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Author: Richard Jaffe

A Injured Stem Cell Patient’s Story

A Injured Stem Cell Patient’s Story

I previously posted about a west coast stem clinic which had injured several dozen patients with its autologous based stem cell product. Here is a link to the prior post:
http://rickjaffeesq.com/2019/01/13/what-should-happen-if-a-stem-cell-clinic-harms-many-patients-revised/

Here is the story on one of the patients, written in her own words, with some deletions and redactions to de-identify the clinic.

The clinic told me I was an excellent candidate for their Lyme SVF stem cell treatment. They promised this treatment would boost my immune system to help my body fight off the infections and heal the damage from the infections. The thought of going somewhere and finally getting taken care of after 7 years of struggling sounded heavenly, but this place was anything but.

Before I signed up, I gave them all of my labs, genetic mutations, scans, you name it, they had it. I was still told I was “perfect for this treatment.” I was told there were “no risks” and it was an “85% success rate.” The only risk would be I might not notice any positive changes.

With this hope I scrambled to come up with the fee [in excess of 20,000]. I refinanced my home and gave them the last bit of money we had to invest into my health. It was scary, but I was reassured this would be what my body needed to heal from all of the neuro damage Lyme had caused. I was promised by several staff members and the doctors that I would heal from all of my damage. I have vision loss, hearing loss, loss of taste and smell, and neuropathy all over, just to name a few.

When I arrived my first day, I was greeted by friendly staff, but the person I expected to be introduced to, I never actually met, which was odd since that person was the face of the clinic and it was my impression that it was the person who designed the treatment plan for the patients.

They never ran any labs for me, just a body scan which I was told later that wasn’t as accurate as they made it out to be when I was there. I did ok with most of the IVs, but I did have a really bad reaction to two of the them. I did notice a bit of an improvement from the detoxing and felt hopeful. I woke up every night after the IVs gasping for air and being in a hotel alone like that was terrifying. I had never experienced that before and believed it was a good thing.

The day of my stems the procedure went ok, but I was bruised up pretty bad and ended up with a dent on both sides of my hips that are still there two years later. The night after the procedure I noticed my tinnitus got louder and everything sounded like I was in a fish tank. I was hoping this was a good sign of healing.

I went home and was told not to take any supplements, do not detox, don’t do any other treatments, and “just let the stems do the work!” This sounded really great after being on so many treatments and supplements for so many years. I was so hopeful!!!

I noticed a lot of ups and downs. Weird blood pressure dips, constant tingling all over my body and for the first time I was having a hard time sleeping. I took the tingling to be the stems working. I continued to believe I was healing.

Five months after stems, I developed mast cell activation syndrome after trying to work out. I took one small sip of white wine and five minutes later started having an anaphylactic reaction. I had never even heard of it before or had any allergies to foods or medications. I was so scared to be allergic to all foods, my environment, and anything I put on my skin.

I saw a local allergist first who was so worried for me and had never seen someone so overreactive. She was really angry and told me to contact the FDA. They wouldn’t explain what they gave me or the procedure. She didn’t know what to do for me so I was left to figure it out on my own. I researched it and found a mast cell specialist who put me on a mast cell stabilizer, Zantac and Claritin around the clock. It didn’t make all of my symptoms go away, but it made me not die!! I reached out to the clinic and they told me this was “normal and part of neuro healing.” I had a hard time believing this was normal, but stayed hopeful and waited for this to pass. They agreed antihistamines and a mast cell stabilizer were necessary. I was told there was no problem with adding these meds.

Months passed and I continued to get worse. I could not sleep or eat for two months straight. I don’t even know how I made it through it. I was so desperate and thought I was dying. The clinic doctors called it “neuro healing” for a long time. They said MCAS was a normal, temporary part of healing and I was to remain calm and hopeful. I was told to wait a year to 18 months for the neuro healing to be complete.

Somehow, I managed to change my meds and calm it down, but with every flare, my body would never be the same. It was even more confused as the month before. During this time, I started hearing the stem cell clinic changing its tune. Now genetics mattered, mast cell was not a good thing and we should never be on any antihistamines or mast cell stabilizers or it could make the stems continue to push out mast cells. They blamed all of my issues on my genetics when they damn well knew my genetics before I went! I was sent a ton of supplements hoping to help my body calm down, but I reacted to all of them. My throat turned red, I would get panicky and my throat would close up.

I believe the stem cell clinic doctor knew that they messed me up and offered free treatment and offered to pay for my flight. The doctor wanted to give me steroids and wouldn’t tell me what else. Steroids are extremely dangerous for someone with Lyme Disease and Mast Cell. I could not fly safely. It was risky to even go to the store. I was allergic to everything around me. I realized at this point I was on my own. So I was left to fend for myself closer to home. I begged for a refund since I spent everything for this treatment, but they wouldn’t offer one. It was devastating.

