Antipsychotic medications are the most expensive and most sold medication class of drugs on the market. However a new study implies there is a severe lack of proof that these medications are helpful, but do in fact cause massive side effects. In addition, an estimated $6 billion was spent in 2008 on off-label use of antipsychotic medication nationwide, of which $5.4 billion was for uses with uncertain evidence.
Quetiapine for example, which is the highest seller in the United States and is intended to treat schizophrenia, bipolar disorder and depression is more often used for anxiety and dementia treatment, making it the antipsychotic with the biggest U.S. sales. Simply put, drugs should not be prescribed for ailments for which they are not intended or approved by the FDA for treatment.
Antipsychotic use for indications that lacked FDA approval by the end of 2008 increased from 4.4 million prescriptions during surveyed doctors' visits in 1995 to 9 million in 2008. These include afore mentioned quetiapine, aripoprazole (brand name, Abilify), olanzapine (Zyprexa) and risperidone (Risperdal), each with sales exceeding $1 billion per year in the United States. Antipsychotic treatment prescribed during the surveyed doctors' visits nearly tripled from 6.2 million in 1995 to 16.7 million in 2008, the most recent year for which researchers had data.
In 2008, 54% of the surveyed prescriptions for the new-generation antipsychotics had uncertain evidence.
Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center says:
"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. 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, especially if there are no approved treatments or if a patient has not responded to approved drugs."
"Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits. These are commonly used and very expensive drugs."
The U.S. government's original stamp of approval in 1989 for the new drugs was for treating schizophrenia, but they're used more today for other conditions, including other psychoses, autism, bipolar disorder, delirium, dementia, depression and personality disorders. Most of these uses have not been FDA approved to date. 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.
As documented in 2008, this class of drug amounted to over $19 billion USD in pharmacy sales, the largest of its kind and 5% of all drug spending; even more than cholesterol control medications. According to a 2004 study, 25% of all residents of U.S. nursing homes had taken them.
These substances 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. Stafford suggests the upswing in prescriptions for antipsychotics despite the absence of good evidence for their value in many instance is the result of marketing, whether legal or illegal, and ingrained cultural tendencies.
Clinical assistant professor of psychiatry Anthony Mascola, MD, provided expertise on the treatment of psychiatric conditions:
"Physicians want to prescribe and use the latest therapies, and even when those latest therapies doesn't necessarily offer a big advantage, there's still a tendency to think that the newest drugs must be better. In many cases, physicians don't realize they're prescribing off-label."
Information about Stanford's Department of Medicine, which also supported this work, is available at http://med.stanford.edu/medicine.
Written by Sy Kraft, B.A.