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Research Ethics

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…

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…

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…

Resurrectionism at Easter

23 Apr, 14 | by Iain Brassington

There’s a provocative piece in a recent New Scientist about what happens to unclaimed bodies after death – about, specifically, the practice of coopting them for research purposes.

Gareth Jones, who wrote it, points out that the practice has been going on for centuries – but that a consequence of the way it’s done is that it tends to be the poor and disenfranchised whose corpses are used:

[T]he probably unintended and unforeseen result [of most policies] was to make poverty the sole criterion for dissection. [... U]nclaimed bodies are still used in countries including South Africa, Nigeria, Bangladesh, Brazil and India. While their use is far less in North America, they continue to constitute the source of cadavers in around 20 per cent of medical schools in the US and Canada. In some states in the US, unclaimed bodies are passed to state anatomy boards.

For Jones, the practice of cooption ought to be stopped.  His main bone of contention is the lack of consent – it’s a problem that’s made more acute by the fact that the bodies of the disenfranchised are more likely to be unclaimed, but I take it that the basic concern would be there for all.

One question that we might want to ask right from the off is why informed consent is important. more…

This will hurt a bit

11 Apr, 14 | by David Hunter

In a piece titled in a fashion to simultaneously win the internet and cause every male reader to wince, Michelle Meyer asks “Whose Business Is It If You Want a Bee To Sting Your Penis? Should IRBs Be Policing Self-Experimentation?

In this piece she describes the case of a Cornell graduate student who carried out a piece of self-experimentation without IRB approval (based on the mistaken belief it wasn’t required) which aimed to assess which part of the body was worst to be stung by a bee on and involved:  “five stings a day, always between 9 and 10am, and always starting and ending with “test stings” on his forearm to calibrate the ratings. He kept this up for 38 days, stinging himself three times each on 25 different body parts.”

While IRB approval was required and not sought in this case, Meyer argues that this isn’t problematic effectively because in her view regulating researcher self experimentation constitutes an unacceptable level of paternalism:  “The question isn’t whether or not to try to deter unduly risky behavior by scientists who self-experiment; it’s whether this goal requires subjecting every instance of self-experimentation, no matter how risky, to mandatory, prospective review by a committee. It’s one thing to require a neutral third party to examine a protocol when there are information asymmetries between investigator and subject, and when the protocol’s risks are externalized onto subjects who may not share much or any of the expected benefits. Mandatory review of self-experimentation takes IRB paternalism to a whole other level.”

Perhaps this is just my inherent lack of a distaste for relatively benign paternalism but I don’t quite see this objection to regulating self experimentation working for three reasons.

Firstly the distinction Meyer draws between self and other experimentation assumes a high level of understanding of the risks and benefits on the behalf of the researcher in a way that negates the need for the normal consent process. This is probably right most of the time and so we can assume consent is present. Does this negate the need for external review? I am not sure it does since the researchers understanding is not perfect and they may be self deceiving in regards to the magnitude and level of risk. Meyer notes for example that this project originally involved stings to the eye, until the supervisor of this student pointed out that this risked blindness. So review by external experts regarding risks and benefits of research can and does reduce the levels of risks in research. In Research Exceptionalism James Wilson and I argue that this is a general justification for external research regulation – the ethics and risks and harms of research are complex and unpredictable and hence external regulation helps clarify these risks and ethical issues to enable researchers to fulfil their moral duties. This is of course paternalistic in the case of self-experimentation, but I presume that the student in this case is grateful to his supervisor for saving his vision, so I think it is the kind of paternalism we ought to endorse, since it is in regards to a risk that the person wouldn’t want to run.

Secondly valid consent, doesn’t just consist of having information, it also requires competency and particularly in these types of cases an absence of coercion. This is a graduate student who is to be frank in a vulnerable institutional position (like many of us in academia…) – if they want to improve their standing and move to the next level they need to keep their superiors happy. This makes them vulnerable to self exploitation and risk taking, which external regulation can reduce and remove.

Finally I suspect that what is going on here is a kind of reverse research exceptionalism where the regulation of research is seen as somehow more problematic than the regulation of other aspects of our lives. It is commonplace for health and safety to require us in the course of our employment to to act and not act in particular ways. This is both paternalistic insofar as it protects us, but it is also not paternalistic insofar as it protects both others and the instution we work at. In this case, this student is working in a lab in an institutional context and if something had gone wrong for the student or others in the course of this research then the institution could well have been held liable for damages arising from this. As such it seems perfectly within their rights to me to decide how to regulate these risks to them, and to decide to regulate these via prospective review.

Now as Meyer notes this is an external requirement rather than a choice that Cornell has made, but I don’t think this changes the justification for the regulation – given that we know in markets competition tends to drive towards failures to protect workers and others, there is nothing inappropriate with the state correcting the market failure here via legislation.

 

 

 

 

 

An Attack of the What-Ifs

25 Oct, 13 | by Iain Brassington

Among the comments to the last post, there’s this from Parmenion59:

So…if a cure for lung cancer is found, and the study has been funded through money from a tobacco company…the BMJ won’t publish said study?
Way to go BMJ.

Hmmm.  At least on the face of it, this looks like an important point – one that deserves a bit of unpacking.  We can begin by distinguishing between responses to this particular point, and responses to the general idea behind it.  First things first.

