The Rule of Rescue and Healthcare in Crisis
Sometime ago I wrote a piece on my policy blog on HTA and NICE (see here: http://www.tremblay-consulting.biz/?p=49). This had to do with the NICE view that the NHS Cancer Drug Fund should not pay for drugs NICE had rejected. The conclusion is logical but only if you are satisfied that the NICE reasoning exhausts the argument, which I doubt.
NICE, now, is to review of its methods. Things on their mind include:
- dealing with uncertainty, indeed whether it can be quantified and how it can be reduced;
- how quality of life is incorporated into assessments;
- costings and equality considerations;
- topic selection criteria, and others.
In my original blog post, I noted that while NICE is tasked with parsing the performance of medicines and clinical practice, they are not above challenge. The issues they propose to review will I believe raise the need to determine where NICE models ‘break’, i.e. where the logic fails. One question is whether NICE believes it methods are universal in application or suffer from ‘discontinuities’.
For many people, some of NICE’s rulings fly in the face of our beliefs as humans if not logic. But we do some things when logical models break because not to act is morally wrong.
If we think of the challenges NICE faces it is evident that their logic is just one way of deciding and choosing. It is to their credit that they want to maintain an up-to-dated-ness, but it is also incumbent on critics to recognise that NICE is, itself, working within a particular paradigm, that values quantification as the preferred way of dealing with ambiguity, vagueness and ethics.
My view is that NICE has a troublesome relationship with the notion of ‘rule of rescue’ and so has decided to ignore it. There replacement, the “end-of-life premium” is one solution, which has been found wanting certainly by Cookson.
In my original blog post, I focused on the rule of rescue because it has particular public policy implications. It can be thought of as a meta-rule — it is a rule that tells us if other rules are working properly and in the context of the nine other methods Cookson examines, can be determining of how those are interpreted in policy.
The rule is often invoked in a particular form: that people facing death should be treated regardless of cost. The rule as originally formulated is really about assisting identifiable individuals facing avoidable death (Jonson, 1986). The bioethicists and economists have shifted this to a cost-effectiveness approach, making it one about trade-offs instead, indeed, an example of the needs of the many outweigh the needs of the individual (remember Star Trek?).
The rule of rescue has a new-born flip side: the cost of saving a premature baby may exceed the total taxes that individual might pay over the course of their lifetime. Is that how we want to think of situations like this? Is that the sort of society we want to live in?
If there is an end-of-life premium, there is no doubt a beginning-of-life premium too. Think about this and see what a consistent response, yes or no, either way means to you.
The problem for healthcare systems is that all patients are becoming identifiable in the ethical sense and as medicines become personalised. All diseases may in the end be genetically unique and possibly rare and all medicines may become orphan drugs.
The problem for state-run systems that do not offer opt-outs to other sources of funding for treatment, is they do not allow such people to rescue themselves. Doesn’t this fly in the face in our beliefs that all people are worthy of respect and their humanity cannot be diluted by administrative practices, such as HTA assessments? It is also, for some a short hop from people could rescue themselves to people ought to rescue themselves, achieving in effect a complete moral opt-out from any collective or social action, particularly for those who cannot rescue themselves. The dreaded is/ought strikes again!
Sticking to the NHS since this is NICE’s focus, individuals have no other public options so the NHS must be the healthcare system of last resort and therefore of rescue, otherwise, identified individuals are destined to a death sanctioned by public policy. Is that a policy or healthcare system worth having?
The rule of rescue sets a tough standard to meet. So it is natural to ask why should specific classes of individuals, qua patients, be given preferential treatment as against any other group?
The moral dilemma that the economists at NICE are trying to reduce to an equation is whether a new therapy is extending life, or delaying death — the problem is that we don’t know how to assess this.
We can visualise the various policy options (using a Wilson matrix) to summarise the four basic positions for NICE. Which option for policy do you like? For those not familiar with Wilson, the matrix is explained like this: concentrated costs/benefits are individuals, while diffuse is society, without reference to any particular individual. When benefits and costs are concentrated, only those who pay for something get the benefit (like a private country club membership; when benefits and costs are universal, we all pay and we all benefit but no one keeps score. The diagnonal (upper right/lower left) is the zone of serious political interest. When costs are concentrated and benefits universal we have a NIMBY situation: you pay for having the toxic waste disposal in your community while society at large benefits; when costs are universal and benefits concentrated, you have the free-rider issue of some people getting benefits for which they have not paid. I leave you to think about issues that interest you to think this one through.
The matrix looks like this is a simplified form:
The Oregon approach collapsed when the hard choices emerged and people were unable to resolve this dilemma, which is not a quantitative issue, but one of how we value our humanity. Kierkegaard’s Concluding Unscientific Postscript speaks of the leap to faith as involving self-reflection and the emergence of scepticism.
One hopes that NICE will take that thought to heart.
Postscript: What does this mean for pharmaceutical companies, patient groups and payers?
I would argue that NICE’s decisions must pass not just various analytical tests based on evidence, but also social tests that could challenge whether the quantitative evidence out-weighs other considerations. It does not advance a critique of a NICE decision to challenge the methodology alone as that is a close box system such as are they making a Type error. While it may make some folks uncomfortable to have tough science challenged by ethics, it is worth remembering that there is along history of ethics and science in conflict and how individuals reflected on their moral culpability for their scientific work. I think Oppenheimer said it best with the first atomic bomb detonation, quoting the Bhagavad-Gita: “Now I am become Death, the destroyer of worlds”.
Pandemic Postscript
The public / government response to the pandemic has broadly worked on the costs of the pandemic being universally distributed as much as possible (everybody is at risk and everybody experiences comparable restrictions) while the benefits are collective, that Covid will be contained, no second wave and then there will be a vaccine.
Not all countries or societies have seen the pandemic this way. Some have seen this as a matter of restrictions on individual freedom, and rejected the costs (restriction of freedom), while likely benefiting from the policy which will likely protect them (others wear masks and take precautions). These are classic free riders.
Further reading
Cookson R, McCabe C, Tsuchiya A. Public healthcare resource allocation and the Rule of Rescue. J Med Ethics. 2008 Jan 7 [cited 2014 Sep 4];34(7):540–4.
Jonsen, AR 1986, Bentham in a box: technology assessment and health care allocation, Law, Medicine and Health Care, Vol 14, pp172–4.
Kierkegaard S, Concluding Unscientific Postscript, Princeton, 1996.
Richardson J, McKie J. The rule of rescue, working paper 112, Centre for Health Program Evaluation, Monash University
