(Image: Unsplash)

Next time you go to a nursing home and are confronted with a sea of grey heads zonked out and near immobile, think of this name: risperidone, the Johnson & Johnson creation that became the go-to drug for nursing home administrators.

The story of how risperidone, designed originally for schizophrenia, became widely used as a chemical restraint is a remarkable demonstration of the power of one drug company.

It is also the story of how commercial imperatives overrode the objections of medical experts as risperidone and its imitators became central to the aged care business model struggling to deal with increasing rates of dementia.

As a result risperidone and similar drugs were misused — or overused — in up to 90% of cases, Professor Brendan Murphy, then Australia’s chief medical officer, told the aged care royal commission, which is due to be handed to the governor-general tomorrow.

Murphy also gave evidence that the overprescribing was based on a “misguided belief” in nursing homes that the drugs would be effective. The drug didn’t work and wasn’t needed.

So how did one drug pave the way for such massive abuse?

The beginning

The risperidone story begins in the United States in the early 1990s with the ambitions of the Johnson & Johnson pharmaceutical company, a healthcare behemoth with a market capitalisation which soars over US$400 billion.

The full story of its determination to expand the market for risperidone beyond its original purpose has been unfolding ever since via a series of US government court filings.

In 1993 risperidone hit the market as a breakthrough antipsychotic drug used to treat schizophrenia by controlling symptoms of hallucinations, delusions and incoherence. It worked on the brain’s neurotransmitters, rebalancing dopamine and serotonin production.

Over subsequent years the US Food Drug Administration (FDA) approved additional conditions it could be used to treat, bipolar disorder and mania and later autism.

Yet Johnson & Johnson sought an even larger market: the growing aged care sector — a good bet given the ageing population and projections of more and more elderly with dementia or Alzheimer’s. It said risperidone could be used to control associated behaviours such as agitation, aggression, shouting out, wandering and restlessness — the behaviours that make life so hard for everyone in a nursing home environment.

But a US government court filing shows that the FDA consistently questioned its safety for the elderly. It pointed to clinical trials which indicated that risperidone increased the risk of strokes in the elderly and diabetes in all patients.

Those clinical trials included ones sponsored by Johnson & Johnson itself. Later work would also link the drug to an increase in deaths. But that didn’t stop the company from promoting the drug. Far from it.

The US government alleged Johnson & Johnson promoted risperidone “for uses that were not approved as safe and effective” for six years, from 1999 to 2005.

The case was settled in 2013. Johnson & Johnson agreed to pay US$2.2 billion to settle criminal and civil liability. Allegations included that the company had paid kickbacks to doctors and created “written sales aids” for the company’s ElderCare sales force which emphasised the symptoms but played down any mention that the drug was actually approved for schizophrenia.

The company had also provided incentives for “off-label” uses by basing its bonuses to sales reps on the uptake in nursing homes. (“Off label” refers to drug applications which are not approved by the regulator.)

The Johnson & Johnson settlement was one of the largest healthcare fraud settlements in US history.

The company faced other legal action over risperidone with the case of a severely autistic boy, Austin Pledger, who developed size 46DD breasts from the age of 12 after using risperidone. A jury found the drug had affected the boy after Johnson & Johnson had encouraged his doctor to prescribe it without warning of its risks.

Although the FDA had prohibited promoting the drug for the treatment of children, Johnson & Johnson went ahead anyway. “By the time young Austin started growing breasts,” The Huffington Post reported, “Johnson & Johnson was reaping more than half of its [risperidone] sales from prescriptions written for children to alleviate all kinds of behaviour disorders, and for the elderly, who were given the drug for simple symptoms of dementia or restlessness.”

Back in 1995 the FDA argued to Johnson & Johnson that anxiety and restlessness in dementia patients were not necessarily psychotic manifestations and “might even be construed by some as appropriate responses to the deplorable conditions under which some … patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioural control”.

Now, 25 years later, the aged care royal commission in Australia seized on the same point. In its interim report in late 2019, it homed in on the reliance of antipsychotic drugs like risperidone:

The aged care system has fallen behind, to the significant detriment of people who are subjected to unjustified chemical and physical restraint.

In its final report it is promising to address “the regulatory framework as well as other measures designed to reform this neglected area of aged care”.

Next: How Johnson & Johnson’s schizophrenia drug took hold in Australia’s aged care homes.