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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…

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.

Consigned to the Index

28 May, 14 | by Iain Brassington

There’re probably times when all of us have had a solution, and just had to find a problem for it.  It’s an easy trap; and it’s one into which I suspect Gretchen Goldman may have fallen in an article in Index on Censorship about scientific freedom and how it’s under threat from disputes about Federal funding in the US.  No: I’m not going to be arguing against scientific freedom here.  Only against a certain use of the appeal to scientific freedom in response to a particular problem. First up, let’s note the points on which Goldman may well be correct.  She notes that the disputes in the US about federal funding that have led to big cuts and a short-but-total government shutdown are very bad for science.  She points out that political machinations even meant that researchers working in government-funded areas couldn’t access their emails.  This had direct and indirect consequences, all of which were pretty undesirable.  For example,

[m]any government scientists were not allowed to access email, much less their laboratories. One scientist noted that his “direct supervisor … confiscated all laptop computers on the day of the shutdown”.

Without access to work email accounts, federal scientists were also prevented from carrying out professional activities that went beyond their government job duties. Several scientists pointed out that their inability to access emails significantly slowed down the peer-review process and, therefore, journal publication.

In the wider sense, to have science and funding bodies that are vulnerable to political shenanigans isn’t good for science, and is probably not good for humanity.  You don’t have to think that research is obligatory to think that it’s often quite a good thing for science to happen all the same.  And shutdowns are particularly bad for students and junior researchers, whose future career might depend on the one project they’re doing at the moment; if a vital field trip or bit of analysis or experiment is liable to get pulled at almost any moment, they don’t have a reputation yet to tide them over.

So far, so good.  However, things are iffier elsewhere. more…

The Definition of Mental Disorder: Evolving but Dysfunctional?

12 Feb, 14 | by Iain Brassington

Guest post by Rachel Bingham

In 1973 the American Psychiatric Association removed homosexuality from the official classification of ‘mental disorders’.  This was the result of a successful public campaign and changing political views.  Yet, if homosexuality could be (wrongly) diagnosed as a mental disorder – using an official classification – what does this say about the other states that remain in the classification?  How can we be sure that other states are not being labeled as mental disorders solely due to discrimination and stigma?

One way to respond to these concerns is to offer a definition of mental disorder, aiming to capture all and only genuine mental illness.  Unfortunately, this has proved exceptionally difficult to do.  Definitions that rely only on ‘facts’ – information about the brain, the genes, and so on – do not tell us whether or not a condition is really an illness.  They simply tell us about the underlying biology once we already recognize an illness to be present.  For example, finding differences in the brains of people who are criminals or of people who have recently fallen in love would not prove these states to be “illnesses”; it would only show that different states of being are reflected differently in the brain.  It is widely acknowledged that defining mental disorder requires some sort of value judgment – that is, recognition that the state in question is undesirable or harmful.  But once we bring value judgments into play concerns about social discrimination are amplified.  Might other states be wrongfully diagnosed solely because of social or political dimensions that have not yet been recognized for what they are?  If value judgments are permitted to define disorder, do we risk repeating a history of wrongful psychiatric diagnosis?  These questions are explored at greater length in the full paper in the JME, available here.

Identity and IVF

11 Jan, 14 | by Iain Brassington

It’s good to see that Stephen Latham is blogging again after a short hiatus; and he’s come back with a really thought-provoking post on IVF and problems of identity.

The background is this: apparently, there is evidence that children conceived by IVF are at an elevated risk of health problems compared to kids conceived naturally:

Compared to spontaneously-conceived singletons, singletons from assisted conception were almost twice as likely to be stillborn, more than twice as likely to be pre-term, almost three times as likely to have very low birth weight, and twice as likely to die within the first four weeks after birth. Outcomes varied by type of assisted conception. Very low and low birth weight, very preterm and preterm birth, and neonatal death were “markedly” more common in births from IVF and, to a lesser degree, in births from ICSI. Use of frozen embryos elminated the risks of ICSI, but not of IVF. But frozen embryos also had increased risk of macrosomia.

This is the paper that Stephen mentions; but it’s not the only one to report potential risks associated with IVF.  A rather kneejerk response to this is to go “Eeeep!  This means that IVF is dangerous, and we’re harming kids by conceiving them by this method”.  (I suspect that there’s an element of that in posts like this – though admittedly if that element is there, it’s being deployed merely as a part of a wider attack on IVF, motivated for different reasons.)  But, of course, kneejerk reactions are rarely all that morally insightful, and the conventional response to concerns about IVF is rather more sanguine.

