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FOOD AND DRUG ADMINISTRATION - page 128 / 263

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these various preparations were substituted, was not achieved.  In this chart, the TSH colored white is the normal people with TSHs within the normal range.  Those in green are those considered hyperthyroid as TSHs are below the normal range, and those in red are considered hypothyroid as their TSH was above the normal range.  If these four products were indeed truly interchangeable, the color of all these blocks, of course, would be white as all of these patients should have been euthyroid at the beginning of the study.

There is no internal control assessment here to estimate the degree of variability that would have been expected should, for example, a patient be treated with the same product from study period to study period.  So, the overall variability observed here is somewhat unclear.

What I do know, however, is that all the changes in TSH classification observed here would likely have, again, resulted in clinical action by a clinician with new doses being prescribed followed by biochemical and clinical reassessment necessitating increased cost and patient inconvenience.  As these results do show us, these products were not interchangeable.  Clearly, we need

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