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Revised and Updated Breaking FDA News: Finally Some Action Against a Cord Blood Manufacturer & MORE TO COME SOON!

Revised and Updated Breaking FDA News: Finally Some Action Against a Cord Blood Manufacturer & MORE TO COME SOON!

For some reason, and for the life of me I can’t figure out what it is, up until now, the FDA has been extremely shy about confronting cord blood manufacturer/resellers. I can’t think of a single warning issued against these folks, even though they claim to their physician customers that their products are FDA exempt, which I have publicly doubted is the case. (See my post:…-treatment-legal/

Per the NY Times today, that changed last Friday, and for those living under a rock, but with access to the internet, here is the NY Times article.

Here is the actual warning letter sent to the company on Friday, March 29, 2019.

Big surprise, the FDA takes the position the company’s umbilical cord stem cell product is an unapproved new drug, not an exempt or solely regulated under a Section 361 type HCT/P product, under 21 CFR 1271.10. Also, and again no surprise here, the manufacturing facility is not up to cGMP snuff.

If you read my stuff, you know what’s coming next procedurally: a response by the company in which they’ll claim they are exempt and a promise to endeavor to look into fixing some of the cGMP issues, dead time, FDA response that the compnay’s response to the warning letter is unsatisfactory. Maybe another response, then more dead time and thereafter, if the company still has the same name and location, an FDA injunction lawsuit.

If the FDA has performed inspections at other umbilical cord facilities, and there are a number of them out west, expect another warning letter or two.

What effect is that going to have on the doctors buying and using this and other company’s product?

In the short term, none, whatsoever.

Why? Think whack-a-mole, and some economic and market realities. The econmic realities are that cord blood products are typically cheaper or alot cheaper than the autologous fat/MSC/SVF surgical proceedures, and cheaper is more popluar obviously, since the entire market is cash/non insurance reimbursable. Second, less training and equirement outlays for the docs for injecting products manufactured by others. Even chiros and naturopaths are getting into the non-autologous market. Third, skyrocketing demand based on the ineffectiveness of current treatment for many othopedic and other conditions. When you combine all three, you’re going to need a whole lot of hammers to whack all these moles.

But at least I give the FDA credit for going after the manufacturers, or the discredit for interfering with people’s rights to get the treatment they want without government interference. It all depends on your perspective.


In a statement released eariler today, April 3, 2019, the outgoing FDA Commissioner issued a public statement about this warning letter and 20 others that have recently been filed. These are not on the FDA’s web site, but I suspect they soon will be. We’ll see if it includes the usual cord blood suspects in the western part of the country or if it includes folks other than manufacturers.

Here is the commish’s public statement:

Stay Tuned!

Rick Jaffe, Esq.

The Smartest Thing the Vaccine Concerned Have Done Recently (or maybe ever)

The Smartest Thing the Vaccine Concerned Have Done Recently (or maybe ever)

But first, the dumbest thing the VC do, IMO. I have been very critical of both the tactics and strategic decisions made by the Vaccine Concerned powers-that-be. For example, although I understand the emotions behind them, I think all the lawsuits challenging SB 277 were a waste of time and money.

No court is going to create a constitutional right to a personal belief exemption, or stop mandatory vaccination under the current medical vaccine paradigm.  (You all know and hate the paradigm/mantra: vaccines are safe and effective, serious side effects are rare, herd immunity is a thing and vital, and vaccines have saved zillions of lives.)

I think the VC community has it backwards by looking to the judiciary for protection. The judiciary basically enforces medical norms/paradigms, at least when it comes to public health and safety. Judges do not create rights that jeopardize public health according to the accepted state of medical knowledge.

In explaining why every single vaccine rights case has upheld mandatory vaccination and denied a right to a PBE, one of the most prominent thought leaders candidly stated at the recent Physicians for Informed Consent workshop that judges don’t want to make a decision which could cause an infectious disease outbreak. That sums up the futility of attempting to obtain any kind of vaccine relief from judges on direct challenges.

In my view, there are only two viable ways to move things in the VC’s direction. The first is legislation, but even that’s hard in light of the vaccine paradigm.

The good news for the VC is that most states still have either a PBE or a religious exemption. In Arizona, expanding vaccine concerned rights is on the legislative table.  The bad news is that there is a renewed effort afoot to eliminate the PBE (recently failed in Washington, still pending in Oregon) and a new concerted effort to eliminate negative vaccine information from the Internet is underway.

