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Category: Stem cells regulation

stem cell mis-regulation

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Earlier this month, the New York Attorney General’s Office filed a false advertising case against a Manhattan Stem Cell clinic owned by Joel Singer, M.D. The clinic offers autologous stem cell transplant procedures for a wide variety of medical conditions. The clinic used to be affilated with the California Cell Surgical Network run by Mark Berman and Elliot Lander, who as you know, are defendants in one of the two FDA’s civil injunction lawsuits.

Here is the Washington Post article about the case.

https://www.washingtonpost.com/national/health-science/fda-sends-letters-to-20-companies-in-attempt-to-rein-in-stem-cell-industry/2019/04/03/7e01556e-564e-11e9-8ef3-fbd41a2ce4d5_story.html?utm_term=.e6c968d5d4c1

It was also reported in the New York Times

https://www.nytimes.com/2019/04/04/health/stem-cells-lawsuit-new-york.html

and the New York Post.

The articles reported that they couldn’t reach the clinic or its attorneys for comment.

The clinic’s attorney just filed the answer to the complaint. It’s not half bad, but you can judge for yourself.

Here it is.
singerfiledanswer

STAY TUNED!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

Per Pacer, on April fools day (with whatever significance that has to you), both sides submitted their replies on their respective summary judgement motions. The case is now as lawyers say, sub judice, (submitted for and pending decision).

No big surprises in these last papers. The government says the defendants are violating FDA laws and regulations, based on the FDA’s interpretation of the FDA statutes, and that the defendants admit the violations. The defendants argue that they are not subject to FDA drug requirements because the law doesn’t apply to them because it’s the practice of medicine and it’s a same day exempt surgicial procedure under 21 CFR. 1271.15.

The papers filed on both sides are excellent. The arguments were clearly made, and professionally and forcefully highlight the differences between the parties’ position.
I don’t think there was any more to be said on behalf of the defendants.

High quality papers like these help the judge make a decision, and I’m sure are appreciated by the court. So, congrats to both sides for a job well-done.

Look to a decision by late April.

Still, I don’t think that a Government win will have the effect the FDA or the anti-private stem cell clinic folks are hoping for. The industry has already, or is in the final process of moving on to the next HCT/P’s, and some of these puppies are likely to be harder for the FDA to stop under the current regulations and guidance documents. And, even if not, the whole process is going to have to start over again, the outcry from the stem cell establishment, inspections, delays, warnings letters, lawsuits. My prediction is that we will be well into the mid-2020’s before we’re at the same point with the next batch of products, at least if the FDA follows its current game plan. That’s going to make some folks happy, and others, not so much.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

US Stem Cell Case Update; No breaking news but . . . .

US Stem Cell Case Update; No breaking news but . . . .

Per the Court’s scheduling order, the parties filed their pre-trial materials yesterday, March 29th, including what’s called the Joint Pre-trial Stipulation (“JPTS”) which lays out for the Judge what each party’s contentions are, lists disputed and agreed-to facts and legal issues. It’s about as good of a summary of the case as the judge or the public will get prior to trial.

Because federal court cases like this have tight scheduling orders, it’s not an infrequent occurance that the pre-trial materials have to be filed before the judge resolves dispositive motions (i.e., summary judgment), and or even as in this case, where the pre-trial filing deadline is earlier than the submission deadline for the final response (called a reply) in summary judgment. In this case, the summary judgment replies aren’t due until the end of next week.

I explain this because while the pre-trial filings give a road map to the scheduled trial, both sides are arguing in their summary judgment papers that a trial is not necessary. I think they are right, and I’ve predicted that the judge will agree with them on this point.

That all being said, the JPTS provides a clear and succinct distillation of each’s side’s position, both factual and legal, what’s agreed to and what’s not, and that makes the document invaluable for anyone involved in the private stem cell clinic business, as well as anyone opposed to them.

For the ADHD among you, here is the essence of the case, as taken from the Government’s statement of the case:

“Defendants are violating the FDCA in two basic ways. First, Defendants’ SVF product is adulterated because Defendants are not abiding by CGMP. FDA inspections of USSCC in 2015 and 2017 revealed serious and obvious CGMP violations by USSCC. CGMP requirements are designed to ensure that drugs (including biological products) have the identity, strength, quality, purity, and other attributes for safe and effective use. Here, the evidence shows that Defendants violated CGMP by failing to aseptically process their SVF product to prevent microbiological contamination or test the product for sterility and for the presence of endotoxins (which can cause fevers and other health complications), among other violations. Because Defendants’ SVF product is not manufactured, processed, packed, or held in compliance with CGMP, it is adulterated. See 21 U.S.C. § 351(a)(2)(B). Second, Defendants’ SVF product is misbranded. Under 21 U.S.C. § 352(f)(1), a drug’s labeling must bear adequate directions for use. If it does not, the drug is misbranded. Specifically: (1) the SVF product does not bear labeling that contains information required for adequate directions for use, as defined in 21 C.F.R. § 201.5; (2) the SVF product is an unapproved prescription drug that is not excepted from labeling requirements requiring directions under which a lay person can use the drug safely; and (3) it is currently impossible to draft adequate directions for use because there is no scientifically valid evidence to show that the SVF product is safe or effective for any indication.

Defendants do not dispute the evidence of these violations. Defendants admit that they use their SVF product to address patients’ symptoms of neurological, autoimmune, orthopedic, and degenerative diseases and conditions, which makes it a “drug” under the FDCA. See 21 U.S.C. § 321(g)(1)(B), (C) (“drug” includes all articles “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body of man or other animals.”). Defendants admit that FDA’s 2015 and 2017 inspections of USSCC found that their manufacture of the SVF product does not comply with CGMP. And Defendants further admit the relevant facts about the labeling of their SVF product and the required information that is missing. Nor is there any question that Defendants’ SVF product contains at least one component that has been shipped in interstate commerce. These undisputed facts establish that Defendants’ unapproved SVF product is an adulterated and misbranded drug under the FDCA. See 21 U.S.C. §§ 351(a)(2)(B) & 352(f)(1).”

The defendants’ statement of the case explains what they do and why they are right about their three defenses.

There is one other noteworthy thing which came out in the JPTS (and Defendant’s summary judgment papers).

You know how TV network shows sometimes have crossover episodes? You know when the the LA NCIS agents work a case with New Orleans NCIS agents, and the case spills over from one show to the other. Well we’ve got a crossover in this case. US Stem Cell’s primary expert witness is Elliot Lander, otherwise known as Defendant Elliot Lander in the Government’s parellel case in California against the Berman and Lander’s stell cell clinic and organization. It’s not surprising since the venerable Venerable law firm is involved in both cases. Still, it’s alittle disspointing, though not surpirsing to see the lack of third-party support for the defendants.

Of all the arguments made by the Government, I think the toughest one to overcome is the adulteration argument based on all the cGMP violaitons. In my view, it’s not financially feasible for a medical clinic to be cGMP compliant, unless the clinic is attached to a drug manufacturing facility. There have been only one or two guys in the country that have pulled that off (one of whom was my long time fomer client). I don’t think there is any private stem cell operation that could do that.

So, you’re the judge in this case, and both sides agree that the way the injected product is processed doesn’t meet the FDA’s manufacturing standards in part because of drug safety concerns embodied in regulations to protect the public against dangerous, adulterated products. What do you do? Tell the company to go with god, and hopefully the lack of compliance with the standards which govern safe drug processing won’t kill or hurt anyone, because of defendant’s three arguments about why the rules don’t apply to them?

To me, the only interesting part of this case is what the FDA does after a permanent injunction is entered. I have to believe that through discovery, the feds now have a list of all the affilate/co-investigators (and in the California case as well). Is a letter, a copy of the permanent injunction and a proposed consent agreement in the future of these co-investigators? What can these folks do, if anything, to protect themselves?

What action will the state medical boards take against some of these doctors once there is a federal court injunction holding that the procedure is illegal under federal laws, which are both civil and criminal violations. Most states have a law which makes a violation of state or federal law, a sanctionable violation of the state medical licensing act. I’ve had some success resisting this type of argument in the FDA context, but seems likely it will be employed when all the facts line-up.

And that’s what keeps me up at night about this case.

Here is the JPTS. It’s well-worth a close reading for anyone involved or interested in the field.

jtpto

ptorderwitnessesandexhibits

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

US Stem Cell Co-Defendant Gradel Throws in the Towel; Mediation fails (big surprise)

US Stem Cell Co-Defendant Gradel Throws in the Towel; Mediation fails (big surprise)

The consent order of defendant Theodore Gradel has been filed. He is no longer involved with the company and has agreed to a permanent injunction enjoining him basically being in what the FDA considers to be the illegal private stem cell clinic business.

here it is: gradelconsentdecree

On top of that, the mediation between the FDA and US Stem Cells and its remaining individual defendant, Kristin Comella has failed. No surprise here.

What does that mean?

