Take sustainability serious in healthcare to avoid harming future patients!

 

In a brand new blog post at the BMJ Journal of Medical Ethics blog, me, Davide Fumagalli and Erik Malmqvist write about a severe ethical challenge for healthcare systems that arises due to structural deficiencies in established systems for healthcare resource allocation: 

 Most countries with publicly funded healthcare systems have ethically informed priority setting schemes to decide how to allocate scarce resources. Established principles in such schemes recognise patients’ need of care, the effects of interventions, and background requirements of equal consideration and cost-effectiveness. However, the typical use of such schemes is alarmingly short-sighted, systematically allowing the future resource base of healthcare to be undermined. In short: our way of helping current patients is systematically exposing future patients to serious harm and risk.

As a remedy, we propose that a sustainability principle is added to estableshed ethical framworks that govern this central aspect of health policy. Read more about the challenge, as well as our proposal over at the JME blog!

 

New article online: Conscientious Refusal in Healthcare: The Swedish Solution

Indeed, as flagged before, I have a new article published online in the Journal of Medical Ethics on the topic of the Sweden's longstanding policy on conscientious objection by health professionals. I briefly describe the policy and its background and chart some recent challenges to it.

The published article, which is to be included in a coming special issue on conscientious objection, is here.

Preprints for free reading and download those of you who lack institutional access to the JME are here and here.

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Consensus statement on conscientious objection in healthcare

  

  

Just a very brief pointer to this post at the Oxford Practical Ethics blog, showcasing a consensus statement on how states and health systems should handle the phenomenon of healthcare staff conscientiously objecting to practices included in medical practice that comes out of the symposium on this very topic that I related in a recent post.

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Conscientious refusal / objection in health care: new article draft online, and an upcoming symposium

A while back, I made a post with a number of critical remarks on the idea of a legal right of health care professionals to so-called conscientious refusal/objection. That is the idea that such professionals should enjoy a guaranteed exemption from the standard labour law rule, that employee's are obliged to carry out legal instructions of their employer, in cases when they object to the practice they are instructed to carry out, or its legal status. I made the post mainly to get some opinions of particular relevance to current health care policy off my chest, but as it turned out, these ideas have attracted attention within the international community of more systematic research undertaken in this area.

First, the post lead to an invitation to contribute to a coming special issue of the journal Cambridge Quarterly of Health Care Ethics, guest edited by Alberto Giubilini and Julian Savulescu, on the very subject of the ethics of conscientious objection/refusal in health care.

Second, I was invited to contribute to a symposium on the same topic at the Brocher Foundation in Geneva in  June this year, organised once again by Julian, now in collaboration with Sharyn Milnes. My contribution to the symposium is entitled "All or nothing: The legal, ethical and jurisprudential basis of legal rights to conscientious objection of voluntarily employed professionals", and the contribution to the special issue also focus on the combination of ethical and legal reasons in this area.

The work on this article has been undertaken in collaboration with my Danish colleague Morten Ebbe Juul Nielsen, who made contact almost immediately when the blog post was online to suggest that we collaborate, as he had been thinking along the lines of some of the central points of the post already, and had started to scan the relevant literature in more detail. Said and done, the first result of our efforts, the submitted draft manuscript to the mentioned special issue, entitled "The Legal Ethical Backbone of Conscientious Refusal",  can now be viewed online here and here. As this submitted manuscript is undergoing review and will almost certainly be subject to revision, me and Morten are happy to receive any sort of constructive comments.

Addendum Re. Using Medical Methods to Determine the Age of Unaccompanied Refugee Children

After my post on this issue a few days ago, I've debated the issue with a number of people from within medicine and also bioethics in different fora.

Due to the presence of significant uncertainties of the methods debated, my suggestion was that use of this methods should be amended by the following methodological rule (assuming 18 to be the age of adulthood, if it is different we may simply insert another variable for that):

... for any method, M, for the assessment of the age of a person, P, with a margin of error +/- X years, M is taken to indicate adulthood if, and only if, its result is 18+X years or higher, and otherwise taken to indicate childhood

Here are a few points that may be added to the complexities of this particular issue:

1. The nature of the uncertanties
Some have argued to me that the methods are not only uncertain in a way possible to describe in terms of a margin of error. One reason for this put to me is that besides the usual margin of error within the dimension of a variable, there is also the background confidence interval behind this margin, and the known effect of having this confidence deteriorate considerably when aggregated population probabilities are projected onto individual cases. I, of course, do not deny that there is also this source of uncertainty, but as far as I can see, my formula above can easily include that: X can be the aggregation of both these uncertainties (this was my original thought as well). This probably means that X becomes considerably larger than 4 (the number used in the example in the original post, based on claims by critics of the model). However, this in no way undermines my suggestion, as this will probably mean that all unaccompanied refugee children will most likely be determined to be children (and, if there are any people like that, in addition a number of refugee adults who falsely claim to be children). That is, the best interest of children, as well as the proper priority of legal provisions is upheld. Suppose, for instance, that the margin of error, accounting for all sources of uncertainty, becomes +/- 15 years. Then my rule says that P is to be considered an adult if, and only if, M finds P to be 33 years or more.

Another claim has been that some of the methods depend on the existence of relevant tables and charts or background data, and that such are missing in this case, meaning that the methods are not really uncertain, there is no method at all. The bewildering thing is that the same people are at the same time officially repeating the argument that the methods are uncertain and have unacceptably wide margins of error. These two claims are, of course, inconsistent; if it's not possible to have any result at all, there is no margin of error, and if there is a margin of error there is some results that create this margin. If it turns out that, in fact, the variable X (accounting for all kinds of sources of uncertainty), cannot be given any empirically based numerical estimate, I concede that my rule is inapplicable. However, if even an interval numerical estimate can be grounded, my rule can be used, by simply adding (supported by the same basic principles as before) that, the high extreme of this interval should be used to define X (in order to err in the right direction). Again, this may mean that the method will determine all tested as children, but, as already argued, it is difficult to see what the ethical or legal problem with that would be.

2. Professional Health Care Ethics and Ethics
Another aspect that has been raised is the fact that my suggestions means that health care professionals pragmatically accommodate to flawed public policies in the best interest of concerned parties (i.e. the children). This is wrong, some say, health care professionals should demand to regulate themselves and never do anything they themselves collegially don't find suitable to do, not even if this is harming third parties. Some have even gone so far at to claim that it is irresponsible of a health care professional to ever act the slightest in any other interest than his or her patient's.

The latter would, of course, mean that we would have to abandon all public health practices, communicable disease management, forensic medicine, large segments of insurance and sports medicine, and not least the involvement of doctors in issuing certificates underlying decisions by public authorities, such as sick leave or work-related disability benefits, and so on. Since health care professional organisations have as yet made no move whatsoever in such directions, I trust that this is not the line underlying the criticism in the present case. In other words, formalised professional health care ethics already accepts a number of cases where medical methods are used to other ends than the best interest of patients and many of these uses are being pragmatically accommodated to still make the best out of an imperfect thing. A very clear illustration is the assessment of "ability to work" nowadays made routinely by medical doctors in many countries, strategically adapted not to harm their patients while still abiding by required formalities.

It is thus unclear to what extent the principle of never doing anything to right the wrongs of public policies is a part of professional health care ethics. Even more unclear is if, had it been such a part, it would have been ethically defensible. To illustrate with the issue at hand, suppose that the health care professional community was to refuse to participate in the practice decided by the Swedish government. This may have three outcomes: (a) the government and parliament creates a legal room for some other class of officials to use the methods (not using my rule), (b) no method is used, (c) alternative suggested methods based on psychological models are used.

• If (c) is the outcome, the issue reappears, as also these methods can be expected to have margins of error, sources of uncertainty and so on. Then my rule can be used to secure that determinations err in the right direction.

• If (a) is the outcome, the results for the persons concerned, namely the children, is worse than if the profession had chosen to participate, using my rule to secure that they act solely in the best interest of the children, although also accommodating societal requests.

• If (b) is the outcome, the situation stands that unaccompanied refugee children where there is uncertainty as to whether or not they are children, will not be given their rights as children.

Now, compare this with (d): health professionals decide to pragmatically accommodate, and use the methods, amended by my rule.

• If (d) is the outcome, the concerned children's interests and Sweden's legal needs are better served than if any of (a) and (b). If these children are seen as patients, it would then be in their best interest to go for (d) rather than (a) or (b). If there is an option (c), this is even better, provided that my rule is used, but if not it may be better for the patients to go for (d).

3. The Ethics of Clean Hands, Politics of Power and Professional Integrity as Strategic Tool
Against this form of reasoning, some debaters I've talked to have claimed that the downsides for refugee children of the options (a) and (b) (as well as (c) without my rule) cannot be laid at the door of health professionals, but is the sole moral responsibility of the government. That is, they apply the standard of an "ethics of clean hands", denouncing responsibility for bad outcomes they could have avoided by acting differently just because the same is true of some other acting party (here, the government). This is like when the car driver, displeased with the rule that gives pedestrians priority at crosswalks, blames the government while electing to run people over, who cross motivated by the rule. Not very splendid ethics, I'd say.

