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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.