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In the News

Flibanserin and Regulatory Failure

25 Sep, 15 | by Iain Brassington

Guest Post by Adriane Fugh-Berman

On August 18th, 2015, the FDA approved flibanserin (brand name Addyi), a purported aphrodisiac that can drop blood pressure so precipitously that users sometimes pass out and require medical intervention to regain consciousness.  The labelling for flibanserin indicates that it is for:

the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

• A co-existing medical or psychiatric condition,

• Problems within the relationship, or

• The effects of a medication or other drug substance.

Focus for a moment on “Low sexual desire that causes marked distress or interpersonal difficulty”.  So a woman upset by a belittling spouse who wants sex more often than she does is eligible for a prescription drug?  It gives a whole new meaning to the term “drugs of abuse.”  Note that even if the putative patient isn’t distressed, she is still eligible for being drugged if her partner is creating interpersonal difficulty.  Here’s a thought – why not sedate him instead?

Not every partner is a jerk, and there are certainly women distressed by loss of libido, but flibanserin isn’t the answer for these women either.  As an aphrodisiac, it’s no great shakes; its predominant mechanism may simply be sedation.  Flibanserin increased “sexually satisfying events” by less than one event a month (the event, by the way, need include neither an orgasm nor a partner).

The labeling of flibanserin reveals the absurdity of this “disease” and its treatment. more…

Assisted Dying’s Conscience Claws

11 Sep, 15 | by Iain Brassington

Aaaaaaaand so the latest attempt to get assisted dying of some sort onto the statute books in the UK has bitten the dust.  I can’t say I’m surprised.  Watching the debate in the Commons – I didn’t watch it all, but I did watch a fair chunk of it – it was striking just how familiar the arguments produced by both sides were.  It’s hard to shake the feeling that, just as is the case with the journals, the public debate on assisted dying has become a war of attrition: noone has much new to say, and in the absence of that, it’s simply a matter of building up the numbers (or grinding down the opposition).  The Nos didn’t win today’s Parliamentary debate because of any dazzling insight; the Ayes didn’t lose it because their speakers were measurably less impressive than their opponents’.  If the law does change in the UK, I’d wager that it’ll be because of demographic brute force rather than intellectual fireworks.

(Every now and again I hear a rumour of someone having come up with a new approach to assisted dying debates… but every now and again I hear all kinds of rumours.  I live in hope/ fear: delete as applicable.)

Still, I think it’s worth spending a little time on one of the objections that’s been raised over the last couple of days to this Bill in particular; it’s an objection that was raised by Canon Peter Holliday, the Chief Executive of a hospice in Lichfield:

In an interview with the Church of England, Canon Holliday said: “If there is no possibility within the final legislation for hospices to opt out of being a part of what is effectively assisted suicide, then there is nervousness about where our funding might be found in the future. Would the public continue to support us and indeed would the NHS continue to give us grants under contract?”

Canon Holliday said the Assisted Dying Bill also contains no opt out for organisations opposed to assisted suicide in spite of high levels of opposition to a change in the law amongst palliative care doctors. Where hospices did permit assisted suicide the potential frictions amongst staff could be ‘enormous’ with possible difficulties in recruiting doctors willing to participate, he said.

“The National Health Service requires us, in our contracts, to comply with the requirements of the NHS. Now if the NHS is going to be required to offer assisted dying there is of course the possibility that it would require us or an organisation contracting with the NHS also to offer assisted dying. If we as an organisation were able, and at the moment under the terms of the bill there is no indication we would be able, but if we were able to say that assisted dying was not something that would happen on our premises, would that prejudice our funding from the NHS ?”

Is this worry well-founded? more…

Psychology Is not in Crisis? Depends on What You Mean by “Crisis”

3 Sep, 15 | by bearp

By Brian D. Earp

*Note that this article was originally published at the Huffington Post.


In the New York Times yesterday, psychologist Lisa Feldman Barrett argues that “Psychology Is Not in Crisis.” She is responding to the results of a large-scale initiative called the Reproducibility Project, published in Science magazine, which appeared to show that the findings from over 60 percent of a sample of 100 psychology studies did not hold up when independent labs attempted to replicate them.

