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Once More unto the Breach of Covenant?

31 Oct, 14 | by Iain Brassington

The “Military Covenant” is in the news again:

The government is failing to abide by its military covenant, medical experts who treat injured soldiers have said.

Leading professors in psychology and orthopaedics say the healthcare system is not providing veterans with the service they have been promised. [...]

The moral obligation to treat veterans should not stop when service ends, the covenant states, saying veterans should receive priority healthcare from the NHS when they are being treated for a condition dating from their time in the armed forces.

The Covenant is set out here; most of it is pretty vague, and what isn’t vague is largely predictable in its tone.  In respect of healthcare, the relevant part is on p 6:

The Armed Forces Community should enjoy the same standard of, and access to, healthcare as that received by any other UK citizen in the area they live. [...]  Veterans receive their healthcare from the NHS, and should receive priority treatment where it relates to a condition which results from their service in the Armed Forces, subject to clinical need.

This, at first glance, seems to be saying that members of the forces, and ex-members, should be treated in the same way as everyone else, except that they shouldn’t.  (There’s a fuller version of the statement here.)  The Government repeats this confusing attitude elsewhere: its own website explains that

[i]t’s not about getting special treatment that ordinary citizens wouldn’t receive, or getting a better result. For those that have given the most, such as the injured and the bereaved, we do make an exception

But maybe that’s just a terminological infelicity.

The Covenant itself does not have the status of law (and even if it did, that wouldn’t make any moral difference, unless you happen to think that all law is de facto good law).  However, the Armed Forces Act (2011) does state that the Secretary of State must prepare and present before Parliament every year a report on the covenant; and, according to §343A(3), more…

Saatchi Bill – Update

28 Oct, 14 | by Iain Brassington

Damn. Damn, damn, damn.

It turns out that the version of the Medical Innovation Bill about which I wrote this morning isn’t the most recent: the most recent version is available here.  Naïvely, I’d assumed that the government would make sure the latest version was the easiest to find.  Silly me.

Here’s the updated version of §1(3): it says that the process of deciding whether to use an unorthodox treatment

must include—

(a) consultation with appropriately qualified colleagues, including any relevant multi-disciplinary team;

(b) notification in advance to the doctor’s responsible officer;

(c) consideration of any opinions or requests expressed by or on behalf of the patient;

(d) obtaining any consents required by law; and

(e) consideration of all matters that appear to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment, including assessment and comparison of the actual or probable risks and consequences of different treatments.

So it is a bit better – it seems to take out the explicit “ask your mates” line.

However, it still doesn’t say how medics ought to weigh these criteria, or what counts as an appropriately qualified colleague.  So, on the face of it, our homeopath-oncologist could go to a “qualified” homeopath.  Or he could go to an oncologist, get told he’s a nutter, make a mental note of that, and decide that that’s quite enough consultation and that he’s still happy to try homeopathy anyway.

So it’s still a crappy piece of legislation.  And it still enjoys government support.  Which does, I suppose, give me an excuse to post this:

Many thanks to Sofia for the gentle correction about the law.

An Innovation Too Far?

28 Oct, 14 | by Iain Brassington

NB – Update/ erratum here.  Ooops.

One of the things I’ve been doing since I last posted here has involved me looking at the Medical Innovation Bill – the so-called “Saatchi Bill”, after its titular sponsor.  Partly, I got interested out of necessity – Radio 4 invited me to go on to the Sunday programme to talk about it, and so I had to do some reading up pretty quickly.  (It wasn’t a classic performance, I admit; I wasn’t on top form, and it was live.  Noone swore, and noone died, but that’s about the best that can be said.)

