The Texas stem cell clinic Celltex was one of the most controversial businesses in the world of stem cells in 2012 and 2013 (see here for background and as an update see this new post on how the Texas clinic has teamed up with a local university).
The FDA essentially shut down the Celltex clinical operations in Texas for a host of issues, but the company itself has forged on even so. Now the firm is part of a new controversy involving dubious, experimental interventions including on at least one pediatric patient as well as the use of a child patient in marketing of such unapproved therapies.
This new situation surprisingly involves the Arthritis Foundation.
In fact, Celltex has formed a partnership with the Arthritis Foundation. This relationship raises serious ethical questions. For example, is it ethical for there to be an exchange of money between a charity that is supposed to be looking out for the best interests of patients and a dubious for-profit company selling unapproved medical interventions to such patients?
Another ethical concern is the use by for-profit clinics of clients, including potentially children, as potential marketing tools. A kid in such a situation cannot themself give consent to be part of experimental medical interventions or advertising campaigns.
Why would the Arthritis Foundation want to be mixed up in such ethically dubious stuff?
Here’s what the Arthritis Foundation had to say of their “joint” partnership:
“The Arthritis Foundation continues to support new and more effective interventions to fight arthritis. “We are excited about the groundbreaking advancements in adult stem cell research leading toward new treatments and therapies for arthritis patients,” says Fiona Cunningham, director of community advancement for the Arthritis Foundation South Central Region. We are proud and honored to partner with Celltex and companies like them who demonstrate their commitment to bring the future of stem cell technology for arthritis and related diseases to the United States.”
I have sent an email to the national office of the Arthritis Foundation hoping to communicate with their relatively new CEO Ann Palmer or other leadership about this situation with Celltex, but have not heard back. I wonder if the national leadership of the Arthritis Foundation knows about and approves of this apparent South Central Region relationship with Celltex?
Also in a recent newspaper piece that reads like an advertisement for Celltex, the Arthritis Foundation is linked with Celltex. In so doing has the Arthritis Foundation indirectly promoted potentially risky “treatment” of patients including children by Celltex in Mexico?
In the article and also in a video testimonial by a specific pediatric patient and his family–see screenshot below from the end of the video indicating that the video was paid for by Celltex–the deep ties between Celltex and the Arthritis Foundation are clear.
Celltex has been most famous in the past for its links with Texas Governor Rick Perry and for running afoul of the FDA, which again basically forced Celltex to stop their clinical operations in the US due to numerous problems including most prominently the fact that the clinic was involved in giving patients transplants of an unapproved drug made of laboratory-processed stem cells and doing so without a license from the FDA.
Celltex’s IRB provider Texas Applied Biomedical Services (TABS) also ran afoul of the FDA and the warning letter it received mentioned unapproved research on pediatric patients amongst those whose IRBs it oversaw. While in principal that may not have referred specifically to Celltex, it raises concerns.
Today Celltex has footprints both in Texas still and also in Mexico. However, because of its non-compliance with FDA regulations, Celltex stem cell “treatments” are apparently administered only in Mexico at this time since that country has relatively weaker regulatory oversight of biological drugs, but a sizable proportion of Celltex clients are still Americans. Amongst the menu of numerous diseases that Celltex has claimed it can “treat” is arthritis including in kids.
In late 2014 and now early in 2015, Celltex has ramped up a major PR campaign and surprisingly a substantial part of this PR push has been this puzzling alliance between Celltex and the Arthritis Foundation.
What gives?
I’ve been trying to learn more about this odd couple of the Arthritis Foundation and its partner Celltex. What have they done together more specifically?
They linked up on the links ( on the golf course).
Late in 2014 they also threw a joint “Bone Bash Gala“, which raised more than a quarter of a million dollars for the Arthritis Foundation. I would call that big bucks.
Celltex wrote about the event on their website:
“Celltex Therapeutics Corporation (Celltex) helped to sponsor the Arthritis Foundation’s 2014 Houston Bone Bash, the foundation’s signature costume gala. The Bone Bash, held on Saturday, October 25 at Hotel Derek, was established with the goal of raising awareness of arthritis and helping the foundation provide resources to those living with this disease and their caregivers. This year, the Bone Bash raised more than $260,000 for the Arthritis Foundation.”
