14 DAY TRIAL // Johnson & Johnson was directly involved in funding a research clinic, aimed at testing the effects of its various drugs on children suffering from bipolar disorder and autism, new evidence shows. The Wall Street journal reported yesterday that the research center was located at Massachusetts General Hospital, as stated in an e-mail a J&J employee posted to the newspaper's website. The mail contained information about Dr. Joseph Biederman of Harvard University meeting with officials at MGH, to discuss the set up of the clinic.
"The rationale for this center is to generate and disseminate data supporting use of risperidone in this patient population," the e-mail, sent as far back as 2002, said. Risperidone is an antipsychotic drug, known by its commercial name of Risperdal. According to the data in the message, J&J also helped plan the research center, even aiding Dr. Biederman compile some of his research. Supposedly, company officials were involved in the elaboration of the reports as well.
"We promote our products only for their FDA-approved indications," said Kara Russell, a spokeswoman for Janssen, in a statement, adding that the institute had the purpose of conducting "rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children."
To that end, experimental medication was given to teenagers between the ages of 13 and 17, suffering from schizophrenia. Additionally, young children between the ages of 5 and 16 were also given Risperidone, to study its effect on the kids' irritability levels. These behaviors had been associated with autistic disorders before the children were experimented upon. After the tests were complete, the Food and Drugs Administration (FDA) approved the medication for this usage, and doctors were allowed to prescribe it at will.
Now, such drugs are also prescribed off-label, as doctors hand them out for the treatment of such conditions as attention deficit hyperactivity disorder (ADHD), for which the medications do not have FDA approval. After learning of the charges against them, backed up by US Sen. Charles Grassley, officials at the Massachusetts Hospital said that “The MGH takes these allegations very seriously and intends to investigate these issues thoroughly."