It’s easy to see the appeal of the Bill: drugs can take ages to come to market, and off-label use can take a hell of a long time to get approval, and all the rest of it – and all the while, people are suffering and/ or dying.  It’s reasonable enough to want to do something to ameliorate the situation; and if there’s anecdotal evidence that something might work, or if a medic has a brainwave suggesting that drug D might prove useful for condition C – well, given all that, it’s perfectly understandable why we might want the law to provide some protection to said medic.  The sum of human knowledge will grow, people will get better, and it’s raindrops on roses and whiskers on kittens all the way; the Government seems satisfied that all’s well.  Accordingly, the Bill sets out to “encourage responsible innovation in medical treatment (and accordingly to deter innovation which is not responsible)” – that’s from §1(1) – and it’s main point is, according to §1(2), to ensure that

It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition, in the circumstances set out in subsection (3), if the decision to do so is taken responsibly.

Accordingly, §1(3) outlines that

[t]hose circumstances are where, in the doctor’s opinion—

(a) it is unclear whether the medical treatment that the doctor proposes to carry out has or would have the support of a responsible body of medical opinion, or

(b) the proposed treatment does not or would not have such support.

So far so good.  Time to break out the bright copper kettles and warm woollen mittens*, then?  Not so fast. more…

Ebola in the US: Privacy, public interest and the ethics of media reporting

3 Oct, 14 | by David Hunter

The first confirmed case of ebola has been found in the US, in Texas – unsurprisingly someone who had recently been to Africa. This has prompted an outbreak… of unethical media reporting about the case, with several breaches of privacy which seem unlikely to be in the public interest. Specifically the media has disclosed the victim’s full name, then to add insult to injury they published both his address and then a map of where he lives.

The media frenzy around this case is as unwarranted as it is unsurprising – scarily reminiscient of the painfully telling Onion piece – which claimed just 50 more white people needed to die of Ebola before a vaccine would be developed…

But even if we accept that the public is interested in the case (which no doubt they are) and that this interest warrants reporting on it does that give the media the right to release this person’s personal details and movements?

The main argument that can be offered for breaching typical standards of confidentiality is that the breach is in the public’s interest – this is the defense typically usually used in whistle blowing cases and in cases where medical professionals break confidentiality to prevent harm to others.

So isn’t this justification enough? Aren’t all Americans now at risk of ebola, amd hence have a right to know about who has it and where it is so they can choose to minimise their own risk?

It is worth noting that whilst Ebola is to be frank a terrifying disease it is relatively easily containable by the use of routine public health measures such as surveilance, isolation, contact tracing and modern hygiene standards and practices as it is spread through fairly obvious contact with bodily fluids, rather than airborne. And these fluids are only generated once someone is obviously symptomatic. As such there is little chance of a significant outbreak in countries like America or Australia because the number of contacts likely to be exposed to bodily fluids are usually minimal.

So this information is unlikely to help anyone protect themselves from being exposed to ebola – those who were already exposed (if any) have been exposed and are being contacted, and no one will now be exposed to this particular victim, so having their details in the public domain does no good, and has a potential to do harm in three ways:

1. It can reinforce false beliefs – “why would they tell us this if we weren’t at a significantly increased risk?”

2. It creates the potential for witch hunting – where the victim is blamed and potentially harmed – “civic-minded” citizens might take it upon themselves to “minimise” the risk of infection by burning down the apartment building he lives in for example.

3. It may perversely discourage other exposed travellers from seeking medical treatment and attention – it is worth noting that the victim took himself to hospital to seek treatment. If there is considerable public outcry, stigmatisation, distaste and displeasure the next victim may feel their details will be exposed in a similar fashion and avoid medical attention with predictably disasterous effects both for them, and for those potentially exposed to them.

Could spreading this information be helpful for contact tracing? Contact tracing is a public health practice where all those who might have been exposed are identified and contacted – both to see if they have symptoms and in some cases to isolate them until they are cleared. Reporting these details might enable a few people who haven’t been identified as being in contact to self identify, but practices of contact tracing are well established and this is a relatively easy case since his movements are well known and the victim has been able to communicate with public health officials about those he has been in contact with, so it is likely to be of minimal benefit, if anything it might well create more false positives than anything else – with worried people who think they were exposed using up valuable time and resources.

