Risperdal was approved in 1993 for adults with schizophrenia — a relatively small patient population. With little profit to be made, J&J launched an aggressive marketing campaign to promote Risperdal “off-label” for children and elderly patients.
The problem was that early studies showed that Risperdal elevated levels of prolactin, a breast-growth hormone, in children and teens. Studies also showed higher rates of cardiovascular events in elderly adults on Risperdal.
One study published in 2001 indicated that Risperdal posed serious risks to children. According to Brill:
“The claim on the current label that gynecomastia was “rare” (meaning that it occurred in fewer than one-tenth of 1 percent of patients) was understated by a factor of more than 50. The final tally was 5.5 percent of the boys.”
Instead of scaling back marketing efforts, J&J ramped up efforts to target those populations. They worked out a plan with Excerpta Media to place 39 articles in medical journals promoting Risperdal for general mood disorders.
J&J also recruited the famed pediatrician Joseph Biederman to open a center at Massachusetts General to “move forward the commercial goals of J&J.” What the drug-maker didn’t know was that they had also recruited a future whistleblower.