Another version of this reasoning instead comes in the form of a political power bidding in the name of professional autonomy. It is simply the claim that health professionals should insist on the right to decide for themselves what standards they act on. While this is understandable (we all would like the privilege not to give a damn about the opinions of others, don't we?), it either comes without any underlying defense, or is compatible with sometimes choosing to compromise with other parts, interests and powers in society. As mentioned, the latter seems what in fact is happening in a number of areas, so then the question moves to what reasons pro or contra are present in the area at hand. Here, I have argued that (d) is the superior position.

The same outcome seems to ensue when analysing a final (and, to my view, better) variant of this sort of argument. Instead of an empty insistence on professional autonomy at all cost, this argument points to the political importance of professional integrity as a strategic tool in certain areas. The most obvious of these are torture, capital punishment and military interrogation. Here, the profession has adopted zero tolerance policies, which are thought to have an accumulated preventive effect, as these practices in various ways "need" the participation of doctors. However, this point does not demonstrate that age determination of unaccompanied refugee children belongs to this set of absolutely prohibited practices. As those who criticise the presently proposed methods also say that they could accept methods with a better degree of precision and exactness, it doesn't seem that they are trying to argue this in the present case. Which is understandable, as that would mean arguing against any claim to special considerations of the interests and rights of children.

In sum, therefore, unless it is demonstrated that there is no method at all that could produce any sort of empirically grounded numerical estimate (even in the form of a wide interval) in this area, my suggestion holds up to scrutiny. In fact, it is better supported by both professional health care ethics and more general ethical analysis, than alternative suggestions.

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The NHS "Care.Data" Disgrace Continues: Up to 700 Thousand Patients' Requests to Opt Out Actively Ignored

Remember the Care.Data project in the UK, whereby NHS patients' medical records are supposed to be made available against a handsome fee – often not fully anonymised – to private business interests, which may many times clash with those of patients? If not, read the background story here, here, and here. There are a great many reasons why this project is faulty at its very roots (all explained in the above links), but one of the things that have been a basic rot the whole way is Care.Data's utter disregard for basic medical ethical principles, as for patient basic rights. The apparently deeply dysfunctional  Care.Data organisation Health and Social Care Information Centre (HSCIC) started out by trying to plainly ignore any claim to a right of patients to decline having their medical records sold to business interests or other third parties. When that didn't swing and the HSCIC was forced to supply patients with an opt out opportunity, they did their very, very best to cloak it from patient attention and impede access to what was in reality a simple straightforward exercise of filling out a form. It also surfaced that HSCIC in the meantime obviously didn't give a damn about patient consent and rights, as it was caught with its pants down having prematurely shared patient data with private insurance companies. Simultaneously, unsurprisingly, private pharma industry have been shown to enact heavy pressure, bordering on trying to incite bona fide corruption, on the HSCIC to provide "easy access" to Care.Data. This, apparently, was the last straw for governing bodies, and the Care.Data plan "was shelved" in March 2014. Later the same year the General Practioners' Committee (GPC) voted to demand a complete change to the Care.Data set-up, making it opt-in, in the meantime opting patients out of the scheme by default due to lack of trust in the HSCIC and Care-Data organisation, while  working actively to make patients aware of what Care.Data amounts to and their right to opt out of it, as well as into it. In August 2014 it was revealed that plans to relaunch the scheme have been forced to be abandoned due to the continuous problems to have Care.Data fit even basic standards of law and ethics.

Now, in today's Guardian, it reported (also here, here) that the HSCIC chair Kingsley Manning, in a letter to the House of Commons health select committee this February, has been pressed to admit to MP's that up to 700 000 patient requests to opt out of the Care.Data scheme were never logged, and thereby actively ignored by the Care.Data organisation, thus effecting sharing of their medical records with private business parties against these patients explicitly and lawfully expressed and legally protected wants before the shut down in March 2014.

The GPC lead on Care.Data issues Dr Beth McCarron-Nash is reported to to have characterised the Care.Data organisation: "basically it's a mess". Leader of data protection advocacy Phil Booth summed up the gist of the revelation neatly:

The material fact is, hundreds of thousands of people, last January, February, March, exercised their right to opt out of having their data passed on by the HSCIC, and that has not been respected.