In a deeply misleadingly titled piece: “With Ebola, the public’s right to know trumps patient privacy” Art Caplan an American bioethicist argues that rebuilding and maintaining trust requires the public be given some normally confidential information. He argues there is a public interest in knowing the process of how this case was handled, and his movements so that the public can be reassured about the system and that they were not exposed. It is fair to note that mistakes were made in this case – he then went to hospital and was discharged despite having disclosed that he had recently travelled from Africa. However there is as Art acknowledges a significant difference between releasing this information, and the victims personal private details. It is hard to see how releasing that information really would provide public reassurance? I’d suggest it doesn’t really, instead it feeds fear and distrust which are the greatest killers in epidemics.

Highly dangerous infectious diseases create unique ethical challenges because by their very nature those who suffer them are as Battin et al put it “both victims and vectors of disease“. But whether someone is a victim or a vector of a disease, we ought to remember that they are still a person and as such deserve to have their private information protected, especially if disclosure is unlikely to benefit and may well harm the public’s interests, no matter how interested they are in knowing it.

Paper Preview: Implementation of a Consent for Chart Review and Contact

23 Sep, 14 | by BMJ

Guest post by Irena Druce
Our article “Implementation of a Consent for Chart Review and Contact and its Impact in one Clinical Centre” focuses on issues regarding patient health information privacy and recruitment for medical research studies.  Research studies are an integral part of the advancement of medical therapies; however, recruitment into research studies can be challenging.  In Canada, the use of health information is governed by Personal Health Information Protection Act and at our institution a policy is in place that allows only those health professionals directly in the circle of care access to patient information to further protect patient’s privacy.  This policy could have a potential negative effect on recruitment rates into research studies.  Physicians and other clinical personnel often do not have the time to discuss ongoing research projects with patients as time is spent focusing on the patient’s medical issues.  In addition, there is concern that if  physicians use the information that they gather in a clinical encounter to recruit for research studies, it is equivalent to that physician sharing medical information  with someone who does not have a right to it.

In light of these challenges, the Division of Metabolism and Endocrinology at the University of Ottawa implemented a consent for chart review and contact (CCRC).  The CCRC is a document presented to a patient on their first meeting a new physician.  The CCRC gives permission for the patient’s medical file to be reviewed by research personnel to determine whether a patient is eligible for a research study.  If the patient meets the study criteria, the CCRC also grants permission for the patient to be contacted by research personnel to be provided with the details of the research study so they can decide if they wish to participate.

It has been proposed that patients may feel pressured to agree if a  CCRC is presented on their first meeting a new health professional.   Patients may feel that refusing the CCRC would affect the future care they receive.  Our  paper discusses how we have addressed this possible pitfalls with our CCRC document.

In addition, we performed an analysis to assess the impact the CCRC was having at our institution.  We compared the basic demographics of the patients who did and did not agree to the CCRC.  Furthermore, we analysed our centre’s recruitment rate into a known, ongoing, multi-centre, international trial.  Of the participating centres, we found that our institution had some of the highest recruitment rates into the trial, and that the majority of our patients were being recruited via our novel approach of the CCRC.  It is not certain that the use of a CCRC would consistently translate into higher recruitment, but certainly our experience has been encouraging.  Data suggest that participation in research trials has been decreasing in recent years.  Any measure to preserve recruitment may be beneficial, especially a measure which allows for the conduction of research, without having to sacrifice any patient rights with regards to privacy and confidentiality.

Read the paper here.

 

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Posted in clinical ethics, Guest Post, JME

The Ebola Outbreak in Western Africa: Ethical Obligations for Care

11 Sep, 14 | by BMJ

Guest post by Aminu Yakubu, Morenike Oluwatoyin FolayanNasir Sani-Gwarzo, Patrick Nguku, Kristin Peterson, and Brandon Brown

In our article “The Ebola Outbreak in Western Africa: Ethical Obligations for Care” we focus on the health care system’s ability to combat the recent epidemic of Ebola in Western Africa.  This is a timely and urgent issue.  Many medical ethicists – including those called upon by the WHO – are focusing on availability of experimental drugs, but little is being discussed about on-the-ground care and human rights.  By the time this article was written, in August 2014, there were 1145 deaths from Ebola.  In the news, Ebola treatment facilities were being taken over by armed civilians who stole medicines to protect themselves, resulting in Ebola patients fleeing for their lives and further spreading the virus.  This action has taken a toll on an already limited infrastructure.

The unspoken heroes of the Ebola epidemic are the healthcare workers who brave potential infection to save the lives of those infected.   In Nigeria, nine health care workers were infected, and three health care workers had already died by the time this blog was written.  With this news, willingness of medical staff to provide care for patients with Ebola virus is limited, as the danger to their own life is great.  Moral obligations of healthcare staff to provide care should have limited sanctions for non-compliance so as not to infringe on the healthcare workers right to life.  Workers who do care for Ebola patients must be provided with adequate protective equipment and a safe working environment, as well as compensated if they become infected in the course of duty.  Traditional public health ethics has paid little attention to the protection of the rights of healthcare workers, but the Ebola epidemic has brought this issue to the forefront.  Its time those who are responsible for saving our lives have a voice.

 

Read the full paper here.

UPDATE:  Brandon Brown emails:
I just received a nice on the ground photo (Ebola decontamination) from my collaborators in Nigeria if we can attach to the blog entry.  [Click image for bigger.]

IMG_20140728_182522

 

 

 

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Film Review: “Obvious Child”

3 Sep, 14 | by Iain Brassington

We’ve not had a film review here before, have we?  OC-poster-screenshot-121013

As far as I can tell, the ratio of talked-about-ness to actual screenings of Obvious Child is unusually high; it doesn’t seem to have got all that much time in mainstream cinemas, which meant that I had to schlep along to Manchester’s Cornerhouse to see it.  (I have a theory about cinemas, which is that the artistic quality of the establishment is inversely proportional to the comfort of the seating.  The Cornerhouse is a nice example of this rule in action.)  Why it’s attracted so much attention is captured in the elevator pitch: it’s a romantic comedy about abortion.  It certainly got certain elements of the US commentariat all excited – RightWingWatch has a nice little compilation here – though admittedly, as far as I can tell, the objections haven’t been matched in the UK, where the emphasis has been much more along the lines of “It’s that film that got the American right all antsy”.

I can see why certain sectors of the commentariat have got upset about it; the film is remarkable in just how down-to-earth its handling of the plot is.  The plot is dead simple: a woman (Donna, played by Jenny Slate) loses her boyfriend and her job within the space of about three frames, gets drunk, has a one-night-stand, gets pregnant, decides to have an abortion, lets the father of the child know all this in the course of a stand-up routine, has that abortion, then decides to watch Gone with the Wind.  It’s that straightforward.

For Donna, it’s less a matter of obvious children than obvious decisions.  She doesn’t want to be pregnant, and sets about not being.  There’s no indication that she’ll regret the decision; there’re no lingering shots of Donna agonising over whether it’s the right thing to do; the father (Max, played by Jake Lacy) says he wants to be a grandfather in passing, but doesn’t try to talk her out of it, or even insist that he should have a say.  Donna is a little nervous about the procedure – but then, it makes sense to be a little nervous about having a mole removed or any other minor surgery.  There’s no moral freight, though.  Donna is not irresponsible – I mean, she might have done something a bit irresponsible in not taking more care with the contraception, but that’s a shared thing with Max; and making a decision about what to do in the wake of having done something a bit daft is responsible.

In other words, Obvious Child is just about a person making a decision. more…

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Oh, dear, Richard…

20 Aug, 14 | by Iain Brassington

Look, I know that Twitter really isn’t the place for nuanced debate.  But, by that token, everyone else should realise that as well – especially intellectual superstars. So how, then, to explain Richard Dawkins’ spectacular foot-in-mouth moment earlier today? It started off reasonably enough, with him tweeting about Catholicism’s stance on abortion and providing a link to this piece by Jerry Coyne in the New Republic; lots of people are going to agree with both Coyne and Dawkins, and lots to disagree, but we should expect that.  The tweet got a couple of replies.  I can’t be bothered transcribing them, but here’s a screenshot; you should be able to click to enbiggen it. Screen shot 2014-08-20 at 19.50.23

