Yet another Ersatz World: The ICER Final Evidence Report for Additive Cardiovascular Therapies

Previous commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the lack of credibility in modeled claims for cost-effectiveness and associated recommendations for pricing by the Institute for Clinical and Economic Review (ICER). The principal objection to ICER reports has been that their modeled claims fail the standards of normal science: they are best seen as pseudoscience. The purpose of this latest commentary is to consider the recently released ICER report for Additive Cardiovascular Disease therapies. This report should not be taken seriously in its claims for cost-effectiveness and pricing in cardiovascular disease (CVD). The analytical framework applied by ICER fails to meet the standards of normal science in demarcating science from pseudoscience. Irrespective of the value judgements and recommendations of an ICER report, these lack credibility. They were never intended to be evaluable and replicable across treatment settings. The claims made are constructed, driven by assumption, and should be put to one side by health system decision makers. In this review the focus is on to the ICER modeled estimates of utility scores in CVD, the insistence on utilizing a generic utility algorithm (the EQ-5D-3L) and the consequent quality adjusted life year (QALY) estimates. Two issues are raised that will be the subject of future commentaries: the lack of appreciation of fundamental measurement and (ii) the importance of the patient voice in benefit claims. Given the importance in the ICER methodology of QALYS, the ad hoc nature of the ordinal utilities introduced to the cardiovascular model must raise concerns over the role the ICER evidence report may play in health care decision-making. These concerns extend to the claim by ICER that, on ICER’s own affordability threshold for individual new molecular entities, the anticipated uptake of these therapies may raise questions of overall affordability. Again, we are dealing with an arbitrary construct that may adversely impact patient access. Article Type: Commentary

Introducing the architectus

Vitruvius prioritizes the ideal architectus over the ars architectonica and thus also restricts access to the body of architecture. The architectus embodies architecture, but he becomes complete only through a “well-rounded” course of training in various disciplines, which Vitruvius likens to a corpus. This encyclios disciplina has recalled the artes liberales for many readers, who imagine that Vitruvius invokes these disciplines to “elevate” architecture or indeed Vitruvius himself. Yet it is also clear that architecture was already viewed as intellectually meticulous. By creating an asymmetry between his training (multidisciplinary but moderate) and his influence (extending even to the products of all other arts), Vitruvius creates a gap reminiscent of a similar disparity that characterizes the ideal orator in Cicero’s De oratore. Vitruvius recreates the ebb and flow of De oratore in order to put architecture in competition with the oratory as the best sort of civic knowledge. Of special importance is that both Vitruvius and Cicero demur on whether their disciplines were true “arts,” recalling the principal objection leveled by Socrates against rhetoric in Gorgias. Cicero effectively sidesteps these issues by negating the possibility of a Roman ars oratoris and by insisting instead on oratory’s embodiment. Vitruvius’s architectus also becomes a distinctively Roman master of signs and representation, precisely because he embodies architecture. Vitruvius’s account ultimately differs from that of Cicero, however. Whereas the orator’s attention to decorum proved his suitability as an ambitious leader in the interest of the republican civitas, the training of the architectus ultimately ensures that he will faithfully (but not obsequiously) serve the princeps.

Hume and the Common Sense Philosophers

Hume anticipated the principal objection that the Scottish common sense philosophers would have to his scepticism. In An Enquiry concerning Human Understanding he sought to make it clear that the scepticism of the Treatise was not conceived of as a scepticism that would affect everyday life. It was not a scepticism that would destabilize moral and other practical beliefs. The common sense philosophers misrepresented Hume’s scepticism insofar as they failed to grasp this point, and therefore failed to grasp the crucial difference between Hume’s scepticism and ancient scepticism. Despite this misunderstanding on their part, common sense philosophers like Campbell and Reid were taken seriously by Hume. The fact that he did not respond in detail to their criticisms is not evidence that he thought them philosophically incompetent.

The European Model of Transnational Democracy: A Tribute to Ernst-Wolfgang Böckenförde

Ernst-Wolfgang Böckenförde is one of the most eminent German constitutional theorists of the twentieth century. The following article connects with two themes that reappear in Böckenförde's writings. The first theme, which Böckenförde actually borrowed from Hermann Heller, is that democracy presupposes “relative homogeneity.” The second theme is that there would not be any principal objection against Europe growing into a nation state.

