BULLETIN ONE - SUMMER 2007
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Welcome to the first edition of the SCI Bulletin. This issue has been timed to appear after some of the first results from the SCI initiative have been completed, and the new fellowships funded through SCI have begun. The Bulletin will be published 4 times a year through to mid 2009, solely as an electronic format newsletter of the ESRC network working on stem cells and regenerative medicine more widely.
Applying basic science: what is ‘translational research? And is it over-regulated?’
The social science network in the UK now numbers about 45 researchers devoting much of their time to exploring the development of stem cells as a field. Why social science should be involved: not simply to map and track the impact of stem cells, but also because, much of the work focuses on the translation of results from the lab to the bedside. This is an oft-heard expression that has become well-established in UK and overseas policy. But what it means in practice is not as straightforward as might appear. Not only does novel development depend on moving ideas out of the lab, it also depends on the feedback between those delivering therapies and those trying to develop the basic science. Indeed, it seems that much of the time the basic principles of the work in the lab can only be interrogated further by trying them out. So, for example, in exploring how the fundamentals of stem cell differentiation works, scientists need to implant stem cells into a patient but then need some sort of genetic markers that could signal if the cells were going wrong and kill them off, before becoming carcinogenic. This is not just the conventional experimental stage of research to test out a hypothesis nor an application of some model system developed in the lab, but more about trying to track an unknown process and its effects.
The more precise and sophisticated our basic science becomes – say in the precision associated with the identification of stem cell markers – the more difficult it is to make that knowledge work unproblematically within its context of application, and the trickier it is to determine whether something is a risk or simply an unknown that can be ignored. Indeed, in the case of implanted stem cells (principally somatic cell lines) it is often observed that we don’t know whether the stem cells are surviving and have a direct therapeutic effect, or whether they are creating a permissive environment through which the patient’s own stem cells are triggered to function properly.
A number of the projects are tracing the management of uncertainty in the field and how this effects regulation, governance and innovation (such as those of Salter et al, Martin et al, and Kent et al). Standardisation of experimental protocols helps to stabilise the field and will be key to its eventual scale-up, a topic which continues to dominate the national science-based meetings in the UK and globally, as will the development of more GMP facilities to enable clinical implantation of cell lines, such as those recently established at Newcastle . NHS-based research labs, such as the new translational research unit at Addenbrookes in Cambridge , are being established across the UK . Here again, questions of safety, reproducibility and scale up through novel delivery dominate the debate. The role of the UK Stem Cell Bank (see project of Glasner et al) in providing a central role as source of quality assurance is key.
These and related issues informed the recent House of Lords debate on May 3 2007 (reported online at www.publications.parliament.uk/pa/ld200607/ldhansrd/text/70503-0002.htm#07050365000002). The SCI network along with input from social science colleagues from the ESRC’s Genomics Centres provided a series of questions and commentary which we were pleased to see shape some of the discussion. These questions appear below as ‘Annex 1’ to the Bulletin.
The Lords debate concentrated on whether enough funding is going into UK research or not (and whether the government is living up to its promise of funding following the Pattison review), and whether the UK was ‘over-regulating’ the science base here. The latter is somewhat ironic given the claim that British success in the field relates principally not only to good science but appropriate regulation. Yet Lord Winston observed:
‘I am not convinced that regulation is ideal. Germany, which bans such research, can import cells from the UK; Italians buy eggs from Oregon; Australians do their work in Singapore; the Chinese have a different view of embryos from that in almost any other country. We need a change in attitude to how we control the work that is going on, with a better understanding of the responsibility of scientists.’
While it may be the case that regulatory work-arounds are possible, constraints continue and scientists press for liberalisation: in Germany last week (May 9) a group of ES researchers appeared before the parliamentary committee to seek a relaxation in the law.
Regulatory tourism and diversity is common to most areas of innovation, so we should not perhaps be surprised by this. But decisions about how these new therapies will be regulated are likely to have a direct impact on innovation trajectories beyond the lab; an important issue that has often been neglected. For example, as the work at the ESRC Centre Innogen in Edinburgh suggests, if it is decided that stem cell treatments should be regulated in the same way as conventional pharmaceuticals, this will favour the existing multinational pharmaceutical companies at the expense of small biotechnology companies and public sector research organisations, which are conducting most of the basic science in stem cells. It has not been fully recognised what impact choice of regulatory system will have on various commercial and public sector researcher organisations, and their ability to develop innovative therapies for patients.
At the same time, as Baroness Helena Kennedy noted, regulation plays an important role in reassuring public confidence in the field, which could be easily lost: she noted, ‘Public confidence is hard won and very easily squandered. To maintain it, it is important that the benefits of stem cell research are communicated honestly and without hyperbole’. Work in SCI on hype and expectations in the media and elsewhere is tracking more precisely what effect this ‘hyperbole’ might have on the field.
A number of projects and Fellowships are explicitly geared towards examining the ways in which stem cell research is ‘translated’ into clinical use. Among the projects, Williams and Wainwright’s project (Mapping stem cell innovation in action) which has recently been completed examined the prospects and problems of stem cell research and cell transplantation in the fields of diabetes and liver disease. They report that translation is constrained through institutional influences on interactions between scientists and clinicians; and the unique difficulties of stem cell science itself as a major barrier to potential future therapies.
Martin et al. (Haematopoietic Stem Cells: The Dynamics of Expectations in Innovation) are exploring the historical, present-day and prospective clinical and commercial take up of haematopoietic stem cells as therapeutic agents for haematological (carcinogenic and other) disorders. The interim findings report on two ‘waves’ of commercial and clinical development, and the ‘promise’ it has for the future, notably through the rapid growth of cord blood banking. Expectations of future medical breakthroughs in stem cell therapy have been crucial in mobilising the financial and policy investment necessary for the formation of these innovative networks.
Ongoing research by Kent and Pfeffer (Forgotten Fetuses - A Sociocultural Analysis Of The Use Of Fetal Stem Cells) explores the role of foetus and foetal tissue as a research resource for bioscience. They have recently published some interim conclusions with respect to the biotechnical and regulatory status of the foetus following on from the Polkinghorne Guidelines (see www.rsm.ac.uk/media/downloads/ce06-12pfefferkent.pdf) Kent and Pfeffer argue that the rules in relation to consent to the use in research of aborted foetuses and embryos are inconsistent. They note that "Women who agree to the use of their aborted foetuses in stem cell research may only be provided with general information. There is no consistency across hospitals on the type of information provided and women are unable to refuse to allow foetuses to be used in some projects but not others". Stem cell research using embryos created in an IVF clinic is regulated by the Human Fertilisation and Embryology Authority (HFEA) which requires specific consent to be sought. Women are provided with detailed information about the type of research and/or medical conditions for which their embryos may be used before they give consent. They are also told whether the research is basic research or intended for commercial purposes. Research using foetal tissue is covered by the Polkinghorne Guidelines which state that consent from a woman should be general and not specific. These guidelines are in turn interpreted and implemented by Research Ethics Committees, who have no remit to public engagement. Kent and Pfeffer's results indicate that the Polkinghorne Guidelines, drawn up before the current interest in stem cell had developed should be re-addressed so that there is consistency with current standards of consent in other types of research. In their paper at the BSA annual conference they described how in effect procedures are taking what are defined as 'dead' foetuses and then 'immortalising' them in the Petri dish as material for stem cell research.
The UK National Stem Cell Network was recently launched at Lancaster House in London , and it includes the SCI network through membership of Professor Brian Salter on the Co-ordinating Committee. He has recently been asked to take the lead on policy links between the research communities and government, especially in respect to anticipating regulatory development. We will be reporting on this activity over coming months.
The SCI ran a special stream of papers on stem cells at the annual British Sociological Association’s conference at UEL in London: 13 papers covered a range of topics and attracted considerable interest, with the stream getting extensive coverage in the Times Higher Education Supplement
(see www.york.ac.uk/depts/soci/SocMagic.pdf ).
More recently, Paul Martin organised a one day meeting ‘ Stem cell identities, governance and ethics: implications for social and political theory’ at the University of Nottingham , with keynote speaker professor Jane Bennett from Johns Hopkins exploring the materiality of stem cells
(see www.york.ac.uk/res/sci/events/stemcellidentitiesNottsMay07.pdf )
Christine Hauskeller held an interdiciplinary event at the ESRC Egenis Centre supported by SCI, which examined the ethical, legal and wider governance practices around stem cell research at the national and the international levels
(see www.centres.ex.ac.uk/egenis/events/ESRCCentreforGenomicsinSocietyEgenisUniversityofExeterUK-CBAR_000.htm )
Finally, the Genomics Forum has been provided with funds to be used for a series of national/international seminars in 2007/08 as well as a short course sometime in autumn 2007 for post-doc stem cell scientists: here, the idea is to introduce early career scientists to some of the social sciences work in the area. This two-way relationship is novel to SCI and one the network hopes to learn from and build on in the future.
Six new Fellowships have been supported by SCI in its last Call, and these are now well underway. These are all reported in detail on the SCI web site at www.york.ac.uk/res/sci/researchfellows.htm. The Fellowships have both international and translational objectives, and will provide some of the first detailed and sustained analysis of global developments in the field. But they are also designed to enable young researchers to build capacity in terms of fieldwork, publication and new grant applications at a later date. We shall report on the interim results of the Fellows towards the end of this year.
HOUSE OF LORDS DEBATE ON STEM CELL RESEARCH AND APPLICATION: 3 MAY 2007
Submission of questions to the UKNSCN Steering Committee from the ESRC’s social science Stem Cell Initiative Network (www.york.ac.uk/res/sci ) and Genomics Centres, complied by Professor Andrew Webster, University of York, Initiative Co-ordinator
Many of the issues below are the basis of current research being undertaken within the UK .
Regulatory matters
1.0 The debate should consider the HFEA’s statement on egg donation which is allowing women to donate altruistically for research including via egg sharing arrangements.
