Today the United States District Court of the Southern District of Florida entered a permanent injunction against stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmed by the unproven treatments sold by these firms.
US Stem had lost the case a couple weeks back, but now we know the details of the permanent injunction on them by Judge Ursula Ungaro.
The order against US Stem, which is likely to be appealed, is appropriately strict in my first quick read through. I’d be curious of other’s views of it. Update: Here’s the FDA’s PR on the injunction.
I need to read it more carefully later today, but here are some highlights:
- “The SVF Product is a drug within the meaning of 21 U.S.C. § 321(g)(1).” Again, SVF is a drug.
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“Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of SVF Product to become adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B), and misbranded within the meaning of 21 U.S.C. § 352(f)(1) while the SVF Product, or one or more of its components, is held for sale after shipment in interstate commerce.” In this case, the SVF drug was adulterated and misbranded.
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“Defendants and each and all of their directors, officers, agents, employees, representatives, successors, assigns, attorneys, and any and all persons in active concert or participation with any of them, who have received actual notice of this Order by personal service or otherwise, are permanently restrained and enjoined under 21 U.S.C. § 332(a) and the inherent equitable authority of this Court from directly or indirectly receiving, manufacturing, processing, packing, repacking, labeling, and/or distributing the SVF Product, unless and until:” Here the court lists many conditions including getting a cleared IND for the defendants potential future use of SVF. My prediction would be that the defendants will not meet these conditions in the future and they’ll switch to something to focus on other than SVF. We’ll see.
- The court also orders careful oversight of the defendants. They will be essentially examined (by an “Expert”) and regularly monitored (by an “Auditor”) at the defendants’ expense.
- Defendants must correct CGMP problems.
- Defendants must destroy their frozen stocks of SVF within 30 days. This may be a big one as my impression (I could be wrong) is that they have banked quite a few people’s SVF on a for-profit basis. Will they have to refund all those people’s money? From the injunction, “Within thirty (30) calendar days after the entry of this Order, Defendants, under FDA’s supervision, shall destroy any and all SVF Product that is in Defendants’ possession, custody, or control. Defendants shall bear the costs of destruction and the costs of FDA’s supervision.”
- If the defendants don’t comply with the order, it will likely get very costly for them. If I understood the injunction text right, violations could result in tens of thousands of dollars a day in what seem to me to be fines: “If Defendants fail to comply with any provision of the Act, its implementing regulations, and/or this Order with respect to any of Defendants’ SVF Products and/or Defendants’ facility, including any time frame imposed by this Order, then, on written notice of FDA in this proceeding, Defendants shall pay to the United States of America: fifteen thousand dollars ($15,000) in liquidated damages for each day such violation continues; an additional sum of fifteen thousand dollars ($15,000) in liquidated damages for each violation; and further additional sum equal to the retail value of SVF Products.”
My impression in a general sense from having looked at the government’s proposed order submitted earlier in the evolution of this case is that the FDA got nearly everything it wanted.
I suppose this injunction could be overturned on appeal, but in my view as a non-attorney, I kind of doubt that.
What happens next?
I can’t be sure, of course, but I suspect in the end that a similar injunction will be put in place in the California case probably before the end of this year. What happens then to their scores of network member clinics? Presumably they will be subject to the same injunction as the Network if indeed the California case goes the way I think and results in similar language as the Florida one has.
State Medical boards may finally get engaged if doctors continue to sell unproven stem cells that are now unambiguously not permitted based on a federal court ruling. The Florida ruling may also be used in the many patient lawsuits against clinics, aiding the plaintiffs.
Some fat stem cell clinics are probably going to just switch to other unproven stem cell types, but it won’t be that easy. Many will drop out of the unproven clinic industry entirely. Other clinics may move overseas. A few might continue to try to sell SVF in the U.S. without FDA approval, but I bet not many and not for long.
Overall, this is good news for the stem cell & regenerative medicine field and for patients. Former FDA Commissioner Scott Gottlieb and current CBER Director Peter Marks deserve recognition for their hard work in this area. I see it as a victory for science-based regenerative medicine even as the larger conflict continues.
Dr Noll,
I would be happy to speak with you in any appropriate format. I am a clinician with 35 year experience, not a researcher although I have 3 publications in exercise physiology and a surgical technique paper from the 1980s.
I pulled out some recent papers from the orthopedic literature, of which there have been hundreds. Actually PRP was first used in MAX Facial surgery in the 1950s. I first observed it as a first year resident in Orthopedics in San Francisco in 1984. Dr D Cannon would draw blood and extract the clot to place in meniscal repairs to facilitate healing. This and articular cartilage is the Holy Grail of Orthopedics. Currently there have been protocols for years in sports medicine clinics using PRP for tendinopathies . These have shown marginal benefit, but certainly are a money maker for Docs. There are also accepted protocols for intra-articular injections with some marginal benefit. I am not aware of it being used as an epidural and it seem risky to me. It could be used around the spine as in prolotherapy. My practice it in joint replacement in Medicare patients and I have rarely used it in the office. Also the equipment and supplies are expensive and not covered by insurance. There is a good recent review in The American Journal of Orthopedics July/August 2016. Also check out the Mayo Clinic Orthopedic Surgery Update Vol 13 No1 2019 Novel Stem Cell Therapy for Repair of Knee Cartilage.
