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November 5, 1997

Investigational Treatments: Process, Payment, and Priorities

Author Affiliations

Medical College of Georgia Augusta

JAMA. 1997;278(17):1403. doi:10.1001/jama.1997.03550170033021

To the Editor.  —In his article on investigational treatments, Dr Eddy1 describes "the minimum evidence required to provide physicians and patients with the information they need to determine how the treatment will affect the patient's outcomes." In addition, he asserts that "denial of coverage is one of the few barriers that delays the dissemination of procedures, tests, and off-label uses of drugs before their effectiveness can be determined."Who should make these determinations? Eddy states that the evidence should be "sufficient to enable appropriately trained, motivated, and impartial people to draw conclusions about the magnitude of the effects." The determination of payment (ie, access) for standard treatments or tests that have proven efficacy, much less the determination of investigational status, is frequently in the purview of health insurance and health maintenance companies. These sources can hardly be deemed "impartial" and, in most states, are free of medicolegal liability for their decisions. In effect

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