The upcoming big FDA 2-day public stem cell meeting next week is generating a lot of interest within the stem cell community and also with members of the media. I expect there to be tons of coverage, which should be a good thing (note that there’s a different FDA stem cell meeting tomorrow). If you can’t make tomorrow’s stem cell meeting in person and it is now closed to additional in-person participants, you can watch the webcast here.
Amongst the many speakers on the agenda for next week are quite a few patients/customers of stem cell clinics. These folks have in one way or another publicly indicated on the Internet that they went to clinics for stem cells. These particular patients mostly speak in glowing terms about the clinics that sell unapproved stem cell therapies, but often very negatively about the FDA.
Patient voices are very important and add to the depth of the meeting. At the same time context is needed given that some of these patients may at this meeting be de facto representatives of one or more clinics.
Since the FDA meeting will be in Bethesda, MD and most of these patients do not live in that area, a reasonable question to ask is if these individuals themselves are paying their own travel expenses including airfare and hotel, etc. or if instead specific clinics in some cases might be paying part or all of the way for their customers?
If this is occurring, why would clinics do this? Because they are hoping that the patients will be their powerful representatives at the meeting and exert pressure on the FDA for less oversight.
I’m sure some of the patients are paying their own way and if they are, kudos to them even if we don’t see eye to eye on stem cell oversight, but if any have had their travel costs paid in whole or part by clinics or received anything financially from the clinics in the past (or will in the future) including discounted treatment then they should publicly disclose that at the FDA meeting as it is important context in the same way that scientists disclose conflicts (e.g. owning shares in or having their travel paid by a biotech company) when they give presentations at a meeting.
I’m paying my own way.
And in case anyone wants to ask again, I’m not paid by pharma companies or any other for-profit, and certainly not by the FDA.
My lab is developing a cell replacement therapy for Parkinson’s disease using autologous induced pluripotent stem cells (iPSCs) differentiated into dopamine neurons. I’m following FDA regulations, which will assure that this therapy can be done by others safely in the future. We know the mechanism by which these cells work, and have developed stringent quality control measures to ensure that they are not harmful. We will not charge patients and we will follow them for years to be sure there aren’t any late-emerging adverse effects.
Pharma companies are not investing in stem cell therapy. This is not because they fear that they will lose drug revenue…it’s because they don’t like risk, and stem cell therapies are not yet proven. We have to demonstrate that therapies work-scientifically- before we can expect pharma to step in.
My therapy is a stem cell therapy. I don’t like the unregulated clinics claiming that they are also doing stem cell therapy when they ignore FDA regulations, haven’t done the work to find out if their therapy is safe, charge patients for treatments, and don’t follow up on the patients.
I will be happy if all we can accomplish at the FDA meeting is to educate people about the difference between science-based stem cell therapies like ours and the science-free stem cell therapies being done by careless clinics just for the money.
You are developing a drug, which is completely different from a medical doctor practicing medicine.
I’m amazed that the potential conflict of interest remains invisible for some of the people commenting on this blog. Paying a patient to attend would be construed as just that – a potential conflict of interest. If clinics want to pay a patient to attend and give positive testimony about their treatments at the FDA hearing, those same clinics should also pay (an equal number of) patients who have had a negative experience with those clinics to attend a give testimony at the hearing. That would provide a balance of opinion, would it not?
There isn’t any evidence that any patients have been paid by clinics to attend this meeting. This post is nothing but baseless speculation.
The upcoming big FDA 2-day public stem cell meeting next week is generating a lot of interest within the stem cell community and also with members of the media.
Amongst the many speakers on the agenda for next week are quite a few people against stem cell clinics. These folks have in one way or another publicly indicated on the Internet that they don’t think autologous (using your own cells) should be allowed. (Please note that autologous skin grafts/bone grafts/fat grafts have been used safely in plastic surgeries, orthopedic surgeries and spine surgeries for years.) These particular people mostly speak in glowing terms about the FDA, but often very negatively about the entire spectrum of clinics (i.e., how can you compare a board certified sports medicine specialist treating knee osteoarthritis with some sheister (who may be not board certified in anything) offering a miraculous stem cell treatments for everything ranging from from ALS to COPD?
Different voices are very important and add to the depth of the meeting.
Should stem cell clinics continue to expand, the greatest potential losers are the pharmaceutical companies (i.e., one need only look at Vioxx, as one example, to see how far merck went to protect its profits.)
At the same time context is needed given that some of these people at this meeting are de facto representatives the pharmaceutical industry.
Since the FDA meeting will be in Bethesda, MD and most of these people do not live in that area, a reasonable question to ask is if these individuals themselves are paying their own travel expenses including airfare and hotel, etc. or if instead specific pharmaceutical companies in some cases might be paying part or all of the way for their lobbyists?
