly sold umbilical cord stem cells to a couple in Florida whose son has cerebral palsy. At one point the segment’s lead investigative reporter Scott Pelly brought up stem cell treatment offerings on the Internet with stem cell expert Joanne Kurtzberg, MD (Duke University):
Scott Pelley: You know, I wonder how often it happens that you have to tell a patient, ‘I’m sorry. There’s nothing we can do.’ And then they come back to you two days later and say, ‘Well, I see all these cures on the Internet.’
Dr. Joanne Kurtzberg: I get many of those calls and emails and, and, see many of those patients. But it’s very dishonest to mislead people when there’s nothin’ you can do.
“Nothin’ you can do” seems to fly in the face of what appears on the Web concerning Dr. Kurtzberg’s work with cord blood and cord blood stem cells for cerebral palsy:
“Kurtzberg says that of the children she has treated so far, only Dallas and one other child have made such dramatic improvements.”
Neurological Disorders: A Focus On Cord Blood Stem Cells As A Potential Treatment Option – 23 Jun 2008 – 2:00 PDT
“This research also lends support for the pioneering clinical work at Duke University, focused on evaluating the impact of autologous cord blood infusions in children diagnosed with cerebral palsy. Dr. Joanne Kurtzberg, a professor of pediatrics and pathology and director of Duke’s Pediatric Blood and Marrow Transplant Program, is infusing the child’s cord blood stem cells back into the body in an effort to facilitate repair of brain tissue damaged by perinatal hypoxic (oxygen-deprived) events. To date, more than 20 children have participated in the experimental treatment.”
Cord Blood Reverses Cerebral Palsy in Colorado Girl – Nov. 9, 2009
“The Levines were in luck: Dr. Joanne Kurtzberg, a professor of pediatrics and pathology at Duke University, was conducting a study where children with cerebral palsy were injected with their own cord blood cells.”
WRAL VIDEO: “Duke researchers are exploring a stem cell treatment they hope will help children with cerebral palsy.”
News article: “Stem cell treatment helps Valley child walk” (June 4, 2012)
“Katie was six months old when she was diagnosed. Her parents say she started to make more progress when she got stem cell treatment from Duke University.”
It would seem that work with cord blood stem cells done outside a particular venue constitutes “smoke and mirrors” (A scam) while that done in proscribed settings (university labs, hospitals and research clinics and centers) is genuine and bona fide.
From what I can determine, even the most outspoken and prominent ivory tower bioethicists missed such instances of hypocrisy on the part of mainstream researchers and others, probably because they filter reality and cherry pick reality in ways far worse than that of the stem cell doctors and clinics they routinely criticize and attack for doing this.
Protecting the Status Quo…
In the final analysis, maybe some of the things so quickly dismissed by dogmatic skeptics, academic (lab) researchers, journalists, and other “keepers of the status quo” are legitimate discoveries; the kind that medicine should welcome, once did, but appears now does not – at least in some quarters (This at least is how many mainstream doctors and researchers react to anything discovered outside their purview or control or that seems to fly in the face of accepted “truths” or “established facts”).
This leads me to ask: Is the war being waged against private doctors using a patient’s own cells (including stem cells) nothing more than another attempt to place medical progress in the hands of those who actually hinder progress and make advances that wind up costing patient far more than they can afford, both financially and in terms of side or adverse effects?
RECOMMENDED ADDITIONAL READING
Anecdotal evidence and observational studies are regarded by some researchers as a more reliable means of discovery and explanation than formal studies. One very cogent paper on this subject is “Observational Research, Randomised Trials, and Two Views of Medical Science” that appeared in the PLoS Hub for Clinical Trials. It can be accessed by licking this link: http://bit.ly/M8WwEV
How the FDA Manipulates the Media (Scientific American, October 2016)
Quoting from this summary article:
“A yearlong study of stroke patients has found that stem cells from a patient’s bone marrow can be safely infused in the brain through the carotid artery to promote recovery. Researchers at the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine followed 48 patients, more than half of whom who were treated using stem cells, and found recovery along with no adverse side effects when compared with their counterparts.
“Each patient was assessed at 24 hours post-procedure and again at 90, 180 and 365 days
“….both the placebo group and the treated group of patients were given traditional stroke-recovery therapy. Patients who were given the stem cell treatment were noted to recover motor skills and speech.
“Yavagal explained the stem cells act as drug factories in the area of the brain damaged by the stroke, secreting a number of useful substances to promote recovery. The cells help repair damaged cells, including ones that encourage growth and act as anti-inflammatory aids. Some of the properties also act to salvage cells that are on the edge of dying, helping to preserve brain tissue and act as neuroprotectors.
“Previously it was thought that they transform into neurons and brain tissue, but especially with bone marrow cells that does not seem to be the case,” Yavagal said. “The main effect seems to be through the supportive functions or nursing functions.”
A Glimmer of Hope About ALS Causation: An Interview with David Steenblock, D.O. by Bob Frost (Townsend Letter, June 2016)
© 2017 by David A. Steenblock, D.O., Inc. All rights reserved.