- 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 [Friday].
-
- 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 re searcher 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 in the past two financial
years, 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 cholin- esterase 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.
-
- Guardian Unlimited © Guardian Newspapers Limited
2004 http://www.guardian.co.uk/medicine/story/0,11381,1246967,00.html
|