Obviously, the best way to change things wholesale is to change the vaccine paradigm.

Beginning last week something surfaced which I think is the smartest and most exciting development in the VC area, maybe ever. I think if played right, it could be the game-changer the community has been searching for.

Here is is:

Rock Star physician Paul Thomas announced on Rock Media Star Del Big Tree’s podcast last week that in response to an Oregon medical board investigation about his public vaccine position, he commissioned an outcome study on his patients.  So far, he’s focused on the rates of autism in his pediatric practice. He’s a popular guy and reports seeing 3345 pediatric patients.

Here are the numbers:

CDC published autism rates:    1 in 45

Autism rate in his signature “Vaccine Friendly Schedule               1 in  440

Autism rate in his complete unvaccinated patients

(actual numbers, not rate)             1 in 715

Here is the link to a U tube where Thomas discusses this.

That’s a dramatic difference, but of course, it’s only one pediatric practice.

I’m wondering what the autoimmune disease picture would show with the same stratification? I would speculate that if you take a historical graph of the explosive acceleration of autoimmune disease over the past few decades and plotted it against the graph showing the dramatic increase in the number of vaccines given in the last few decades, there would be a strong correlation. (Or maybe that’s already out there in the VC world.)

Of course, that proves nothing. But then if you take what we have learned over the past decade or so about SNPs/genetic polymorphisms and adjuvants, a causation hypothesis/mechanism of action starts to appear. But that’s just the speculations of a lawyer.

So, what’s needed to help change or challenge the current paradigm?

More data for sure.

Here is my suggestion to the VC thought leaders. Think by example or for strategic guidance, medical and recreational marijuana, and right to try, and for goal purposes, think cancer registries.

Look, it’s clear that the feds aren’t part of the initial solution. Indeed, based on all the conflict, collusion and outright fraud at these agencies, the feds seem to be at the heart of the problem. Same with the main professional organizations. So, they have to be bypassed.

Impossible you say?

Look at the marijuana situation. It’s still federally illegal, but the pot movement bypassed the feds and went right to the states. They are winning the legalization battle, state by state. The feds have largely been marginalized in the medical marijuana field.

Same thing with the right to try. I worked on federal right to try legislation back in the 90’s and got nowhere. (In fairness, we had no money and some were some other problems). In the last few years, the right-wing Goldwater Institute has engaged in a fabulously successful campaign to make right to try the law in most states. The feds came around with its own right to try law last year, but that was only after dozens of states already had the law on their books.

The point is bypassing the federal vaccine mafia in favor of individual states is a plausible and probably better strategy to start to change the vaccine paradigm.


What if what the data Paul Thomas collated was required to be reported under state law? Suppose every pediatrician was required to register autism cases, severe autoimmune conditions and say vaccine status, and maybe even when each condition appeared in relation to vaccination. This is like what happens in state cancer registries, part of the reason for which is to identify cancer clusters. I think within a year or two, things might become much clearer on many fronts.

What if all the data was made public and you could look up a pediatrician’s autism and autoimmune disease rate? We are a society of consumers and consumers are entitled to as much information as possible to make an informed decision about their health care professionals. Why shouldn’t such information become a standard part of shopping for a pediatrician?

In addition, what I’ll call the “Thomas Gambit” should be employed by every pediatrician who comes under attack by a state board for vaccine beliefs or exemption activities. Also, I’m thinking it might be an interesting talking point, to demand that this information be collected and made public from the pro-vax pediatrician talking heads. Sort of a head-to-head comparision. Think there will be any takers?

Anyway, slick move Paul. Keep it up!

Rick Jaffe, Esq.

Is there a First Amendment right to share negative information/concerns about vaccines on Facebook?

Is there a First Amendment right to share negative information/concerns about vaccines on Facebook?

Whether you’re a hard core anti-vaxxer (and it seems no one claims to be one anymore), or have even the mildest concerns that some vaccines might be harming a small subset of people, it’s been tough times recently. The measles outbreaks in Washington, Oregon and New York have really stirred things up in both the public and private sectors.  

