That old Chinese proverb ‘Be careful what you wish for as you might just get it’ comes to mind when we hear the calls from multiple sclerosis (MS) sufferers in the UK for free access to the drug interferon beta-1b.
It’s widely available as a therapy for MS in the United States, and the Food and Drug Administration (FDA), the US drugs regulator, has just approved Avonex, an interferon beta-1a drug, for use among patients with MS.
The news will no doubt add fuel to the protests in the UK, where the drug is available only for limited use and cannot be obtained by a standard prescription on the NHS.
The ‘bad guys’ in this case are NICE (National Institute for Clinical Excellence), that part of the NHS officially responsible for determining which drugs should be available on the NHS by assessing their efficacy against their cost. Advocates claim that the drug can reduce relapses among MS sufferers by one-third, whereas critics say the evidence is not there to support such a claim and, in any event, it is a very expensive drug.
Trials on interferon beta-1b as an MS therapy began in the US in 1993, and in the UK in 1996, with the interferon beta-1 drug Betaferon (Betaseron in the US).
Early feedback suggested that the drug was not effective (J Neurol Neurosurg Psychiatr, 1996; 61: 239-41). The side-effects included allergic reactions, nausea, headache and confusion (Ann Neurol, 1993; 343: 310).
More serious reactions included suicidal feelings – indeed, one participant in an early trial did actually kill himself (Lancet, 1996; 347: 1417).
The FDA in its approval of Avonex has underlined these early findings. Patients who are depressed or suffering from a severe psychiatric disorder should not take the drug. New side-effects, including anaphylaxis (severe allergy-related shock) and a sudden drop in peripheral blood counts, have also been noted.
Perhaps NICE is being nice after all.