Every day tens of thousands of Americans in nursing homes are chemically restrained by powerful, dangerous and expensive antipsychotic drugs. Prescribed to “treat” people with Alzheimer’s and other dementias, antipsychotics have no therapeutic value for most of these vulnerable patients. They are used, against best evidence, for extended periods, risk fatal side effects and are usually dispensed “off-label” since, in almost every instance, they lack FDA approval for treating dementia.
The British Medical Journal recommends that for dementia, “antipsychotics should be carefully targeted, time limited, and reserved for severe and distressing symptoms after careful assessment of risk and benefit.” Yet in 2010, almost 40 percent of nursing home residents with signs of dementia but no diagnosis of psychosis got antipsychotics, often at higher than recommended dose and duration.
If you know an Alzheimer’s victim, you likely have watched them buried alive in confusion, hopelessness and fear. Shedding language, social interactions, and their own minds and memories, many grow depressed and agitated. Some suffer constant pain from untreated conditions they cannot communicate. Families, doctors and caregivers are desperate for relief, but there is no chemical fix. In most cases, antipsychotics simply control problematic behavior by doping patients into docility. Side effects include accelerated cognitive decline, dizziness leading to falls, strokes, cardiac events and embolisms, all contributing, according to the FDA, to a doubled risk of death.
What patients need instead, according to the Centers for Medicare and Medicaid Services (CMS), is “consistent staff assignments, increased exercise or time outdoors, monitoring and managing acute and chronic pain, and planning individualized activities.” And trained caregivers. Nursing homes with largely untrained staff drugged up to 80 percent of patients with antipsychotics, the Boston Globe reported.
Political will is also essential. Between 2008 and 2011, Britain’s National Health Service acknowledged the problem, and more than halved antipsychotic prescriptions for dementia patients. America — with an $18.2 billion antipsychotics market as of 2011 — has lagged in educating and regulating doctors, nursing home administrators and pharmacists. CMS’s 2012 goal was a 15 percent reduction. As for BigPharma, it games the system, reaps vast profits and, when caught in criminal activity, pays fines as a cost of doing business.
In 2009 Eli Lilly pled guilty to a misdemeanor criminal charge and paid $1.4 billion for targeting doctors at nursing homes and assisted living facilities to prescribe its antipsychotic olanzapine off-label to dementia patients. This year, Omnicare, which provides pharmacy-related services to long-term care facilities, accepted a $2.2 billion settlement for taking kickbacks from Johnson & Johnson for recommending J&J drugs, including the antipsychotic Risperdal, at nursing homes it serviced. Increased FDA vigilance spurred Abbott Laboratories to get clever. It pushed off-label use of Depakote — not technically an antipsychotic — for dementia. From 1998 to 2006, Abbott maintained a sales force specifically trained to market Depakote in nursing homes for “control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use,” the Justice Department charged in May. What’s more, Abbott bribed long-term care pharmacy providers with millions in “rebates based on increases in the use of Depakote in nursing homes.” Abbott pled guilty, and agreed to pay $1.5 billion. Its 2011 earnings were $39 billion; Lilly’s topped $24 billion.
Ultimately, tax dollars feed those profits, since Medicaid, Medicare and veterans’ benefits pay for many of the meds taken by America’s 5.4 million Alzheimer’s patients.
Dementia patients, however, pay in pain, stupor and death. “Excessive prescription of antipsychotic drugs in nursing homes is elder abuse,” said Sen. Richard Blumenthal (D‑Conn.) in a press release. “It is chemical restraint, as pernicious and predatory as unnecessary physical restraint.”
Since fines fail to deter BigPharma crime, perhaps we should chemically restrain the executives responsible with their own drugs. Or better yet, physically restrain them with jail sentences.