‘Fairness for Healthcare Technologies’: some detail on the risks to PHARMAC at last?

Thursday, June 11th, 2015 | John McMillan | 3 Comments

Calls within New Zealand for the Trans Pacific Partnership negotiations to be conducted with at least a modicum of transparency have been denied. Our Trade Minister Tim Groser is reported as saying that calls for transparency are motivated by wish to blow the deal apart before it is signed. That is despite calls from the US, which one would have presumed is best placed to benefit if the TPPA is signed, for there to be greater transparency about negotiations which will affect millions of Americans. The New York Times points out that the usual reason for classifying negotiations as involving ‘national security information’ is to protect American security interests rather than negotiations its politicians are entering into.

The European Union has moved to increase the transparency of its equivalent trade agreement with the United States, including details about the opportunities member states will have to comment upon the details of the proposed agreement before it is voted on.

Those concerned about the secrecy of the TPPA negotiations have been particularly worried about the impact of a new agreement upon the ability of PHARMAC, New Zealand’s pharmaceutical purchasing agency, to negotiate as effectively as it has in the past. Some have gone as far to claim that the TPPA will gut PHARMAC. News items from 2011 report Trade Minister Groser as saying that the ‘fundamentals’ of PHARMAC are not on the table but that it would be foolish to rule discussion of PHARMAC out of trade negotiations.

The release by wikileaks of what appears to be a discussion document prepared for the TPPA titled ‘Fairness for Healthcare Technologies’ has confirmed that principles which will impact upon PHARMAC have been part of the negotiations. Jane Kelsey has said that the principles in this document would cripple and hold PHARMAC to ransom.

The title of the report itself raises a question, how does the idea of fairness apply to healthcare technologies? Or ‘what does fairness for healthcare technologies amount to?’ Surely fairness with respect to health care technologies only makes sense if we move to thinking about the interests of parties involved in the production, provision and use of healthcare technologies. So tax payers (in the case of New Zealand), the government and agencies such as PHARMAC, those needing healthcare and companies creating pharmaceuticals and other health technology. With that thought in mind it is interesting to see the principles the report includes, so as to form a view about whose interests are foremost in the TPPA negotiations.

PARA X.1, principle (b) does mention generic pharmaceuticals as being of importance, so far so good. But if we move to PARA X.3 which is about the procedures that a government might choose for listing pharmaceuticals there are a number of provisions that could conceivably threaten PHARMAC in the ways that critics have worried about.

(b) disclose to applicants within a reasonable, specified period all procedural rules, methodologies, principles, criteria (including those used, if any, to determine comparator products), and guidelines used to determine the eligibility for, and amount of, reimbursement for pharmaceutical products or medical devices

While this seems like a fairly benign requirement, it is one that might be very effective in the event that a PHARMAC decision to decline to list a pharmaceutical company’s product. They might reply that it’s only fair and in the interests of creating a level playing field that there is complete transparency about the basis on which such decisions are made. However, this is not, nor will it ever be, a level playing field. The resources at the disposal of large corporations to lobby, appeal, produce contradictory evidence and so on will always outstrip the modest resources of a New Zealand governmental agency. Rather than fairness in negotiating perhaps this will function to lean an already tilted board game so far that all of the pieces fall into the lap of the biggest player.

(c) sound economic incentives and the operation of competitive markets, or the adoption or maintenance by a Party of procedures that appropriately value objectively demonstrated therapeutic significance of high quality patented and generic pharmaceutical products and medical devices, for the efficient development of and access to such products and devices.

I am puzzled by what ‘objectively valued’ might mean in this context. One way to judge that would be by looking at the price of pharmaceuticals within a global marketplace, but surely that might amount to an argument for New Zealand paying more than we already are. ‘Party’ in (d) refers to agencies such as PHARMAC.

(d) ensure that the Party’s determination of the reimbursement amount for a pharmaceutical product or medical device has a transparent and verifiable basis consisting of competitive market-derived prices in the Party’s territory, or an alternative transparent and verifiable basis consisting of other benchmarks that appropriately recognize the value of the patented or generic pharmaceutical products or medical devices at issue

The thought seems to be that the prices PHARMAC negotiates should be ‘competitive market prices’ or other benchmarks that ‘appropriately recognise the value’ of pharmaceuticals or devices. Given that PHARMAC negotiates with corporations about which products they will list and at what price, why should any other price setting deliberation enter into this apart from what PHARMAC will pay and what the corporation will provide it for? There is something very counter intuitive about very powerful companies needing additional principles to strengthen their arm when it comes to negotiations and something incoherent about it being in an agreement that is ultimately supposed to be about free trade. The relationship of these principles to fairness is puzzling, the only interests promoted here are those of the pharmaceutical and health care technology companies. That’s not fairness.