Reid's response to Hume's perceptual relativity argument

Reid declared Hume's appeal to variation in the magnitude of a table with distance to be the best argument that had ever been offered for the ‘ideal hypothesis’ that we experience nothing but our own mental states. Reid's principal objection to this argument fails to apply to minimally visible points. He did establish that we have reason to take our perceptions to be caused by external objects. But his case that we directly perceive external objects is undermined by what Hume had to say about the role played by color in our perception of the primary qualities of bodies.

Forebrain mechanisms of dreaming are activated from a variety of sources

The central question facing sleep and dream science today seems to be: What is the physiological basis of the subset of NREM dreams that are qualitatively indistinguishable from REM dreams (“apex dreams”)? Two competing answers have emerged: (1) all apex dreams are generated by REM sleep control mechanisms, albeit sometimes covertly; and (2) all such dreams are generated by forebrain mechanisms, independently of classical pontine sleep-cycle control mechanisms. The principal objection to the first answer is that it lacks evidential support. The principal objection to the second answer (which is articulated in my target article) is that it takes inadequate account of interactions that surely exist between the putative forebrain mechanisms and the well established brainstem mechanisms of conscious state control. My main response to this objection (elaborated below) is that it conflates nonspecific brainstem modulation – which supports consciousness in general – with a specific pontine mechanism that is supposed to generate apex dreaming in particular. The latter mechanism is in fact neither necessary nor sufficient for apex dreaming. The putative forebrain mechanisms, by contrast, are necessary for apex dreaming (although they are nor sufficient, in the limited sense that all conscious states of the forebrain are modulated by the brainstem).

Preserving Property: History, Genealogy, and Inheritance in “Upon Appleton House”*

“I hope that they may live to see the power of the King and the Lords thrown down, that yet may live to see property preserved.”— Colonel Petty at Putney, 28 October 1647 (Woodhouse, 61)The famous army debates held at Putney in 1647 provide us with some remarkable insights into the misgivings of the men who were soon to bring about the trial and execution of their king. Their very practical need to placate the then powerful “Leveller” faction within the army drew the “Grandees” into talks which clearly reveal the limits of their revolutionary aspirations. The principal objection of both Oliver Cromwell and Henry Ireton to the proposals of the Levellers is also the most telling: both men saw in the proposed Leveller constitution, The Agreement of the People, a threat to the current economic order, an order based upon the ownership of property by a relatively small number of men.

Wittgenstein and Religious Belief

I find myself in profound disagreement with Wittgenstein's philosophy of religion and hence in disagreement also with those philosophers who have undertaken to elaborate and defend Wittgenstein's position. My principal objection is to the idea that religion is a language-game (or perhaps that each religion is a language-game) and that because of the kind of language-game it is, religious believers are not to be thought of as necessarily harbouring beliefs about the world over and above their secular beliefs. I reject this position, not because I think that there are language-games and that religion happens not to be one, but because I find the very idea of a language-game to be indefensible. Put another way, I find myself out of sympathy with the recent idea that in philosophy of religion we ought to be discussing something called ‘religious language’ or ‘the kind of language involved in religious beliefs’.

In Reply: Indications of Operations in Craniostenosis

Dr. Freeman's principal objection is that the morbidity rate of 14% is too high for a purely cosmetic operation. We would like to redirect attention to Table III on page 834, where the complications are tabulated so that their significance may be fully appreciated. May we again emphasize that of all 519 patients, 2 have died as the result of their surgery, and only 3 have anything undesirable to show as a complication of the surgery.

Drug Distribution by Mail; Prescription by TV

The communication of Dr. Joel J. Alpert which appears in the April issue of Pediatrics (37:700, 1966) bears notice by all physicians. The danger of freely sending medications via unsolicited mail to both the layman and the doctor is very likely to be quite underestimated. Even one life is too high a price to pay! My principal objection beyond the danger of poisoning is the usurping of prescribing medicines from the physician to the mailman and the TV set.