A year after mast cell started, I developed POTS and dysautonomia. Just when I didn’t think things could get any worse, this was way worse than I ever imagined. I faint all the time, I have vertigo when I fall asleep, and I cannot work alone anymore because it’s too risky. Traveling is impossible. I don’t go out to eat anymore. I’ve lost my taste completely. I have weird rashes and itch all over. I have SEVERE INSOMNIA and I cannot sleep without taking Xanax or my throat closes up. I have zero social life. I’ve lost half my hair and have bald spots. My skin is aging like crazy and I had great skin before this. I eat 10 foods and I react to almost everything. I have major digestive problems that I never had before this. My throat closes up and I have difficulty swallowing. Needless to say, I have been through HELL and I wish I could go back and not do this treatment!!

A full refund would be nice. I’ve asked them three times very nicely and they said no. I now have to raise money for all of my expensive medications and treatments needed to survive this. I cannot bind, detox or treat which makes me a ticking time bomb for death.

The stem cell clinic has people in all the Facebook groups trying to shut the sick patients up. They are all about marketing and control. They have threatened to sue two of my friends for sharing their experience in other Facebook groups. This is extremely stressful as you can imagine for a sick person to deal with. This is why I’ve chosen to stay quiet until now.

I messaged the clinic and asked them to take my positive posts down on all social media. I told them I was doing horribly and they responded with the option of exosomes. I would never trust them ever again or recommend anyone to this clinic. What a nightmare.

I am told that there are several dozen other patients with similiar stories of harm from this clinic. Although I support private stem cell clinics using autologous products, clearly there are risks involved and patients should be made aware of them. I doubt this paticular clinic is advising patients of all the horrible adverse events suffered by this an other patients, and that’s a shame, license sanctionable for sure, and possibly even criminal.

I’m hoping the folks operating this clinic get what’s coming to them. Even though I am a private stem cell clinic supporter, I’m going to do what I can to make that happen.

Stay tuned!

Rick Jaffe, Esq.
www.rickjaffeesquire@gmail.com
rickjaffeesquire@gmail.com

To my vaccine-concerned friends: stop saying that the Supreme Court decided that vaccines are “unavoidably unsafe.” It didn’t.

To my vaccine-concerned friends: stop saying that the Supreme Court decided that vaccines are “unavoidably unsafe.” It didn’t.

One of things that drives me crazy is when nonlawyers misstate the law. I have been informed by some of my vaccine-concerned friends that the Supreme Court actually stated that vaccines are “unavoidably unsafe,” and use the Supreme Court finding to support their argument that people should not be forced into vaccination because even the Supreme Court acknowledged how unsafe vaccines are.

I’m here to tell you that it never happened.

The Supreme Court has never held or decided or even affirmatively stated as a proposition of medical fact that vaccines are “unavoidably unsafe.” Those who make that incorrect assertion have misread or misstated the Supreme Court’s decision in Bruesewitz v Wyeth, LLC, decided in 2011.

The legal issue decidedin Bruesewitz v Wyeth, LLC

The issue in the case was whether after an adverse decision from the federal vaccine court, the alleged vaccine-injured party could pursue a state law, design-defect lawsuit. The district court dismissed the lawsuit on preemption grounds, and the court of appeals affirmed. The Supreme Court, per a majority opinion by Justice Scalia, affirmed, holding that all state law, design defect vaccine injury lawsuits were preempted by the 1986 federal vaccine act.

Before taking a closer look at the decision, a point about how lawyers analyze cases (which we call “legal method”) and how appellate courts write opinions.

The precedential rule of law established in a case is often called the holding. In Bruesewitz, the rule of law or holding is that any and all state court design defect vaccine injury lawsuits are preempted by federal law.

Anything other than the holding is called dicta, and would include the discussions which the majority and dissent opinion writers put into their respective opinions to show that the other side is wrong. And that’s what happened in this case, which gave rise to the incorrect notion that the Supreme Court decided or stated that vaccines are “unavoidably unsafe.”

Justice Scalia focused on the key language supporting preemption:

“the Act expressly eliminates liability for a vaccine’s unavoidable, adverse side effects: “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

(Page 5 of the opinion. Here is the link:
https://www.supremecourt.gov/opinions/10pdf/09-152.pdf)

So, the vaccine statute does in fact suggest that some vaccines could have adverse effects which are unavoidable. But of course, all vaccine-concerned know that. What this language means is that as long as the vaccine was properly manufactured and proper warnings were given (and that means using the FDA approved labeling language, including warnings and contraindications) then a vaccine manufacturer can’t be sued (outside of vaccine court) for any harm or side effects the vaccine caused.

