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WANT to stay young forever, cure autism, asthma or Parkinson’s, overcome spinal cord injury, or be rid of the pain caused by arthritis?
Somewhere in the world, a clinic will be offering stem cell therapy that is designed just for you.
None of these treatments are evidence based, but that’s hardly a consideration in the unregulated world of the internet.
Australia has its share of private clinics offering unproven stem cell therapies, thanks to what the consortium of Australia’s leading researchers in the field, Stem Cells Australia, describes as “a controversial loophole” in our regulations.
“[The loophole] means that unproven stem cell treatment is excluded from the regulatory framework provided the treatment is being offered by a registered Australian doctor, is using the patient’s own cells and is a one-patient treatment”, the consortium’s Australian Stem Cell Handbook (2013) says.
“It is not a requirement that such treatments have to be first proven safe and effective in clinical trials.”
Late last year the NHMRC also warned of the risks associated with unproven treatments on offer in Australia for conditions including multiple sclerosis, spinal cord injury, arthritis, heart disease, autoimmune diseases, cerebral palsy and autism.
Although stem cell therapy offers promise in a number of conditions, the only application that has so far proved to be safe and effective is the long established practice of using bone marrow transplants in disorders such as leukaemia, the NHMRC said in its accompanying guide for medical practitioners.
But we shouldn’t let a little thing like evidence get in the way when we’re talking about cures for sick children.
Italian researchers Elena Cattaneo and Gilberto Corbellini found out just how nasty things can get when you take up arms against purveyors of unproven therapies — in their case the Stamina Foundation, a private organisation claiming stem cell treatments offer benefit in conditions as varied as Alzheimer’s disease, diabetes, heart disease and Tourette’s syndrome.
Despite the lack of evidence supporting its claims, Stamina won a number of court battles and even accessed public funding for some of its treatments.
Writing in Nature last week, Drs Cattaneo and Corbellini describe their ongoing battle to rid Italy of such unproven treatments and the vilification they received in some quarters for “keeping children from life-saving treatments”.
An article in the same issue of Nature argues stem cells are being used as “a wedge” in a broader international push to allow marketing of unproven medical interventions and reduce the power of regulators.
Right-wing American think tanks like the Heartland Institute and the Goldwater Institute have mounted emotive campaigns to such ends.
Heart-rending patient stories, articles about regulatory obstacles preventing access to those life-saving treatments … you can probably imagine the kind of stuff.
Who do such campaigns really serve? They may claim to be motivated by the needs of desperate patients, but their real constituency is probably commercial organisations that find the regulators’ insistence on evidence, well, a little annoying.
It’s no accident that the claims made for stem cell therapies tend to cluster around conditions for which mainstream medicine doesn’t have a solution.
So what are doctors to do when a patient tells them about a wonderful new treatment they have discovered online?
The NHMRC guide for medical practitioners has a list of tips. My favourite is: “Encourage your patients to think twice about statements describing the therapy as a ‘quick fix’, ‘scientific breakthrough’, ‘miracle cure’, or similar. It may help to suggest to patients that if it sounds too good to be true — such as a claims that a therapy can cure a disease or treat a variety of conditions — it usually is.”
Jane McCredie is a Sydney-based science and medicine writer.
The Australian Rheumatology Association (ARA) has also published a position statement that said there was not enough high-quality evidence to be confident of the safety and efficacy of stem cell treatment in OA.
As a practitioner involved in the research and development of stem cell therapies for osteoarthritis I too share the concern highlighted in this article that stem cell therapies are used without proven efficacy or safety. The NHMRC correctly advises that `medical treatments should be tested through clinical trials to show that they are safe and effective’.
However, I dispute the articles assertion that ‘none of these treatments are evidence based’. In the area of osteoarthritis this comment is incorrect.
Both pre-clinical and clinical data confirm the efficacy of mesenchymal stem cell (MSC) therapy in osteoarthritis. A randomized controlled trial assessing the use of MSCs post knee arthroscopic osteoplasty showed significant improvement in quality of articular cartilage repair [Saw 2013]. Most recently, Jo and colleagues have shown consistant regrowth in knee cartilage volume after a single intra-articular injection of MSCs [Jo 2014].
Systematic review of trials involving intra-articular injection of MSCs (844 injections with mean follow-up of 21months) has shown no association with significant adverse events including infection, death or malignancy [Peeters 2013]. Further, meta-analysis of trials using intravascular injections of MSCs – over 1000 participants – showed no adverse events other than transient fever [Lalu 2012].
Whilst I acknowledge and share the concern regarding uncontrolled development of stem cell therapies I also believe that we have a responsibility to both be informed and inform patients of the current and correct scientific evidence.
As a respiratory specialist, I have not seen the benefits of the stem cell procedures in osteoarthritis. However, I have looked after one patient with catastrophic complications immediately following such a procedure. While it is difficult to prove the association, no other explanation has emerged, despite extensive investipation, and the temporal relationship was undeniable. The patient has been left with significant disability. I’m not going into details here in the interests of preserving patient confidentiality (the case is being written up). However, my point is that we must remain vigilant for adverse events potentially related to these new therapies.
Proof in medicine is a risk benefit analysis. Doctors do this everytime they treat a patient. Proof for the safety of the cell therapy we offer is continuing to build with lots of case series and some small trials completed. Clinical trial proof of efficacy for Osteoarthritis is low. I am sufficiently convinced by the improvements I see in my patients that we are now completing ethics committee approval for a clinical trial using improved protocols to manage Osteoarthritis.
It is incorrect to call this a loophole. The TGA have clearly stated that they made a considered decision to exclude autologous cell therapy performed without cuture. This is an endorsement of the low risk of this procedure. Culturing cells increases risk and needs regulation – this captures embryonic, foetal, cord cells and most allogeneic cells.
The cost of this procedure in Australia is low. Rheumatologists, Orthopaedic surgeons and Cosmetic surgeons all tel me that they earn more money in their chosen profession than when doing stem cell treatments. They choose to do stem cell treatments because they believe they are practising better medicine.
Everyday I am asked about new stem cell treatments for chronic musculoskeletal pain. Everyday I point out that the technology is promising but should not be used in clinical practice until it is proven to be safe and effective. Musculoskeletal disorders are responsible for 27.4% of chronic disability in Australia, and new treatments are desperately needed. Unfortunately, there is little interest amongst the stem cell community for musculoskletal research and even the NHMRC places little importance on this area of medicine. (Bourne A et al, Med J Aust 2014:200(2):88-91). When medical research does not adequately address the needs of the population, in the presence of potential regulatory loopholes – this is called an opportunity. Therefore, it is hardly surprising that entrepreneurial biotech companies are now flourishing, and promoting the fact that Drs can earn $3,000.00 for a miniliposuction and simple injection. (The total procedure costs patients $9 or 10,000.00). Unfortunately, money can buy medical ethics.
This not only applies to stem cell therapies but a myriad of other “cures’ or potential cures for rare or obscure conditions, especially in children. You only have to watch current affairs programs and Sixty Minutes to see illustrations of unproven and expensive therapies requiring fundraising and trips overseas, major family disruptions etc. Local specialists ” can do nothing” or “refuse treatment”, or worst of all ‘ told, go home and die’ ( has any doctor ever actually said this?). i agree patients should be encouraged to critically examine treatments that are not available here in Australia and be reminded that there are no ‘secrets’ in mainstream medicine.