Friday June 25, 2004
Drugs for Alzheimer's disease, which pharmaceutical companies and campaigners have lobbied the government to provide to large numbers of elderly patients with dementia across the country at a cost of over £39m a year, have little effect on their memory and do not stop the distressing deterioration of their lives, according to an important study published today.
The five-year study, paid for by the NHS and not the drug companies, found that the drugs are a waste of the scarce resources available for the condition, said the lead researcher Roger Gray, director of Birmingham University's clinical trials unit.
"Sadly, there are a lot of people with dementia and far too little money available to look after them," he said. "Doctors and healthcare funders need to question whether it would be better to invest in more doctors and nurses and better social support rather than spending huge sums of money prescribing these expensive drugs."
There is no cure for Alzheimer's and the drugs are the only existing treatment, which is why they have become an emotive issue among carers. There was an angry reaction from the drug companies who have pushed for the drugs to be prescribed everywhere since the National Institute for Clinical Excellence (Nice) approved them for use in the NHS in January 2001.
There are 39,000 people in the UK on the drugs, which cost £1,000 a year per patient. Eisai and Pfizer UK, who manufacture and distribute donepezil, known more commonly by the brand name Aricept, claimed there was "an overwhelming body of evidence" that the drugs helped people with dementia.
The drug companies' statement went out in the name of the Alzheimer's Society as well, but the patient group, which has campaigned hard for the drugs, later said that was a mistake and issued its own. The society received £68,258 from drug companies last year, but said this was a small part of a total income of £27m.
In its statement, the society said it "would be concerned if the findings were to further restrict access to drug treatments that we know can delay the symptoms of Alzheimer's disease". Evidence from people with dementia and their carers had shown that the drugs slowed the progress of the disease, it said. But Professor Gray's randomised trial, published in the Lancet medical journal, shows the drugs help patients to a higher score in memory tests, but not to cope any better with their lives.
Patients taking the drugs were able to name 11 different fruits in a minute instead of 10. but were not able to stay in their own homes or care for themselves any longer than those without the drugs.
In the original trials to get the drugs a licence, said Prof Gray, "the real questions haven't been asked - whether patients can walk home and don't undress themselves in the street.
"The Alzheimer's Society is lobbying very vigorously for access to these drugs. They would be better off lobbying for more social support for patients. There has been a debate recently as to whether some of the patient groups should be accepting money from the pharmaceutical companies.
"They [the society] have been asking for people with a good experience with the cholinesterase inhibitors (the class of drugs to which donepezil/Aricept belongs) to write in and they will submit it to Nice. There has been far too much reliance on anecdotal evidence of people getting better on the drugs."
The study, called AD2000, recruited 565 Alzheimer's sufferers living in the community, who were randomly assigned to receive either donepezil or a placebo.
The researchers found there was a low-level improvement in mental and functional ability in the tests, but that there was no difference in the length of time before patients were institutionalised or in the progress of their disability. The drugs made no difference to the costs of their care, the time unpaid carers had to spend with them, nor to the timing of deaths. Nice is updating its advice on Alzheimer's drugs, and will be taking the study into account.
Battle was immediately joined by a consultant in old age psychiatry from Swindon, Roger Bullock, who said the study was flawed in its design and execution.
The study was originally intended to recruit 3,000 people. It ended up with only 565 "primarily because many of the clinicians forced to participate in it by draconian public health policy in the Midlands did not believe in what they were being asked to do", he alleged.
The respected Drug and Therapeutics Bulletin assessed donepezil in 1997 and again in 1998 and concluded that there was no evidence that it improved patients' or carers' lives.
Jo Collier, professor of medicines policy at St George's school of medicine
in London and editor of the DTB, said surveys by the drug companies have
shown that many doctors have not been prescribing the drugs. "Prescribers
clearly were unhappy with the product and have voted with their feet. It
is now time for Nice to urgently review its advice," he said.
Copyright © 2004, Guardian Newspapers Limited