Introducing stem cell research .1 Scientific aspects

Stem cells are unspecialised cells which under specific conditions may develop to form a range of different cell types (liver, heart, pancreas, nerves etc.). Stem cells in adult humans have been found to exist in small numbers, for example in bone marrow, and have the ability to develop into a narrow range of tissue types, forming the basis of bone marrow transplants, for example. Stem cells have also been found in umbilical cord blood and have been obtained from human foetuses (aborted or still-born). The first public announcements that stem cells had been isolated from human embryos (Thomson et al.

1998) caused little public attention, but gradually, this development, particularly when associated with the prospects of human cloning, became very high profile. Sourcing stem cells from foetuses has been much less discussed (e.g. Pfeffer & Kent, 2007), a situation that is replicated in this research.

Until the time that human embryonic stem (ES) cells were isolated, the main species from which embryonic stem cells could be isolated was mice (as already mentioned in Chapter

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-four). Numerous attempts were made to isolate embryonic stem cells from farm animals but these had not been successful, although the derivation of human embryonic stem cells was preceded by the isolation of primate embryonic stem cells in 1995 (Rubin, 2008). The scientific breakthrough demonstrated by deriving human embryonic stem cells should therefore not be underestimated. Furthermore, human embryonic stem cells were isolated at a time when the ability of cells to differentiate into different types of cells, and to be reprogrammed back into an embryonic state, had been given new impetus from research on somatic cell nuclear transfer (see Chapter four).

A brief summary of the various sources of human stem cells, their strengths and ethical considerations associated with them is given in table 6.1.

Stem cells are of interest particularly due to their potential to develop cell therapies to treat and repair serious disease and injury for which there are currently few or no cures.

Examples of potential targets for treatments include diabetes, spinal cord injuries, heart disease and neurodegenerative diseases. However, embryonic stem cells can also cause tumours so have to be handled with care. A recent development has been the discovery that it is possible to induce ‘normal’ adult cells to become stem cells by manipulation in the lab (Takahashi et al. 2007, Yu et al. 2007). The process involves genetic manipulation of the cell by inserting three or four genes that cause the cell to become like a stem cell in its behaviour. These iPS cells have changed the landscape of stem cell research

considerably, although as yet their Tull potential is not known. The empirical research conducted for this case study predates the development of iPS cells and therefore iPS cells are not considered further.

Table 6.1 Sources of human stem cells

In the UK, a stem cell bank has been established to ensure widespread availability of cell lines that have been isolated from a variety of different sources. As of 15th November 2010, 16 stem cell lines were reported as available for distribution from UK stem cell bank.41 Eight of these are registered as UK in origin, four from Sweden, three from the USA and one from Australia. However, most of these cell lines are of research origin and not of a suitable quality for use in therapeutic treatments.

Some stem cell therapies based on ‘adult’ cells are beginning to be realised. As early as 2005, Wilan et al. (2005) listed 37 companies world-wide with preclinical and clinical trials in therapies based on ‘adult’ (including cord blood-derived) and foetal stem cells. In terms of therapies based on non-adult stem cells, the lead products are probably a therapy for spinal cord injury based on human embryonic stem cells, produced by Geron Corporation

41 Available from http://www.ukstemcellbank.org.uk/ [accessed 15/11/10]

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-in the USA which was given regulatory approval from the Food and Drugs Adm-inistration to begin Phase 1 clinical trials and recruited its first patient in October 201042 and a potential treatment for stroke based on foetal stem cells produced by the company ReNeuron that was granted approval in February 2010 for Phase 1 clinical trial in the UK.43

There are other indications that industry activity in this area is increasing, for example Pfizer announced in November 2008 that they were investing in a stem cell research unit44 and GlaxoSmithKline announced a collaboration with the Harvard Stem Cell Institute also in 200845. Products from stem cell research are expected to be applied within the health care sector and there is also some experimental clinical activity (e.g. skin grafts, the transplant of a cadaveric trachea impregnated with a patient’s own stem cells). However, it is too early in the development of therapies to determine which, if any, prove to be widely adopted.

6.2.2 Literature review

The main themes relevant to this thesis are the values expressed in the ‘promise’ of stem cells and how this has shaped subsequent discussion and regulation (e.g. Martin et al.

2008, Rubin 2008), views on values associated with embryos^ and the negotiation of the values and interests related to the status of the embryo and the interests of patients.

i) The promise of stem cells

The promise of therapies has been a key feature of arguments advocating stem cell research. Parry (2003, p23) for example found that in the context of Parliamentary debates “Potential users were constructed as not only demanding but also needing stem cell therapies; without them they would continue to sufferJ' (p24). The strength of the expression of need suggests that not only is the research in the interests of patients but it

42 Available from http://www.geron.com/ [accessed 15/11/10]

43 Available from http://www.reneuron.com/ [accessed 15/11/10]

44 Available from http://www.inpharm.com/news/pfizer-makes-maior-stem-cell-investment [accessed 17/03/10]

45 Available from http://www.qsk.com/responsibilitv/research-practices/cloninq-technoloav-and- stem-cell-research.htm [accessed 17/03/10]

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-is a right of the patients to have these therapies and obtaining these therapies -is an absolute good that should be sought, in other words in the definitions used in this thesis, a values-based argument is being advanced.

