At last year’s ISSCR 2010 Meeting in San Francisco, President Irv Weissman talked about the dangers of unvalidated stem cell treatments. He talked about the responsibility of stem cell scientists to stand against these and the importance for scientists not to endorse or serve on advisory committees of companies peddling such products and “therapies”.
As I sat in the audience, I thought it was important when Weissman very bluntly said they are:
Beware of “someone trying to treat your wallet and not you”.
I was encouraged that collectively us scientists were not only aware of the problem, but were doing something about it.
A year later and I’m discouraged very discouraged. What was Irv’s message this year?
At this year’s 2011 ISSCR meeting, Irv talked about how the ISSCR website devoted to reigning in stem cell tourism and unregulated, unproven clinics had been shut down due to threat of lawsuits from the clinics’ lawyers, effectively asking “What do we do now?”. No one had an answer.
So in the past year the situation with these potentially dangerous clinics has if anything just gotten worse as I discussed on last week’s podcast. This is not Irv’s fault of course. I think it is actually not the job of the ISSCR to police stem cell clinics. Rather it is the FDA’s responsibility.
Unfortunately, the number of products and “treatments” involving stem cells continues to rapidly increase just as it was last year as are the advertisements for such products.
I have written before about the dangers of stem cell tourism. However, the number of people trying to take our money for alleged stem cell-related services and products is increasing so fast even just here in the U.S. that we may not have to travel far to give them our money and in some cases you can get them off the internet.
If you simply Google “Stem Cells”, the side bar lights up with Ads. Some are totally legit. Some are downright frightening. One problem is that the ads for legit and frightening places are all mixed together, giving them all an air of legitimacy. The same is true for searches on Yahoo. Google and Yahoo do not care–they are simply money-making machines. In a way, I don’t totally blame them because once Yahoo and Google starting censoring their ads, where do they stop? But it is still worrisome.
Frequently the ads show pictures of patients and stories about their successful treatments. Often these are children.
Clicking on one of these ads, I see that places might charge thousands of dollars for a non-FDA approved treatment.
If you are considering any such treatment for yourself or a family member, use extreme caution. Learn all you can. I wouldn’t let anyone I know get a non-FDA approved stem cell treatment unless I had talked to our own personal doctors first.
One would hope the FDA would crack down on all this stuff.
Why don’t they?
It is a huge mystery to me. Are they waiting for someone to be killed by one of these treatments as has happened in other clinics, most recently in Germany? In Germany it was the death of a baby that finally led to the questionable clinic being shutdown. We have an opportunity to prevent that from happening in the U.S., but it must be prevented at the federal level.
Stem cell tourism is spreading like wildfire on the Internet, not just medical treatments but also medicines.
If you search for “stem cells” on Ebay, some scary things pop up as well.
I thought this situation was bad in 2010, but it is even worse in 2011 and we can only expect this to get worse. One glimmer of hope is the rumor percolating through the stem cell field that the feds are working behind the scenes to perhaps eventually take some action…we can only hope this becomes a reality.
@Susan
Susan, my best wishes to you!
Paul
@Susan
Susan is correct about people raising money out of desperation no matter what the economy might be doing. I met someone in their late teens recently who had a stem cell treatment in another country even though in theory this person’s family could not really afford it. Also take a look at this very controversial piece in Forbes: http://blogs.forbes.com/markgibbs/2011/07/11/sick-child-real-treatment/ . Clearly entire communities are raising funds in some cases for stem cell tourism.
I can not disclose everything about me for obvious reasons. All I can say is that I am personally part of a prominent stem cell trial. I can tell you that it is not helping all the patients but it is helping me. No I am not referring to a placebo effect, we are talking qualatative, measurable, empirical data. This information is being tightly guarded as of now while they study the results and try to learn more.
@Alexey
I understand where your theory on the economy choking the growth of stem clinics. However people going to these clinics are desperate, not thinking rationally and willing to risk their life savings for a “cure”. If we were talking about beauty treatments or other elective type treatments I would concur with you. However most of these people are in life and death situations so they and their loved one’s are willing to risk their life savings.
@Dave
Thanks, Dave. I can’t speak for everyone, but I can say that stem cells scientists generally are very worried about this problem and most of us predict that it will be get far worse in the coming years, that is barring some high-profile action by the feds.
@Susan
I eat Cheerios and drink POM.
As a lay person and as a patient, the concern is this:
At present many people like myself suffer from an at present incurable condition. But with the advent of stem cells research, a goal of a cure can be perceived in (as yet) an undateable but forseeable horizon.
With the gap between unmet need and current lack of treatment, regrettably human nature being what it is will allow charlatans, fraudsters and shysters to come in to offer their false hopes of treatment and cures with unlicensed clinics. Hopefully most people will agree, these people are grave robbers of peoples hopes and dreams – and I hope at some point they will get their comeuppance. Painfully in most cases.
Sadly I think the media reporting drives people towards these shysters.
I’ve lost count of the number of newspaper articles which ALL seem to follow the same formula.
