Benita Pledger was reduced to tears after hearing testimony from former FDA Chief about how Johnson & Johnson subsidiary Janssen Pharmaceuticals tried to manipulate data in some reports involving its antipsychotic drug Risperdal to cover up a side effect known as gynecomastia, a condition in which boys grow breasts.
“The most important thing to me, as someone who worked for the FDA, as a physician and someone who served on the boards of pharmaceutical companies, is you tell the truth and you tell the whole truth,” former FDA Commissioner Dr. David Kessler testified. “You tell me the story. You make sure the data supports the message. What they want to convey doesn’t match what the data shows and to me, that doesn’t tell the whole story. Make sure the FDA knows and make sure the doctors know. Tell them the good and the bad.”
The Pledgers’ son took Risperdal for about five years beginning in 2002 at age 8 to treat irritability with autism. He is now 20. The Pledgers’ lawsuit claims that Johnson & Johnson and Janssen knew Risperdal side effects could cause a hormonal imbalance that could cause gynecomastia, but the company refused to warn doctors or patients. The condition is not only embarrassing for adolescent boys, it can cause pain from tender breasts and even lactation. Treatment generally involves surgeries to remove the breast tissue such as liposuction or mastectomy.
Risperdal was not approved to treat children until 2006; however, Pledger’s pediatric neurologist testified that a Janssen sales rep had come to his office 20 times between 2002 and 2004 to illegally promote the drug for pediatric use. The drug company was later slapped with criminal charges and other allegations and fined $2.2 billion for illegal promotion of Risperdal.
In Pledger’s case, Kessler pointed to a 2001 study conducted by Janssen that showed children younger than the age of 12 and adolescents 12 and older who were taking Risperdal had a higher than normal incidence of gynecomastia. Company emails and manuscript drafts for publication suggested efforts were made to re-analyze data in order to downplay the prevalence of gynecomastia.