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.
Being in a dementia unit while your body and mind degenerate as you wait to die is something many of us will encounter one day.The loneliness and fear is palpable.
We can only hope that the staff resident ratio is balanced well enough for workers to be able to provide support and some comfort.
The idea that farming the aged for their final years has a profit motivation is sickening. Neglect as a money spinner is too great a temptation for a corporate mindset
By raising the retirement age, increasing working hours, stagnating wage growth, it is increasingly difficult for their children to come and visit, let alone be equipped to manage having them at home, even for short periods, your own parents.
New legislation works to acknowledge our elders rights but can only be truly effective with better ratio’s and time/money allotted by employers and government that allows for visiting, it should never have come to this.
“We can only hope that the staff resident ratio is balanced well enough for workers to be able to provide support and some comfort” – it isn’t and I can’t see that it ever will be. It is my opinion as a registered nurse who has worked in aged care that frequently the problem is that the resident is hungry. I found that when I could find time to make the noisy resident (who was calling and keeping others from sleep) something simple like a toasted sandwich and a cup of tea and was able to sit with them whilst it was consumed the problem would be solved. But then management banned nursing staff from using the kitchen, so we used the staffroom and bread, butter, etc. was brought in by staff. Sometimes antipsychotics are necessary, but not until other interventions have been tried.
Active sitting and listening is a financial calculation that the time management people don’t seem to be able to comprehend that it saves money and improves standards in just about every aspect of their business model including desirability and profit.
i 2 did a brief stint in aged care in the 1990’s not as nursing but cleaning kitchen laundry up till about 8pm …i found the same thing. they were just hungry i used 2 just give sum things that i pocketed out the kitchen or even bought things from home. making sure i checked their charts 4 special dietary needs. things like sultanas crackers etc. all hygienically packed. but i think it was mainly the attention touch & voice of anotha human being. personally. i think the family collectively shuld b paid by the government 2 look afta their loved ones. much much betta. people who care. have a vested interest. money wise it will b far more cost effective then building “homes”. the concept of ‘homes’ is a thing of the past. spread the cost & care. 1st with the family. people cant b in 2 places @ once. work & care. life is a business. society is evolving. communications is @ our fingertips. but you cant beat the personal touch. real people in real time.
Excellent article — I love your work. And I know I’ve previously been a stickler about the TGA acronym being misassigned as the Therapeutic Goods Association when the ‘A’ is for Administration. I’m at it again. The FDA is the Food and Drug Administration not the Federal Drug Administration. TGA is Australia’s regulator for drugs; including vaccines, blood and tissue products, ‘biologicals’ which we don’t separately define, and complementary medicines; plus medical devices and in vitro diagnostic products. The FDA has remit over food; drugs, vaccines, blood/blood products, ‘biologicals’; medical devices; radiation emitting goods; cosmetics; & tobacco products — so broader. Soz about my wonkness — it’s my turf.
Thank you. Fixed now. Much appreciated.
Thank you for reporting on one of the most unreported issues. The Pharmecutical Holocaust. Big Pharma has out muscled the MSM for the mantle of the Fourth Estate. The tentacles of this monster stretch far beyond corporate and to the highest level of govt. Prescription drugs and over prescribing is one of the biggest killers in the US. I don’t have the figures but I am sure it would be the same here. Great article.
Big pharma is a blight on this earth. Profit is always the mantra. The legal cases against pharmaceutical corporations are rarely mentioned in the media, although a few books have been written of their shady practices (mainly American). The covid pandemic has shown their corporate greed with :a) taxpayer funding: b): intellectual property rights and protection from future litigation (on side effects etc) and all profits accruing to the corporation.
The continued use of harmful and useless drugs in the aged care sector seems to be one of “it’s best for care of elderly in a mass setting”. Will anything drastically change after this report? Sorry, but I have my doubts.
Very valid commentary -many Australians seem to be brain dead to the fact that Big pharma is responsible for pushing out an untested Vaccine. Big Pharma has no conscience & they have a history of terrible foul ups that have injured & killed tens of thousands.
Some interesting links below –Google the Highlighted:
consentfactory.org — The Vaccine (Dis)Information War
Professor Philipp Bagus on the “Political Economy” of Covid Hysteria-Mises Institute
The vaccine is many things, but it’s not untested.
You are a far can lya. It is common knowledge that the vaccines have been rushed and inadequately tested. You might have to sell those shares in Big Pharma and get a real job. I suggest a 6ft by 6ft easel. At least you see that one, Andy.
I doubt the 3 downvoters even bothered to exercise their tiny brains by investigating the links provided. A fixed mind with fixed assumptions is in every case dangerous to your health or wellbeing. A thoughtful mind weighs various assumptions. To believe what has been hammered at us by MSM for 14mths as Gospel is beyond stupid. We destroyed Iraq & other Nations based on MSM Lies!
“Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one.” Charles Mackay
Having been involved in Aged Care over past 7 years its sad how we treat the elderly in this nation.But nursing homes are the only answer for families but it is expensive to run a nursing home properly and somehow we have to pay for good care. We tend to rely on lowly paid unqualified workers to mainly look after our older loved ones and that is what society has created. Govts have privitised it and profit driven providers have risen to the challenge. But it is difficult to get people to take on carer roles due to high workloads and low pay and the stigma of being a aged care worker, so it becomes short staffed and that causes extra stress on staff. With high care dementia residents where family cannot look after them anymore due to their extreme behaviours, nursing homes are the only way they can go.Sometimes drugs are the only way to protect them and staff as the dementia takes hold, it is quite a insidious and horrible disease. Aged care workers should be more valued in this society of ours, but the elderly should be valued more and held in high esteem not tossed aside and neglected.