Jane McCredie: Stem cell loopholes

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.