One of the arguments which the vaccine-injured family made, which was adopted by the Supreme Court dissenters, was that the word “unavoidable” in the statute is a term of art, and refers to a comment in the Restatement of the Law on Torts.

We need to go sideways, times two, to explain:

What’s a Restatement?

Restatements are compilations the law by a group of legal scholars. They are like legal reference books which summarize the law on a given subject. They are not state specific. They relate the common or judge made law on a topic across the country. Restatements are not binding, but are frequently cited by judges, especially if there is no state case law on a legal point.

Products liability lawsuits

The easiest way to sue a product manufacture is to sue under a products liability theory because of strict liability, meaning you don’t have to show that the manufacturer was negligent.

There are three types or grounds for successful products liability cases: defective manufacturing, defecting warning, and defective design. It’s the third which was the basis of the vaccine injured plaintiff and the dissent’s argument.

Comment k to a Restatement section, states in effect that you can’t sue for products liability for “unavoidably unsafe products,” meaning, if there is no way to make the product safe or make a better designed product.

The dissent argued that because the vaccine statute used the word “unavoidable” that meant Congress intended to incorporate the “unavoidably unsafe products” concept from the Restatement section comment. (Note that Restatements don’t usually directly apply to, or interpret federal statutes, so to me the argument was pretty lame). With this and other arguments, the dissent tried to argue that not all vaccine design defect lawsuits should be automatically preempted (and presumably only those where there is proof that the vaccine is “unavoidably unsafe,” and that would open the door to more involved litigation in this and all other similiar cases issue).

Scalia discussed this argument in his majority opinion and mentioned the “unavoidably unsafe products” language from the Restatement, discussed in the dissent’s opinion. Scalia said there was no indication that the authors of the statute intended that the statute be interpreted by the Restatement comment.

This oversimplifies things somewhat, but the important point is that while Scalia did quote the Restatement’s comment’s words it was done in the context of the majority’s rejecting the application of the Restatement comment to the federal vaccine statute. (Scalia’s discussion of the Restatement comment is on pages 8-11. I confess to having a hard time following some of his semantic points, but his esoterica is not relevant to my point in this post).

So, I’m thinking that if you’re using Bruesewitz to try to argue that even the Supreme Court acknowledged that vaccines are unavoidably unsafe, now would be a good time to stop.

Rick Jaffe, Esq.
www.rickjaffesquire.com
rickjaffeesquire@gmail.com

Is cord blood/umbilical cord stem cell treatment legal?

Is cord blood/umbilical cord stem cell treatment legal?

Virtually all the attention I’ve given to stem cells in my prior posts has been on autologous stem cell transplants. But the private stem cell clinic industry actually started with cord blood back in the early part of this century. I have written about the start of this field and the FDA’s first two cord blood clinic criminal investigations in Galileo’s Lawyer. The short of it is that even back then, the FDA didn’t think a private clinic’s use of cord blood was legal (though in my first case, the feds decided not to indict my client, out of the goodness of their hearts. I got involved in the second case after the clinic owners were indicted. One of them is living abroad as a fleeing felon, as the government has been unsuccessful in extraditing him).

And despite the misinformation spread by the most of the cord blood manufacturers selling cord blood or Umbilical Cord Stem Cells (“UCSCs”) to the private medical clinics, the FDA hasn’t changed its position:

Allogeneic cord blood use is still considered illegal by the FDA except for blood transfusions/FDA approved uses manufactured by companies which have NDA drug approval or an FDA biological license.

To restate the point in the affirmative, there are in fact a handful of cord blood-based products which are FDA legal, either by an NDA or a biological license.

Here is one such example approved via a biological license.

https://dailymed.nlm.nih.gov/dailymed/index.cfm

Of course, the company manufacturing this product has an FDA approved label, which is something that none of the products being sold to the private stem cell clinics have.

But beyond these handful of FDA approved or BLA licensed products, every other cord blood product on the market is considered illegal by the FDA, as they violate the FDA trifecta of misbranding, adulteration and introducing into interstate commerce an unapproved new drug.

So, what are the approved uses of cord blood?

Here is some language from the FDA’s web-site explaining the law from its page on cord blood.

“Approved Uses
Cord blood is approved only for use in “hematopoietic stem cell transplantation” procedures, which are done in patients with disorders affecting the hematopoietic (blood forming) system. Cord blood contains blood-forming stem cells that can be used in the treatment of patients with blood cancers such as leukemias and lymphomas, as well as certain disorders of the blood and immune systems, such as sickle cell disease and Wiskott-Aldrich syndrome.

