This is the second of a two-part series. Read the first part here.
After two years of at times excruciating evidence of systemic abuse inside the nation’s aged care homes the royal commission into aged care this morning handed its final report to the governor-general, having already flagged the need for sweeping change. Countering the widespread practice of chemical restraint is likely high on the commission’s priorities.
But real change will mean attacking a culture built on a decades-long reliance on antipsychotic medications which have been used to manage the symptoms of dementia. It would also mean attacking the commercial interests of the pharmaceutical and aged care industries.
So how did it get this far in Australia? And what warnings have been ignored on the way?
The giant pharmaceutical company Johnson & Johnson first targeted aged care and the growing epidemic of dementia back in the mid-’90s as it sought to create markets in the United States for its powerful antipsychotic drug risperidone. It did so despite official warnings the drug might be harmful for older people.
Then it set its sights on Australia where a familiar story unfolded, with the drug set to become a staple in managing the at times severe behavioural issues associated with dementia.
Risperidone made it on to the Pharmaceutical Benefits Scheme (PBS) in 1995 — a holy grail for drug companies because it means the government subsidises the cost of prescriptions, a key to boosting sales. Risperidone was the first of the so-called atypical antipsychotics listed on the PBS. Back then, as in the US, it was officially approved only for schizophrenia and mania associated with bipolar disorder.
Other antipsychotics with similar properties soon joined the fray. Eli Lilly’s olanzapine was listed on the PBS in 1997 and AstraZeneca’s quetiapine gained PBS listing in 2000. Both were for the treatment of schizophrenia.
Both Eli Lily and AstraZeneca — just like Johnson & Johnson — later ran foul of US authorities for illegally promoting their drugs for dementia symptoms in the elderly. Eli Lily entered into a near $2 billion settlement with the US government, with its drug being found to increase the risk of severe adverse effects, including sudden cardiac death, heart failure, and life-threatening infections.
AstraZeneca paid a US$520 million fine for marketing its drug for use with children and the elderly people, contrary to FDA approvals. In AstraZeneca’s case the allegations included paying doctors to put their name to articles which had been ghostwritten for them as a way of promoting off-label uses of the drug.
Johnson & Johnson’s risperidone though stayed ahead of the competitors. By 2005, 10 years after its initial listing for schizophrenia, it gained PBS status for treating behavioural disturbances in dementia. It has remained the only drug with that approval, though the other drugs can be prescribed off-label.
Risperidone and the other antipsychotic drugs soon had an unshakeable hold in nursing homes. So much so that by 2007, according to a study in the Australian and New Zealand Journal of Psychiatry, the drugs were being used “extensively” to control behavioural disturbances in patients with dementia. Its use was markedly higher in women than men.
The study also found that Eli Lili’s and AstraZeneca’s drugs had been used for dementia patients even though it had restricted approval for schizophrenia and bipolar disorder. (Risperidone had official approval for dementia uses.) This, the authors found, had “significant financial implications” on the PBS.
By 2015 risperidone had become one of the top 10 drugs prescribed nationally by nurse practitioners.
Tracking by the Australian Institute of Health and Welfare showed that in 2016-17, close to 30% of all people in permanent care in a facility were being given at least one antipsychotic drug.
The survey also tracked risperidone specifically and found that 20% of people with dementia or Alzheimer’s in permanent care were on Johnson & Johnson’s drug.
Warnings made, warnings ignored
A remarkable feature of the risperidone story is that it continued to be used extensively with elderly nursing home residents despite clear warnings stretching back at least 20 years from medical researchers.
Dozens of Australian and international studies have warned that these powerful antipsychotics were likely to do harm.
In 2009 the UK government commissioned a landmark study which concluded that risperidone and its ilk appeared to have “only a limited positive effect” in treating symptoms but could cause “significant harm” to people with dementia.
The report measured the harm in terms of deaths and cerebrovascular “adverse events” — around half of which may be severe — per year. It suggested it was possible to reduce the use of antipsychotic medication to just one third of its level. The report, like others before and after it, made a plea for urgent change to address the fact that 65% of prescribing was unnecessary.
In 2013, independent Australian agency the National Prescribing Service analysed PBS data and found evidence to suggest “a high level of inappropriate prescribing of antipsychotics in older people”.
In 2014 a Senate committee raised its concern about the “overreliance on medication” to manage the behaviour of residents. It made a series of recommendations, including a three-monthly review of use, recording why antipsychotics are used and attempts to reduce use, and annual audits.
In the same year Alzheimer’s Australia published a review of the medical evidence, linking antipsychotic medications to confusion, fractures, falls, urinary tract infections, sedation and much more in a laundry list of nasty side effects.
