The deadly business of an unregulated global stem cell industry

Journal of Medical Ethics 2017;43:744-746.
Authors: Lysaght T, Lipworth W, Hendl T, et al.
“In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale’s death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells.”
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The Deadly Business of an Unregulated Global Stem Cell Market

BMJ Blog, 30 March 2017
Authors: Tereza Hendl, 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.”
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Destroying research embryos within 14 days limits chance of medical breakthroughs

The Conversation, 30 January 2017
Author: Patrick Foong
“Primarily due to moral considerations, stem-cell scientists have to work within many limitations placed on their research. One of these is the 14-day rule that outlaws research on pure human embryos over two weeks old. It is encoded in laws in at least 12 countries, including the US, UK, Australia and New Zealand.”
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Divisions run deep over how to regulate stem cell clinics

CNN, 19 September 2016
Author: Jacqueline Howard
“Stem cells have the potential to divide and develop into many different cell types in the body. They are so enchanting and so promising — they may help paralyzed patients regain use of their limbs or help the nearly blind to see — that they have Food and Drug Administration officials scratching their heads. Officials are mulling regulations to address how stem cells are used in various medical and cosmetic procedures, to avoid any exploitation of and harm to patients, and they have asked for input from the public.”
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Evidence and Access to Biomedical Interventions: The Case of Stem Cell Treatments

Journal of Health Politics, Policy and Law 2016; 41(5): 917-937
Authors: Karen J. Maschke, Michael K. Gusmano
“The controversy over patients’ access to stem cell interventions is familiar to scholars of the drug regulatory system and the politics of evidence-based medicine. What counts as evidence of a biomedical intervention’s safety and effectiveness? Who should define and assess safety and effectiveness, and how? In the first section of the paper we describe the types of stem cells that may be therapeutically effective. We then describe how the US Food and Drug Administration asserted regulatory authority over certain stem cell interventions and the legal challenge to the agency’s actions. Next, we place the debate about patients’ access to stem cell interventions in the broader context of efforts in the US to promote and implement health technology assessment and the debate about standards of evidence.”
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Researchers Question Safety, Value Of Untested Stem Cell Treatments

NPR, 5 September 2016
Author: Rob Stein
“So far the Food and Drug Administration has not aggressively regulated stem cell clinics. The reason is the stem cells being used typically come from the patient’s own body — an autologous transplant. And the clinics don’t process the cells much before injecting them. But now that the treatments are being offered so much more widely, the FDA is considering more aggressive regulation. As part of that process, the agency will hold a workshop this Thursday, followed by a two-day hearing next week.”
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Stem Cell Therapies Are Still Mostly Theory, Yet Clinics Are Flourishing

NYT, 28 July 2016
Author: Gina Kolata
“Health regulators in the United States are talked about as the best in the world, but a new study on the spread of stem cell clinics shows what can happen when regulations fall behind. Out of nowhere, over the past two to three years, the clinics have sprung up — 570 in the United States, according to a recent paper — offering untested stem cell treatments for just about every medical use imaginable.”
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‘Hallmarks of quack medicine’ in fatal stem cell treatment, coroner finds

ABC, 15 July 2016
Author: Ann Arnold
“An inquest finds a cosmetic surgeon’s performance led to the death of 75-year-old woman with Alzheimer’s, amid calls to tighten the medical regulations that cover stem cell treatment. The NSW deputy coroner has found that a 75-year-old woman died from uncontrolled blood loss caused by a mini-liposuction stem cell procedure. It is understood to be the first reported death as a result of this experimental procedure.”
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A Cautionary Tale of ‘Stem Cell Tourism’

NYT, 22 June 2016
Author: Gina Kolata
“A growing number of clinics, often in places like Russia or China, but also in Europe and elsewhere, say on websites that they can treat, even cure, diseases like muscular dystrophy, Alzheimer’s, Parkinson’s, and spinal cord injury as well as strokes, by injecting patients with stem cells that, in theory, could develop into a missing nerve, a muscle or other cells and repair damage from an illness or an injury. Estimates are that tens of thousands of patients around the world have had such treatments and that the industry is worth hundreds of millions of dollars. Academic researchers say stem cells hold enormous promise, but they are proceeding cautiously.”
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Rethinking on ethics and regulations in cell therapy as part of neurorestoratology

Dove Medical Press, 11 January 2016
Authors: Alok Sharma and Ziad M Al Zoubi
“Ethics, regulations, and evidence-based practices form the foundation of modern medicine. However, in recent years, and particularly in reference to cellular therapy, they have become obstacles to the growth and development of this new form of treatment. Based on four important documents, it is proposed that regulatory bodies and medical associations recommend an alternate way of looking at regulations for cell therapy, so as to ensure that only safe and effective treatments are offered to patients, and that greater availability of these new treatment options is also encouraged.”
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