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Biomedical Science

The Dangers Of Deferring To Doctors

By Charles Foster

(Image: tctmd.com)

There is a dizzying circularity in much medical law. Judges make legal decisions based on the judgments of rightly directed clinicians, and rightly directed clinicians make their judgments based on what they think the judges expect of them. This is intellectually unfortunate. It can also be dangerous.

There are two causes: Judges’ reluctance to interfere with the decisions of clinicians, and doctors’ fear of falling foul of the law.

In some ways judicial deference to the judgment of professionals in a discipline very different from their own is appropriate. Judges cannot be doctors. The deference is best illustrated by the famous and ubiquitous Bolam test, which is the touchstone for liability in professional negligence cases.1 A doctor will not be negligent if their action or inaction would be endorsed by a responsible body of professional opinion in the relevant specialty.

In the realm of civil litigation for alleged negligence this deference is justified. The problem arises when the deference is exported to legal arenas where it should have no place. The classic example relates to determinations of the ‘best interests’ of incapacitous patients. Something done in relation to an incapacitous patient will only be lawful if it is in that patient’s best interests.Read More »The Dangers Of Deferring To Doctors

Damages and communitarianism

By Charles Foster

The Lord Chancellor recently announced that the discount rate under the Damages Act 1996 would be decreased from 2.5% to minus 0.75%. This sounds dull. In fact it is financially tectonic, and raises some important ethical questions.

In the law of tort, damages are intended to put a claimant in the position that she would have been in had the tort not occurred. A claimant who, as result of negligence on the part of a defendant, suffers personal injury, will be entitled to, inter alia, damages representing future loss of earnings, the future cost of care and, often, private medical and other treatment.

Where damages are awarded as a lump sum, there is a risk of over-compensating a claimant. Suppose that the claimant is 10 years old at the time of the award, and will live for 70 years, and the future care costs are £1000 a year for life. Should the sum awarded be £1000 x 70 years = £70,000? (70, here, is what lawyers call the ‘multiplier’). It depends on the assumption one makes about what the claimant will do with the lump sum. If she invests it in equities that give her (say) an annual 5% return, £70,000 would over-compensate her.

In the case of Wells v Wells1, the House of Lords decided that, to avoid the risk of under-compensation, claimants should be treated as risk-averse investors. It should be assumed, said the House, that the discount rate should be fixed by reference to the return on index-linked gilts – Government securities. The rate was 2.5% from 2001 until February of this year. The reasons for the change to minus 0.75% are here. Read More »Damages and communitarianism

Guest Post: Mind the accountability gap: On the ethics of shared autonomy between humans and intelligent medical devices

Guest Post by Philipp Kellmeyer

Imagine you had epilepsy and, despite taking a daily cocktail of several anti-epileptic drugs, still suffered several seizures per week, some minor, some resulting in bruises and other injuries. The source of your epileptic seizures lies in a brain region that is important for language. Therefore, your neurologist told you, epilepsy surgery – removing brain tissue that has been identified as the source of seizures in continuous monitoring with intracranial electroencephalography (iEEG) – is not viable in your case because it would lead to permanent damage to your language ability.

There is however, says your neurologist, an innovative clinical trial under way that might reduce the frequency and severity of your seizures. In this trial, a new device is implanted in your head that contains an electrode array for recording your brain activity directly from the brain surface and for applying small electric shocks to interrupt an impending seizure.

The electrode array connects wirelessly to a small computer that analyses the information from the electrodes to assess your seizure risk at any given moment in order to decide when to administer an electric shock. The neurologist informs you that trials with similar devices have achieved a reduction in the frequency of severe seizures in 50% of patients so that there would be a good chance that you benefit from taking part in the trial.

Now, imagine you decided to participate in the trial and it turns out that the device comes with two options: In one setting, you get no feedback on your current seizure risk by the device and the decision when to administer an electric shock to prevent an impending seizure is taken solely by the device.

This keeps you completely out of the loop in terms of being able to modify your behaviour according to your seizure risk and – in a sense – relegates some autonomy of decision-making to the intelligent medical device inside your head.

In the other setting, the system comes with a “traffic light” that signals your current risk level for a seizure, with green indicating a low, yellow a medium, and red a high probability of a seizure. In case of an evolving seizure, the device may additionally warn you with an alarm tone. In this scenario, you are kept in the loop and you retain your capacity to modify your behavior accordingly, for example to step from a ladder or stop riding a bike when you are “in the red.”

