The Times (KC) 08-Aug-08

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We need cancer drugs. NICE must go

The Government's penny-pinching body has made yet another stupid decision

Jonathan Waxman Our Government has been a fabulous custodian of healthcare. Public memory is short and many of us have forgotten how difficult things were for patients before 1997. During the past decade we have seen a doubling in NHS spending. As a result, patients don't have to wait for scans, are seen in hospitals within a reasonable time, and surgical waiting lists are relatively short.

But there are areas of healthcare where things have gone badly wrong, where wrong meets bad, becomes worse, and then spirals to appalling, and these areas are approached through the bloodstained portals of the National Institute for Health and Clinical Excellence (NICE).

This week's NICE announcement on treating kidney cancer, a preliminary opinion about the value of new drugs, has sent doctors into apoplexy. Kidney cancer affects approximately 7,500 people in the UK each year, and there are 2,500 deaths. We have recently begun to understand the molecular biology of kidney cancer, and to know of its specific characteristics. Understanding these characteristics allows us to design treatments that exploit the differences between kidney cancer cells and normal cells. As a result, we have wonderful new treatments that double life expectancy in this condition.

NICE has evaluated these four new drugs for kidney cancer and indicated that these drugs will not be recommended for use in patients. This is against all sense, and contrary to the situation in the rest of Europe and in the United States, where these drugs are available. NICE has made its decision on the basis of an arcane and extraordinarily complex calculation which relates the benefit of treatment with these new drugs to a treatment that is comparatively ineffective.

So, a fabulous new treatment has been compared to junk, and the costing for the new treatment ratioed up to give a conclusion on costs, which is absolute nonsense (and here I underplay the argument against the decision). In its defence, NICE might feel it has a moral responsibility to save money. But it is a short-sighted morality if the sums involved - as they are in the case of kidney cancer treatments - are paltry.

In the past seven years there have been 407 NICE guidances on cancer. It would be an understatement to remark that virtually all of them have been controversial. Many guidances have been stomped on by judicial review or overruled by health ministers. Now, with this latest decision NICE has told us all how irrelevant it is and why it should be abolished.

NICE was set up in 1999 with a brief to provide clinical guidelines and technology assessments for England and Wales (there is a separate panel for Scotland). But there is no equivalent of it in any other European country, or in the US. In Europe and the US, decisions about the value of treatment are made at the time of licensing of the drug, through either the European Medicines Agency or the American Food and Drug Administration. In Europe and America squabbles about costs are ironed out at this stage, after negotiations between pharmaceutical companies and governments.

NICE is slow about making decisions. It takes two or three years to give its judgment after a drug has been licensed. Input into NICE is made through the Department of Health, by health professionals, patients and pharmaceutical companies. NICE's timetable for the review of cancer drugs is dictated by the Department of Health. The department tells NICE when to start the review process and when to conclude its review. The NICE committees are patrolled and staffed by health economists - with minority involvement by clinicians - who give a view as to the value of a drug or treatment in the context of a QALY, which is a “year of quality added life”. To put this in simple terms, if a drug is reasonably effective, and also reasonably cheap, then NICE concludes that it can recommend that the drug is used by the community.

But, before the “community” gets to use the drug, there is a second rank of decision-making. Primary care trusts, which are not legally obliged to follow NICE advice, are local area committees that make decisions on how the NHS budget is spent in their part of the country. There are 149 trusts in England and Wales issuing decisions about whether or not it is reasonable to prescribe a drug within its domain. So if the administrators of the PCTs for Bolton, Bognor and Bournemouth are all able to make independent decisions as to whether to follow NICE rulings, why do we need NICE?

Now with this absurd and arrogant decision on the value of drugs for kidney cancer, NICE has told us that it is absurd, arrogant and unnecessary. Our country should no longer underwrite the costs of NICE, which are currently at £30 million a year, and due to increase. This is a sum that could usefully be spent on providing drugs for cancer patients in a country where we spend less on cancer treatments than on drugs for constipation - in a country where, as a result of NICE's appalling and uneducated interventions, we spend less than two thirds of the European average on drug treatments for our cancer patients.

Jonathan Waxman is Professor of Oncology at Imperial College, London

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