√ Reactions To California’S New Stem Cell Law On Non-Fda Approved Clinic Offerings

What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds?

You probably already know that I am supportive of the California law. With more than 100 clinics in California as of last year marketing non-FDA approved “treatments” and this number apparently increasing, something needs to be done to protect patients. You can see the 2016 map of just the S. California clinics at right from Leigh Turner and my Cell Stem Cell paper last year.

Notably, Texas also has a stem cell law, but one that is not ideal overall and tends toward promoting stem cell businesses relatively more than protecting patients. Due to the efforts of some stem cell advocates in that state, the Texas is not nearly as bad as it started out.

Below I’ve listed some of the reactions I’ve seen ranging from stem cell scientists to policy makers to clinics themselves.

From stem cell scientist Jeanne Loring:

“This is a really good start to educating people that the FDA is working to approve safe effective stem cell therapies, and warning people that the unapproved clinics only care about money, not people’s health.”

From the Sacramento Business Journal, stem cell scientist and former President of ISSCR Sean Morrison supports the new stem cell law, but emphasizes as well that more needs to be done:

“The new law is “one small step in the right direction (to ensure) consumers are informed,” he added, but it will be important for the FDA and state agencies to remain vigilant against unscrupulous stem cell clinics. Morrison suggests that one reason the number of clinics increased in the first place is because the FDA was too lax in its oversight.”

I agree that more needs to be done, but sometimes progress is in steps.

And from the same article, the operator of the Nervana stem cell clinic here in the Sacramento area (see my past posts on it here) also says he supports it:

“Locally, Dr. Tushar Goradia, president of Nervana Stem Cell Center in Fair Oaks, said he supported the law. “I am in favor of it and anything that improves patient awareness and informs consent,” he said.”

I’d be curious if Dr. Goradia believes the law applies to Nervana or not, which seems to predominantly sell non-FDA approved amniotic stem cell therapies.

Some amniotic stem cell clinics have argued that they are exempt from FDA oversight, but an important issue is whether such firms are using living cells (and if so, are these really “stem cells”?), as they most often seem to be marketing, or just dead extracts of amniotic membranes. In either case, could the products still be considered drugs because of non-homologous use (e.g. injection into a knee joint, as joints have no homology to amniotic membrane).

A bit of other coverage out there so far including from David Jensen and RAPS.

Comments on Tuesdays’ blog post here on the new law range from skeptical it will have much impact to criticism of the FDA.

I saw a number of reactions on Twitter. From Tim Caulfield and Blake Murdoch:

Nice! Indeed redundant, but the providers of these unproven therapies don't seem to respond unless we sasaran them directly. Great news!

— Blake Murdoch (@BlakeMMurdoch) October 3, 2017

From Leigh Turner:

New CA law requires health care providers to disclose when advertised stem cell interventions are not FDA approved https://t.co/vajn0k2khc

— Leigh Turner (@LeighGTurner) October 3, 2017

From Geoff Lomax:

A win for patients considering #stemcell treatments; CA lead the way on Right-to-Know about unproven treatments: https://t.co/KFqME0H2O1

— Geoff Lomax (@Geoff_Lomax) October 3, 2017

What do you think of the law?

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√ Washington State Bill To Require Unproven Stem Cell Clinics To Post Notices

There’s some also encouraging action at the state level on direct-to-consumer stem cell clinics operating without FDA approval including most recently in Washington State.

Professor Charles Murry, UW

Last year here in California we passed a bill into law that (1) requires stem cell clinics selling non-FDA approved therapies to post notices for patients and (2) instructs the state medical board to keep track of the situation. Democratic Senator and Dr. Ed Hernandez was the sponsor.

More recently Republican lawmakers in the Florida State legislature sponsored a bill aiming to go much further with clinic oversight. Now Washington State has a pending bill (H.B. 2356) sponsored by Democratic Rep. Eileen Cody that would follow California’s lead in requiring clinic notices to patients.

You can learn more about the Washington bill in this opinion piece by two leaders in the stem cell research field up in the Seattle area, Drs. Chuck Murry and C. Anthony Blau of the University of Washington (UW). I was up visiting the UW just a few months ago to give a talk at their Institute for Stem Cell and Regenerative Medicine. It was great to visit there and learned a lot about the stem cell research ongoing at the UW including from Dr. Murry.