Headline: Breakthrough with X treatment to cure Y condition
The Sell: New discovery leads to treatment which COULD help with Y condition for many people
The Science: How this discovery was made and what it’s supposed to do (with a few scientific jargon words to impress the masses)
But…….
Footer: “Cure not imminent warn scientists” / “This breakthrough can bring us ‘one step closer’ to a cure ONE DAY”
The overuse of the phrase “ONE DAY” is my personal favourite!
If enough people read this type of reporting their hopes are raised and dashed so many times that when ANY opportunity presents itself (FDA or NICE approved be damned) they are going to try it.
So whats the answer? Well I’m pleased to say I am commenting on the blog that could be part of the answer. People aren’t – on the whole – idiots. If scientists trust us enough to be able to share the “whole journey” of the development of treatments/cures using stem cells research, I’m willing to bet more people might be prepared to wait for the official end product. They will know what the problems are, what side effects there could be and what research is doing to make those treatments as safe and efficacious.as possible – and what hurdles they are trying to overcome.
Doesn’t make the wait any easier, but it sure gives it some purpose.
Conclusion: Science needs to be more open and accessable to all – so well done to Paul and his blog for doing just that. But we need others to do the same.
@rich
Rich,
Pretty much every stem cell / regenerative medicine conference, started 3 years ago include this topic and speakers in agenda. So what? Nothing have changed. They like to speak. Nobody like to do something.
@Lee Buckler
Lee and Susan,
I guess our disagreement based on perception of current economic situation. I believe that world economies are in trouble and therefore number of “stem cell therapy” buyers (aka “middle class people”) will shrink. You and Susan believe that this is not a factor and number of seekers able to pay will not change or will increase.
According ICMS and other societies. By some reasons seem like they don’t like each other, they do everything to avoid collaboration. But collaboration is essential in this issue. ISSCR, ISCT and ICMS largely ignore each other. I proposed the collaboration between ISSCR and ISCT last year on ISCT 2010 meeting. Nobody care! So each society keep doing their own things – release positions, documents, white papers and so on, with zero outcome. it’s not productive. it looks stupid to me.
As I think the comment stream to Ledford’s recent article in Nature (http://www.nature.com/news/2011/110628/full/474550a.html) demonstrates, this sides on this issue are becoming increasingly entrenched and polarized.
I’m in the unusual position of disagreeing with Alexey’s prognostication in this instance. I agree with Susan that the more early data we see (before therapies are approved as alternatives to these clinics), the more people will perceive these clinics as proffering real treatments involving minimal (or acceptable) risk. I think the activity of these clinics will only increase over the next 2 (and several years – not diminish. In the absence of any real (approved) alternatives (which is not going to happen in the next 2 years) patients will continue to pursue these treatments and these clinics will continue to provide them.
The regulatory agencies are handicapped because it is an international issue. The FDA may be able to limit how such clinics can market in the US but the FDA has very few tools to regulate what such clinics do in countries outside the U.S. Furthermore, given FDA’s continued delay in publishing guidance on the use of social media, internet marketing by these clinics will continue unfettered.
The FDA regulates POM and Kellogs because those cases are clearly within FDA’s accepted authority. Treatments being offered in other countries are not.
At the risk of starting to sound like somehow I’m their advocate, I will repeat here what I said in the commentary to Ledford’s article. I think we need to look at and figure out how to work with the ICMS (www.cellmedicinesociety.org) because I believe they are pursuing the only approach that will make any appreciable difference on this issue.
The ICMS approach is one that recognizes these clinics are not going away and so attempts to set up a system of standards and accreditation to help patients and doctors (and potentially regulatory agencies in due course) distinguish between the more and less legitimate clinics (or as some might prefer me to say… the bad from the worse).
ICMS may be the wrong vehicle. Other organizations might be better. Other organizations could – and are likely even be much better suited to – take on this standards/accreditation task …but they won’t. ICMS is the only organization with the cahonas to take this on – as foolish and thankless as it is – and if we can help them do it right we will be thankful they stepped up where no one else would.
Perhaps it is the undying lawyer in me but I do believe there is a way for even the most conservative (albeit not fundamentalist) stakeholder to hold the position that no patient should EVER buy what these clinics are offering but that in the alternative should a patient decide they are going to (god forbid) against all good advice, then at least (we beg you) get ‘treated’ by a clinic that is accredited by and in good standing with ICMS.
Most of scientific and clinical community has thus far chosen to not recognize or participate ICMS’s activity in fear it might somehow be perceived as providing legitimacy to the clinics ICMS purports to accredit.
Each of us will have to decide whether it is better to take this “ivory tower’ position or determine if there is a way we can help patients through these muddy waters and make the best choices they can even where we may fundamentally disagree with their decisions. I submit that while the former is easier, the latter is a lot messier and a LOT more helpful to the patients we are here to serve.
I recommend we hold our nose and figure out a way to help ICMS do what even it admits is a thankless job trying to “regulate” clinics which want no regulation and help patients distinguish (in Paul’s language) the “legit” from the “frightening”.
