Tamra Lysaght

Regulating Autologous Adult Stem Cells: The FDA Steps Up

The Food and Drug Administration (FDA) has sought an injunction to prevent a US-based company from offering an autologous adult stem cell treatment for musculoskeletal and spinal injuries. Given the alarming number of clinics promoting stem-cell-based interventions, the outcome of this case could have wide-ranging implications.

Oversight for Clinical Uses of Autologous Adult Stem Cells: Lessons from International Regulations

Autologous adult stem cells (ASCs) are being administered by physicians for indications that have not been demonstrated as safe and effective in formal clinical trials. Examination of regulatory frameworks across five countries suggests that balancing the demands of research with clinical freedom has created structural weaknesses that are being exploited.

Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

Australian Undergraduate Biotechnology Student Attitudes towards the Teaching of Ethics

In recent years, ethics has become part of most tertiary biotechnology curricula. There is, however, considerable variation in the extent and manner of ethics education provided to students in different institutions. In addition, the perceived need that students and employers have regarding ethics education, and the aims and expected outcomes of ethics education, are rarely made clear. This research reports the findings of a questionnaire administered to 375 undergraduate biotechnology students from 19 Australian universities to determine their attitudes towards the teaching of ethics. The results suggest that undergraduate biotechnology students generally regard ethics education to be important and that ethics should be included in undergraduate biotechnology curricula. Students tended, however, to emphasize the professional and industrial side of ethics and not to recognize the personal effects of morals and behaviour. We provide suggestions for rethinking how ethics should be taught.

Introducing One Health to the Ethical Debate About Zoonotic Diseases in Southeast Asia

Abstract Pandemic plans recommend phases of response to an emergent infectious disease (EID) outbreak, and are primarily aimed at preventing and mitigating human‐to‐human transmission. These plans carry presumptive weight and are increasingly being operationalized at the national, regional and international level with the support of the World Health Organization (WHO). The conventional focus of pandemic preparedness for EIDs of zoonotic origin has been on public health and human welfare. However, this focus on human populations has resulted in strategically important disciplinary silos. As the risks of zoonotic diseases have implications that reach across many domains outside traditional public health, including anthropological, environmental, and veterinary fora, a more inclusive ecological perspective is paramount for an effective response to future outbreaks.

The deadly business of an unregulated global stem cell industry

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 Drysdales 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.

Ethical issues of CRISPR technology and gene editing through the lens of solidarity.

Background The avalanche of commentaries on CRISPR-Cas9 technology, a bacterial immune system modified to recognize any short DNA sequence, cut it out, and insert a new one, has rekindled hopes for gene therapy and other applications and raised criticisms of engineering genes in future generations. Sources of data This discussion draws on articles that emphasize ethics, identified partly through PubMed and Google, 2014-2016. Areas of agreement CRISPR-Cas9 has taken the pace and prospects for genetic discovery and applications to a high level, stoking anticipation for somatic gene engineering to help patients. We support a moratorium on germ line manipulation. Areas of controversy We place increased emphasis on the principle of solidarity and the public good. The genetic bases of some diseases are not thoroughly addressable with CRISPR-Cas9. We see no new ethical issues, compared with gene therapy and genetic engineering in general, apart from the explosive rate of findings. Other controversies include eugenics, patentability and unrealistic expectations of professionals and the public. Growing points Biggest issues are the void of research on human germ cell biology, the appropriate routes for oversight and transparency, and the scientific and ethical areas of reproductive medicine. Areas timely for developing research The principle of genomic solidarity and priority on public good should be a lens for bringing clarity to CRISPR debates. The valid claim of genetic exceptionalism supports restraint on experimentation in human germ cells, given the trans-generational dangers and the knowledge gap in germ cell biology.

Open for business: a comparative study of websites selling autologous stem cells in Australia and Japan

AIM This article examines online marketing practices of Japanese and Australian clinics offering putative autologous stem cell treatments. MATERIALS & METHODS We conducted google searches for keywords related to stem cell therapy and stem cell clinics in English and Japanese. RESULTS We identified websites promoting 88 point-of-sale clinics in Japan and 70 in Australia. CONCLUSION Our findings provide further evidence of the rapid global growth in clinics offering unproven stem cell interventions. We also show that these clinics adopt strategies to promote their services as though they are consistent with evidentiary and ethical standards of science, research and medicine. Unless addressed, these practices risk harming not only vulnerable patients but also undermining public trust in science and medicine.

Zika in Singapore: insights from One Health and social medicine.

The detection of the Zika virus in Singapore in the last week of August 2016 has generated concern in the community, particularly among pregnant women, and prompted the authorities to take swift action to contain the spread of the virus. In addition to public health efforts currently under way, including the lively ethical discourse on dealing with this mild disease and its significant risk of congenital malformations, we believe that important insights can also be found in the One Health (OH) approach. OH is an ethical, ecological approach that takes into consideration justice and respect for human and animal populations as well as the environment.(1-3) This approach considers the wider social and environmental factors that shape disease transmission, and helps us to identify three populations that are particularly vulnerable but may be overlooked in this scenario: transient foreign workers, their sexual partners and local monkey populations.

Rhetoric, power and legitimacy: A critical analysis of the public policy disputes surrounding stem cell research in Australia (2005-6).

In December 2006, the Australian Parliament liberalized regulation governing stem cell research. This decision and preceding legislative review generated considerable public debate, which centred on objections to the deliberate creation and destruction of human embryos for research purposes. This paper draws on qualitative research conducted on the public debate surrounding this policy episode. The aim of this research was to examine how science and scientific knowledge are mobilized by participants in these debates to support their arguments. Data were collected from 109 newspaper opinion editorials as well as 23 in-depth interviews and examined using qualitative content and thematic analysis. Results of this analysis depict science as a rhetorical, moral and political resource that provides opportunities for participants to gain legitimacy, negotiate meaning and assert authority in the public domain. The mobilization of science in public discourse is discussed along with suggestions that are aimed at encouraging greater transparency and inclusiveness in public debates around contested science and emergent technologies.