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Elaine Wyllie, MD; A. David Rothner, MD; C. E. Pippenger, PhD
The Cleveland (Ohio) Clinic Foundation

JAMA. 1989;261(17):2499.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

In Reply. —

We presented the events of our case honestly and completely, just as they occurred, and our report passed a critical peer review before publication. Most important, the Food and Drug Administration investigation provided no new evidence to alter the reported critical facts in the case.

The key issues in our report were that our patient had been taking Mysoline (Ayerst Laboratories, New York, NY) for 13 days before the October 1985 hospital admission, that serum primidone and phenobarbital concentrations were adequate at the time of that admission, and that serum drug concentrations dropped dramatically during hospitalization, with no other plausible cause than the switch to generic medication. These facts remained firm after the Food and Drug Administration investigation and are dated clearly in the medical record just as they were reported in our article. No relevant or important information was excluded from our published report. Eventually, after . . . [Full Text PDF of this Article]

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