She argues that “the failure to replicate is not a cause for alarm; in fact, it is a normal part of how science works.” To illustrate this point, she gives us the following scenario:

Suppose you have two well-designed, carefully run studies, A and B, that investigate the same phenomenon. They perform what appear to be identical experiments, and yet they reach opposite conclusions. Study A produces the predicted phenomenon, whereas Study B does not. We have a failure to replicate.

Does this mean that the phenomenon in question is necessarily illusory? Absolutely not. If the studies were well designed and executed, it is more likely that the phenomenon from Study A is true only under certain conditions. The scientist’s job now is to figure out what those conditions are, in order to form new and better hypotheses to test.

She’s making a pretty big assumption here, which is that the studies we’re interested in are “well-designed” and “carefully run.” But a major reason for the so-called “crisis” in psychology — and I’ll come back to the question of just what kind of crisis we’re really talking about (see my title) — is the fact that a very large number of not-well-designed, and not-carefully-run studies have been making it through peer review for decades.

Small sample sizes, sketchy statistical procedures, incomplete reporting of experiments, and so on, have been pretty convincingly shown to be widespread in the field of psychology (and in other fields as well), leading to the publication of a resource-wastingly large percentage of “false positives” (read: statistical noise that happens to look like a real result) in the literature.


Jeremy Hunt and Costs to the Taxpayer

2 Jul, 15 | by Iain Brassington

“Personal responsibility” is a strange phrase: while not as slippery as some, it can mean any number of things, and be put to use in any number of political contexts.  It was the title of the speech that the Health Secretary, Jeremy Hunt, gave yesterday.  In that, he spoke of three aspects to the concept.

First up, he talked about the need for personal responsibility for health – that while the NHS tops the leagues in a lot of respects, the UK as a whole is bad when it comes to “lifestyle illnesses”, particularly things derived from obesity and smoking.  I guess that telling us that that’s bad and we could look after ourselves better is something of a bromide; but slightly more jarring was the statement that

[t]hankfully people are starting to take more responsibility. Doctors report dramatic increases in the number of expert patients who Google their conditions and this can be challenging for doctors not used to being second-guessed. But it is to be warmly welcomed: the best person to manage a long-term condition is the person who has that long term condition. The best person to prevent a long term condition developing is not the doctor – it’s you.

This is worth noting for a few reasons: first, it’ll be interesting in the context of what I’m going to say in a couple of paragraphs’ time; but there’s a couple of other things worth noting.  While the final sentence may be fairly unobjectionable at first glance, the penultimate and antepenultimate ones seem much less obvious.  Management of long-term conditions may be best left to the patient in some cases; but in all?  That’s not nearly so obvious.  It’s particularly unlikely when Dr Google is the purported source of information.  Dr Google, after all, may send you to NHS Choices – but it may also send you to What Doctors Don’t Tell You*, or sites that are even more obviously written by and for what we may politely call aluminium milliners.  Sometimes, patients doing a bit of homework is a good thing.  But sometimes, they’ll just end up asking for colloidal silver therapy.  (What could possibly go wrong?)

I’ll come to the second theme in a moment; the third thing he talked about was taking responsibility for our families. more…

Child Euthanasia: Should We Just not Talk about It?

12 May, 15 | by Iain Brassington

Guest Post by Luc Bovens

In 2014 Belgium passed a law that extends its euthanasia legislation to minors.  There were strong parliamentary majorities in favour of this law but nonetheless a scream of “Murderers!” was heard in the public galleries of the Chamber of Representatives.  What is the opposition like in Belgium?

Euthanasia for adults has been legal in Belgium since 2002.  Many opponents of this legislation, including the Catholic Church, abhor the decision to further extend this legislation to minors.  I do not engage with the legalisation of euthanasia in general.  What I am asking is whether, considering that euthanasia is legal, it is or is not reasonable to limit the legislation to adults only.  This is a separate moral question.  One may be an opponent of a particular practice, yet at the same time believe that, if the practice is legalised, then it would be wrong to restrict the legalisation to a particular subgroup.   (Likewise, one may be an opponent of, say, legislation permitting abortion, and yet, if abortion is legalised, oppose a restriction that would make it accessible to only certain sectors of society.)  I distinguish between two lines of opposition that focus on the extension of the euthanasia legislation to minors in the Belgian debate.