1.1 The safeguards in place warrant careful consideration as issues relating to the independence of the person giving consent would be very hard to establish. Although overt coercion will no doubt be avoided, more implicit imperatives to share may derive from egg sharing schemes especially. The House should discuss whether such proposals risk taking ethical parameters from a clinical situation and utilising them in another situation (where assessments of risk may take on different meanings and implications). There is a need to raise the gender implications of such proposals and how female bodies may be regarded as a resource for science. A recent CESAGen seminar produced a statement that provides a more detailed and cross-referenced discussion: www.cesagen.lancs.ac.uk/events/eventsdocs/HFEA_sourcing_eggs.pdf
1.2 HFEA's public engagement strategy raised the question of what constitutes an adquate explanation to 'the general public' of the basic science or the issues. The HFEA consultation document was somewhat narrowly framed and consideration should be given to whether the information provided was presented in a way that would successfully inform and engage the public (see Donating eggs for Research: Safeguarding Donors, at www.hfea.gov.uk/cps/rde/xchg/SID3F57D79BA850329D/hfea/hs.xsl/1417.html). For example, it may appear from the HFEA document that egg donation is crucial to the future of stem cell research when, in actual fact, this is not the case.
1.3 HFEA extended ‘temporary’ licenses held by Newcastle stem cell team (NESCI) whilst the public consultation was ongoing. What are the implications of this timing for public engagement process and the avoidance of cynicism?
2.0 The debate should consider the Government’s current line regarding the use of hybrids. We would not anticipate a public backlash here if the development is framed in terms of enhancing safety of research for developing clinical models, and the scientific case seems strong. The use of hybrids will also mean research can advance without the need for ‘fresh human eggs’ thus diverts us from the gendered ethical and health related considerations of egg donation.
3.0 How do existing tissues/cells and medical products regulatory regimes interact with emerging stem cell activity at national and transnational (e.g. European and wider) level? For example, stem cells research falls under Article 18 of the Convention of Human Rights, and if commercialised under the MHRA, which in turn applies international conventions on GMP and GLP, and if commercialised as tissue engineering falls under the European Directive on Tissues and Cells, then implemented within the UK via Clinical Trials Regulations soon to be under the jurisdiction of the new RAFT.
4.0 How do smaller companies (SMEs) secure the regulatory intelligence they need to inform their medium-term business models?
5.0 What developments are we likely to see between the ethical oversight of new products and the protection of the same via forms of intellectual property. The European Patent Office acknowledges that IP review for patent applications needs to consider ethical issues in relation to any patent filing for stem cells research yet refuses to formally include bioethicists in its examining procedures, content to rely on ‘relevant experts’.
Managing Expectations
6.0 The debate should consider the ways in which UK science and government manage both the hype and hope associated with the field: although stem cell scientists seem to be becoming more circumspect regarding the hype and promise of stem cell research, we are concerned that expectations among patients may be raised inappropriately and the debate may wish to consider how scientists, their PR departments and the media can reduce the ritual reproduction of hype and hope.
The debate should consider how to encourage public engagement and what should its place be in Stem Cell Research activity? It might also consider how the stem cells issue is reported in the national media. How do the mass media frame and circulate the issues? How do various ‘publics’ respond? In this regard, the points relating to the HFEA consultation (section 1 above) are important for any discussion of public engagement with science policy. House of Lords debates and Science and Technology Committee statements in 2000 and 2002 have in the past noted the public importance of stem cell debates and the disjuncture between policy and public engagement. The Third Report of the House of Lords Select Committee on Science and Technology in 2000 strongly criticised existing public engagement practises, calling them ‘ad hoc, passive and disconnected from the policy making process’ (www.parliament.thestationeryoffice.co.uk/pa/ld199900/ldselect/l dsct ech/38/3801.htm).
Stem cells in the consumer market
7.0 The boundary between ‘enhancement’ (increased longevity; cosmetic use) and reducing the effects of diseases of old age – how can this boundary be assured and what commercial pressures might encroach to erode it?
8.0 Should any different or particular oversight be given towards the new cord blood banks in the private sector that are providing storage of cordblood stem cells to parents of the newly born?
Global challenges
9.0 At a more global level, the debate should consider what are the short and long-term consequences of the growing involvement of East Asia in the development of stem cells research and regenerative medicine more generally? Countries such as China , South Korea , Singapore and India are investing heavily in the area of new biomedical technologies and are making rapid advances on the traditional world leaders in biotech. How is this development likely to affect the international mobility of scientists, the scientific labour market in general (as a result of off-shoring), and the investments of traditional high-tech leaders such as the UK and the US . Recent moves by China and India to adopt similar conventions and codes of practice as advocated by the UKSCB are to be welcomed, but the need for a genuine institutionalisation of governance among scientists is still key to their effective implementation, as was seen in the Hwang controversy.
10.0 Does the emergence of global scientific networks of research with such networks always work to strengthen UK stem cell science?
Professor Andrew Webster
Co-ordinator, ESRC Stem Cell Initiative