Death following experimental stem cell therapy

The Inquest into the death of Sheila Drysdale (NSW Coroners Court, findings published 15 July 2016) gave rise to a finding that Ms Drysdale died due to hypovolaemic shock she suffered following uncontrolled blood loss caused by a mini-liposuction stem cell procedure (for dementia) performed upon her at a time when her anti-coagulant medications had not been ceased.

The recommendations made by the Coroner at [93] included:

  • That  the Therapeutic Goods Administration (Commonwealth) and the NSW Ministry of Health consider how best to manage and regulate the provision of “experimental” or “innovative” medical or surgical procedures that have not yet been approved following clinical trials or other recognised peer-reviewed evaluation processes.
  • That the questions of potential conflict of interest and informed consent be given high priority.
  • That the National Health and Medical Research Council and the NSW Clinical Excellence Commission consider formulating guidelines and protocols to ensure that “experimental” or “innovative” medical procedures conform with scientifically respectable clinical practice.

In relation to the experimental nature of the treatment, the Coroner noted at footnote 2 that “as at 11 July 2016, SCA’s website has letters posted that imply that their stem cell treatment has cured or reversed Alzheimer’s Disease in two patients. It has also posted letters from patients that imply their treatments have cured or reversed the effects of strokes, anoxic brain injury, autism, brain damage, cerebral palsy, epilepsy, and many other conditions. …. Curiously, however, the website also posts references to real scientific research including a paper on experiments in mice in relation to the possible use of stem cells in treating dementia. That paper warns: “Many important questions remain before we could envision moving forward with early-stage trials [with humans]” …”

At [40] the Coroner observed:

While all medical and surgical procedures necessarily start off experimentally, there is a world of difference between rigorously and ethically conducted clinical trials that are reviewed at every stage by qualified peers and this procedure which, in relation to treatment of dementia at least, has some of the troubling hallmarks of “quack” medicine: desperate patients, pseudo-science and large amounts of money being charged for unproven therapies.

And at [88]:

On a broader scale, it is disturbing that [a named medical practitioner] (and presumably others) would market this “experimental” or “innovative” therapy for profit to vulnerable and desperate people in the full knowledge both that there is little scientific support for the “therapy” in relation to dementia and that he is not conducting a clinical trial of any scientific standing or worth. The obvious potential for the providers of such purported remedies and therapies to exploit such consumers is great and therefore troubling. So too is the potential conflict of interest between the principle of harm minimisation and commercial medicine.

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