Big Pharma’s Defeat Devices

“The worse the data on the elderly got, and the worse the potential for the FDA reaction to it got, the more J&J seemed to intensify its sales effort.”

So writes investigative journalist Steven Brill in his chilling, meticulously researched “docuserial” America’s Most Admired Lawbreaker, concerning Johnson & Johnson’s efforts to market the antipsychotic Risperdal off-label — that is, without authorization — to seniors with dementia and children diagnosed with pediatric bipolar disorder. The series ended its fifteen-day run on The Huffington Post last week. It follows the spring publication of Brill’s compelling, widely reviewed book America’s Bitter Pill: Money, Politics, Backroom Deals, and the Fight to Fix Our Broken Healthcare System (Random House, 2015).

What did we learn from the series? Among other things, that in September 2000 the FDA told Johnson & Johnson it would not approve the use of Risperdal for children with “conduct disorder” (a term, officials said, that “could mean anything”). J&J also should scale back the drug’s accepted treatment indicators — from management of “psychotic disorders” to the “treatment of schizophrenia” alone. Among other concerns, the agency warned that J&J had “failed to fully explore and explain what appeared to be an excess number of deaths” among the elderly treated with Risperdal — chiefly, a sharp increase in strokes and heart-related fatalities.

The FDA’s Division of Drug Marketing, Advertising and Communications had warned the drugmaker the previous January that it was distributing information about Risperdal that the agency “considered to be false or misleading,” including by listing side effects in “pale and tiny font” on published ads and industry presentations. “The warning regarding tardive dyskinesia” — involuntary twitching — “is minimized” on the literature, regulators added. (Johnson & Johnson was invited to comment on this post; its response will be —> Read More