KPBS reporter David Wagner has an important new piece out today on for-profit investigational stem cell treatments and he focuses to a large extent on a stem cell business in San Diego called Stemedica. If you’ve heard of this company it might be in part because they were involved in the Gordie Howe stem cells for stroke story that got so much buzz.
At a personal level the KPBS story is about the experience of patient Jim Gass, who received a number of non-FDA approved stem cell treatments outside the U.S. and ultimately ended up with a tumor on his spine.
To be clear, Gass was not directly treated by Stemedica, but Wagner’s article makes the case that there are two relevant links with the stem cell business: a referral of Gass by a Stemedica director to a doctor in Mexico who did a treatment and the use of an MSC product made by Stemedica in that treatment.
Gass was brave enough to go public with his overall stem cell story a few months back. As part of her New York Times piece on Gass earlier this summer, Gina Kolata just briefly mentioned a possible indirect tie to Stemedica:
“I began doing research on the internet,” Mr. Gass said. He was particularly struck by the tale of the former football star and professional golfer John Brodie who had a stroke, received stem cell therapy in Russia and returned to playing golf again.
So Mr. Gass contacted a company, Stemedica, that had been involved with the clinic, and learned about a program in Kazakhstan. When Mr. Gass balked at going there, the Russian clinic referred him to a clinic in Mexico. That was the start of his odyssey.”
In the new piece on Jim Gass’ experience, Wagner provides additional concrete material on this situation in the form of emails to/from Gass, new information in the written part of the article, and via a startling video interview with Stemedica spokesman Dave McGuigan (below).
Wagner writes about how Gass’ treatment took shape:
“Gass traveled to Hospital Angeles in Tijuana, Mexico with the hope of recovering from a debilitating stroke. He received stem cells from Dr. Cesar Amescua based on a referral from Stemedica Cell Technologies, Inc., a San Diego company known for reportedly helping famous former athletes like hockey legend Gordie Howe make “miraculous” recoveries from strokes.”
What is the evidence for that referral that is mentioned?
The email documentation included with the article indicates that Marcie Frank of Stemedica referred Gass to Amescua (see image of part of the email below) in the form of saying, “Please contact Dr. Cesar Amescua”.
There are also Jim Gass’ own recollections of his experiences and his photo/video of being injected.
What happened next?
Gass went forward with the treatment, writes Wagner, which involved two kinds of stem cells:
“Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.
The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from adult bone marrow.
Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).”
It’s not at all clear how Gass developed a spinal tumor nor for sure which of the several stem cell treatments he got around the world over the years might have contributed to the tumor.
We are all now having to stay tuned for part 2 of Wagner’s piece, which should provide even more information and perspectives on this situation.
Gass has cautionary words for other patients considering pursuing unproven stem cell treatments who think they may have nothing to lose:
“Gass now knows he did have a lot to lose. He said all told, he lost hundreds of thousands of dollars pursuing stem cell treatments around the world, and now he’s left with a painful tumor and significantly decreased mobility.
Gass hopes other patients considering reaching out to companies promoting unproven stem cell treatments will be more educated about the risks than he was.
He said, “Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.”
At a big picture level of course, a broader concern is that there are hundreds of stem cell clinics in the U.S. and worldwide selling stem cell therapies that are not proven to be safe or effective. Right now they seem to have a lot of buyers willing to take the risk in the hope of some tangible benefit.
Jim Gass inquired of Stemedica Cell Technologies Inc. where he could get their stem cells — these are ADULT stem cells — and they simply told him. It was merely fielding an email inquiry. Stemedica is a research and manufacturing company and does not treat patients; authorized agents may treat patients, and HIPPA protects those patients. Stemedica therefore wouldn’t know whether or not Gass ever followed through and got treated, unless he told them: he wasn’t on their books. There is no particular reason they should recall fielding his inquiry three and a half years later. Not recalling it is an innocent and small mistake — hardly something to hang your big case on — as any sane and honest person would readily recognize (unless they have been duped by cleverness and sleight of hand — which was the point).
It is clear — and even David Wagner knows this — that Jim Gass’s tragedy arises from FETAL stem cells he received, in Tijuana, that were manufactured by Global Stem Cell Health. Who administered those stem cells? Wagner does not tell us. Exactly where and when were they administered? Wagner doesn’t tell us that either. Did Wagner even bother to find out? There’s no sign that he did; he doesn’t seem to care about the real story here, the one centrally involving GSCH, their business practices, their fetal stem cells, and the effect of those cells on Gass’s health. Does any of this have anything substantive to do with Stemedica? No, but likely you’ve been played for a fool by Wagner and think otherwise. If there were any substantive connection, maybe Wagner should, you know, actually present it. But he has nothing, and he knows he has nothing — unless he really is massively incompetent. Wagner had an agenda: he wants you to think that Stemedica is directly culpable in Gass’s tragedy. And the careful maneuver on his part to effect this in his reader’s and listener’s minds argues for likely something far worse than massive incompetence.
