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Ethics and the Limits of the Randomized Controlled Trial: Time to Enhance Access to Novel Therapies in Lethal Diseases?

Ethics and the Limits of the Randomized Controlled Trial: Time to Enhance Access to Novel Therapies in Lethal Diseases?

Parts of this blog are drawn from ‘Improving access to medicines: empowering patients in the quest to improve treatment for rare lethal diseases’, a forthcoming paper  in the Journal of Medical Ethics

Jenn McNary witnesses the miracles that modern medicine can produce every day when she sees her son Max, once increasingly reliant on a wheelchair due to his Duchenne muscular dystrophy, now able to walk, run and jump, the progression of his deadly disease apparently halted due to his enrolment in a clinical trial of a new drug, Eteplirsen.

Tragically, she also witnesses the suffering of her son Austin, who has the same genetic condition, denied the drug as his disease progresses and left no longer able to leave his wheelchair unaided. Like most with Duchenne muscular dystrophy, he is expected to die in his early twenties.

Eteplirsen works by rewriting some of the genetic code that is linked to the disease. If Max’s improvement is repeated in other patients in the trial who are receiving the drug and not the placebo, it is likely that in a few years this treatment will be revolutionizing the prognosis for Duchenne sufferers and offering hope to many of the 1 in 3600 boys who are affected by the disease.

In the meantime, patients like Austin are denied treatment, on the grounds that the drugs have not been tested- in order to protect him from unknown side effects and complications, and to test its efficacy scientifically. Yet the alternative for Austin is continuing degenerative disease, and in a few years, death.

Les Halpin, founder of Access to Medicine, and himself a motor neuron disease sufferer has argued that for those with life threatening and rare illnesses, current drug approval procedures do not work. He argues in our forthcoming paper that “for such individuals, the “risk-return ratio” is different compared to patients with more benign conditions and drug regulations should be adapted to allow such people the opportunity to try out new combinations of drugs”. He has argued for greater use of new media to track patient progress, and cites the use of the website ‘Patients Like Me’ by MND patients to track their progress on lithium treatment.

Read More »Ethics and the Limits of the Randomized Controlled Trial: Time to Enhance Access to Novel Therapies in Lethal Diseases?

Cultural bias and the evaluation of medical evidence: An update on the AAP

By Brian D. Earp Follow Brian on Twitter by clicking here. Cultural bias and the evaluation of medical evidence: An update on the AAP Since my article on the American Academy of Pediatrics’ recent change in policy regarding infant male circumcision was posted back in August of 2012, some interesting developments have come about. Two major critiques of… Read More »Cultural bias and the evaluation of medical evidence: An update on the AAP

Why it matters whether you believe in free will

by Rebecca Roache

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Scientific discoveries about how our behaviour is causally influenced often prompt the question of whether we have free will (for a general discussion, see here). This month, for example, the psychologist and criminologist Adrian Raine has been promoting his new book, The Anatomy of Violence, in which he argues that there are neuroscientific explanations of the behaviour of violent criminals. He argues that these explanations might be taken into account during sentencing, since they show that such criminals cannot control their violent behaviour to the same extent that (relatively) non-violent people can, and therefore that these criminals have reduced moral responsibility for their crimes. Our criminal justice system, along with our conceptions of praise and blame, and moral responsibility more generally, all presuppose that we have free will. If science can reveal it to be an illusion, some of the most fundamental features of our society are undermined.

The questions of exactly what free will is, and whether and how it can accommodate scientific discoveries about the causes of our behaviour, are primarily theoretical philosophical questions. Questions of theoretical philosophy—for example, those relating to metaphysics, epistemology, and philosophy of mind and language—are rarely viewed as highly relevant to people’s day-to-day lives (unlike questions of practical philosophy, such as those relating to ethics and morality). However, it turns out that the beliefs that people hold about free will are relevant. In the last five years, empirical evidence has linked reduced belief in free will with an increased willingness to cheat,1 increased aggression and reduced helpfulness,2 and reduced job performance.3 Even the way that the brain prepares for action differs depending on whether or not one believes in free will.4 If the results of these studies apply at a societal level, we should be very concerned about promoting the view that we do not have free will. But what can we do about it?Read More »Why it matters whether you believe in free will

Enhancement: Rat Race or Supermarket? (Podcasts)

In this special Enhancement seminar, visiting speakers Rob Sparrow and Chris Gyngell discussed two aspects of enhancement. You can hear the podcast here (mp3). Rob Sparrow on ‘Enhancement and Obsolescence: Avoiding An “Enhanced Rat Race”‘: A claim about continuing technological progress plays an essential, if unacknowledged, role in the philosophical literature on “human enhancement”. Advocates for… Read More »Enhancement: Rat Race or Supermarket? (Podcasts)