Seales v Attorney General: report from the court

Wednesday, May 27th, 2015 | Colin Gavaghan | 4 Comments

Lecretia Seales’ quest to be permitted aid in dying is both tragic and important. It raises myriad legal and ethical questions. I spent the first two days of the case in Wellington High Court, listening to her legal team present their arguments. (Full disclosure: I also presented an expert witness affidavit in support of her case.)

Much of her claim centres on the NZ Bill of Rights Act, as explained by my colleague Andrew Geddis here. But the case also involves some detailed consideration of some core criminal law concepts like intent and causation.

Lecretia’s claim refers to “aid in dying” – it avoids the question-begging term “assisted suicide”; whether what she wants the right to do constitutes “suicide’ is one of the points in dispute. This “aid in dying”, though, can take two forms. As described in her claim, “administered” aid in dying (AAID) involves the direct administration of a lethal drug by a doctor. “Facilitated” aid in dying (FAID) involves the provision of the lethal drug by that doctor, but requires the final step of taking that drug to be by Lecretia herself.

The concern with AAID is that it may form the basis for a charge of culpable homicide or even murder. For that to happen, s 160 of the Crimes Act requires that the doctor must have caused death by “an unlawful act”, which is now defined as “a breach of any Act, regulation, rule, or bylaw.” 

What the “unlawful act” might be would depend on the form that the AAID took. If the doctor injected the patient with the lethal drug, the possibility has been discussed that this could constitute assault. But what if the doctor merely added the lethal agent to an IV drip that was already in place? It seems unlikely that this could be seen as the “application of force”. An alternative possibility would be “poisoning with intent to cause grievous bodily harm”.

Lecretia’s claim, though, is that, in circumstances like hers, the administration of a lethal drug does not constitute an “unlawful act” at all. This interpretation, she argues, is necessary to render the Crimes Act compliant with sections 8 and 9 of the BORA. If AAID in those circumstances does constitute an “unlawful act” for the purposes of s 160, then s 160 is inconsistent with the BORA.

What, then, of FAID? This would be dealt with under a different part of the Crimes Act. Although suicide is not a crime in New Zealand, s 179 makes it an offence to “aid or abet” someone to commit suicide. Providing someone with the means to commit suicide would violate that provision, if the assistant knew that suicide was being contemplated, and had the intent to assist.[2]

Would providing someone like Lecretia with a lethal prescription be an offence under s 179? At first glance, the answer seems obvious. But there are two reasons why things may be more complicated.

First, an act can only amount to assisting suicide if what the other party does or attempts to do amounts to “suicide.” I can’t assist you to do X if you are actually doing Y. Part of Lecretia’s argument is that ending her life in such circumstances would not amount to “suicide” for the purposes of s 179.

This may seem like a curious claim – surely we all know what “suicide” means, and we don’t need smart-alec lawyers to tell us. The Crimes Act, though, doesn’t offer a definition of “suicide”, which means that it has been left up to New Zealand courts to do so. So, last year, we had the High Court decide that a prisoner on hunger strike was not attempting suicide.

The manner in which Pankhurst J explained that decision is a bit ambiguous. At one point, he seemed to be basing it on the fact that All Means All (that was actually the prisoner’s name!) did not want or intend to die as a result of the hunger strike, but instead, to force the authorities to concede to his numerous demands. But the judge also cited with approval Lord Goff’s judgment from Bland, where he said that a refusal of treatment could never amount to suicide.

Whether it makes sense that no-one can ever commit suicide by “omission” is an interesting question. It doesn’t seem obvious that starving oneself to death would differ in any of the important ways (intention, causation, etc) from taking a lethal overdose. What’s more, if true, it would raise the potentially troubling possibility that inciting someone to do so – say, by stopping eating or foregoing their insulin – would not violate s 179. But that’s a thought to pursue another time.

For Lecretia and her team, what’s relevant is that it is already accepted that “suicide” is a term that’s open to a degree of judicial interpretation. The question is whether the interpretation she seeks would require more judicial flexibility than Collins J feels able to adopt.

There is also overseas precedent for distinguishing “suicide” as commonly understood from the sort of rational life-ending decision that Lecretia might want to take. In the USA, the 9th Circuit appeal court has recognised “a strong argument that a decision by a terminally ill patient to hasten by medical means a death that is already in process, should not be classified as suicide.” So if Collins J is persuaded to accept this distinction, he would not be the first to do so.

The alternative claim regarding FAID is that, even if Lecretia’s final act would constitute “suicide” for the purposes of s 179, the doctor providing the lethal drug would lack the requisite intent to be guilty of “assisting” her.