I’m willing to bite the bullet and admit without worrying too much that the policy of not accepting papers funded by the tobacco industry may mean that some research is not publicised.  There’s a small handful of reasons why I’m willing to do that.  One of them – admittedly the weakest of the lot – is based on the idea that it’s not wholly clear that much tobacco money really is directed at finding a cure for lung cancer, rather than firefighting other research about the detrimental properties of tobacco.  But that, as I say, is weak, based on suspicion rather than anything enormously substantial; and even if the hunch is correct, it’s merely empirical rather than anything conceptual.  Still, even if the hunch is wrong, it shouldn’t matter, because there’re stronger reasons.

One is based around the idea that there’s a special providence in the fall of a pipette – or, put another way, you can’t keep a good truth down.  If something is there to be discovered and is worth the effort, then it’ll be discovered sooner or later; if not by Smith, then by Jones.  And, because scientific progress is invariably a matter of the accretion of the work of several teams, all working independently and making minor discoveries, rather than one heroic person who would be solely responsible for The Cure For Cancer ™, the loss of one paper here and there probably won’t make all that much of a difference in the grand scheme of things. If that’s correct, then the idea that we might lose the cure for cancer is not all that compelling – not one about which we should worry too much.

A final reason is that, as I’ve said before elsewhere, I’m not persuaded that research is obligatory: it’s admirable, but not required by duty.  There’s a range of second-order arguments one might present here, but most relevant has to do with the benefits that research might generate.   more…

Smoking out Tobacco Industry-Supported Research

18 Oct, 13 | by Iain Brassington

BMJ Open, along with a couple of other journals, published a statement a couple of days ago saying that they’d no longer accept papers based on research wholly or partially funded by the tobacco industry.  The gloss on the statement is damning:

The tobacco industry, far from advancing knowledge, has used research to deliberately produce ignorance and to advance its ultimate goal of selling its deadly products while shoring up its damaged legitimacy.  We now know, from extensive research drawing on the tobacco industry’s own internal documents, that for decades the industry sought to create both scientific and popular ignorance or “doubt.”  At first this doubt related to the fact that smoking caused lung cancer; later, it related to the harmful effects of secondhand smoke on non-smokers and the true effects of using so called light or reduced tar cigarettes on smokers’ health.  Journals unwittingly played a role in producing and sustaining this ignorance.

Some who work within public health and who buy the notion of “harm reduction” argue that the companies that now produce modified cigarette products and non-cigarette tobacco products, including electronic nicotine delivery devices (e-cigarettes), are different from the tobacco industry of old, or that the tobacco industry has changed. For “hardened” cigarette smokers who can’t or won’t quit cigarettes, the argument goes, new tobacco products could represent potential public health gains, and company sponsored research may be the first to identify those gains.

But one fact remains unassailably true: the same few multinational tobacco companies continue to dominate the market globally and, as smaller companies develop promising products, they are quickly acquired by the larger ones. However promising any other products might be, tobacco companies are still in the business of marketing cigarettes. As US federal court judge Gladys Kessler pointed out in her judgment in the case of US Department of Justice versus Philip Morris et al, the egregious behaviour of these companies is continuing and is likely to continue into the future.  And just this summer documents leaked from one company showed a concerted campaign to “ensure that PP [plain packaging of tobacco products, bearing health warnings but only minimal branding] is not adopted in the UK.”  The tobacco industry has not changed in any fundamental way, and the cigarette—the single most deadly consumer product ever made—remains widely available and aggressively marketed.

What should we make of the policy?

A bad argument against the ban – yeah, I know that that misses some linguistic subtlety, but it’s close enough – is that it’s a violation of free speech: it really is no such thing, for the simple reason that noone is trying to stop the tobacco industry making its case – a right to free speech doesn’t imply a right to a platform.  Of course, if every reputable publisher denies the industry a platform, than this might be a de facto rather than de jure curb on free speech – but that’s just the way it goes: just as noone gets to insist that a particular person gives them a platform, they don’t get to insist that they be provided with one at all.  (Also – though it doesn’t apply in this case – merely to splutter “B…b.. but free speech!” isn’t an argument anyway.)

Still, I guess I am uneasy about a ban. more…

Research Ethics and Ethical Problems

16 Aug, 13 | by Iain Brassington

Noted on Ben Goldacre’s twitter feed a couple of weeks ago was this article in Slate about the recruitment of pregnant women into drug trials.

Essentially, there’s a situation in which there’s a dearth of information about the impact of drugs during pregnancy.  According to the article,

[p]harmaceutical companies are not willing to navigate the legal and ethical minefield of testing drugs on pregnant women, especially because pregnancy lasts only nine months, a short window in which the tests could pay off in additional sales.  As a result, drugs are often prescribed to this population off-label, meaning that they haven’t been specifically approved for pregnant women.

Of course, that doesn’t explain why testing is an ethicco-legal “minefield” to begin with.  Still, it’s not all that hard to come up with at least a skeletal explanation: the whole point of trials is that the effect of a drug is unknown, and this might mean that it’s not safe.  When we’re talking about a volunteer, then it’s important that they know the risks before enrolling; but when a woman is pregnant, another dimension is added: she’s effectively volunteering her unborn child as well.  And it might be problematic to expose another human – even a foetus – to an unknown risk.

But this leaves us with a paradox: more…

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…

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