There are calls for the abolition of upper-age limits in clinical drug trials, with one medical specialist saying not enough is known about how medication affects frail elderly patients.
There is evidence that increasing numbers of elderly Australians are being hospitalised because of the combined side effects of the cocktail of medications they take.
Professor Richard Lindley from the George Institute for Global Health estimates about 10 per cent of elderly patients end up in hospital because of the mix of medications they are taking.
He says the fact older people are usually excluded from clinical drug trials is not helping the problem.
“In many situations we really don’t know whether the treatments that were shown to be effective in young, fitter healthy people are going to work in older frail people - so we’ve got a bit of an evidence-practice gap,” he said.
“So I think an upper-age limit isn’t scientifically sensible and especially as our population is ageing and the world is ageing, I think it really is important to get good evidence in older people.”
Professor Lindley says older people make up 63 per cent of cancer patients in the United States, but they represent only a quarter of participants in trials of the relevant drugs. He says it is a problem across a number of other illnesses as well.
“As geriatricians, in fact, one of the major interventions we do in hospital is to actually stop a lot of medication because we’re finding as our patients have got older and frailer, the mix of medications that perhaps kept them well in their 50s and 60s are now starting to cause problems in their 70s and 80s,” he said.
Professor Lindley estimates about a quarter of Australians whot live in nursing homes are taking at least four medications. He wants the people most likely to be using particular drugs included in their clinical trials.
“There’s actually a variety of methods available now where we can measure frailty,” he said.
“So rather than exclude patients because they become frail, I’m saying let’s put them in the trials, let’s measure their frailty, let’s see if people willing to go into clinical trials benefit from the sorts of typical treatment that doctors like myself are prescribing.”
But Professor Lindley acknowledges including elderly people in clinical drug trials does pose some challenges.
Memory loss can mean an older person may not remember when to take the drug and they must be able to give clear consent to participating in the trial.
Professor Lindley thinks it may be hard to persuade those running trials to include frail elderly people.
“In terms of the commercial sector you could understand that if you’re a pharmaceutical company and you have a new drug and you’ve just got it licensed because of promising results from younger people, the last thing you want to do as a pharmaceutical company is to do a trial in an older, frailer population that might produce bad news for your product,” he said.
“I suspect it will be important for government funding agencies to consider the trials for the older frail patients.”
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