You don't need to be signed in to read BMJ Blogs, but you can register here to receive updates about other BMJ products and services via our Group site.

JME

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

15 Aug, 13 | by BMJ

Post by Julian Savulescu

Cross-posted from the Practical Ethics blog, and relating to this paper in the JME.

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. 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.

JME Special Edition on Infanticide and “After-Birth Abortion”

2 May, 13 | by Iain Brassington

It’s going to be a little while before regular blogging resumes here – I’m aiming to get back up to speed in the next 10 days or so – but, in the meantime, the special edition of the JME devoted to The Paper Of Which We Do Not Speak is now out and available here.  Some of the papers are open access; others aren’t.

For better or worse, part of being unable to do much blogging at the moment is that I’m not going to be around much to mod any comments that come in – as I’m sure they will – over the next few days.  Don’t go thinking you’re being blocked: it’s much more likely that I’m marking essays.

A bit more on Circumcision

28 Mar, 13 | by Iain Brassington

Maybe he should have been invited to contribute to the special edition: Somegreybloke seems to have the debate wrapped up perfectly…

Are Biomedical Ethics Journals Institutionally Racist?

25 Mar, 13 | by Iain Brassington

So there’s this letter published in the Journal of Bioethical Inquiry that moots the idea that the top biomedical ethics journals might be institutionally racist.  In it, Subrata Chattopadhyay, Catherine Myser and Raymond De Vries point out that the editorial boards of a good number of journals are dominated by members who are located in the global North – countries officially listed as being high or very high on the development index, with only 1.3% drawn from countries classed as least developed.

Developing World Bioethics has the highest proportion of its editorial board located in the least-developed nations; but even there, the figure is only just over 11%.  On the face of it, this doesn’t look too good, especially given the proportion of the world’s population in general that lives in the poorest countries.  The JME, by comparison, draws 100% of its editorial board members from people located in highly and very-highly developed nations.

Still: this isn’t likely to be the whole story.  Udo Schucklenk – a founding editor of DWB, of course – takes issue with the letter on a number of grounds.  For one thing, he he suggests that Chattopadhyay et al might be performing a sleight of hand with their metrics; by lumping together countries ranked as high and very high on the development index, they’re lumping together the UK, Germany, and the US with Iran, Malaysia, and Jamaica.  Neither Iran nor Jamaica is a classic basket-case economy; but, still, “high” and “very high” development covers a vast range of income levels.  Treating all these countries in the same way obscures that there’s a huge range of locations from which editorial staff may be drawn.

I’ll come back to this in a moment. more…

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

19 Mar, 13 | by BMJ

Guest Post by Julian Savulescu

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. more…

Journal of Medical Ethics – Special Issue on Circumcision

19 Mar, 13 | by BMJ

Guest Post by Brian Earp

The Journal of Medical Ethics is pleased to announce the forthcoming release of a special issue – “The Ethics of Male Circumcision”  - to be published in full in the coming days.  Selected papers have already been posted Online First and can be seen by clicking here. Contributions cover a wide range of perspectives, and were invited from leading legal scholars, bioethicists, political theorists, pediatricians, and medical historians with expertise in this area. All essays were subjected to rigorous peer review. A list of main contributors and highlights from the arguments showcased in this Special Issue can be found below.

Background

Recent events have re-ignited controversy around the oft-debated issue of the moral and legal permissibility of infant male circumcision.

According to a recent German court ruling, circumcising minors on religious grounds amounts to grievous bodily harm.  The court held that children have fundamental rights to bodily integrity and self-determination that cannot be outweighed by the right of parents to practice their religion and raise their children as they see fit. German chancellor Angela Merkel suggested that the ruling was an affront to religious liberty, while anti-circumcision groups as well as a number of ethicists hailed it as a victory for child rights.  In December of 2012, the German parliament passed a law to protect religious circumcision from future legal threats.

Meanwhile, in New York City, health officials recently succeeded in enacting a consent form requirement for circumcision after it was revealed that dozens of infants have contracted herpes in the last decade from a form of the surgery practiced by some Orthodox Jews. This form, called  , involves the sucking of blood directly off of the infant’s penis. Disagreements about the relative importance of religious tradition versus health concerns have shaped the ensuing controversy there.

Finally, in late summer of 2012, the American Academy of Pediatrics (AAP) issued a new circumcision policy statement and technical report, in which the child health organization suggested that the possible health benefits of circumcision outweigh the risks and complications.  This pronouncement was cited favourably by some commentators, while other groups, such as Doctors Opposing Circumcision, issued harsh criticisms.  The Journal of Medical Ethics announces today that it is hosting a continuation of this debate in the pages of its Special Issue, publishing a further critique of the AAP report and policy statement, alongside a formal reply by the AAP. more…

Is Medical Equipment Halal? Kosher?

23 Nov, 12 | by Iain Brassington

A recent intercalating student of mine got in touch with this query the other day:

Total parenteral nutrition is given as a replacement for nutrition where the patient cannot or should not be digesting food: it is given intravenously so bypasses digestion.  Two patients have asked my current educational supervisor if the TPN solution is halal, and no-one, including the manufacturers, seems to know. There are various parts that are derived from animals but the manufacturers can’t say where from, even which animal seemingly.

