Biomedical Engineering Reference
In-Depth Information
unproven therapies put patients at risk, but that they also threaten the
progress of legitimate translational stem cell research (Hyun et al.,
2008). The core principles that the ISSCR would like to see adhered
to are contained in the ISSCR's Guidelines for the Clinical Translation
of Stem Cell Research (Hyun et al., 2008). They include: independent
review and oversight by experts in the field, properly and voluntarily
informed consent, and adequate patient monitoring and reporting of
adverse events (Hyun et al., 2008). The potential need for innovative
new therapies outside the clinical trial context for specific patients is
also acknowledged within the guidelines, as is the requirement that
any benefits of translational stem cell research be distributed
according to the principles of social justice (Hyun et al., 2008).
A Task Force on Unproven Stem Cell Treatments was established
in 2009 in order to develop the patient-based resources that the
ISSCR now have on their website (Taylor et al., 2010). The key
recommendations of the Task Force included developing a list of
providers and an indication of what safeguards they provide,
developing educational resources explaining how stem cells work
and what the clinical translation process involves, and providing a
list of questions that patients should ask prospective providers about
the treatments they offer (Taylor et al., 2010). The working party
was deemed to be necessary on the grounds that 'excitement' about
the possibilities of stem cell research '… has led to unacceptable
exploitation of patients' hopes and fears' (Taylor et al., 2010: 43).
While the development of resources like the ISSCR's
Patient
Handbook on Stem Cell Therapies
and website are laudable goals in
attempting to mitigate any potential harm from unproven treatments,
the underlying argument that unproven treatments are exploitative
is contested. Evidence from studies conducted with patients who
have actually elected to undertake unproven stem cell treatments
show that there are in fact quite complex and sophisticated
decision-making processes attendant in such decisions (Petersen,
2010). Moreover, emerging case law from around the world shows
that it is not at all clear that unproven therapies are either exploitative
or damaging to patients, and that in some instances, the patient's
choice to undertake unproven stem cell therapies is a reasonable
outcome given their circumstances (Zarzeczny and Caulfield, 2010).
