This week, ABC Radio National’s Background Briefing highlights the
challenges involved in delivering on the promise of stem cell science and
regenerative medicine.
Although
scientists continue to make progress in this exciting area of medical research,
the development of safe, effective treatments will take time and a substantial
ongoing financial investment by governments and industry.
But,
having heard about the promise of stem cell technology, many Australians (and
others around the world) are not prepared to wait and decide to pursue unproven
stem cell treatments overseas (stem cell tourism) at great cost and risk.
In
keeping with the maxim “first, do no harm”, there are very strict rules in
place to evaluate any potential new treatment. Stem cell-based therapies are no
exception and indeed, there are many clinical trials involving stem cells
underway around the world.
Clinical
trials are conducted in “phases” with the early phases usually involving a
small number of participants primarily to test whether the treatment is safe.
Once this is done, trials are then undertaken to test whether the treatment
actually works.
In all
clinical trials, it’s required that participants are fully informed of all
risks, are not required to pay to take part and are carefully monitored
following treatment. No matter what the outcome of the trial, doctors and
scientists involved are encouraged to share their results so that others can
learn and benefit from the study.
Contrast
this cautious approach with the practice of clinics already offering unproven
stem cell treatments for many different conditions. These clinics effectively
operate outside the accepted regulatory framework; offer little or no
scientific evidence from studies in animals to support their approach; and have
little if any real capacity to follow patients' progress once they have left
the clinic.
These
organisations are also reluctant to share their results with other members of
the medical community or have their claims independently verified.
There
is no doubt that the treatments they offer are expensive. Arecent study I was involved
in found Australians who travelled overseas for experimental stem cell
treatments paid between $10,000 to $60,000 per treatment, with additional costs
if carers were required to travel with them or if they wished to pursue further
treatment.
Many of
the people interviewed for the study acknowledged their reliance on community
fundraising and the generosity of family and friends to fund their trips. They
also cited the high emotional cost of being separated from loved ones for
several weeks or months at a time.
What
was also clear was that the decision to pursue such experimental treatment was
not taken lightly. The people we interviewed believed they had done their
research. They had used the internet to find out more and spoken to other
patients who had received the treatment. But they had rarely consulted their
Australian doctor about their decision and took advice from the overseas doctor
providing the treatments, who was often the same doctor receiving payment for
their treatment.
Indeed
the financial cost, rather than potential risk to health, was seen as the main
risk for many of those we interviewed. One of the participants, who had a child
with cerebral palsy, said, “The worst that could happen was we could spend our
money and would have gotten no results.”
Unfortunately,
reports of serious complications following experimental stem cell treatments
may mean that you could lose more than your money. A boy with a rare neurological condition who
received fetal stem cells in Russia, and a woman treated with her own stem cells in
Thailand for kidney disease, developed tumours. An otherwise healthy child with
cerebral palsy and a young British paraplegic died in Germany and Ecuador , respectively,
following stem cell treatments.
Given
the highly invasive way stem cells are administered – often injected into the
space surrounding the spinal cord or even directly into the brain –
complications are unfortunately not unexpected. Questions should, and have been
raised, especially given there was no substantiating evidence to warrant any of
these highly experimental treatments. It shouldn’t be enough that the doctors
offering these treatments hope that it’ll work.
While
stem cell research and regenerative medicine remain the next exciting frontier
in medical research, caution is required. We need patients willing to be
“guinea pigs” (all medical research does) but this should only be in the
context of a clinical trial, under the supervision of a specialist in the
relevant field of medicine, with full disclosure and informed consent of the
participant. Neither risks nor benefits should be hidden; the cost to the
patient and to the field is simply too high.
What to look out for
Major
warning signs of dubious, unproven therapies (from ISSCR Patient Handbook on Stem Cell Therapies):
– Claims based on patient testimonials;
– Multiple diseases treated with the same cells;
– The source of the cells or how the treatment will be done is not clearly documented;
– Claims there is no risk; and
– High cost of treatment or hidden costs.
Megan
Munsie
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