The two relevant patients have been told the ‘don’t know’ answer and have agreed to continue taking the TPN but the team is now left wondering whether to tell all patients before they commence TPN that they do not know the origin of the products used and therefore the TPN cannot be guaranteed as halal, or indeed kosher either.

A pharmacist has also pointed out that beef gelatine is also used in many tablet coatings and this is generally never discussed with patients.

There is a suggestion in this paper that we should routinely be telling all patients about gelatine in tablets and IV infusions, which is definitely what my instinctual reaction agrees with.  The authors suggest that continuing not to do so would mean modern medicine “might be thought to be following the sort of self certain, paternalistic line that doctors were accused of decades ago in relation to Jehovah’s Witnesses”. I think that sums it up quite nicely!

Another interesting question comes from a legal point of view – of the regulations surrounding labelling of food products, which I think are increasingly strict, and the information provided by manufacturers about origins of medical products and then how much of that is communicated to patients.  (I think Margot Brazier might have mentioned this issue in our regulations seminar.)

Having chatted with the student in the pub since, we agree that, ethically at least, it’s a bit of a no-brainer: since it isn’t an imposition on anyone to warn that we can’t be sure of the origin of the treatment, there’s no harm in doing so – and, for the sake of preserving patients’ control over what goes into their bodies, we ought.

The legal question is potentially quite interesting here.  Going off on one a bit, could there be a negligence issue here – on the grounds that it’s reasonable to suppose that at least some patients might want to know the information, even if they don’t expressly say they would (because it never crosses their mind)?  Not to warn could be a serious omission here – and I’m wondering whether it might make a difference to consent.  I genuinely don’t know: were someone to make a case that they should have been warned and would not have consented had they known, would there be legal mileage in it?

Any thoughts, anyone?

Kelly Hills, Data Miner

7 Nov, 12 | by Iain Brassington

Kelly Hills has been data-mining – collecting and collating information about the frequency with which certain terms appear in paper titles in three journals: the JME, Bioethics, and the AJoB.

I was going to say that the charts are not much use, but that they are pretty and quite cool; and I was going to add that their lack of utility doesn’t matter at all because prettiness and coolness is sufficient to make them worth looking at.  Not everything worthwhile is worthwhile because it’s useful, after all.  Being a philosopher, I have to believe that.

But then it occurred to me that there probably is some utility to them.  Taken with some care, they help us to see what is held to be important by people publishing work – and, I suppose, they might also help decide which journals are more receptive to certain topics (or, conversely, which journals are saturated with them).

Here’s what the JME‘s chart looks like:

The image isn’t perfect, of course: because size is a mark of brute numbers and the algorithm that generates the image isn’t sensitive to context, “ethics”, and “ethical” get separated, when the reality might not indicate that they merit separate consideration.  “Euthanasia” gets only a small amount of attention – which tells us something about the heat-to-light ratios in debates on the topic.  It also gives some support to John Coggon’s idea that it’s getting hard to find anything new worth saying in that particular field – though I’d’ve thought the same, and more, would apply in respect of consent, and that seems to generate a heck of a lot of attention.

198!

23 Oct, 12 | by Iain Brassington

Seriously!  Theoretical Medicine and Bioethics has published a paper with a hundred and ninety-eight listed authors!

I’ve always been slightly puzzled by multi-authored papers – by just how many people get to add their names to a piece of work.  A friend of mine who is a proper scientist once tried to explain how it works in the sciences to me – about how you need to give credit to the people who ran the experiment, but also to those who did the titration and general donkey-work.  That seems fair enough.  Having said that, I suspect that there’s often a bunch of people who get credits that shouldn’t be there.  (I remember once seeing a CV from a guy that had 45 pages’ worth of publications listed.  Granted, it was double-spaced… but, still: there must have been the thick end of a thousand papers listed; there’s no way on God’s good Earth that he could have played a significant role in all of them.  So why was he entitled to claim them?  Why did he take the credit?  Apparently, it was because, although not all of the papers referred to work he’d done, they did all refer to work done by other people in a lab he ran.)  Anyway… the Steinhauser et al ad infinitum paper, with its 198 authors, isn’t lab-based, so the credit-where-it’s-due argument wouldn’t work.

(Jozsef Kovacs, writing in a paper currently available as a pre-pub in the JME, is also concerned about authorial inflation, and who should get the credit for a given paper, and how to improve things.  It’s definitely worth a look.)

The author list for the Steinhauser paper seems to have been generated at least in part via the membership of a Facebook group (and one that no longer exists, or at least one that is so private that it doesn’t show up on a search).  That’s just silly, and there’s no way that anyone can successfully marshall so many contributors.  That turns a paper into an open letter.  Indeed: the “authors” seem to think that their paper could be treated as such without loss: more…

JME blog homepage

Journal of Medical Ethics

Analysis and discussion of developments in the medical ethics field. Visit site

Latest from JME

Latest from JME

Blogs linking here

Blogs linking here