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The FDA brings the hammer down on two quack stem cell clinics

Last year, the FDA announced a regulatory framework for stem cell clinics, and hopes were raised that it would finally crack down on the hundreds of quack stem cell clinics in the US. Yesterday, the FDA dropped the hammer on two clinics, seeking injunctions in federal court to stop them. Is this the beginning of a real (and long overdue) crackdown on these clinics?

I’ve been writing about stem cell quackery for a long time. Out of curiosity, I searched the blog for the first time I addressed this particular form of dubious treatment. Believe it or not, the very first time I wrote about stem cell pseudoscience was way, way back in 2005, and the very first time I wrote about stem cell tourism (i.e., traveling to countries with—shall we say?—laxer regulations about medical research and practice to receive “stem cell” treatments) was way back in 2008.

Since then, stem cell quackery has been a regular topic on this blog, more so since hockey legend Gordie Howe traveled to Mexico to receive an unapproved stem cell therapy for his severe stroke, resulting in a flood of credulous stories in the media about his “miraculous recovery” and even resulting in Keith Olbermann taking a run at me on Twitter for criticizing the company involved for using its partner clinic in Mexico as a way of bypassing US stem cell regulations because Howe was not eligible for the company’s US trial and for giving the stem cell treatment to Howe for free in order to garner publicity. Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies, the company involved, deny it was for that, of course, claiming that as hockey fans they only love Gordie Howe as the legend that he is and wanted to help him, but I don’t believe them when they say that was their only reason. After all, they’re businessmen.. Certainly love for Gordie Howe was nowhere near the main reason to invest greater than $30,000 to treat Howe. It was money well spent, because Stemedica got a lot of fawning publicity. I subsequently learned that the company had previously sold Penta Water woo.

Of late, as quack stem cell clinics have proliferated right here in the good ol’ USA, some using extremely dubious (and unethical) hard sell techniques. It’s not all bad news, though. In November, the FDA announced that it was going to crack down on clinics selling unproven stem cell treatments. At the time, I was a bit skeptical, given how toothless the FDA has been over so many other treatments (homeopathy, Stanislaw Burzynski, and others). I wondered what form that crackdown would take.

Now, I might be getting an idea. From the New York Times:

The Food and Drug Administration said on Wednesday that it was seeking court orders to stop two clinics from using unapproved stem cell treatments that in some cases have seriously harmed patients.

The clinics remove fat from patients’ bellies by liposuction and then inject an extract of it into various parts of the body like knees or the spinal cord, on the theory that the extract contains stem cells that can provide replacement cells that will repair the damage from injury or illness.

The agency filed two complaints seeking permanent injunctions in federal court, one against U.S. Stem Cell Clinic L.L.C. of Sunrise, Fla.; its chief scientific officer, Kristin Comella; and its co-owner and managing officer, Theodore Gradel.

The second complaint was against the California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills; the Cell Surgical Network Corporation of Rancho Mirage; and Dr. Elliot B. Lander and Dr. Mark Berman.

I’ve noted before that Florida seems to be a haven for these sorts of quack stem cell clinics. (I referred to it as a “paradise for dubious stem cell clinics.”) Actually, there are more of these clinics in California, but on a per-population basis Florida has way more.

But what about the other clinic, the California Stem Cell Treatment Center? The names sounded familiar.
As is my wont, I did a little Googling and perused the relevant websites. US Stem Cell Clinic, LLC offers a wide range of quackery, not just stem cell quackery. There are various flavors of stem cell quackery, of course, but there are also food allergy testing, IV nutritionals, ozone therapy, infrared therapy, and more. Like pretty much all quack stem cell clinics, the owners of US Stem Cell Clinic admit that their treatments are not FDA-approved, but try to use the dodge that “our procedure falls under the category of physician’s practice of medicine, wherein the physician and patient are free to consider their chosen course of treatment.” Basically, this claim refers to the FDA regulation in which cells can be removed from the body and reimplanted elsewhere, as long as they are “minimally manipulated.” The FDA has never fully defined what constitutes “minimal manipulation,” and of course stem cell companies try to define that as narrowly as possible, so that they can get away with as much manipulation as possible.

