This past week’s coverage of unproven stem cells exhibited a wide range both in tone and in topics including golfer Jack Nicklaus.
There were the three critical articles on clinics that I blogged about earlier and then there was a CNN puff piece by Dr. Sanjay Gupta and Roni Selig mostly focused on Nicklaus.
Note that “unproven” is not necessarily a bad word or pejorative adjective for stem cells as pretty much everything in clinical trials is still unproven, but if unproven stem cells are oversold or literally sold to patients for money, then things can get messy.
The CNN piece isn’t about stem cell clinics selling unproven offerings, but it still has its issues.
There is also video (see screenshot) of Gupta talking to Nicklaus at the meeting.
What’s my beef with this article?
The CNN piece had nearly zero balance. It did not discuss the challenging issues out there and failed to mention recent cases where patients have clearly been harmed by unproven stem cells such as being blinded. It’s important context given that some people will probably read the piece on Nicklaus and if they have their own golf issues or other orthopedic problems, they may go to a risky clinic too. This reminds me of the press coverage of the unproven offerings that other sports celebs and former stars have gotten: Gordie Howe, Boris Becker, and others.
The CNN piece was more a stem cell ‘feel good’ item than a real, carefully researched or well thought-out medical piece. In that way it was more hype than substance. This quote from the piece is not only awkward, but also seems intent on claiming the upbeat outcome of research in this area before it is done:
“The evidence to support Alt’s claims are still in progress, and further proof is expected from an FDA approved clinical trial at Sanford Health in the US.”
Proof is expected?
“Alt” here refers to Dr. Eckhard Alt, a German stem cell researcher offering stem cells to patients like Nicklaus. Alt and Sanford health appear to be working together on some stem cell research efforts.
Note that Sanford Health is conducting FDA-approved stem cell trials here in the U.S. so that is definitely a positive. It doesn’t mean these stem cell investigational therapies will turn out to be safe or effective, but at least Sanford is doing IND-based trials.
In the bigger picture, there’s nothing wrong with optimism or even looking for good news, but one should keep it balanced. Pieces like this CNN one are generally more harmful than helpful to the stem cell field and patients.
Also, I can’t help but wonder if the Vatican conference had its own religious agenda to promote supposed adult stem cell success stories no matter what and perhaps that permeated into the CNN piece, which again should have been objective biomedical journalism.
On a different note, I wish Jack Nicklaus the best.
“If there are very specific conditions met like getting FDA approval via a compassionate use approach for fatal illnesses then I can see how that kind of rationale, sober approach may be workable. Patients can also of course choose to participate in clinical trials, but they shouldn’t have to pay exorbitant costs and the “trial” shouldn’t be designed to be profitable”.
Dr. Knoepfler…This sort of rhetoric is why I don’t think that healthcare and its’ delivery should be left only in the hands of the so called experts. It is not up to you how folks wish to spend their money. Clinical trials are not the answer either as they often exclude not only those with pre existing conditions (like age), but they ensure that many will not be treated at all….like the control groups. By their very construct, clinical trials are not designed to treat or cure anything. At best, they work to test safety and efficacy in, relatively speaking, a small population of sufferers only. I think it can be argued that clinical trials in this sense are somewhat unethical particularly with regard to a person’s own autologous tissue,
“Sometimes the hype comes from the media. This CNN piece really struck me as mostly lacking medical or scientific balance”.
However, the hype often times promotes an awareness into what folks like you are doing in your laboratories. It draws attention as well as tax payer/corporate contributions into scientific endeavors which you are dependent upon. I’ve seen your name quoted in the mainstream press as well. Many mainstreaim (corporate) journalists seem to share quite a few of your points of view and philosophies concerning the practice of regenerative medicine.
“I’ve also carefully followed the scientific and medical developments and studied what direct-to-consumer clinics are up to. I’m confident I have a clear picture of the situation”
Me thinks you are still very biased. Your rhetoric regarding “Predatory Clinics” is difficult to ignore despite your expertise into the technical areas of how stem cells behave. Experts can be biased and often times are particularly where money, funding and medical and scientific politics are concerned. It happens to the best of us. Being a technical expert into how stem cells communicate does not make you an expert into the business of stem cell medicine. Regenerative clinics charge the prices they do because, generally speaking, insurances won’t cover what many patients know through experience works pretty well for them.
“We have and still do study adult stem cells as well.”
Okay. How about some references into papers that you have published on the topic? And I mean something that the general reader can comprehend…..not necessarily that which was written with only other experts in mind.
” I’d say most of the stem cell scientists I know are excited about each of the major types of stem cells and many labs study more than one type”.
I don’t see the same excitement with regard to patients. I don’t think we ought to be excluded from utilizing that which by most accounts has at the very least a relatively safe profile while waiting on you scientists to sort things out financially and politically. Pluripotent stem cell research has yet to bear any clinical applications. Some, to include Dr. James Sherley MD PhD believe that pluripotency may never have any useful clinical applications. His work now involves essentially only multipotency and adult stem cells. And, you seem to cherry pick the worst cases of all of these regenerative clinics while short shrifting smaller studies of adult stem cells that at the very least demonstrate far greater potential than their pluripotent counterparts.
