| 2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research | |||||||||||||||||||||||
| FDA Comment Number : | EC12 | ||||||||||||||||||||||
| Submitter : | Mr. Stewart Ferry | Date & Time: | 05/11/2004 06:05:33 | ||||||||||||||||||||
| Organization : | California Neuroalliance | ||||||||||||||||||||||
| Consumer Group | |||||||||||||||||||||||
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| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| Health outcomes research should consider the full range of health care interventions and evaluate total health care costs or savings over the length of a treatment horizon, not just the costs of specific treatments.
Patients have unique medical needs that are not reflected in population-level research. Government health outcomes research should be just one tool to inform doctor-patient decision-making. Clinical judgment and patient choice, within the bounds of acceptable medical practice, must always be the overriding force in decisions about individual care. | |||||||||||||||||||||||