It has not taken long for the National Institute for Clinical Excellence to get into a controversy. No-one should be surprised at this. The institute, at least so far as drugs are concerned, stands between a large, resource-rich and inventive pharmaceutical industry and a large, resource-starved and conservative institution, namely, the National Health Service. Clashes are inevitable. Could it be that the time has now come to break the mould, so far as current prescribing conventions are concerned?
The controversy, as must be known by all pharmacists by now, is over Glaxo Wellcome's new influenza treatment Relenza (zanamivir). The treatment does not cure influenza, but is claimed to reduce the severity of its symptoms (PJ, September 11, p374). To anyone who has had influenza - and not just the bad colds that are often thought to be the disease - this will be recognised as an objective greatly to be desired. True influenza is a most debilitating infection and around 4,000 people die from it in an average year and many more in an epidemic year.
According to reports, the NICE's fast-track committee has decided that there is not sufficient evidence of clinical efficacy in practice to allow the product to be used on the NHS (see p561). The cost, at £24 for a course of treatment, will also have been taken into account. This decision will, of course, delay the use of Relenza in the NHS and slow down the gathering of the evidence base that the NICE believes to be essential. Catch 22.
What, we wonder, would the NICE have done if it had been around when penicillin was introduced in war-time Britain? Would it have asked for a full gamut of trials before this life-saver was brought into widespread use? Surely, new types of treatment should be handled in a more sensitive fashion than the NICE has demonstrated so far.
But even if the NICE had approved the product for use within the NHS, general medical practitioners, to judge by a spokesman (Dr George Rae, BBC Television News, October 1), would not want their waiting rooms cluttered up with people wanting Relenza. He would rather offer vaccination to at-risk groups and leave the unvaccinated to self-treat at home for a couple of days and not trouble the doctor until their conditions became severe. Relenza should be started within two days of the onset of symptoms. Another Catch 22.
So, as well as a more sensitive approach to new treatments, a new approach to prescribing may be needed. New chemical entities are prescription-only when they are brought to market. If NHS doctors do not want to prescribe them, some other means of making them readily available to the patients who would benefit from them should be found. In The Journal's view, pharmacists should be able, with appropriate training and guidelines, to fulfil a prescribing role in this area. Doctors could hardly resist this, because they want patients to self-treat anyway and most of the treatments that patients will use will be bought in pharmacies.
The Crown review proposed two categories of prescriber: the "independent prescriber", who was responsible for the assessment of undiagnosed conditions, and the "dependent prescriber", who was responsible for the continuing care of a patient who had been clinically assessed by an independent prescriber (PJ, March 13, p347). Relenza could be a candidate for independent prescribing by the pharmacist. This would increase availability and help the NICE get the data it wants. It could also, serendipitously, help to establish community pharmacy as a suitable arena for clinical trials.