* * * *
“Cord blood stored for use by a patient unrelated to the donor meets the legal definitions of both a “drug” and a “biological product.” Cord blood in this category must meet additional requirements and be licensed under a biologics license application, or be the subject of an investigational new drug application before use. The FDA requirements help to ensure that these products are safe and effective for their intended use.”

Here is the link to the FDA page:
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm405558.htm

How do the manufacturers of cord blood and UCSC’s try to get around the law? Or how do they try to convince their customers that what they’re selling is legal?

Sellers of cord blood and UCSC products argue the legality of their products by reference to the tissue regulations and specifically 21 CFR 1271.10 (a) (1)-(3). But that doesn’t work because they cannot meet the (4)(i) requirement of no systemic effect or metabolic activity. With a few notable exceptions, all stem cells work via a systemic effect or is dependent on metabolic activity (exceptions would include HCT/P’s for wound covering, fat transfer, or blood transplants for medical procedures, or to treat the above listed blood related diseases).

Here is a link to 21 CFE 1271.10

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=1271.10

An FDA’s guidance document makes this clear, albeit indirectly. This is an except from the FDA’s HCT/P guidance document for small firms:

“3. What are examples of some 361 HCT/Ps that meet the criteria in 21 CFR 1271.10(a)?
[meaning the facility only has to register and its products are not new drugs]
• Amniotic membrane when used alone or without added cells • Bone • Cartilage • Cornea • Fascia • Ligament • Pericardium • Peripheral or umbilical cord blood stem cells (for autologous use or use in a first or second degree blood relative) • Sclera • Skin • Tendon • Vascular graft • Heart valves • Dura mater • Reproductive cells and tissues (e.g., semen, oocytes, embryos)
All of the above are minimally manipulated, intended for homologous use only, and not combined with another article, with some exceptions.”

In other words, UCSC’s for autologous or first or second degree blood relatives are not considered drugs and are just regulated under tissue registry rules (part 361 referenced above). Otherwise, and that means all allogenic uses, are regulated as a drug and requires an IND, NDA or a biological license.

The clearest and most recent statement from the FDA (or maybe I’ve just buried the lead)

The most definitive FDA statement showing the illegality of allogeneic, non-FDA approved cord blood or UCSCs comes from its November 28, 2018 warning letter to Genetech concerning the cord blood product it manufactured for Liveyon, which product caused infections in at least 12 people. Here is an article about the recall of the product:

https://www.biospace.com/article/cdc-and-fda-conduct-investigations-into-umbilical-cord-stem-cell-products-that-infected-12-people-so-far-/

Here is the heart of the FDA’s warning letter:

“Specifically, the umbilical cord blood products fail to meet the criterion established by 21 CFR 1271.10(a)(2), that “The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” As noted above, the umbilical cord blood products are intended to treat a variety of orthopedic conditions. Because the umbilical cord blood products are not intended to perform the same basic function or functions of umbilical cord blood in the recipient as in the donor, such as forming and replenishing the lymphohematopoietic system, using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c).

In addition, the umbilical cord blood products fail to meet the criterion set forth in 21 CFR 1271.10(a)(4). Specifically, the products, manufactured from donated umbilical cord blood, are dependent on the metabolic activity of living cells for their primary function and are not for autologous use, allogeneic use in a first-degree or second-decree blood relative, or reproductive use. (emphasis added)

As stated above, because your products do not meet all the criteria in 21 CFR 1271.10(a), and Genetech does not qualify for any exception in 21 CFR 1271.15, the products are regulated as drugs under section 201(g) of the FD&C Act [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. Please be advised that to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after showing that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]. The umbilical cord blood products are not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, we have determined that your actions have violated the FD&C Act and the PHS Act.”

It’s a mouthful, but in short, Genetech’s cord blood product is an unapproved new drug and there was no biological license for it, making it illegal under federal law. There’s more in the warning letter about why the product is illegal, like the fact that the products are being produced in a facility which is NOT complaint with current good manufacturing or tissue practices (CGMP and CGTP), which makes the products adulterated, but that’s just shooting a dead horse.

Here is a pdf of the FDA’s warning letter to Genetech:

genetechwarningltr

So, what does this all mean practically for the patients receiving these treatments?

FYI: I’ve worked on the defense side of FDA criminal investigations of unapproved new drugs for upwards of thirty years.

