By the beginning of 1999, Johnson & Johnson had expanded the ElderCare unit to 136 salespeople from 83, and the materials they were using to pitch doctors had caught the FDA’s eye. On January 5, Lisa Stockbridge of the FDA’s Division of Drug Marketing, Advertising and Communications wrote to Janssen’s director of regulatory affairs complaining that “presentations that focus on this population are misleading in that they imply that the drug has been found to be specifically effective in the elderly population.
“Risperdal is indicated for the management of manifestations of psychotic disorders,” Stockbridge added. “However, Janssen is disseminating materials that imply, without adequate substantiation, that Risperdal is safe and effective in specifically treating hostility in the elderly.”
Stockbridge also cited a sales tactic that seemed to stand R.W. Johnson’s Credo of putting patients first on its head. Janssen’s materials, she wrote, “are lacking in fair balance because the risk information appears in pale and tiny font at the bottom or back of a journal ad or other presentation.” For example, she wrote, “the warning regarding tardive dyskinesia”—involuntary movements such as facial grimacing—“is minimized,” and “the claim[s] that ‘Risperdal can enhance daily living’ or that [it] offers ‘quality control of symptoms for daily living’ are considered to be false or misleading.”
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To read Chapter 3 in its entirety and view the accompanying materials online, visit The Huffington Post: Highline website: http://huff.to/1QzzJl1.