To the Editor.—The lead article in the Ear, Nose & Throat Journal for June 19891 concluded that fluoride therapy for otosclerosis is experimental and unproven. Kerr and Hoffman1 base their conclusion on the fact that in the United States there has been no double-blind placebo-controlled study in a large number of cases as required by the Food and Drug Administration for approval of a new drug. The reason such a study has not been made is that fluoride cannot be patented, and no drug company will go to the expense of funding such a study for a substance for which they cannot expect to recoup the cost. There is no private source of funds for such a study, which may cost in the millions (the cost of obtaining approval for a new drug).
The research that has been published on the positive effect of moderate-dosage sodium fluoride on
SHAMBAUGH GE. Fluoride Therapy for Otosclerosis. Arch Otolaryngol Head Neck Surg. 1990;116(10):1217. doi:10.1001/archotol.1990.01870100111026
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