Responsibility for this article and the damage it causes goes beyond David Wagner. His superiors at KPBS (assuming they include careful professionals, people who are capable of correct close reading, and who understand investigative journalism) surely know this article fails even basic standards of journalism. What salient facts did Wagner know and not present? What did he misrepresent? What did he not bother even trying to find out? Wagner is careful not to produce outright lies; but what do you call using journalism to instill falsehoods in the public’s mind? For that is what is going on here. Wagner has hijacked the personal tragedy of one individual to further his own agenda and aggrandizement, and done all this with disregard for the truth. As a journalist, he is either massively incompetent, or something far worse. This work of his is not journalism: it is an assault. By allowing this to happen — grossly misleading readers and radio listeners — KPBS have performed a disservice to their community and themselves.
There will be no response to trolls regarding this posting.
You say Stemedica does not treat patients, but they’re running five clinical trials? Go figure!
Andy, you have been played for a fool by Wagner and his kind. “Run clinical trials”: you have no idea what that means. Others run the clinical trials; Stemedica does not keep track of enrollees.
Dominic – I have run clinical trials as CMO in a biotech and as PI for Pharma, so maybe I do have an idea what that means – do you? What is your experience running clinical trials?
And please explain what you mean by “keep track of enrollees” – in-study treatment, at follow-up, documentation, banking? How would you do it better?
And, Dominic, what is your knowledge and experience specifically with stem cells?
Paul, our group focuses on unmodified or expanded subpopulations of allogeneic hematopoietic stem cells (alloHCT) or cord blood stromal cells for therapy of GVHD and leukemias. Mostly in small proof-of-concept studies and P1/2 IITs.
http://www.ncbi.nlm.nih.gov/pubmed/25573333
http://www.ncbi.nlm.nih.gov/pubmed/26551637
http://www.ncbi.nlm.nih.gov/pubmed/25154823
http://www.ncbi.nlm.nih.gov/pubmed/26855152
Andy:
Hospital Angeles in Tijuana sponsored and ran their stroke trial; Stemedica merely provided the mesenchymal stem cells. Whether or not Hospital Angeles was their own CRO is another matter, but Stemedica did not sponsor, run, or operate as CRO for the trial involving Gass, and so were not privy to enrollee personal information. Wagner has no interest in your being clear on any of this. He has done a good job intentionally misinforming and fooling everyone. Why trust him? Do your own research.
Paul:
You asked what is my knowledge and experience specifically with stem cells. I can tell you that I do not know less than David Wagner. Did you ask him how much he knew? Or was that somehow not relevant?
Comments on Wagner’s article
————————————–
Wagner’s opening words are: “Jim Gass made sure to record the moment…” Wagner is foregrounding this because he wants to connect in your mind Stemedica and Gass’s tumor on his spine.
But Stemedica has nothing to do with the tumor on Gass’s spine. So, what is Wagner up to?
In the 4th paragraph, Wagner says Gass got those stem cells in his arm based on a “referral” from Stemedica. What do you understand by “referral”? Technically true, but wide open to interpretation. The truth is that Gass enquired of Stemedica where he could get their stem cells and they simply told him in a brief and polite email exchange: end of connection with Stemedica. That’s it. Full stop. Wagner, however, wants you to think there was a deeper connection – and deception. In particular, he wants you to think that Stemedica have behaved in unethical and unprofessional ways, preying on innocent people. But he actually has nothing whatsoever to support that.
Next, Wagner engages in underhand journalism. It’s all in the judicious textual associations:
(1) Gass gets a stem cell injection in his arm; Wagner does not tell us yet that these are mesenchymal stem cells.
(2) He gets these after a “referral” from Stemedica.
(3) “What he didn’t know was that his paralysis would get worse.”
(4) “Nor did he realize that his doctors back home would later find what they call a bizarre tumor in his spine…”
Whoa! Stemedica evil!… OK. Let’s step back. The central story here should be that Gass was offered (by whom? when?) fetal stem cells manufactured by Global Stem Cell Health Inc.; that he accepted the offer; had the stem cells injected in his spine; and as a result, his paralysis got worse and he developed a bizarre tumor in his spine. That is a major and tragic story. But it has nothing – repeat, nothing – to do with Stemedica. So what is Wagner up to? Why is he foregrounding, and thereby targeting, Stemedica? Why does he want you to make a completely false connection between Stemedica and Gass’s tragedy?