It turns out that I’ve written about US Stem Cell Clinics before. It’s worth revisiting. In November, the FDA wrote a letter to the clinic, and its findings were brutal. The clinic claimed, with little or no evidence, that its stem cell produce could be used to treat Parkinson’s disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease, pulmonary fibrosis, Crohn’s disease, lupus, and diabetes. I didn’t quote the letter the first time around; so I’ll quote it here:

During an inspection of your firm, US Stem Cell Clinic, LLC (USSC)1 located at 12651 W. Sunrise Blvd., Suite 104, Sunrise, FL 33323, conducted between April 10 and May 11, 2017, the Food and Drug Administration (FDA) found that your firm recovers and processes adipose tissue, a structural tissue, from donors for autologous use. Your firm uses (b)(4) to (b)(4) components from adipose tissue, which are further processed into stromal vascular fraction (SVF). Your SVF product is generally administered intravenously or intrathecally for a variety of diseases or conditions.

Records gathered during the inspection reflect that your SVF product is intended to treat a variety of diseases and conditions, including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. In addition, on your website you claim to “offer stem cell treatments” for “neurological . . . autoimmune . . . degenerative” and other conditions, including but not limited to “Parkinson’s, ALS . . . Rheumatoid Arthritis, Crohn’s, Colitis, Lupus . . . COPD, Diabetes, [and] Congestive Heart Failure.” See http://usstemcellclinic.com.

Therefore, your SVF product is a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)].2 It is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d). 3

So, basically, the FDA doesn’t view isolation of the stromal vascular fraction and further isolation of stem cells as “minimal manipulation,” nor should it. Personally, I was truly horrified to learn that this clinic is injecting this concoction intrathecally (into the spinal canal, to circulate in the cerebrospinal fluid bathing the brain and spinal cord). I’m also often quite skeptical that these “stem cell” concoctions actually contain any stem cells.

There were a number of other violations, too, including failure to “establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile,”” failure to “establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess, and more. Particularly indicative of the sloppiness of these stem cell clinics was the FDA finding that the clinic had failed to establish “procedures for testing the final SVF product, including tests for identity, strength, quality, and purity.” Also, the clinic impaired the FDA’s ability to carry out an inspection by refusing to allow FDA inspectors entry except by appointment and denying investigators access to its employees. In other words, it sounds as though US Stem Cell Clinics has something to hide to me.

I also can’t help but note that US Stem Cell Clinics’ activities had resulted in patient harm, including loss of vision. Indeed, an investigation by the Sun Sentinel revealed aggressive marketing strategies and three women who lost vision after “stem cell treatment” for macular degeneration.

The Stem Cell Treatment Center and Cell Surgical Network also sounded very familiar. In particular Mark Berman sounded familiar, and—surprise!—I had written about Berman and his clinic before, and he made as many excuses as any naturopath:

But a website for his Cell Surgical Network, an umbrella for dozens of stem cell clinics nationwide, lists more than two dozen other conditions the physicians are “currently studying,” including Parkinson’s, amyotrophic lateral sclerosis — more commonly called Lou Gehrig’s disease — congestive heart failure, lung disease, glaucoma, and muscular dystrophy.

The website is careful not to promise that the stem cell injections can cure or treat those diseases, and Berman said he makes it clear to all patients that the work is investigative and not FDA-approved.

Berman acknowledges that he has no published studies to back up his treatment. But he says he’s certain it works and is safe. As proof of his confidence, he notes that he used the therapy to successfully treat his wife for hip pain.

He says critics, including pharmaceutical companies and academics, want to profit by patenting stem cells and fear “disruptive technologies” that come from entrepreneurs rather than from their own incremental research.

Yes, Berman’s a quack, in my not-so-humble opinion. Worse, like the owners of so many of these quack stem cell clinics, he seems to be following the example of Stanislaw Burzynski by having patients pay to be part of their (crappy) research. For instance, this “study” of adipose-derived mesenchymal stem cells is “patient funded and not approved by the FDA.” The clinic describes initiating a “a pilot study to investigate the effectiveness of high dose adipose derived stem cells on interstitial cystitis,” noting that “followed closely through our research registry and data collected carefully to help establish effectiveness of our treatment protocols.” In other words, this is not particularly useful research. It’s not randomized. It’s not blinded. It’s just a glorified case series with longitudinal followup.

And, of course, the clinic has a Quack Miranda Warning right on its website:

The Cell Surgical Network and its affiliate treatment centers are not offering stem cell therapy as a cure for any condition, disease, or injury. No statements or implied treatments on this website have been evaluated or approved by the FDA. This website contains no medical advice. All statements and opinions provided by this website are provided for educational and informational purposes only and we do not diagnose or treat via this website or via telephone. The Cell Surgical Network and its affiliate treatment centers are offering patient funded research to provide individual patients with Stromal Vascular Fraction that contains their own autologous stem cells and growth factors and the treatment centers provide surgical procedures only and are not involved in the use or manufacture of any investigational drugs.