Again, at first glance, this may seem unlikely. But on closer analysis, this seems to me the part of the claim that may have the highest likelihood of success. It’s already well established in many jurisdictions that a doctor who administers a palliative medication that she knows might hasten a patient’s death will not necessarily be deemed to have intended that death. Such a doctor will be able to rely on the so-called doctrine of double effect, the rule that seeks to distinguish outcomes that are truly intended from those which are merely foreseen side-effects.

Whether the DDE makes an important moral distinction, or constitutes a dishonest fudge, is a matter of great debate in bioethics and law. Nonetheless, it is a defence that has been accepted in English law (albeit less commonly and less clearly than is sometimes assumed). Its status in NZ law is a bit less clear, but if it is part of our law, then it may be thought to apply as much to the doctor in the FAID situation.

As we know from Oregon, where such assistance has been legal for many years, a substantial number (more than a third) of people provided with lethal prescriptions never actually go on to use them. Many of those patients speak of the reassurance and relief they gained from knowing that the option was available should their suffering ever become unbearable. A doctor providing such a prescription may sincerely hope that the patient would never have occasion to use it. She may be confident that the patient’s symptoms could be managed to a tolerable level. Her “primary purpose” may be to provide the patient with the relief of knowing that the option was there, should worst ever come to worst.

Following the rationale of double effect, such a doctor will not have “intended’ the patient’s suicide, even though she will surely have foreseen it as a real possibility. (though interestingly not, on these statistics, a “virtual certainty”, the standard usually required to infer intent from foresight.)

Suzanne Uniacke has suggested a “test of failure” to help distinguish truly intended outcomes from those that are merely foreseen.[1] On this approach, we would ask how the doctor would feel if, having administered the analgesia, the patient actually lived. If the doctor would be pleased with that outcome, then we can say that she did not in fact intend the patient’s death. If not, if that was a disappointing outcome, then it becomes hard to argue that death was not at least part of what was intended.

The same test, I have argued, could be applied to FAID. Imagine the doctor provides her patient with a lethal prescription, hoping against hope that the patient never has to take it. As it happens, the patient is one of that 35% who dies without ever using the drug, but derives comfort from knowing that it was there. If the doctor would regard that as a good outcome, then – on Uniacke’s ”test of failure” – the patient’s suicide was not part of the doctor’s intention.

Is this approach to “intention” a bit artificial, or likely to encourage a degree of self-deception? Maybe. Maybe it would be more honest to deem everyone to have intended all of the foreseen consequences of their deliberate actions. But that doesn’t seem to be the approach that the courts favour in other end-of-life contexts.

That being so, then it does look like a strong case might exist for regarding at least some instances of such provision to lack the required mens rea for “assisting suicide.” Intriguingly, the Solicitor General seemed to accept this possibility when Collins J put it to him on Tuesday.

For Lecretia, of course, the main concern is that she is allowed a peaceful and dignified death. But however Collins J decides, it seems inevitable that the reasons for his decision will bear very close analysis.

[1] Uniacke, S. ‘The Doctrine of Double Effect.’ In Ashcroft R, Dawson A, Draper H, McMillan J, eds. Principles of Health Care Ethics (2nd ed.) Hoboken: Wiley 2007

[2] R v Tamatea (2003) 20 CRNZ 363. This case dealt with inciting and counselling suicide, which is dealt with in a different subsection, but it seems certain that similar elements would have to be present for aiding and abetting.

ICU research ethics and trials on unconscious patients

Friday, May 16th, 2014 | Grant Gillett | 3 Comments

In intensive care there are standard practices which, as is the case throughout medicine, either outstrip the best evidence for their efficacy in the conditions they are used for or are being constantly improved to increase their safety and/or efficacy. ICU specialists are activists (and therefore, in one important respect, like surgeons) and experimentalists because they deal with a constantly evolving range of conditions that have been shifted from the category of fatal to the category of seriously life threatening or potentially rescue-able. ICU also requires rapid definitive intervention often under extreme time pressure and despite considerable uncertainties about the clinical situation or the best way to treat it. Therefore it is not surprising that many of our treatments, as in crisis medicine in general and in surgery, are based on current theories about the human body and its workings and things which have been found to work in some cases but not definitely proven as effective and safe interventions. In ICU we have near total control over what goes on in the body, we have drugs to manipulate bodily physiology, we regulate breathing patterns, we induce unconsciousness, and so on. We are working by guesswork as much as and no more than in any other complex area of science but the complexities of holistic human function can sometimes confound the “knowledge” that our theories endorse (as we see in the case of alternative healing methods and things like the placebo effect).

