Event May 22nd: “The Ethics and Practice of Disinvestment: On Knowing What Not to Do in Health and Social Care”

We are delighted to announce a forthcoming event titled “The Ethics and Practice of Disinvestment:  On Knowing What Not to Do in Health and Social Care” .

 When: Wednesday May 22nd, 2019, 10:00-18:30.

 Where: Anatomy Museum, King’s Building, Strand Campus, King’s College London, London WC2R 2LS. Directions: The Anatomy Museum is located on Level 6 of the King’s Building. Access to the King’s Building is via the main entrance on the Strand. Please note: The Anatomy Museum is a different room from the Anatomy Lecture Theatre (also on the 6th floor, right next to the Anatomy Museum).

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Book Launch Event – Synthesizing Hope by Anne Pollock – Tuesday 28th May

synthesizing-hope
Tuesday 28th May, 4pm
Anatomy Museum, King’s College London
6th Floor, King’s Building, Strand Campus, The Strand, London, WC2R 2LS

All are welcome for the London Book Launch of Synthesizing Hope: Matter, Knowledge, and Place in South African Drug Discovery, released this month by the University of Chicago Press.  The event will be chaired by Professor Nikolas Rose, and will feature comments by Jenny Reardon, Jarita Holbrook, Ann Kelly, and the author.  The audience will be encouraged to join in the discussion, and to continue the conversation over drinks and nibbles.

Author:
Anne Pollock (Global Health and Social Medicine, King’s College London)

Chair:
Nikolas Rose (Global Health and Social Medicine, King’s College London)

Discussants:
Jenny Reardon (Sociology, University of California-Santa Cruz)
Jarita Holbrook (Physics, University of the Western Cape)
Ann Kelly (Global Health and Social Medicine, King’s College London)

Synthesizing Hope opens up the material and social world of pharmaceuticals by focusing on an unexpected place: iThemba Pharmaceuticals. Founded in 2009 with a name taken from the Zulu word for hope, the small South African startup with an elite international scientific board was tasked with drug discovery for tuberculosis, HIV, and malaria. Anne Pollock uses this company as an entry point for exploring how the location of scientific knowledge production matters, not only for the raw materials, manufacture, licensing, and distribution of pharmaceuticals but also for the making of basic scientific knowledge.  Consideration of this case exposes the limitations of global health frameworks that implicitly posit rich countries as the only sites of knowledge production. Analysis of iThemba identifies the problems inherent in global north/south divides at the same time as it highlights what is at stake in who makes knowledge and where. It also provides a concrete example for consideration of the contexts and practices of postcolonial science, its constraints, and its promise.  Synthesizing Hopeexplores the many legacies that create conditions of possibility for South African drug discovery, especially the specific form of settler colonialism characterized by apartheid and resource extraction. Paying attention to the infrastructures and laboratory processes of drug discovery underscores the materiality of pharmaceuticals from the perspective of their makers, and tracing the intellectual and material infrastructures of South African drug discovery contributes new insights about larger social, political, and economic orders.

https://www.press.uchicago.edu/ucp/books/book/chicago/S/bo38181532.html

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Response to CAS ruling on Semenya’s case: Why this is a disappointing, although not surprising, decision. And what type of evidence should be considered in an appeal.

This blog post was written by Dr Silvia Camporesi and originally posted on her research blog here.

As pretty much everybody else except those who were expert witnesses to the case or the judges, I was in London on Wednesday May 1st  anxiously waiting for 12 pm for the Court of Arbitration for Sport  to release the ruling on Semenya’s and Athletics South Africa’s appeal on the 2018 IAAF Regulations on Eligibility of female athletes with disorders of sex differentiation (DSDs) to compete in the female category.

semenyaNow we all know that in the press release announcing the ruling on Wednesday May 1st, (https://www.tas-cas.org/en/media/media-releases.html),  CAS dismissed both challenges on grounds that regulations are a discriminatory although necessary means to regulate the eligibility of women with DSD to run in the female category.

However, not many may have noted that in the same press release CAS also advised IAAF to defer their applications of the regulations for two events (1,500 m and the mile) until they have more evidence about a concrete advantage because of “difficult of relying on concrete evidence” . Ironically, but sad, I note that IAAF has not really taken up this piece of advice as they have given 1 week (yes, 1 week!) to athletes to lower their testosterone levels in advance of the IAAF World Championships in Doha, as can be read here: https://www.iaaf.org/news/press-release/cas-female-eligibility-regulations.

In a press release on Thursday May 2nd in Doha ahead of the track meeting today which will see Semenya competing for the last time before the new regulations come into force on May 8th, a seemingly unfazed IAAF President Sebastian Coe praised the CAS decision and added: “The question is pretty straightforward, very straightforward”.

