Headline Bioethics: The balance of safety in publication of H5N1 research

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Nick McDonald

Clip: Experts delay call on releasing controversial H5N1 work

Date of story: 17^th February 2012

 

Summary of story: In the period 2003–2011, 566 cases of people infected by bird flu worldwide were reported to WHO (2011), with 59% of the cases being fatal. The virus has been known to infect people since 1997 (Grady and Broad, 2011), but only through infected birds, and not via person-to-person transmission(Yong, 2012b). Herfst et al (2012) and Imai et al (2012) mutated H5N1 to see if it could acquire the mutations necessary for airborne transmission between ferrets (considered a good model for humans) in the wild. This research was due to be published in the journals Nature and Science, but the National Science Advisory Board for Biosecurity (NSABB) asked the journals to delay publication, and recommended that key methods should be omitted (Grady and Broad, 2011) due to fears of the virus being released “by error or by terror” (Keim, 2012) and the “potential risk of public harm to be of unusually high magnitude” (Berns, 2012). Eventually in March of 2012 the NSABB agreed that the two papers should be published in full (Yong, 2012a). The video from February 2012 reports on the decision to delay publication.

Discussion of ethical issues: The decision about whether or not to publish details of the process by which H5N1 could be render easier to transmit is a good example of a dual-use dilemma, defined by Atlas and Dando (2006: p276) as “the generation and dissemination of scientific knowledge that could be misapplied for biological weapons development and production”. Kuhlau et al (2011) argue that if a dual-use technology poses a legitimate threat, the science community is obliged to develop, implement and adhere to precautious measures to meet the concern.

Headline Bioethics: Change to organ donation law in Wales?

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Christopher Jones

Clip: Will Wales change organ donation law?

Date of story: 8^th November 2011

Summary of story: The Welsh government’s has published a White Paper Proposals for Legislation on Organ and Tissue Donation: A Welsh Government White Paper in which they outline their intention to change the law regarding organ donation. In keeping with the rest of the UK, Wales current has an “opt-in” system, in which a person has to actively indicate (e.g. by signing organ donor register) that they give consent for their organs to be used by the NHS. Under the proposed system of presumed consent, all adults resident in Wales will automatically be placed upon the register; if anyone wishes to withdraw their consent they must actively remove themselves from the list. Many countries already operate this “opt-out” system; including, in Europe, such countries as France, Spain, Austria, Belgium, Norway and Sweden. In the news coverage, Glyn Davies MP state his opposition to the proposal, highlighting concerns about both the efficacy of the new system, and whether adequate consideration will be given to ethical aspects of the change.

Discussion of ethical issues: One ethical argument against presumed consent suggests that it violates the patient’s right to make an informed decision, and so does not uphold respect for their autonomy (Gillon, 1994). The specific purpose of informed consent is to protect a patient’s right to autonomy, as made clear by both the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005) and the Declaration of Helsinki (World Medical Association, 2008). Enforcing presumed consent would remove the need for informed consent, and as such would be “a violation of an individual’s autonomy” (Kurosu, 2008).  Presumed consent, it is argued, forces patients either to become donors, or to state their wish to not become donors; in both instances the patient’s autonomy is violated, as  “compelling patients is unethical” (Kurosu, 2008). This deontological argument suggests a move to presume consent in Wales would be intrinsically unethical. Similarly, Kennedy et al. (1998) consider that a government body “assuming possession of our body parts” would be “a step too far”.

Headline Bioethics: Enviropig – significant advance or environmental ‘band-aid’?

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Rebecca Hyde

Clip: ‘Enviropigs’: genetically modified for food consumption

Date of Story: 4 January 2011

Summary of story: For the past decade, researchers at the University of Guelph, Canada, has been developing a line of Yorkshire pigs now known as Enviropig. In January 2011, a BBC reporter had the opportunity to see the pigs in a research facility while applications to approve the Enviropig for human consumption were being deliberated by the US Food and Drug Administration. The Enviropig has been genetically modified to contain genes from Escherichia coli and mice and bred over several generations to become more environmentally friendly by reducing the toxicity of their waste.

Discussion of ethical issues: Development of the Enviropig raises a number of ethical questions. Some of these relate to issues of animal rights, some relate to genetic modification of organism in general and foods in particular. Given the reasons behind the investment in the Enviropig research, there are also specific issues relating to environmental ethics, and this represents a good place to begin evaluation.

Intensive pig farming produces large amounts of manure which contains high levels of phosphate. Whilst some phosphate is vital to life, and is necessary for good plant growth, high concentrations can lead to disruption and poisoning of ecosystems. Runoff from pig farms can lead to eutrophication of nearby water ecosystems, which can potentially lead to the water becoming anoxic and unable to support life (University of Guelph, 2011). Enviropig has been genetically modified to produce phytase in its saliva. This enzyme is important for the breakdown of phytic acid, an indigestible form of phosphorus commonly found in cereal-based foodstuffs. Bacteria in the guts of cattle and other ruminants, but not pigs, normally provide this enzyme allowing this dietary phosphate to be released and used by the mammal.

Headline Bioethics: Too NICE to Push? Ethical issues surrounding a woman’s decision for elective caesarean section

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Matthew Taylor

Clip: Women can choose caesarean birth

Date of story: 23^rd November 2011

Summary of story: In November 2011, The National Institute of Health and Clinical Excellence (NICE) updated its clinical guidance to health care professionals regarding caesarean sections. This update helps ensure “every mum-to-be in England and Wales can request [a caesarean birth].” The story examines the case of Leigh East, who had concerns over a vaginal birth due to a pre-existing back injury. She was initially refused a caesarean section (CS), but was allowed the treatment after her own research persuaded her midwife to allow it. East said, “There was a great deal of pressure initially to not plan a caesarean”.