Two examples help to make the point:

  • It is reasonable to believe that because blood carries oxygen and nutrients around the body and nature has designed the human blood system to work with a certain level of haemoglobin (Hb – the oxygen carrying protein) then maintaining a level close to that would provide optimal conditions for healing and recovery from major trauma or illness. Not so. An important study found that patients maintained at a haemoglobin level of 10-12 g/l (close to the normal values of 12-18 g/l) did worse than those who were only transfused when they dropped below 7g/l.
  • It is plausible that patients who have cardiac arrhythmias (irregularities in the heart beat) after heart attacks are at greater risk of death than others and therefore that anti-arrythmic drugs would be of benefit to such patients in terms of mitigating that risk. Indeed it seems almost unethical not to give such drugs to patients after heart attacks. However a PRCCT (Prospective Randomised Controlled Clinical Trial) of anti-arrythmics against placebos showed a totally unexpected increase death rate in the actively treated group.

In each of these cases we see that plausible theories about the human body and how it works can mislead us about whether this or that intervention is beneficial and that we can only tell whether what we fondly believe to be the right way of treating certain serious conditions is actually the best way of treating them. Thus there is a real need in ICU care (as there is in surgery) to do the trials that will show us what should be done in a given clinical situation but there is also a need to protect patients from unilateral decision-making that may put them at risk (as we saw in the Cartwright inquiry that led to a reformation in New Zealand medical ethics).

But this immediately provokes a set of questions about the need for informed consent to medical research. This need should be discussed in the light of the facts already mentioned which ground a number of substantial conclusions about research on those who cannot give consent. In fact, those conclusions are predictable from an informed discussion of advances in surgery, the need for clinical trials in modern medicine so that we all benefit from evolving and improved medical care, and the best interests of patients who cannot speak for themselves.

First, any person making choices about treatment should opt for the treatment that stands the best chance of returning him or her to health. There may, however, be specific reasons why some particular intervention is not acceptable to a person, for instance a Jehovah’s Witness patient may, on the strength of their interpretation of the Old Testament, refuse a blood transfusion. We could also imagine a person with extreme racist views not wanting an organ transplant from someone of a different race – a decision which might be abandoned when the patient is in extremis.

Second, it is rational for any patient to accept the best available treatment according to the current state of knowledge at the time of their illness and contemporary clinical care particularly in academic hospitals, recognises this is the prevailing standard of treatment. But it is quite possible that an ideally informed clinician would be unable to decide between a currently accepted standard treatment and a suggested modification or innovation. In such a case the doctor does not know whether the treatment proposed for a given patient at a given time is the best thing to do or whether what is being trialled may be a whole lot better (given that safety assessments have been done). Therefore, looking at it from the patient’s point of view, the patient has no reason to opt for the standard treatment rather than any other of the possibilities on offer. In fact the patient, considering that he and others like him may require further treatment at a later date, has a definite interest in his doctors getting to know as much as possible about his condition, and making well-considered judgments about his management as he undergoes it. This is most likely to happen in the context of a well-designed scientific trial (where the patient is guaranteed to get treatment equal to the currently accepted standard of care).

Now, given that a treatment in ICU is only trialled if it is unclear whether a new treatment actually offers more benefit to patients than the existing ones, it follows that it is a matter of indifference, ethically speaking, which of the two arms of a clinical trial (the treatment arm – where something new is tried, or the control arm – where standard treatment is used) any given patient is assigned to. For this reason it is best, on the grounds of self-interest or care of the patient – for an ICU patient to be enrolled in a trial of treatment where a sensible question can be asked about how he ought to be treated.

Third, it would be in accordance with good care and the best interests of patients, more broadly conceived, for people to want to contribute to medical knowledge in conditions of uncertainty. This is almost self-evident because it is always good for a health care system to be extending and using knowledge about the patient and his problem and there are real benefits to a patient in being cared for by a medical system in which active clinical research is going on. Indeed, given that there is a certain amount of community feeling in all of us, we should all want the members of our community to benefit from lessons learnt when misfortune befalls any of us if we can be sure that gaining that knowledge will not increase the risks of clinical treatment. In retrospect, of course, it may turn out that patients enrolled in one or other arm of a study (sometimes the opposite one to that expected) have been disadvantaged by the clinical trial but that fact cannot be known at the time of enrolment and the dangers continue to exist until the relevant facts are discovered.

Therefore we should conclude that clinical research trials of treatment in ICU exposes no patient to any extra risk over and above those that exist for them in virtue of their eligibility for the trial and that the cessation of that research means that they and their fellow citizens will probably be exposed to unnecessary risks in the future.

Fourth, it is reasonable to assume that everybody has some altruism, however limited, and that it should be encouraged by ethicists for the following reasons.

