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Thread: Stem-cell scientists grapple with clinics

  1. #1
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    Default Stem-cell scientists grapple with clinics

    Dr. Centeno makes a good point in his comment. Why wasn't anyone from ICMS contacted? I would also like to know how ISSCR is planning to "educate the media". Please post some comments. I think they need to hear from us as patients. What is the point of bashing Dr. Centeno or ICMS? It seems to me that the ISSCR has forgotten the real issue here - bringing therapies from the lab to clinical practice so that patients who are suffering can make their own decisions with their doctors on whether they could benefit from stem cell treatment. Here is the link:

    http://www.nature.com/news/2011/1106...l/474550a.html

    Published online 28 June 2011 | Nature | doi:10.1038/474550a

    In the absence of regulation, researchers weigh their options for educating patients about unproven treatments.

    Heidi Ledford

    When stem-cell clinics are asked for documentation about the treatments they offer, some are quick to produce letters from lawyers instead. In the face of legal threats from clinics, the Inter*national Society for Stem Cell Research (ISSCR) has suspended a service intended to help patients wade through claims about therapies. It is now pondering its next move.

    For stem-cell researchers, the worldwide proliferation of clinics offering regenerative medicine is frustrating. Many of the treatments such clinics offer injecting a patient's own stem cells back into his or her body in a bid to treat conditions ranging from Parkinson's disease to spinal-cord injuries are at best a waste of money, and at worst dangerous. "There's real potential to damage the legitimacy of the field," says Timothy Caulfield, who studies health law and policy at the University of Alberta in Edmonton, Canada.

    Theres real potential to damage the legitimacy of the field.
    Last June, the ISSCR, which is based in Deerfield, Illinois, launched its 'Submit a Clinic' website in an effort to educate patients. "Have you seen an advertisement for a stem cell clinic or other stem cell treatment provider and want to know more about it?" the site asked, and invited users to submit the names of centres. The ISSCR offered to find out whether providers had medical-ethics committees and were overseen by a regulatory agency such as the US Food and Drug Administration (FDA) or the European Medicines Agency. The answers were to be posted on the society's website.

    But some of the initial inquiries drew letters from lawyers, challenging the society's authority to question the clinics. Elaine Fuchs, a stem-cell researcher at Rockefeller University in New York and former president of the ISSCR, says that the society sought legal advice and was assured that it stood on firm ground. Even so, she says, everyone recognized that lawsuits would quickly drain the society's limited resources.

    In February, the ISSCR shelved the project. At the society's annual meeting in Toronto, Canada, this month, Irving Weissman, a stem-cell researcher at Stanford University in California, turned to the audience for advice. "What should we do?" he asked. "Should we risk litigation?" The audience could not come to a consensus, and the programme is still on hold.

    Some researchers worry that patients will now turn for guidance to the International Cellular Medicine Society (ICMS) in Salem, Oregon an organization of patients and physicians, some of whom have close ties to the regenerative-medicine industry. The ICMS, which offers accreditation to stem-cell clinics, was co-founded by the medical director of Regenerative Sciences, a clinic based in Broomfield, Colorado. Last August, the FDA requested a federal injunction against Regenerative Sciences for failing to adhere to proper manufacturing standards (see Nature 466, 909; 2010).


    Clinics operate without controls in many countries. In May, Germany shut down a notorious stem-cell clinic linked to the death of a toddler and the near-death of a ten-year-old boy, but other centres offering unproven treatments remain open around the world. In the United States, clinics have tended to escape regulation. The FDA steps in only if the treatment fits certain criteria for instance, if the agency determines that the stem cells are significantly manipulated after being extracted, or if they are being used in a patient other than the donor.

    Fuchs emphasizes that the ISSCR still has options for educating patients and policy-makers about the risks of unproven treatments. Its website lists questions that patients should ask when evaluating a clinic, and the society is discussing ways to educate the media, which sometimes gives uncritical coverage to such clinics (A. Zarzeczny et al. Nature Biotechnol. 28, 12431246; 2010). It already has plans to target primary-care physicians, says Caulfield; the ISSCR hopes to publish an article on stem-cell clinics in Canadian Family Physician, a medical journal sent to every general practitioner in Canada, he notes.

    In the meantime, stem-cell researchers face a steady stream of e-mails seeking advice about clinics. Caulfield responds to these inquiries cautiously, mindful of the threat of litigation. "And I'm a little bit cowardly when I write articles about this," he says. "I don't mention the clinics by name."

    Comments

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    #24692
    This is Dr. Centeno from Regenerative Sciences. It's unknown why ICMS was never asked for a comment on this story. While I'm a co-founder of ICMS, linking our case against FDA to ICMS makes no sense, as ICMS is a professional organization-one where I play less and less a role as time goes on.

