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risperdal.jpgBloomberg News obtained documents from a Louisiana court hearing a case seeking reimbursement of public funds paid to Johnson and Johnson for Risperdal. Bloomberg discussed how drug companies define a culture of acceptance for a drug, and then redefine the market for using it. Strategies include mining physician prescribing lists, planting shills in continuing medical education seminars and lectures, and providing gifts to physicians, nursing homes, the Veterans Administrations. This trial also includes allegations of kickbacks. The Johnson and Johnson blockbuster drug earned $4.5 billion in 2007 before the patent expired.

Risperdal was initially marketed to treat schizophrenia, but its reach expanded to include children and the elderly in nursing homes. Ten law suits are pending alleging marketing off-label use despite FDA concern about overstating benefits and understating side effects. Bloomberg's reporters (Margaret Cronin Fisk, Jef Feeley and David Voreacos) cite evidence from documents the court released:

"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."

Criminal investigations have increased while FDA oversight and enforcement has lapsed in the last few years. Along with pressure from Sen. Charles. Grassley (R-IA), plus a new report of the Government Accounting Office about the lax oversight and enforcement capabilities of the FDA, Pharmalot reports the agency is considering prosecuting executives.

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