√ When The Fat Stem Cells Hit The Fire, Will Clinics Sued By Fda Opt To Stop Soon?

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? Or will things heat up further?

In the interview I did last week with Patti Zettler she mentioned the possibility of a voluntary stop by the clinics. The more I think about it and read other things out there including a helpful piece on this situation by attorney Richard Jaffe, it seems like this is the most immediate question today related to this situation. Jaffe’s piece paints a pretty difficult picture for USRM and CSCTC/CSN. It seems like the companies are stuck between a rock and a hard place. So, what are they going to do?

Jaffe discusses potential factors for the two firms in favor and against shutting down the stem cell offerings, starting with those in favor of the firms stopping: “The FDA can seek a preliminary injunction barring treatment pending the outcome of the case” and “Potential criminal prosecution.” Keep in mind this is somewhat hypothetical at this point, as to the latter possibility, Jaffe lays out how this might unfold and possibly even end up in what he calls “Felony Land”. He writes that the felony possibility would hinge in large part on intent and he continues:

“Based on the operators’ prior receipt of the warning letters in late summer 2017, and more importantly, the fact that the operators are now being charged with FDA violations in a civil action, well that goes a long way towards proving they had intent or knowledge that what they are doing is illegal.”

If Jaffe’s right, that’s a big risk for USRM and CSCTC/CSN to take on if they opt not to cease doing what the FDA wants them to stop. Of course, Jaffe could be wrong. We’ll see soon how it plays out. One point of clarification on the above Jaffe quote is that to my knowledge based at least on what’s in the public domain, CSCTC/CSN has not yet received an actual warning letter, although the 483s on their inspections were notable.

Jaffe also mentions the relevance of the past USA vs. Regenerative Sciences case:

“…when the FDA filed a permanent injunction action against Regenerative Sciences and its physician owner, Chris Centeno, he decided to stop treating patients with his expanded cell, stem cell procedure pending the outcome of the case. Turned out he made the right decision since he lost both at the district and appellate court levels. I suspect that no criminal charges were brought against him in no small part because of that decision.”

I asked attorney Andrew S. Ittleman, who was counsel for Regenerative Sciences in the case, for his take on Jaffe’s point and about the relevance of the USA vs. Regenerative Sciences to the new suits:

“Regarding the Regenerative Sciences case, there was never a risk of criminal prosecution. Keep in mind that that case started more than 10 years ago, and at that time there was virtually none of the authority we have today defining the scope of FDA’s jurisdiction or the meaning of the terms in the Part 1271 regulations. That case is still instructive though, mainly because it reveals how unwilling the courts can be to wade into a technical dispute between a federal agency and a regulated business. Keep in mind that the government’s motion for summary judgment was granted and Regenerative’s counterclaims were dismissed before discovery even began! In matters like these, where the case is based on concepts which have been delegated by Congress to FDA and which the government describes as impacting the public health, expect the courts to defer to the agency and keep the litigation brief.”

Getting back to Jaffe, he goes on to list those factors he feels might favor the firms not choosing to shut down stem cell offerings at this point:

“Factors weighing for not closing down pending the end of the case:

1. There’s been no decision by a judge yet, and everyone is entitled to present a defense.

2. Their case is different from Chris Centeno’s case in the following ways: ____________,_______,______ (the defendants will have to fill in the blanks.

3. These folks are very, very motivated to seek vindication. Both Berman and Comella have been quoted in the stem cell press as expressing a high degree of motivation and belief in the righteousness of their actions, and caving-in just might not be in their DNA.

4. And here is the biggest factor and the consideration which could carry the day if they decide not to close down pending the outcome of the case:

Both operators have networks of physicians or franchisee physicians providing stem cell treatments throughout the country. (And that’s a big part of the reason why the FDA chose to go after these two first)….One way or the other, there might be some collateral legal/liability issues between the operators and their networkees.“

With all of this in mind, what happens next?

Jaffe has an overall prediction, “Having defended medical mavericks for a long time, my guess is that at least one of them (and probably both) is going to stay open, but we’ll see. It would be hard to overestimate the impact of these cases as they wind their way through the courts.”

Jaffe didn’t mention the additional possible considerations for USRM in deciding what to do based on the fact that it is a publicly-traded firm, which makes a big difference. Jaffe also could have mentioned that USRM itself disclosed it was subpoenaed by the SEC recently, which doesn’t exactly help lower the pressure on the firm.

Will one or both of these firms (including potentially CSN’s entire network of clinics) decide to stop taking customers perhaps even as early as in the coming week? The fact that we are even discussing this as a possibility shows just how different the stem cell clinic arena is today than it was just a week or two ago prior to the new FDA suits.

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√ As 2 Fda Stem Cell Clinic Suits Slowly Unfold, More Action Needed Now

For me there was a sense of “finally” when just under 3 months ago the FDA filed suits via the DOJ against 2 stem cell clinic firms, U.S. Stem Cell (and its affiliate U.S. Stem Cell Clinic, collectively referred to here as USRM) and California Stem Cell Treatment Center/Cell Surgical Network (collectively referred to here as CSN) seeking permanent injunctions. However, since the filings in May not much of anything has changed on these fronts and it appears that the FDA has taken no action against other apparent non-compliant clinics more broadly. In my opinion there’s a simple but troubling equation that applies here: the longer this limbo period persists, inevitably the more patients will get hurt and/or lose their hard-earned money.