  1. Most people have a positive interest in the well-being of the fellow members of their community and in the best treatment being used in the care of the community.
  2. Where someone stands to gain by a community practice such as best ICU care and the research that supports we should support and participate in it.
  3. We all recognise that altruism is something to which, in our best moments, we aspire so it does no harm to assume that people should be treated in a way that reflects their values (unless that decision involves forgoing one’s own objective best interests). Therefore we should enrol each other in properly conducted trials of ICU research even without consent.

Fifth, relatives are often badly placed to make life and death decisions as has been objectively demonstrated and is easy to understand. All the uncertainties associated with life and death decisions cluster around every conversation between an ICU team and relatives. In addition to the informational turmoil there is an emotional cauldron – some feel shocked, others guilty, yet others protective. So a mortal decision must be made; the context is heavily overlaid by technology, the power of the medical establishment, and urgency; and there are often conflicted feelings so that it is unrealistic to believe that anything like informed consent can prevail. In reality, we can only hope for a sensitive and supportive partnership between the clinical team and the patient’s whanau and a climate in which a duty of care is clearly thought through.

Sixth, clinical staff have a duty to make the best decisions for any given patient, to be suitably sensitive to the realistic interests, concerns, fears and expectations of ordinary folk (and not be influenced by distorting factors such as extreme right to life or euthanasia views, the fear of litigation, or financial gain). That implies that the best chance of getting soundly researched clinical care in an area of medicine where intuitions and theory based reasoning can both mislead even the best of well-intentioned clinicians is if we continue to enrol unconscious patients in clinical trials.

Therefore it is best for the clinical team looking after you to make a plan for your management if you are incompetent and your life is in danger. It is clear that in ethical terms, this should be the default position with disputed cases being arbitrated by some suitably impartial body such as an ethics committee and with the courts being used only when, here as elsewhere in medical care, things cannot be managed in a better way. In any event, we can commend, in ethical terms, the general practice of doing ICU research under the condition that the clinical team, acting in good conscience, can enter their patients into well designed trials, even where informed consent prior to entry into the trial cannot be obtained.

Grant Gillett

Coaches and doctors need to recognise when they are vulnerable to “win or else” pressure

Tuesday, February 4th, 2014 | Lynley Anderson | No Comments

Originally posted on the BJSM Blog

John Orchard’s recent blog On Andre Villas-Boas, the unreasonable pressure on coaches/managers, and why player health should be in clinician’s hands’, raises some interesting points for debate. Dr Orchard laments that decisions regarding return to play following concussion were made by a coach who is ‘forced by the nature of the job to think in the short term’. Orchard says that coaches are under “ridiculous pressure to win”, and so cannot be trusted to have the long term welfare of players in mind. Furthermore, he believes that the typically short term nature of a coach’s job (that is, they may be sacked if their team is not successful) compromises their decision-making about issues of player safety – as a result, Orchard believes that coaches should not be involved in decision making about return to play from concussion lest they put players at risk of long term harm.

We wish to expand upon Orchard’s useful and provocative contributions by making several points for consideration. Firstly, we think that Orchard gives the impression (perhaps unintentionally) that coaches such as Andreas Vilas-Boas can either try to win, or can be concerned about player safety – but are unable to do both. We believe that this describes a false dilemma for coaches. The pressure to win is certainly a factor that places coaches in a potentially vulnerable state when it comes to player safety – there are going to be circumstances where this vulnerability is heightened and, if not managed appropriately, lead to harm. But implying that the “win or else” pressure precludes coaches from having any concern about player health and welfare is perhaps not the most accurate or useful way of viewing things. Giving the impression that it is not within the scope of a coach’s obligations to care about player safety may be even more detrimental to player safety. If coaches are absolved of any obligations to the health and safety of players they may see this as encouragement to push the envelope further in their decision making in the belief that it is simply someone else’s job to tell them when they’ve gone too far.

Secondly, it is not surprising that Orchard thinks return to play decisions should be the domain of the team doctor because they ‘are in a position to think longer term with respect to the player’s health later in life’. Those in charge of football teams (and perhaps even those in charge of entire football leagues) could be accused of wanting to have it both ways when it comes to team doctors. On the one hand they want access to medical expertise when it comes to optimising performance and treating injuries because such expertise may facilitate winning. Furthermore, cynics might consider that the involvement of medical professionals allows coaches and administrators to trot out the well-worn line that “the player’s welfare and safety are paramount” – if nothing else, it makes for good PR to concerned mums and dads. But in the event that those medical professionals provide recommendations that do not facilitate the team achieving its goals (or may hinder their achievement), then some coaches and administrators may be apt to ignore such expertise or seek to circumvent it. This appears to be Orchard’s concern too.

