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Wednesday, 16 January, 2002, 13:10 GMT
NHS drugs regulator 'flawed'
New drugs have to be approved for the NHS by NICE
The independent body set up by the government to decide whether drugs should be prescribed on the NHS gives flawed guidance, MPs have been told.

The Consumers' Association (CA) criticised the way the National Institute of Clinical Excellence (NICE) takes decisions at a meeting of the House of Commons Health Select Committee on Wednesday.

NICE guidance issued so far appears to raise as many problems as it seeks to resolve

Ike Iheanacho
CA representatives said that as a result NICE has made the wrong decisions about some drugs.

NICE has been the target of mounting criticism since it was established in 1999.

Last year doctors and patients complained about a delay on deciding whether the drug Herceptin should be offered to breast cancer patients.

Multiple sclerosis campaigners were also furious at the decision to ration the availability of the drug beta interferon - a recommendation made only after a substantial delay.

The CA says there are also serious question marks over NICE guidance on the following treatments:

  • Influenza
  • Type 2 diabetes mellitus
  • Attention deficit hyperactivity disorder (ADHD) in children
  • Alzheimer's disease
  • Motor neurone disease
  • Obesity in adults

Ike Iheanacho, deputy editor of CA's Drug and Therapeutics Bulletin, said there was nothing with NICE's aim of ensure that NHS patients received the best treatments in the fairest way possible.

But he said: "NICE guidance issued so far appears to raise as many problems as it seeks to resolve.

Several problems

"We have reviewed and found serious flaws in all nine NICE guidance documents that we examined in detail.

"Guidance from the Institute should be a credible, reliable 'gold standard'. On current evidence, it often is not."

Health authorities are now compelled to implement NICE's recommendations.

The CA is concerned that this will mean that provision of other treatments which are effective and necessary - but which have not been reviewed by NICE - may be reduced inappropriately in order to contain costs.

Mr Iheanacho said: "This is a serious issue about resources and access that the government must address.

"Processes on involvement of patient organisations, and transparency on how NICE reaches its decisions need to be subject to a full-scale independent review."

Multiple sclerosis

The Health Committee also heard from Glynn McDonald, policy and campaigns manager for the Multiple Sclerosis Society, complained about a lack of openness in the way the institute reaches its decisions.

The mixing up of the clinical and cost-effectiveness processes pollutes the outcomes of both

Rebecca Miles
He argued that the deliberations of the institute's appraisal committee "should be opened up by allowing patient representative organisations to observe discussions".

Rebecca Miles, director of the National Cancer Alliance, said patients were suspicious that the institute attached too much weight to cost effectiveness considerations.

She said: "Currently, the mixing up of the clinical and cost-effectiveness processes pollutes the outcomes of both, especially when the methods are unclear or questionable."

The charity Macmillan Cancer Relief said NICE was failing to listen to patients' views.

Chief executive Peter Cardy said: "At present, Nice is neglecting the concerns of its principle stakeholder, the patient.

"It needs to rebuild patients' trust, by openly giving equal weight to their views along with those of other interested parties, including pharmaceutical companies."

See also:

05 May 01 | Health
Drug prescribing methods queried
16 Nov 00 | Health
Nice decisions to be 'public'
05 Dec 01 | Health
Drugs watchdog 'must be obeyed'
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