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April 16, 1997

Bioequivalence of Levothyroxine Preparations: Industry Sponsorship and Academic Freedom

Author Affiliations

President Knoll Pharmaceutical Company Parsippany, NJ

JAMA. 1997;277(15):1200. doi:10.1001/jama.1997.03540390030021

To the Editor.  —Knoll Pharmaceutical Company appreciates the opportunity to comment on the study by Dr Dong and colleagues.1In 1987, Knoll's predecessor, Flint Laboratories, entered into an agreement with Dong and colleagues to study 4 levothyroxine preparations, including Flint's Synthroid (levothyroxine sodium tablets) brand. The protocol included a provision that "all data obtained by the investigator... is also considered confidential and is not to be published or otherwise released without written permission from Flint...." In April 1989, while the study was ongoing, the company communicated concerns about the study's execution to Dong and colleagues. Despite repeated requests, we were unable to reach agreement with the investigators on the resolution of these concerns. We did not withdraw funding because the study was nearly complete when the flaws were discovered and dialogue with the investigators on their resolution had just begun.As a partner in research, we have a responsibility