Toolised medicine: an anthropological study of ‘experimental’ cell therapy during a period of regulatory change in China

Between December 2011 and autumn 2015, Chinese health authorities developed new regulations for stem cell clinical research. During this period, all pre-existing stem cell clinical research and practices were halted, and no permission was given to new project applications. Nevertheless, other biotechnologies, including immunotherapy, continued to be developed and offered in China. My fieldwork, from early 2014 to mid-2015, allowed me to learn how this regulatory change affected the life and work of some Chinese patients, researchers, health care professionals, biotech entrepreneurs, industry analysts and investors, and how differently each group understood, valued, and in some cases, used stem cell- and immune cell- therapy. Nevertheless, I noted then, and contend in this thesis that what the developers and users of ‘experimental’ cell therapy all valued and worked with was the medicinal potentiality of these cells. In the making and use of cell-based medicinal products, the users and developers integrated their own values and purposes that derived both from within, and outside of, the medical arena. In other words, the developers and users conceptualised and used cell-based medicine like a “tool” to address particular issues rising from specific situations - not just for health reasons. I develop the concepts of “toolised medicine” and “tooling work” to depict and analyse this “tool-like” feature and use of biomedicine, and use these concepts to reassess China’s recent regulatory change in this field. In so doing, I contribute to social science theorisation and studies of biomedicine

Comparing national home-keeping and the regulation of translational stem cell applications: an international perspective

A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the notion of ‘national home-keeping’, referring to the way governments articulate international standards and regulation with conflicting demands on local players at home. Identifying particular dimensions of regulatory tools – authority, permissions, space and acceleration – as crucial to national home-keeping in Asia, Europe and the USA, we show how local regulation works to enable development of the field, notwithstanding international (i.e. principally ‘western’) regulation. Triangulating regulation with empirical data and archival research between 2012 and 2015 has helped us to shed light on how countries and organisations adapt and resist internationally dominant regulation through the manipulation of regulatory tools (contingent upon country size, the state's ability to accumulate resources, healthcare demands, established traditions of scientific governance, and economic and scientific ambitions)

The diploid genome sequence of an Asian individual

Here we present the first diploid genome sequence of an Asian individual. The genome was sequenced to 36-fold average coverage using massively parallel sequencing technology. We aligned the short reads onto the NCBI human reference genome to 99.97% coverage, and guided by the reference genome, we used uniquely mapped reads to assemble a high-quality consensus sequence for 92% of the Asian individual's genome. We identified approximately 3 million single-nucleotide polymorphisms (SNPs) inside this region, of which 13.6% were not in the dbSNP database. Genotyping analysis showed that SNP identification had high accuracy and consistency, indicating the high sequence quality of this assembly. We also carried out heterozygote phasing and haplotype prediction against HapMap CHB and JPT haplotypes (Chinese and Japanese, respectively), sequence comparison with the two available individual genomes (J. D. Watson and J. C. Venter), and structural variation identification. These variations were considered for their potential biological impact. Our sequence data and analyses demonstrate the potential usefulness of next-generation sequencing technologies for personal genomics

Users’ motivations to purchase direct-to-consumer genome-wide testing: an exploratory study of personal stories

The relatively rapid growth of the direct-to-consumer (DTC) genetic testing market in the last few years has led to increasing attention from both the scientific community and policy makers. One voice often missing in these debates, however, is that of the actual user of these genetic testing services. In order to gain a better picture of the motivations and expectations that propel individuals to purchase DTC genome-wide testing, we conducted an exploratory study based on users’ personal stories. Through qualitative content analysis of users’ personal stories found on Internet blogs and DTC genetic testing companies’ websites, we identified five major sets of motivations and expectations towards DTC genome-wide testing. These themes are related to (1) health, (2) curiosity and fascination, (3) genealogy, (4) contributing to research, and (5) recreation. Obtaining such information can help us to understand how users consider genome-wide testing and forms the basis for further research

“It’s our DNA, we deserve the right to test!” : A content analysis of a petition for the right to access direct-to-consumer genetic testing

Aims: Various companies are currently advertising or selling genetic tests over the internet using a model of provision referred to as ‘direct-to-consumer’ (DTC). This commercial offer of DTC genetic testing (GT) has fueled a number of scientific, ethical and policy debates. To date there have been few studies published regarding the users’ perspective. This study aimed to obtain information regarding the issues raised by individuals who signed a petition in support of DTC GT and the ‘unrestricted’ access to their genetic information. Materials &amp; methods: We conducted qualitative content analysis of comments written by individuals who signed a public online petition initiated by DIYgenomics (CA, USA) to support “personal access to genetic information”. Results: Of the 523 individuals who signed the petition sponsored by DIYgenomics, 247 individuals also wrote individual comments. A content analysis of these comments reveals that petitioners raised six main issues in support of unrestricted access to DTC GT: that their ownership of their DNA should allow them to have unrestricted access to their genomic information; that they should have the right to their genomic information; that the government has no place in (further) regulating DTC GT; that healthcare professionals should not be placed as intermediaries when purchasing DTC GT services; that many petioners who had already obtained DTC GT had positive experiences with this model of provision; and that genealogy or ancestry DNA testing is one of the main activities petitioners wish to have ‘unrestricted’ or ‘direct’ access. Conclusion: These results give insight into why individuals may support unrestricted access to their genomic information and confirm some of the motivations of users for purchasing DTC GT. Our analysis also brings to the forefront themes that have been raised less often in empirical studies involving motivations to purchase DTC GT services; these include the strongly held beliefs of some petitioners that, since they own their DNA, they should have the right to access the information without (further) government control or physician involvement. Interestingly, the comments left by petitioners also reveal a certain distrust of governmental agencies and healthcare professionals. This urges us to further study the public’s views of these services and the potential impact of these views in order to responsibly address the ongoing debate on DTC GT. </jats:p

Country report: stem cell research in China

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