I have never heard an OCI investigator (FDA office of criminal investigations) even suggest that a patient could be a target. The patients are the victims of the crime, duped by the scum-sucking purveyors of false hope, such is the mindset of the FDA OCI. So, there is zero chance you will get into trouble with the feds if you fall prey to these possible future federal prisoners.

Of course, you’ll be using a treatment which is not FDA approved or biologically licensed. More importantly, the product you’re taking has been produced in a facility which has not met the rigorous requirements of a drug approved or biological licensed manufacturing facility. Don’t be fooled by claims that the facility has an FDA tissue or bank facility registration (the above described part 361). That’s different and a lesser standard.

So, if you’re someone who would only take legal FDA products, then taking cord blood or UCSCs for the treatment of a disease where the product does not have FDA approval and was not produced in an FDA biologically licensed facility is not for you.

If, on the other hand, you don’t mind taking a treatment which the FDA hasn’t blessed, then you need to do a risk/benefit analysis after being properly informed. The point of this post is to advise you that despite what the clinic owner is telling you, or what the manufacturer is telling the clinic owner, the product you’re receiving is not FDA approved or biologically licensed and has not been manufactured in a facility which has met the FDA drug approval or biological license standards. With this information, you are better able to make an informed decision.

What does this mean for the UCSC clinics and the cord blood product manufacturers of non-FDA approved non-biologically licensed products?

The above is how the FDA views what you’re doing. Most of the time, the FDA gets it way when it decides to take on people who sell drugs which violate the FDA’s trifecta, but not always. (See e.g. chapters 2, 4 and 9 of the aforementioned Galileo’s Lawyer.)

Still, to relate one of my favorite quotes from Damon Runyon: “The race isn’t always to the swift, or the fight to the strong, but that’s the way to bet.” So, be careful (and lucky).

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

THE BEGINNING OF THE END OF THE FDA’S REGULATION OF AUTOLOGOUS STEM CELL TREATMENTS FOR ORTHOPEDIC USE

THE BEGINNING OF THE END OF THE FDA’S REGULATION OF AUTOLOGOUS STEM CELL TREATMENTS FOR ORTHOPEDIC USE

A little over a year ago, the FDA made public its final guidance documents in the stem cell field (HCT/P’s in FDA parlance). The documents were highly restrictive and all but eliminated the use of autologous stem cells outside of clinical trials. (I have written about this many, many times. Just scroll through some of my prior posts in the stem cell category on my home page). Apart from being wrong, my view has been that the FDA does not have the resources to eliminate private stem cell clinics.

More importantly, I predict that the standard of care is going to incorporate same day, autologous stem cell transplant way before there are completed clinical trials which shows drug level efficacy, irrespective of the FDA’s and the stem cell institutional opposition to so-called “unproven” stem cell treatment. I’ve been saying that HCT/P’s treatments for various orthopedic conditions will probably be the first such accepted use. Proof is now here!

A recent blog on the Niche laments the fact that the highly regarded and exceptional Swedish Medical Center (“SMC”) was now promoting autologous stem cell and PRP (Platelet-rich plasma) treatments for orthopedic conditions. https://ipscell.com/2019/02/swedish-medical-center/

Needless to say, these advertised uses fall on the wrong side of the FDA guidance documents. The post further laments the fact that this “is part of a bigger trend where more legit medical centers have begun selling regenerative medicine “treatments” that are still being developed.”

GAME, SET AND MATCH!

Now that SMC and a few other big players are doing it, the pressure will dramatically increase on other “legit” institutional players to offer similar treatments and do so in a more public way, via their web sites and promotional materials.

The six or seven hundred private stem cell clinics have no doubt been taking market share from the major orthopedic entities. The big places self-promote as providing cutting-edge, state-of-the-art, except that they haven’t been since the many of the major players have been slow to introduce HCT/P’s into their institutional practices. Market/competitive forces are not and will not allow that to continue. All the players are going to have to go all-in, or they will lose their competitive edge and be viewed as practicing last century’s medicine.

Right now the FDA’s blind eye to these big players can be justified by its statement in the guidance documents that it would give everyone three years to come into compliance except for the entities which create the greatest risk of harm (like the defendants in the two current FDA injunction lawsuits and the few others who have received warning letters in the last year).

There are two years left in the FDA’s grace period, but I predict that in that remaining time, “unproven” HCT/P use will increase in all areas, and will dramatically increase in the orthopedic area. Even now, but more so in two years, it will be too late for the FDA to try to reign in the orthopedists from providing HCT/P treatments to patients. The patient demand will be too great.

So what’s going to happen?

For sure: after the end of the three-year grace period, the orthopedists will continue to use HCT/P’s whether or not the use for any particular orthopedic condition has NDA drug approval.

