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What Should Happen if a Stem Cell Clinic Harms Many Patients? (Revised)

What Should Happen if a Stem Cell Clinic Harms Many Patients? (Revised)

Here’s my core position: I support a patient’s access to his/her own stem cells (autologous use) for any use agreed to by the patient after proper informed consent which is not tainted by false or misleading advertising claims by the stem cell clinic. This post is about autologous use, not allogeneic, i.e., another person’s stem cells.

My philosophical/public policy/constitutional thinking is that people do/should have a right to determine what happens to their own bodies, so long as that right doesn’t endanger public health or safety, or impinge on another’s protected rights. I don’t see why someone else or some government agency should be able to stop me from using my body parts as I and a licensed physician see fit. If I want to waste my money or endanger myself with unproven and even potentially harmful treatments, I think I should be able to do so. People make foolish decisions which are actually harmful, like smoking and drinking to excess. It’s their right, self-destructive as it may be.

Further, my experience of being involved with stem cell clinics and keeping my ear to the ground in the field tells me that autologous stem cell transplants almost never causes serious problems, if the treatment is administered by a competent physicians.

I think the few highly publicized stem cell blindness cases at the Florida stem cell operation was an outlier based on some incredibly poor judgement on the part of the clinic operators. The other infamous clinic/defendant in the FDA’s injunction actions, the California stem cell treatment group was accused of using a deadly vaccine toxin which could cause harm. I don’t know much about that their use of toxins, but I know is was part of a protocol for stage 4 cancer patients. And what I haven’t heard or read about was any actual harm to patients receiving that treatment. In fact, third or fourth hand and I’ve heard that the results are good. If so, too bad they’re not making more of that. That’s what I’d be advising them to do, if that’s really the case. (And as some of you might recall, I’ve got some experience with this. See chapters 1, 2 and 4 of Galileo’s Lawyer.

My sense of the relative safety of these procedures was confirmed by a recent published report which did a google search of all reported stem cell adverse events. I wrote about that study. Here is the link:

Bottom line less that 40 reported serious adverse events, 11 or so deaths worldwide associated with stem cell treatment, one of which occurred in the U.S.

Of course, there could be and most likely have been serious adverse events not reported in the media, but still, the numbers of reported events seem to me incredible small based on the Knoepfler et al reported 700 plus stem cell clinics in the US alone.

(I am aware of the recent reporting of serious adverse events and harm caused by an allogeneic stem cell drug manufacturerer, but the regulation of allogeneic stem cell or other tissue based products do not implicate the same constitutional or public policy issues as do a person use of his/her own stem cells, or tissue. I don’t see why the FDA can’t or shouldn’t regulate these allogeneic products for non homologous, non approved use. And in fact it does, just not very effectively.)

All that being said,

recently I’ve been in contact with a couple of patients complaining they have been seriously harmed by a stem cell clinic.

I’m told that there are forty or more patients who experienced the same kind of injury resulting from stem cell treatments for Lyme disease. I’m not a doctor, but I have worked on a few Lyme cases for doctors, and it’s not obvious to this layman why stem cells alone would do any good for Lyme disease. And it’s possible that the harm is resulting may not be from negligent administration, but from the treatment itself causing MAST cell issues, exacerbating autoimmunity problems, and that would be a very bad thing for a Lyme patient.

The patients are starting to talk about a class action against the clinic (and hence the call to me). Supposedly, the FDA is looking into the clinic, and perhaps the state medical board. I think the FDA is too blunt of an instrument if there is demonstrable continuing actual harm. Rather, this should be initially and primarily a state board issue. I hear an investigation is underway, but if there are really several dozen patients who have been harmed, what the state board should do is start a summary suspension proceeding which stops the doctor administering the treatment immediately, pending a full board case.

The other disturbing aspect to this is that it could be that the physician isn’t even making the decisions in this case. The board needs to investigate that as well.

So even though I’m an advocate for private stem cell clinics which use autologous treatments, if you’re a Lyme patient contemplating any kind of stem cell treatment by a private stem cell clinic, here is my three-word advice: Don’t do it!

If you’ve taken the treatment and think you’ve been harmed, at least complain to your state board.

Rick Jaffe, Esq.

