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It has largely been a troubled first decade for the
new organisation, hitting the headlines mainly for the
wrong reasons. Perhaps this is understandable due to the
sector in which it operates but it has led to growing
criticism which has peaked at times when the refusal of
key drugs have hit the headlines.
The first teething problems of the organisation were
found when deciding on the anti-influenza drug Zamavir.
Rejected at first by
NICE, the decision was fiercely
criticised by some, most notably the manufacturers
Glaxo
Wellcome, whose chairman threatened to withdraw future
research from Britain as a result. NICE later relented
and recommended that the drug be available for elderly
patients and other people at a greater risk of dying
from influenza.
In June 2000 the organisation was back in the
headlines, through its refusal to authorise another
drug, this time beta interferon for multiple sclerosis
sufferers. Once again patient groups complained and
again NICE relented.
Two years later, another storm, related to a drug to
treat age-related macular degeneration which leads to
blindness.
NICE initially decided that only those
patients who had already lost the sight in one eye were
eligible to receive the drug in question, verteporfin,
but that was eventually replaced by the organisation
issuing no specific advice, thereby leaving it as a grey
area.
Many probably know NICE through the arguments over
Herceptin, the breast cancer drug. The drug was
initially licensed for use in Europe for patients with
advanced breast cancer as far back as 1999.
In 2006 Ann Marie Rogers was angry when, following
radiotherapy and chemotherapy, Swindon Primary Care
Trust refused to pay for the cost of the drug. It was
the beginning of her campaign to get Herceptin made
available to all women diagnosed with early stage breast
cancer. Eventually she won a landmark victory in the
courts and the drug was fast-tracked for use on the NHS
as a result.
More recent criticism came NICE’s way in 2008 in a
row over drugs for Alzheimer’s patients. NICE had
refused to approve the drugs Aricept, Exelon, Reminyl
and Ebixa for sufferers in the early stages of the
disease, leading to fury from the families of sufferers
who were effectively being told they had to wait for
their relatives’ conditions to deteriorate before they
would be given the drug. The fight eventually brought
the parties before the Court of Appeal who criticised
the original decision.
Also in 2008, NICE ruled that four new drugs, used in
fighting kidney cancer, were too expensive. This time
the organisation fought back with scathing words for the
pharmaceutical industry. Sir Michael Rawlins, chairman
of NICE said at the time that it was the industry’s
fault that the drugs were too expensive, claiming that
they could be produced at a tenth of the cost.
NICE eventually backed down on one of the drugs,
Sutent, approving it as a ‘first line’ treatment, but it
was rejected as a ‘second line’ treatment where an
initial therapy had failed. The ban remained in place
for the other three drugs and the episode led to more
questions being asked of how could an organisation;
supposedly to be of benefit to patients, deny them a
drug, that was a potentially crucial breakthrough in
treatment.
Last year MacMillan Cancer Support criticised NICE
for rejecting Nexavar, a drug that can extend the lives
of people suffering from liver cancer. The cost of the
drug, estimated at about £3,000 a month was seen as too
high by NICE, despite it being routinely offered to
cancer patients elsewhere in the world.
Just last year another storm brewed up over bowel
cancer drug Avastin, which in trials was shown to have
extended life by up to two years. Despite most of Europe
having met the cost of treatment there was
criticism of
NICE because, despite the drug costing £18,000 for a
10-month course of treatment, the formula used by NICE,
the quality adjusted life year, gave the annual cost as
£36,000, over the maximum limit of £30,000 so the drug
was not approved.
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