Big Pharma Gone Wild

By Martha Rosenberg, AlterNet. Posted February 3, 2009.

Nor did the continuing-medical-education courses like "Individualizing ADHD Pharmacotherapy with Disruptive Behavioral Disorders" taught by the J&J-funded Robert L. Findling and referring to Risperdal/risperdone 13 times hurt. Credit was available until 2009.

But most of Risperdal's success comes from the unsung doctors -- you know who you are -- who extolled the drug for unapproved use in pediatric bipolar disorder, ADHD, depression, "agitated, expansive, grandiose" "psychopathologies" [per Biederman], Alzheimer's, jealousy, "oppositional" disorder, borderline states, assorted neurological diseases, sleep and mood disorders and whatever else would stick to the wall.

Like the doctors who upheld the "long-term safety and effectiveness of risperidone for severe disruptive behaviors in children," on the basis of a one-year study in the Journal of the American Academy of Child and Adolescent Psychiatry in 2005. Hello?

How else could a drug known to cause diabetes, obesity, breasts in men, lactation in women and the very tardive dyskinesia it was supposed to prevent be a first-choice drug in state formularies and on Medicaid protocols? Given to children?

How did it become a preferred nursing home treatment despite a warning label that says it increases death in elderly patients with dementia-related psychosis? Bruce Bowman, a resident of Taylor Park Nursing and Rehabilitation Center in Rhinelander, Wis., died last June after being put on Risperdal, reports the Milwaukee Journal Sentinel.

Nor did the FDA's why-hold-up-a-drug-just-because-it's-dangerous attitude hurt. In 2007, it approved Risperdal for adolescents 13-17 with schizophrenia, and children and adolescents 10-17 with "short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder" on the basis of two six- to eight-week studies. Barely long enough to need validated parking.

In fact, the FDA was surprised when a panel of drug experts in November unanimously rejected out of hand its routine safety monitoring for Risperdal and related drugs for children.

"I’m a little puzzled about the statement that the label is inadequate," said Dr. Thomas Laughren, director of the agency's division of psychiatry products according to the New York Times. "I’m anxious to hear what more we can do."

How about not approving a drug in the first place?

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Martha Rosenberg is a columnist and cartoonist who frequently writes about the impact of the pharmaceutical, food and gun industries on public health. A former medical copywriter, her work has appeared in the Boston Globe, San Francisco Chronicle, Los Angeles Times and Chicago Tribune, as well as on the BBC and in the original National Lampoon.

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