The tendency of innovators to overstate their claim is often highlighted and is frequently referred to in the context of stem cell research (e.g. Martin et al. 2008). However, as Solbakk (2003) points out that there is the possibility of over-stating the opposition case resulting in “over-killing of therapeutic arguments” (p389).

Bonnicksen (2002) suggests that as research has moved from fertility treatments to stem cell treatments there has been an associated change in emphasis of research benefits for potential future embryos to benefits for people with debilitating diseases. This change in emphasis, she argues, has subtly shifted the politics of embryo research.

“Traditionally, the potential beneficiaries of embryo research were a compact segment of the population interested in fertility treatment...The potential harms fell on human embryos and on society if embryos were treated as commodities and as means to other ends. In addition, the harm of not proceeding (lost knowledge) would be largely contained in populations with a stake in fertility treatment and reproductive research... The debates [now] highlighted a growing group of potential beneficiaries of embryo research, namely, persons with debilitating diseases. The harm of not proceeding (lost knowledge) took on sharper form with the possibility that this would prolong the suffering of people with chronic diseases.” (p67)

Thus, the promise that stem cell therapies offer to suffering humanity forms an important part of the context within which embryonic stem cells are considered. The presence of a carer or a patient within a debate provides a stark reminder of who might be the losers if embryonic stem cells research is discontinued. Nevertheless, as Parry (2003) points out, this does not mean that there is always a rigorous examination of alternative approaches to therapies.

ii) Values relevant to embryos

Research into how stem cell research scientists understand embryos, provides a varied picture. Parry (2009) emphasises how research scientists portray (and also presumably understand) the material they are working on as ‘a bunch of cells’ which lack sentience.

Wainwright et al. (2006), on the other hand identified a more discriminating approach.

They found embryonic stem cell researchers in two specific UK laboratories were comfortable with researching spare IVF embryos or embryos discarded in Pre- implantation Genetic Diagnosis procedures but were opposed to creating embryos solely for research. Furthermore, they found that some research scientists working with embryonic stem cells held strong Christian beliefs but nevertheless were able to reconcile their beliefs with their work.

In terms of citizens, Flo et al. (2008) studied public attitudes to embryonic stem cell research in the USA explicitly taking into account values-predispositions, by which they meant religiosity, political ideology and degree of deference to scientific authority. Their conclusion was that public opinion about embryonic stem cell research was strongly shaped by a values-based predisposition. In comparison, the amount of scientific knowledge had negligible impact on attitudes towards hESC research. This echoes the more general findings in Chapter two that, where values-based considerations are important, scientific evidence is unlikely to change opinions. Flo et al. also found that respondents who believed that scientists would make decisions that would be in the public interest were more likely to rely on scientific evidence in forming their views. Again this echoes the more general findings presented in Chapter two that people are more likely to trust information from sources that appear to share their value-predisposition.

iii) Negotiation of hESC research

Central to many analyses of debates around hESC research is the worth attributed to early human embryos, either valued the same as adult humans, of no more worth than a laboratory reagent or something in-between. Several analyses have highlighted how UK

regulation on hESC research has been influenced by earlier debates relating to embryo research in the context of In-Vitro Fertilisation (IVF) treatment. This established the principle of research being allowed on embryos up to 14 days old, given sufficiently good reason and under a licence from the Human Fertilisation and Embryology Authority (HFEA). Interpretations of the influence of earlier debates have, however, varied.

Parry’s analysis (2003) suggests a re-run of old debates:

“ The 1990 HFE [Human Fertilisation and Embryology] Act debates were a rich source of rhetoric and tactics for the stem cell debates. Put simply, those against [stem cell research] seized upon the opportunity for redressing the embryo question and those in favour drew upon the successes of the 1990 debates by arguing that the pro-research lobby had already ‘won’ ” (p10).

Because of this re-run of old debates she also notes that several issues remained unaddressed in the parliamentary debates, for example (p11) “ What is surprising is the absence of discussions about the sociocultural implications of cloning technologies for kinship relations and health inequalities”

Hauskeller (2004) perceives regulatory drift to have taken place. For Hauskeller (p 517):

“ This refusal [by the Donaldson committee] to review former decisions and instead debate new issues strictly on the grounds of the currently existing regulation - regulation that passed [sic] under circumstances in which cloning, for example, was not possible - is an example of the tendency to a policy via stepwise watering down of prohibitive regulations”.

Hauskeller thus suggests an inexorable process of regulatory relaxation that has allowed hESC research to take place in the UK.

Whilst Parry and Hauskeller are critical of the policy communities for not re-evaluating existing regulation, Banchoff (2004) in contrast, stresses the importance of institutional legacies in development of norms and values that strongly influence the subsequent debate. The previous Warnock debates (around the acceptability of research on embryos for fertility treatment) and 1990 Human Fertilisation and Embryology Act are given as

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