It gets nasty for Nice

Bryan Hubbard — Fri, 17 Nov 2006 14:50:00 GMT

For such a haven of faceless bureaucrats, NICE has suddenly become the hate figure of the UK. NICE - or the National Institute for Health and Clinical Excellence - is the gatekeeper of the National Health Service, and it is the ultimate arbiter of the drugs that are prescribed by doctors.

Sometimes drugs are turned down on grounds of cost, sometimes because they just don't work. For the drug company, a rejection is nothing less than a commercial disaster, especially if the drug concerned is a pioneering one that would have cost at least £150m to get approved.

The patient, too, may see the drug as the great hope. It happened with the *** cancer drug Herceptin, and it's happening again with the Alzheimer's drug Aricept. If the drug is the 'answer', then NICE's rejection is nothing less than a callous disregard of human life.

Alzheimer's sufferers and their carers are planning a major protest against NICE's decision with nationwide marches and demonstrations. The same thing happened with Herceptin, and the government finally wilted to public demand.

In the case of Aricept, the protestors are being joined by the manufacturer, Pfizer, which is calling for a judicial review of NICE's rejection. If it goes ahead, it will be the first time that NICE has been challenged in court, and itvmay well not be the last.

But how does the patient know that the drug is the solution to his or her ills? In the case of Aricept, there are a few anecdotal reports that the drug has helped, but a major review that was published in 2004 concluded that it wasn't providing any benefits, even to the early-stage patient.

A similar story can be told about Herceptin. Many of the protests were encouraged by the drug manufacturer which eventually got its way.

Will the same happen with Aricept? You betcha it will.

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Mr Bush's poodle

Bryan Hubbard — Thu, 16 Nov 2006 17:22:00 GMT

Most agree that the American health model is in meltdown. Driven by insurance money, surgeons perform too many unnecessary operations while doctors dispense too many unnecessary drugs. Not only does this aggressively interventionist approach keep medical costs high, it also means others wait longer to get on the medical merry-go-round.

Not content that the model is plain wrong, health officals in the USA want to export something similar to the UK. The US's deputy health secretary Alex Azar is lobbying the UK government to allow America's drug companies unlimited access to the National Health Service (which, in case I'm accused of bias, also doesn't work well).

Azar wants a free for all, where every drug that's been approved is made available on the NHS as part of a free market culture. And to add meaning to this market, drug companies would also be permitted to advertise directly to the patient, just as they are in the US right now.

There's a very special reason for Azar's remonstrations, and it's all to do with an organisation called NICE (National Institute for Clinical Excellence). NICE's principal function is to act as gatekeeper to the NHS to ensure that its budgets are not overstretched by drugs that are either ineffective or just too expensive.

NICE has been seen as the bad guy over a range of drugs that patients believe might be their saviour. If by chance they are, it would be a world first in medicine. Follow the threads and you discover that many patients have been 'encouraged' to demand a drug be made available either directly or indirectly by the manufacturer itself.

Poor old NICE is seen as the party pooper. And several recent heated meetings between UK government officials and drug company representatives bear out this image. The drug companies made it clear they were prepared to withdraw their substantial investment in the UK unless a 'better environment' for novel and innovative drugs was established.

So what will Mr Blair do in the months left to him as Prime Minister? Will he continue to be the Bush poodle that we all know him to be, or could it be that the recent mid-terms in the USA have shifted the power balance between the two war mongers?

For once, Mr Blair won't cave in. The NHS is too much of a sacred cow to meddle with, and the American drug companies will be seen to be hollow blusterers.

Adverse Reactions : national institute for clinical excellence

It gets nasty for Nice

Mr Bush's poodle