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Julian Savulescu

Safety First? How the Current Drug Approval System Lets Some Patients Down

Andrew Culliford, whose story is featured in the Daily Mail, is one of the estimated 7 in 100,000 people living with Motor Neuron disease, a progressive degenerative disease which attacks muscles, leaving those affected eventually unable even to breathe unassisted. For Andrew, a young father who has a severe form of the disease, it means a two to five year life expectancy.

Like Les Halpin and Jenn McNary, the mother of twins afflicted with a similar rare disease, he has a simple request: earlier access to medicines that might help improve or extend his life.

The US introduced a mandatory pre-approval process for pharmaceutical drugs after over 100 people were killed by an untested drug formulation . Today, each drug must go through a series of strictly controlled trials, including Phase 1 tests on healthy volunteers, followed by Phases 2 and 3 which test the drug and dosages on smaller and then larger patient groups. The process is estimated to cost $500 million per drug and to take 8 – 12 years.

The process is designed to ensure the efficacy of drugs has been scientifically demonstrated to a very degree of confidence, and to ensure that patient safety is sufficiently protected. In many ways it has been a triumph of science and regulation.

But it has been a failure for one small group of patients: those with rare, imminently lethal diseases, for whom there are no existing good treatments. Those who will die in less than 8 years. It is these patients who are asking to have access to untested medicines, and to avoid placebo controlled trials, where half the participants are given no drug at all. Les has proposed innovative methods of patient recording data. I have discussed this proposal previously on this blog , and in a joint paper with Les Halpin and clinicians.

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Press Release: Ethical Meat

On Monday, London will see the world’s first artificial meat burger cooked and tasted, by Professor Mark Post of Maastricht University. Artificial meat stops cruelty to animals, is better for the environment, could be safer and more efficient, and even healthier. We have a moral obligation to support this kind of research. It gets the… Read More »Press Release: Ethical Meat

The Ethics of Private Payment for Health Care: The Example of Vaccination

30  July. This blog is an extended version of the post ‘Vaccines: All or Nothing’ (posted 29 July). 

A vaccine which would protect children from Meningitis B has been rejected by the Joint Committee on Vaccination and Immunisation (JCVI) as not cost effective, despite the fact the cost is not yet known.

The Department of Health’s director of immunization explained:

“This is a very difficult situation where we have a new vaccine against meningitis B but we lack important evidence. We need to know how well it will protect, how long it will protect and if it will stop the bacteria from spreading from person to person.

“We need to work with the scientific community and the manufacturer to find ways to resolve these uncertainties so that we can come to a clear answer.”

A call for more research is a standard answer to many dilemmas in healthcare, though perhaps one which is easy to ignore. As far as we know there are no current plans to ensure that this research takes place but the vaccine has already been found to be safe, and according to the BBC, “tests have suggested the vaccine is effective against 73% of the different strains of the disease”.

Resource allocation is an inevitable part of any health care system, and perhaps especially so in the NHS. Whilst we would like to provide all available treatments, prioritizing according to effectiveness and cost is necessary, though the exact method of calculating this (currently Quality Adjusted Life Years, or QALYs) is of course under intense debate and scrutiny.

In the meantime, children continue to suffer avoidable, lifelong disability due to infection with Meningitis B. I argue with Lach de Crespigny in a forthcoming paper on homebirth that actions (or failures to act) taken today which cause harm in the future are as wrong as if that harm were realized today. The plight of these children and adolescents should not be ignored.

Put simply, if you could prevent a child from getting brain damage, now or in the future, at little cost to you, you ought to perform that act.

One possible way forward would be to allow parents to pay for the vaccination of their child, at whatever price the company sets, just as holiday vaccinations can be provided by the NHS at a cost to the patient. Vaccinated children could be monitored and their data recorded. Not only would this generate the data that would establish how high up funding agendas this vaccine should be, but some individual children would be prevented from suffering this deadly and debilitating disease. To increase take up, the company would be under market pressure to keep the price as low as possible.

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Doping…When Will We Learn?

The second fastest runner of all time, USA’s Tyson Gay, has reportedly tested positive for a banned substance, along with the Jamaican sprinters Asafa Powell, and Sherone Simpson making for shocked headlines across the world.

But this is just one high profile story amongst a recent rash of news stories across sports and across countries. In athletics, 24  Turkish athletes are confirmed to have tested positive this year; Australian Rules Football is still reeling from the ongoing Essendon scandal; and over in the United States, inquiries into an anti ageing laboratory said to supply human growth hormone to top baseball players are ongoing. Whilst the 100th Tour de France is so far untainted by positive tests, cycling doping cases have continued this year with two Giro D’Italia riders testing positive.

Still there is a sense that we are just seeing the tip of the iceberg. Chris Froome, now tested at the end of each stage as the yellow jersey, has been relentlessly hounded over whether his recent impressive performances are due to doping.

1. The Failure of Zero Tolerance

We don’t know which individuals are doping and which are not. One thing we do know is that the zero tolerance ban on doping has failed.

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Announcement: New Open Access ‘Journal of Practical Ethics’ Available

We are pleased to announce the first issue of the Journal of Practical Ethics, a new open-access journal in moral and political philosophy (and related areas) published by the Oxford Uehiro Centre for Practical Ethics. All the papers are free to read online or download and print. The first issue includes three papers: ‘Associative Duties… Read More »Announcement: New Open Access ‘Journal of Practical Ethics’ Available

Empathy ethics: How to get a lung for your child

By Julian Savulescu & Brian D. Earp

[updated version – as of 17 April 2016]

Sarah Murnaghan is a 10-year-old from Pennsylvania. Suffering from cystic fibrosis, she was likely to die without a lung transplant. Her situation was deteriorating. But because of a rule that says that children under the age of 12 have the lowest priority for adult donor lungs, Sarah would have to wait for another child’s lungs to become available, a much rarer occurrence.