Update: I’m not entirely clear on just who forged the links with Celltex as it seems that it is not just in Texas, but the bigger regional South Central branch of the Arthritis Foundation as well. Again it is not clear if the national office is onboard, although Celltex has been tweeting about their new friends at the Arthritis Foundation (see below) including what I understood to be the national Arthritis Foundation’s Twitter username.
Our very own Dr.Jones is speaking about #stemcells at the @ArthritisFdn legends and leaders luncheon pic.twitter.com/7zClAFN6EP
— Celltex Therapeutics (@CelltexCorp) April 24, 2014
Why would the Arthritis Foundation be a partner with Celltex? The simplest answer might be they are doing it for money, but I was not sure.
So I called Arthritis Foundation South Central Region office on the phone.
They confirmed that they do have a financial relationship with the controversial Texas stem cell clinic.
Celltex donates money to the Arthritis Foundation and then in return Celltex is a “sponsor” of the Arthritis Foundation.
The person that I talked to on the phone from the Arthritis Foundation South Central Region office said “Celltex gets their name out there” and in exchange the Arthritis Foundation gets money in the form of donations from Celltex. Essentially this appears to be a way for Celltex to pay for publicity and for the legitimacy associated with the Arthritis Foundation.
For the Arthritis Foundation to be arguably selling its name to do this seems highly questionable. It is also risky both to itself and to kids with arthritis as well as adult arthritis patients. I hope that they reconsider.
Celltex has made a big deal of the case of a particular pediatric patient that it transplanted with stem cells in Mexico.
Could Celltex be using this child as part of a marketing plan?
That plan might include newspaper articles such as the one mentioned above, the video discussed earlier, and even pictures of the pediatric patient dressed up in a Halloween costume with the leader of Celltex, which Celltex posted on its website.
I’m not going to name that patient, or show the pictures of him that have been put up on the web, or link to the video involving him out of respect and privacy for him and his family. I wish him and the family all the best and I’m glad that this brave kid is feeling better.
This situation certainly reminds me of the Stemedica case in a number of ways in which hockey legend Gordie Howe was given a stem cell transplant in Mexico made possible by the American company Stemedica followed by a media blitz centered on the supposedly miraculous recovery.
It’s a shame for the Arthritis Foundation to be mixed up in this.
I agree that patients are not and should not be satisfied with the over $1 billion price tag and 10 years that it takes for FDA approval. However, that doesn’t mean that the opposite extreme of instant approval without any clinical trial is OK. Questioning the methodology and experimental design of a cell therapy is not the same personally attacking the patients that are involved. Voices like Paul’s are needed to balance out those who would seek to exploit the desperate situations that many patients are in.
No one should be satisfied with the $1 billion price tag and 10 years that it takes for FDA approval. What is your solution?
The FDA’s dubious medical regulatory efforts go beyond stem cell therapy. State legislators have passed Right To Try laws in 5 states and 2 more are in progress, and this includes biologics like stem cells.
Congressional reps have 2 bills underway to reform the FDA drug/device approval process.
H.R. 5805 (113th): Andrea Sloan Compassionate Use Reform and Enhancement Act
H.R. 2090 (113th): Patient Choice Act of 2013
Energy and Commerce Cures – A path to 21st century cures
http://energycommerce.house.gov/cures
Citizens are not satisfied with the $1 billion price tag and 10 years for FDA approval.
Did you hear that 80% of Americans polled think that foods should be labeled as containing DNA?
Now, I’m sure that those people who are pushing for stem cell treatments to have no oversight are in the 20% who know what DNA is. But don’t you worry that you don’t know what these “stem cells” are? Surely you don’t want a storefront on every corner offering a sale on “stem cell therapies” and undercutting their competitors. What is the motivation to offer a safe effective therapy if there is no standard of therapy?
I’ve said this before, and I guess I’ll keep saying it. If these clinics would do two simple things, there could be some value extracted from their activities.
First, spend a few hundred dollars of the patient’s payment and send the cells you’re using to an outside lab for analysis.
Second, follow up on your patients using unbiased observations.
These two pieces of data would allow assessment of the identity and consistency of your preparations, and allow correlations to be made about what you put into people and how they respond.