Topic of the Seattle area for-profit stem cell clinics also came up during the visit. The main newspaper up there, The Seattle Times, has run several ads for stem cell clinics selling unproven therapies that lack FDA approval just as we’ve seen happening across the U.S. with mainstream media ad buys these days including here in Sacramento.

I hope more common sense state laws get passed that then as laws provide consumer protections and protect patients. The Washington State bill seems right on track toward that goal. We’ll see if it and the Florida bill end up passing.

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√ Update On State Laws On Stem Cell Clinics: California, Washington, Florida

Photo from ISCRM at UW

California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved.

At this point, 4+ months into the enforcement period, I’m not sure if anyone has looked into compliance. Anyone know? If you run a stem cell clinic, have you posted notices? Is you are a patient in California who has been to such a clinic, have you seen a notice? According to the new law, the California state medical board in a broader sense is supposed to keep tabs on the situation.

What’s going on in other states?

A similar bill to our California one popped up a few months back in Washington state and stem cell scientists lobbied for it. I’m happy to report that just over a month ago, it became law so the growing number of clinics in that state need to start doing a better job educating patients as well. See picture above from the moment captured in time.

Florida is another hotbed for stem cell clinics with all kinds of things happening there ranging from patient lawsuits to federal lawsuits seeking permanent injunctions. Republican legislators there sponsored a bill that was even more assertive in oversight of clinics than that of California or Washington. Sadly, the bill died in committee or something like that before it even got voted on (HT to commenter “Bill Jones”). I’m not sure of any back story there on why.

Of course, there’s also that Texas stem cell clinic law too that to me seemed more pro-clinic, but my impression is that it hasn’t really practically speaking come into effect.

Anyone know of other states where stem cell clinic-related legislation is being discussed or if there’s an actual bill elsewhere?

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√ Top 10 Questions On Fda Suits Targeting Stem Cell Clinics

The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally going to be a drug product requiring premarket approval.

You can see my first quick take on these federal suits here as well as initial responses to the suits from the firms here and my Q&A with Patti Zettler on the cases here. It seems that the California case will unfold in the US District Court Eastern District of California in Irvine.

There’s still a great deal of uncertainty about what happens next. Here are what I see as the top 10 questions about these cases below.

1. Who wins? The biggest question is whether the FDA or the stem cell clinic firms will prevail in court. Of course, you never know, but I’d say USRM and CSN face really long odds for a variety of reasons.


2. Will the main defense be ‘patient rights to own stem cells’? I don’t see a clear legal basis to counter the FDA’s actions, but my impression is that the two firms both seem in their initial responses to have invoked what they see as patients’ rights to use their own cells. While there might be some scattered legal precedents for patients having rights to their own biological materials, I don’t see this defense flying. I’ve written before how we all may have fewer rights than we think to our biological materials like cells once they are removed from our bodies. See “Our bodies, not our cells?”


3. Will these clinic firms also cite the new Right-To-Try law in their defense?


4. Who will side with clinic firms if anyone? It’ll be interesting to see whether other entities take sides with the clinics. For instance, will the Goldwater Institute, which has taken a libertarian, I’d say somewhat anti-FDA stance on stem cells, support the defendants against these injunction suits? Or will conservative think-tank-like organization have to think twice given that both firms have been linked to patients allegedly losing vision? I’d lean toward predicting that Goldwater will not get involved, but we’ll see. Will other groups like Right-To-Try organizations might chime in? Nobody?


5. Will FDA ask for and if so get temporary injunctions? So far, no, but much may depend on the next question.


6. And related, will one or both clinics voluntarily shut down their offerings to patients in the interim as the suit progresses?


7. Will CSN lose a substantial number of its affiliates in the sense of some of those 100 affiliates at least temporarily stopping stem cell injections or going their own way outside of CSN?


8. Will FDA expand on stem cell clinic oversight with substantive action against other clinics while the current cases are pending? Or is this going to be the peak of activity from Gottlieb’s FDA?


9. More patient suits on clinics? Will other clinic customers potentially see the federal suits as a foundation for civil suits against more stem cell clinics? There are already quite a few suits recently settled and ongoing.


10. Move some offerings offshore? Will either of the two firms shift some of their clinic efforts outside the U.S.? We’ve seen that before quite a few times with stem cell clinics including Celltex. If USRM or CSN, which notably both already have some international presence, shift substantial adipose stem cell offerings to other countries, will they retain an active U.S. presence doing something?