“Finally, I agree that patients have unique and valuable perspectives”
You are a cancer survivor, Dr. Knoepfler. The FDA and Parke Davis removed in the 1960’s from the market bacterial toxins that had been used in this country for cancer since the 1890’s. The FDA referred to these bacterial substances known as Coley’s Toxins as “new drugs.” Sound familiar? And, It simply was not in Parke Davis’s financial best interest to submit them for new FDA clinical trials particularly since they had no patent on them. Yes. Patients are so unique with such valuable perspectives that the medical/science/business community never asked them what they thought about the nation’s first cancer immunotherapies in this country about to go the way of the dinosaurs. Sure. Immunotherapies for cancer have reemerged. But at many times the cost and with side effects seemingly worse than their predecessors. Mainstream scientists and doctors will tell you that today’s immunotherapies regarding cancer are a fairly new phenomena. God forbid cancer patients and survivors like yourself discover the financial reasons why they were really taken off the market.
“Proof is expected?” No, Dr. Knoepfler. The article says that FURTHER proof is expected. I don’t think Dr. Alt is just some fly by night operation. He’s very likely operating on evidence that already exists.
https://www.argusleader.com/story/news/business-journal/2017/01/03/sanford-starts-historic-stem-cell-trial/96078396/
“Alt, who estimates he has treated 200 human orthopedic patients in the last few years along with hundreds of dogs and horses, said he has not seen any adverse effects. It also has been PROVEN safe in European trials”. (Capitalization mine)
“Pieces like this CNN one are generally more harmful than helpful to the stem cell field and patients.”
Dr. Knoepfler. To my knowledge, you’ve never had a condition that could potentially be treated by a regenerative clinic either state side or over seas. Yet you take it upon yourself to blog about how this article which reports on a well known golfer’s lower back pain is more harmful to patients than helpful. I’m a patient and you do not speak for me. So, why don’t you simply interview Jack Nicklaus and see if his golf game and his mobility have improved? Ask him if, as a patient whether he thinks he’s been helped or harmed by the autologous therapy he received overseas. You don’t even have to publish it in a scientific journal. Certainly such an interview would make a lot more sense to the majority of folks who don’t work in academic/corporate laboratories.
The type of therapy that Jack Nicklaus received has, as far as I know, little or nothing to do with pluripotency which is what your laboratory research (as opposed to patient research) seems to essentially be limited to. His therapy deals with multipotency. I’ve been on the receiving end of regenerative therapies like PRP. And, as far as I’m concerned my experiences as a patient eclipse yours as a researcher where everything seems to remain in the realm of the theoretical and potential clinical applications are always “decades away”.
But, I will in part agree with you that the more folks who benefit from multipotent regenerative therapies (like Jack Nicklaus) the more harm could potentially come to the field of pluripotent research. After all, why continue laboratory investigation spending billions of dollars on pluripotency research that has yet to see any clinical relevance when patients are already reportedly benefiting by way of their own autologous multipotent therapies?
Douglas, I don’t believe it is ethical or safe to hype unproven medical therapies. Also, they shouldn’t be offered in a for-profit manner.
Sometimes the hype comes from the media. This CNN piece really struck me as mostly lacking medical or scientific balance. I realized some would disagree with my view and clearly you do.
If there are very specific conditions met like getting FDA approval via a compassionate use approach for fatal illnesses then I can see how that kind of rational, sober approach may be workable. Patients can also of course choose to participate in clinical trials, but they shouldn’t have to pay exorbitant costs and the “trial” shouldn’t be designed to be profitable.
Yes, I’ve never so far had a medical condition that seems likely to be something one would go to a stem cell/regenerative clinic for, but I have communicated with probably a few hundred patients who have over the years. I’ve also carefully followed the scientific and medical developments and studied what direct-to-consumer clinics are up to. I’m confident I have a clear picture of the situation. But I also encourage differing views via guest posts, posting comments like yours, etc.
My lab hover the years has studied pluripotent stem cells more than other types, but we have and still do study adult stem cells as well. I am strong believer in the potential of all the major types of stem cells to be helpful to patients including adult stem cells.
There seems to be this misunderstanding that somehow stem cells are a zero sum game where people have to pick sides (e.g. adult vs. pluripotent, or ES cells vs. IPS cells, etc.). In fact instead, there is broad enthusiasm. I’d say most of the stem cell scientists I know are excited about each of the major types of stem cells and many labs study more than one type. There isn’t some kind of race between stem cell types or conflict between those studying different kinds of stem cells. A few people in the field think that way, but my impression is that most don’t.
I try to be equally skeptical with and ask tough, but fair questions about clinical research involving stem cells of any kind. In fact, in past years on this blog I actually got heat for being tough on IPS cell research intended for clinical use and asking questions about possible mutations in those cells, etc.
Finally, I agree that patients have unique and valuable perspectives.
just take a look at this amazing new study
https://www.colorado.edu/today/2018/04/19/novel-antioxidant-makes-old-blood-vessels-seem-young-again