This is the minimum required for evidence-based medicine. Without it, you might as well be selling placebos–there is a positive correlation, I’ve heard, between the cost of a treatment and the extent of the placebo effect.
They 80% statistic is remarkable — assuming it was a well posed survey.
I’m not going to draw the conclusion that 80% of Americans are intellectually incompetent. It may be that the statistic is more an indicator of the relentless misinformation and fear-mongering that we are all subject to nowadays (even up here in the wild white North).
Stem cell is a very simple procedure and you could do it in every hospital in the USA. Yes, that would be great and everyone who needs it could do it. Of course, that would not apply to specialty implants. But 85% of all stem cells around the world are done with a simple procedure either from the abdomen or the hip. A common procedure to anyone trained.
And……..do you really think the FDA would allow clinics to do stem cell in the USA with just the 2 pieces of data you mention. You are in a dream world. Billions of dollars are at stake for the medical field and pharmas. It will not be approved until patents are applied for and recieved and big bucks will be required for any clinic to do the procedure. Much of it at the taxpayers cost.
I live in a real world and most people going outside the USA in almost any direction are getting stem cell and getting results. People are not near as gullible and ignorant on these issues as the labcoat population thinks they are.
Hi Robert,
Actually, you aren’t really correct about this. The procedures that you describe, where cells are removed and administered back to the patient in the same procedure are not regulated the same way because the FDA considers the cells to be “minimally manipulated”. This usually/legally occurs in a cosmetic procedure or during a visit with a specialist. Still, this is limited by the amount of cells that you can remove from the fat tissue at that time, to be administered in the same session.
In the process that Celltex employs (as well as other stem cell therapeutic companies), cell removal , cell separation, cell banking and weeks-months of culture is involved to produce a therapeutic dose of the cells. This culture process involves multiple reagents, chemicals, media changes and manipulations to expand the cell population. There are many opportunities for the product to become contaminated with impurities during the manufacturing process. This is why the FDA regulates this type of biological drug in the U.S.
And this is why we cannot get stem cells here in the USA. Are you aware that the Bahamas are planning on coming a major stem cell center? Do you think they will be FDA approved? I know of a 70 year old 3 months ago who had stem cell for Parkinson. He could not feed himself, now he is driving, and no shakes. We have seen it. Oops, I guess that’s a testimonial so it doesn’t count. But it sure counts to him. 2 weeks ago another man was treated for Parkinsons and he could not talk, today he is talking away and feeding himself.
The stem cell industry is getting ready to explode and it will do it without the USA and without the FDA. The FDA has lost all its credibility with me and many others. So sit back and keep talking about the FDA and watch the progress pass you by. Good luck.
Hi Again Robert,
One last thing, if i may ask what you are suffering from in particular( not to assume, but relevant none the less)? There are a number of clinical trials available for a wide range of diseases. At no cost to the patient of course. See https://clinicaltrials.gov/
I just noticed Paul has mentioned this before, it’s a pretty great resource. https://www.ipscell.com/find-a-clinical-trial/
I have been involved in all aspects of this process. R&D, Manufacturing, Quality Control and Quality Assurance. Yes, it’s a LONG road for these therapies. But there are many exciting things happening currently. And potential patients do have access to this! Have you looked around before? Any luck? Can you tell me about your experiences if so? All the best.
I am really appalled at this new low in blogging that seems like a heartless attack on a child. You may not realize it (although you should considering Gordie Howe’s family who did respond to the negativity of your opinion on his treatment) that this type of rhetoric is very hurtful especially when spread across social media. I hope that you can see your way to softening up and showing some heart for those are suffering. And please find a synonym for dubious. The over use of it is starting to sound like someone scratching a chalk board with their fingernails.
As for your concern about the child’s privacy, I think someone of your intellectual caliber would know that anyone with half a wit can find the video with this child. You could have included the link in your article. The little boy does himself proud.
Barbara, your comment implying an attack on a child is hyperbolic and just flat out wrong. If a company conducts an experiment on a child in a for-profit setting and then publicizes it, then a blog raising questions about that company and its financial supporters is entirely reasonable.
Just because some folks might be able to ID the patient in question does not mean I will mention the child by name on my blog.
As to the term “dubious” and fingernails on a chalk board, can you suggest a better term? What does this bother you so much? Why do you care what I write?
