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FOOD AND DRUG ADMINISTRATION - page 161 / 263

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(Laughter.)

DR. BARR:  I have received money specifically from MOVA, from Abbott, Vintage, and Alara, all of whom make these products, make levothyroxine products, but would like to emphasize that my views today are my own and haven't been either approved or sanctioned or disapproved by anybody.

I'd like to present some data that I think are relevant to the issues today and then present some views which I hope will be useful.

This is a study which we ran several years ago and which I'm going to refer to just as test and reference in which we studied two levothyroxine products, a test and a reference product, that were tested in patients that had been stabilized previously on 100 micrograms of levothyroxine.  We then switched them over.  They either started them with test or reference, and then we switched them over after a month, after they reached steady state again.

During this procedure, we did in fact measure TSH.  We did it actually for safety reasons, but we did measure TSH, and when we looked at TSH, we did find

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