Stem Cell Policy: Bernard Siegel to Provide Keynote Address at Stem Cell Europe, Edinburgh, July 20-21
“It is critical for researchers and industry leaders to align themselves with patients to address the policy and regulatory hurdles blocking the advancement of stem cell research and its translation to effective treatments and cures. I am pleased to present this topic at this important international gathering,” said Bernard Siegel.
http://www.businesswire.com/news/home/20110711005999/en/Stem-Cell-Policy-Bernard-Siegel-Provide-Keynote
@admin
Very astute point, I believe they did the same thing to Cheerios for their claims about reducing cholesterol.
If they do not become strict quickly, it is going to be too late. Good news, in regards to stem cells, is on the horizon.
It mystifies me why the FDA spends time and energy doing stuff like going after POM for saying that their pomegranate juice helps the prostate and heart (which at least has a reasonable chance of being true), but then seemingly entirely leave these dangerous stem cell clinics–which are definitely offering medical even surgical treatments–alone with no apparent regulation.
Especially like you predicted Susan with the proliferation of these stem cell clinics only likely to increase further after stem cell medicine gets a lot of good press, shouldn’t the FDA lay down the law now to set a good precedent?
Honestly I feel it has the potential to get worse. Once a company such as Neuralstem, ACT, Geron or others produce data that supports efficacy improvement, then stem cell cures will begin to go from myth to reality. At that point unscruplous people will push the fact that we are no longer dealing with potential but documented results. The problem will be that what they will be peddling will not have gone through the strict documented clinical trials that the FDA requires. Think about it once one of these trials rolls out the first person who has been helped by stem cells then fradulent stem cell clinics will start popping up all over the place.
It is coming, sooner then we think.
I hope you are right, Alexey. I think the FDA needs to take action now. My fear is that it will take someone dying as happened in Germany, before the FDA shuts down these clinics in the U.S.
Paul,
As I noted in 2009 –
http://hematopoiesis.info/2009/12/22/some-thoughts-about-stem-cell-tourism/
it’s also a fault of professionals – scientists, doctors, organizations (ISSCR, ISCT, TERMIS). I’ve proposed some kind of “plan of actions” or suggestions if you will for professionals and for patients. None of those suggestions were implemented. Professionals largely ignored those suggestions. Of course, who cares about voice of “postdoc from academia”, you better “keep your mouth shut and go do your damn work!” At least I tried. Maybe my suggestions were not perfect, but nod bad and some of them very easy to implement. So, I proposed something, I put it on my blog for public read, I spoke about it on ISCT 2010, and what? Nothing changed.
It’s unclear to me why professional societies came up with something only just last year when problem persists for at least last 5-8 years. It’s unclear to me why professional organizations are not hiring a person who can pitch guidelines/ official position/ white paper… in the first search page of Google/Yahoo/Bing? It’s unclear to me why ISSCR or ISCT are not writing “open letter for FDA” and communicate with government agency? It’s unclear to me why everything published about danger of stem cell tourism is not in open access, therefore not available for public. Bioethicists keep publishing papers on this subject (very good ones btw) in their journals and NOBODY read them! Journal will ask for $40 for paper. Is it normal? It is unclear to me why professional organizations web-sites do not promote any other sources of valid information, for example our blogs? Is that so hard? I can continue for one more hour, but you got my message. Whom should we blame?
Why crowd in ISSCR 2011 stayed silent after Irv’s question? Nobody care! Scientists care about grants/ money/ career, nobody even think about patients! Nobody advocate anything. And when i’m trying to speak up on my blog about it, scientists laugh at me – “blogs are not serious, it’s a time waste, it’s a joke”, “you better get your ass in the lab and focus!” Why professional organizations largely ignore social media? Why they ignore advocates who actually speak up? Why each individual scientist and doctor largely ignore Web and social media as a tool for protect patients and spread valid information?
Nonetheless, I’m optimistic about future on stem cell tourism. It will decline, maybe will gone completely. How soon? I think we can see declining in 2 years from now already. I think so based on the following reasons:
1. “stem cell therapies” will remain a service for middle class people, not for poor. Taking in account current economic situation around the world indicating to trend the “disappearance of middle class”, all services for this category of people will decline (including stem cell tourism).
2. We will get more “stem cell doesn’t work” cases and it will leak in social media. So regulatory agencies will be alarmed.
3. I hope we will get more individuals who is advocating and speaking up on the web. I hope number of blogs and web resources with valid information will increase.
4. I believe that patients will get smarter and more educated. They will read more and ask more questions. Few years ago patients were not able to read your blog (it didn’t exist), today they have this possibility.
5. Regulatory agencies will figure out how to regulate stem cell and cell therapeutic products. In many countries this process is unregulated or very weak. FDA is not sure for 100% how to work with complex cell therapeutics, they never deal with them before.
So it will decline naturally. But we have power to accelerate this process. I did everything I can.
People would not be going to these clinics if they were better served at home.