My understanding is that CellTex is using adipose stem cells to treat a wide range of diseases. While it is quite possible that sometimes they are doing something useful to relieve inflamation, the overall literature (as far as I can determine) suggests that bone marrow derived stem cells are better for regenerating cartilage and bone. A recent publication indicates why this is so. Apparently there is a population of stem cells within bone marrow that are destined to make cartilage and bone.
http://www.ncbi.nlm.nih.gov/pubmed/25594183
What matters is efficacy, safety, and the relative risks and benefits of alternative treatments — or doing nothing. Sometimes, doing nothing (because no treatment is approved) can also be very bad for your health. The FDA sets an “approved/unapproved” switch. The truth is almost always more nuanced. Just because something is not approved doesn’t mean that it has to be harmfull or totally useless.
Given such circumstances, I don’t agree with your view that for-profit companies should be automatically vilified just because they offer treatments (outside USA) that are not approved by FDA. (Even university researchers expect to get paid for experimental work.) Of course they should be villified if what they are doing is clearly useless and harmful.
The Arthritis Foundation may have quite pure motives — they may simply see that autologous MSC therapies have some basis for being helpful and offer promise for further development. Scaning the peer-reviewed literature, I can see how the Arthritis Foundation could reasonably come to such a point of view. If you think otherwise, show them why they may be wrong or would be better to bet on another horse (as I did in my introductory paragraph).
Behind all of this is a question that I have never seen addressed by FDA acolytes. Is it even possible for an autologous MSC therapy to be “manufactured” as an FDA-approved drug without being made so expensive by the approval process that is simply unaffordable? I have seen one paper (written by engineers, of all people) that at least broadly considered this issue — without offering any concrete hope of finding a cost-effective way forward, in so much as I could tell.
Hey Brian,
You raise some very good points. There is risk of doing nothing. The issue of cost is very important. The FDA is far from perfect and I myself have advocated for key reforms in my book and on this blog. People warned me not to do that, but I did. I’m definitely not an FDA-acolyte. But at present I do not see a better option than the FDA evidence-based medicine system as much as it needs reform. As to going abroad, of course biomedical science in other countries can be excellent, but specifically conducting clinical operations in another country besides the US after the FDA identifies a host of problems with their business is a unique situation that raises red flags to me.
Sorry Paul, I didn’t mean to characterize you as anyones acolyte. But I suspect that there are FDA-acolytes out there and I’d certainly be interested in how they would answer my question.
No worries, Brian. The FDA has its ups and downs…
Really Paul? Attacking the joy of a 6 year old and his family at finding relief from a crippling incurable disease, this is a new low for your curmudgeon opinion on adult stem cell therapy. The testimonial video is easy to find on youtube under Celltex. This little boy was already the poster child spokesperson on JRA for the Arthritis Foundation, and gives an eloquent explanation of what he’s been through, and the amazing improvements stem cells have brought. Why don’t you offer any positive input, like how this could be the start of funding for trials to follow up this great case report with research to prove it out and make it available to all who are suffering.
Hi SammyJo,
Thanks for your comment.
I have no issue with the child patient or his family. In fact, I wish them the very best.
My issue is with dubious stem cell clinics and now there’s this puzzling thing with the Arthritis Foundation being buddies with Celltex. My view is that is a negative thing for patients. I’m thinking you disagree with me.
If laboratory grown adipose stem cells can be proven to really help juvenile arthritis I would be thrilled. But we are a very long way from that being a known reality.
My opinion is that charging a kid and their family to be part of an experiment in Mexico to avoid the FDA and then using that as public relations material is concerning and important to discuss. If Celltex did it for free then a reasonable question is was that because they planned to use it for publicity? And again why is the Arthritis Foundation part of this dubious situation?
There’s a lot to discuss here.
Paul
Could you please stop using the term “dubious”.
I’d be happy to if you can come up with a better term. Thoughts?
How about “unvalidated.” Even if, hypothetically, the therapy is effective, there have been no objective clinical tests to confirm this.
Validated has that on/off problem that gets people worked up. In my field, CFD, if some theory/model is validated against measurements/calculations then we would indicate how well it is validated by determining the margin of error (relative to discretization error in the case of a calculation).
That might be difficult in your field.
