The deadly business of an unregulated global stem cell industry (original) (raw)
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Stem Cell Research & Therapy, 2015
An increasing number of private clinics in Australia are marketing and providing autologous stem cell therapies to patients. Although advocates point to the importance of medical innovation and the primacy of patient choice, these arguments are unconvincing. First, it is a stark truth that these clinics are flourishing while the efficacy and safety of autologous stem cell therapies, outside of established indications for hematopioetic stem cell transplantation, are yet to be shown. Second, few of these therapies are offered within clinical trials. Third, patients with chronic and debilitating illnesses, who are often the ones who take up these therapies, incur significant financial burdens in the expectation of benefiting from these treatments. Finally, the provision of these stem cell therapies does not follow the established pathways for legitimate medical advancement. We argue that greater regulatory oversight and professional action are necessary to protect vulnerable patients and that at this time the provision of unproven stem cell therapies outside of clinical trials is unethical.
The promise of stem cells and the prospect of curing disease, for which no therapy currently exists, continue to drive global interest. However, several misconceptions persist in general society and, to an extent, among the medical fraternity. These misconceptions, coupled with irresponsible clinical practices, have resulted in a multitude of controversies, all of which are to the detriment of vulnerable patients. Stem cell tourism is an international industry that has been on the rise in recent years, and thousands of families have been enticed into paying for unproven stem cell therapies. Guidelines and legislation in this regard are presently being developed and implemented globally with the aim of providing ethically sound reference material for patients, practitioners and regulators. Although governments and policy makers worldwide are actively trying to protect patients by regulating the sources, research and uses of stem cells in humans, the existing rules and regulations have been the source of much controversy and sometimes function in contradiction. Regulatory environments also differ significantly between countries, which need global scientific cooperation for sound and safe translation of stem cell therapies. This also makes global regulatory cohesion very difficult. Without legal and regulatory certainty regarding stem cell research and the translation thereof, scientists risk their research integrity and liability, while patients might suffer harm and exploitation. This chapter aims to provide an overview of the current global regulatory framework and the ethical contexts in which it is embedded, as well as anticipated legal developments and recommendations. Chapter objectives The primary objective is to describe the scope of currently accepted stem cell therapies and to align this with the expectations of society. International guidelines and legislature play a critical role in striking a balance between the current status of stem cell research and the hope of society, while also limiting the extent of
Ethics of International Stem Cell Treatments and the Risk-Benefit of Helping Patients
Biochemistry, 2023
Numerous and diverse participants are involved in the development of novel therapies: patients, physicians, scientists, sponsors, governing bodies, lawmakers, institutional review boards, and bioethics proponents. While the welfare of the patient must always and unquestionably be at the forefront of any intervention along with informed consent, their wishes, their requests, and their expectations should also be considered at every step. The availability of stem cell research in various countries with dissimilar regulatory agencies has opened the door for thought-provoking questions about their validity from an ethical, legal, and moral perspective, which will be addressed in this chapter, framed within the doctor-patient relationship.
Banking on it: Public policy and the ethics of stem cell research and development
If the therapeutic potential of stem cell-based therapies is ever realized, demand for stem cells and derivative tissues will be tremendous and will create new challenges for health care systems, especially publicly funded health care systems. We propose a framework for the ethical analysis of stem cell research and development that considers the welfare of communities, tissue recipients, and cell sources in relation to a range of stem cell production and distribution options. Ethical desiderata include: equitable access, maximized potential therapeutic benefit across demographic and disease groups, and reasonable cost. Other ethical priorities include the minimization of stem cell line and tissue wastage, risk of immune rejection, risk of transmitting diseases, the use of human embryos, and risk to those contributing source cells. We array plausible sources of stem cells and distribution strategies to characterize 12 potential models for producing and distributing cells and tissues in the future. We describe ''personalized'', ''matched'', and ''universalized'' models, and compare the ethical acceptability of these models. Popular and scientific discourses about stem cells typically emphasize personalized or matched stem cell distribution models. We show that universalized models may ultimately best serve the interest of taxpayers, communities and patients who hold high stakes in the therapeutic success of stem cell science. They are therefore highly worthy of scientific pursuit. This conclusion is provisional and the framework must be reapplied as scientific knowledge, technological capacity and ethical mores evolve.
GOING TO THE ROOTS OF THE STEM CELL CONTROVERSY
The purpose of this paper is to describe the scientific background to the current ethical and legislative debates about the generation and use of human stem cells, and to give an overview of the ethical issues underlying these debates.
BMC Medical Ethics
Background: The marketing of unproven direct-to-consumer stem cell interventions is becoming widespread in Canada. There is little evidence supporting their use and they have been associated with a range of harms. Canada has been slower to act against clinics offering these interventions than other jurisdictions, including the United States. Here, we outline the regulatory and policy tools available in Canada to address this growing problem. Main body: Health Canada's regulations governing cell therapies are complex, but recent statements make it clear that Health Canada believes it has jurisdiction over many of the currently marketed stem cell interventions. Still, further regulatory clarity is needed from Health Canada, as are increased directed enforcement efforts on interventions that fall within their scope. The Competition Bureau, via the Competition Act, prohibits advertisers from making materially false or misleading promotional representations. The Competition Bureau could collaborate with the scientific community to analyze the claims of existing clinics in Canada, and impose sanctions upon those who breach the established standard. Professional regulators, including provincial colleges of physicians and surgeons, have considerable power over what products and services their members can offer. Every college of physicians in Canada requires, via policy and codes of ethics, that doctors maintain evidence-based practices. This requirement is incompatible with offering many unproven stem cell interventions. Litigation may be another tool, including the use of fraud, misrepresentation and/or negligence claims for failing to meet the required standard of care. Finally, political pressure on federal and provincial lawmakers could encourage changes to marketing, cell therapy and professional regulations that would allow a more comprehensive response. Conclusions: In sum, there are many existing tools that can be used to protect the public from unproven stem cell interventions. Increased bureaucratic will and grassroots efforts are needed in order to effect a positive policy response.