In December 13, 1993, the FDA approved Risperdal for treating psychiatric problems in adults. Nearly 10 years later — in April 2002 — FDA revised its recommendations and said that Risperdal could be used for “treatment of schizophrenia” in adults. A year and a half later, in December 2003, FDA approved Risperdal for use in adults with bipolar disorder to treat manic episodes “over the short-term.” In October 2006, the FDA approved Risperdal for use in autistic children. In August 2007, the FDA approved the drug to treat schizophrenic adolescents and bipolar children adolescents.
Those are the facts, and it all sounds pretty “by the book.” So what is the source of contention?
Believe it or not, executives at Janssen understood that Risperdal could make the company a lot of money, if they could figure out a way to create a market for the drug among children and adolescents. Once the FDA approved the drug for use in adults, Janssen immediately sought to market the drugs to children. In 1996, the FDA declined that approval, stating the following:
“You have not identified any pediatric interventions for which you believe Risperdal could be approved, and you have provided no data from adequate and well-controlled trials to support any such approvals… to permit the inclusion of the proposed vague references to the safety and effectiveness of Risperdal in pediatric patients and the non-specific cautionary advice… would only serve to promote the use of this drug in pediatric patients without any justification.”
Still, the company could not take its eyes off the prize — the potential to make a lot of money. It worked diligently to bypass the FDA’s due diligence and bring this medicine to the child/adolescent market as rapidly as possible.
Irrespective of other sins that J&J/Janssen committed (many of which this book will explore in detail), stop and reflect just on this cynical act. The FDA chastised the drug company for trying to market a strong drug to children, despite the fact that the company “provided no data from adequate and well controlled trials to support… the use of this drug in pediatric patients.”
In plainer terms: there was no medical point in promoting this drug to kids, yet the company still eagerly wanted to do it.
How is that ethical? How is that even remotely acceptable? The next posts will address these burning ethical questions. For now, if you need insight into your Risperdal case, call the Davis & Crump team now at 800-277-0300 or email us at info@daviscrump.com.