Sincerely,
Larry Schrader
drschrader83@protonmail.com
Office 901-465-4300
I feel compelled to comment as I have seen this before. 25 years ago as an Orthopedic Surgeon I was trained and educated in Unicompartmental Knee Replacement. There was plenty of evidence as to safety and benefits, but it was performed with a large procedure as in a Total Knee. The “new ” technique was not minimally invasive but rather appropriately sized. A I started to grow that part of my practice due to its success others took notice. I was branded as a “Quack” and persecuted for more than a decade. My competitors even manage to convince the Hospitals I used to ban this procedure. Even a false manufactured study was commissioned by a nationally renowned clinic. Fortunately I persevered and relocated and found a hospital to allow me to treat these patients. Subsequently I have been a teaching consultant and had about 8,000 successful patients and less than a dozen revisions over 20 years. Eventually most of my competitors took courses to learn how. Interestingly as insurance has reduced reimbursements an now Partial knees are paid 1/2 as a Total knee I am nearly to only Surgeon providing this ( although I also perform Total Knees) service.
I have also been using PRP in Surgery for 20 years due to its benefits. Last year Medicare and all insurances have stopped paying for this. So now I have to charge a fee outside of insurance with appropriate consent. I occasionally do this in my office and also have to charge outside of insurance. Insurance interestingly pays for viscosupplementation provided by pharmaceutical companies which the Orthopedic Academy “strongly cannot recommend” due to no clinical benefit after 20 years. So, am I selling “snake oil” and money grubbing when I provide these services for my patients benefit.
I was introduced to stem cells and SVF after I became a patient 7 years ago for inoperable shoulder injuries. Definitely nicer to sleep more than 30 minutes at a time. I also continue to perform shoulder surgery. Maybe this was placebo. I have trained and offer this in my practice following protocols, in addition to PRP. I have only educated patients and NEVER stated or implied any outcomes. I have seen years of patients conditions improving. Again maybe just placebo like a knee replacement. Aristotle defines courage as deliberating the risks of an action for a achieving some defined “good”. I think more physicians should be courageous when caring for patients and relieving their pain as this is good. I am confused that most of academia unequivocally says that stem cells are the future of medicine then immediately says not to use it. If you want to stop it, just get insurance to cover it and they will reduce reimbursement to the point that its will cease to be done just like a Partial knee .
lawrence schrader MD, FACS I’m surprised to read that you have used PRP for 20years, i must be wrong but never came across a publication from you standardizing that method. I have been wondering why or how would PRP do all the magic that has been showing lately only in ortho clinics, and now PRP epidurals. According to Biochem and Immunology, this is not making sense to me but I would love to know the hypothesis behind all this. Could I private message you regarding PRP? Thank you.
This is all very good. It’s good to see effective action against quack practices for a change.
Fat is being used for autologous stem cells by a different means in the USA right now. Do your research and you’ll realize this is merely a shift in the landscape. MSC-based regenerative medicine derived from SVF is alive and well in the USA, thankfully!
If the FDA would protect patients from doctors who perform poorly, instead of letting the fox (medical boards) guard the henhouse, perhaps we wouldn’t have MEDICAL ERROR as the THIRD LEADING CAUSE OF DEATH.
The enzymes given to fat aren’t the problem here – it’s the marketing and the competency of doctors. The gov’t wins on a technicality, but doesn’t address the root of the problem, which is medical injury.
Do you have any idea how hypocritical this is when the FDA let’s drugmakers sell ACIDS that eat plastic for INJECTION into SPINAL CORDS?
The following link is from Australia, but the same practices and injuries persist in the good ole USA! https://www.dailytelegraph.com.au/lifestyle/health/derek-morrison-tells-of-how-the-toxic-xray-dye-affected-him-and-prompted-his-pursuit-for-justice/news-story/6242b2c54637e125886562801cf1c2fb?fbclid=IwAR3ugKUPuz7ZEJoVaNjBfeNCjLnnLjMNMzUB6Z5R7qACrGjNt6tLeWBHF50
There is NOT INFORMED CONSENT in MANY MAINSTREAM MEDICAL PROCEDURES. This is squarely on the FDA and the industry players who successfully defang many meaningful regulations.
So, enjoy the stroke against the system – I pray it actually has a net protective affect rather than preventing people like me who have had LIFE CHANGING improvement in pain levels from fat-based stem cells. I vote for FREEDOM of CHOICE backed by TRANSPARENCY with TEETH behind it and MANDATORY INFORMED CONSENT laws that SPELL OUT ALL KNOWN and PLAUSIBLE RISKS.
While I agree that I am unconvinced with the FDA view that enzymatic treatment of adipose tissue turns the injectate into a drug. I am also completely unconvinced that the ‘treatment” of almost everything from eczema to Macular degeneration can be safely and adequately treated by SVF. It is nothing more than the unadultrated ‘treatment of everything by any means under the guise of a hear of gold’ which is causing the issue.
And to try to insinuate the use of pantopaque, which has not been used in medicine in any realistic way, in the last 20 years, to a failure of the FDA is ridiculous. Pantopaque was the best we had… but was replaced with iodinated contrast when it became available. Your conflation is ludicrous.
I do not believe, in any way, in the infallibility of the FDA. I’ve been around too long to see it’s utter failure and manipulation. But, as a physician for over 20 years, in this space, I have also seen the charlatans come out in force, just as they are now. I am not ‘anti-SVF’, but I am anti-ridiculous treatment. I am anti-charlatan. I am anti-scam.
As I am a victim of a similar so called clinic I am VERY excited that the FDA is FINALLY taking action against these people.
As a Stem Cell Biologist, yes I wonder HOW did just thoughts or maybe a few publications (working or not) made into treatments offered at Clinics? Whether an enzyme makes fat a drug or not, the simple rule used to be preclinical studies, Clinical studies i.e. Trials I, II, III and so on. Then seeing the positive over negative effects, a treatment, a drug/medication used to be marketed and that is called phase IV still. However, FDA taking action now is great as well.