By 2015 evidence linking risperidone to an increased risk of cerebrovascular events in older people with dementia — highlighted in the UK back in 2009 — forced the Therapeutic Goods Administration to put restrictions on the use of risperidone among people with Alzheimer’s disease and remove its recommendation for use in other forms of dementia.
But those attempts ultimately had little impact according to pharmacist and former senior lecturer in dementia care at the University of Tasmania Juanita Westbury. Westbury found that the use of other medications, especially oxazepam and quetiapine, rose as a result of the restriction on risperidone and that “by 2019 overall risperidone use had returned to original levels”.
Westbury’s evidence to the aged care royal commission in 2019 was that the public purse was “effectively subsiding the unlicensed use of antipsychotics in residents of aged care”, with prescribers having “free range to prescribe these agents”.
Westbury appeared to speak for many well-intentioned medical workers who’ve worked with mixed success for years to reduce the use of antipsychotic drugs.
For all their efforts, progress has been slow or non-existent. Some change has come in the shadow of the royal commission. For years it has not been possible to tell from PBS data what the precise rate of prescribing for different drugs is in aged care facilities — a key gap in the data.
That was fixed only last year when then chief medical officer Brendan Murphy was put on the spot at the royal commission.
For all the gains in consumer rights when it comes to nursing homes, there is still no publicly available information on what drugs individual nursing homes use, a step that might allow consumers to make their own judgments.
The health department has told Inq that things will change from July 1 this year when aged care facilities will be required to report the percentage of care recipients who are receiving antipsychotics, a step which it said would provide “a vital mechanism for aged care providers to engage in continuous quality improvement and achieve improved clinical outcomes for senior Australians in residential care”.
The sobering fact though is that this stems from a recommendation first made by Senate committee in 2014.
In the intervening years the number of those with dementia in nursing homes has only grown further — and with it a systemic dependence on the pharmaceuticals made, promoted and sold by Johnson & Johnson and others.
“In the intervening years the number of those with dementia in nursing homes has only grown further — and with it a systemic dependence on the pharmaceuticals made, promoted and sold by Johnson & Johnson and others.”
Yes. The problem is not confined to one drug or one company. It is not even confined to one government.
As late as 2019, I had to argue, fight and eventually use my power of attorney and advanced care directive to ban in writing the use of antipsychotic drugs and benzodiazepines for the treatment of my wife, dying of semantic dementia.
The record of the Australian government is appalling. Its policies have promoted this off-label prescription and funded it with taxpayer money. The blunders have been clear for all to see for years.
why was she prescribed those drugs for?
My wife’s dementia symptoms included agitation, “vocalisation” (wailing), distress and accusations. These are common in dementia patients, especially those suffering one of the fronto-temporal dementias. They are now known as “the rage stage”. The correct treatments can include some medications, but not antipsychotics and not benzodiazepines.
My regret is that poor government policies obliged me to learn that the (very) hard way and to advocate without help.
Actually the problem is that each demented person responds to a variety of drugs including anti-psychotics depending on the dose – but benzodiazepines definitely should not be used – a doctor friend of mine has written a plan for his patients in care which includes antipsychotics which have been shown to work in the appropriate doses- so this global decrying of certain medications is actually counterproductive for the overall care of the demented and the carers. Talking to doctors who actually take care of these cases [rather than academics who have the time to give their unfounded ideas at the interminable talk fests called Royal Commisssions] behaviour control eventually finally comes down to simple choices chemical restraint or physical restraint in very difficult cases.
I think you’ve missed the point of the academic arguments which was something like that as much of 65 – 70 percent of antipsychotic prescribing for people living with dementia is inappropriate. No one has suggested it is entirely inappropriate. The point is that residential aged care facilities are federally funded and operate with minimal clinical governance and poorly qualified and poorly paid care assistants in place of adequate clinical practitioner staffing including registered nurses and pharmacists. This is the climate in which misuse of these heavily sedating medicines flourishes and certain commercial interests make profits (from government [taxpayer] dollars at the expense of our elders). This is not about decrying doctors–although no practitioner can be perfect–this is about how inadequate systems fail to prevent harm of the vulnerable and how academics and experts who have highlighted the failings repeatedly can be ignored because of the profit motive. The aged and disability care sectors in Australia have always been a federal responsibility and have always had a significant level of service delivery provided from non-government agencies. Aged care started as little more than hostels in which elders were physically and chemically restrained as a matter of course and sadly very little has changed despite multiple inquiries over multiple decades.
I had a very circular conversation with a GP who had a lucrative contract with a nursing home, who attempted to dismiss me as an “Over invested family member”.
