September 15, 2015 — Johnson & Johnson has been named “America’s Most Admired Law Breaker” and their conduct regarding Risperdal will go under the microscope in a 15-part exposé by the Huffington Post’s Highline longform features section.
J&J has its roots in feel-good consumer products like Band-Aids and Tylenol, but 91% of its profits actually come from medical devices and prescription pharmaceutical drugs. Last year, those pre-tax profits exceeded $20 billion.
In 1986, J&J’s antipsychotic drug Haldol was set to go “off-patent” and be replaced by inexpensive generics. Facing diminishing sales, the company developed a second-generation antipsychotic called Risperdal.
At the time, Haldol was prescribed to treat adults with mental illness, children with ADHD, elderly adults with dementia, and more. To compete, Risperdal would have to do the same — and J&J would have to convince doctors it was better than Haldol to justify the higher price.
The problem was that Risperdal was only approved for adults with severe mental illnesses — and the FDA specifically cautioned against its use in children and the elderly. Furthermore, studies did not show it was any better than Haldol.
Led by Alex Gorsky, J&J launched an aggressive marketing campaign. According to a $2.2 billion plea bargain with the Justice Department, from 1999-2005, sales representatives were illegally told to target doctors who treat children and elderly adults with mental illnesses.
During that time, sales reps visited a well-known physician in Birmingham, Alabama and gave him thousands of samples of Risperdal in child-sized doses. The doctor prescribed Risperdal to a 12 year-old boy.
Over the next few years, he grew 46DD-sized breasts. He was diagnosed with a disfiguring condition called gynecomastia that is caused by elevated levels of breastfeeding hormones, a side effect of Risperdal. His mother filed a lawsuit accusing J&J of concealing side effects and was awarded $2.5 million in February.
The campaign was overseen by Alex Gorsky, the former head of Risperdal sales who led the subsidiary that marketed Risperdal. His company admitted illegally marketing Risperdal and paid a settlement to the Justice Department. However, no individuals were held accountable and Gorsky was promoted to chairman and chief executive of J&J.
According to Highline:
“The Houdini act … raises equally significant questions about the standards of conduct we can expect from those who run what is becoming the world’s most powerful industry, and about how much we can rely on the medicines they sell.”