Leading article: Unjust and unsustainable

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The Independent Online

Trials have shown that Herceptin is extremely effective against the type of early breast cancer that Ms Clark has, reducing recurrence rates by up to 50 per cent. Bupa agreed last May that its private patients could have it. Ms Clark argues, with reason, that a life-saving drug should not be reserved only for those who can pay for it. But Herceptin does not yet have a licence in this country for early breast cancer and is not expected to have one before May 2006. Although doctors can prescribe drugs off licence (which allows Bupa to offer it), they do so at their own risk.

This is only the first of the bureaucratic hurdles placed between patients and the drugs for which many, like Ms Clark, cannot wait. Most health authorities refuse to pay for new drugs until they have been approved by the National Institute for Health and Clinical Excellence (Nice), the Government's medicines watchdog, which assesses cost-effectiveness - a process which can take years.

Yesterday's dossier of 23 cancer drugs held up in this process, some for more than two years, published by the charity CancerBacup, highlights the problem. What puzzles and infuriates people is that many of the same drugs are available in Scotland, having been fast-tracked to approval by the Scottish Medicines Consortium, a slimmed-down version of Nice.

The current system for assessing drugs in England is unjust, inhumane and unsustainable. Fortunately Nice is expected to announce today a new fast-track procedure to grant interim approval to new drugs where there is clear evidence that they are beneficial. Such interim decisions can later be modified once the full appraisal is complete.

The final barrier is cash. Even when approved by Nice, many health authorities decline to implement its advice, pleading the cost of new drugs. A review by the Audit Commission this month blamed poor financial planning rather than shortage of funds, but wherever the problem lies, the outcome is the same - patients denied drugs they need.

There is one caveat in all this. In our enthusiasm to embrace new drugs such as Herceptin, which hold great promise, we must not sacrifice the rigour with which they are examined. Remember Vioxx? It was the revolutionary painkiller which had to be withdrawn last year, after being linked with heart attacks. The latest estimate is that Vioxx caused more than 60,000 deaths worldwide. Robust, rigorous scrutiny of new drugs is essential.