Decision Analysis and FDA Drug Review: A Proposal for Shadow Advisory Committees

The FDA seems to acknowledge that sometimes different standards of proof for assessing drug efficacy should be used. Dr. Mendeloff thus proposes a methodology that might illuminate the FDA\u27s decision-making and help better to assess its decisions

The social value of a QALY : raising the bar or barring the raise?

Background: Since the inception of the National Institute for Health and Clinical Excellence (NICE) in England, there have been questions about the empirical basis for the cost-per-QALY threshold used by NICE and whether QALYs gained by different beneficiaries of health care should be weighted equally. The Social Value of a QALY (SVQ) project, reported in this paper, was commissioned to address these two questions. The results of SVQ were released during a time of considerable debate about the NICE threshold, and authors with differing perspectives have drawn on the SVQ results to support their cases. As these discussions continue, and given the selective use of results by those involved, it is important, therefore, not only to present a summary overview of SVQ, but also for those who conducted the research to contribute to the debate as to its implications for NICE. Discussion: The issue of the threshold was addressed in two ways: first, by combining, via a set of models, the current UK Value of a Prevented Fatality (used in transport policy) with data on fatality age, life expectancy and age-related quality of life; and, second, via a survey designed to test the feasibility of combining respondents’ answers to willingness to pay and health state utility questions to arrive at values of a QALY. Modelling resulted in values of £10,000-£70,000 per QALY. Via survey research, most methods of aggregating the data resulted in values of a QALY of £18,000-£40,000, although others resulted in implausibly high values. An additional survey, addressing the issue of weighting QALYs, used two methods, one indicating that QALYs should not be weighted and the other that greater weight could be given to QALYs gained by some groups. Summary: Although we conducted only a feasibility study and a modelling exercise, neither present compelling evidence for moving the NICE threshold up or down. Some preliminary evidence would indicate it could be moved up for some types of QALY and down for others. While many members of the public appear to be open to the possibility of using somewhat different QALY weights for different groups of beneficiaries, we do not yet have any secure evidence base for introducing such a system

Individualized Cost-Effectiveness Analysis

John Ioannidis and Alan Garber discuss how to use incremental cost-effectiveness ratios (ICER) and related metrics so they can be useful for decision-making at the individual level, whether used by clinicians or individual patients

The Declining Effects of OSHA Inspections on Manufacturing Injuries, 1979 to 1998

This study examines the impact of OSHA inspections on injuries in manufacturing plants. The authors use the same model and some of the same plant-level data employed by several earlier studies that found large effects of OSHA inspections on injuries for 1979–85. These new estimates indicate that an OSHA inspection imposing a penalty reduced lost-workday injuries by about 19% in 1979–85, but that this effect fell to 11% in 1987–91, and to a statistically insignificant 1% in 1992–98. The authors cannot fully explain this overall decline, which they find for nearly all subgroups they examine—by inspection type, establishment size, and industry, for example. Among other findings are that, across the years studied, inspections with penalties were more effective than those without, and the effects on injury rates were greater in smaller plants and nonunion plants than in large plants and union plants