it’s no joke: seroquel and risperdal illegally marketed to treat elderly people with dementia

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John Oliver’s tragically funny Big Pharma lampoon went viral. Maybe because, like most incisive satire, his piece is rooted in truth. Here’s some of the shocking evidence with respect to the marketing of antipsychotic drugs such as quetiapine (Seroquel) and risperdone (Risperdal) to elderly people with dementia such as Alzheimer’s disease:

On April 27, 2010, as mentioned in Oliver’s piece, AstraZeneca LP and AstraZeneca Pharmaceuticals LP was ordered to pay $520 million to resolve allegations that it illegally marketed the anti-psychotic drug Seroquel (quetiapine) for uses not approved as safe and effective by the United States Food and Drug Administration.

Specifically, it marketed the drug for uses that were not FDA improved including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.

According to the settlement agreement:

“AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder [for which the drug had FDA approval], such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.” (Italics mine.)

In April 2014, a joint CBC/Canadian Press report revealed the widespread inappropriate use of quetiapine as a “sleeping aid” for female inmates in the Canadian prison system. When I read it, I was struck by the parallels between subduing women in prison and sedating vulnerable elderly people with dementia using quetiapine.

In November 2013, Johnson & Johnson agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it improperly promoted the antipsychotic drug Risperdal (risperdone). The Wall Street Journal reported:

“The agreement is the third-largest pharmaceutical settlement in United States history and the largest in a string of recent cases involving the marketing of antipsychotic and anti-seizure drugs to older dementia patients. It is part of a decade-long effort by the federal government to hold the health care giant — and other pharmaceutical companies — accountable for illegally marketing the drugs as a way to control patients with dementia in nursing homes and children with certain behavioral disabilities, despite the health risks of the drugs.” (Italics mine)

On February 24, 2015, Johnson & Johnson was ordered to pay $2.5 million in damages to Austin Pledger and his family for failing to warn that its Risperdal antipsychotic could cause gynecomastia, which is abnormal development of breasts in males. Read Steven Brill’s shocking online ‘docubook’ on the case here; in addition to Pledger’s story it documents how J&J marketed Risperdal to eldercare physicians, long-term care facilities and nursing homes in the USA.

In May 2015, Johnson & Johnson was ordered to pay $7.8 million to settle the state of Arkansas’s claims the company illegally marketed Risperdal. According to BloombergBusiness, as part of that case:

“Janssen (a J&J subsidiary) pleaded guilty to a criminal charge tied to claims it marketed the drug for uses not approved by the U.S. Food and Drug Administration, including treating elderly dementia patients.” (Italics mine.)

These fines and settlements are mere drops in the BigPharma profit bucket.

Meanwhile, many physicians still prescribe antipsychotic medications for elderly people living with dementia. On average, about one in three residents in long-term care facilities in North America are given antipsychotics. Why is that? Is it because antipsychotics actually work in reducing responsive behaviours in people with dementia despite the fact that’s not what they’re intended for? The answer to that question is no–evidence shows people in LTCFs are for the most part better off WITHOUT antipsychotics.

I continue to blog about this issue. Read more shocking facts at the links here.

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Image copyright: amenic181 / 123RF Stock Photo

6 Comments

  1. My mother walked into a hospital Sep 10, 2015, to check on a bump on head after a fall. She clinically had no injury. She walked in, stated her name. From there the “experts” determined she was a fall risk and wouldn’t allow her to get out if bed. Many statements of “I’ve got to go”, led to multiple failures of bed pan. My mom was NOT incontinent or incompetent.

    On the transfer to floor for overnight observation, she was agitated, I convinced an intelligent nurse to try a commode, my mom voided. Back to bed, then in diaper. Receiving fluids, she filled up and needed to go. She kept saying, “I need to go!”, a “sitter” told the doctor she was trying to escape, as she kept trying to get out of bed.
    In ER, I had stated CLEARLY, NO psychotropics, I received a call my mom had calmed down after I was told to leave and thus lost my advocacy to allow her to void. The call stated , no worries, your mom calmed down, we gave her kolonopin and seroquel.

    With a new dr following NH stay-off the poison, he places her (against my will) on risperdone. Ended up in hospital.

    My mom is now confined to wheelchair, groans, SCREAMS, and drools. I’m in IL, medicinal cannabis is available for aggravated dementia. Why are we KILLING Our most vulnerable with off label use of DANGEROUS drugs?

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