The Cell Surgical network does not claim that any applications, or potential applications, using autologous stem cells are approved by the FDA, or are even effective. We do not claim that these treatments work for any listed nor unlisted condition, intended or implied. It’s important for potential patients to do their own research based on the options that we present so that one can make an informed decision. Any decision to participate in our patient funded experimental protocols is completely voluntary.

This is, of course, utter bullshit. If you read the website, there are all sorts of claims for efficacy. True, they’re implied claims, but they’re strongly implied claims for diseases like asthma, myocardial infarction, Parkinson’s disease, muscular dystrophy, spinal cord injury, amyotrophic lateral sclerosis, and many more. Even worse, last August the FDA had the US Marshals Service seize five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact. Inspections also confirmed that the vaccine had been used to create an unapproved stem cell product and that the product had then been administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm.

A statement from the FDA noted that these clinics had not cleaned up their acts and therefore injunctions were being sought in federal court:

“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety. We cannot allow unproven products that exploit the hope of patients and their loved ones,” said FDA Commissioner Scott Gottlieb, M.D. “We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products. But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.”

I was skeptical before that much would changes as a result of new FDA policies, but now I am cautiously optimistic. However, the real test will be in how aggressive and persistent the FDA will be in following through and cracking down on the hundreds of quack stem cell clinics out there. All I can say to the FDA now is: More, please.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

30 replies on “The FDA brings the hammer down on two quack stem cell clinics”

It is good to see the FDA taking some action but it would be nicer to see all the clinic principals facing criminal charges.

Injecting some crap into the spinal canal seems to indicate that they are mad or psychopathic.

Before that, they were injecting it into patients’ eyeballs. Hence the “three women who lost vision” whom Orac mentioned.

U.S. Stem Cell Clinic L.L.C. of Sunrise, Fla.; its chief scientific officer, Kristin Comella
Her highest qualification appears to be her experience as a YMCA aerobics-class instructor,

It’s beginning to look like anyone can perform whatever-the-hell bizarre procedures they want on unsuspecting patients, as long as they don’t specifically claim (with some very exact wording) that they can cure or treat any particular medical condition. This is exploitation as well as harm… and the law can do nothing?

Perhaps it is time to rewrite the law?

Of course, it may be that there are existing laws that could be applied that either no one has realized are applicable or there may be policy reasons not to apply them.

It’s a lucrative enough business that these people can afford to hire top lawyers[1] to argue their side of the case. So unless the FDA, etc., can point to specific statutory language prohibiting some aspect of what they are doing, it’s hard to win a civil (let alone criminal) case against the operators of these clinics. That’s what the FDA was doing in the letter they sent to the Florida clinic (the one Orac quoted): pointing to specific statutes of which they found the clinic in violation.

[1]Not that they always pay those lawyers. See Burzynski, Stanislaw. See also Trump, Donald, who has similarly made a career of living at the edge of the law.

I think that Congress could do a great deal of good by outlawing the practice of charging patients for participating in clinical trials. That would take care of not only the quack stem cell clinics, but many other quacks, including Burzinski.

Anyone want to place bets on whether it will happen? I suspect that I would lose.

The two Chicago area perpetrators of this therapy that I’m familiar with are chiropractic clinics. One has been advertising daily [DAILY!] in the Chicago Tribune for well over a year – large ads, including occasional 2 1/2 page wraparounds. I’ve attended some of their “free education seminars” (read: sales spiels) and confronted the “doctor” of chiropractic, telling her that I believe stem cell therapy is a medical procedure. Her reply was that the clinic has an MD on staff. One wonders what kind of medical doctor would associate him/herself with a scam like this.

Checking today’s paper for the name of the clinic so I could include it here, I didn’t see the ad. Luckily I still have yesterday’s paper and found it. I called the number, twice – just to verify, but it’s no longer in service!

Perhaps they’ve been caught and put out of business. One can only hope…

Heh. I saw something similar on the cover of the Sun-Times yesterday and was perplexed, but I’m basically always in a hurry lately.