The FDA will be forced to revisit its position, perhaps by a select committee of major hospital practitioners (not the lettered stem cell institutionalist organizations), perhaps via a revision to the draft guidance documents of what constitutes homologous use and more than minimal manipulation.

But here is the most likely scenario:

The FDA will simply post a notice that it will continue to exercise its enforcement discretion and not stop HCT/P use for all or most orthopedic conditions. I’d look for that to happen in at least one other HCT/P use as well. This way, the FDA can save face and still maintain its jurisdiction over these folks and their procedures.

In short, the fact that entities like the Swedish Medical Center and a few others are now advertising HCT/P treatments for orthopedic use means that such use will quickly become the standard of care and the practice of medicine, which will make these procedures untouchable by the FDA, notwithstanding the agency’s flawed guidance documents.

That’s my prediction anyway.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

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. http://rickjaffeesq.com/galileos-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:
https://wp.me/p7pwQD-fd

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.
www.rickjaffe.com
rickjaffeesquire@gmail.com

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

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

Here’s my core position: I support a patient’s access to his/her own stem cells 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.

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. http://rickjaffeesq.com/galileos-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:
https://wp.me/p7pwQD-fd

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 Knoefpler et al reported 700 plus stem cell clinics in the US alone.

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, 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.
www.rickjaffe.com
rickjaffeesquire@gmail.com

Is CAM under stealth attack by the Monopoly Internet Megacompanies ?

Is CAM under stealth attack by the Monopoly Internet Megacompanies ?

CAM (Complementary and alternative medicine, now more commonly known as integrative medine) has always been polarizing in the medical community, and has consistently come under attack by conventional medicine advocates. In the time since I became active, it was the quackbusters, then the sceptics who evolved into the bloggers who attack all things CAM. Heretofore, they have have had a relatively small impact on the CAM community.

However, there might be a new threat developing which could have a much more serious impact on the CAM community.

I’ve only heard about a few specific cases, so it’s far too early to say it’s a trend, plan or a concerted effort. Here is what I’ve heard:

Amazon has recently stopped marketing a homeopathic line because of the products’ claims, which, according to Amazon, make them unapproved new drugs and hence illegal to market on Amazon. This may or may not have something to do with the FDA draft guidance document on homeopathic products published in late 2017. To my way of thinking, the draft states that essentially all homeopathic products are illegal new drugs, but that the FDA would only actively pursue those products which posed a substantial risk to consumers based on its published criteria. (Depending on who you ask, this is either a new poistion by the FDA, or the same position which the FDA always had on homeopathic remedies.)

Here is the draft guidance document:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM589373.pdf

The company is contesting Amazon’s determination. We’ll have to see how this shakes out.

Second:

Periodically, Google updates its search algorithms. It’s most recent update was on August 1, 2018. As part of the update, it does a medic update which among other things updates the algoithms for searches for health problems and clinics offering treatment for medical conditions.

Here is an article published a week after the August, 1st update, describing the update process. The article contains comments of some folks who appeared to be initially adversely affected.

https://www.seroundtable.com/google-medic-update-26177.htm

There are at least 3 CAM clinics whose organic searches have dropped precipitiously, and heretofore successful adwords have stopped producing eyeballs.

Is this an intentional effort to stiffle CAM therapies, or is it just an unintended consequence from a global medical update?

It’s to early to tell. There are not enough data points and there’s no smoking gun (yet). But it’s worth keeping an eye on the situation and see how many CAM places and products are adversely impacted.

Is the Amazon thing connected to the Google thing? Again, way too early to tell. But again, it’s worth keeping an eye on.

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

Five Things the FTC won’t like about Private Stem Cell Clinic Advertising and What it Can do About it

Five Things the FTC won’t like about Private Stem Cell Clinic Advertising and What it Can do About it

There have been some recent musings about what the FTC (Federal Trade Commission) might think about how the private stem cell clinics are advertising their treatments.

See https://ipscell.com/2018/12/upside-down-sometimes-wacky-fine-print-on-stem-cell-clinic-sites/

The post quotes advertising claims and disclaimers from a few of these websites and wonders what the FTC might think of this. I’m guessing the author already knows the answer, but for those who don’t, here are the five things the FTC is going to have a problem with any stem cell clinic employing the advertising/disclaimers commonly used by these web sites:

1. Lack of adequate substantiation for the claims and implied claims

Under FTC law, claims made by businesses (including medical businesses, to the extent the FTC choses to assert jurisdiction over them) require adequate substantiation. In the medical field that means that the claims have to be supported by well-controlled clinical trials. (Of course, FDA approval would do the job as well.) My guess is that at least initially and without a fight, the FDA wouldn’t think any of the autologous MSC/SVF claims made by the stem cell clinics have adequate substantiation, and hence the FTC would view all such claims and implied claims of efficacy as false advertising.

