Stem Cell Researchers Caution Against Using Unproven Stem Cell Therapies

One of the therapies that has arisen within conventional veterinary medicine, but which shares many of the worrisome features of an alternative approach, is stem cell therapy. Though it is a plausible intervention with promising preclinical evidence to support investigating its possible clinical benefits, it remains an unproven and inadequately investigated form of treatment. As a result, it is currently legal for human use in the U.S. only under very restricted conditions.  Unfortunately, many people seek such therapies in other countries with less robust laws and regulations protecting the public, through so-called “medical tourism.” And since the same strong public health laws rarely apply to our veterinary patients, stem cell therapies are aggressively marketed in the U.S. despite having even less evidence to support their use than is available for human medical uses.

I have written about this marketing and about the concern researchers in human stem cell therapies have expressed about the premature clinical use of inadequately tested stem cell treatments. Some of these researchers have recently reiterated their cautions about medical tourism and stem cell therapies, and their arguments are just as applicable to the domestic market in veterinary stem cell treatments.

Master Z, Resnik DB. Stem-cell tourism and scientific responsibility.EMBO Rep. 2011 Jul 29.

With a few exceptions—such as the use of bone-marrow haematopoietic cells to treat leukaemia—novel stem-cell therapies are often unproven in clinical trials. Even well-proven therapies can lead to tumour for­mation, tissue rejection, autoimmunity, permanent disability and death. The risks of unproven and unregulated therapies are potentially much worse…

Any medical innovation is ethically responsible when it is based on animal studies or other research that guarantee evidence of safety and clinical efficacy. Adequate measures must also be taken to protect patients from harm, such as clinical monitoring, follow-up, exclusion of indi­viduals who are likely to be harmed or are unlikely to benefit, use of only clinical-grade stem cells, careful attention to dosing strategies and informed consent.

The authors also address the issue of educating patients and doctors about the inadequate evidence for most stem cell therapies and the dangers of employing these therapies without a clear understanding of their risks and benefits. Their conclusions, however, are disappointing for those of us involved in such educational efforts, regarding both stem cell therapy and other kinds of unproven or even disproven methods.

Educating patients about the risks of unproven therapies can also help to address the problem of stem-cell tourism. However, education too has significant limitations, since many people will remain ignorant of the dangers of unproven therapies, or they will simply ignore warnings and prudent advice. For many years, cancer patients have travelled to foreign countries to receive unconventional and unproven treatments, despite educational campaigns and media reports discussing the dangers of these thera­pies. Since the 1970s, thousands of patients have travelled to cancer clinics in Mexico to receive medical treatments not available in the USA.

Education for physicians on the dangers of unproven stem-cell therapies can be helpful, but this strategy also has limitations, since many will not receive this education or will choose to ignore it. Additionally, responsible physicians might still find it diffi­cult to persuade their patients not to receive an unproven therapy, especially when con­ventional treatments have failed. The history of cancer treatment offers important lessons here, since many oncologists have tried, unsuccessfully, to convince their patients not travel to foreign countries to receive questionable treatments.

Given the lack of impact educational efforts often have on patient and clinician behavior, another possible method for limiting the potential harm of inadequately tested therapies is regulatory oversight requiring a reasonable degree of scientific evidence before such therapies can be marketed outside of the clinical research and compassionate use contexts. This has worked to prevent much inappropriate use of stem cell therapies in humans in the U.S., though the practice of medical tourism is a way around such regulations. Regulations on veterinary therapies are far less restrictive, and this has both benefits and costs. Lax regulation makes investigating novel therapies easier and cheaper, which may lead to more rapid and affordable development of new therapies. However, the same loose regulatory environment also subjects pets and their owners to unproven therapies which may not benefit them and may even be harmful. In any case, regulation is often not an especially effective way of constraining the use of therapies not supported by reasonable scientific evidence.

The recommendation these authors make for reducing stem cell tourism involves denying essential materials to practitioners overseas who use unproven stem cell therapies. This is, obviously, not relevant to the issue of veterinary stem cell therapies marketed in the U.S. What is relevant is the fact that leading researchers into stem cell therapies for humans, those scientists most likely to believe in the promise of such therapies because they have made investigating them their life’s work, are consistent in warning against the premature clinical use of these treatments without adequate supporting research evidence. Caution about such therapies seems prudent when even their advocates recommend it.