And this kind: naturopaths:

“The Nardella Clinic in Calgary also has a relationship with CSN but it is not an official affiliate and says it doesn’t conduct stem cell treatments. But practitioners at the naturopathic clinic sometimes refer patients to the California clinics run by Lander and Berman.

“A lot of patients come with stem cell questions because they know about them — they Google it,” said Ed Trahan, Nardella’s business manager. “If they were interested, [our naturopaths] would put them in contact with a clinic.”

http://www.cbc.ca/news/health/second-opinion180511-1.4659092

Dr. Lobe in Chicago is injecting umbilical cord stem cells into autistic children intravenously.

I had to talk my mother-in-law out of one of these clinics. I had a heck of a time explaining why it was a bad idea, and my job is development for removing cells from patients and putting them back. (Which is FDA approved and done in a super, super clean space with a huge amount of sterility monitoring and air sampling and all of that stuff.) The idea that someone in a basic lab is taking cells and putting them back into a person, when the cells were processed maybe not even in a BSC? I have no words, just screaming.

I am so, so glad that the FDA is coming down on this crap.

Oh man, that was covered over at Science Based Medicine and last time I checked it had 500+ comments from people talking about how wonderful EOs are. And trying to tell people that a pain killer is not an analgesic. (For real.)

Perhaps accomplished woo-meisters might find it easier to evade the FDA and simultaneously circumvent the costs and problems associated with running a clinic :

MIT researchers found that a 24 hour fast boosts the regenerative abilities of intestinal cells in mice. ( May 2018)

Mercola pushes the idea of eating only during a window of several hours a day and fasting for 12 hours or more. Similarly, Null
praises the merits of fasting for both physical and spiritual health. It regenerates Chi.

I’m sure that they can spin this study so that a multitude of “cures” will be “discovered”.
Just think: cancer, obviously, ASDs ( a la Wakefield), diabetes, arthritis, aging skin etc.

Books, videos and retreats can be created that will pad their wallets as well as special fasting formula supplements and dried vegetable/ fruit powders. .” Try this new all green drink: Rapid FAST

I suppose I have great stem cells because I usually only eat in the late afternoon/ evening .

I have a friend who’s into body building (not weight lifting, that’s a totally different thing) and he was all about the fasts (and working out while fasting) and how much weight he had lost and on and on. It doesn’t work for me, but hey, whatever floats your boat, as long as you’re not claiming miracle cures.

I suppose I have great stem cells because I usually only eat in the late afternoon/ evening .

I keel right over if I eat during the day (as this afternoon, missing most of the Cubs game and accomplishing nothing), but sometimes I get stuck if I’m too tired to eat at night. It was just a slice of spanakopita, hypothalamus.

I learned not to eat early when in grade school – I used to get upset.
I suppose it’s something of a family tradition: both my grandmother and aunt hardly ate until early evening. My mother DID eat and was heavy. So perhaps I learned by observation. AND I am almost thin.

I count myself as lucky as I made it to this age without any GI emergencies – both of my parents/ families had bleeding ulcers, GERD, IBD and similar. I am so far mostly self-treated for more minor problems.

Some inherited blood disorders can be cured with stem cell transplantation. This is essentially bone marrow transplantation, a complex procedure. No intravenous stem cells here.

Over at The Niche, I’m following this story after being on this topic for 8 years.

E.g. see my new posts with various reg experts & lawyers weighing in on what the clinics will do next, including one invoking potential to end up in “Felony Land”.

https://ipscell.com/2018/05/when-the-fat-stem-cells-hit-the-fire-will-clinics-sued-by-fda-opt-to-stop-soon/
https://ipscell.com/2018/05/helpful-zettler-insights-from-qa-on-fda-suits-against-stem-cell-clinics/
Paul

[…] Silly Dr. Gottleib. He actually thought that right-to-try was about expanding access to experimental therapies to terminally ill patients. Gottleib, as I’ve discussed, was the “least bad” choice Trump could have made for FDA Commissioner. Sure, he’s all for “streamlining” drug approval processes (translation: making them easier and less rigorous), but he still exists within a continuum of “normal” among FDA Commissioners, albeit on the conservative end. He’s not a hyper-libertarian Peter Theil crony who thinks the free market will take care of drug safety, nor does he think that online rating systems, a “Yelp for drugs” if you will, would be effective at assuring drug safety. Gottleib is, in contrast, the sort of FDA Commissioner that any Republican administration might have appointed. He actually believes in the mission of the FDA, as he showed when under his leadership the FDA started cracking down on quack stem cell clinics. […]

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