Sarah’s parents sprang into action. They got the attention of members of congress and the media. They shared Sarah’s story on social networking sites, showing pictures of their daughter in the hospital bed. They said that the “Under 12” rule was discriminatory against children, and got a federal judge to agree. So, with the help of a court order temporarily preventing the enforcement of the Under 12 rule, Sarah got a second chance at life. An adult lung match became available, and Sarah is now recovering from transplant surgery.

It’s a story with a happy ending—depending upon how you tell it. Certainly the news is good for Sarah. Yet as Sarah’s mother acknowledged in a post on Facebook, “We … know our good news is another family’s tragedy.”

But who are those families? What are their stories? What are the names of those who will die—or who have already died—without a lung transplant of their own?

What this case illustrates is something we might call “empathy ethics” – pushing one’s own story, or that of one’s family member, into the moral spotlight in order to trigger an empathic response. Since ordinary human beings—from news anchors to congressmen to federal judges—are more likely to feel empathy for known individuals with compelling narratives of suffering, they can become motivated to bend the rules in favor of those specific individuals whose stories best capture their attention.

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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.

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Male Circumcision and the Enhancement Debate: Harm Reduction, Not Prohibition

This blog is a brief response to ‘Out of Step: Fatal Flaws in the Latest AAP Policy Report on Neonatal Circumcision’ by Steven Svoboda and Robert Van Howe, and the AAP Task Force on Circumcision’s Response. This is part of a special issue summarised by Brian Earp.

 

Around one third of men worldwide are circumcised. It is probably the most commonly performed surgical procedure. Circumcision is also one of the oldest forms of attempted human enhancement. It is and has been done for religious, social, aesthetic and health reasons.

Circumcision has a variety of benefits and risks, many of which are discussed in this issue.  There is some dispute about the magnitude and likelihood of these benefits and risks. Some argue that the risks outweigh the benefits and circumcision should not be performed on children who are not competent to make their own decisions.

If it were true that the risks of circumcision clearly outweighed the benefits, great harm has been done and is being done globally through this procedure. Around one third of men have been harmed. This is an extraordinary public health injury. Presumably, some would be entitled to compensation.

The fact that few people think that there is not such a bad situation affecting millions of men indicates that most people implicitly believe that circumcision is not a significant harm, if a harm at all. (This is an example of the kind of argument called modus tollens. If p, then q. Not-q, therefore not-p.)

It is reasonable to conclude either that:

1) It is not clear from existing evidence whether the risks of properly performed circumcision outweigh the benefits, or vice versa.

Or

2) If circumcision is against the interests of an infant, it is only mildly so.

In general, people should make their own decisions about body modification and human enhancement when this is possible. Such an approach speaks in favour of waiting until a child is adult to make his or her own decision about circumcision. And procedures which are not clearly in a child’s interests should not be performed on that child. However, religious and other social exclusion may make delay in circumcision psychologically harmful.

It would be a mistake to ban circumcision, given its importance to many people. A dangerous “black market” would be created. As with other forms of potentially risky human enhancement, the best policy is one of harm reduction, not prohibition. Non-medical circumcision should be discouraged, but not prohibited(for further discussion see ‘Rational Non-Interventional Paternalism: Why Doctors Ought to Make Judgements of What Is Best for Their Patients’and ‘Liberal Rationalism and Medical Decision-Making’).

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If The Jury System Is The Best Option, Can We Make it Better?

By Julian Savulescu and Anders Sandberg

Vicky Pryce, wife of disgraced ex-MP Chris Huhne, is back in court this week after  the jury trying her case  was  discharged last week having failed to reach a verdict on her charges of perverting the course of justice. In 2003, Pryce accepted Huhne’s speeding points, but is claiming a defence of marital coercion. In 10 questions to the judge, the first jury showed an alarming and deep lack of understanding. Questions included:

“Can a juror come to a verdict based on a reason that was not presented in court and has no facts or evidence to support it?”

They also showed the jury had apparently forgotten key concepts which were explained during the trial:

“Does this defence require violence or physical threats?”

“Can you define what is reasonable doubt?”

Following the jury’s discharge, the judge said the jury showed “absolutely fundamental deficits in understanding”, adding that he had never seen this in 30 years of presiding over criminal trials. In Pryce’s trial, the questions the jury asked after several days of deliberations raised alarm bells, but in another  trial where a verdict was reached, we would never know what the standard of jury understanding or deliberation had been. Yet juries are asked to decide (in some countries) on matters of life or death.

The Pryce case may have been unusual, but in any trial, and particularly in complex fraud cases, juries are asked to juggle and compute vast amounts of information, and to retain it throughout the trial in order to make an informed decision at the end. We have argued in “The Memory of Jurors: Enhancing Trial Performance”  and “Cognitive Enhancement in Courts” with Walter Sinnott-Armstrong, that cognitive enhancement, particularly memory enhancers should be made available to jurors. If this had been available in the Pryce case, would the jury have spent more time discussing the decision at hand, and less on (mis-)remembering the judge’s instructions on reasonable doubt or the definition of coercion? If we ask people to take on a civic duty we should offer them all the tools we have available to assist them in its completion.

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“The Best Interests of the Family”: Parents v Baby?

There is much that is good to be said about Dominic Wilkinson’s new book Death or Disability? The ‘Carmentis Machine’ and decision-­making for critically ill children. My favourite part of the book is how Dominic confronts head on the issue of the best interests of the family in relation to care, and withdrawal of medical treatment,… Read More »“The Best Interests of the Family”: Parents v Baby?