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√ Law Firm Blasts Stem Cell Clinics In New ‘3 Shocking Facts’ Video

I’m becoming increasing convinced that patient suits against stem cell clinics are going to have strong impact, including based on the new steps taken by a particular law firm. For background, I’ve written extensively about these suits over the years and we’ve seen more recently that another academic group (Claire Horner, Evelyn Tenenbaum, Douglas Sipp, Zubin Master) has published a paper on the suits.

Screenshot from Andrew Yaffa stem cell clinics video, GRYC law firm

The law firm stepping up against clinics is GRYC or Grossman, Roth, Yaffa, and Cohen. They not only have and continue to represent patients in suits against unproven, for-profit clinic firms including most prominently against U.S. Stem Cell (USRM), but also they’ve become more outspoken about the duduk masalah of stem cell clinics and risks to patients.

GRYC attorney Andrew Yaffa has been quoted pretty extensively in the media and now speaks in a GRYC law firm website video (below and on the firm’s website) on “3 shocking facts about stem cell clinics.”

The video has three main accusations about the clinics:

1. Clinics are basically advertising on clinicaltrials.gov.


2. Clinics are using unproven fat stem cells, but often promising some kind of panacea


3. They are not following good manufacturing processes and are using “industrial grade enzymes” from a janitorial supply company.

 

This video is a tough blast directly at the clinics, but the stakes are high for patients and the clinics need to be confronted. The video has only been up a few days, but already has more than 3,000 views.

I have a feeling we’re going to see more lawsuits against such firms across the country.

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√ Romania Fines 5 Stem Cell Groups For Alleged ‘Dirty Practices’

It’s a funny thing how having this blog can provide insights into unexpected stem cell events and news going on around the world such as, most recently, action by the government of Romania on stem cell firms there for alleged “dirty practices”, news that as far as I know has only been reported in Romanian.

How did I learn of this?

I know a small amount of Romanian myself, but on my site I have a project called SCOPE, which provides a basic stem cell white paper “What is stem cells?” in dozens of languages. I developed SCOPE, but it was made possible via the generous offers of time by volunteer translators, mostly scientists who are bilingual. One of the languages is Romanian and the Romanian version of the white paper is entitled, “Ce sunt celulele stem?“

For whatever reason, when people search for “stem cells” or “what are stem cells?” in their own languages, often times Google and other search engines send them via search results to the SCOPE webpage here on The Niche. This seems to be true of Romanian as well. I noticed a huge spike in visits to the “Ce sunt celulele stem?” page last week over a couple days. To me this was a signal that something in Romania was happening with stem cells.

Doing my own searching I found this news article entitled, “Amendă pentru 5 grupuri medicale din România. Practici murdare cu celule stem”, which according to Google loosely translates as, “Fine for 5 medical groups in Romania. Dirty practices with stem cells.”

Overall, it reported (at least as I gathered with Google translate) that some Romanian authorities were acting on stem cells somehow. It’s not quite what I first thought from the title as I had guessed it meant something related to non-sterile technique or something like that, but going on to the subtitle it seems more related to alleged marketing or financial practices.

“MedLife acknowledged the anticompetitive practices of the stem cell market and announced the Bucharest Stock Exchange regarding the fine imposed by the Competition Council.”

The article goes on:

“The Competition Council has fined five medical centers (Medicover Hospitals, Med Life, Arcadia Hospital, Genesys Medical Clinic and Rur Medical) and two Stem Sure Solutions and CBC Laboratories (Stem Sure Solutions) to complete anti-competitive agreements private. The centers had exclusivity contracts with the two stem cell banks and were directing their patients to them.

In conclusion, the patients had minimal possibilities to opt for another stem cell source. If they had chosen another institution, they would have paid a much higher price.”

The fines seem pretty hefty as the largest was as best as I can tell just under the equivalent of $190,000 USD (converting the Romanian currency of Lei to USD), with some other fines in a lower range. A week or so later, I found an English language article on this topic that had popped up. The focus seems to be mostly on birth-related “stem cell” banking.

I wonder how much else is going on with stem cell firms around the world that many of us have no clue about (especially not in a timely manner) because we don’t speak the language and/or get the news feeds from those countries?

Note that I have no direct knowledge of the practices of nor allegations against the firms mentioned in the Romanian news article.

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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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√ Reactions To Historic Stem Cell Clinic Court Loss, New Court Order, What Happens Next?

