Antipsychotic drugs used to manage aggressive outbursts in intellectually disabled people are no more effective than placebos for most patients and may be less so, researchers report, challenging established worldwide medical practice. Researchers focused on Janssen’s Risperdal and Haldol but said findings applied to similar medications such as Zyprexa. These drugs account for over $10 billion in annual sales and at least half of all prescriptions are for unapproved off label uses to treat aggression or irritation. While it is illegal for drug companies to market approved medications for off label uses, how a drug is used remains at the prescribing physician’s discretion; many use antipsychotics—developed for schizophrenia—as tranquilizers for children with attention-deficit problems, college students with depression, Alzheimer’s patients, and intellectually handicapped people.
The study tracked 86 adults—aged 18 to 65—with low IQs living in community housing in England, Wales, and Australia for more than a month and found a 79 percent reduction in aggressive behavior among those on placebos as compared to a 65 percent or less reduction in those on antipsychotics. Dr. Peter J. Tyrer, professor of psychiatry at Imperial College London, led the team. Patients were given Risperdal, Haldol, or a placebo and behavior was tracked—many with very low IQs tend to lash out at others and themselves quickly. Patients in all three groups improved; those on the placebo improved significantly compared to those on medication.
Researchers said the results would likely spur requests for government review of British treatment standards. Others feel these findings will add to the continuing debate over the widening use of antipsychotic drugs and patient advocates and some psychiatrists feel the medications are overused. While studies have been mixed, the drugs do have serious side effects and doctors have little to guide them. Johnny L. Matson, a professor of psychology at Louisiana State University in Baton Rouge, co-author of an editorial with the study in the journal Lancet said, “The message to doctors should be, think twice about prescribing or just don’t do it. We know that behavioral treatments can work very well with many patients.” Others disagreed, saying the study did not reflect previous research or their experience. Janssen, a Johnson & Johnson subsidiary, said Risperdal only promotes approved uses, which in Great Britain, includes treating autism-related irritability. Tyrer said there was no reason to believe other antipsychotics used for aggression, like Zyprexa from Eli Lilly or Seroquel from AstraZeneca, would be more effective. “These people tend to get so little company normally, they’re neglected, they tend to be pushed into the background and this extra attention has a much bigger effect on them that it would on a person of more normal intelligence level,” said Tyler.
Study authors included researchers from the University of Wales and the University of Birmingham in Britain and the University of Queensland in Brisbane, Australia. Authors claim results “should not be interpreted as an indication that antipsychotic drugs have no place in the treatment of some aspects of behavior disturbance,” but the routine prescription of drugs for aggression “should no longer be regarded as a satisfactory form of care.”