• by: |
  • 05/07/2007
Recently Congress considered adding cost-effectiveness as a criterion for selecting and paying for medicines under Medicare.

This model (variously called “evidence-based medicine,” “healthcare technology assessment,” or "comparative effectiveness”) relies heavily on findings from randomized clinical trials. While these trials are essential to demonstrating the safety and efficacy of new medical products, the results are based on large population averages that rarely if ever will tell us which treatments are “best” for which patients. That is why it is so critically important for the physician to maintain his or her ability to combine study findings with their expertise and knowledge of the individual in order to make the optimal treatment decisions.

Government sponsored studies that conduct head-to-head comparisons of drugs in "real world’"clinical settings are regarded as a valuable source of information for such coverage and reimbursement decisions -- if not for making clinical decisions. Two such studies, the Clinical Antipsychotic Trials in Intervention Effectiveness or CATIE study and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were two such “practice based” clinical trials, sponsored in part by the National Institutes of Health, to determine whether older medicines were as effective in achieving certain clinical outcomes as newer ones.

While media reports and the government agencies that sponsored the studies claimed that “older and cheaper” were equally effective, these conclusions were not without critics or controversy.

The Center for Medicine in the Public Interest held a day long conference on Media, Medicine and the Public Interest in Washington DC on January 26, 2007 that included an expert panel on the conduct and implications of CATIE and ALLHAT.

And when we say "expert" we mean "expert." Panelists included Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University, and Matt Herper of Forbes.

The panel was chaired by Kate Rawson, senior editor of th RPM Report, who also edited the panel transcripts.

Here is a link to the paper, ALLHAT and CATIE Reconsidered: Reflections on Big Studies and Evidence Based Medicine as the Measure of Comparative Effectiveness.

Download file

Thoughts and comments most welcome.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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