September 17, 2015 — Steven Brill’s “DocuSerial” America’s Most Admired Law Breaker continues with the story of how Johnson & Johnson eluded the FDA to market Risperdal for “off-label” (unapproved) use in children and the elderly.
The law prohibits off-label marketing, but doctors are allowed to prescribe drugs for whatever use they see fit. So J&J launched a campaign aimed at doctors — starting in Texas, with Medicaid and health officials, some of whom were paid “consulting fees” for their involvement.
Using marketing materials masked as “Expert Consensus Guidelines,” sales reps convinced doctors that the extra cost of brand-name Risperdal was justified because it was so much more effective than inexpensive generic Haldol — despite the fact that J&J’s own studies showed that Risperdal was no more effective than Haldol and had more serious side effects.
By 1999, taxpayers in Texas were paying $3,000 per year for each patient on Risperdal, compared to $250 for patients on Haldol. In the meantime, J&J paid doctors in Texas kickbacks to give speeches all over the country promoting Risperdal as a first-line treatment for mental illness.
J&J also worked with Omnicare, a company that provided pharmaceuticals to nursing homes. The companies worked out a kickback scheme to share profits when Omnicare doctors prescribed Risperdal — often to elderly patients with dementia.
Risperdal now carries a “Black Box” warning that it increases the risk of death in elderly patients with dementia. It can also cause boys to grow large breasts — one boy developed 46DD breasts and was awarded $2.5 million by a jury in February.
J&J eventually pleaded guilty and paid more than $2.2 billion in penalties for ripping off taxpayers and the goverment. However, global sales of Risperdal topped $30 billion worldwide. Alex Gorksy, who led the marketing campaign for Risperdal, is now the C.E.O. of J&J and earned $25 million last year.
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