There is a long overdue crisis of confidence in the biological and medical sciences. It would be nice – though perhaps rather ambitious – to think that it could transmute into a culture of humility.
A recent comment in Nature observes that: ‘An unpublished 2015 survey by the American Society for Cell Biology found that more than two-thirds of respondents had on at least one occasion been unable to reproduce published results. Biomedical researchers from drug companies have reported that one-quarter or fewer of high-profile papers are reproducible.’
Reproducibility of results is one of the girders underpinning conventional science. The Nature article acknowledges this: it is accompanied by a cartoon showing the crumbling edifice of ‘Robust Science.’
As the unwarranted confidence of scientists teeters and falls, what will – and what should – happen to bioethics?
By Dominic Wilkinson, @Neonatalethics
Earlier this year, the Lancet published a trial (the ‘ACT’ trial) involving 100,000 babies at risk of being born prematurely in developing countries. Half of the mothers in the ACT trial did not receive a simple cheap medicine that has been previously shown in multiple trials and meta-analysis to reduce the risk of death for premature babies. From the ACT trial results, it appears that 89 additional babies died as a result of their mothers taking part in the trial.
Surely this is an egregious example of unethical research? It appears to be in breach of the World Medical Association Declaration of Helsinki standards. Why did ethics committees allow the research? Why did a major journal like the Lancet publish it? Why aren’t bioethicists and activist and advocacy groups like Public Citizen jumping up and down in outrage?
By Daniel K. Sokol
Daniel Sokol, PhD, is a bioethicist and lawyer at 12 King’s Bench Walk, London. He has sat on several ethics committees, including the UK’s Ministry of Defence’s Research Ethics Committee.
In a recent Opinion piece in the Boston Globe, Professor Steven Pinker made the surprising suggestion that the primary moral goal of today’s bioethics should be to “get out of the way”. “A truly ethical bioethics”, he argued, “should not bog down research in red tape, moratoria or threats of prosecution”.
This bold assertion no doubt echoes the thoughts of many scientists whose research requires the approval of an ethics review committee before springing to life. As a PhD student many years ago, I experienced first hand the frustrations of the tedious review process. I spent hours drafting the protocol, revisions and responding to the Committee’s questions, time I would have preferred to spend conducting research. While a popular sentiment, getting out of the way is not the goal of bioethics.
The goal of bioethics is to allow potentially beneficial research while ensuring that the risk of harm to participants and others is proportionate, reduced to the lowest practicable level, and within morally acceptable limits. The risk of harm can never be eliminated, but it can usually be reduced with minimal effort or cost. It may be as simple as testing a new piece of equipment one more time in a laboratory before attaching it to a human for testing.
Many people are suspicious about being manipulated in their emotions, thoughts or behaviour by external influences, may those be drugs or advertising. However, it seems that – unbeknown to most of us – within our own bodies exist a considerable number of foreign entities. These entities can change our psychology to a surprisingly large degree. And they pursue their own interests – which do not necessarily coincide with ours.
Last week I attended a conference on the science of consciousness in Helsinki. While there, I attended a very interesting session on the Minimally Conscious State (MCS). This is a state that follows severe brain damage. Those diagnosed as MCS are thought to have some kind of conscious mental life, unlike those in Vegetative State. If that is right – so say many bioethicists and scientists – then the moral implications are profound. But what kind of conscious mental life is a minimally conscious mental life? What kind of evidence can we muster for an answer to this question? And what is the moral significance of whatever answer we favor? One takeaway from the session (for me, at least): it’s complicated.
By Hannah Maslen, Jonathan Pugh and Julian Savulescu
According to the NHS, the number of hospital admissions across the UK for teenagers with eating disorders has nearly doubled in the last three years. In a previous post, we discussed some ethical issues relating to the use of deep brain stimulation (DBS) to treat anorexia nervosa (AN). Although the trials of this potential treatment are still in very early, investigational stages (and may not necessarily become an approved treatment), the invasive nature of the intervention and the vulnerability of the potential patients are such that anticipatory ethical analysis is warranted. In this post, we show how different possible mechanisms of intervention raise different questions for philosophers to address. The prospect of intervening directly in the brain prompts exploration of the relationships between a patient’s various mental phenomena, autonomy and identity. Continue reading
Hannah Maslen and Julian Savulescu
In a pioneering new procedure, deep brain stimulation is being trialed as a treatment for the eating disorder anorexia nervosa. Neurosurgeons at the John Radcliffe Hospital in Oxford implanted electrodes into the nucleus accumbens of a woman suffering with anorexia to stimulate the part of the brain involved in finding food rewarding. Whilst reports emphasize that this treatment is ‘highly experimental’ and would ‘only be for those who have failed all other treatments for anorexia’, there appeared to be tentative optimism surrounding the potential efficacy of the procedure: the woman who had undergone the surgery was reportedly ‘doing well’ and had shown ‘a response to the treatment’.
It goes without saying that successful treatments for otherwise intractable conditions are a good thing and are to be welcomed. Indeed, a woman who had undergone similar treatment at a hospital in Canada is quoted as saying ‘it has turned my life around. I am now at a healthy weight.’ However, the invasive nature of the procedure and the complexity of the psychological, biological and social dimensions of anorexia should prompt us to carefully consider the ethical issues involved in offering, encouraging and performing such interventions. We here outline relevant considerations pertaining to obtaining valid consent from patients, and underscore the cautious approach that should be taken when directly modifying food-related desires in a complex disorder involving interrelated social, psychological and biological factors. Continue reading
The discussion that the scientists in Nature and Science called for should remain in realism, not go on to superhumans
Just over a week ago, prominent scientists in Nature and Science called for a ban for DNA modification in human embryos. This is because the scientists presume that now it actually would be possible to alter the genome in a human embryo in order to treat genetic diseases. Consequently, this would result in modified DNA in germ cells that would be inherited to future generations. The scientists wish to have a full ethical, legal, and public discussion before any germ-line modifications will be made. Furthermore, issues of safety are of importance.
The scientists’ statement is of utmost importance and hopefully this ethical, legal, and public discussion will emerge. However, the discussion on germ-line DNA modification is at danger if the debate will be taken to the level of science fictional superhumans, as already has happen. Not only can such discussion cause unnecessary public worry, it also leads the deliberation away from the actual and urgent questions.
Guest Post by Bill Gardner @Bill_Gardner
Many researchers and physicians assert that randomized clinical trials (RCTs) are the “gold standard” for evidence about what works in medicine. But many others have pointed to both strengths and limitations in RCTs (see, for example, Austin Frakt’s comments on Angus Deaton here). Nancy Cartwright is a major philosopher of science. In this Lancet paper she provides insights into why RCTs are so highly valued and also why they are by themselves insufficient to answer the most important questions in medicine.