The Lack of Studies

There are a small number of recent studies looking at the issue of cost-effectiveness and cost utility. Barriers to performing such studies include, but are not limited to lack of sponsorship; (2) cooperative group efforts to accrue large enough sample sizes to detect the small differences seen; and (3) the lack of glamour associated with studies that seek to limit resource utilization and possibly come to uncomfortable conclusions regarding how to ration health care.

These studies generate little enthusiasm as they require large patient populations to detect relatively small differences in cost-effectiveness, and there are rarely additional funds to support them. Cooperative groups are more interested in spending money on trials of new therapies than showing cost-effectiveness (partly because there is no ready market for the results), and sponsors are not willing to spend money that puts their product at risk. Several pharmacoeconomic trials that made perfect sense to perform in the cooperative group setting, based on preliminary data, generated no support. The first suggested trial tested 2 mg/kg filgrastim instead of 5 mg/kg filgrastim for prevention of neutropenia, based on a small randomized trial that showed equivalence.22,23 The second trial would have used bisphosphonates to prevent skeletal complications from metastatic breast cancer every 3 months rather than monthly, as monthly pamidronate had a cost-effectiveness ratio outside the usually accepted bounds.24 Both trials were turned down by the cooperative group for similar reasons: the job of the cooperative group is to cure cancer, not to save money; someone else should concentrate on saving money; and there are more important questions to answer from the same budget. Drug or device companies may not have much reason to do this, either: the only aspect of a large randomized clinical trial in cancer pain management24 that was not funded by the company was the cost-effective analysis.

Comfort levels of this type of healthcare rationing may also depend on where a clinician practices. In general, Americans spend more on heroic end-of-life intervention than their European counterparts, who are more likely to divert healthcare dollars into preventive strategies. In the United States, more than 20% of all medical expenditures are spent on the last year of a patient's life.25

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