Do you have ED? (not the guy thing, but rather endocannabinoid deficiency)

Do you have ED? (not the guy thing, but rather endocannabinoid deficiency)

The absolute best part of my job is that I get to work on really interesting medico legal issues, interact with very smart experts who know their stuff.
In July, I tried a California medical board case for a doctor who recommended medical marijuana to five-year-old who was having severe mood disorder problems at home and school. The doc saw the patient back in 2012, before the CBD oil explosion, and it was also back when the closest diagnosis for this kind of behavior was ADHD/bipolar, even though bipolar wasn’t normally diagnosed in children that young. In part based on the recognition of this diagnositic conundrum, and other similar problems, in 2015 the American Psychiatric Association in the DSM-V made up a new label for kids who had chronic or episodic mood disorder, and named it disruptive mood dysfunction disorder (DMDD). But that’s not the interesting part.

One of our experts was a leading practitioner/expert on medical marijuana, Jeff Hergenrather, who is the head of the California medical marijuana physician group, a researcher, extremely knowledgeable on the subject, and an all-around good guy.

The Board’s experts testified about all the harm that marijuana could cause children. In many of my cases, I use what I call a fractal defense, meaning, I go a quantum level deeper than the other side, like a different fractal level of magnification. I felt this would be a good case to go deep, so I had Jeff explain to the judge the endocannabinoid system and how it functions. I thought it was incredibly interesting, important, and it’s something which most layman and even most conventional physicians don’t know anything about. So I thought it was worthy of a post.

I can’t put it any better than Jeff did in his testimony, so for all those wondering whether they have any ED (endocannabinoid deficiency) disorder, here’s what it is:

Q Doctor, in your opinion, based on your years of experience using cannabis, is it generally a safe medication?
A Yes. It is remarkably safe.
Q What kind of information or explanation would you need to give to the Court in order to explain your opinion that cannabis is a generally safe medication? What type of explanation, I’m asking.
A I would want the Court to understand that this is a — cannabis works in our bodies in a system in the body, augmenting a natural system that’s already there.
Q What’s that system called?
A That system is called the endocannabinoid system.
Q What is the function of the endocannabinoid system? And you’re saying in humans?
A Well, it’s not only in humans. The endocannabinoid system is seen throughout the animal kingdom, so it’s seen — probably excluding insects, but it’s seen all the way into the oceans, in primitive creatures, hydra, sea squirts, and when you look at the genes of these animals, you can see that they have an endocannabinoid system. The system is there to bring the body into balance, to modulate the body, to help it to come into balance. So it’s really what fits the word homeostasis. The endocannabinoid system brings us into homeostasis.

Q What are the components of that system, physiologically?
A It’s based on a receptor, which is like a socket, and molecules that fit in that socket called the endocannabinoids. So these are small molecules that fit into the protein receptors. These receptors reside in two areas of the body. One is in the brain and in the nervous system and the other is in the immune system. So wherever they are in the body and in the — in the brain and in the immune system, they modulate the way that these systems work.
Q “Systems” meaning what system?
A The nervous system and the immune system. They modulate the way these systems work in the bodies, so they bring them into balance. Otherwise, the body would tend to go haywire, literally, overactivated if you get nervous, and the nerves can’t turn off again. Then you burn up nerves. You literally damage the nerves. So the endocannabinoid system is there to protect the body, to protect the brain, and to protect and modulate the way the immune system works as well.
So it’s a very key system. It’s been evolving along for — it’s thought to be for 600 million years along with the evolution of all these sea creatures through the animal kingdom, the amphibians, and the reptiles and the mammals. We see this system in these animals and we know that the natural cannabinoids are responsible for bringing that system, that body, back into balance.
So its main roles are to help us eat and to sleep and to relax, which is both mental and physically relaxing, and to forget in a helpful kind of a way, but it does have a role in helping forget or — I’ll talk more about that — and to protect, and the protective role is very interesting because there are mobile endocannabinoids in this immune system that are circulating cells and they are going around the body looking for problems, either abnormal cells or cells that are cancerous, and when they come upon them, they program the cell death of those cells and rid them from the body. So they’re key to the health of an organism of a human, to have a healthy endocannabinoid system working in the body.

