Off-label use of powerful antipsychotic drugs has come in for plenty of debate in recent years. The expensive, newer-generation “atypicals” have been used to treat dementia, depression, anxiety, post-traumatic stress disorder, dementia, attention-deficit hyperactivity disorder…the list goes on. And all this while the Justice Department was investigating Big Pharma for off-label promotion of the drugs.
WASHINGTON — Two high-ranking senators have urged the Centers for Medicare and Medicaid Services (CMS) to take a closer look at potential over-prescribing of atypical antipsychotics to nursing home residents. Atypical antipsychotics are not approved to treat dementia, and must carry black box warnings that elderly people who take atypical antipsychotics have an increased risk of death, compared with those who take placebo pills for dementia. Still, it’s clear that these drugs are being used in nursing homes to control behavioral problems related to dementia. A 2011 report from the Department of Health and Human Services Office of the Inspector General (OIG) found that 14% of all nursing home residents with Medicare had claims for antipsychotics and 88% of the atypical antipsychotics prescribed off-label were for dementia.
And in 2009 Elli Lilly, the makers of olanzapine (Zyprexa), pled guilty and paid $1.4 billion to the federal government for allegedly targeting doctors who worked in nursing homes and assisted living facilities to prescribe olanzapine off-label to elderly patients with dementia. In their letter, Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.), urged CMS administrator Donald Berwick, MD, to examine the issue of overuse of antipsychotics in nursing homes more closely. The letter is a follow-up to one the senators sent in May after the release of the OIG report, which the senators themselves requested.
For any mental illness or passing mood swing that may trouble a person, the Diagnostic and Statistical Manual of Mental Disorders — better known as the DSM — has a label and a code. Recurring bad dreams? That may be a Nightmare Disorder, or 307.47. Narcolepsy uses the same digits in a different order: 347.00. Fancy feather ticklers? That sounds like Fetishism, or 302.81. Then there’s the ultimate catch-all for vague sadness or uneasiness, General Anxiety Disorder, or 300.02. That’s a label almost everyone can lay claim to.Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.
In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.
These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder. The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.
The New York Review of Books‘ recent two-part article (1) by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks. (All statistics and quotations herein are drawn from Dr. Angell’s article.) It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so. The profits in psychoactive drugs, however, make it tempting to flout the law. In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.
At just 6 years of age, still grieving over the death of the only mother he had ever known, his foster mother, Giovan Bazan would receive the first of many psychiatric ‘diagnoses’ and drugs that would plague him for the next twelve years of his life. Moved from foster home to foster home, orphanages and other modes of state care, Giovan was stigmatized with a plethora of psychiatric diagnoses and drugs until the age of 18, when he could finally make his own medical decisions and quit. Now a child advocate working part time at the Division of Family and Children Services (DFCS) in Georgia, Giovan is on a mission: To get a full-time job with DFCS and help enact laws to combat the wholesale labeling and drugging of foster children. In the video below, Giovan tells his story and why he decided to fight back against the abuse of kids in foster care.