‘Precarious (Bio)ethics: Research on Poisoning Patients in Sri Lanka’

On 9 May 2013, Salla Sariola, from ETHOX, gave a fascinating talk at the St Cross Ethics Seminar, based on work done collaboratively with Bob Simpson (Durham). The presentation focused on the large number of self-poisonings which have been taking place in Sri Lanka, often using lethal agricultural pesticides and herbicides unavailable in many developed countries. This presentation is now available as a podcast at the bottom right of the Oxford Uehiro Centre main webpage.Read More »‘Precarious (Bio)ethics: Research on Poisoning Patients in Sri Lanka’

Why are we not much, much, much better at parenting?

We’ve come a long way, as a species. And we’re better at many things than we ever were before – not just slightly better, but unimaginably, ridiculously better. We’re better at transporting people and objects, we’re better a killing, we’re better at preventing infectious diseases, we’re better at industrial production, agricultural and economic output, we’re better at communications and sharing of information.

But in some areas, we haven’t made such dramatic improvements. And one of those areas is parenting. We’re certainly better parents than our own great-great-grandparents, if we measure by outcomes, but the difference is of degree, not kind. Why is that?Read More »Why are we not much, much, much better at parenting?

Frej Klem Thomsen, ‘Rescuing Responsibility from the Retributivists – Neuroscience, Free Will and Criminal Punishment’ (Podcast)

Do advances in neuroscience threaten the idea of free will, and if so, what practical implications does this have, for instance when it comes to criminal responsibility and punishment? In a stimulating talk at the Uehiro seminar (the podcast of which is available here), Frej Klem Thomsen, assistant professor of philosophy at Roskilde University, discussed the answers that the prominent American neuroscientists Joshua Greene and Jonathan Cohen have proposed to those questions [1]. Briefly put, Greene and Cohen predict that cognitive neuroscience will make it increasingly apparent to everyone that (as some philosophers have argued centuries ago already) there is no such thing as free will as commonly understood. This, they add, will shift the approach to punishment in criminal law from the current “retributivist” one to a consequentialist one – a change they also judge desirable, on the grounds that the current approach relies on intuitions they take to be scientifically untenable.

Read More »Frej Klem Thomsen, ‘Rescuing Responsibility from the Retributivists – Neuroscience, Free Will and Criminal Punishment’ (Podcast)

Phones 4 U, Ke$ha and becoming offensive

Channel 4 was censured by Ofcom this week for cutting to a light-hearted sponsorship advert just after viewers had watched the particularly graphic and disturbing rape scene in the film The Girl with the Dragon Tattoo. The Phones 4 U sponsorship ad was thought to be especially inappropriate for that moment as it features a couple apparently having sex, during which the woman pauses and asks to the camera ‘I’m faking it, can I upgrade’? Ofcom received 17 complaints about the timing of the advert and this week concluded that ‘the juxtaposition of a light-hearted sponsorship credit featuring a woman during sex with a disturbing and distressing rape scene in a film was clearly unsuitable… In Ofcom’s view this clearly had the potential to be offensive to viewers’.

The timing was clearly unfortunate, but to say that the juxtaposition was offensive is a stronger claim.  Of course, the psychological effect of being immersed in a violent scene at one moment and then confronted with the same(ish) subject matter presented trivially will not do much for the viewer’s aesthetic experience. But the regulator’s suggestion seemed not only to be that the juxtaposition detracted from the viewer’s enjoyment, but also that it was in some way wrong.Read More »Phones 4 U, Ke$ha and becoming offensive

Non-consensual testing after needlestick injury: A legal and ethical drama

By Charles Foster and Jonathan Herring

Scene 1: An Intensive Care Unit

Like many patients in ICU, X is incapacitous. He also needs a lot of care. Much of that care involves needles. Late at night, tired and harassed, Nurse Y is trying to give X an intravenous injection. As happens very commonly, she sticks herself with the needle.

Nurse Y is worried sick. Perhaps she will catch HIV, hepatitis, or some other serious blood-borne infection? She goes tearfully to the Consultant in charge.

‘Don’t worry’, he says. ‘We’ll start you on the regular post-exposure prophylaxis. But to be even safer, we’ll test some of X’s blood for the common infections. I doubt he’ll be positive, but if he is, we’ll start you straight away on the necessary treatment. We needn’t take any more blood: there are plenty of samples already available.’

A sample of blood is submitted for analysis. Read More »Non-consensual testing after needlestick injury: A legal and ethical drama