Pace Coe, as a matter of fact, the question of whether female athletes with high levels of testosterone should be able to compete in the female category is anything but straightforward, as  pretty much everybody else in the world seems to think except Coe who is downplaying the complexities of the case.

Having worked on Semenya’s case since 2009, I have spent a lot of time investigating the question of what type of evidence CAS should be asking for to achieve a resolution of a case which has ignited controversy for the last ten years. In what follows I will explain why a different ruling, based on considering different type evidence, could have been possible. In order to do so it is necessary to take a step back and look at Dutee Chand’s case in 2015.

In the same press release released on Wednesday and announcing the dismissal of both challenges, CAS stated that “The CAS Panel was restrained in its task, due to the strict framework of the arbitration, to solely determine whether the DSD regulations were invalid or not”.

The constraints or “strict framework of arbitration” on what CAS could rule or could not rule on in this case can only be understood by taking a step back and looking at  the 2015 Dutee Chand vs AFI vs IAAF CAS Interim Arbitral Award, and at the grounds on which the former IAAF Hyperandrogenism regulations were suspended. The Indian sprinter Dutee Chand appealed to CAS after having targeted by the former Hyperandrogenism Regulations, which required athletes to lower their testosterone levels to less than 10 nmol/lit (hence, less restrictive) to be able to participate in any events. CAS suspended the regulations in 2015 on grounds that the regulations were discriminatory on the female category as only women were asked to lower their testosterone levels, and that there was not enough evidence about the correlation between increased levels of testosterone and a performance advantage in competition. However, The CAS panel at that time concluded that there is “presently insufficient evidence about the degree of advantage that androgen-sensitive hyperandrogenic females enjoy over non-hyperandrogenic females” (paragraph 522, Interim Award) and suspended the regulations for up to two years (later, extended) in order to give IAAF time to do research and come up with more evidence about the quantitative relationship between enhanced testosterone levels and improved athletic performance in hyperandrogenic athletes.

So what CAS  requested at that time was to prove that there is indeed an advantage derived by higher levels of testosterone. While the suspension of the regulations was obviously good news in the short term for Dutee Chand, Semenya and other athletes with hyperandrogenism, it was concerning right from the bat that the proviso for the suspension of the regulations falls within the scientific track of the IAAF. Indeed, the panel explicitly states that the IAAF assumption (that increased testosterone confers an advantage) “may well be proved valid“ (paragraph 543, Interim Award) but sufficient evidence has not yet been provided to show evidence of correlation, and currently the “onus of proof remains“ on the IAAF (paragraph 534, Interim Award).

In other words,  in the Dutee Chand vs AFI vs IAAF case, CAS bought into the assumption that if it were proven that testosterone provide an athletic advantage, then the regulations should be reinstated. And this is exactly what happened. Indeed, the IAAF was quick to happily note in the CAS Panel’s ruling that there is a sound scientific basis to the Regulations in that endogenous testosterone is “the best indicator of performance differences between male and female athletes,” and the court’s acceptance that hyperandrogenic female athletes may have a competitive advantage over athletes with testosterone levels in the normal female range.

Going back to the most recent CAS ruling on Wednesday, in their press release announcing the dismissal of both challenges, CAS stated that “The CAS Panel was restrained in its task, due to the strict framework of the arbitration, to solely determine whether the DSD regulations were invalid or not”. I have explained above what “strict framework of the arbitration” means in light of the Dutee Chand’s Interim Award in 2015.  Now onto the second question: what does “difficulty of relying on concrete evidence” mean?

What this means is that  not even the first requirement (of more evidence between levels of testosterone and performance advantage) has been met by IAAF. The evidence submitted by IAAF in support of the 2018 DSD regulations is just not robust enough, as demonstrated by myself with Simon Franklin (London School of Economics) and Jonathan-Ospina Betancurt (Brighton University, Isobel Burgos University) for  British Journal of Sport Medicine (https://bjsm.bmj.com/content/52/7/420 ) among others who have challenged the science underlying the regulations.  A consistent results of the different challenges is that the data by Bermon and Garnier in 2017 and submitted by IAAF to CAS as evidence supporting the new DSD regulations could not been replicated, and the 5 events selected in the regulations are more likely than not to be false positives. When this happens in science, we arguably have a problem. Even more so, when the data are used as a basis for policies and regulations to control bodies.

So going back to CAS’ ruling on Wednesday, what does the dismissal mean in practice, in light of the “strict framework” of the arbitration, and of the “difficulty on relying on concrete evidence”?

