Our California stem cell agency, CIRM, started as a baby even before I came to California in 2006 to start my lab here at UC Davis School of Medicine, but now CIRM or to use its full name the California Institute for Regenerative Medicine is I’d say a full-grown, mature 4dukt at about age 13 in humans years. Maybe CIRM years don’t go for the 7-year equivalent of dog years to human years, but perhaps 2 or 3 CIRM years to one human year.
I’ve covered the stem cell agency extensively here on The Niche over the last 8+ years. There have been critics and fans of the agency, and everything in between since its inception 13+ years ago, and many have weighed in here on this blog. While some critics used to focus years ago on the agency’s funding of embryonic stem cell research, the agency mostly funds other kinds of research now and its leadership has even been invited to speak at the Vatican the last couple years a few times. Other critics said the equivalent of, “Where’s the clinical trials?”, but with 49 funded clinical trials that issue could pivot now to be a positive that agency supporters can point to as a strength. Still other critics were focused more on economics of whether proposition funding in the billions was a wise investment.
Now that CIRM is in its prime but is poised to potentially run out of funds for new grants in the next year or two, how do you feel about it and would you support refunding it for another 10 years?
This kind of question might be on the mind’s of the California Legislature as it holds a hearing tomorrow on CIRM even though the hearing is not to my knowledge specifically focused on that question.
Elliot Lander and Mark Berman of Cell Surgical Network and California Stem Cell Treatment Center.
When the FDA has a major dilema with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman.
Berman and his clinic partner, urologist Elliot Lander, run an adipose stem cell firm called California Stem Cell Treatment Center. This clinic seems effectively to also be the HQ of a network of about 100 stem cell clinics called Cell Surgical Network. The FDA described the clinic’s and the network’s adipose cell product as a drug and the agency has not approved its use in patients.
The letter pertains to a breast augmentation-related device meant to deal with a side effect called capsule contracture. The FDA says in the letter that Berman is using this device called the Pocket Protector on patients despite a lack of agency approval. The FDA also has a long list of other more specific issues with the device and practices related to it.
In a press release accompanying the warning letter, FDA Commissioner Dr. Scott Gottlieb used some striking words. Here’s just one sample excerpt from the lengthy PR (emphasis mine):
“This is not the first time the FDA has notified Dr. Berman concerning his illegal marketing of unapproved medical products and potentially putting his patients at significant risk. Dr. Berman is well aware that the FDA has never approved any product to prevent or treat capsular contracture. By illegally manufacturing and marketing this device, Dr. Berman is taking advantage of patients and exposing them to a broad range of unknown health risks, including not effectively preventing capsular contracture as the product claims or causing additional harm such as infection or adverse reactions with the breast implant. We’ll continue our efforts to protect patients from those individuals who choose to skirt laws intended to keep patients safe and sell unproven and potentially unsafe medical products.”
I asked Dr. Berman for comment on the warning letter and Gottlieb’s statement. Here was his response:
“The FDA comments (written by Dr. Gottlieb or one of his associates on his behalf) are nothing short of libelous. I’ve never taken advantage of a single one of these breast patients. They’ve found me through friends and other doctors after desperately trying to find a way to obtain normal breasts after multiple failed surgeries for capsule contracture. I was the first surgeon in the world to use e-PTFE (i.e. “Gore-Tex” known as one of the safest synthetic implant materials) for plastic surgery patients. Over the years, I figured out how to prevent the recurrence of capsule contracture by lining the breast pocket with e-PTFE and preventing it from contracting around an implant. Over time, I was able to get a .3mm thick sheet of e-PTFE with 40 micron porosity made so there would be tissue in-growth without concentric scar tissue formation, thus preventing scarring of a typical breast pocket around an implant. Since 2003, I’ve treated many women with recalcitrant capsule contractures – many had over 5 operations and some as many as 12. They always got firm again – something well-known to the surgical community.
With the device I developed I could finally give women a chance to heal with normal soft natural appearing breasts – even in the most difficult cases. It required a total capsulectomy with implantation of the e-PTFE bladder and an implant.
Gottlieb may think he cares about advancing women’s health, but I actually have patients that have real problems and I actually have to take care of them and, thankfully, because of a little creativity and good engineering, I’m able to do just that. I’ve been working with the FDA for years trying to get this approved for simple IDE studies. The regulations keep growing quicker than I can finish an IDE application.
There is nothing about me that ranks as a “bad actor.” I’m here for my patients and frankly, I think doctors have turned into sheep and we rely on government agencies to make decisions that should be our responsibility. We’ve really lost control of our practices to so many other industries within healthcare. I take the Hippocratic oath seriously – “If you can help your patient, it is your duty to try.” I’m not happy that I can’t get this exceptionally successful product to market. I just don’t have the unlimited funding necessary, but I’m getting closer and still trying.”