Our point is that, team doctors can’t have it both ways either. Given the obligations and goals of coaches, Orchard says that team doctors need greater scope to say who can and can’t play, and that there is a need to redress “the power imbalance on match day between the coaching and medical staff”. In other words, doctors should be the ones with the final say on return to play, and doctors should be the ones to tell coaches when they’ve gone too far. There may be good reasons for this, but we can’t forget that team doctors (like coaches) have many conflicting pressures too – from their patient, the coach, their employer, and perhaps even their medical colleagues.1,2  Not all of these stakeholders necessarily have aligning interests when it comes to each case of injury. Orchard’s call for allowing team doctors longer assessment times seems like a sensible proposal, but it doesn’t eliminate the potential for the assessor to be swayed by these conflicting pressures – just like coaches. So Orchard’s solution is fairly neat, as long as we assume that team doctors are the only stakeholders who are immune to external pressures on decision making! Player welfare is a stated priority for all stakeholders, but Orchard’s most recent post creates the impression that coaches will always lean towards winning over player safety, but no team doctor ever will. We saw this as curious because we agreed with Orchard’s earlier blog post ‘Concussion, risk assessment, and practical steps to reform’, where he suggested that doctors are indeed at risk of losing their job if they do not toe the party line.

In that post, Orchard calculated the chance of the Tottenham medical team being sacked at 1 in 5 to 1 in 20, noting that the risk is ‘demonstrably lower than the manager but far higher than a colleague working in the NHS’. He goes on to state that:

… this level of risk becomes lower if they all “stick solid” with the manager on the decision to return the player to the field and much more likely if a public statement was made to the media along the lines of “the medical team requested that the player be substituted for safety reasons but the manager over-ruled us.”

The message is that members of the medical team are also vulnerable to losing their job and might tailor their medical advice or decision-making to please those who determine whether or not they retain their job.  Doctors are best placed to medically assess a concussion injury, BUT team doctors may not always feel able to make a call that goes against the wishes of the coach and their decision making may involve a compromise between what is in the athlete’s best interest and what is in their own. This raises doubts about the independence of team doctors and places them in a similar position to coaches – a point that seemed lost in Orchard’s most recent blog post.

Furthermore, in a blog post from March 2012 Orchard relayed how coaching staff at the NRL club he was working for made it clear that they would not refer potentially concussed players to him for assessment if there was a chance he would exclude them from further play. Whether or not this ever occurred is unclear, but it clearly made Orchard uncomfortable. Interestingly, when interviewed in 2012, the chief medical officer of the National Rugby League (NRL) implied that team doctors do not have any conflicts of interest affecting their decision-making about concussion:

“There have been questions about whether club doctors have a conflict of interest because they are being paid by the clubs … their number one priority is the welfare of the player. They will always make the right decision by him.” (quoted in Prichard 2012).

Echoing this sentiment, a co-author of the Australian Football League’s concussion management guidelines also appeared to discount the influence of third parties by claiming that team doctors only ever make clinical decisions with their obligation to the player in mind:

”I may be idealistic, I may be wrong, but my feeling is that the guys are going to follow what they’ve been doing which is making sure players are safe. … You have very experienced doctors working in the AFL … we’re not going to be doing anything that compromises or risks player welfare.” (quoted Lane 2011).

Orchard has raised some important concerns for the care of athletes and been refreshingly frank in confronting ethical issues facing team doctors – in this post we have sought to clarify some of these issues. There is a need for good research to elucidate the mechanisms that make coaches and medical support staff more vulnerable to decisions with the potential to compromise the wellbeing of players.  This will help develop strategies for managing these issues.

References

1.              Partridge, B. (2013). Dazed and confused: Sports medicine, conflicts of interest and concussion management. Journal of Bioethical Inquiry. DOI: 10.1007/s11673-013-9491-2

2.              Anderson, L., & Jackson, S. (2013). Competing loyalties in sports medicine: Threats to medical professionalism in elite, commercial sport. International Review for the Sociology of Sport, 48(2), 238-256.

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Dr Lynley Anderson is a Senior Lecturer at the Bioethics Centre, Division of Health Sciences University of Otago

Dr. Brad Partridge is a NHMRC Research Fellow at the UQ Centre for Clinical Research, The University of Queensland

 

Fluoridation on trial

Tuesday, November 26th, 2013 | Mike King | 1 Comment

The South Taranaki District Council decision to fluoridate the water supplies of Patea and Waverly is being questioned through judicial review by New Health New Zealand (NHNZ). Among other things, NHNZ claims that addition of fluoride to public water supply breaches the New Zealand Bill of Rights Act (1990) S11, which states “Everyone has the right to refuse to undergo any medical treatment.”