Q And from your answer, just to be clear, because this is like a physiology thing, the body — you’re implying that the body produces these endocannabinoids?
A That’s correct. These are molecules that are mimicked by the cannabis molecules, so we know of THC and CBD. There’s some molecules we hear about in the press. There are actually over a hundred cannabinoids in the cannabis plant and these cannabinoids are uniquely similar, almost identical, in shape to the natural endocannabinoids.
Q Produced by the body?
A Produced by the body. They’re produced on demand as a response to a stress, as a response to something needing correcting. And so the natural cannabinoids are produced, they activate the receptors, they bring the body back into balance, and then they’re broken down again.
So here’s cannabis that comes along. The same shape molecule from the cannabis plant fits into these receptors and in being there, in activating these receptors, we’re augmenting the natural cannabinoid tone of the body and in this way we’re helping the body to come back into balance.
Q What you call homeostasis?
A What I would call homeostasis.
Q Why — if the body produces these natural cannabinoids that fit these receptors, why would you ever need to what you call augment the system?
A Perfect question. The reason is that not all receptors are the same. The cannabinoids are the same we think between all animals and humans, but these receptors are a little bit different. The ones in the brain are 472 amino acids long. It clumps into a socket. The ones in the circulating cells are 360 amino acids long, a little shorter, but they’re the mobile ones and they go floating around the body in the bloodstream.
So these receptors, with one change of an amino acid, you can measure that this endocannabinoid system isn’t working as well. So many human conditions are now being recognized as endocannabinoid deficiency syndromes.
Q Really? Like what? What kind of conditions now do you think are —
A Migraine, fibromyalgia, M.S., mood disorders.

Q How are they recognized? Because that’s relevant to our case. Talk about how mood disorders are now becoming recognized as an endocannabinoid —
A Deficiency.
Q — deficiency.
A This is simply because we can see in the genes that these are not the same from person to person. There was a clever test done by a Japanese researcher called Matsunaga a few years ago and he looked at — he tested people for happiness and he gave them a questionnaire and those that tested very happy in their outlook on life, he looked at their genes and they all have the same endocannabinoid genes, a similar polymorphism, a similar shape of their cannabinoid receptor.
Similarly, we’re able to look at the genes with people with depression or other mood disorders and these other diseases that I’ve spoken of and many, many others and we can see schizophrenia as well is one of those conditions considered to be an endocannabinoid deficiency.
So by augmenting the natural system, we’re basically helping the body to bring itself back into homeostasis where it’s having a hard time doing it with its natural receptor and cannabinoids.

Q Okay. So let’s tie this in. How does that explanation of our endocannabinoid system and the lock and key, how does that help the Court understand your testimony about why cannabis is a relatively safe drug? So tie it up and then we’ll move on, because I’m sure the judge is going to want to move on.
A Sure. Well, we’re looking at — we have a situation here where the body is in need of coming in to balance and so in mood disorders and anxiety disorder, it just — a person tends to be anxious. In PTSD, you tend to dwell on aversive memories; in depression and so forth, there’s a tendency in various mood disorders to not be able to really recover very well and so we see family histories of mood disorders. The same family will have depressive disorders. The same family will have anxiety disorders or bipolar disorders and so forth.
We see that in the families and now we’re actually able to look at the genes of these people and understand this in a different way, in a better way. So these molecules and cannabis mimicking the natural cannabinoids are, in fact, bringing us into balance and helping to cure these — not cure, but to pharmacologically improve the situation for these — for these individuals, and we really — the clinicians doing cannabis medicine see this every day and it’s very impressive to be able to use cannabinoids and modulate these diseases and bring them into control with an herb.
So it’s rather remarkable. These aren’t synthetic molecules which have proven to be dangerous. They’re plant cannabinoids. They’ve evolved along for -¬the cannabis plant has supposedly been on earth for 60 million years. It’s been around and been used by human beings for probably 100,000 years, maybe 5,000 where we actually have evidence of it in the literature, but this plant has been used for many, many years, eons as far as a plant that seems to have gained a great deal of use and a degree of safety that is rather remarkable.
It’s only in the synthetic molecules that are manufactured that we actually see problems where people get into trouble and even have died with synthetic molecules.