Wagner’s underhandedness gets worse. He says
“When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua.”
OK. This is no big deal. McGuigan understood that Gass wasn’t treated by Stemedica’s stem cells, because he was told as much by Hospital Angeles. And remember, Stemedica wouldn’t know this one way or the other on their own: they did not sponsor, run, or act as CRO for the trial. The referral, such as it was (a friendly email responding to an enquiry as to where he could get the stem cells) was several years ago (and the “referral” wasn’t recalled when Wagner inquired). Got all that?
But Wagner decides to make a huge deal out of this: it’s his smoking gun indicating unseemly behavior on the part of Stemedica. He’s got documentary evidence (!) of Stemedica’s email correspondence with Gass (you should read it, if you haven’t already), and the oh-so incriminating video (!) where our soldier fighting the good fight confronts the untrustworthy people at Stemedica: “KPBS showed him emails and footage contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone…”.
I’m sorry. This does not pass the laugh test. All Wagner has done is played a little gotcha with perfectly innocent people, which amounts to nothing except it tells us more about Wagner’s character. If he were a competent journalist, he’d know it amounts to nothing (I’d bet he does know, but that’s inconvenient for his little agenda, so what’s an upstanding journalist to do?). Is he not competent? Or is he worse than not competent? But here’s the thing: Wagner succeeded in fooling practically all of his readers and listeners. They think he’s really got something here. Seems like he intentionally sought to besmirch innocent people. This would make him despicable.
And it gets worse.
“Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.
The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from adult bone marrow.
Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).”
What does “further down the line” mean exactly? Who told Gass “for $30,000, he could receive a round of treatment involving two different types of stem cells”? Where exactly was he to get those treatments? Who exactly was to administer them? $30k to whom for a round of GSCH stem cells and for Stemedica stem cells? What does this have to do with the stroke trial? Regardless, Stemedica Cell Technologies Inc. is not involved in any of this.
Later we read:
“Gass said he went to Tijuana twice for two separate rounds of treatment in 2014, and his bank statements show that he wired $30,000 to GSCH on two separate occasions that year.”
What’s going on here? Why $60k to GSCH? Two “rounds”? Each round involving GSCH and Stemedica stem cells? Dr. Cesar Amescua in Hospital Angeles in Tijuana administered Stemedica’s mesenchymal stem cells in Gass’s arm; this is clear. How many times? Twice? But there seems to be two other separate stem cell injection events NOT involving Stemedica stem cells. Who else is involved here that Wagner has not clearly reported on? Where else did Gass go to in Tijuana to get treatment? With whom did he interact? Who administered the GSCH stem cells to Gass? And where? Why does it seem that GSCH is paid for Stemedica stem cells? This reporting is a mess.
Wagner could have investigated and written the really important story here, the one I have outlined above, and presented it in a clear and focused way. He could even have written a separate article about regulations and efficacy, or lack their of, of different types of stem cells provided by perfectly respectable companies like Stemedica, and done some sleuthing on companies that may not be as above board, while discussing the dangers of medical tourism. But instead he chose to write a contorted, tendentious article, craftily targeting a particular company that had essentially nothing to do with the tragedy of Mr Gass. He owes more than his readers an apology.
Andy:
Hospital Angeles in Tijuana sponsored and ran their stroke trial; Stemedica merely provided the mesenchymal stem cells. Whether or not Hospital Angeles was their own CRO is another matter, but Stemedica did not sponsor, run, or operate as CRO for the trial involving Gass, and so were not privy to enrollee personal information. Wagner has no interest in your being clear on any of this. He has done a good job intentionally misinforming and fooling everyone. Why trust him? Do your own research.
Dominic – you don’t seem to have a background in how companies and PIs organize clinical trials in different ways. I’ve worked with companies who “give” test compounds to us for testing in our IITs in order that they remain at arm’s length – in part so that the trial is independently run. But it is illusory to believe that those companies aren’t affected when something goes wrong – it reflects on their product.
Do my own research? I see a poster who obviously has an issue with Mr. Wagner – personally I take the report with a pinch of salt – but you are seemingly “in the know” about the background and fixated on it. So what are your credentials for criticizing him, why should I believe you? You could be in the employ of Stemedica for all we know. Just doing my research 😉
Yes, I know that the IND companies must be informed of adverse events regarding their drug. That did not happen in this case because there was no adverse event (perhaps you thougt there was? Wagner would be delighted). But we weren’t discussing that. One of the primary issues was: Would Stemedica know of Gass as an enrollee, and did they know. The answers are no, and no. But Wagner wants you to think otherwise. I am repeating myself here.