In order to complete this argument they must defend the premises that (1) fluoridation of water is a medical treatment under the Act, and (2) that consumption of fluoridated water from the public supply cannot be refused in the relevant sense.

Neither premise is straightforwardly acceptable. Is fluoridation a medical treatment like vaccination or merely a health-promoting (setting aside claims to the contrary) mineral like iron? When it is present in water without being an additive, is it still a treatment? If so, is eating a balanced diet a medical treatment because it promotes good health? If fluoride is harmful to health as anti-fluoride campaigners seem to think, is elimination of it from the water supply a medical treatment? Medical treatment is not, it seems to me, a well-defined category and I don’t see compelling reasons on either side. However, I think clearer and more decisive debate can be had in other aspects of the argument.

Paradigmatic medical treatment is individualisable and the effect of the right to refuse it primarily accrues to the right holder directly. My right to refuse the surgery you recommend for me allows me to forgo something done to me, and the benefit or cost of forgoing it accrues to me in the first instance. The fluoridation in this case (if it is a medical treatment at all) is a treatment deployed at the public level rather than that of the individual, so it cannot easily be distributed to all and only those who want it. Nevertheless, one can exercise a right of refusal by obtaining the water one desires elsewhere (such as by filtration, bottled non-fluoridated water, or if you live in Dunedin going to the Speights Brewery and filling as many containers as you like from the tap outside). Exercising the right in this way is primarily self-regarding and is quite compatible with the liberal, individualist foundations of the right. Given this, premise 2 (that fluoride cannot cannot be refused) looks false.

But it seems that the argument being made is that the public health measure in its entirety must be abolished. This seems like claiming that a human right to refuse oxygen is best asserted by eliminating earth’s atmosphere rather than the holding one’s breath. Given that abolishing fluoride is not required by the right to refuse treatment, this line of argument seems in need of further justification. In fact, it suggests that a separate right needs to be asserted by the anti-fluoride campaigners: that they have a claim-right to a non-fluoridated public water supply, and the council has a duty to provide it by halting fluoridation (and removing any naturally occurring fluoride?). I haven’t heard it reported that this is part of the case being made by NHNZ, and I have no idea whether there is a legal means available for asserting such a right.

Given this description, it might be possible to cast the situation as fundamentally a clash of claim-rights between those with sufficiently strong interests in fluoridated and non-fluoridated public water supplies, respectively, which justify holding the council to a duty to provide it. Since it can’t do both, in these cases, and other things being equal, it is best to choose the option that minimises the overriding of rights. Or jettisoning the rights-talk, choosing the option that satisfies the greatest weight of interests. Given recent referenda, this seems to be to continue with fluoridation provided those who want to refuse have the ability to satisfy their preference for non-fluoridated water by other means.

It is worth noting that other things are not necessarily equal, in that dental health is often worse in those in society with the least, and it is for these people that fluoride seems to be of greatest benefit. To the extent that one cares about reducing health inequalities by improving the welfare of the worst off, this gives a further reason not to reduce access to this public health measure.

News coverage of the case:

 

Gareth Jones and Maja Whitaker on anatomists’ use of unclaimed cadavers

Thursday, November 21st, 2013 | Mike King | No Comments

Emily Bazelon has a piece in Slate on the history and present of unclaimed cadaver use in anatomy. This is a topic that Gareth Jones and Maja Whitaker have written on extensively, and Bazelon makes use of their work, and email communication with Gareth, in the piece. Here’s a sample:

As Jones and Whitaker write, “There will always be tension between obtaining a satisfactory range of acceptable human material both for teaching and research, and abiding by demanding ethical standards.” The field of anatomy has long failed to get the balance right. That helps explain what went so wrong among the anatomists of Nazi Germany. “It is deeply unfortunate that they belonged to a discipline that at that time gave little thought to ethics (a criticism that applied for many years after the 1940s in any country),” Jones wrote to me. “Consequently they were operating in an ethos that allowed for appallingly unethical behavior. This in no way justifies any of their practices, but if anatomy as a discipline had been radically different, at least some of the horrors of this corner of Nazi atrocities may not have taken place.”

More of Jones and Whitaker’s analysis can be found in:

Jones, D. G. (2011). The anatomy museum and mental illness: The centrality of informed consent. In C. Coleborne & D. MacKinnon (Eds.), Exhibiting madness in museums: Remembering psychiatry through collections and display (pp. 161-177). New York: Routledge.

Jones, D. G., & Whitaker, M. I. (2012). Anatomy’s use of unclaimed bodies: Reasons against continued dependence on an ethically dubious practice. Clinical Anatomy, 25(2), 246-254. doi: 10.1002/ca.21223

Jones, D. G., & Whitaker, M. I. (2009). Speaking for the dead: The human body in biology and medicine (2nd ed.). Farnham, UK: Ashgate, 296p.