If this is occurring, why would pharmaceutical companies do this? Because they are hoping that their lobbyists will be their powerful representatives at the meeting and exert pressure on the FDA for more oversight.
I’m sure some of the people are paying their own way and if they are, kudos to them even if we don’t see eye to eye on stem cell oversight, but if any have had their travel costs paid in whole or part by pharmaceutical companies or received anything financially from the pharmaceutical companies in the past (or will in the future) including stock options then they should publicly disclose that at the FDA meeting as it is important context in the same way that scientists disclose conflicts (e.g. owning shares in or having their travel paid by a biotech company) when they give presentations at a meeting.
“These folks have …publicly indicated on the Internet that they don’t think autologous (using your own cells) should be allowed.”
Really, I’ve never heard anyone say that. That use of autologous cells should be made safe and efficacious, yes, but not allowed? Please cite sources.
This article is nothing more than totally biased, completely baseless speculation; the lowest form of “journalism” – if one can even call it that.
Concerns of undue influence from entities whom might be offering compensation…from the man who has been feeding from the government trough for many years. Smacks of “do as I say, not as I do”!!
What I love is how you introduce doubt that anybody could actually have had a good experience in one of these “dubious stem cell clinics”.. Its like no one would actually go out there on their own dime because its probably all a sham, right?.. I mean c’mon, how could 12 people, let alone patients come up with a whooping $400-$600 for a plane tix and a cheap hotel room??
When you give quotes to papers, NPR, this blog etc.. do you ever give full disclosure that if doctors in clinical practice are already doing the procedures that you are hoping to research successfully, then that decreases grant money for you? Im not trying to be a jerk but isn’t that true that most of the reason you are constantly speaking about how bad these clinics are is because it directly effects your ability to get grants, keep a job etc??
I know that you say that you are only looking out for the patients… but thats not being totally honest either.. you are less than honest in a great deal of the propaganda that you put out. Im not saying that what you are saying doesn’t have SOME truth to it but you choose to omit key points that people deserve to know.
Although I highly doubt you will post this because it doesn’t fall in line to what you want people to read on this blog. i.e “dubious stem cell clinics are the devil!!” At least I know that you will have read it and just maybe think a little more about your response or maybe rather than attacking clinics who really do want the best possible outcomes for the patients you reach out to them and see if there was a way that you could work with them.. Why couldn’t you help out with some of the research the clinics are doing? Im sure most would welcome you in with open arms. You have a powerful voice on this blog and I wish that you would use it for more than just anti dubious stem cell clinics..just my two cents
Hi Dan,
I don’t see the clinics having a positive impact for patients or the stem cell community, but they do make a lot of profit for themselves.
Regarding grants, actually my grant funding is far removed from anything that the clinics are doing. I’m doing mostly basic research. If they were to prove their interventions are safe and effective, I’d be happy and it wouldn’t have any negative impact on me.
If what they are doing really works and is safe, then yeah they should prove it scientifically via research. I challenge them to do so. Until they can meet that challenge, they shouldn’t be charging for it or at the very least they should be offering it just “at cost” without a profit. I haven’t seen that happening. These folks are not medical “robin hoods”. They also should be following the existing laws and regulations, which if they don’t like they should challenge in court for example rather than putting patients at risk.
Paul
Actually, if patients are expected to pay their own travel expenses then that in itself introduces a huge bias. I wonder how many other attendees will be paying out of their own pocket with after-tax dollars?
@Brian, what bias would it introduce if patients pay their own way? That some then could not attend?
If most of the 12+ patients who are attending are in fact paying all of their own way then that shows they were able to come anyway and indeed they make up a very large proportion of all the individual speakers along with some stem cell clinic docs, etc. on the agenda.
It’s not like 100% of the speakers can be patients only, right?
If on the other hand some of them are getting something of value such as free travel from stem cell clinics or discounted treatments, etc. then that definitely introduces bias.
I can’t say for certain, but I’m guessing some of the other non-patient speakers are paying their own way. Others maybe have some funding for that sort of thing. I don’t know. If I had been able to attend schedule-wise, I would almost certainly have paid out of my own pocket for the costs.
Paul
Any sort of threshold introduces bias by the method of exclusion. In this case, it’s a financial threshold. Financial power is very evident in the shaping of the gestalt.
Hi Brian,
You have a point, but I’m not sure what the solution would be. Clinics paying the travel costs is a very complicated way to go if a person is then going to in effect advocate for that clinic. If that’s the case, at the very least that should be disclosed at the meeting.
Paul
Please feel free to give input. I have a “Stem Cell Clinical Trials” on LI and this is a red hot topic: https://www.linkedin.com/groups/4117443