Guest Post: The deadly business of an unregulated global stem cell industry
Tereza Hendl and Tamra Lysaght
In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.
The patient at the centre of this case, Sheila Drysdale, underwent a liposuction procedure administered by cosmetic surgeon, Dr Ralph Bright, at his private Sydney clinic. Dr Bright did not perform this procedure for cosmetic reasons, but rather to ‘treat’ her advanced dementia with adipose (fat) derived stem cells. Mrs Drysdale died within ten hours of the surgery. Following an inquest into her death, the New South Wales Deputy Coroner stated that the utilisation of stem cells to ‘treat’ dementia was “highly questionable” and displayed “some of the hallmarks of ‘quack’ medicine,” particularly owing to the lack of scientific evidence supporting such ’therapy.’ The Coroner, thus, called for a more rigorous regulation of ‘innovative’ medical procedures in Australia that would protect vulnerable patients. Sadly, the relevant regulatory authorities have done very little to bring about any justice for Mrs Drysdale, or to address the systemic problems in Australia’s legislative framework that allows medical professionals to offer unproven stem cell-based interventions to patients without any accountability.
This case came to our attention as part of the work being done on an Australian Research Council funded Linkage Project “Regulating autologous stem cell therapies in Australia.” (LP150100739) This is a major study being conducted in a collaboration between researchers at the University of Sydney, the University of Melbourne, the Australian National University, and the National University of Singapore, and partner investigators at Multiple Sclerosis Research Australia, Arthritis Australia and Motor Neurone Disease Association of Australia. The project generates theoretical, ethical and legal insights that will guide the responsible development, translation and regulation of innovative stem cell interventions in Australia and internationally. Our study is engaging a wide range of stakeholders in workshops and interviews, including patients and patient advocacy groups, policymakers, regulators, scientists, medical practitioners, researchers, legal experts and stem cell providers.
Based on our findings so far, it is not surprising that Mrs Drysdale’s death occurred in a private clinic. Globally, private clinics are marketing autologous adult stem cells for the treatment of a wide range of conditions, including osteoarthritis, autism, asthma, infertility and dementia, where little to no scientific evidence supports their use. While adverse events leading to death occur in all clinical settings, the boundaries between medical innovation, practice and clinical research are more likely to be blurred within the private sector, where healthcare is sold and delivered outside of the critical gaze that more easily penetrates public facilities and where commercial imperatives can, and often do, conflict with patient’s best interests. In addition, some private healthcare facilities are set up in such a way that medical errors are more likely to occur, and peers are less likely to interrogate the errors and implement institutional changes to prevent them from re-occurring. Finally, medicine in the private sector is increasingly being marketed and sold directly to consumers. While this partly reflects the democratisation of medical information, it also sets up situations in which consumers have more direct relationships with providers who may not take seriously their duties of care.
Unfortunately, the death of Mrs Drysdale is far from an isolated case and will not be the last unless regulators take action. Prior to Mrs Drysdale’s death, cases of lethal harm from these interventions were reported in Germany, Ecuador, Japan, China and the US. In the most recent case, published last week in the New England Journal of Medicine (Kuriyan et al. 2017), three women were reported to have lost their eyesight after being administered with autologous adipose-derived stem cells for age-related macular degeneration at a US clinic. Like Mrs Drysdale, there was no scientific or clinical basis to justify administering these types of stem cells for these diseases, and both were provided commercially in private clinics.
While innovation is important in medicine, weakly regulated innovation leads to significant harms to patients and public health. The evidence of harm caused by unregulated ASC interventions is of immense concern and generates a pressing need to foster ethical and socially responsible innovation in regenerative and cellular medicine. Medical professionals and responsible authorities should recognise Mrs Drysdale’s death, and others that preceded it, as a tipping point towards a regulatory reform. Not acting accordingly risks that more preventable tragic deaths will inevitably follow.
References
Coroners Court, New South Wales. 2016. Inquest into the death of Sheila Drysdale. Available at http://www.coroners.justice.nsw.gov.au/Documents/Findings%20Drysdale.pdf. Accessed 30 March, 2017.
Kuriyan, A. E. et al. (2017). Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD. N Engl J Med, 376:1047-1053.