    The issue here, is whether one set of physicians practicing medicine using body parts (stem cells) should be held to a different set of standards when compared to other physicians practicing medicine using using body parts (for example cultured, human eggs). Let's review. When a physician cultures stem cells, FDA considers that a drug, but when he cultures fertilized eggs (5 day blastocyst procedure) that's the practice of medicine and not regulated by FDA. In addition, there are now more than 150,000 published scientific abstracts indexed in the National Library of Medicine for "stem cells", but only 5,000 for "blastocyst procedure". The published risks for an autologous stem cell re-implant are minimal (we published the world's largest safety paper for MSCs at http://www.ncbi.nlm.nih.gov/pubmed/19951252), yet the blastocyst procedure I referenced carries with it the risk of death and congenital defects in the child, just to name a few.

    So why are the body parts called "stem cells" classified as a drug? Well since FDA classifies them as a drug, they must be produced in a drug factory and not a medical clinic (like cultured embryos). Hence the stated rationale for FDA's injunction mentioned in the story. The blastocyst procedure described above would also flunk FDA's test of "drug manufacture standards", yet is used to help tens of thousands of US couples on conceive every year. Perhaps these quotes from the president of the American Society of Clinical Oncology (ASCO) will let someone else speak on the issue. This letter was in response to FDA's proposal to turn the body parts known as stem cells into a drug:

    "A striking aspect of FDA's proposal to regulate stem cell procedures is the virtual absence of any justification for the initiative. The principal "concerns" previously cited by FDA in support of the new regulatory apparatus are preventing the transmission of communicable diseases and assuring that stem cell procedures are safe and effective. But FDA has adduced no evidence whatever to suggest that communicable diseases are presently being transmitted through stem cell procedures or that stem cell transplants are unsafe or ineffective. Instead, FDA has proposed to subject physicians and facilities performing stem cell procedures to an extraordinarily burdensome and restrictive regulatory regime based solely on theoretical issues.”

    @Chris Centeno

    You seem to have made a mistake in your initial assessment of the situation.

    'The issue here, is whether one set of physicians practicing medicine using body parts (stem cells) should be held to a different set of standards when compared to other physicians practicing medicine using using body parts (for example cultured, human eggs).'

    No. The issue is whether a scientist, university, student or anyone for that matter, should have the opportunity to understand the treatments available. The service described above gives the layman an easier route to understanding, and that service has been ruined by the fear of clinics that may very well be in the wrong. If they aren't then there is no need for law suits, and no need for this service to be regarded as anything to be afraid of.

    It's shameful that good people are afraid of you, but I don't see shame in your words.
    2011-06-28 01:12:09 PMPosted by: kevin gallagher


    #24696
    As a patient, my fear is how ISSCR plans to "educate the media". While researchers may be frustrated by the proliferation of clinics offering regenerative medicine worldwide, patients are frustrated by the endless research that has so far produced little in therapies for patients at the cost of billions of dollars, much of it from taxpayers. Research is a huge business and many depend on it to make a living or support university programs, but there comes a point when the research needs to move forward. Perhaps, the media could do some investigative reporting as to why that isn't happening for the most part.
    2011-06-28 01:12:34 PMPosted by: Barbara Hanson


    Kevin,

    You appear to have taken my comments in a direction they were never meant to go and misunderstood their content, perhaps due to a story that sounds like our law suit is somehow connected to the ISSCR decision? Not sure. To set the record straight, my clinic has had no interaction with the ISSCR over their web-site. So whatever ISSCR refers to as threat of litigation wasn't in any way shape or form related to my medical practice. In fact, I was surprised to hear the news that they had ceased their program. To your other comment, my medical practice, publishes our treatment data, giving everyone you listed ample opportunity to understand what's being done, where it works, where it doesn't work, complication rates, etc... We have just had two more medical papers on our technique accepted for publication (one efficacy (n=250) and the other a complications follow-up (n=339)) that should be out this late summer/fall, again giving everyone ample opportunity to understand what we do.

    Chris Centeno, M.D.
    2011-06-28 01:38:26 PMPosted by: Chris Centeno


    #24698
    Chris

    I was simply correcting your initial assumption. As for the information you offer to the people I listed, I don't see how it's relevant. Unless you're defending your territory
    2011-06-28 01:46:45 PMPosted by: kevin gallagher


    #24699
    I for like this article. IMO, something is very wrong when a reasonable request for information produces a legal threat. Fertility clinics (to which comparisons are made above) are happy to detail their procedures. Now here we have stem cell clinics that are loathe to.