2. Use of testimonials

Most of these clinics use testimonials from successfully treated patients. The FTC doesn’t particularly like testimonials, and it thinks that disclaimers following testimonials that “results may differ” or that the “testimonial doesn’t imply success in your or any other case” are not usually adequate to negate the implied efficacy claim.

3. Lack of clear and conspicuous disclaimers

Most of the disclaimers in these web sites are at the end of the page, require scrolling down, and are in small print. From the FTC’s point of view, that’s a violation of its clear and conspicuous disclaimer policy.

(Here it is: https://www.ftc.gov/system/files/documents/plain-language/bus41-dot-com-disclosures-information-about-online-advertising.pdf

4. Disclaimers which are contradicted by the claims

The author points out that the there is an inconsistency between the claims made and the disclaimers. If the FTC agrees, that would also be a problem, especially as the claims are prominent and the disclaimers/caveats are not.

5. Based on all of the above individual problems, the FTC might well conclude that the overall net effect of these web sites constitutes false advertising, perhaps even if there was no clear and conspicuous disclaimer problem. The FTC is big on looking at the overall effect of a web site as viewed from the average person, and if it concludes that the overall effect is to make one or more therapeutic claims which is (are) not substantiated, then that’s a problem for the FTC which becomes a problem for the claim-making clinic.

So, what can the FTC do about it?

We’ve seen one example already, where it forced a settlement from a stem cell clinic.

What happens if an offending clinic doesn’t settle?

The FTC has two options. It can bring a federal injunction lawsuit in the district in which the stem cell clinic operates. Second, and the preferred approach seems to be to bring an administrative action in Washington, D.C. before an FTC employed administrative judge. All these FTC judges do is apply FTC law to businesses which other agency employees have determined has violated FTC law. Let’s just say that for a litigator (and a client) it’s not the best possible forum. Practically what that means is that if you’re in an FTC administrative proceeding and what you’ve done is in violation of an FTC guideline, you’re going be found in violation of FTC law, enjoined and probably fined.

So, what does all this mean for the private stem cell community?

The bad news for the clinics is that FTC cases are much easier cases to pursue than FDA cases, since they don’t require a week or two site visit by multiple federal investigators. It can all be done by FTC investigators at their desks. The good news for the clinics is that the FTC, like the FDA has limited resources, and heretofore, medical clinics have not been a FTC high priority, and I sort of doubt that will change in a big way, because they have overlapping jurisdictional authority with some other government agencies which have more direct and obvious oversight, like the FDA, medical boards and the consumer fraud divisions of the state attorney generals offices.

I’m curious why all these agencies haven’t sat down together and figure-out and implement a comprehensive approach and prioritizing to the private stem cell clinic issue. That’s what I’d do. Or maybe it’s coming. We’ll see.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

The free pass given by the federal and state authorities on private stem cell clinic’s publicly professed exuberance (aka web site advertising) is coming to an end.

By early 2019, I expect both federal and some state regulators to bring lawsuits and/or announce settlements with more than a few private stem cell clinics, many of which are affiliates of the two stem cell networks which are currently defendants in the FDA injunction lawsuits in California and Florida.

Having looked over a web site or two, it might be time for you folks to rethink your marketing strategy. The authorities have a different and quite technical view of what constitutes false advertising and what constitutes substantiation of actual and implied claims. And don’t even get me started on their view on implied claims. It’s not to be believed.

It’s the end of the year and now would be a good time to implement a correction plan for advertising which is likely to be viewed by the authorities as deceptive trade practices, for a couple reasons. First, of course it’s always to better to comply with what the authorities think is the law, which is better than having to duke-it-out with the authorities in an injunction action brought by the FDA/FTC or the state’s attorney general office, because it’s not really a fair fight. There might be arguments to be made in defense of some commonly made stem cell claims. However, per the above, the best choice is not to have to make them.

Second, there could be medical board implications for physicians who consent to or have a judicial finding of false advertising. That opens-up a whole other front, and who needs that!

In short, now is a good time.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
rickjaffeesquire@gmail.com

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

A few days ago, the big dog blogged that a San Diego TV station was reporting that the Medical Board of California (MBC) has announced its intention to form a task force to “investigate” private stem cell clinics, presumably following the Federation of State Medical Board’s (Federation) report on the subject.