First, there is an Open Letter signed by (mostly) paediatricians and there are various arguments in the press against the extension of the legislation: We should never grant euthanasia requests to minors, because such decisions are too weighty for minors, minors are not capable of discernment, the pressure on minors is too great, minors are particularly sensitive to such pressure, and there is sufficient palliative care for minors.


My One Appearance in “Cosmo”…

28 Apr, 15 | by Iain Brassington

… and they go and screw it up.

A few weeks (months?) ago, I got a call from Cosmopolitan to ask if I’d talk about home-testing kits for genetics – stuff like what 23andMe offers.  We talked, and I like to think that I said something useful… and promptly forgot all about it, until just now, when the University of Manchester press office sent me a link to this: a story about HIV self-testing kits in the UK.

It’s a piece that quotes me.  It quotes me from that interview I did about genetic – genetic! – tests:

Iain Brassington, Healthcare Ethics professor at the University of Manchester told Cosmo Body:

“People invest a lot in genetic information and it could have a serious psychological impact. Someone could feel anxious, distraught, even suicidal if they find out they are carrying a gene associated with particular diseases.”

Can you see the problem here?

Apart from the fact that I’m not, and am unlikely soon to be, a Professor, I mean?

OK: for clarity’s sake (and just in case there are any Cosmo readers who’ve drifted here): genetic tests and HIV tests are VERY DIFFERENT THINGS, and raise CORRESPONDINGLY DIFFERENT PROBLEMS.  I don’t think that HIV is a genetic condition.  Only idiots think that.  Some of the problems with one might well be problems with the other.  But we can’t leap between the two so easily.  I don’t know what I think about home HIV tests; I’ve not thought about them much, and noone’s asked me to have an opionion on them yet.  THIS QUOTATION MAKES ME LOOK LIKE AN IDIOT.

Also, they put words in my mouth.  I can’t remember what I said, but I doubt it’d’ve been anything as fatuous as “Someone could feel anxious, distraught, even suicidal if they find out they are carrying a gene associated with particular diseases.”  That’s simply not the kind of thing I say.

Yes, I’m posting here shamelessly, because I don’t want that particular piece to appear if people Google me without some kind of balancing act.  And I’m posting a screengrab just below the fold for posterity’s sake, just in case Cosmo deletes the page.


Incentives, Penalties, and Vaccination.

13 Apr, 15 | by Iain Brassington

This popped up on my FB feed yesterday: a proposal from the Australian government that certain child welfare payments should be withheld from parents who refuse to vaccinate their kids based on “conscientious objection”.

Parents who do not vaccinate their children will lose welfare payments of up to $2100 per child under a federal government policy set to be announced before the May budget.

Under changes that could save more than $50 million a year, Social Services Minister Scott Morrison is preparing to scrap a “conscientious objection” provision which allows anti-vaccination parents to still claim welfare benefits including childcare assistance and Family Tax Benefit A.

Fairfax Media understands the Family Tax Benefit A is worth up to $2100 per child.

What to make of the idea?

Well, I think that certain things can be taken more or less as read.  The first is that vaccination is a good thing, and is quite possibly a prima facie duty.  The second is that governments may, and perhaps must, encourage vaccination.  So it looks as though an argument in defence of the idea could be valid.  Measures to increase levels of vaccination are desirable; this is a measure that (if it works) would increase levels of vaccination; therefore this is desirable.  We’d have to do a bit of work to see whether the argument actually does work – formal validity won’t guarantee that – but in the meantime, the policy may be justified on the basis that it’s reasonable to believe that it would work.

But that is not, of course, the whole story.  Effectiveness is a necessary condition for a policy being justified, but it ain’t sufficient.  It’s likely that there’s more to say. more…

The Death of Sidaway: Values, Judgments and Informed Consent

15 Mar, 15 | by BMJ

Guest post by Kirsty Keywood (University of Manchester)

On 11th March Nadine Montgomery won her case before the UK Supreme Court to gain compensation for the failure of her obstetrician to warn her of risks associated with the vaginal delivery of a large infant – a risk which she would have averted by requesting a caesarean section.[1] Shortly after his birth, her son was diagnosed with cerebral palsy and a brachial plexus injury, resulting from the occlusion of the placenta during a “very stressful” vaginal delivery.