 Meanwhile the HSCIC chair is reported to have ...

... told MPs that it “does not currently have the resources or processes to handle such a significant level of objection” and it also encountered technical issues over logging the preferences. /.../ [and] admitted it “may take some time” to resolve the issue.

As I said, the whole Care.Data setup is simply extremely badly thought up from the start, and its main organisation HSCIC is now admitted by its own head to be both dysfunctional and incompetent to carry out even the most elementary task to have the scheme meet even the most paramount of requirements for ever being fit for operation. In spite of this, it has went along and made Care.Data operative, thus violating hundreds of thousands of patients legal and ethical rights. If there ever were reasons to make the obvious decision to put the Care.Data freak out of its misery for good, it is now plain for all to see. Go back to the drawing-board with basic ethics and law at the forefront and do better. In the meantime, humbly (as I know UK law too bad to be specific), I suggest that leading Care.Data and HSCIC officials should be legally investigated and possibly charged with complicity in what has been revealed. For surely, it has to be in breach of some legal statute in the UK to just hand out people's medical records to third parties in spite of their legally submitted denial of the right to do so (?).

New Book on the Ethics of Screening in Health Care and Medicine

So, once again, some self-promotion, but this time not only, since the new book I'm plugging in this way is the result of a truly collaborative enterprise with Niklas Juth, senior lecturer in medical ethics at the Karolinska Institute. Published by Springer, the title of this book is The Ethics of Screening in Health Care and Medicine: Serving Society or Serving the Patient?

 To quote the summary:

Medical or health-oriented screening programs are amongst the most debated aspects of health care and public health practices in health care and public health ethics, as well as health policy discussions. In spite of this, most treatments of screening in the research literature restrict themselves to isolated scientific aspects, sometimes complemented by economic analyses or loose speculations regarding policy aspects. At the same time, recent advances in medical genetics and technology, as well as a rapidly growing societal focus on public health concerns, inspires an increase in suggested or recently started screening programs.

This book involves an in-depth analysis of the ethical, political and philosophical issues related to health-oriented screening programs. It explores the considerations that arise when heath care interacts with other societal institutions on a large scale, as is the case with screening: What values may be promoted or compromised by screening programs? What conflicts of values do typically arise – both internally and in relation to the goals of health care, on the one hand, and the goals of public health and the general society, on the other? What aspects of screening are relevant for determining whether it should be undertaken or not and how it should be organised in order to remain defensible? What implications does the ethics of screening have for health care ethics as a whole?

These questions are addressed by applying philosophical methods of conceptual analysis, as well as models and theories from moral and political philosophy, medical ethics, and public health ethics, to a large number of ongoing and proposed screening programs which makes this book the first comprehensive work on the ethics of screening. Analyses and suggestions are made that are of potential interest to health care staff, medical researchers, policy makers and the general public.

The book is available for purchase via its homepage, linked to above, and as e-book via its Springerlink page, where there is opportunity to sample the contents, parts of chapters, bibliography and the index. More generous sampling is accessible through Google books. Note, that if you are a student, academic, health care professional or official or policy maker, it may very well be the case that you can access a free e-book copy through a library (e.g., your university library) that subscribes to Springerlink!

Myriads of Indecency: Ruling Against Patenting Cancer Genes Makes Scientific, Legal and Ethical Sense

Addendum 2014-04-25: I have updated some of the links and an image below, since Myriad has now updated its site. Still the same moonshine, just a slightly polished bottle.

The decision of a US federal judge to rule against the patenting of the BRCA-1 and BRCA-2 genes this Monday came as a pleasant surprise after a period of several years when the ability to patent human genome segments within the US legal context has been taken for granted. The ruling - a result of the efforts of the American Civil Liberties Union in conjunction with the Association for Molecular Pathology, individual women and others - was, of course, not welcomed by the commercial company Myriad Genetics, which during the period when it thought it had its patent rights secured has been pestering genetic health service providers in the US and around the world with their absurd claims (by implied threats of massive compensation suits) to world monopoly on predictive genetic testing for breast and ovarian cancer, alternatively the cashing in of handsome licensing fees.

Just a quick browsing of the Myriad Genetics website tells you that this company embodies just about everything bioethics researchers have been warning for in connection to the commercialisation of genetic testing since the late 1980's. The University of Utah Research Foundation that held the claimed patent together with Myriad - and that may be assumed to have been cashing in handsomely as a passive partner - should be held equally, if not more, accountable for this attempt to undercut sound business law, decent health care ethical standards, scientific progress and, not least, the health of those people belonging to families burdened by hereditary cancer, whose access to the preventive opportunities offered through genetic testing, and forthcoming advances of medical research, has been undercut. But back to the poverty of Myriad Genetics.