    So take a closer look. Fertility treatments have come to be very well proven and mainstreamed. The current fertility treatments have a plenty of early experimental validation and ongoing and well documented success in the clinic. In the meantime, stem cell therapies are still being worked out, and only within the last couple of years have I seen evidence of early experimental success using these treatments. In fact, I think that Barbara's comment above really tells the story:

    "... [P]atients are frustrated by the endless research that has so far produced little in therapies for patients"

    If the researchers at major medical institutions have not been able to produce working stem cell therapies, then on what basis should we expect a small clinic to have a battery of working stem cell therapies ready to go?

    The clinics are producing legal threats not because they have working but proprietary treatments. Instead it is because they are just a bunch of charlatans preying on the hope that many patients have that stem cell therapies will cure whatever ills they have.

    The day will come when stem cell clinics will be staffed by real and competent doctors and will offer real and effective therapies. However, we are not there yet.

    Report this comment2011-06-28 01:56:38 PMPosted by: Edward Schaefer
    #24703
    Since this article takes the stance of being against progress and is biased, I also take the liberty of presenting the "other side" of the hung jury.

    The FDA has no jurisdiction to dictate what therapies are "allowable" since they have such a pathetic record of maintaining a high level of food and drug standards.

    The FDA does not have the legal right to govern medicine and I would not trust that it has the capacity, the expertise or an unbiased system who's goal it is to introduce drugs to stem cells so that the pharmas may profit.

    If you want to bring in the Constitution, a person, citizen, American has the right to life, liberty and their own body is sovereign-it does not belong to the state.

    The FDA is not about successful treatments of disease but rather a profit producer for drug companies.

    I have studied stem cell treatments in animals and the success rate is astounding but only when scientists deny the benefits of this treatment do people and doctors of medicine get their back up and I don't blame them.

    If, you studied the success rate of stem cell treatments in dogs, horses and animals you would see the process works in self-healing arthritis, hip and elbow dysplasia and bone disease. The proof is in thousands of animals that have benefited if not healed arthritis and disease from stem cell treatments. This is without surgery, without 6 months of healing time and a lot less cost to the pet owner.

    What is the problem with that?

    From the layman's perspective (which I am) I want the use of my own body parts, to be of my choice and under my ownership, that includes: blood, blood transfusions, collection of eggs for fertilization, my stem cells, my skin and all of my body belongs to me, not the FDA.

    When I have kidney dialysis it is my blood that is being circulated, cleaned and reintroduced to my body for my use for my benefit. Same goes for stem cells, they are for my use, do not need the addition of drugs and work perfectly well as part of my immune system.

    The FDA and their partners the drug companies seem to believe that a human immune system does not exist, well it does and operates quite well without the introduction of drugs of foreign substances. The greatest part of healing is done by the human body and if scientists don't get that they should get out of their profession.

    I would not wish to wait 20 years while the FDA "decides" what I can or cannot do with my own stem cells, its none of their business and it is between me and my doctors.

    I do not want someone else's stem cells, I want my own cells with no rejection factor. The money being put into fetal stem cells in my opinion is a huge waste of assets, money and time, much of which people are running out of today.

    The foreign cells from an aborted baby has religious implications but also require a lifetime of rejection drugs which is ludicrous and the most difficult path to undertake for successful stem cell treatments. This is what the FDA is spending money on, to lead to a very long, drawn out process and delay proven treatments.

    If we have the great potential that is exhibited by our own stem cells to heal our own bodies, what's the problem? Is it a matter of no money in it for the billion dollar drug industry? That's too bad.

    Medicine is not a "profit" center and if the scientists cannot see their way to actually producing cures for diseases, perhaps they should change occupations and become pharmaceutical salesmen.

    For this is the question: Is the potential cure for diseases being stifled, banned and aggressively attacked by the FDA for money or are we seriously the champions of cures for diseases?

    Instead of thwarting these leaders of the stem cell era it is apparent the FDA through the media and paid sources are denying not only the benefits of adult stem cell treatments but are actually trying to stop clinics.

    China, India, Canada, Europe and South American are way ahead of the USA because they are not influenced by a government agency that is more geared towards stopping cures for diseases than promoting new advanced technology of the future.

    The money being wasted in the FDA fighting cures for diseases is astounding, in attacking all that is natural, organic, healing and successful in curing diseases and that is what taxpayers are fighting today.

    I myself am a cancer survivor and I am shocked at what the FDA is attempting to do along with pharma driven anti-stem cell organizations.
    This article assumes the FDA has authority to dictate what therapy is allowed and mounted a shut down against US clinics that are actually helping patients and this needs to be challenged legally.