He was taken aback when I allowed him to attempt to fob me off with big words and at the end of the conversation I informed him that I was reporting him to Health Ombudsman and APRHA.
I then explained that I was not a family member, I had assessed him and the prescriptions he was signing were in appropriate
I had been asked as a relative of his best friend to assess him. He is a “locked in syndrome” with a brain that works and able to stand on one leg, transfer himself into a 4 wheel drive/
Good work, Ratty !
Everybody now knows (because I have slammed it down the throats of Dementia Australia and the AMA and Dept Health and the Royal Commission for years) that risperidone, antipsychotics and benzos are hugely over-prescribed for dementia patients and I have copied them all the published authorities.
Thanks to David Hardaker and this article, they now know that the flogging of this dope is caused by the commercial interests of Big Pharma and contrary to patients’ health interests.
The people paid to regulate this stuff are going to get a well-deserved hammering.
I can but imagine your ordeal on that. Much appreciate your commenting.
Thanks for the interesting article, David. It spurred me to do a quick bit of research on risperidone, and that small amount of research left me wondering how on earth people decided that it was a good idea to use it as a treatment for dementia patients.
Essentially, the dopamine theory of schizophrenia, was the rationale behind its development. This nowhere near universally agreed upon theory, posits that the more delusional symptoms of schizophrenia, are a result of excessive dopamine in the brain. Therefore, administering a dopamine antagonist, like risperidone, should modify those symptoms.
However, for Alzheimer’s and most forms of dementia, excessive dopamine would have little or nothing to do with the pathology. Dementia is largely caused by tau tangles and amyloid plaques, both destroying neurons and interfering with neuronal transmission. So, it would seem counterproductive, to introduce a dopamine antagonist, that would hinder some of the neurotransmission that is still occurring.
It would also be likely to have problematic side effects. When we feel pleasure, a proportion of that is due to dopamine being released in the brain’s pleasure circuits. Dopamine antagonists are likely to make someone, who is already feeling a bit down about being in a nursing home, even more down. And without dopamine rewards, a person might be less likely to seek out stimulating company or attempt to do challenging tasks: and those are exactly the the sort of activities, that are recommended to delay dementia. Although, paradoxically, they might attempt to take some crazy risks, just to get a significant dopamine reward. Also, other diseases associated with aging, like Parkinson’s, are thought to be a result of dopamine deficiency, so there’s the likelihood that risperidone would contribute to the development of those.
Anyway, just that quick bit of research, suggests that you’re right in claiming that its widespread use is a scandal.
Thank you for that clear explanation of the matter.
Greatly appreciated.
Agreed. That was good.
Risperidone was/is a definite No No for people with Parkinson’s disease,
You will find the use of antipsychotics in the otherwise healthy elderly is not based on its therapeutic effect, that starts at a much higher dose than the elderly are given. The low dose use, of respiridone in particular, is for its side effects of drowsiness and somnolence, amongst others. The doctors are encouraged to write full scripts and pharmacy encouraged to fill them. This makes the market share of that particular agent look healthy and goes a long way to help change a doctors prescribing habits to fit the ground swell of prescribing opinion.
Pharmaceutical companies are For Profit organisations.
The real question is when did a health/ care facility (Maximum qualification registered nurse) become the decision maker regarding the use of anti-psychotics and sedatives on a patient clearly unable to consent.
These facilities have become resident’s asset munching mistreatment giving, money making machines.
Whenever there is a profit making motive, there is a clear reason to minimize staff maximize profit and really, the resident is only a profit center.
John Howard is to blame for this entire mess.
He was the one that privatized nursing homes and opened the vulnerable to the rapacious.
The last four years of my wife’s life with dementia were spent in full time care in nursing homes. She was given antipsychotic drugs including risperidone and benzodiazepines including valium which my research showed to be inappropriate.
All that time, the yarn spun was that this was a matter of difference of medical opinion.
I am hugely shocked to find from David Hardaker that I was snowed. I gave these people the benefit of acting with good intentions.
No, they were being bribed by Big Pharma. They were corrupt. The authorities who regulated them declined to act and inaction was not among their legitimate options. The regulators were conspirators. I am ready to join a class action, and I have the evidence documented.
I am waiting for the day when it dawns on people that the Pharmaceutical companies are the real wholesale drug dealers and the corner doctors are the real street dealers. Too harsh? Show me evidence to the contrary.
“The blunders have been clear for all to see for years.” – if only they were ‘blunders’ rather than the purposeful use of the taxpayers’ purse by the aged care industry to make their businesses easier and more profitable to run
Bang on Roberto. it’s built into the system.