The report continues by covering how women who have had a traumatic experience with natural childbirth in the past should be treated. This includes offering counselling and, ultimately, the option for a caesarean birth if the woman is not reassured. Jenny Clery, Head of Midwifery at Whittington Hospital, said “you shouldn’t force anything on anybody, i.e. go into labour and we’ll see what happens.” The report finishes by stating the new guidelines are there to help women make an inform decision regarding mode of birth (BBC, 2011a).

Discussion of ethical issues: There are many ethical issues surrounding a woman’s choice regarding the mechanism of delivery for her unborn child. Doctors are faced with decisions requiring them to take each case individually, taking a consequentialist approach to each mode of birth, whilst also considering patient autonomy. The Changing Childbirth report (Expert Maternity Group & Cumberlege J., 1993) makes it an explicit right for a woman to be involved in decisions regarding all aspects of her pregnancy and childbirth.

Headline Bioethics: Cut out by the NHS

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Arnold Gangaidzo

Clip: NHS obesity surgery court bid lost

Date of story: 27^th July 2011

Summary of story: In July 2011 Tom Condliff, a 22-stone man lost his Court of Appeal case for a life-saving gastric bypass operation which had a detrimental impact on his family life and mental well-being (BBC, 2011a). The North Staffordshire primary care trust (PCT) refused to fund the procedure arguing that he failed to fulfil their IFR (individual funding response) policy and his body mass index (BMI) of 43 was below their threshold. He claimed the main reason he gained weight stemmed from drugs that he took for long term diabetes and the procedure was the best solution in order to prolong his life. In August 2011, subsequent to the events in this story, the PCT reviewed his case again and decided to fund his procedure as they now saw his case as an exceptional circumstance (BBC, 2011b). After having the operation, Condliff was reported to have lost six stone (Doward, 2012).

Discussion of ethical issues: The ‘four principles’ of autonomy, beneficence, non-maleficence and justice are widely recognised as the cornerstones of biomedical ethics. In this case, the principle of justice is brought into question. Chadwick (2008) says ‘justice in allocation’ is a bioethical issue since resources can be unfairly distributed and people can be discriminated against. Article 2 of The European Convention on Human Rights (ECHR, 1950) state “everyone’s right to life shall be protected by law…” but also notes that this must not be interpreted in a way as to put an impossible burden upon the authorities (Foster, 2007). Tom Condliff, a man seeking a gastric bypass, had to battle against his PCT to have them fund the operation. He argued that it was a breach of his rights under Article 8 of the ECHR (right to a family life) for the PCT to restrict their decision to clinical factors, and Article 6 (right to a fair trial) for not giving him sufficient details regarding their reasoning (Alexander Thomas Condliff v North Staffordshire Primary Care Trust, 2011). The Court found against Mr Condliff (though, as noted above, the PCT eventually relented).

Headline Bioethics: GM chickens offer solution to bird flu problem?

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Rachel Bell

BBC News Clip: Chickens that cannot spread bird flu developed

Date of story: 13^th January 2011

Summary of story:   Scientists from the Universities of Edinburgh and Cambridge have created genetically modified chickens that are unable to transmit the H5N1 “bird flu” virus between individuals. This effect was generated by inserting genetic information coding for a ‘decoy’ RNA hairpin molecule that acts as an inhibitor for the RNA polymerase enzyme required for replication of the flu virus (Lyall et al, 2011). It has been suggested that this approach may offer a means to reduce the extent to which bird populations act as a reservoir for flu and other diseases.

Discussion of ethical issues:  This story presents ethical tension on two levels; the possible benefits and complications for the chickens themselves, but also the implications for the human population. Laws relating to the use of Genetically Modified Organisms (GMOs) vary in different parts of the world. In the UK, the law covering the creation and use of GMOs is set out by the Health and Safety Executive. This requires any experimentation to undergo strict risk assessment, notification of the authorities regarding any GM activity, and total clarity and public availability of information gathered by the research (HSE, 2011). In this case, Sang and her team at the Roslin Institute, Edinburgh have complied with these regulations and the necessary details are included in the final paper (Lyall et al, 2011).

Headline bioethics

The Headline Bioethics study guides are being hosted on the Virtual Genetics Education Centre at the University of Leicester

Headline bioethics is a new series of resources for teaching about bioethics. There will be two styles of Headline bioethics resources – study guides and commentaries. For both sets of material, each resource is focussed around a news story which raises interesting ethical question in the fields of biology and biomedicine. The selected stories must all be available as a video clip on the BBC news website.

Study guides include background information and structured worksheets which teachers can either use “of the shelf” or customise for their own purposes. Commentaries are authored by undergraduate students and offer reflections on some of the ethical issues raised by the news story.

The ethics of GM crops is one of the topics considered in Headline Bioethics

The first two study guides, on Genetically Modified crops and Preimplantation Genetic Diagnosis, are now available.  These Headline bioethics resources was authored by Sarah Curtis, a TULIP intern at the University of Leicester. If you have thoughts about these materials, or suggestions for future topics that you’d like to see covered in this way, then please let us know.