Well it’s obviously not good news for Comella or the future of her company. I had thought that the Judge was sending her a message in her denial of the joint motion to cancel mediation, that now would be a good time to fold. If so, the message wasn’t received.

My guess is that the judge will use the consent order as a basis of the summary judgment order she issues against the defendants, meaning the language of the permanent injunction order.

Look to the judge to accept the FDA’s position in toto, now more than ever since one of the two individual defendants has already accepted the FDA’s position. Interestingly, the consent agreement was also signed by the primary or local counsel for all defendants. Technically, it means nothing that the attorneys fighting a case for the two remaining defendants have agreed to the relief requested in the lawsuit for a third defendant. But still . . . . I incorrectly predicted a separate firm would be signing the consent agreement.

The only thing different between this case and the Regenerative Sciences case on which there is binding or almost binding federal circuit court authority is that the Colorado clinic expanded its HCT/P’s, so it didn’t have the same-day surgical procedure exception going for it (21 CFR 1271.15).

But the FDA guidance documents say, imply, or are being interpreted by the FDA to reject the 1271.15 exception to US Stem Cell Clinic because it is not the same HCT/P. In other words, the HCT/P which is extracted via liposuction (belly fat containing MSC’s) are not the same HCT/P which are reimplanted (some MSC processed SVF). That view is consistent with the FDA’s new “more than minimal manipulation” position in its guidance documents.

So unless this district court has a crystal ball and knows how the Supreme Court is going to rule on a pending case dealing with continued judicial deference to administrative agencies’ interpretations of their own statutes, I am going with the judge giving deference to the FDA’s interpretation of the same-day surgical exception, which knocks US Stem Cell Clinic out of 1271.15 safe harbor land.

The cross motions for summary judgement should be submitted to the court by April 5th. Expect a decision a week or three before the mid May pre trial conference.

Bottom line and practically speaking, Gradel’s consent agreement agreeing to the relief sought, which was signed-off by counsel of record for all defendants is just one more step to the inevitable, in my view at least.

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com

Breaking News in the US Stem Cell Injunction Case!

Breaking News in the US Stem Cell Injunction Case!

But first a ho hum update

Last week, both parties filed motions for summary judgment. What that means is that both sides are arguing that there is no need for a trial and that the judge can decide the case on the summary judgment papers.

The government argues of course that the defendants are violating FDA law by using their more than minimally manipulated products for non homologous use, and that it doesn’t fit within the same day surgical procedure exception (21 CFR 1271.15) because what’s being reinjected is not the same HCT/P as what was taken out.

US Stem Cell Clinic argues that it’s just a medical procedure over which the FDA has no jurisdiction, it is the same HCT/P, both out and in, and the court shouldn’t consider the FDA’s guidance documents because it did them without complying with proper administrative procedures, and also because the Supreme Court may soon reject the Chevron deference standard granted to administrative agencies.

The parties have another week to submit responses to their opponent’s motions, and then a week to reply to those responses. So look to the case being submitted to the judge for consideration around April 5th.

The pre-trial conference is mid May, and I’d look for a decision on the cross motions for summary judgement a week or two before the conference. Unfortunately, the parties have alot of paperwork due end of March, which in US Stem Cell Clinic’s case translates into a to six figure legal bill just for this month, I’d bet.

The judge has three options: Grant the government’s motion and the case is over. Grant the Defendants’ motion and the case is over. Deny both motions and the case goes to trial. Or actually there are a fourth and fifth option, which is partially grant one or the other motions and have a trial on the remaining parts of the case.

Now for the breaking news!

You’ll recall from my last update that the parties filed a joint motion to eliminate the required mediation. I thought the motion should be granted because both sides seemed intractable. Well, I was wrong about that, because something big has happened, but not formally yet.

In denying the joint motion to cancel mediation, the judge noted that one of the Defendants, Theodore Gradel, who is a co-owner of the company has entered into a consent order!

In her decision, the judge refers to the Defendants’ motion, which was filed by US Stem Cell Clinic and Kristin Comella, because as set forth in the papers:

Defendant Theodore Gradel does not join this motion for summary judgment as he has signed a consent decree, which the parties anticipate will be filed shortly for entry by the Court.”

In the judge’s order denying the cancellation of mediation, the judge asked the FDA to try again to convince the remaining defendants (read Comella) to give up, or maybe I’m reading too much into it. Here is the operative language. You decide for yourselves.

