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