Thursday, March 11, 2010

J&J - Risperdal; Did J&J Plan to Break Rules?


Documents from a lawsuit by the state of Louisiana accusing J&J of off-label marketing shed fresh light on the company's long-standing desire to broaden the market for Risperdal beyond the ailments listed initially on the label—psychotic disorders linked to schizophrenia. J&J disclosed the documents from the suit, filed in the Opelousas district court in September 2004, after Bloomberg News asked the court to unseal them. The case is scheduled to go to trial in September.

As early as 1994, the filings show, the FDA ordered J&J's Janssen Pharmaceuticals unit, which developed Risperdal, to stop making false and misleading marketing claims about the drug's superiority to competing medicines. In 1999 the FDA warned J&J in a letter that its marketing materials for geriatric patients, including brochures, journal ads, and letters, overstated Risperdal's benefits while minimizing its risks. The letter said J&J misleadingly implied that Risperdal had been found effective for illnesses such as bipolar disorder and elderly psychosis. Months later J&J drew up a business plan that called for increasing Risperdal's market share in treatments for elderly dementia, aiming at $302 million in sales, the filings show.

"Egregious Examples"

Louisiana cited dozens of internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and to children for unapproved, off-label uses. Professor Jerry Avorn of Harvard Medical School, who isn't involved in the case, says the papers add up to "one of the more egregious examples" of marketing drugs to vulnerable patients. Medical professionals know "that drug companies resort to unsavory practices to promote drugs," he says, but seeing the details of this campaign "is still pretty upsetting."

More at BusinessWeek

No comments: