Drug Giant Fined for Marketing Risperdal as a Dementia Treatment

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In one of the largest health care fraud settlements in U.S. history, pharmaceutical titan Johnson & Johnson (J&J) will shell out $1.7 billion to resolve legal claims surrounding one of its most popular antipsychotics, Risperdal.

The company faces criminal and civil allegations that it—via subsidiary, Janssen Pharmaceuticals—inappropriately marketed Risperdal as a way to manage anxiety and other psychological symptoms in people with dementia.

The antipsychotic has never received FDA approval to treat dementia behavior, yet from May 1998 until November 2005, Janssen's "ElderCare" sales force was supposedly directed to seek out and promote Risperdal to pharmacies in long term care facilities and doctors with elderly patients, according to a statement by the Department of Justice (DOJ).

During the sales process, representatives were allegedly encouraged to downplay Risperdal's approved function—treating schizophrenia—in favor of endorsing its off-label use as a dementia therapy. Despite repeated warnings from the FDA that such claims were "misleading," company representatives also appeared to gloss over the fact that the drug carries a research-backed warning of increased risk of diabetes, stroke, TIA and overall death in the elderly.

A sales aid developed by Janssen in 2002 contained the patient profile of an older woman named Helen D. The hypothetical Helen had recently been placed in a nursing home and was "feeling deserted and depressed," "agitated and hostile," and "experiencing delusions and hallucinations."

As any caregiver can attest, this description could fit the majority of aging adults who enter nursing homes, especially those with Alzheimer's and other forms of dementia. But, it could also be the description of someone suffering from schizophrenia, the primary condition that Risperdal was approved to treat. However, Janssen sales representatives were not instructed to include the schizophrenia caveat when describing Helen D. to doctors and pharmacies.

The government's complaint also claimed that when Janssen hired doctors to speak at medical conferences, they based the physicians' pay on the number of Risperdal prescriptions they wrote.

So powerful were these practices that nearly 50 percent of people age 65 and older who were prescribed Risperdal in 2003 had been diagnosed with some form of dementia.

The actions of Janssen and J&J, "jeopardized the health and safety of patients and damaged the public trust," according to Attorney General Eric Holder. "These are not victimless crimes. Americans trust that the medications prescribed for their parents and grandparents, for their children, and for themselves are selected because they are in the patient's best interest."

Janssen has pleaded guilty to misbranding Risperdal and, together with J&J, will pay over $1.7 billion to settle the criminal and civil claims involving the drug.

Should someone with Alzheimer's be given antipsychotics?

Caregivers often wonder whether a loved one with dementia should be given Risperdal or other antipsychotic medications, such as Zyprexa or Seroquel. It's impossible for physicians to come up with a set of hard and fast rules regarding these prescriptions, since their efficacy often varies from person to person.

A report released by the American Academy of Family Physicians found that Risperdone produced "mixed results," Seroquel showed promise, and Zyprexa was "an effective treatment," when it came to managing psychotic and behavioral symptoms in people with dementia.

Ultimately, caregivers and the elderly are advised to thoroughly discuss all medication decisions with their doctor.

Here are some questions to ask your parent's doctor about medications.

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5 Comments

The thing is he is now himself again since being off that drug. I would say he has some dementia typically of a frailer 92 year old but what that drug did to him was unbelievable. I really thought we had lost him. Relatives questioned our decision to bring him home saying there was no way he could come home he was so out of it. And they assumed it was that he had severe dementia. I was told by the staff there that he didn't know if he had to pee, that he wasn't capable of forming food in his mouth and other nonsense.

While he isn't the person he was at 85 mentally, that drug caused him to be out of his mind.
Today they are still prescribing Risperdal as an aid for dementia. What can we do to act on this violation???
My mother is currently on resperidone and what a relief! Prior to taking the med she was highly agitated, argumentative, combative, suffering delusions, hallucinations, up all night with a flashlight looking thru closets, moving things around, sleeping til afternoon (she wasn't getting her sleep, being up all night).
She's like her old self. Asks questions, responds, wants to go out shopping, etc. Quite a mood enhancer. Working for us!