Tag Archives: FDA

Big Pharma’s Slimy Crusade to Push Anti-Psychotics on Kids

In the past decade, America’s pharmaceutical industry has knowingly marketed dozens of dangerous drugs to millions of children, a group that executives apparently view as a lucrative, untapped market for their products. Most kids have no one to look out for their interests except anxious parents who put their trust in doctors. As it turns out, that trust is often misplaced. Big Pharma spends massive amounts to entertain physicians, send them on luxury vacations and ply them with an endless supply of free products. As a result, hundreds of thousands of American kids—some as young as three years old—have become dependent on amphetamines like Adderall and a pharmacopeia of other drugs that allegedly treat depression, insomnia, aggression and other mental health disorders.

Scandalous Off Label Use Of Antipsychotics: Another Warning For DSM-5

I never would have entered the DSM-5 controversy were it not for two of its proposals that risk furthering the already frightening overuse of antipsychotic medication, particularly in children and teenagers. DSM-5 plans to introduce two new and untested diagnoses that would offer natural targets for poor drug prescribing–psychosis risk syndrome (AKA attenuated psychotic symptoms) and temper dysregulation (AKA disruptive mood dysregulation). There is no evidence whatever that antipsychotics would confer any benefit on the kids so labeled (and too often mislabeled), but great reason to worry that this would not stop their being used needlessly and recklessly.

Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids

The FDA told Johnson & Johnson (JNJ) in 1997 that its request to market the antipsychotic drug Risperdal for children was “without any justification.” In the following years, J&J’s army of pharmaceutical sales reps made 100,000 sales calls on child and adolescent psychiatrists, justifying this by “qualifying” the docs if they had as few as one adult patient exhibiting signs of schizophrenia, according to a lawsuit.

It was a distinction only a lawyer can love, and now the Massachusetts attorney general is using it against J&J and its Janssen unit, alleging that J&J’s promotion of Risperdal for children was misleading.

Attorney General Alleges Jansen Illegally Marketed Antipsychotic Drug – to kids and the elderly

Drug manufacturer Ortho-McNeil-Janssen is being sued by Attorney General Martha Coakley for illegally marketing Risperdal, an atypical antipsychotic medication. The complaint, filed this week in Suffolk Superior Court, further alleges that Janssen failed to disclose serious risks associated with Risperdal’s use, including the risk of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.

Drug firms paid ‘independent’ experts

Doctors working in state hospitals and community mental health centers began switching patients to the atypical antipsychotics because they were deemed the best treatment by an expert panel convened by the Texas Department of Mental Health and Mental Retardation.

But a detailed examination of public records documents on file in a whistleblower lawsuit that has been joined by the Texas Attorney General’s Office allege that the experts hired to evaluate the drugs and make recommendations for their usage were also accepting hundreds of thousands of dollars in payments from the companies developing and marketing the medications.

It started in the middle 1990s when MHMR contracted with University of Texas and some of its professors to evaluate the medications and develop a set of treatment guidelines.

The program was named the Texas Medication Algorithm Project, or TMAP. The result was step-by-step guidelines for treating major depression, bipolar disorder, schizophrenia, attention-deficit hyperactivity disorder.