Kickbacks to doctors
Last November, in what the U.S. Department of Justice called "one of the largest health care fraud settlements in U.S. history," Johnson & Johnson and its subsidiaries were fined more than $2.2 billion to resolve criminal and civil charges because of their aggressive marketing of drugs, including antipsychotics, to nursing homes, when they knew the drugs had not been approved by the U.S. Food and Drug Administration (FDA) as safe and effective for a general elderly population. The corporation also allegedly paid kickbacks to physicians, as well as to Omnicare, the nation's largest long-term-care pharmacy provider. Omnicare pharmacists were recommending Johnson & Johnson's drugs, including the antipsychotic Risperdal, for use by nursing home residents.
Back in 2009, Eli Lilly did the same thing with its antipsychotic Zyprexa, marketing to older people in nursing homes and assisted living facilities, federal prosecutors charged. In a settlement, the company agreed to pay $1.4 billion. "This case should serve as still another warning to all those who break the law in order to improve their profits," Patrick Doyle, special agent in charge of the Office of Inspector General for the U.S. Department of Health and Human Services in Philadelphia, said at the time.
A report released in March by the inspector general of Health and Human Services charged that one-third of Medicare patients in nursing homes suffered harm, much of which was preventable. "Too many nursing homes fail to comply with federal regulations designed to prevent overmedication, giving patients antipsychotic drugs in ways that violate federal standards for unnecessary drug use," Inspector General Daniel Levinson said. "Government, taxpayers, nursing home residents, as well as their families and caregivers, should be outraged — and seek solutions."
Antipsychotic drugs are intended for people with severe mental illness, such as patients with schizophrenia or bipolar disorder. As such, they carry the FDA's black-box warning that they are not intended for frail older people or patients with Alzheimer's or dementia. In those populations, these drugs can trigger agitation, anxiety, confusion, disorientation and even death. "They can dull a patient's memory, sap their personalities and crush their spirits," according to a report from the California Advocates for Nursing Home Reform.
Kept in the dark
What's more, the law requires "informed consent" by a patient or, if that is no longer possible, by his or her family before such drugs are administered. Yet advocates say that, all too frequently, this doesn't happen. Levine, for example, says she didn't know about all her mother's medications until she transferred her mom to another facility. "When I saw the list of what she'd been given, I freaked out. I was upset and angry, in tears," she recalls.
How can such things happen? One explanation is that many facilities don't have enough properly trained staff: Most of the patient care in nursing homes falls to certified nursing assistants (CNAs) who need as little as 75 hours of on-the-job training to get certified. "Yet if you want a license to be a hairdresser, you need 1,500 hours of training," Harrington points out.
What's more, CNAs are paid low wages so many of them work long hours. "They are totally exhausted, with extremely heavy workloads," she says. That leads to high employee turnover and caregivers who don't know their patients well enough to recognize their needs.
Compounding the problem, many nursing home patients require a high level of care. Some are incontinent, and an estimated 60 to 70 percent have some form of dementia. There should be one CNA for every seven patients, but in some cases, the ratio is 1 to 15 — or even more, Harrington says. There also tend to be too few physicians actually present in nursing homes. "These facilities are highly medicalized, but doctors are rarely there," says Tony Chicotel, staff attorney for California Advocates for Nursing Home Reform. He says that because of their low rate of reimbursement from Medicare, nursing homes are too often seen as a place where few top doctors practice.
The result of all this can be so-called behavior problems among patients — which is the explanation nursing homes cite for giving patients unnecessary antipsychotic drugs, according to the U.S. Centers for Medicare and Medicaid Services (CMS). And pharmaceutical companies have been aggressively marketing their products as an easy and effective way to control these issues.
Next page: Putting patients first. »