Read More »Guest Post: Mind the accountability gap: On the ethics of shared autonomy between humans and intelligent medical devices

Organ Mules

Julian Savulescu

While politicians wring their hands about sensible solutions to the organ shortage, scientists are progressing with genetic manipulations that may see human organs grown in pigs.

US scientists are creating novel life forms: “human pig chimeras”. These are a blend of human and pig characteristics. They are like mules who will provide organs to us. A mule is the offspring of a male donkey (jack) and a female horse (mare). Horses and donkeys are different species, with different numbers of chromosomes but they can breed together.

In this case, they take a skin cell from a person and turn it back in time to make stem cells capable of producing any cell or tissue in the body, “induced pluripotent stem cells.” They then inject this into a pig embryo. This makes a pig human chimera.

However they do a modification to the pig embryo first. They use gene editing, or CRISPR, to knock out the pig’s genes which produce an organ, say the pancreas. The human stem cells for the pancreas then make an almost entirely human pancreas in the pig human chimera. It functions like an organ mule. (The blood vessels are still porcine.)

In this way, your skin cell could grow a new liver, heart, pancreas, or lung.

This is a technique with wider possibilities: other US teams are working on a chimera –based treatment, this time for Parkinson’s disease which will use chimeras to create human neurones.

CRISPR is also credited with enhancing the safety of this technique, with the BBC reporting  that a Harvard team were able to use the new and revolutionary technique to remove copies of a pig retrovirus.

Safety is always a major concern when science crosses new boundaries. But even if a sufficient guarantee of safety could be reached, are there ethical problems?

Read More »Organ Mules

Guest Post: Scientists aren’t always the best people to evaluate the risks of scientific research

Written by Simon Beard, Research Associate at the Center for the Study of Existential Risk, University of Cambridge

How can we study the pathogens that will be responsible for future global pandemics before they have happened? One way is to find likely candidates currently in the wild and genetically engineer them so that they gain the traits that will be necessary for them to cause a global pandemic.

Such ‘Gain of Function’ research that produces ‘Potential Pandemic Pathogens’ (GOF-PPP for short) is highly controversial. Following some initial trails looking at what kinds of mutations were needed to make avian influenza transmissible in ferrets, a moratorium has been imposed on further research whilst the risks and benefits associated with it are investigated.Read More »Guest Post: Scientists aren’t always the best people to evaluate the risks of scientific research

Why edited embryos won’t lead to designer babies or eugenics (unless we want it too)

The UK became the first country to officially approve gene editing research in human embryos on Monday. The HFEA decision means experiments in which the genes of embryos are manipulated will likely begin at the Francis Crick Institute within the next few months.

Gene editing (GE) technologies are immensely powerful. They have already been used to manipulate mosquitos so they cannot carry diseases like malaria or Zika. They have been used in medicine to reprogram human immune cells to target cancer. When used for research purposes, they promise to greatly increase our knowledge of genetics and human heredity. This will lead to a better understanding of disease, which in turn will allow better treatments – including better drugs.

Read More »Why edited embryos won’t lead to designer babies or eugenics (unless we want it too)

The reproducibility problem and the status of bioethics

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?

Read More »The reproducibility problem and the status of bioethics

Why are unethical neonatal trials still taking place in developing countries?

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?

Read More »Why are unethical neonatal trials still taking place in developing countries?

The Ethics of Compulsory Chemical Castration: Is Non-Consensual Treatment Ever Permissible?

By Jonathan Pugh

Tory Grant, the justice minister for New South Wales (NSW) in Australia, has announced the establishment of a task force to investigate the potential for the increased use of anti-libidinal treatments (otherwise known as chemical castration) in the criminal justice system. Such treatments aim to reduce recidivism amongst sexual offenders by dramatically reducing the offender’s level of testosterone, essentially rendering them impotent. The treatment is reversible; its effects will stop when the treatment is ceased. Nonetheless, as I shall explain below, it has also been linked with a number of adverse side effects.

Currently, in New South Wales offenders can volunteer for this treatment, whilst courts in Victoria and Western Australia have the discretion to impose chemical castration as a condition of early release. However, Grant’s task force has been established to consider giving judges the power to impose compulsory chemical castration as a sentencing option. Notably though, New South Wales would not be the first jurisdiction to implement compulsory chemical castration in the criminal justice system. For instance, Florida and Poland also permit compulsory chemical castration of sex offenders.

Read More »The Ethics of Compulsory Chemical Castration: Is Non-Consensual Treatment Ever Permissible?

Guest Post: The Moral Imperative for Bioethics

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.

Read More »Guest Post: The Moral Imperative for Bioethics