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Thursday, July 26, 2012

FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012)


As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.

 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 

In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents....



Chris Centeno, M.D. said...


Very accurate post-you're 100% right. This was always positioned as a case that would be decided by the DC circuit, so that's were it's headed now. Not much changes for now, as we haven't done the Regenexx-C (cultured) procedure in the US since the 2010 stipulation. The FDA has reviewed the same day autologous cell procedures we still perform here and found them to be "practice of medicine", so those will continue. In the meantime, we look forward to getting answers to many of the important legal, regulatory, and constitutional questions the DC district court didn't address.

Chris Centeno, M.D.

Lee Buckler said...

Thanks for the comment Chris. It scares me a little if we don't disagree on something! We will certainly continue to watch the case with interest.

Barbara Hanson said...

Your blog was the most sensible I have read yet. Many seemed to be celebrating the ruling with champagne. As a patient and co-founder of the Stem Cell Pioneers forum, patients are devastated, but have a renewed vigor to support Dr. Centeno and to make our own voices heard. We do not need nor want regulatory protection like this. We have the protection of state licensing boards and malpractice insurance that physicians carry. So many refuse to have a dialog about patients that most of us believe that this issue is about their own protection, not ours.

Lee Buckler said...

Barbara. Thank you for your comments. I am pleased to be tagged as "sensible".

I would argue we DO need regulation like the FDA has created and that state licensing boards and other protections are NOT enough. There must be a line in the sand. The questions is where it should be drawn.

Please do not misinterpret my 'sensibility' or ability to understand both sides of the issue as support for RSI's position. If I had to choose a side right now I would choose FDA's on this one. I don't have to choose so I can be 'sensible' and grey and sit in the middle without cheerleading for either side.

I happen to think that where the FDA is currently drawing the line or how they are interpreting the regulation they created is less than ideal but I also happen to think it IS better than nothing.

I also know that if the FDA is too strict, in this world of global commerce, patients will go where they can to get the treatments they want. I'm more comfortable with this than many of my colleagues because I happen to believe there is a legitimate way to do medical tourism that involves world-class science, good clinical and manufacturing practices, informed consent, and ethical business practices and yet still provides treatments that are not allowed in very strictly regulated jurisdictions.

I don't think strict always equals safe just like I don't think permissive regulation always equals dangerous. I also don't think medical tourism is always fraudulent, unethical,and the result of poor science.

I also happen to believe that the current regulation does not stifle doctor-driven innovation as Dr. Centeno suggests. We see lots of physician-initiated clinical trials. What this prevents is doctor's charging for certain things before they pass a certain threshold of safety and efficacy. Maybe that's the big issue here. RSI could be treating patients today with the cultured version of Regenexx if they wanted to (under clinical trial) but they couldn't be charging for it. Maybe that's the real issue?

Mario Salinas said...

Hi,Lee. Thanks for this post. Just some thoughts and observations and questions:

It seems that patients will go out of the country with or without the FDA ruling; it has been done by celebrities and lay folk alike. Dr C has taken his product out of the country, so it has already taken business out of the U.S. And it is assumed that’s where the patients will follow. Until the FDA gets its act together, the off shore business model will become more prevalent.

Who checks on cell quality now? We need a way to assure the quality of the stem cells being used in the U.S. Dare I say? a regulatory entity to do QA certifications. DR. C mentioned companies doing quality checks on each other. This is commonplace, but does it improve overall quality? And how are patients to know they are getting the real deal? As it is now, one company just knows it has a better product than the competition.

States are establishing stem cell regulatory and quality certifying entities. Among other things, these institutions will give patients a measure of confidence in the therapies they receive in the U.S.

And lastly, Good luck to Dr C. He has a good chance of winning his case given the amount of evidence and knowledge to date with bone marrow stem cells. But the case in Texas is a little different.

Anonymous said...

Hi Lee,
Thanks for the great points. The decisions should be mutual and protective. As it comes to monetizing these research and applications should be evaluated case by case depending on the type of the disease, condition of the patient.

There are many diseaases without a cure/treatment. Regulation and protection with choice should be visited. The point of personalized medicine is not one size fits all as we know.

Furthermore, discouraging investigators and scientist to do research in this field since 90s due to ethical, legal or malpractice is not the solution. This is a cutting edge technology combined with single cell detection nanomedicine.

Patients should receive nationwide transparent information to make the best choices for their or loved ones lifes.

Dr. Danilo Zangani said...
This comment has been removed by a blog administrator.
Lee Buckler said...

I've deleted Danilo's comment because while I have high tolerance for and even try to understand and consider all points of view, I see no need - and thus have no tolerance - for making criticisms or disagreements personal. I have zero tolerance for personal attacks either on this blog or in my LinkedIn group. In my opinion, Danillo's post crossed that line. I will accept any post discussing the issues on their own merits and certainly love a heated debate.

Dr. Danilo Zangani said...

Mr. Buckler, you simply deleted my post because already Centeno menaced to sue you for the use of a correct common word that, in english, had the correct meaning in that contest. I read your conversation and Centeno menaces on your blog. So, please, avoid giving people this "ethic" stories. You are simply scared and you do not want any trouble.

Lee Buckler said...

Danilo. I have never run scared from threats of litigation. I have made corrections to but have never retracted a statement. I encourage you to post comments and criticisms but please keep them related to the issues without making personal attacks. Thank you.

Lee Buckler said...

For readers of this post, you may also find my Sept commentary an interesting re-read in light of developments in this case and the CellTex affair

Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy

American Patent Agent said...

I think youve made some truly interesting points. Not too many people would actually think about this the way you just did.

Anonymous said...

What is difficult for me, a scientifically literate husband of a wife afflicted with a neurodegenerative disease, to understand is this.

A statistical analysis that I made in 2010 showed that the U.S. (mainly NIH) is the overwhelmingly dominant supporter of stem cell RESEARCH, but is at the bottom of 13 advanced nation in the proportion of published articles referring to TREATMENT in contrast to clinical results.

Why does the FDA expend most of its energies running around shutting down stem cell treatment clinics and operations instead of seeking to encourage their establishment under appropriate guidelines and safeguards?

Of course we understand that it's in the nature of U.S. society to generate more quacks and frauds than other nations with more respect for authority and propriety. However more proactive and generous certification rules could readily distinguish between medically credible providers and shadier operations and bring the legitimate operators to support effective accreditation and regulation systems.

I understand there is also a major difference between U.S. requirements for new drugs, which are now defined as including stem cells outside of the body, requiring both safety and efficacy, and EU rules that require only safety.

The former seems to me to make much more sense. If you are dealing with a complex, labile field like stem cells and require efficacy as well as safety as
a criterion, how will the pitifully small number of clinical trials ever give us approved stem-cell treatment assurance of efficacy?

As long as tis - to me questionable- guideline is in force will we ever have meaningful, cutting-edge stem cell treatment ever be available in the U.S. or will we, like Governor Perry of Texas, continue to have to go abroad to get it?