Q Does this explanation shed any — do you have an opinion as to whether medical marijuana cannabis is safer than psychoactive drugs or is that a reasonable question?
A It is a reasonable question and, quite honestly, I have people coming to me because they have tried conventional drugs and the side effects have just been horrible and they don’t want to continue use of those drugs.
Q Okay. I’m going to ask a more refined question now, is there something in the explanation in terms of the biochemistry that you just explained that would lead you to conclude why cannabinoids natural would be inherently safer than antipsychotics or stimulants or Ritalin? I mean, what about your explanation might help explain the fact that — I don’t know — an earlier witness said that it’s a safer drug than some of the other antipsychotics, because now we can get to the biochemistry as you explained and tie it in all together, briefly, very briefly.
THE COURT: Can you do that?
THE WITNESS: I think I can do that.
THE COURT: All right.
THE WITNESS: Well, from the side of the question of
pharmacologic drugs that are very commonly used, many of them, especially in the antipsychotic division of these drugs, have boxed warnings on the drugs.
Q Black box, you mean?
A Black box warnings. They are in some cases dangerous drugs that may result in deaths and that’s why the black box warning is there. These are drugs that commonly have fairly significant side effects. They’re not tolerated by people very well and at least in my patient population, which is to some degree self-selected because they want to come and see if cannabis will work, they’ve tried conventional drugs and they’re not working. They are looking to cannabis to see if this herbal medicine can modulate their mood disorder, their mental disorder, and keep them from needing conventional drugs.
And quite honestly, this is a mix in my practice. Some people use cannabis only, quite successfully, and other people rely on both cannabis and conventional drugs to be able to maintain a good mental health. So it’s not necessarily going to work in everybody. Some people don’t like the feeling of using cannabis as a medicine, so they’ll move along and try something else.

Q Okay. And unless there’s some other thing I missed about the biochemistry in all this stuff, I’m going to move on. Do you think I’m —
A Briefly, we all hear about neurotransmitters such as dopamine and serotonin and adrenalin. These are common neurotransmitters in the brain. What the cannabinoids are doing is they’re modulating all of the neurotransmitter systems in the brain. They’re there as a retrograde messenger in the synapses of the brain to calm the system down.
So if in — let’s say in an anxiety, for example, if the nerve impulses are firing away and you’re very anxious, cannabinoids have an ability to turn this neurotransmitter down or off to where it relieves the anxiety or whatever the problem is. It can be a movement disorder where dopamine is involved. It can be a mood disorder where serotonin is involved. It can be an anxiety neurotransmitter where adrenalin might be involved. In any of these neurotransmitters, the cannabinoids are there to modulate the way the brain works and so it’s good across the spectrum of many diseases as an effective and safe medicine.
Q And does that, what you’re talking about, have anything — make it more or less likely that the cannabis would alter the brain chemistry or the personality of the patient? Is that a relevant — is that related in any way?
A Well, it is related but in a way that I think I should make a comment about because since we know that these cannabinoids in the plant can turn the brain down a notch to bring it into balance to down-regulate it to reduce the neurotransmission, it has an effect on the brain.
Q Okay.
A There’s no question about that. It does alter the brain while those molecules are active in the system and once they’re metabolized — in the case of most of these molecules, they’re largely metabolized when they’re inhaled over the course of three hours and when they’re ingested, they’re metabolized over the period of about eight to ten hours — and then the effects may linger for a few more hours or even a few more days before they’ve finally worn off, but then the brain goes back to its natural state, unaltered, by having had these plant cannabinoids.

Q Okay. Let’s zoom in now on that issue but on kids because the patient in this case was a child and there’s been discussion about how this cannabis can harm the patient. Let’s continue just on the biochem- — the physiology and biology and the receptors. What effect -¬how does — is there increased risk of harm in cannabis in light of the fact that it’s a child and, if so, what’s the harm or what’s the reason there is no harm? Because that’s really what we’re talking about in this case, because there’s been testimony about some of these issues.
A I see. Well, in a word, it is not a harmful substance. Just in a one phrase, it is not a harmful substance. Granted, it’s not for everybody, but it does not harm the brain. It alters the brain while the active molecules are there, but it doesn’t harm anything.
Q How about in kids? What’s the basis, a biological basis, of you’re thinking it wouldn’t harm kids? Doesn’t it kill receptors or something like that?
A No, it actually doesn’t. It does articulate with the receptor. It activates the receptor. It increases the natural cannabinoids to work better for the
Q Do children have as many of these receptors, these ethno — endocannabinoids?
A They’re born with fewer —
Q Do children have as many of these receptors, endocannabinoids receptors?
A They’re born with fewer and through the earlier years of life, these cannabinoid receptors in the brain increase in population. When we use cannabis as medicine, this population of receptors diminishes in response to having this added load of natural — of plant cannabinoid.
Q Isn’t that a bad thing?
A No, because the cannabinoids that are there as plant cannabinoids and natural cannabinoids are providing a better ability to respond to whatever the stress is.”

I think this is pretty interesting stuff, especially considering all the kids who are being diagnosed with hyperactivity and more serious emotional/behavioral problems. I hope the explosive growth in the CBD field leads to research or at least publication of case studies of kids successfully treated with CBD or cannabis for their serious behavioral issues. Imagine a world without having millions of kids on Ritalin and other similar drugs.

Rick Jaffe, Esq.