Sunday 24 September 2000
By Jenny Booth And Martyn Halle
NEUROLOGISTS have discovered that multiple sclerosis (MS) can be delayed
and may even be halted altogether by prescribing the drug beta interferon
immediately after diagnosis.
The research breakthrough will increase the pressure on the Government's advisory body for new medicines to review its decision that the drug, which costs an estimated £13,000 a year per patient, should not be generally available on the National Health Service.
The latest findings are the result of two large-scale clinical trials. The findings of one, by the American drug company Biogen, are due to be published next week in the New England Journal of Medicine, where it will be reported that the results were so conclusive that many neurologists aware of the study have already changed the way they treat patients.
A second study by the Swiss drug company Serono, involving more than 300 patients across Europe and using another beta interferon drug, has shown that patients given the drug at an early stage are 31 per cent less likely to develop further MS symptoms than untreated patients.
At present the drug is usually only prescribed to patients with a milder form of the disease, known as relapsing remitting MS, where it is acknowledged to slow the progress of the debilitating and eventually fatal nerve disease. The new research suggests, however, that it would be valuable to all new MS patients, even those with primary progressive MS, the most aggressive and unrelenting form.
MS specialists met in France two weeks ago to discuss the research and concluded that all newly-diagnosed patients should be given beta interferon. Professor Lance Blumhardt, a leading British MS doctor who attended the meeting, said: "The evidence from the trials shows that we can stop the disease in its tracks right at the outset.
"We already have patients who have gone several years without having another attack of MS after being put immediately on the drug. The trick is to start treating in the first instance, even if the patient has had the mildest of attacks. The chances are patients treated in this way may never develop any symptoms of the disease or, if they do, it could be many years before they experience another attack."
About 15 per cent of MS sufferers in European countries are prescribed beta interferon, until recently the only drug treatment for the disease. The medicine is available only in some parts of Britain. Many health authorities either refuse to pay for it or ration it so strictly that patients wait months or years for it to be prescribed. Just under two per cent of British sufferers are estimated to receive the drug.
In June, the British advisory body for new medicines, the National Institute for Clinical Excellence (Nice) provoked an outcry by recommending that the use of beta interferon be further restricted because, according to Professor Sir Michael Rawlins, the institute's chairman, the medicine's "modest clinical benefit appears to be outweighed by the very high costs".
Last Friday, Nice's appraisal committee heard eight appeals against the recommendation and it is expected to make a ruling within a fortnight. Professor Blumhardt, who works at the Queens Medical Centre in Nottingham, said that continuing the ban would be a tragedy for existing MS patients "decaying" on waiting lists.
He said: "Some of these people were able to walk around a couple of years ago. Now they are in wheelchairs because we haven't been prepared to give them interferon. It is quite appalling that the world's fifth largest economy cannot make available the latest advances in MS medicine to those who are unfortunate enough to have this disease."
Nice maintains that there is no evidence that beta interferon has any effect on the progress of MS. A spokesman this weekend refused to say whether its appraisal committee had seen the Biogen research, saying that its deliberations were confidential.
If Nice does recommend a ban on NHS prescribing of beta interferon for MS, the drug will remain licensed for use in Britain but will probably only be available privately for those able to pay more than £1,000 a month for it.
Mike Taylor, 35, a graphic designer from south London who has MS, said:
"It is ridiculous that people should be denied drugs on the grounds of
money. Hope is the biggest thing that anyone with MS has, and if beta interferon
gives you hope you will get better, or at least not get worse, then it
is worth £1 million, let alone £13,000."