Salvador Dali, The Persistence of Memory

As far as I know, USRM and CSN are continuing to sell what I see as unproven and unapproved stem cells to patients, and that could continue for a very long time. Already there have been delays granted by the court. The two court cases themselves are going to be slow, which is not unexpected. The USA vs. Regenerative Sciences case took a couple of years.

If these cases could take up to two years too and that could be easily anticipated, why didn’t the FDA go for temporary injunctions (a possibility discussed in my Q&A with Patti Zettler here)? Did they believe the temporary injunction requests would be denied?

The agency sent a clear message in May, but that message is already fading somewhat now today on August 1. The more time that goes by with no additional action, the less likely it is that non-compliant clinics will even think much about this.

It’s not just about risks for patients and the stem cell field, but also for the FDA itself in terms of its credibility if it’s seen as tolerating large-scale, non-compliant use of unapproved stem cell-based drugs in the context of (A) known harms from it and (B) the FDA’s very vocal pledge to do much more on what it called “bad actors” in this stem cell clinic arena.

Plus, there are more unapproved stem cell clinics opening every week too.

Beyond adipose stem cell and bone marrow-based clinics, amniotic and other birth material-related clinics are exploding in numbers with potentially non-compliant products often being transplanted by non-physicians. Talk about a dangerous combination.

While of course not all of the hundreds of stem cell clinics are non-compliant and some that are non-compliant may be relatively much less risky than others, in my view there are loads of specific, very problematic firms out there that warrant serious action by the agency and I believe these are known to the agency.

FDA, you need to do considerably more on the stem cell clinic persoalan and do it quickly. If there are wheels turning behind the scenes as I suspect there are, spin them much faster. The stakes are high and could include preventable patient serious injuries and even deaths, as have occurred already as documented comprehensively by a new paper (with my UC Davis colleague Gerhard Bauer as first author) just out today.

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√ Arthritis Patient With Pain’S Email On Stem Cell Clinic My Answer

Example of a joint (knee in this unrelated case) with osteoarthritis evident by x-ray.

Stem cells for arthritis and pain are hot topics these days and I’m getting an increasing number of patients reaching out with questions and sharing their situations related to arthritis or pain (or usually both together). I asked one arthritis patient who reached out to me if they would be OK with me sharing their email, with all identifying information removed, along with my answer to them. The point was to use this as example that would be helpful to the community. They agreed. Below you’ll see their slightly edited and redacted email and my answer.

The patient email:

Hi Paul,

I am in my fifties and was scheduled for a Stem Cell Therapy procedure here in —–, CA at —– Therapy with Dr. —–. I cancelled my appointment today because I was afraid of any risks in my future health. I didn’t really research it. I was just desperate to be out of pain due to an injury that has become inflamed in the joint, has loss of cartilage, and now has osteoarthritis degeneration. I was given a book of testimonies but when I was signing the consent forms and release of liability, I became suspicious of it being experimental and not approved by the FDA. Can you shed any light on the liposuction that extracts stem cells from your own fat in the belly and then injected back into the joint? Dr. —– would be in charge of injecting it in the joint after the extraction. He works at —–.

After cancelling my appointment, the receptionist said I should have done my research before making my decision and directed me to Cell Surgical Network. She said Dr. —– is affiliated with that organization. But I could not find how to maneuver through this site. I was supposed to then go to Stem cell resolution(or revelation) Not sure which one. I didn’t find anything. I was truly afraid to go through with it in ignorance. Can you please help me settle my wonderings? I want to know is this safe or not? Will it help or not? Am I foolish or not? Am I passing up an opportunity to be pain free or jeopardizing my health?

Thank you for your time, Paul.

And my answer:

Hi —–,

These are good questions and I understand where you are coming from with the pain.

I personally wouldn’t get a fat stem cell treatment for a variety of reasons. While these cells are unlikely to produce tumors, there are some risks particularly from the systemic injection into the blood. Although the risks probably aren’t high for each individual patient, they aren’t very well understood and aren’t zero. 

Beyond the safety question, a big reason in my opinion to not do it is that there isn’t good evidence that this stuff really works so I think in the big picture that the fat stem cells sold by the various clinics around the U.S. are going to be a waste of hard-earned money. 

I also tell people: At a minimum give it as much thought as you could before buying a car — would you buy a car if you didn’t know it would work? If there was no information on MPG, no warranty, and no crash safety data at all? 

You mentioned the FDA and also a group called Cell Surgical Network. Check out this recent FDA action via the Department of Justice in federal court (scroll down about half way): https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm. For me this is another reason to pause.

My best wishes to you,

Paul

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√ Stem Cell Clinic Doc Being Sued By Fda Now Gets Agency Warning For Unapproved Breast Device

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.

A lengthy FDA warning letter to Berman popped up this week on a different front.

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 defendants in 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” letters to 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.

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