An obscure rider obstructing science: the conflation of parthenotes with embryos in the Dickey-Wicker amendment.

In 1996 Congress passed the Dickey-Wicker Amendment (DWA) as part of an appropriations bill; it has been renewed every year since. The DWA bans federal funding for research using embryos and parthenotes. In this paper, we call for a public discussion on parthenote research and a questioning of its inclusion in the DWA. We begin by explaining what parthenotes are and why they are useful for research on reproduction, cancer, and stem cells. We then argue that the scientific difference between embryos and parthenotes translates into ethical differences, and claim that research on parthenotes is much less ethically problematic. Finally, we contextualize the original passage of the DWA to provide an explanation for why the two were possibly conflated in this law. We conclude by calling for a public discussion on reconsidering the DWA in its entirety, starting with the removal of parthenogenesis from this prohibition of National Institutes of Health (NIH) funding.

[Does 2009 mark a revival of embryonic stem cells?]. / ¿Resucitan al inicio del 2009 las células troncales procedentes de embriones?

The legal possibility of using federal funds to work with embryonic cells and destroy embryos started on March 2009 in the USA. It has nothing to do with regenerative therapies. It is directed to create banks with human cells, banks directed by a few scientists involved in biotechnology enterprises connected with centers of in vitro reproduction. They pursue the use of ad hoc human embryos for biomedical research. The idea of using cell lines derived from embryos is quite spread, and even the idea of obtaining new lines of this type to validate reprogrammed somatic pluripotential cells, the so called iPS cell (induced pluripotent stem), without destroying embryos or using ovules. This type of cells is indeed of great value in medical research and it is opening new possibilities in Cell Therapy. Recent data are analyzed and considerations are advanced encouraging rational alternatives to eliminate embryonic cells in the evaluation of iPS cells.

Product regulation and the clinical translation of stem cell research.

The recent approval by the United States Food and Drug Administration of a clinical trial involving a product derived from human embryonic stem cells, along with recent concerns about unproven stem cell therapies being offered to patients, highlight the importance of regulation at the critical stage of beginning human trials of novel therapies. The regulations governing therapeutic products (drugs and related products) are one part of the broader legal framework, but will play an increasingly prominent role as we move into clinical translation. The classification of products as drugs or biologics, on one hand, or minimally manipulated cell and tissue products for homologous use, on the other, will determine the requirements that will apply, including whether use in clinical trials requires approval. Product regulation works alongside other parts of the legal and policy framework, notably research ethics review and legal responsibilities of medical professionals, that play important though limited roles. Three key developments and challenges currently facing product regulation and related areas will affect stem cell research in this phase: regulatory reform, fragmentation, and capacity.

Stem cell researches in Brazil: present and future challenges.

A bill allowing researches with human embryonic stem cells has been approved by the Brazilian Congress, originally in 2005 and definitively by the Supreme Court in 2008. However, several years before, investigations in Brazil with adult stem cells in vitro in animal models as well as clinical trials, were started and are currently underway. Here, we will summarize the main findings and the challenges of going from bench to bed, focusing on heart, diabetes, cancer, craniofacial, and neuromuscular disorders. We also call attention to the importance of publishing negative results on experimental trials in scientific journals and websites. They are of great value to investigators in the field and may avoid the repeating of unsuccessful experiments. In addition, they could be referred to patients seeking information, aiming to protect them against financial and psychological harm.

Embryo as epiphenomenon: some cultural, social and economic forces driving the stem cell debate.

Our human embryonic stem cell debates are not simply about good or bad ethical arguments. The fetus and the embryo have instead become symbols for a larger set of value conflicts occasioned by social and cultural changes. Beneath our stem cell debates lie conflicts between those who would privilege scientific progress and individual choice and others who favour the sanctity of family life and traditional family roles. Also at work, on both the national and international levels, is the use of the embryo by newly emergent social groups to express resentment against cultural elites. The organisational needs of religious groups have also played a role, with the issue of protection of the embryo and fetus serving as a useful means of rallying organisational allegiance in the Roman Catholic and evangelical communities. Because the epiphenomenal moral positions on the status and use of the embryo are driven by the powerful social, cultural or economic forces beneath them, they will most likely change only with shifts in the underlying forces that sustain them.

Animal eggs for stem cell research: a path not worth taking.

In January 2008, the Human Fertilisation and Embryology Authority (HFEA) (London, UK) issued two 1-year licenses for cytoplasmic hybrid embryo research. This article situates the HFEA's decision in its wider scientific and political context in which, until quite recently, the debate about human embryonic stem cell research has focused narrowly on the moral status of the developing human embryo. Next, ethical arguments against crossing species boundaries with humans are canvassed. Finally, a new argument about the risks of harm to women egg providers resulting from research involving the creation of humanesque cytoplasmic hybrid embryos is elaborated. Taken together these ethical concerns about the moral status of the human embryo, about the ethics of crossing species boundaries with humans, and about the potential harms to women (concerns that independently are more or less weighty for different constituencies), provide good reason to eschew humanesque cytoplasmic hybrid embryo research in favor of less ethically controversial means to the laudable end of successful regenerative medicine.

The road to pluripotence: the research response to the embryonic stem cell debate.

The controversies surrounding embryonic stem cell research have prompted scientists to invent beyond restrictive national policy and moral concerns. The impetus behind these reports comes from different sources, including individually held moral beliefs, societal pressures and resource constraints, both biological and financial. Along with other contributions to public policy such as advocacy or public testimony, experimentation and scientific curiosity are perhaps more natural responses scientists use to surmount impediments to research. In a research context, we review the history of the first stem cell discoveries, and describe scientific efforts leading up to recent reports of pluripotent lines made without the use of human embryos and eggs. We argue that despite the promise of these new lines, we must not lose sight of fundamental questions remaining at the frontiers of embryology and early human development. The answers to these questions will impact studies of genetics, cell biology and diseases such as cancer, autoimmunity and disorders of development. Human embryonic stem cell research is barely a decade old. The recent pace of discovery--in spite of federal restrictions--is testament to the potential of these cells to uncover some of biology's most intractable mysteries.

Informed consent and federal funding for stem cell research.

A review of the consent forms signed by those who donated embryos for the NIH-approved embryonic stem cell lines reveals several problems, providing ethical as well as scientific reasons to overturn the Bush administration's restrictions on federal funding for stem cell research.

Paid to share: IVF patients, eggs and stem cell research.

Following a recent decision by the human fertilisation and embryology authority (HFEA), British women undergoing in vitro fertilisation (IVF) treatment can be 'paid to share' their eggs with stem cell researchers. The HFEA and the clinic proposing the scheme present this as a 'win-win' arrangement benefiting both infertile women and couples and British science. It is also represented as concurrently both 'business as usual' and an exceptional case. Constituting a significant departure from the previous policy and practice of altruistic donation, the scheme has raised significant concerns among clinicians and activists. Here, we ask what questions feminists can bring to these debates without resorting to a position of either refusal or affirmation. Drawing on diverse materials from public debates, as well as social scientific literature on gamete and embryo donation, we undertake a close analysis of the discursive framing and justification of the proposal. We argue that these discourses are characterised by three linked areas of elision and distinction: treatment and research; eggs and embryos; and donation and selling. Our analysis highlights the need for innovative social, ethical and political consideration of egg sharing for stem cell research.

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.

Stem cells: the blue print for the future.

The investment going into stem-cell therapies and technologies is impressive. The objectives are great, including the aim of tissues on demand within 20 years, and the rewards potentially huge with a suggested annual market of US dollar 500 billion. This article outlines current activities on both sides of the Atlantic.