A bitter pill to swallow

Should the NHS buy expensive treatment for a few multiple sclerosis sufferers? Medical history is littered with such difficult decisions, says Nicholas Timmins
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The Independent Online
Another new and expensive treatment hits the headlines - this time beta-interferon, for the treatment of multiple sclerosis. The drug is not yet licensed but is expected to cost between pounds 7,000 and pounds 10,000 a year. A paper in the British Medical Journal warns that eventually perhaps 45 per cent of Britain's 80,000 MS victims might benefit - a potential bill of pounds 380m annually, or 10 per cent of the National Health Service drugs budget.

A leading article in the same journal thunders that "clearly the NHS is not going to be able to meet the costs of new treatments" - just as the Department of Health insists that the drug will not be rationed.

Is the NHS in crisis over new and high-tech treatments? The answer is no. There is, without doubt, a problem and, for the first generation of patients who might benefit, an acute one. Plainly, not everyone will receive it immediately, not least because there is limited manufacturing capacity and because more research is needed to determine precisely who will benefit and by how much.

The Department of Health estimates that beta-interferon could prove effective for perhaps only one in eight sufferers. None the less, some priorities will have to be set about who gets it, and the issue is raised all the more starkly because beta-interferon is not a cure: it reduces the frequency of relapses.

However, we have been here before; this is not the first time the NHS has felt itself at the mercy of a costly, even unaffordable, technological imperative. That first struck in the Sixties as a string of new and more expensive treatments became available. Health economists calculated in 1967 that 90 per cent of the medicines then available were unknown in 1938 and 50 per cent were unknown five or six years earlier. The NHS survived that apparent crisis and will survive this one.

Projections that such treatments are unaffordable ignores falling real costs over time as products become more widely used. In 1980, Michael Bewick, a transplant surgeon at Dulwich Hospital, south London, virtually bankrupted his health authority single-handed by spending pounds 350,000 - more than pounds 1m in today's money - on an anti-rejection drug. Today, according to Mr Bewick, its real cost has fallen by more than 80 per cent and it is in widespread use around the country.

When Britain's heart transplant programme restarted in the late Seventies and early Eighties, the transplants proved so costly that Patrick Jenkin and Gerry Vaughan, the health ministers, considered stopping the NHS programme as unaffordable. Today the real cost of a heart transplant is down, as it has proved possible to discharge patients earlier. Again, scanners now do more and cost less in real terms than when they were launched, and the same is beginning to apply to the new keyhole surgery equipment and a range of other technological interventions. Medicine is a moving picture, not a static world.

At present, beta-interferon and many of the other new bio-technology products are expensive because they have to be produced in small batch sizes. Some in the industry believe that will always be the case and they will remain permanently expensive. Others hold that someone, somewhere, will find a cheaper way of producing them if the demand is there - a lesson that has applied in the past to a huge range of different technologies, from computers to cars and telecommunications.

This does not mean hard choices do not have to be faced when new treatments first appear. In the late Seventies, in many kidney units the only people to be dialysed were married men, with children, under the age of 55. There were too few machines, the treatment was too expensive, resources had to be concentrated on those who would most benefit and had families to support.

That was a rationing decision far more brutal and harsh than any made in the string of recent announcements by Berkshire, West Yorkshire and one of the Essex health authorities which have been attempting to cut out unproven and ineffective treatments, or by the possible need to restrict the supply of beta-interferon - a treatment which, unlike kidney dialysis, does not save lives.

The dilemma over dialysis reached the media because kidney specialists made a fuss - but it may have created less of a sense of crisis because the process was less transparent and open than the one now being produced by the Government's division of healthcare into purchasers and providers. The process may be more open, but it is no more difficult than in the past.

As more was spent on health, however - and growing nations, seemingly inevitably, spend a higher share of their greater wealth on healthcare - kidney dialysis became much more widely available.

This still leaves hard choices to be made when new treatments first appear. The problem is not unique to the NHS; it is a problem of healthcare everywhere. In the United States, for instance, the most costly and profligate healthcare system in the world, doctors are increasingly being forced by insurers and health maintenance organisations to work to agreed protocols of what can be provided in order to ensure that only effective treatments are provided and costs are contained.

If the beta-interferon treatment does prove to cost pounds 10,000 annually per patient, then, when average earnings are just over pounds 17,000 a year, it is plainly not going to be affordable for everyone instantly, whether on the NHS or not. Private insurance offers no answers here - MS sufferers are anyway not covered for their condition under Bupa-style policies - and beta-interferon would not be, either, because it alleviates a chronic condition but does not provide a cure.

How should such new treatments be handled? The first and crucial thing is to evaluate them properly. The history of modern medicine is littered with "miracle" cures and treatments which proved, on closer examination, to be of far more limited value than the optimists first believed.

For example, for decades, the removal of inflamed tonsils and adenoids was by far the most common operation that ear, nose and throat surgeons performed - more than 190,000 such operations a year as late as the Sixties. But as surgeons and paediatricians came to realise that the condition cleared up spontaneously in many children, the operations dropped - so that fewer than 10,000 are now performed annually.

Equally, the rapid, unevaluated adoption of the monitoring of babies through scalp electrodes, which appeared to offer the prospect of super- safe deliveries, proved to do nothing of the sort when applied indiscriminately. Today, the technique is used much more sparingly and precisely.

Or take an operation for boring out the carotid artery after a stroke to reduce the chances of a second one. The procedure has been performed 20 times more frequently in the US than in Britain, leading to arguments that Britain was rationing it to the point of under-provision. The latest trials, however, according to Bryan Jennett, emeritus professor of neurosurgery at Glasgow University, show it is beneficial only where the artery has become narrow and occluded - the cases on which British surgeons have concentrated. Performed in milder cases, the risks of the operation have been discovered to outweigh the gains.

This does not apply just to surgery. Boots's heart drug, Manoplax, when fully evaluated, was just the latest in a long line of drugs that have failed to live up to their early promise and have had to be withdrawn. By the time beta-interferon is fully evaluated - and its long-term consequences are, inevitably, unknown - it may turn out to be of real value only to a limited group of patients.

How should the decision be made as to who should get it? The department's approach is reasonable. It is to issue guidelines recommending that the drug be prescribed solely by consultant neurologists after a full assessment - ensuring only that those where there appears to be proven benefit receive it, while properly conducted clinical trials establish whether it is of value to other patients.

Is this rationing? Only in the sense that it is rational. Will it deny the treatment to patients who might benefit? Some, initially, inevitably - but that is part of the price of progress, of ensuring that, ultimately, healthcare money is spent on effective treatments, a requirement felt as strongly in privately funded systems as in the NHS.

There is one further point. In the same week that the BMJ was bemoaning beta-interferon's unaffordability, Britain's other leading medical journal, the Lancet, was reporting early but encouraging work on a vaccine for MS. It appears to offer the same benefits - fewer relapses, but no cure - to similar patients to those who look set to gain from beta-interferon. Should it work, its costs may prove a fraction of those of the drug.

Medicine does not stand still. No one can be sure that history will repeat itself and that healthcare will remain affordable, within rising health spending and funded by rising wealth. But it is a not unreasonable bet.