Here is the post:
https://ipscell.com/2018/11/medical-board-of-california-task-force-to-investigate-stem-cell-clinics/

The intended or unintended implication is that all these clinics are about to be shut down by the MBC. But let’s take a breath.

What effect does this MBC proposed action actually have?

Short term: None. Task forces take time, even non-government task forces like the Federation’s stem cell task force took a year, and all it did was produce a relatively benign report.

It’s way more complicated when a state agency wants to study something, because the end result could change the law, create a new regulation or prompt agency action. Implementing a state agency’s task force’s recommendations requires either a new statute passed by the legislature, or an agency approved regulation, policy statement or guideline (like the compassionate use medical marijuana guideline). Anything substantively new by a state agency requires a lengthy administrative process involving input from the stakeholders and the public at large, through public comment and/or hearings. And that takes a lot of time and effort.

So, like I said, in the short term – say a year or eighteen months (at the very least) – I don’t see any change in the MBC’s practices resulting from its announcement that it will be setting up a task force to study/deal with the issue.

What could the MBC do after studying the issue?

A possible answer might come from the Federation’s 11 recommendations contained its task force report.

(Here is a pdf of the entire task force report. The recommendations start on page 10)

fsmb-stem-cell-workgroup-report[1]

The Federation’s first and main recommendation

The Federation’s first and central recommendation relates to the core issue in the private stem cell clinic model, namely the lack of clinical trial evidence supporting the efficacy of stem cell intervention for the conditions promoted/treated.

The Federation’s recommendation relating to this core issue is that there be a “appropriate rationale” or a “basis in theory” to use the “unproven” therapy and that unproven stem cell therapy should only be given when “proven treatment modalities have been exhausted.”

There are many facets and complexities to this recommendation. For example, the notion of “proven” modalities is a vast oversimplification of the state of medical knowledge in many serious diseases. Many “proven modalities” are not curative. For example, many cancer chemotherapeutic agents are only “proven” to extend median survival by a clinically insignificant period of time (like six to eight weeks), or provide no increased survival, but only have a proven palliative benefit. (Don’t even get me started about how cytotoxic chemotherapy gets approved based on evidence of palliative benefit.) Risperdal may be a standard of care treatment for autism, but it’s not a cure, it just suppresses some of the symptoms (and usually causes side effects as bad or worse than the behavior it’s meant to supress).

Nonetheless, in some sense, the Federation’s recommendation that “unproven” stem cell therapy only be used after proven modalities have been exhausted will be easy to satisfy by the private stem cell industry. Most of the patients who go to private stem cell clinics have incurable chronic conditions or fatal diseases which are refractory to other forms of treatment. There is no cure for MS or autism, and many MS patients and some autistic kids receive stem cell treatments for their conditions. Anecdotal evidence and solid theory supported by pre-clinical studies about how stem cells can affect some of these serious and terminal conditions likely supply the rationale for treatment under the Federation’s recommendation.

Many of the Federation’s other recommendations are innocuous, like raising awareness among physicians about the state of the law on stem cells, making sure physicians and patients engage in “shared decision-making,” making sure physicians don’t charge excessive fees (good luck with that, since boards don’t normally get involved in the cost of medical services).

There is a recommendation that medical boards review stem cell advertising claims and pursue false advertising physicians. That might be a good idea, but probably not practical since most boards are underfunded and investigations are complaint driven. There are not yet board investigative departments which search out false advertising by physicians. Maybe there should be, but I just don’t think that’s going to happen. So I think anti-private stem cell clinic forces are going to have to find another way to have the boards go after the stem cell advertising doctors.

An obvious recommendation was that the medical boards monitor FDA warning letters and investigate those involving “unscrupulous and unprofessional practices” relating to providing stem cells. The problem, as I’ve oft stated in prior posts, is that the the FDA doesn’t have the resources to do more than a couple of warning letters in the stem cell field in a given year. So, if the anti-private stem cell folks were looking to this recommendation to dramatically curtail private stem cell clinics, they will likely be disappointed and will have to figure out a work-around.

In short, my opinion is that the Federation’s recommendations, even if implemented in toto by the MBC, are not likely to slow down the proliferation of the private stem cell clinics. While there might be some things which the MBC could do to stop or slow them down in California, it’s going to have to do more than just adopt the Federation’s recommendations to get the job done.

Like what you ask?

Well, that’s not my job, so I’ll let the smart and competent people working at the Medical Board and the Attorney General’s office figure out what they can and should do to implement its task force’s recommendations. However, that will be many moons from now, and that is a long time in the stem cell world. By that time, I think other things are going to happen, both to the good and bad in terms of regulatory enforcement and developments in standard of care.

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffesquire@gmail.com