 

 

Colin Gavaghan on law and policy for emerging technologies

Tuesday, September 10th, 2013 | Mike King | No Comments

Nice long interview by Kathryn Ryan on Radio New Zealand National with Colin Gavaghan, Associate Professor in the University of Otago’s Faculty of Law and Affiliate of the Bioethics Centre. The interview is wide-ranging, covering general desiderata for law and policy regulating emerging technologies, as well as specific issues arising from regulation of nanotechnologies and the internet.

RNZ interview with Colin Gavaghan

Andrew Moore on animal use for safety testing of party pills

Friday, August 30th, 2013 | Mike King | 1 Comment

Andrew Moore, Associate Professor in the Department of Philosophy and Bioethics Centre Affiliate, comments on the justification for use of animals in safety testing of party pills in this report on Radio New Zealand National.

The relevant section of the Psychoactive Substances Act 2013 can be found here.

Andrew Moore on animal testing of party pills

Edit: Link corrected, thanks John!

The clinician’s dilemma: Two dimensions of ethical care

Tuesday, July 16th, 2013 | Grant Gillett | No Comments

There is a continuing intense medico–ethico–legal debate around legalized euthanasia and physician assisted suicide such that ethically informed clinicians often agree with the arguments but feel hesitant about the conclusion, especially when it may bring about a change in law. We trace this confusion and its roots in the convergence of two continua that underpin the conduct of a clinician and are especially prominent in psychiatry. The two continua concern the duty of care and the importance of patient autonomy and they do not quite map into traditional divides in debates about sanctity of life, paternalism, and autonomy. As ethical dimensions, they come into sharp focus in psychiatric disorders but also in the psychological complexities of end-of-life care and they form two key factors in most ethical and legal or disciplinary deliberations about a clinician’s actions.Whereas both dimensions are important when a clinician reflects on what s/he has done or should do, they need careful balancing in patient care in psychiatry and also in any request for euthanasia or physician assisted suicide or generally where the patient seems to want to take a decisive role in his or her own end-of-life care. Because both psychiatry and end-of-life care are situations where clinicians often encounter ‘cries for help’  both continua are importantly in play in both areas of clinical care. Balancing these two continua without using blunt legal instruments is often required in psychiatric care in such a way as to problematize the idea that patient decisions should dominate the care options available. A simplistic approach to that issue arguably plays into what has been called an ‘impoverished construction of life and death’ and, some would say, devalues the basic commitments fundamental to medical care.

Gillett, G. and Chamberlain, J. The clinician’s dilemma: Two dimensions of ethical care. International Journal of Law and Psychiatry, doi: 10.1016/j.ijlp.2013.06.017 (in press)

 

What we owe the psychopath: a neuroethical analysis.

Friday, June 28th, 2013 | Grant Gillett | No Comments

Psychopaths are often regarded as a scourge of contemporary society and, as such, are the focus of much public vilification and outrage. But all psychopaths begin as children at the mercy of a social context so that psychopaths are both sinned against as well as sinners. If that is true, then their status as the victims of abusive subcultures which are created in a certain socio-historico-political context partially mitigates their moral responsibility for the harms they cause. These affect their brain development as well as their psychology and may compound vulnerabilities they inherit with their genetic endowment. We argue, from the neuroethics of psychopathy and antisocial personality disorder (ASPD), that the communities that have produced them have occurred a moral obligation to psychopaths as well as a case against them. A reflection on the genesis and developmental epidemiology of psychopathy reveals that we blame the individuals or their families  in ways that do not stack up against the dire statistics relating to indigenous and immigrant populations in so called developed societies with their highly individualist approaches to life and the law. The attribution-type error (the tendency to locate problems within the psychology of individuals) evident in much Western psychological and legal thinking—has a tendency to obscure important moral truths about psychopaths and their development. An analysis that criticizes this style of thinking and looks carefully at the combination of nature and nurture that produces criminal behaviour makes us reconsider the distinction between disorders and moral failings and the ethical significance of the biological or neurocognitive mechanisms underpinning psychopathy. We claim that casting aside the deficit model (based on the presupposition that psychopaths are intrinsically unlike the rest of us) in favor of a relational and holistic view of personality potentiates a more informed and inclusive set of ethical, forensic, and therapeutic attitudes towards this unpopular and troubling group of human beings.

‘What We Owe the Psychopath: A Neuroethical Analysis’ Grant Gillett, Jiaochen Huang, AJOB Neuroscience, 4(2): 3–9, 2013.

 
 
 

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