Nadine Montgomery had diabetes, which increased her chances of giving birth to a larger than average-sized baby. This, in conjunction with her small stature (she was 5 feet tall), indicated a risk that a natural delivery would bring with it a 9-10% chance of shoulder dystocia. Were dystocia to occur, attempts to dislodge the infant’s shoulders through mechanical manoeuvres would generate a risk of occlusion of the umbilical cord resulting in death or cerebral palsy of 0.1%. According to the obstetrician, Dr McLellan, the risk of shoulder dystocia did not merit specific mention in discussions with diabetic patients, because the risk of an adverse event associated with shoulder dystocia was very small indeed.

Mrs Montgomery’s case before the UK Supreme Court hinged on the question of the nature of the obstetrician’s duty to the patient. more…

Flogging and the Medic

3 Mar, 15 | by Iain Brassington

You must, by now, have heard of the Saudi Arabian blogger Raif Badawi.  Just in case you haven’t (really?), here’s a potted biography: having set up the secularist forum Free Saudi Liberals, he was arrested for insulting Islam and showing disobedience.  Among the formal charges he faced was one for apostasy, which carries the death penalty in Saudi.  The apostasy charge was dropped, but he was convicted on other charges and sentenced to seven years in prison and 600 lashes.  He appealed, and this sentence was changed: it became 1000 lashes and 10 years in prison.  Why?  Does it matter?  Because Saudi Arabia.  The latest update is that the apostasy charge may be renewed, so for a second time, he faces beheading.  Part of the evidence against him is that he “Liked” a post on a Facebook page for Arab Christians.  (Remember: Saudi is one of our allies against religious extremism.)

The lashes were to be administered in batches of 50, weekly, after Friday prayers.  As I write this, he has only been flogged once; doctors have attested that he is not well enough to be flogged again.  And – with thanks to Ophelia for the link – it’s  not hard to see why:

Dr Juliet Cohen, head of doctors at Freedom from Torture, explained: “When the cane strikes, the blood is forced from the tissues beneath… Damage to the small blood vessels and individual cells causes leakage of blood and tissue fluid into the skin and underlying tissue, increasing the tension in these areas.

“The more blows are inflicted on top of one another, the more chance of open wounds being caused. This is important because they are likely to be more painful and at risk of infection, which will cause further pain over a prolonged period as infection delays the wounds’ healing.”

There is also the long-term damage done to the victim’s mental health caused by flogging.

“Psychologically, flogging may cause feelings of fear, anxiety, humiliation and shame. Anticipation of the next scheduled flogging is likely to cause heightened emotions especially of fear, anxiety and difficulty sleeping… pain and fear together over a prolonged period have a deeply debilitating effect and recovery from such experiences may take considerable time,” said Cohen.

At the beginning of February, Vincent Iacopino had a post on the main BMJ blog in which he claimed that health professionals should play no part in Badawi’s flogging: more…

Bye-Bye Saatchi Bill?

1 Mar, 15 | by Iain Brassington

It would appear that Lord Saatchi’s Medical Innovation Bill is toast.

The Lib Dems, who are reportedly the ones to have vetoed it, are nevertheless being mealy-mouthed about something they should be proclaiming from the rooftops: the Bill is/ was needless at best, and possibly dangerous.  But, hey: there’s an election coming up, and cancer treatment is politically important; meanwhile, the party isn’t popular, and could probably have expected a set of “Lib Dems veto miracle cure” headlines had they made that move.

Which, when you read the Graun‘s article, isn’t a million miles away from Saatchi’s response:

“By killing the bill they have killed the hopes of thousands of cancer patients. It is as simple as that. Nick Clegg has handed down a death sentence to cancer patients.”

Which is, of course, untrue.  But, hey: whatever else he may be, Saatchi’s a great ad-man, and there’s an election coming up…

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