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L. Ross Pierce, MD; Diane K. Wysowski, PhD; Thomas P. Gross, MD, MPH
Food and Drug Administration Rockville, Md

JAMA. 1990;264(23):2992.

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In Reply.—

We agree with Dr Goldstein that our article illustrates that drug therapy to modulate lipoproteins is not without risk and that the apparent benefits and risks to populations studied for short periods prior to drug approval may not be reliable in predicting benefit and risk over the long haul. The report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults¹ places limited emphasis on age and sex of hypercholesterolemic patients in suggesting approaches to drug treatment. This report has been criticized for extrapolating prevention trial results from middleaged men to the rest of the adult population, because substantive data on the effects of lipid-regulating drug treatment on cardiovascular events in other populations are lacking.^2,3 We agree that long-term intervention trials of adequate size and power to address both cardiovascular efficacy and overall safety in the . . . [Full Text PDF of this Article]

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