Risperdal is a powerful antipsychotic that was only initially approved for adults with schizophrenia. With little profit to be made in that limited patient population, J&J started marketing Risperdal “off-label” for children with mood problems and elderly people with dementia.
In 1999, J&J worked out a plan with Excerpta Media to place 39 articles on Risperdal in medical journals. The articles promoted Risperdal for broad treatment of patients with mood disorders.
Meanwhile, executives at J&J downplayed the risk of elevated prolactin levels — a risk-factor for gynecomastia — and a study linking Risperdal to cardiovascular events in elderly patients with dementia.
In 2001, a long-term study of children and teens on Risperdal confirmed that the label did not adequately warn about gynecomastia:
“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.”
Despite studies linking Risperdal and severe side effects in children and the elderly, J&J ramped up sales efforts and recruited Joseph Biederman, a famed pediatrician, to open a center at Massachusetts General, to “move forward the commercial goals of J&J.”
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