So far so good.  Dawkins’ reply is about as good a version of the sentience argument that you could cram into 140 characters; and InYourFaceNewYorker’s point articulates a problem faced by any number of women who are carrying a child with a disability of some kind.  (Well, by any number of parents, I suppose, except that it’s women who hold the moral trump here simply by dint of being the one carrying it.  Fathers could agonise about the best thing to do, too; it’s just that they don’t get to make the final decision.  Oh, you know what I mean.)  Where you stand on abortion doesn’t preclude recognising that it’s a genuine moral dilemma for many people, and a that there are respectable arguments and proponents of those arguments on both sides – by which I mean that people on either side should be able to recognise that their opponents are at the very least worth the effort of an argument. InYourFaceNewYorker goes on to articulate some of the aspects of the debate that make it so emotive and so intellectually rich:

Screen shot 2014-08-20 at 19.58.49

That doesn’t reflect Dawkins’ response to the dilemma, though.  Brace yourselves. more…

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Adrenaline, Information Provision and the Benefits of a Non-Randomised Methodology

17 Aug, 14 | by Iain Brassington

Guest Post by Ruth Stirton and Lindsay Stirton, University of Sheffield

One of us – Ruth – was on Newsnight on Wednesday the 13th August talking about the PARAMEDIC2 trial.  The trial is a double blind, individually randomised, placebo controlled trial of adrenaline v. normal saline injections in cardiac arrest patients treated outside hospital.  In simpler terms, if a person were to have a cardiac arrest and was treated by paramedics, they would usually get an injection of adrenaline prior to shocks to start the heart.  If that same person was enrolled in this study they would still receive an injection but neither the person nor the paramedic giving the injection would know whether it was adrenaline or normal saline.  The research team is proposing to consent only the survivors for the collection of additional information after recovery from the cardiac arrest.  This study is responding to evidence coming from other jurisdictions that indicates that there might be some significant long term damage caused by adrenaline – specifically that adrenaline saves the heart at the expense of the brain.  It is seeking to challenge the accepted practice of giving adrenaline to cardiac arrest patients.

Our starting position is that we do not disagree with the research team.  These sorts of questions need to be asked and investigated.  The development of healthcare depends on building an evidence base for accepted interventions, and where that evidence base is not forthcoming from the research, the treatment protocols need changing.  This going to be tricky in the context of emergency healthcare, but that must not be a barrier to research.

There are two major ethical concerns that could bring this project to a grinding halt.  One is the opt-out consent arrangements, and the other is the choice of methodology.

Consent, then. more…

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Advance Directives, Critical Interests, and Dementia Research

14 Aug, 14 | by BMJ

Guest post by Tom Buller, Illinois State University

In my paper, “Advance Directives, Critical Interests, and Dementia Research”, I investigate whether advance directives can be applied in the context of dementia research. Consider, for the sake of argument, the following fictional case. William, a 77-year-old man who has moderate to severe dementia. When he was first diagnosed and while still competent he declared on many occasions that he wished to do all he could to help future sufferers of the disease and find a cure for Alzheimer’s, and he repeatedly said that he very much wanted to participate in any clinical trials, even those that might involve hardship and risk. With the full agreement of his family William was enrolled in a five-year clinical trial testing a new treatment for Alzheimer’s that involves.

I think it can be legitimately argued that William has the right to make a future-binding decision to participate in the above trial, for the reasons that justify the use of a decision in the treatment context also apply in the present research context. First, William’s beneficent desire to help future sufferers of Alzheimer’s is part and parcel of his character and what gives his life value. Second, the principle of precedent autonomy is not invalidated by the fact the person is encouraging, rather than, refusing intervention, and that the chosen course of action requires the assistance of others. Third, William’s decision is not invalidated by the fact that it is motivated by beneficence rather than self-interest.

If this analysis is correct, then it would seem that there are good reasons to think that a competent person has the right to decide to participate in future research once competence has been lost, even research that is (significantly) greater than minimal risk.

 

Read the full paper online first here.

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