I do not have an issue with Wagner per se: I have an issue with bullshit, and he has been the vehicle of that in this case. No need to confuse matters.
Consider me a messenger, and sure, don’t trust me either — though the truth will bear me out. By “Do your own research” I meant seek out the truth from the primary sources: Hospital Angeles, Stemedica, and Wagner’s notes and correspondence on the subject (good luck with that!). If at this stage you do not think you have good reason to be distrustful or, at a minimum, deeply skeptical of Wagner, there’s nothing I ca do about that.
Fixated? It seems to be excruciatingly difficult to get people to reconsider a narrative when they have already been fed a story (however tendentious and sloppy) that they are, for whatever reasons, at least a little inclined to agree with ab initio. In this case, a pinch of salt is hardly adeqate — and I’m sure most readers and listeners didn’t even have that. The power of a journalist is not to be underestimated. It is not good when that power has been abused. And I am witnessing that in real time.
I have provided enough information. I have nothing more to add to this thread.
Once again, you’re fixation with Wagner is too personal to be balanced. The criticisms you throw at him are only your interpretation and I found the answers to these in his KPBS article.
I suggest you read it (again). It makes it very clear what Stemedica did and didn’t do.
Oh well done Andy! You make yourself very clear. You really do. If only I’d known earlier! Which also means I shouldn’t bother saying the following, but, why not!
To wit, I forgot to point out to you (it appears you don’t know this) that even if there were an adverse event, enrolee informaiton would stil be anonymize.
Such fun. This was a discussion with a diningroom table. Tralalala. Good bye.
@Dominic,
You make many statements that factually questionable. When you say things like “he wasn’t on their books”, how would you know that?
Wagner works on innuendo and syntactically suggestive association, while having nothing of merit to show for himself. Can you not smell it? For example, his weasel-words “further down the line” are designed to have you think of direct association with Stemedica, without actually saying it unambiguously. You know, he doesn’t want to be caught in a direct lie, just wants you to be a sucker for his agenda. If you think his little email gotcha is some kind of smoking gun, you’ve been played for a fool by him. How about you questioning Wagner and his abundance of “implications”. Go back to the beginning: Wagner most definitely wants you to think Gass was very much “on their books”. You should question that. He should, and probably does, know better, but that interrupts his little email gotcha, around which his whole story is hung like wet tissue paper. Look to Wagner: why did he avoid the obvious story here? Why trust him? I suppose you think he is an honest journalist, someone who would never intentionally and grossly mislead his readers and listeners. There’s a story behind Wagner here. I’d like to know what is really going on.
You probably have, for whatever reasons, a prior agenda aligning you with Wagner’s agenda, thus making you susceptible to his “journalism”. Do yourself a favor and step back, way back. Question him. If you find his article cogent, I’m sorry for you.
@Admin stated that the cells (Stemedica) were put through an IV. Wouldn’t it be more likely that maybe the cells (Not Stemedica cells) that were injected DIRECTLY INTO THE CEREBROSPINAL FLUID caused the issue or maybe the EMBRYONIC STEM CELL treatments directly into the spinal cord (also not Stemedica cells) he received in China or Argentina caused the tumors?? Your piece just feels like a hatchet job on a company who is actually doing great work in the US and around the world. The fact that you DON’T mention the other treatments he received and indirectly blame Stemedica for causing tumors on Mr. Gass’ spine is unconscionable.
@Dan,
You claim that I don’t mention the other treatments he received? That’s wrong. I mentioned them twice:
“At a personal level the KPBS story is about the experience of patient Jim Gass, who received a number of non-FDA approved stem cell treatments outside the U.S. and ultimately ended up with a tumor on his spine.”
“It’s not at all clear how Gass developed a spinal tumor nor for sure which of the several stem cell treatments he got around the world over the years might have contributed to the tumor.”
And to be clear, I did not assign blame to anyone.
“a company who is actually doing great work in the US and around the world”
No, you’re wrong – this company is not showing evidence of one single benefit for patients.
Thats funny.. then how are they in phase II clinical trials in other countries around the world?? Why have they been offered astronomical sums of money for the company if its all just a sham who is not doing anything of benefit?