The new warning comes on top of Berman already being in the situation with the agency over marketing of unapproved “fat stem cells” (a diverse mixture of adipose tissue-derived cells with a subpopulation that are stem cells) for a variety of health conditions. Berman, Lander, their specific clinic, and Cell Surgical Network are named as defendantsin an ongoing lawsuit brought by FDA/DOJ. The suit, filed last May, seeks a permanent injunction against the marketing of the unapproved fat stem cells. In parallel the FDA also sued for injunction against a Florida stem cell firm, US Stem Cell Clinic/US Stem Cell (USRM).
Earlier in August 2017 the FDA also reported that it had seized (via US Marshals) an unapproved drug product consisting of a combination of fat stem cells and smallpox vaccine from a firm working with California Stem Cell Treatment Center. The combo was apparently administered at California Stem Cell Treatment Center according to the FDA.
We’ll see what happens next, but the tension here just went up a big notch.
In my view the agency is almost certain to prevail in court. The permanent injunctions could be in place before the end of this year even with appeals or more likely sometime in the first half of 2020. More broadly, recently the FDA also sent out 20 or so of what I’ve called “mini-warning” lettersto other stem cell clinic firms (we don’t know which), advising them that they appear to be out of compliance with the law. Time is running short on these clinic firms as well.
It’s possible we’ll see a wave of clinic firms moving outside the U.S., possibly to the Caribbean or the Middle East, or moving away from marketing fat stem cell injections and perhaps toward cheap, sketchy birth-related “stem cell” products that have flooded the U.S. in the past few years.
StemGenex case court order awarding class action status to the lawsuit.
In the latest blow to the unproven stem cell clinic industry, a California federal district court judge just granted class status to a lawsuit against the fat stem cell clinic Stemgenex.
What this means in practical terms is that the lawsuit alleging fraud in marketing by the clinic firm amongst other allegations will proceed and may have 100s of patients involved.
Many of these people paid nearly $15K per treatment to the company. Presumably some customers got numerous treatments from the company. As a result, millions could be at stake here if the plaintiffs prevail and if StemGenex, et al. must return payments to customers.
This is a huge deal and a somber warning of a sort to many other clinics selling unproven and non-FDA approved stem cells.
You can see a screenshot of the top portion of page 1 of the court order here in this blog post, which begins, “This is a complex and troubling case.”
The firm representing the plaintiffs in this case Mulligan, Banham, & Findley, put up an announcement about the class certification on their website here.
From the news item, they wrote:
“On June 24, 2019, a class action was certified against a San Diego stem cell clinic, StemGenex, Inc., its owners and related entities. The lawsuit claims fraud, false advertising and violations of consumer law relating to stem cell treatments aggressively marketed to people with a variety of diseases and medical conditions. Moorer v. StemGenex Medical Group Inc., et al.,United States District Court for the Southern District of California, Case No.: 16-cv-2816-AJB-NLS, Hon. Anthony J. Battaglia.”
and further:
“The class is comprised of hundreds of customers throughout the United States, all of whom had the same type of treatment, a stem cell process which used each person’s own belly fat, and all of whom paid Defendants the same amount – $14,900 per treatment. The Court ultimately agreed with the patients that their claims were suited for a class action, stating, “The questions asserted are common questions of fact and, as Plaintiffs acknowledge, the answers can apply to all class members in one swoop.”
You can see an example of the type of customer satisfaction infographic that was up at one time some years back on the StemGenex website at right indicating in my view a claim of 100% customer approval, but the plaintiffs argue that some customers including the plaintiffs themselves, told the company they weren’t happy.
Past screenshot from Stemgenex website of claimed 100% customer satisfaction.
In my opinion this class action lawsuit certification is terrible news for Stemgenex, but good news for patients and the stem cell field. The year isn’t even half over and already 2019 is in some ways the worst ever for unproven stem cell clinics more generally.
For instance, another fat stem cell clinic firm U.S. Stem Cell, Inc. just recently lost a federal lawsuit and had a permanent injunction placed on it. A strikingly similar case by the FDA is pending in California against a number of co-defendants including a network of scores of clinics called Cell Surgical Network. The suits are both focused at least in part on whether stromal vascular fraction (SVF) is a drug, its alleged misbranding and 4dukteration, and the scope of FDA authority. In my opinion (as a non-attorney I could be wrong), the clinic network is likely to lose its case to the FDA as well.
A variety of other patient lawsuits are in the works against many clinics and the suppliers of the clinics too.
So even as the number of clinics likely has never been higher, a tide of governmental and patient lawsuits and many resulting court victories or expensive settlements makes the future outlook darker for the clinic firms.
Note that StemGenex may be trying to put the past behind itself as it recently appearedto have reincarnated as a clinic firm by another name, Advanced Cell Medicine.
Our California stem cell agency, CIRM, started as a baby even before I came to California in 2006 to start my lab here at UC Davis School of Medicine, but now CIRM or to use its full name the California Institute for Regenerative Medicine is I’d say a full-grown, mature 4dukt at about age 13 in humans years. Maybe CIRM years don’t go for the 7-year equivalent of dog years to human years, but perhaps 2 or 3 CIRM years to one human year.