“There is no reason that the parties cannot negotiate as to the injunction requested by Plaintiff in its complaint at mediation. Indeed, it appears Defendant Theodore Gradel has entered into a consent decree. See D.E. 41. Moreover, discussion at mediation may lead to agreement or settlement of other related matters, streamlining any remaining issues for trial and/or summary judgment . ***”

We will know more once Thomas Gradel’s consent agreement is filed, but at this point, I don’t think the government is going to accept anything less than a permanent injunction, since by my calculation and judgment, a permanent injunction order is only 4-5 weeks away.

This development is not good news for Comella, and that’s an understatment. Gradel should have new counsel and he probably will now appear on the Government’s trial witness list. It makes the dismissal of the case as sought by the remaining defendants much less likely. The screws are turning.

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com

There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

Recent fillings and orders which were expected:

  1. Longer papers for summary judgement. The parties jointly moved to allow each to file more pages than is allowed for summary judgment under the local rules. The parties wanted double the amount. The judge gave them less.
  2. Yesterday the parties filed a joint motion to cancel the local rule required mediation. Mediation is a waste of time in a case like this. There’s no money damages sought, and the Government already told US Stem Cell Clinic what it wanted (stop selling stem cells). The offer was declined. Nothing has changed. The judge should grant the motion.

Summary Judgment motions are due on or before March 11, 2019, which is this Monday. Look to both sides moving for summary judgement.

Here are the arguments each side will make:

The Government’s motion:

  1. There are no disputed facts requiring a trial. US Stem Cell Clinic (USSCC) is extracting MSC’s from adipose tissue and processing the material into some kind of (SVF) Stromal Vascular Fraction, which it is using autologously on patients for a wide variety of non homologous uses.
  2. The extraction process and subsequent processing of the HCT/P’s constitute “more than minimal manipulation.” as defined by FDA regulations and guidence documents.
  3. As a result, the products are regulated as 351 (new drugs) not just 361 matieral (same day surgical procedure, homologous use and not more than minimal manipulation).
  4. There is no NDA or IND on file for the new drugs.
  5. The lab producing the product is not cGMP or cGTP compliant per FDA inspection memorialized in a 483 inspection report and a subsequent warning letter.
  6. As a result, USSCC’s prior and continued use of these products is illegal under Federal law, and specifically, introducing into interstate commerce an unapproved new drug. In addition, the drug is misbranded (since there is no approved labeling and instructions for use) and adulterated (because the drug manufacturing facility is not cGMP and cGTP compliant, and other reasons).
  7. The court should give deference to the FDA’s opinion under the Chevron doctrine, and there is direct precedent supporting the FDA’s and rejecting the Defendant’s anticipated argument (practice of medicine) in the Regenerative Sciences case decided by the DC Circuit.

US Stem Cell Clinic’s motion

  1. There are no disputed facts requiring a trial. USSCC is extracting MSC’s from adipose tissue and processing the material into some kind of (SVF) Stromal Vascular Fraction, which it is using autologously on patients, for homologous use.
  2. The SVF is not more than minimally manipulated as the character of the cells are not being altered.
  3. The material is removed and reimplanted during the same surgical procedure making the procedure exempt under 21 CFR 1271.15, under which the FDA has declined jurisdiction to regulate this and other similiar surgical procedures.
  4. USSCC is involved in the practice of medicine which is a matter of state law and not within the FDA’s jurisdiction, like any other surgical procedure that uses the patient’s own blood product for same day reimplantation.
  5. (If they’re clever, they might come-up with something else which hasn’t been talked about much, but we’ll just have to wait and see).

The Decision

Government 1 — US Stem Cells 0,

is my prediction

Will it matter?

Not as much as the Government (and the stem cell institutional players) think and hope.

Why is that?

Once you’re bitten by the stem cell bug, you don’t get out just because of a little set-back like a permanent injunction (even affirmed by the Court of Appeals). You adapt (or metastasize depending on one’s perspective). The public company involved or related to the lawsuit is non essential and expendable. There are other public company shells to be had in the next iteration of the business.

Stem cell therapy is the center of the medical universe right now. It’s intoxicating especially for participants who are not licensed physicians. Just look at all the chiros and naturopaths getting into it. And let’s face it, it’s a growth industry with great financial rewards, like the gold rush or the wild west. Once you’re bitten….

My guess is that Comella and her crew already have their Plan B figured out and ready to go, and it wouldn’t surprise me if Plan B is already up and running in a small way. And since she’s not a licensed health care practitioner, she doesn’t have to worry about a state medical board stopping her.

So I’m betting that regardless of inevitable permanent injunction granted on summary judgement or its affirmance by the Court of Appeals, she’s not leaving the field so fast.

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com

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

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 excerpt 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?

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