Off-label use of drugs-that is, taking medication to address a problem other than the one for which it was developed and approved by the FDA-is a common and often appropriate practice.
Unfortunately, off-label use is also commonly abused and sometimes dangerous. Among the more alarming off-label practices these days is taking antipsychotic drugs-those used to treat severe mental disabilities-for lesser problems such as insomnia.
As reported recently in the Washington Post in association with Kaiser Health News, until the last decade, an expensive class of drugs called atypical antipsychotics was reserved for only the 3 in 100 people suffering from the most disabling mental illnesses such as schizophrenia. The most popular-Seroquel, Zyprexa and Abilify-are being prescribed off-label for anxiety and attention deficit disorder. Shockingly, as The Post/KHN notes, “Two recent reports have found that youths in foster care, some less than a year old, are taking more psychotropic drugs than other children, including those with the severest forms of mental illness.”
Pharmaceutical companies, of course, couldn’t be happier. Antipsychotics accounted for more than $16 billion in sales in 2010, and often sell better than meds that lower cholesterol. A Stanford studyfrom last year concluded that off-label antipsychotic prescriptions doubled between 1995 and 2008
Although manufacturers are not allowed by law to market drugs for off-label uses, nothing prevents physicians from prescribing them. Thanks, critics say, to hype-TV commercials promote these powerful drugs, which can cost $500 per month-many professionals believe that they are safer and that the newer drugs address more disorders than their predecessors.
Big Pharma has been so successful in encouraging this perception that it has been willing to pay, according the The Post, more than $2 billion in the last few years to settle lawsuits about illegal marketing. In 2009, Eli Lilly and Co. shelled out $1.4 billion to settle charges that it marketed Zyprexa to nursing homes, among other health-care providers, as a sleep aid. We wrote about another such settlement recently.
And consumers pay the price. As quoted by The Post/KHN, Dr. Allen Frances, former chair of psychiatry at Duke University School of Medicine, said, “Antipsychotics are overused, overpriced and oversold.” If some off-label use is appropriate for people for whom other treatments have not worked for, Frances called their widespread use promiscuous and reckless.
Why would anyone take a drug designed to moderate hallucinations and delusions solely to alleviate occasional anxiety when the side effects can include rapid weight gain of 40 pounds, Type 2 diabetes, breast development in boys, irreversible facial tics and an increased risk of death among elderly patients?
Taking these drugs to solve what can be deemed “problems of living” is like using a machete to slice apples. Doctors might find that a suitable way to make fruit salad, says Wayne Blackmon, a psychiatrist and attorney, because of the financial incentive to prescribe quick-fix drugs instead of taking the time to evaluate nondrug treatments. It’s also about insurance companies quick to subsidize pills but not behavioral therapy.
When military operations exceed their stated purpose, it’s known as mission creep. When doctors ascribe difficulty coping as mental illness, it’s diagnosis creep. And the proper response is not to medicate in hopes of moderating symptoms. It’s to re-evaluate the pressures on both patients and doctors to solve a problem via the path of least resistance instead of the more painstaking path of education and information.
If your doctor, particularly if he or she is not a psychiatrist, prescribes an antipsychotic medication for a disorder other than extreme mental illness, ask:
- what alternative treatments are available?
- what are the possible side effects?
- would you take this drug?