In honor of World Alzheimer’s Day, Pintas & Mullins would like to spotlight a particularly insidious and often-ignored problem. The overuse and misuse of antipsychotics among nursing home residents with dementia is dangerous, rampant, and illegal. We urge anyone with a loved one suffering from dementia in a nursing home to be aware of the signs and symptoms of antipsychotic abuse.
Government reports confirm that at least one-third of nursing home residents with dementia receive antipsychotic drugs like Risperdal, Seroquel, Zyprexa and Haldol. This, despite very clear and repeated messages from the FDA that these drugs are associated with an increased risk of stroke, infection, heart failure and death for these patients. Why are nursing homes knowingly giving residents drugs that not only severely decrease their quality of life, but could ultimately kill them?
In the Pockets of Big Pharma
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Johnson & Johnson (J&J) makes over 90% of its money from prescription drugs and medical devices, and each drug has its own team of salespeople and elaborate marketing initiatives. Salespeople and manager incomes rely heavily on how much product they can push doctors to prescribe, according to an in-depth piece by Steven Brill on this company and the sordid history of Risperdal, America’s Most Admired Lawbreaker.
In 1986, J&J’s original antipsychotic drug, Haldol, went off patent, and the company needed to replace the best-selling drug. By 1994, J&J found its replacement in Risperdal, and projected plans to sell Risperdal to tens of millions of Americans, generating $1 billion per year. A very small fraction of people suffer from schizophrenia, however, the only condition for which Risperdal was approved.
Knowing this, the lead of Risperdal sales, Alex Gorsky, orchestrated special sales units, training manuals, and business plans to target doctors and institutions treating the elderly. The company was not legally allowed to promote Risperdal to treat the elderly, except in the most severe psychotic disorders.
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The FDA was straightforward about this: Risperdal was not safe or effective for the elderly, and it is illegal to promote it to those patients. The FDA was aware that the company was attempting to promote Risperdal for behavioral disturbances in dementia patients, and specifically told the company Risperdal may not be used in this way.
Nevertheless, by 1997, Risperdal sales were climbing rapidly, so much so that it was clear the drug was being prescribed to patients beyond those suffering psychotic disorders. While the FDA can (attempt to) control drug companies, it cannot control doctors. It is perfectly legal for doctors to prescribe drugs “off-label,” or in this case, to elderly dementia patients. Drug companies know this, and go to painstaking lengths to market drugs to doctors under-the-radar, so as not to get caught by federal authorities.
J&J salespeople went hard after nursing home doctors and state-run institutions for the elderly, promoting the drug there quietly so as not to be noticed by the FDA. J&J paid authoritative doctors to recommend Risperdal for Medicaid patients, a program a large number of nursing home residents rely on. Since the company could not itself promote Risperdal for dementia patients, it would pay doctors to. Doctors were literally paid based on the number of Risperdal prescriptions they wrote.
J&J also targeted Omnicare, which is a pharmacy management company for nursing homes throughout the country. It is a major player in deciding which drugs residents receive. In 1997, J&J and Omnicare signed an agreement in which the company would pay Omnicare tens of millions of dollars to favor Risperdal over other drugs to calm restless patients. In 1999, J&J emails revealed the Omnicare was to be considered an extension of J&J’s sales force.
In 1998, J&J formed the Risperdal ElderCare team, whose sole mission was to target doctors treating the elderly or who were medical directors of nursing homes. Team members were to focus on treating behavioral disturbances associated with dementia. They disseminated materials that specifically stated that Risperdal was safe and effective in treating dementia symptoms, and placed the risk information in pale, tiny font at the bottom. One year later, in 1999, the FDA told J&J that it was failing to fully explore and explain an excess of deaths among elderly patients prescribed to Risperdal. Nothing came of this.
To date, J&J has settled thousands of lawsuits involving the illegal marketing of Risperdal, including a $2.2 billion settlement with the Department of Justice. In that case, the company pled guilty to civil and criminal allegations. The man chiefly involved in and responsible this incredibly egregious promotion, Alex Gorsky, was not only not named or found liable in this lawsuit, but he was ultimately promoted to C.E.O.
Dementia and Nursing Home Care
Chemical restraint is a new and especially egregious form of nursing home abuse. It refers to the use of powerful drugs – like antipsychotics – to subdue unruly residents. In other words, it is using drugs as chemical straightjackets.
It does not matter if a resident actually suffers from schizophrenia, or is acting out due to Alzheimer’s, or is simply unhappy living in a nursing home. Staff who find a resident aggressive, annoying, or too much to handle, habitually give residents powerful drugs to calm them down. Doctors do not even need to be present; staff can just phone-in the prescription.
Nursing homes in the United States are increasingly owned and operated by for-profit corporations, which prioritize the bottom line above all else. Registered nurses and nursing staff are by far the most expensive part of nursing home operations, because they are the most important. In efforts to increase profits as much as possible, operators routinely understaff their facilities, with as few nurses as legally allowed. Understaffing nursing homes and overworking the few staff that are around has had dire consequences.
In 2011, the Department of Health and Human Services issued a report stating off-label antipsychotic use was widespread in nursing homes. This report showed that 88% of antipsychotic prescriptions in nursing homes were for elderly residents with dementia
Antipsychotics are given to patients in order to control their behavior. If a patient is too drugged up to walk, move, or talk, they require much less care and staff is better able to handle their overwhelming workload. Since drug makers focus so heavily on recommending antipsychotics for behavioral problems among the elderly, nursing homes can justify giving them out as medically necessary.
There is a wealth of research showing a direct relationship between low staffing levels and high use of antipsychotics. Training and leadership among staff also makes a difference. If you have a loved one with dementia, you know that agitation and other troubling behaviors are patients’ efforts to communicate. Dementia is an awful condition, robbing its sufferers of their ability to communicate normally. They do not need powerful drugs. They need compassionate care.
We Can Help
The nursing home lawyers at Pintas & Mullins have been fighting on behalf of injured residents for 30 years. We have seen the progression of antipsychotic use in these facilities and the devastating effects on dementia patients and their families. If you have any questions about dementia care, antipsychotic prescriptions, or any other form of nursing home negligence, contact our firm today.
Our case reviews and consultations are always completely free, confidential and no-obligation. We never charge our clients any fees out-of-pocket, and we have a wide network of legal and medical professionals that allows us to accept clients nationwide.