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5 Responses to Stem Cell Researchers Caution Against Using Unproven Stem Cell Therapies

  1. Art says:

    Looks like the stem cell cure for dog lymphoma is now promoted to be approaching 40-50 percent. which is promoted to be the same as humans. cool stuff when chemo treatment is promoted to extend life only 9-12 months with no likely cure.
    See
    http://en.wikipedia.org/wiki/Lymphoma_in_animals
    I am guessing a cost of 25 thousand for the stem cell cure but not sure of that. Just what I added up off the vet school website promotions. I am always amazed what can be done if there is enough money and someone can get the right care for that money.
    Art Malernee dvm

    Art Malernee dvm

  2. skeptvet says:

    Hopefully someday that will be available and affordable for more people. I would be interested in the risks and mortality rate associated with the procedure, since that would figure into calculation as well. And I would also point out that chemotherapy is still a vital part of the therapy since, as I understand it, dogs need to be in a complete clinical remission before they are eligible for this procedure

  3. art malernee dvm says:

    Looks like the lymphoma stem cell treatment is promoted to cost 15 thousand not the 25 I estimated. here is the movie from NC State that I think is new. I only found out about the NC state website when i did my literature review for my last lymphoma patient that came in the office.
    see
    http://www.ncsu.edu/featured-stories/innovation-discovery/september-2008/bone-marrow/index.php

    art malernee dvm
    fla lic 1820

  4. skeptvet says:

    It also looks like prospoective transplant patients must go through the entire UW-25 chemotherapy proptocol and maintain a full remission before they are eligible.
    http://www.fightcaninecancer.com/caninebonemarrowtransplants.html

  5. art malernee dvm says:

    look what came in email today.

    No need to ship em to NC state. For only $550 I can buy my own bogus stem cell kit and harvest stem cells in my own office. Where is the FDA when we need them?
    See

    Become a Referral Clinic Today!
    From: Dr Finn
    To: malernee
    Cc: sheila
    Date: Tue, Sep 20, 2011 11:00 am
    AttachmentDr__Mike_Webinar_Invitation.pdf
    Dear Dr. Arthur Malernee,

    As a former practice owner I know you’re busy, so out of courtesy I am sending an email as opposed to calling your office. My name is Kevin Finn and I am a Technical Services Veterinarian with MediVet America. Our company specializes in stem cell therapy and regenerative medicine. Just to give you an idea, stem cell therapy sales is estimated to be around $1.3 billion this year and climbing to around $8.5 billion by 2016. There are currently over 3,000 stem cell-based clinical trials going on across the country right now. Not only is this medicine available today, it is the medicine of the future!

    Our technology allows you to offer this medicine right in your own clinic. The procedure is very simple and only requires about 30 minutes of veterinarian time. The cells are processed by your technician and injected back to the patient the same day. The best part is that you will be practicing life-changing medicine. Many of our colleagues have told me that this technology has made veterinary medicine fun again!

    My main function within the company is to talk with pet owners that call us to inquiry about our technology and to find a veterinarian in their area offering the service. We have been getting a number of phone calls from the South Florida area and this has prompted us to search for referral clinics in the region. We want to make sure that all our customers have access to stem cell therapy. Many have no problem travelling out of the state to have the procedure performed, but we have opted to lower the traditional cost to make it more accessible. While many of our competitors are still charging several thousand dollars, our kit only costs $550. With the nationwide charge to the pet owner being around $1800 – $2200, just a couple of procedures a week can quickly add an additional $100K in revenue each year. The best part is that we do a lot of advertising and bring your clinic new clients.

    I’m attaching an invitation to Dr. Mike Hutchinson’s weekly webinar on Wednesdays where he discusses cases and his experience doing over 200 of these procedures. You can dial in and just listen or ask questions. Sheila Motley of MediVet South Florida has been copied on this email and is readily available to come speak with you at your convenience to show you how easy it is to offer regenerative medicine in your clinic. We’d be happy to schedule a lunch if that works best with your schedule. When would be a convenient time to visit?

    Thank you for your time and we look forward to advertising your clinic as a MediVet Referral Clinic.

    Best Regards,
    Kevin Finn, DVM
    Technical Services Veterinarian
    MediVet America

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