The director of NICE has given the Institute's guidance to doctors in the NHS about zanamivir, the new anti-flu drug. As this is the first such advice we thought some detail might be of interest.

He says: This judgment is based on a very careful consideration of the evidence by our expert committee and we expect doctors to take it fully into account when exercising their professional judgement. Our guidance does not override the individual clinical judgement which doctors must make as to what treatments are appropriate and necessary. We have advised that zanamivir (Relenza) should not be prescribed in the NHS during the forthcoming 'flu season"

"When we examined the evidence, we found that:

1. the use of zanamivir (Relenza), within 48 hours of the onset of symptoms of influenza, reduces the duration of the illness, by 24 hours, from a median of 6 to 5 days;

2. because of small numbers of patients in the clinical trials, there is insufficient information to judge the extent to which the frequency of serious secondary complications in high risk groups of patients (particularly the elderly and those with cardiovascular disease, asthma, chronic obstructive pulmonary disease, or immunosuppression) might be reduced by the use of zanamivir (Relenza)".

"I should also add that the NHS should encourage and where possible, support the manufacturer in the conduct of the four additional clinical trials which are currently underway."

Professor Sir Michael Rawlins (Chair of NICE) said that "NICE has worked hard to develop the guidance that the NHS needs in time for this flu season. I should stress that this guidance will be reviewed, in advance of the 2000/2001 influenza season. The next review will cover both zanamivir (Relenza) and a similar product from Roche oseltamivir (Tamiflu), which is expected to be licensed next year. "

Sir Michael Rawlins added "Whilst I understand that Glaxo Wellcome will be disappointed at our advice, I would wish to pay tribute to their hard work and commitment during the Rapid Appraisal process".

"The company are conducting further trials. We very much support this additional work. NICE and the NHS Research and Development programme (R&D) will meet the company next week to discuss ways in which additional information on zanamivir's (relenza) impact on the NHS, can be obtained through further trials in the primary care context".

"And finally, I would like to stress that those patients Mr. Dillon has described as 'high risk' should contact their local GP surgery now and enquire about flu vaccinations.

Background

1. Key points from the NICE guidance. From the evidence NICE assessed it is clear that the use of zanamivir (Relenza), within 48 hours of the onset of symptoms of influenza, reduces the duration of the illness, by 24 hours (from a median of 6 to 5 days).

2. For most people flu is an inconvenient bout of illness that in most cases can be successfully managed, by taking medicines that can be brought from the chemist.

4. Complications of flu are responsible for 3- 4000 deaths / year in patients at 'high risk'. It is important to note that flu does not kill people, it is the complications of flu that can be dangerous.

5. The NHS recognises that there is this 'high risk' group of patients for whom the complications of flu can be very serious. It is this group of patients who are currently offered vaccinations against flu by the NHS.

6. NICE looked very carefully at this group of high risk patients when making its assessment of zanamivir (Relenza), unfortunately due to the limited numbers of these patients that were treated with the product in clinical trials, NICE has not been able to conclude that zanamivir (Relenza) reduces the frequency of these serious complications in high risk patients. It should be noted that GlaxoWellcome's own advice to Doctors draws attention to this fact.

7. On the basis of its findings and conclusions, the Institute has advised that zanamivir (Relenza) should not be prescribed under the NHS during the 1999/2000 influenza season. The NHS will encourage and where possible, support the manufacturer in the conduct of the four additional clinical trials that are currently underway.

8. Guidance from NICE will not override the clinical judgement of Doctors in the treatment of individual patients, but it is expected that it will be taken into account as representing the views of an eminent body of senior practitioners who have had the opportunity to consider the available evidence.

9. The National Institute for Clinical Excellence (NICE) is a Special Health Authority, within the NHS. It is the Institute's job to look at where a product might be beneficial for patients within the NHS and assess the evidence of both clinical and cost effectiveness to supports its use. NICE then makes recommendations to the NHS and patients.

11. Relenza is the first of a new type of drug which aims to decrease the spread of the virus which causes flu. It must be taken within 48hrs of flu starting. It is taken over a 5 day period from an inhaler device. (Similar to the sort of device asthmatics use).

Concerns regarding the possible role of breast implants (particularly silicone breast implants) in the development of connective tissue diseases were raised in the past by case reports of connective tissue diseases in such women. Within the past few years, epidemiologic studies have begun to appear. Based on a comprehensive literature search, 15 epidemiologic studies on breast implants and connective tissue diseases, which satisfied certain basic epidemiologic requirements, were included in a critical assessment. These studies utilized either the case-control or the cohort study design.

Although each individual study was relatively small, and the statistical power to detect a modest risk increase in specific categories of connective tissue diseases was limited, the results of these studies were strikingly consistent.

Meta-analyses of rheumatoid arthritis, systemic sclerosis (scleroderma), and systemic lupus erythematosus were performed representing a database of 4000 cases of connective tissue diseases. The findings derived from the meta-analyses of case-control studies were supported by results from cohort studies. These all showed that there was no increased risk of connective tissue diseases associated with breast implants.