Borrowing heavily from Parfit, the standard response is this: each of us is reliant on a particular egg and a particular sperm having fused in a particular way.  Had that been different, we would not have come into being.  A month later, and it’d’ve been a different egg; and it could easily have been a different sperm cell.  Any resultant child would be related to us only in the same way as a sibling – except that it wouldn’t be our sibling, because we wouldn’t be there.  This indicates that, if IVF represents a child’s only chance of coming into existence – and it probably is – it is hard to say that the child has been harmed or wronged thereby.  There may be a qualification to add, along the lines that should the child’s life be so bad that non-existence would be preferable, existence may be a harm; but that kind of outcome is probably hyperbolic in practice.  An elevated risk of any congenital characteristic is therefore unlikely to count as a harm.

So, as Stephen points out, we can ask a question: more…

The Value of Role Reversal

20 Jun, 13 | by BMJ

Guest Post by Rebecca Dresser, Washington University in St. Louis

Not so long ago, medical researchers had a habit of using themselves as guinea pigs.  Many scientists saw self-experimentation as the most ethical way to try out their ideas.  By going first, researchers could test their hypotheses and see how novel interventions affected human beings.

Today we rely on a more systematic process to decide when to begin human testing, with experts and ethicists evaluating when a trial is justified.  But a modified version of self-experimentation still makes sense.

People who conduct human research, as well as those serving on research ethics boards, can learn a lot from volunteering for studies.  Just as doctors learn from personal experience as patients, scientists and ethicists learn from personal experience as subjects.

Looking at study requirements and the consent process from the subject’s point of view can be quite educational.  I discovered this myself when I was given the option of enrolling in a cancer treatment trial.  I had never before realized that enrolling in a trial can delay the start of treatment, because of the extra appointments and procedures research enrollment can require.  Nor had I realized that because cancer trials take years to finish, subjects in those trials may lose an opportunity to receive new drugs that emerge during that time.  I’ve spent three decades writing about research ethics and serving on research review boards, but I learned new things once I had to decide whether to become a subject myself.

No one should be forced to participate in research, of course.  But I encourage research professionals to consider becoming subjects themselves (not necessarily in their own trials, but in studies conducted by others).  This modern version of self-experimentation might give researchers and ethicists a better sense of what people need to know before enrolling in a study.  It might also give scientists and review committees a deeper understanding of the risks, inconveniences, and benefits that subjects experience in research.

Rebecca’s paper “Personal Knowledge and Study Participation” is now available online first here.

Is the NIMH Turning its Back on DSM-V?

9 May, 13 | by Iain Brassington

Thanks to Brian Earp for bringing this release from the US’ National Institute of Mental Health to my attention; it concerns the Institute’s decision to move away from DSM as its diagnostic tool.  DSM has been enormously successful – in terms of having established itself at the centre of psychiatry – but it has been enormously controversial, as well; the NIMH moving away from it is very big news indeed.  Whether the new model that they’re going to be working on will be any better, of course, remains to be seen.

The important bit seems to be this:

NIMH will be re-orienting its research away from DSM categories. Going forward, we will be supporting research projects that look across current categories – or sub-divide current categories – to begin to develop a better system.

One or two things about the statement leap out at me. more…

Conference: Compassion Fatigue: Changing Culture in the NHS

18 Apr, 13 | by Iain Brassington

26-28 June, Woodbrooke Quaker Study Centre, Birmingham

(via Andrew Edgar)

Can the language of compassion capture the moral problems confronted by the NHS, or might it obfuscate and distract us from more subtle and demanding issues?

Through a series of plenary addresses, workshops, panels and shared opportunities for discussion, “Compassion Fatigue” will provide an opportunity to explore the language of compassion, and the impact that it has on the practice of health care provision.

More details below the fold. more…

Crime and the Less-Polluted City Solution

10 Jan, 13 | by Iain Brassington

People who listen to Today may have heard an article in the prime 8:10 slot on the 9th about the correlation between a drop in the use of leaded petrol, and a drop in violent crime rates.  (Mother Jones actually beat the BBC, having published a piece on the same research last week: I meant to post something then, but was buried by other stuff.)

The nub of the story is this: that violent crime has been falling in the past few years, and though this pattern seems to lag about 20 years behind a fall in the use of lead in petrol, the fit is pretty good: a decline in leaded petrol predicts a decline in violent crime by about two decades – which is just about the time that we might expect would elapse between the formation of the brain and the highest likelihood of violent behaviour in humans.  Neat.  The Mother Jones piece provides lots of links to the relevant research – links to this (from 1999), and this (from 2007), and this (from 2012).

If the lead hypothesis is sound, it seems to be ethically interesting in a couple of ways. For one thing, it opens the way to at least some antisocial behaviour to be seen as being symptomatic of a deeper public health problem.  That’s interesting enough as it is, but – admittedly – it might be little more than interesting, on the grounds that leaded petrol is pretty much a thing of the past anyway (Wikipedia says that, as of 2011, leaded petrol was widely available only in 7 countries).

But the other way in which it’s interesting has to do with arguments about so-called “moral enhancement”. more…

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