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In our view, value-based frameworks highlighting overall cost-effectiveness are most attractive because cost-effectiveness provides a common scale for comparing products. However, cost-effectiveness analysis is an incomplete tool and doesn't convey all of a drug's salient characteristics. More work is needed to determine how best to consider factors such as adverse events and ancillary benefits that matter to patients alongside cost-effectiveness ratios. Online tools that help stakeholders assign weights to drug characteristics — akin to the MSKCC approach — would be welcome.
Fourth, the frameworks either ignore a drug's overall budget impact (ACC–AHA) or handle it inadequately. NCCN rates “affordability” on a scale of 1 to 5 without explaining the basis for those scores. ASCO lists cost as one of the factors considered but does not combine it with its point score. ICER adjusts a drug's price benchmark to meet cost-effectiveness requirements. It also limits each drug's budget impact to no more than $904 million annually (an amount that ICER estimates would hold growth of total drug costs below the growth rate of the gross domestic product plus 1%, taking into account the number of new drugs approved each year). Although ICER discusses various ways to address budget impact, including reducing spending on other priorities, it has in practice focused on price reductions. For example, its recent evaluation of PCSK9 inhibitors approved for controlling cholesterol levels called for reducing their price from more than $14,000 to $2,177 per year. ICER deserves credit for explicitly introducing budget constraints into value assessments, but reducing a drug's price to satisfy a specific budget criterion isn't always appropriate. For example, ICER's budget criterion might dissuade companies from developing drugs designed to help large portions of the population.
Although some of these approaches are designed to incorporate user preferences, the overall score or recommended price produced may be inconsistent with those preferences. For example, ASCO's approach awards up to 80 points for a drug's effect on survival (or, in the absence of that information, its effect on surrogate end points such as response rate). On the basis of the drug's toxicity, it adds or subtracts up to 20 more points, and then adds up to 30 more points depending on the drug's palliative benefits and whether it statistically increases the time that patients can remain off all therapy. But summing arbitrarily derived values associated with different dimensions does not necessarily produce a coherent overall score. An analogy would be a scheme to measure a car's value by adding its safety rating — on a scale of 1 to 10 — to its passenger capacity and gas mileage. A meaningful score should instead account for how much gas mileage buyers would sacrifice to gain an additional seat and how much safety they would sacrifice to increase gas mileage.
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Whether the desired sensation comes in the form of energy, a means of relaxation, or pain reduction, many people go to great lengths and present their bodies to threatening conditions in order to achieve this euphoric “high.” Unfortunately, the use of these drugs very often comes with dangerous side effects that users must learn to manage with for the rest of their life.
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There are many aspects of the drug war from Mexico and other Latin American states which have effects on United States policy as well as policies from other countries that participate in the global suppression of illegal drugs.
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As mentioned above, the presence of control, or even perceived control, is one of the most important predictors of adverse behavioral effects. Subjects who perceive that they have control over the noise show significantly greater tolerance for frustration than subjects without control, even if the control is never exercised (Glass and Singer, 1972). In a recent experiment, Singer and his colleagues found that subjects who there told that they had control of an A-weighted, 103-dB noise stimulus showed significantly greater persistence on a difficult task than subjects who had no control or subjects that had control for only part of the experiment (Singer et al., 1990). This finding occurred despite the fact that the subjects with only partial control reported feelings of control no different from those with full control. To the extent that these findings can be generalized to populations living in noisy areas, this kind of research may have significant sociological implications.
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Noise has been implicated in the development or exacerbation of a variety of health problems, ranging from hypertension to psychosis. Some of these findings are based on carefully controlled laboratory or field research, but many others are the products of studies that have been severely criticized by the research community. In either case, obtaining valid data can be very difficult because of the myriad of intervening variables that must be controlled, such as age, selection bias, preexisting health conditions, diet, smoking habits, alcohol consumption, socioeconomic status, exposure to other agents, and environmental and social stressors. Additional difficulties lie in the interpretation of the findings, especially those involving acute effects. For example, if noise raises blood pressure on a temporary basis, will prolonged exposure produce permanent changes? In cases where these effects are permanent but slight, what are the long-term implications? These types of questions and problems have caused this particular area of noise research and criteria development to be very controversial.