Stafford's new study adds to concerns about the drugs, which have been the focus of thousands of lawsuits, and as a class make up the single largest target of litigation filed under the federal False Claims Act. All major companies selling new-generation antipsychotics have either recently settled cases for hundreds of millions of dollars or are currently under investigation for skewing results or using questionable marketing tactics.
In 2005, the FDA issued its strongest type of caution, the "black box" warning, for use of new-generation antipsychotics, because of increased risk of death for dementia patients.
"Most people think, 'If my doctor prescribed this, the FDA must have evaluated whether this drug was safe and effective for this use.' That's not true," said Stafford. When doctors prescribe drugs for purposes other than those approved by the FDA, it's called "off-label" use. Though it's riskier for patients, there's nothing illegal about it, and can make sense medically in some instances, Stafford said, especially if there are no approved treatments or if a patient has not responded to approved drugs.
Previous studies had shown that antipsychotic drug use is ballooning. Stafford's new study not only corroborated and updated these findings but also identified the fraction of off-label use that is based on uncertain evidence.
The researchers' first step was to analyze the results of a physicians' survey conducted by health-care information company IMS Health. The IMS Health National Disease and Therapeutic Index survey gives a snapshot of the conditions doctors treated and drugs they prescribed. About 1,800 physicians participate each calendar quarter an
|Contact: Rosanne Spector|
Stanford University Medical Center