Perhaps indicating the “level of evidence” would be a less inflamatory way of expressing ourselves? Of course, backing up “level of evidence” with a measure of error would be even better.
I’d go further. Medical practitioners should inform their patient — or the patient should ask — about what the level of evidence is for any treatment that is suggested.
If stem cell clinics included “level of evidence” on their websites, it might be helpful for everyone concerned.
I declare that I have a certain bias for the “level of evidence concept”. It was a Canadian invention, after all.
Hi Sammy,
It’s not that stem cells can’t give improvements to patients. It’s that this particular company does not operate in a safe and ethical manner. This is precisely why they cannot treat in the U.S. There are many stem cell companies operating within the U.S. with FDA approval and they are going through the clinical trial process. In cell therapy this is extremely important. Why would we want to circumvent this? The material may be contaminated with bacteria, mycoplasma , fungus… just recall what happened with the compounding pharmacies recently and the deaths surrounding that. At that time the FDA had no jurisdiction over them. They are working to change that. With out proper FDA oversight, Quality Assurance, Quality Control arms and outside independent audits a company like this cannot guarantee safety or efficacy. The companies money should be working toward a TRUE clinical trial like all other responsible cell therapy companies.. not finding loopholes and sponsoring with charitable foundations without an approved treatment. I have personally worked on many cell therapy products that were brought from R&D to commercialization.. and by comparison this is a very dubious method Celltex employs indeed.
Jerry, according the the Celltex website, they addressed the issues the FDA cited in 2012, and have continued to operate as a cGMP lab ever since, with continued FDA inspections that have found no issues since.
It’d be great if Celltex posted these more recent 483 FDA inspection reports on its website.
I have not seen a follow up from the FDA proving these were addressed. Since they currently remain unregulated as they practice in Mexico, it’s probable many of the observations were not addressed. For the 2012 document go here:
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM331212.pdf
But to remove all speculation and doubt, I have requested info via the FDA website Freedom of Information Act. I suggest anyone interested in the therapy do this as well. I have requested to see if any subsequent audits/inspections have occurred since 2012. None are currently posted on the FDA website.
http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm
Your writing is obviously another attempt to let the FDA control our rights to get stem cell treatments using our own stem cells to help the pharma who is making no money when we get stem cell. I have had them and they changed my life. People are not going to fall for all your propaganda forever. Pharma owns the FDA.
Robert, I’m glad you are doing better. Over the years I have been a critic of the FDA and big pharma as well as stem cell clinics, which from my view are mostly interested in taking your money. I doubt I can convince you, but thanks for your comment.
You mention nothing about negative or positive results-as if you really don’t care about results,patients or possible benefits
One issue here is patient privacy, especially with a child involved. I avoided mentioning any identifying factors for the pediatric patient.
Another issue is that “results” presented in a the context of what seems to be a promotional effort are questionable.
You can’t have “results” without a true clinical trial. This company does not have a licensed product. Therefore there is no actual clinical data following patients. Feel free to check. There are only “testimonials” . This is not science. It is not clinical data.
The facts as they are: There will never be a clinical trial unless it is leading to a method of stem cell treatment that can be licensed or patented. Although testimonials may not be accepted, you cannot call everyone a liar who gets results. Especially when they return to the USA and their MD’s marvel at their improvements. This is all a big pharce and I will be leaving for stem cell in about 60 days, both MSC and bone marrow combined for less than $10,000 including travel and hotel. I cannot get it at any price in the USA. As far as Celltex goes, it is obvious you have a real vendetta. Can you name one incident where harm was done by Celltex?. I mean harm not including seeing the dollars going in the opposite direction. The only considerations in this blog is putting everything under the control of the FDA, you know the guys who approved Aspartame, along with many other failures as evidenced by hundreds of lawsuits against the Pharmas who got the approvals from FDA. It is a shame that an American can not get stem cell in America, yet can go anywhere else in the world and get treatment.
The FDA has an important role and some spectacular victories- they saved the American children from thalidomide http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/.
I agree that the FDA did protect kids from thalidomide, but in all fairness, the FDA has also has had some deadly fiascos. Margaret Hamburg wrote the article you posted. Would anyone expect her to point out the failures that the FDA has also been responsible for?
Money talks!