Under nourish. Over medicate. If neither accomplish . . physical abuse! Together, they constitute not a humane end-of-life experience but an industrial culture supported by both ‘For-profit Providers’ and ‘Federal Government’. The preferred outcome a given.
The Federal Govt’s mandated oversight of Aged Care negated by support of and for Providers negligence. In exchange for Govt’s non-accountabilities? How many decades more before . . .?
…and a useless incompetent federal minister for age care.
What has been left out of this article is the legislated reduction in required numbers of qualified and experienced nursing home staff in order to permit nursing homes to be run as profit-making businesses as well as the closure of nursing homes that specialised in the management of dementia patients, especially those who might be a danger to themselves or others.
With fewer staff, the only way to manage such patients is by means of drugs. If there are insufficient staff experienced in the management of such people, because such people cost more than the proprietors are willing to pay, then drugging disruptive patients into quiescence is the only solution.
Staffing levels need to be mandated to a level such that difficult patients can be cared for, by qualified staff, without pharmaceuticals. The neoliberal valorisation of the market as the solution to all the problems of humanity cannot provide a humane means of managing the demented elderly while still maintaining the obscene profits that seem at present to be being made from running a nursing home.
Add to the very inadequate staffing levels, the poor training of care staff, and the complete lack of training in language skills for the non-english speaking background (NESB) staff.
Agreed., Adaptive Interaction is a valuable strategy, identifying what is upsetting the resident and finding ways to communicate.
Mearly every harmful outcome in Western society is the tesult of greed and greed is not just tolerated but encouraged, cherished, championed. Discourage greed and make things a bit better.
Thank you David for highlighting the appalling use of these drugs in the elderly.
For me, on a personal level, I recall my beautiful mother being prescribed Risperidone by Campbelltown Hospital in Sydney in 2006 following a diagnosis of Alzheimer’s.
I clearly recall my horror reading her Discharge papers stating she had been diagnosed with Schizophrenia, which had never been mentioned by Geriatricians in conversation with me.
I also vividly recall researching my family tree and spending hundreds of hours looking for evidence of anyone else who may have had Schizophrenia, and finding none.
In fact, I still have the folders full of paperwork.
My Mum went into a Dementia Unit in January 2006 and died there in a week before Christmas 2010.
It was not until late 2009 when I took her to see a Geriatrician for her yearly checkup, that I spoke about the torment of wondering if the Schizophrenia would be inherited by myself, my daughter and her newborn baby boy.
Her reply floored me! “Your mother doesn’t have Schizophrenia! We (hospital staff) have to write that diagnosis so we are approved by the government to prescribe the medication. It’s just to help her with the symptoms of Alzheimer’s/Dementia”…..
What kills me now after reading your article, is that I did nothing about it, didn’t look into it any further…my one consolation being that I was completely rapt up in the wonders of being a Grandma and grateful that the beautiful child and his beautiful Mum had no hope of getting Schizophrenia from either myself or my Mum.
These past two years of the Royal Commission into Aged Care and your insightful discussion into the use of this particular drug, have awakened all the traumas, abuse and suffering my Mum endured during her *care* in the Dementia Unit, along with all the others too, whom I cannot speak for, yet witnessed abuse of on a daily basis for three years and eleven months.
The odds are not in my favour for Alzheimer’s, but I hope I am gone long before that diagnosis comes to me.
Change will not come to these places until such time as the loved ones of Prime Ministers are placed into these *care* homes.
Nor will it come until Geriatricians, GPs, and others in the medical profession stop lying about the kickbacks they’re getting from Drug manufacturers!
Marcia, that is just terrible — scandalous. I would like to know more if that’s OK with you. I wonder if would you kindly email me on dhardaker@protonmail.com.
(Others welcome too.)
These stories are hard to read…
and scary.
I worked in acute aged care as a clinical nurse for 15 years . You missed the drug that really zombies you out: sodium valproate, the mood stabiliser..Risperidone can give men breasts , make you lactate and make you impotent but the alternatives are – haloperidol, worse side effect profile. Olanzepine- good drug but you can have massive weight gain. Sometimes you do need drugs, especially when you have folks who like to clobber other residents or kick you in the face when you are tying their shoelaces . Taxpayers are going to have to be prepared to put a lot more of their taxes into aged care if you want things to get better. No other way out. If you want to have no drugs then some residents will have to be individually ‘specialed’ by a nurse – that will cost $7,000 to $10,000 per person per week all up, cost of wages push cost of employing the person. Are taxpayers ready to cough up that kind of money? Probably not.
Interesting to get your perspective.
Valproate? Really? What dosage for zombification? I’m on it for epilepsy
Thanks for the info, JR. Is sodium valproate used extensively in aged care homes?