To take just one example of this moral morass, Myriad offers predictive genetic testing for hereditary melanoma - a disease for which the actual risk figure is never given at the Myriad website. Clicking this product, you are immediately told that "Changes in the p16 gene increase cancer risk, making a melanoma diagnosis up to 50 times more likely by age 50", which of course tells you absolutely nothing about what risk of melanoma you actually run before the age of 50 if you have the indicated genetic mutation, but for most people convey the impression that a mutation makes your risk of contracting melanoma before 50 an even game. Clicking further on to the page supposed to give you an in-depth background to hereditary melanoma, you're exposed to the following explanation. Take a minute or so to read it!

Having that horrible mutation must make for a helluva risk, doesn't it? Actually: no! Even considering that the people involved in Myriad are presumably not proper clinical doctors (if they were, AMA would have revoked their licenses by now, right? - I'm being charitable to the US medical profession here), but a bunch of lab rats and business executives, this is as close to actual fraud you can get without actually committing it in the strict legal sense. Remember that nice graph you just saw? Its Y-axis measures not the actual risk of contracting melanoma, but - again! - the change in risk compared to what risk of contracting melanoma you would run were you a random member of the general population. But the impression of the picture is not that - the impression is - once again - that if you carry the mutation you run a 50/50 risk. This message is cleverly conveyed by the sinister manner in which the general population risk figure is illustrated in the graph. That blue staple to the left of the tall purple one seems to reach up to the 1 of the Y-axis, right? It's 1% - right? Or something close to 1%? Actually, no! Have a closer look at the graph:

It is "< 1%" = "less than one percent", i.e.the risk is not given. It could be 0.99%, it could be 0.0000000000000000000001% For all we know based on the information provided, the 50% increased risk may thus equal a 0.0000000000000000000002% risk. Who knows? Obviously not Myriad Genetics - or can they really be consciously hiding highly relevant facts from potential customers??
Just to get some perspective, hereditary melanoma is what geneticists refer to as a multi-factorial disease, i.e. it occurs as a result of the interaction between several genetic mutations and the environment. The p16 test offered by Myriad targets just one among many different genes where a mutation may increase the risk for melanoma. This should be conveyed by the explanatory leaflets downloadable from here, but is not explicitly mentioned with one word and not in the presentation of this test either. So, suppose your test negative in a "comprehensive" Melaris test, what Myriad so handsomely calls "no mutation detected" - this is compatible with you carrying any of the other known genetic mutations of other genes that increase the risk of melanoma, what Myriad refers to as the risk being "not ruled out". It would be interesting indeed to have melanoma or cancer patient organisations trying out that concept in US civil courts (in which case, the University of Utah Research Foundation must, of course, be included in the lawsuit)!

Hopefully, the ruling against patenting actual genes or naturally occurring genetic mutations will undercut the sour-tasting business of Myriad Genetics and other similar companies. For one thing, as a legal precedent, it has the potential of putting a stop to attempts of making ethically well-motivated and responsibly handled predictive genetic testing offered by national health services - for instance for colon-, breast- and ovarian cancer - unnecessary expensive and thus accessible for more people at risk. From a moral point of view, it is thus most welcome. From a legal point of view as well, since what judge Robert Sweet argues in the ruling, "...the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter" has been obvious to anyone from the outset interested in applying actual patent law, rather than laying the foundation for a new branch of business. If Myriad has a unique procedure to detect DNA, they may patent that, of course, but do they? It remains to be seen, but my guess is that they use the same state of the art science and technology as does any molecular genetic research lab, and that they knew very well that their only chance to make a buck was attempting the patenting of DNA trick.

The only defense offered by Myriad's and the UURF's lawyer was that patenting genes promotes "innovation" and therefore promotes health. False. In fact, the patent claims on BRCA-1 and BRCA-2 has made medical research based on these genes that may lead to deeper understanding of the mechanisms of these forms of cancer, and thus to newer and better treatments, slower and/or more expensive. Patents have the potential of furthering innovation only when all of the basic scientific work has been done (until then, the scientific principle of openness, free sharing, access and use of information is far superior), and in the case of human genetics, identifying genes connected to disease-groups is just the first letter of the first name of that long process. When Myriad says "innovation" they mean business and so does - shame on them - the UURF.