By Margaret Cronin Fisk, Jef Feeley and David Voreacos
March 10, 2010
Johnson & Johnson made plans to reach $302 million in geriatric sales for its antipsychotic Risperdal just months after federal regulators said the company falsely claimed the drug was safe and effective with the elderly, according to internal documents.
The U.S. Food and Drug Administration told J&J in 1999 that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. A J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use, according to newly unsealed documents in a lawsuit by the state of Louisiana.
“The geriatric market represents Risperdal’s second wave of growth,” J&J officials wrote in the business plan. “The aging population will continue to drive market growth well into the next century.”
Louisiana officials cited the document and dozens of other internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and children for unapproved uses. Professor Jerry Avorn of Harvard Medical School, who isn’t involved in the case, called the papers “one of the more egregious examples” of marketing drugs to vulnerable patients.
“By 2010, most grownups in medicine know that drug companies resort to unsavory practices to promote drugs, but seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting,” Avorn said.
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