Basically, CAS panel was persuaded by IAAF expert witnesses (at least, a majority of the judges have, I am anxiously waiting to see if a “dissenting opinion” will be released in the public domain any time soon!) that regulations to lower testosterone levels in female athletes with DSDs are a necessary and proportionate, even if discriminatory, means of achieving what IAAF’s calls a “level playing field”. This persuading was arguably achieved on the basis of a “theoretical advantage” (as stated in the press release on May 1st) derived by testosterone in a sufficient number of DSD athletes in the 1500m and 1 mile events, but not on evidence of a concrete advantage because of problems in replicability and false positives with the evidence submitted by Bermon and Garnier in their 2017 paper (https://bjsm.bmj.com/content/51/17/1309) and underlying the IAAF DSD regulations.

By ruling in 2015 that IAAF would have to come up with more evidence about the advantage derived by testosterone CAS set up the case in a way to favour IAAF buying into the assumption that more evidence would settle the question of unfair advantage but it does not.

Put it simply: more evidence about the correlation between increased testosterone and performance advantage does not settle the question of whether this advantage is unfair, or not. A wrong question leads necessarily to a wrong answer.

 Since Semenya’s case first emerged at the Berlin World Track Championships in 2009 (https://jme.bmj.com/content/36/6/378.info),  I have always made the point that more evidence would not settle the question of whether an advantage would be unfair. More recently, here: https://bjsm.bmj.com/content/early/2018/04/11/bjsports-2018-099387.info

In order to settle the case, the following question should – and, could! – have been addressed by CAS:

In what (if any) morally relevant ways is testosterone dissimilar from other genetic and biological variations that confer a performance advantage?

 This question would have shaped that kind of evidence that CAS should have been requesting in a different way,  and would have led to different constraints on the type of verdict that CAS could have made on Semenya’s appeal.

However, exactly because of the way CAS had ruled in the Interim Award in the Dutee Chand case in 2015, this verdict, although disappointing, was not surprising to me.

A different ruling could have been possible. Different constraints could have been imagined. Less reductionism and less buying into scientific assumptions could have been contemplated. As noted with my co-author Paolo Maugeri in the Journal of Medical Ethics when this story first broke in 2010 ( https://jme.bmj.com/content/36/6/378.info), “We cannot expect science to provide ready-made answers on our behalf: decisions have to be taken, not found”. The verdict by CAS s extremely problematic as it falls short of recognizing that scientific and clinical knowledge themselves are value-laden, and that the answer to the question of whether testosterone confers an advantage cannot be found only in science or clinical evidence, as it is a question of fairness.

Story could have been made on May 1st. It wasn’t. But it still can. With an appeal that broadens the type of evidence to be considered, and aims to respond to the key question I have highlighted above.

End.

Silvia Camporesi spoke against CAS ruling and in favour of Semenya’s to Imran Khan for Al Jazeera Inside Story on May 2nd: https://www.aljazeera.com/programmes/insidestory/2019/05/athletics-rules-unfairly-target-caster-semenya-190502192112795.html

and can be reached at: silvia.camporesiATkcl.ac.uk

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Bioethics & Society alumni series: Featuring Shayda Kashef (class of 2017), now public engagement research assistant in public health at King’s

Shayda Kashef 2019.jpeg

Shayda Kashef

Shayda Kashef (class of 2017), was one of the students of the very first cohort of the Bioethics & Society programme, as she started studying with us as a part-time student  in September 2014:

“When I finished my undergraduate degree in Philosophy at King’s College London (2013), I knew I wanted to return to higher education for postgraduate study, but I wasn’t entirely sure which programme to apply for.

I knew what I wanted: I wanted a programme that applied the knowledge from my undergraduate degree (philosophy) to real-world and current events; I wanted something related to health, equity and justice; I wanted something to push me out of my moral comfort zone; and I wanted a pathway for me to graduate with the skills to be able to change the world. A short order, no?

Fortunately, the year I started looking for the right programme was the year the right programme for me was launched at King’s College London: in 2014 the Bioethics & Society programme, based in the Faculty of Social Science & Public Policy (SSPP), enrolled its first cohort.

Despite the feeling of being a sort of ‘guinea pig’, our programme organisers and director did a fantastic job of delivering timely, exciting and challenging material that so animated our course discussions that our cohort essentially solidified into a real group of friends and budding scholars.

The programme administration was also streamlined and seamless, which was a huge relief, because as postgraduate taught students, we had enough to worry about! The delivery of the programme was a true testament to the care and consideration that went into its inception. And at the end of the year, despite our numbers (19 students), we unanimously voted to award the now Director of the Programme and Senior Lecturer, Silvia Camporesi, the Teaching Excellence Award 2015, for her much appreciated enthusiasm for the programme and the unwavering support she provided (and no doubt continues to provide) to every single one of her students.