It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently).

There is a wide range of opinions on the long-term meaning of this court ruling. Some like me view it as likely making a major positive difference, while others are more skeptical.

You can see my two posts on it here and here.

But what are others including the clinic firm itself saying and planning?

In this post I’ve included a sampling of views that I thought interesting and a note at the bottom on a new, small court order that seems significant.

I’ll start with the take of Professor Patricia Zettler, who is an expert in biologics regulatory matters including in particular FDA oversight. Dr. Zettler is a Professor at The Ohio State University Moritz College of Law. I reached out to her and here’s her initial take, which was cautiously upbeat:

“I think this is the great news from a public health perspective, and the right outcome from a legal perspective, it is consistent with the Regenerative Sciences opinion. Hopefully this will encourage FDA to continue its momentum in this area.”

She added more later:

“I can add that this is a preliminary victory, in that the defendants may appeal. But I think it is an important victory, even if preliminary, for both FDA and the public health. The opinion agreed with, or deferred to, FDA on all of the key questions of FDA jurisdiction over the defendants’ stem cell products. That bodes well for FDA regulation in this area. It’s a victory for patients too, if this musim continues, because hopefully we’ll start to see fewer hyped, unproven interventions sold.”

This is largely similar to my view too, but Patti is far more of a regulatory and legal expert so I put a lot of weight on her opinion.

Stem cell clinic attorney Rick Jaffe posted just a quick initial reaction to the court decision yesterday on his blog here, but he seems more skeptical of this having major impact:

“I’ll write about this again, once I have reviewed the judge’s decision closely. While I think this decision is legally significant, practically, it will have less effect than the regulators might expect, because, as I’ve said many times before, this was expected and many in the field have moved on to new HCT/P’s and here we go again, from the beginning.”

Unfortunately, he might to some extent be right about some clinics moving on to other unapproved biologics, some of which could be equally concerning. In his blog post he also wondered aloud whether the defendants would comply with the injunction and he thought they would. Consistent with that, we see this statement quoted in the NYT:

“While we believe there is substantial evidence to prove the efficacy of this protocol, we must immediately comply with the court as we review the decision,“ the company statement continued. “US Stem Cell Inc and US Stem Cell Clinic will continue to operate business as usual, but will no longer offer the adipose/SVF procedure.”

I don’t see how it can be “business as usual” without them being able to do SVF. However, it’s good news that they are respecting the injunction.

Instead of fat, they may focus moving forward on bone marrow stem cell-related procedures, but birth-related or other stem cells could also be in the mix, based on this quote in the WaPo story on the court ruling:

“A spokeswoman said the company plans to continue offering stem cell treatments derived from bone marrow and other tissue.”

I haven’t seen compelling evidence of bone marrow stem cell products being proven safe and effective outside of the hematopoietic cancer/disorder arena such as for orthopedic applications, but If the company mainly focuses moving forward on minimally manipulated, autologous bone marrow materials used only in a homologous fashion, that’s at least going to be much lower risk than non-homologous uses of SVF in my view.

The use of amniotic or other perinatal materials could be more complex as if they are living cells and they are by definition allogeneic too and they are often used by clinics across the U.S. in a non-homologous manner, they may also constitute a drug product.

There was another small development in court. USRM asked the judge yesterday for an order for the parties to discuss the nature of the permanent injunction, and here was part of the court’s response:

“ORDERED AND ADJUDGED that the PARTIES SHALL FILE EITHER an agreed proposed order of permanent injunction or a status report, not to exceed five pages, outlining any remaining areas of disagreement by Friday, June 14, 2019. It is further

ORDERED AND ADJUDGED that UNLESS AND UNTIL this Court enters a permanent injunction, pursuant to the terms of this Court’s Order on the Parties’ Motions for Summary Judgment, D.E. 73, Defendants SHALL NOT sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment. D.E. 73.”

To me as a non-attorney, it sounds practically speaking like a de facto temporary injunction is in effect. Lawyers out there — am I right?

I’m not totally clear though on a few things. Will USRM still be able to train others in the production and use of SVF as a for-profit service? I wouldn’t think so, but I’m not sure. Can they keep selling their kits?

The next issuance by the court on the actual ruling in favor of the FDA may help to clear things up.

More broadly, we’ll have to see how things unfold in Florida and at fat stem cell clinics across the US after this key court ruling for the FDA.

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