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Sir: The background research to support the claims of Drs. Kruszewski and Klotz begins and ends with the manufacturer’s package insert. However, the manufacturer’s package insert is neither a standard of care nor the most comprehensive and upto-date review of the preclinical or clinical science about a molecule. Were that so, new knowledge or findings would never be able to be conveyed to the field until the company or the U.S. Food and Drug Administration (FDA) determined to alter the manufacturer’s package insert.’ ‹