The interdisciplinary nature of the bioethics field equipped us with the skills to understand the intricate relationship between medicine and social and moral theory, under the motto that ‘health is more than a medical matter’. The fact that the programme was housed in SSPP Faculty as opposed to a faculty of law or medicine allowed us to contextualise bioethical theory into social policies, without limiting the scope strictly to medicine or law. The SSPP Faculty also gave us access to range of scholars to engage with, which granted us a well-rounded understanding of the bioethical scholarship. Currently, as a public engagement research assistant in public health in the Department of Population Health Sciences at King’s College London, I use the skills I obtained during my Master’s to dissect social theories and critically examine research while unpacking any social, ethical and clinical implications.

Choosing to do a Master’s in Bioethics & Society was easily one of the best decisions I have ever made. I felt incredibly valued and supported as a Bioethics & Society postgraduate student at King’s College London, and continue to feel supported with the skills gained from the programme and by the incredible staff I have the privilege of knowing”.

Shayda is currently working as a public engagement research assistant in public health in the Department of Population Health Sciences at King’s College London. You can follow Shayda on twitter here:

@shayda_k

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BrainEx technology: Consider the pig – killed, humanised, resuscitated, for the benefit of whom?

Consider the pig – they have made the headlines and the cover of the two major American scientific journals in  the last two years: first in Science when scientists led by George Church at MIT created humanised organs in pigs with CRISPR genome editing technology, raising spectre of Margaret Atwood’s “pigoons” , 57578698_2057650081000436_7939556395970461696_o and this week in an article published in  Nature, when scientists at Yale University described how they engineered  a technology – which they named Brain Ex – which was able partially restore cellular functions in pigs severed heads several hours  post mortem.  The Italian saying, “nothing is thrown away of the pig”, seems to be most appropriate here.

While some commentators have rushed to write that the Yale experiments  have  huge implications for our understanding of ‘death’, this is incorrect. As a matter of fact, the BrainEx technology does not change our conception of death, at all. Legally, there are two types of death – cardiac death (absence of pulse) and brain death (defined in the UK, as absence of brainstem functions).

Brain death was established as a legal criterion of death fifty years ago, with a declaration of the World Medical Association in Sydney, and an Ad Hoc Report of the Harvard Committee. What the Yale scientists have been able to do with BrainEx technology is observe a decrease in cell death and some preservation in anatomical and neural cell integrity, in combination with the restoration of specific cellular functions, in the absence of global brain activity.

The 1968 Declaration of the World Medical Association included a paragraph which clearly stated  that cellular function was not necessary for determination of death. (“Cessation of all life at a cellular level is not a necessary criterion for the determination of death”.) Fast forward fifty years,  we have the BrainEx technology that allows us exactly to restore this cellular function, but this has no impact whatsoever on the legal determination of death.

In the West we have a brain-centric conception, which goes back to Descartes’ and the mind body duality, according to which the brain is where our  human identity and essence lies.  Think if instead of the brain we were talking about re-perfusing and reactivating some cellular function in another organ – if we had a LiverEx, or KidneyEx, or LungEx technology, would we make such a big deal out of it? Probably not. But, it would probably be more useful than the current technology, as it could be used to prolong the window of viable for organ transplantation for essential organs (currently, we don’t have brain transplants). As a matter of fact, it is questionable why the Yale scientists did not try their technology on other organs first, where the clinical applications in terms of organ transplantation would have been more straightforward.  I suspect it is because the experiments would have had less of an impact, at least in this part of the world.

The Yale experiments only show us that some cellular function is reactivated a prolonged period post mortem – it is not that surprising   as they would like us to believe that we are able to intervene aggressively with technology and restore some cellular function!

Galvani-frogs-legs-electricity.jpg

Luigi Galvani’s electro-physiology experiments in Bologna, 1791

Indeed, the Italian Luigi Galvani in the late 18th century was conducting pioneer electrophysiology experiments on frogs, and showing that dissected legs of frogs in his laboratory at the University of Bologna seemed to jump to life under various conditions, because of signals going through their synaptic (neuronal) cells. His experiments demonstrated for the first time and the nervous system delivered animal electricity to muscle tissue, and inspired May Shelley to write her famous novel “Frankenstein”

, which by some commentators is now being used to refer to the experiments by the Yale team as “Frankenswine”. The poor Shelley is surely turning in her grave at seeing the latest mis-use of the name of her protagonist to refer to the experiments.

With an homage to David F. Wallace, we could say: consider, again, the pig: often killed, sometimes humanised, lately resuscitated. For the benefit of whom?

This post was written by Dr Silvia Camporesi. Dr Silvia Camporesi spoke  to Adam Rutherford for BBC Inside Science about the experiments carried out by scientists at Yale University reanimating pigs’ heads. You can listen to the April 18th, 2019 episode of BBC Inside Science here:

https://www.bbc.co.uk/programmes/m00046sj

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