Archie, the truth is that you really don’t know what you are talking about when it comes to Stemedica. You are one of @Admins little minions who thinks that by giving people half truths then your side will ultimately get their way.. I get so sick and tired of reading how there are so many side effects and bad reactions with stem cells.. Yet when pressed you name 5??.. 6? Not a lot. You are not going to find someone on this blog or in one of the 570 “dubious” clinics who thinks that a nurse injecting stem cells into someones eyes was a good idea.. But why demonize the whole field? No one talks on here about Chris Centeno’s amazing work. Of the blogs that have been written about him, his recent paper on safety was criticized because it wasn’t written how @Admin would have written it or the proper controls weren’t in place.. How about “great job!!” How about great job on the fact that he is actively enrolling patients in a double blind controlled study with no financial investment required by the patient?.. I’m guessing that it will be crickets..
Jim Gass’ situation is tragic and difficult to comprehend, but targeting Stemedica as the cause of his misfortune is just crappy journalism.. Not that we are looking for pulitzer prize material. It would be nice to have @admin mention that Mr. Gass had EMBRYONIC stem cells in two other countries. All that was mentioned was that he had stem cells in other centers but again I reiterate that embryonic wasn’t mentioned at all which is a pretty large omission. Most of the blog was about Stemedica and how they provided a referral and basically everything pointed to Stemedica being the reason for Mr. Gass’ situation.
@Dan – I think you missed the point. I said the company has not shown any evidence of patient benefit, meaning never published any trial data showing that their therapeutic is efficacious.
You ask “…how are they in phase II clinical trials?” Because this is exactly where they hope to get that data. Just running a trial is not proof of anything.
The rest of your post is irrelevant – conspiracy theories won’t get you the missing data either.
Once again, this company has not shown evidence of one single benefit for patients – fact.
Dan, I think that the fetal neural cells Jim Gass received were the same ones that Gordie Howe, Bart Starr and John Brodie received.
Where are the segments on how many people died or have complications from “FDA approved” drugs? Where did the fetal cells come from? Why is only Stemedica mentioned when it was clearly stated that fetal cells were injected that did not come from Stemedica? There seems to be a lot more to this story.
This was in the story: “Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).”
Keep in mind that this patient was treated in Mexico, not the US so any new FDA regulation won’t apply in this case.
I just got off the phone with Emily from Kaiser, who’s writing another piece on patients’ feelings about stem cell treatments and clinics. (If you-all haven’t seen me posting around here before– I’m a patient advocate.) She asked me my opinions on the subject, and I honestly told her.
Here’s the thing. I was VERY tempted by treatments at stem cell clinics when my medical condition was at its worst (idiopathic macular degeneration. Six doctors in a row were stumped!!) So I totally get how desperate people become, and how they’ll do anything. I’ve been there. BUT, and it’s a big but, I know that stem cell clinics have no guarantees, and a lot of people have ended up worse off than when we went in. I honestly said that I could not recommend them. The only place where I differ from Paul K is that I don’t think we can say that nobody has ever been helped. The problem is that we don’t know why anyone got better, why other people didn’t improve, and why some got a lot worse.
So I told Emily that the only way I would recommend that people go to stem cell clinics was if they had absolutely nothing to lose, no way things could get worse, and they really had the money to spare. Because then at least they’d know that they tried. She said that would probably be the quote she used in the piece! 🙂
สวัดดีครับ ทุกท่าน และ จาก การสูญเสีย สมาชิก ของ ครอบครัว และ ทีมงาน ไป ๑ ท่าน ทำให้ ผม ตกลง กับ งานสเต็มเซลล์ ครับ เพราะ เห็น ใน คุณค่า จาก ผลงาน ของ งาน สเต็มเซลล์ กับ อนาตต ของ มนุษย์ชาติ มาก กว่า ที่ ผ่านมา ครับทุกท่าน
It is what it is. Safety is the FDA’s primary mission, and unregulated stem cell clinics were clearly not safe for Jim Gass, or for the people who were blinded by adipose cell injections. Who can argue that the buyer should beware, when the consequences can be so devastating?
I really think you do a disservice when you lump in fetal stem cell treatments faith autologous MSCs. FDA approval, in your stories, seems to be the only gold standard out there, and some clinics do decent reputable work despite not having explicit approval or the so-called rigorous process required by the FDA.
We hear this so many times about unapproved clinics doing reputable work but none of you provide definitive evidence of improvement in condition as shown by independent metrics.
And since when is it OK to blind a few people and give the occasional patient a tumor just because apparently “some clinics do decent reputable work”?
Currently the FDA is the only gold standard in US where drug approval is are concerned.
@James
Could you please tell us which clinics do you mean?