#1707 - Claxton And Cuyler Wickedness Or Folly - Medical Law

Claxton and Cuyler - Wickedness or Folly?

Affordable of cost effective?

• We are not clear that describing a drug as one “we simply cannot afford” is really different or more acceptable than saying it is “not cost effective”

  • it seems to us natural to suppose that “unaffordable” means no more than that the costs exceed the benefits—that is, we choose to buy something else instead of the thing in question.

    • In the context of NICE and the NHS, this means that the estimated health benefits that could be gained from the technology are less than those estimated to be forgone by other patients,

      • as other procedures are necessarily curtailed or not undertaken

    • It has nothing specifically to do with QALYs.

      • It would remain unavoidable even if the currency of advantage offered by health care were expressed in terms of providing opportunities to benefit, as suggested by Harris,

        • or any other measure of the good done by health care

• Patients with Alzheimer’s disease are (probably) not cost effective to treat with these drugs, because other patients would (probably) get greater benefits from the use of the resources spent by the NHS to acquire the drugs to treat Alzheimer’s disease. (

  • To put it in a brutal fashion after Harris’s style, “the drugs are not worth it”, not “the patients are not worth it”. The worth of the patients is not in question.

    • To describe a procedure as not sufficiently worthwhile is not synonymous with the statement that these patients are “not worth helping”; it is simply the inexorable consequence of the principle of using resources in the most effective known ways to promote people’s health.

      • Nor is this the same as saying “the amount of better life expectancy they provide to these patients is not worth having for society”;

        • rather, it is saying that all patients are to be counted as members of the society that NICE seeks to serve

    • But serving the whole of society requires NICE to take account of the alternative uses to which resources, including drug budgets, can be put.

      • To use a budget to extract the last ounce of benefit for one patient group no matter what benefits were thereby denied to other patients being served by the same budget

        • can hardly be considered to serve the needs of the whole of society.

      • So, Harris may retort, “increase the drugs budget”, to which the further retort is, of course, “at the expense of what other health benefit for which other patients?”

        • The retort to this may be, “increase the NHS budget”. Again, “at the expense of what other benefit to what other group in society?”

Evaluating procedures, not patients

• At various points throughout both editorials, Harris attaches moral significance to a distinction between evaluating treatments and evaluating patients.

  • Such a distinction indeed exists and, as we have indicated earlier, the methods of cost-effectiveness analysis do not evaluate patients but rather they evaluate treatments

  • Now, it goes without saying that all healthcare procedures exist for the care of patients with particular indications and characteristics. It is trivial to point out that one drug may be safe and effective for one group of patients but either completely ineffective or positively dangerous for another

    • Procedures can be evaluated only when they are used for particular patients. So, inevitably, we compare the worth of alternative procedures in terms of the consequences their use has for patients.

      • Patient welfare is the ultimate purpose of it all. But this is not the same as evaluating the worth of patients.

        • At most it can be said to be evaluating their capacity to benefit from the use of the procedures

          • and—one of the ultimately difficult tasks—evaluating one group’s ability to benefit compared with that of another

• Harris contradicts himself in simultaneously holding that NICE should not evaluate pateints

  • and then suggesting that health care ought to be allocated such that all have equal opportunities of benefiting.

    • To do this would certainly require an assessment of which patients can benefit from what procedures and which patients cannot or would be positively harmed.

    • This is also apparent in his suggestion that in vitro fertilisation should be made available to all who have a significant chance of pregnancy.

      • This would require someone to specify what is meant by “significant” and then to identify the groups of patients that met this criterion and those that did not—

        • precisely the type of evaluation of procedures applied to particular patients that Harris describes as contrary to basic morality and human rights

QALYs?

• First of all QALYs are used b/c they are simple to deploy, but NICE recommends departures from the standard assumptions underlying QALYs when they are considered to be inappropriate in a particular case

  • While the measure certainly remains imperfect and, although this is true, it is not particularly more true of QALYs than of any other empirical measure.

    • One has simply to make a judgement on whether it is good enough for the purposes at hand.

    • The main difference between QALYs and kindred indices and other measures lay in the explicitness with which the method identified the necessity of making value judgements and enabled them to be debated

No alternative treatment?

• In the second part of the statement, Harris asserts that this procedure is inappropriate when one alternative under consideration is not to offer a disease-modifying treatment. For example, if we were to interpret the low-cost less-effective alternative A as “no treatment” or “best supportive care”, then Harris would not accept the comparison of the health gain offered by B with the opportunity costs as an appropriate way of deciding whether treatment B was worthwhile. It appears that what Harris objects to is not the use of health gain as a measure of the good of healthcare, or even to QALYs as a measure of that health gain, but to the consistent application of these principles when one of the alternatives under consideration is not to offer disease-modifying treatment, but (say) best...