Over the next few weekends, the gardens of 23 stately homes will be opened up to several thousand sponsored fun-runners who, demonstrating the typically huge generosity shown towards cancer charities by the British public, will raise £2.5 million for oncology research. Elsewhere, the stalls at village shows will heave with home-baked cakes, thousands will empty their lofts to send surplus possessions to Cancer Research shops, and many more will be stuffing ‘pinkie rings’ on to their fingers and toes in order to support work on breast cancer. In all, Britons last year raised £302 million for cancer charities, far more than any other country in Europe.
As a result of their generosity, the British public can bask in the warmth of knowing they have helped to extend many lives. Perhaps Brigitte from Malmo will send a thank-you letter, Jose from Bilbao a card, and little Anders in Zurich a drawing of a reindeer. They are all worthy recipients of our charity, of course. It is just a shame that British cancer-sufferers will have to wait another year or two to benefit from the same treatments which are already saving lives elsewhere in Europe.
The backwardness of cancer treatment in NHS hospitals was brought to light last week by the case of Barbara Clark, a Somerset nurse who won an appeal against the refusal by Somerset Coast Primary Care Trust to treat her with Herceptin. Although the drug has been found to extend the lives of women with advanced breast cancer by 50 per cent, the trust had declined to prescribe it on the grounds that it is not licensed for use within the NHS. Yet it is five years since Herceptin received a licence from the EU’s Committee for Medicinal Products for Human Use, a body set up to provide a single system of safety regulation for all drugs used in the EU. The problem is that in Britain all new drugs must undergo an additional cost-benefit analysis before they are allowed to be used within the NHS. In England this is undertaken by the National Institute for Clinical Excellence (Nice), while — as if to ensure the maximum job creation for public servants — Scotland and Wales have their own equivalents. The manufacturers of Herceptin, Roche, have yet to apply for a licence for Herceptin from Nice, saying they won’t have enough data to satisfy the institute until next February. At the very earliest it will be well into 2007 before English doctors are free to prescribe Herceptin for patients other than Miss Clark. Ironically, the government set up Nice in 1999 with the intention of ending ‘postcode prescription’ and thus to iron out what Labour ministers like to call ‘health inequalities’. The unfortunate result is that whereas under the old system — where the decision whether or not to use certain drugs was left to individual hospitals — patients suffered if they had the wrong postcode, now patients are suffering nationwide.
It isn’t just Herceptin. The charity CancerBACUP recently published a list of 23 drugs which it says are being unnecessarily denied to British patients. Among them are Bevacizumab, found to extend the lives of bowel cancer patients, which was licensed by the EU in January 2005 but will not be available in Britain until November 2006 at the earliest; and Bortezomib, found to extend the lives of myeloma patients by an average of 18 months, which was licensed by the EU in May 2004 but will not be approved by Nice until at least 2007.
A similar point is made by researchers at the Karolinska Institute in Sweden, who last week published a study into the availability of various cancer treatments across Europe. It concluded that British, Norwegian, Polish, Hungarian and Czech cancer patients were all at a disadvantage when it comes to gaining access to the latest drugs. The prime reason in Britain, said the researchers, was the sclerotic bureaucracy of Nice. As a measure of the inefficiency of Nice, take the case of Arimidex and Docetaxel, both breast cancer drugs, the latter of which has been found to reduce by 30 per cent the risk of patients suffering a relapse after surgery. Both have already been approved by the Scottish Medicines Consortium, the equivalent of Nice north of the border. Although Nice, in theory, conducts its cost-benefit analysis according to the same parameters as its Scottish counterpart, it has so far failed to approve either drug for use in English hospitals and is not expected to do so until at least November 2006. Yet even after new drugs are approved by Nice, British hospitals lag far behind their continental counterparts in prescribing them. Trastuzumab, used for breast cancer, Oxaliplatin, for bowel cancer, and Capecitabine, for stomach cancer, have all now belatedly been approved by Nice, yet they are still prescribed far less frequently in Britain than in any other European country. Another culprit, according to Jill Morrell of the charity CancerBACUP, is the Department of Health. ‘Nice can’t appraise new drugs until they have been referred to it by the Department of Health,’ she says. ‘But sometimes, for no apparent reason, the Department just sits on them for a year before it gets round to referring them to Nice.’
