Abstract
“Lithium, the 20-year-old Cinderella of psychopharmacology, is at last receiving her sovereign due.” So stated one of the nation's leading research psychiatrists on the subject of lithium carbonate, newly-approved by the U.S. Food and Drug Administration for treating the manic phase of manic depressive psychosis. The recent FDA approval marked the culmination of a long and sometimes controversial journey for this relatively well-known chemical entity.
A part of the controversy has been conjecture in press reports that because lithium cannot be patented and because of the significant investment contrasted with a modest return, “no company has wanted to market it.” Even as these reports were being circulated, Pfizer's J. B. Roerig Division had completed an extensive laboratory toxicology program supported by clinical investigations, had produced over one million tablets for experimental use by 18 clinical investigators, had organized and collected existing experimental data from sources throughout the world, and had submitted these voluminous data to the FDA in compilation of a New Drug Application.
The approval of Lithane as an addition to the U.S. physician's stock of weapons against mental illness is eloquent testimony to the important public service role played by research-oriented pharmaceutical companies.