    The article points out deaths by stem cells? Is this not fear mongering? Where is the proof that using a part of the body to heal itself, how does this cause death?

    Economically, the government is wasting time, missing out on treatment centers here in the USA, for you will not stop patients from going overseas for treatments. In fact you are hurting the medical field in its ability to treat, develop stem cell treatments and finally cure sicknesses.

    In conclusion, the FDA can either get with the program or be accused once again of siding with the drug trade for profit, stifling cures, preventing progress and putting stem cell treatments using one's own cells through vigorous and unnecessary challenges.

    People are dying each day unnecessarily due to the delays in stem cell treatments and I for one will not put up with this and I will seek whatever treatment I see fit for my illness.

    Enough with the pondering, head scratching, delays- either produce real facts about real dangers or get off the pot. The US again will be the last to approve such treatments and will stand last in the world, again due to profits and money.

    Its about saving lives at this point.
    2011-06-28 03:59:55 PMPosted by: Tara Pyer



    #24704
    The ISSCR is interested in research dollars and patents. It is all about the money. Follow the research dollar and you will see who is treating patients and who is being funded by grants. Here's two little tid bits you might want to read. At one time, Dr. Weissman was more interested in "his" patent than he was in finding a cure for terminally ill children. You might find this interesting.

    http://www.azcentral.com/business/ar...mcell0526.html

    http://lifetechcapital.com/ltc/wp-co...n-02-02-10.pdf

    2011-06-28 04:10:47 PMPosted by: Kaye Angles



    #24710
    A a member of the "traditional" cell therapy industry and someone who's been accused of being a "pharma hack" by those who strongly oppose FDA regulation of autologous cell therapies, the issues of FDA regulation and stem cell tourism have been one of keen interest to me and something I've often discussed online both in LinkedIn forums and through my blog (www.celltherapyblog.com).

    Indeed Dr. Centeno and I have vigorously debated these issues for years. I was deeply suspicious of ICMS's motives given it's genesis but I find myself in the unusual position of agreeing with Chris on this one point: the ICMS has made great leaps forward in attempting to be an organization with the stem cell medical tourism patient at the heart of its mandate and not one driven to further the goals of Centeno or his clinic or his litigation with the FDA.

    I have now come to believe the ICMS is honest in its commitment to try to find a carefully constructed balance of all interests on this issue. I believe ICMS is bravely (albeit perhaps incorrectly at times) going where no one else dares to go in terms of attempting to accredit clinics based on standards similar to what FACT and AABB did in the early days with stem cell transplant centers.

    The ability for patients to be able to use such accreditation to distinguish between legitimate and less legitimate clinics will be way more useful to these patients than anything any other organization has done particularly given that ISSCR has abandoned its initiative (something I was shocked to learn through this article).

    I would strongly encourage us all to take a closer look at what ICMS is trying to do and judge them by their current actions. Even if we are not able to fully endorse their current approach I think we should respect them as a stakeholder that has clearly demonstrated a commitment to this field and sit down at the table with them to try to collectively work on solutions.

    This continued polarization of the debate does little-to-no good for the patients we are all here to serve.
    2011-06-28 06:29:29 PMPosted by: Lee Buckler


    #24712
    As I see it, the ISSCR’s mission is to support research, while ICMS’s mission is to move these valuable treatments into the hands of doctors and patients. The FDA’s role is to regulate drugs, and therefore wants to figure out how to make my stem cells a regulated drug that can be sold back to me according to their regulations. My goal is to have access to treatments that can make a difference, and there appears to be legitimate choices out there. Dr. Centeno and others like him seem to demonstrate this for those that care to do their homework. I for one want to be allowed to make my own choices, especially regarding the right to use my own stem cells to treat myself without the ISSCR or the FDA being a roadblock in the process.

    2011-06-28 09:30:25 PMPosted by: Connie Horn
    Last edited by barbara; 06-28-2011 at 08:42 PM.
    First treatment in 2007. Pioneering ever since.

    Barbara

  2. #2
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    Default

    I see Irv is playing king...again!!!

    The ISSCR is trying to assume the role of world stem cell cop. I want to understand why they feel they have the right to have clinics shut down? What exactly have they accomplished that has given them the gravitas to do so?
    Still Pioneering
    Had UC treatment April 5th, 2007
    Had autologous treatment March 19, 2010
    Had bone marrow and adipose stem cell treatment (autologous) June 16, 2010

  3. #3
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    Default It's all about the money

    Jeannine,

    To answer your question, MONEY, and lot's of it is being jeapordized.

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