The famine of cancer drugs is not unrelated to Britain’s dismal record in cancer survival rates. In France, 81 per cent of patients are still alive one year after being diagnosed with cancer (except skin cancer) and 61 per cent are still alive five years after diagnosis. The figures for Germany are 76 per cent and 58 per cent respectively. In Britain they are just 67 per cent and 48 per cent, significantly lower than any other Western European country, and on a par with the much poorer new EU members in Eastern Europe. Although I am not entirely sure I trust the statistics from Albania, it is interesting to note that cancer survival rates in Britain are now officially lower than in that country.
One has to treat statistics on cancer survival rates with a degree of caution; it is possible to improve them by the simple expedient of setting up screening programmes and diagnosing cancers at an earlier stage — thereby helping patients to survive for longer ‘after diagnosis’ when they haven’t lived any longer in reality. Nor do cancer survival rates take into account the quality of the extra life won for cancer patients through medical intervention: a treatment which extends a lifespan by 18 months is of limited benefit if those extra months are spent bedridden and on a drip. But Britain’s lousy cancer survival rates are certainly not the result of a minimalist medical system which saves taxpayers money and allows us instead to enjoy life to the full while we are well. On the contrary, as a nation we spend E182 per person per year treating cancer, more than any other European country bar Norway (E191) and Switzerland (E189), and double what is spent in Spain (E92) and the Netherlands (E94). All this money to achieve less than any Western European country.
Part of the reason for this non-achievement is that we put cancer patients in hospital who could better be treated at home with new drugs. Bizarrely, the cost-benefit analysis used by Nice to decide whether or not to approve new drugs only takes into account the cost of the medicines themselves, not the cost of associated treatment. While Nice starts with the intention of saving the taxpayer money, it ends up achieving the exact opposite. Take the drugs used in the treatment of bowel cancer. ‘On the cost of the drugs alone it is much more cost-effective to use the old established drug, 5-FU, than a new drug, Capecitabine,’ says Professor John Toy of Cancer Research UK. ‘The difference is that whereas Capecitabine comes in the form of a tablet which can be administered by the patient at home, 5-FU has to be given intravenously in hospital, maki ng it a much more expensive treatment overall.’ As a result of Nice’s flawed assessment procedure, the introduction of Capecitabine in Britain is held up, and British bowel cancer patients are languishing unnecessarily in hospital.
The good news is that Capecitabine almost certainly will one day be approved for use by the NHS. How do I know? Because almost every drug eventually is. But therein lies the pointlessness of Nice. If the organisation was to pass a cost-benefit analysis of its own existence, one might expect it occasionally to reject a new drug, on the grounds that it simply wasn’t value for money or that the risk of side effects was too high. Yet when I asked Nice for the names of any drugs it has rejected for use in Britain, a spokeswoman told me with great pride: ‘We certainly haven’t rejected any cancer drugs.’ When pressed further she said that of the 177 drugs and treatments which have been referred to Nice during the first five years of its existence, the organisation has rejected just one flu drug and one paste which was supposed to prevent tooth decay. Among the drugs which Nice has assessed and approved for use in the NHS, on the other hand, is Vioxx, the arthritis drug which was withdrawn by its manufacturer, Merck, in 2004 after evidence emerged that it doubled the risk of a patient suffering a heart attack or a stroke. In spite of its lingering assessment procedures, Nice never picked up this risk. The organisation’s role appears to be simply one of delaying treatments; it behaves like a giant and unwieldy rubber stamp — and one which cost taxpayers £19.6 million last year, with its chairman and chief executive each trousering salaries of nearly £140,000.
In spite of its absurdity, Nice is an organisation of which the pharmaceutical companies appear to live in fear. When I rang the drugs company AstraZeneca, the tone of the press officer changed sharply when I mentioned that I wanted to speak to the chief executive about Nice. ‘It’s beyond our remit to criticise Nice,’ she said, pointing me instead to the cancer charities. In the face of this corporate wimpishness, it was left to Professor Toy to state the drugs companies’ case: ‘They are considering whether or not they want to carry on conducting clinical trials in Britain or whether to move them to countries where the drugs will be adopted more quickly.’
Combined with the failure of the government to tackle properly the activities of animal rights’ terrorists who have all but put a stop to animal testing in Britain, the threat of losing clinical trials would mean a bleak future for Britain’s pharmaceutical industry. In its campaign to keep drugs out of Britain, the government can claim considerable success — after a fashion. Unfortunately, the drugs it has kept out aren’t heroin and crack cocaine but Herceptin, Capecitabine and numerous other cancer drugs which the British public has generously helped to develop but from which they cannot themselves benefit.