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$2.2 Billion Johnson & Johnson Settlement Sends New Warning: Antipsychotic Drugs Should Not Be Used to Treat Dementia

Statement of California Advocates for Nursing Home Reform, Center for Medicare Advocacy, Legal Aid Justice Center, Long Term Care Community Coalition, and The National Consumer Voice for Quality Long-Term Care

The Department of Justice’s $2.2 billion settlement with Johnson & Johnson over allegations that it illegally promoted Risperdal to treat symptoms of dementia sends a new warning to the pharmaceutical and long-term care industries that antipsychotic drugs are inappropriate and potentially dangerous when prescribed for the elderly. Nationally, almost 22 percent of nursing home residents receive Risperdal and other antipsychotic drugs that can have fatal side effects and are not effective to treat symptoms of dementia. J&J, its subsidiary Janssen Pharmaceuticals, and the long-term care pharmacy giant Omnicare are the latest drug manufacturing and pharmacy companies to settle federal and state charges that they illegally promoted psychotropic drugs to long-term care facilities and doctors who treat the elderly.

In a related complaint, the government alleges that the Food and Drug Administration repeatedly advised Janssen that it would be misleading to market Risperdal, which is approved as a treatment for schizophrenia, as safe and effective for the elderly. The government claims that Janssen deliberately interpreted studies of Risperdal in ways that downplayed or refuted known side effects, such as strokes and diabetes, and aggressively marketed the drug to nursing homes and doctors. According to the DOJ, the FDA warned Janssen that behavioral “disturbances” in dementia patients might be “appropriate responses to the deplorable conditions under which some demented are housed.”

The settlement resolves government allegations that Omnicare employed “hundreds” of consultant pharmacists in nursing homes to recommend Risperdal to doctors. Although consultant pharmacists are supposed to make independent clinical judgments, the government maintains that J&J regarded them as an “extension of its sales force.”

The 1987 Nursing Home Reform Law proscribes the use of psychotropic drugs as chemical restraints to control or sedate residents for the convenience of staff. In 2011, the signers of this statement – a small group of advocates representing national and state consumer organizations – called on the Centers for Medicare & Medicaid Services to make eliminating the misuse of antipsychotic drugs a priority. CMS responded by launching a National Partnership to Improve Dementia Care in Nursing Homes.

DOJ’s continued prosecution of False Claims Act cases involving illegal marketing of antipsychotics and other psychoactive drugs is critically needed to deter companies that, in Associate Attorney General Tony West’s words, “put profit over patients’ health.” However, much more needs to be done to protect taxpayers against fraud and to protect residents and improve their quality of life and care:

Nationally, there has been only a minimal decline in the number of residents receiving antipsychotic drugs since CMS’s National Partnership to Improve Dementia Care in Nursing Homes was launched, suggesting that in most states, regulations proscribing chemical restraints and unnecessary drug use are not being rigorously enforced. After launching the campaign in 2012, CMS challenged nursing homes to reduce antipsychotic drug use by a modest 15 percent by the end of that year. At the end of the second quarter of 2013, there had been only an 11.4 percent reduction nationally, leaving 316,604 residents still on drugs that could harm or kill them or dramatically decrease the quality of their lives.

CMS abandoned plans to promulgate regulations to stop drug manufacturers and long-term care pharmacies from subsidizing or employing consultant pharmacists who advise nursing home physicians. In October 2011, CMS asked the public to comment on whether it should promulgate regulations to require consultant pharmacists to be independent of long-term care pharmacies and pharmaceutical manufacturers. Omnicare had paid $98 million in 2009 to settle government claims that it had received kickbacks from J&J and Janssen to promote their drugs, including Risperdal, using consultant pharmacists as their extended sales force. Commenters, including many consultant pharmacists, overwhelmingly supported the need for regulations to stop conflicts of interest that jeopardized residents. Remarkably, CMS concluded that its concern was “well-founded” that consultant pharmacists’ financial ties to the drug industry had a harmful impact on residents – but elected to let the industry to police itself. No regulations have been forthcoming.

An important drug watchdog, the Office of Inspector General, has reduced its oversight of antipsychotics in nursing homes because of budget cuts. In May 2011, Inspector General Daniel Levinson said nursing home residents and their families should be “outraged” by his office’s report that well over a quarter of a million residents were receiving antipsychotic drugs for medically unaccepted, off-label uses. The report and his remarks became a catalyst for reform, but last July, the OIG announced that a 20 percent reduction in its staff had led it to abandon plans for a follow up investigation. While we appreciate Mr. Levinson’s statement that his office “will work aggressively with our law enforcement partners to hold companies accountable,” we are concerned that unless OIG’s staff levels and priorities are restored, the government’s agreement with J&J will not be effectively monitored and enforced.

Settlements with pharmaceutical manufacturers and distributors should include requiring them to conduct public education programs to correct past disinformation. Significant and potentially permanent harm has been done by “sales forces” that portrayed antipsychotics as safe and effective and swayed prescribers and caregivers to use them to suppress symptoms, rather than to treat the causes, of residents’ attempts to communicate pain, hunger, anxiety, confusion, depression, anger, and fear. These companies should be required to set the record straight.

Families are often troubled because loved ones become sedated and uncommunicative after admission to a nursing home, but they and the resident may not know that an antipsychotic drug is being administered or that they had a right to participate in planning the resident’s care or to refuse the medication. Informed consent requirements should be properly enforced and, where necessary, strengthened. Federal law requires residents to be fully informed in advance about planned care or treatment, to participate in planning for their care and treatment, and to refuse treatment (regardless of whether doing so may be detrimental). Yet in a 2012 review of 375 randomly selected resident records, the Office of the Inspector General found that 91 percent did not contain evidence that the resident or the resident’s family or legal representative participated in the care planning process. Every resident in this study was administered an antipsychotic drug. CMS and the states must strengthen enforcement of these protections, and Congress should pass a law strengthening and clarifying informed consent rights, including requiring that information be provided both verbally and in writing and that consent be in writing and for a limited period of time.