Congress has held hearings. Adam Schiff has even taken a day off from Trump-bashing to call on Amazon and social media to ban anti-vax content. (more about that later).  Amazon has responded by removing “anti-vax” movies from its web site. There is talk about removing books from on-line sales sites. Facebook just announced that it is implementing an anti-vax policy, as have other internet platforms. The soon-to-be former FDA commissioner has threatened unspecified federal action against states with low vaccination rates. See my post at:

I’ve recently written about a case report in a medical journal which was removed because the columnist dared to suggest to clinicals that they consider whether presenting symptoms might be acute encephalitis associated with the HPV vaccine. Here is that post:

 A filmmaker called me recently and told me his films have been removed from Amazon and there was only a peripheral connection to vaccines. He wanted to know what the community is going to do about it. That got me thinking about the obvious:

 Are we getting into First Amendment violation territory with all these actions?

I haven’t heard much of these kinds of issues reaching the courts, and a cursory search mostly confirmed that. But for grins, let’s work through the issue, starting with the where it all starts, the First Amendment:

Here are those magnificent but intentionally vague words:

“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.” First Amendment of the U.S. Constitution passed by Congress September 25, 1789. Ratified December 15, 1791.

I found a good explanation of freedom of speech on the American Library Association’s web site. Here it is:

“The right to speak and the right to publish under the First Amendment has been interpreted widely to protect individuals and society from government attempts to suppress ideas and information, and to forbid government censorship of books, magazines, and newspapers as well as art, film, music and materials on the internet. The Supreme Court and other courts have held conclusively that there is a First Amendment right to receive information; the right to receive information is a corollary to the right to speak. Justice William Brennan elaborated on this point in 1965:

“The protection of the Bill of Rights goes beyond the specific guarantees to protect from Congressional abridgment those equally fundamental personal rights necessary to make the express guarantees fully meaningful. I think the right to receive publications is such a fundamental right. The dissemination of ideas can accomplish nothing if otherwise willing addressees are not free to receive and consider them. It would be a barren marketplace of ideas that had only sellers and no buyers.” Lamont v. Postmaster General, 381 U.S. 301 (1965).

When the Supreme Court considered whether a local school board violated the Constitution by removing books from a school library, it held that “the right to receive ideas is a necessary predicate to the recipient’s meaningful exercise of his own rights of speech, press, and political freedom.”

But here is the really important point from this site:

The First Amendment only prevents government restrictions on speech, not restrictions imposed by private individuals or businesses. Mark Zuckerberg can restrict speech on Facebook because it is a private business and he is not the government, the action of private individuals.” 

Here is the page where this appears:

 Let’s call this the general rule of First Amendment free speech law. It only applies to restrictive action taken by the government. But as we’ll see, the Library’s view might be alittle simplistic and might even be changing. Nonetheless, as a general rule it’s accurate. So, if Facebook, Amazon and the rest of E commerce and the Internet are viewed as private parties, the First Amendment wouldn’t prohibit their content censorship, at least under current jurisprudence.

In terms of government or state restrictions on speech, the courts generally look unfavorably on censorship or government regulation of content of protected speech. Maybe the government can regulate the time, place and manner of protected speech, but that’s about it, in terms of protected speech.

 What about unprotected speech? Well Duhh! It’s unprotected (by the First Amendment).

What kind of speech is unprotected? Libel, slander, false advertising, words meant to incite violence, child pornography, obscenity (hard to define, but as the Justice said, “I know it when I see it”), students advocating illegal drug use at a school event, and of course, yelling fire in a movie theater if there is no fire.  

Well, the cleverer ones are probably thinking, what if the government claims that anti-vax misinformation is like yelling fire in a movie theater when there is no fire? It’s just as dangerous isn’t it? Scarring people by disseminating false information about the dangers of vaccines which we know causes parents not to vaccinate their kids which leads to these horrible outbreaks, or so the argument might go. Seems like a good guess that’s coming if the government decides to step in. And frankly, it seems like a formitable argument, based on the current medical vaccine paradigm (but more about that another time).

But circling back to the main point of this post, namely whether private companies have to comply with the First Amendment or whether they can engage censorship, there might be some wiggle room based on a pending Supreme Court case.  

 What if a private company acts with a public license, like say a public access cable TV station? Can it engage in content-based discrimination/censorship? Does the grant of a public license in some sense make the company a “state actor” which would require it to comply with the First Amendment like the government must?  

That question will be answered by the Supreme Court this term in Manhattan Community Access Corp. v. Halleck, No. 17-1702, My intuition honed by 30 plus years of practice and my deep legal scholarship gives me some insight into the matter. OK, not really, but here is what Wikipedia says about the case:     

“While the case deals with speech limited by a public access television station, questioning whether the station was a state actor or a private entity, analysts expect the case will determine if private operators’ limitations on free speech on social media violate First Amendment rights.”

