Even if there were no links between the use of Risperdal and bad side effects, like gynecomastia, why on Earth would an ethical drug manufacturer push drugs on young children that had not been tested and that offered no clear benefits?
Fortunately, Janssen gave up after that attempt and obeyed the rules.
Actually, that didn’t happen.
On March 3, 2000, the FDA rebuffed another attempt by the drug company to get Risperdal approved for the youth market. FDA officials worried that Risperdal could be used as a “chemical straightjacket” for kids and expressed irritation that Janssen had attempted to move the goal lines and change certain definitions, so that the drug could be used for children with conduct disorder.
Unimpeded by these bleak FDA assessments, Janssen made an internal decision to market Risperdal to children and adolescents anyway.
In 2001, the company came up with a “base business plan,” which championed Risperdal as a major potential moneymaker. The growth rate was “exploding” at a rate of 17+% annually. The drug company asked its sales reps to market the antipsychotic to child psychiatrists and other health professionals as a treatment option for a rouges gallery of child disorders, including autism, obsessive compulsive disorder, and attention deficit hyperactivity disorder (ADHD).
Appreciate that Janssen made this move without financing and constructing randomized control trials to determine whether the drug might actually help kids with these disorders… and to do so without serious side effects. The company just saw a lucrative business opportunity and basically “went for it” — developing an aggressive marketing push to catapult drug sales.
In 2002, Janssen refined its original business plan and came up with a more strategic approach. The “Risperdal Child and Adolescent Market Segment: 2002 Business Plan Summary” was a blueprint that helped to define the “2002 Tactical Plan — Risperdal Child and Adolescent Segment: Reach New Heights with Risperdal 2002.”
Company executives attended a meeting in March 2002 with over a thousand doctors. Insiders celebrated this meeting as “A great way to get the word out to a big part of the child and adolescent prescribing community.”
For insight into your Risperdal case, call the Davis & Crump team now at 800-277-0300 or email us at info@daviscrump.com.