For those who want to get the details and the prior case law. Here is the URL.

So, we might have some Supreme Court authority on the issue in a few months. (oral argument was two weeks ago).

Here’s another question: Suppose a government official tells Facebook or Amazon to engage in censorship? Is that enough for state action? Could that be a conspiracy? (I hate using that word in a vaccine post, but I mean it in a technical legal sense like in 21 USC 371). Probably not technically anyway, since legislators are generally cloaked with absolute immunity. (So, Adam, I think you’re probably OK, legally speaking. Now maybe go back to Trump bashing. You’re really good at it because you’re so measured and circumspect, which has to make it even more galling for our Dear Leader, but I digress.)   

What about search engines?

Can you sue them delisting companies or web sites?  You just know that’s coming as well.

That question was addressed in E ventures Worldwide v. Google. Google delisted the company because it thought the company was spamming. E ventures argued that it was kicked-off because Google didn’t want the competition from the company’s SEO activities.

The court held that Google’s action in removing the company from its search engine was covered by the same First Amendment privilege that attaches to a newspaper editor who decides which articles go on the front page and which are unworthy of publication.

Here is the URL for the decision.

This is just the most recent example of a company not being able to sue Google for being delisted. Earlier decisions go back to the early 2000’s. Here is an earlier one.

So, search engines have a First Amendment right to publish or not publish what they want, even if it’s content censorship, But Facebook arguably can engage in content-based censorship because the First Amendment doesn’t prohibit such companies from doing so?? Hmm. Some might consider that odd, and possibly require some harmonization.   

And at some point (but not here), I’ll need to address some specific federal communications laws applicable to internet provides which might provide additional wrinkles. (For those who just can’t wait, look at the E ventures decision which addresses the issue.)

Does it feel like we’re on a merry-go-ground? Are you getting dizzy yet? Good, that’s the point, meaning the law is still unsettled and has to be developed.

But for now, and I mean right now, my sense is that Facebook and other such places do not have to allow everyone to post anything they want, and these companies can enforce what they call their “community standards” at they see fit, in their absolute discretion. That would include removing material they consider to be anti-vax, at least until some court, (and that ultimately would be the Supreme Court) says they can’t.

But… (and like I’ve said in the past, there’s oftentimes a but), practically speaking, it might be harder than Facebook thinks to enforce its new policy. I’ll explain that in another post. But to give you a forspice (appetizer/taste for the Yiddish illiterati), one of my all-time favorite phases comes from JD Salinger’s Franny and Zooey, “verbal stunt pilots.”

Stay tuned!

Rick Jaffe, Esq.

FDA Commish talks from a place other than his mouth, and I agree with Richard Pan

FDA Commish talks from a place other than his mouth, and I agree with Richard Pan

FDA Commissioner Scott Gottlieb has just threatened states that unless they tighten up vaccine exemptions laws, the FDA may have to come in and federally force school students to be vaccinated

Here’s specifically what he said:

“Some states are engaging in such wide exemptions that they’re creating the opportunity for outbreaks on a scale that is going to have national implications,” FDA Commissioner Dr. Scott Gottlieb said Tuesday in an interview with CNN. If “certain states continue down the path that they’re on, I think they’re going to force the hand of the federal health agencies,” he added.”

Here is the story:

Now, I’m going to utter words I never thought I ever would:  

I agree with Dr. Richard Pan!

Here are his words in response to Gottlieb’s threat:

“Dr. Richard Pan, a pediatrician and state senator in California, said that although he welcomed national leadership on this issue, he was concerned about the legality of the federal government moving into an area that has been controlled by state laws.

“Traditionally, school entry requirements have been the role of the states, so there might be a constitutional challenge if the federal government tried to mandate by law those school requirements,” he said.”

Richard Pan and understatement is something I never thought I’d use together, but yea, there would be one or a hundred constitutional challenges, because it’s hard to see any federal forced vaccination mandate which would be upheld as applied to children in schools which are not run or overseen by the federal government.

There are many, many things that the vaccine concerned have to worry about, but what the FDA commissioner is threatening isn’t one of them, because it won’t happen. But… (and there’s almost always a but), look to some states to use the Commissioner’s words to ratchet-up state legislative efforts to eliminate personal belief exemptions and impose state oversight on medical exemptions. That I can absolutely see happening as another part of the recent national PR campaign against the vaccine-concerned. w

Rick Jaffe, Esq.

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.