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Press releases Saturday 16 June 2007

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(1) Experts question whether expert patient programmes cut healthcare use

(2) Doctor advises caution over flu drug

(3) Drug surveillance system needs to be fixed

(1) IExperts question whether expert patient programmes cut healthcare use
(How effective are expert patient (lay led) education programmes for chronic disease?)
http://www.bmj.com/cgi/content/short/334/7606/1254

The expert patient programme has been heavily promoted by the UK government as part of a drive to reduce use of acute health care and deliver long term cost savings. But researchers in this week±s BMJ examine the evidence and question whether "expert patients" consume fewer health resources.

In 2001, the chief medical officer, Sir Liam Donaldson, concluded that self management programmes for chronic diseases would improve health status, slow the progression of disease, and reduce healthcare use, and that the NHS should invest heavily in the expert patient programme.

To date, the Department of Health has invested ±18 million in the programme, which will be rolled out to 100,000 patients by 2012.

Yet four trials in the UK indicate that although lay led programmes may increase patients± confidence to manage their disease, there is little evidence to date that they make an important impact on either hospital admissions or the use of other healthcare resources in the NHS.

Although improvements in confidence are welcome, questions remain about its impact on health in patients in the UK, say the authors from Queen Mary±s School of Medicine and Dentistry in London.

They suggest that lay led programmes in the UK need evaluation before they can be recommended over other programmes with established impact.

They also point out that primary care trusts or general practice commissioning groups will need to consider carefully the costs of investing in this programme compared with other rehabilitation programmes for chronic disease.

Contacts:
Stephanie Taylor, Senior Clinical Lecturer, Centre for Health Sciences, Barts and The London, Queen Mary's School of Medicine and Dentistry, University of London, UK
Email: s.j.c.taylor@qmul.ac.uk

(2) Doctor advises caution over flu drug
(Editorial: Tamiflu and neuropsychiatric disturbance in adolescents
http://www.bmj.com/cgi/content/short/334/7606/1232

In this week±s BMJ, a senior doctor advises caution over the use of the antiviral drug oseltamivir (Tamiflu).

His concern follows advice by the Japanese authorities in March 2007 against prescribing oseltamivir to adolescents after the separate suicides of two 14 year olds who jumped to their deaths while taking the drug.

So far, oseltamivir has been thought to be well tolerated and safe, but the recent events in Japan have prompted a reappraisal, writes Simon Maxwell from the University of Edinburgh.

Before 2007, there had already been more than 100 reports of neuropsychiatric events (including delirium, convulsions, and encephalitis) with oseltamivir in children, almost entirely from Japan, which has the highest usage of oseltamivir worldwide. But a Food and Drug Administration (FDA) review concluded that these events were not clearly drug related.

Since last November, the FDA has required that doctors be warned that patients should be closely monitored for signs of abnormal behaviour throughout the treatment period and the European Medicine Evaluation Agency (EMEA) took similar steps in February.

In the UK, oseltamivir is a "black triangle" drug so it remains under more intensive surveillance and healthcare professionals are asked to report all minor as well as serious adverse events.

The controversy about oseltamivir is a further reminder that, although common adverse effects of a drug may emerge in prelicensing studies, the detection of rarer and potentially more serious events has to await exposure of large numbers of patients, he says.

In the light of these concerns, how should prescribers proceed?

There seems little doubt that oseltamivir reduces the number and seriousness of flu episodes when used as treatment and prophylaxis, he says. However, the impact of such events in otherwise healthy people is usually modest and of short duration, so they should be encouraged to use conservative strategies such as resting, increasing fluid intake, and taking simple analgesics.

In people at higher risk of serious complications the potential benefit of treatment seems greater, although convincing evidence about reductions in hospital admission or mortality is still awaited, he writes. In these groups, vaccination still offers a cost effective first line of defence.

Contact:
BSimon Maxwell, Senior Lecturer, Clinical Pharmacology Unit, University of Edinburgh, Queen±s Medical Research Institute, Edinburgh, Scotland Email: s.maxwell@ed.ac.uk

(3) Drug surveillance system needs to be fixed
(Editorial: Rosiglitazone and implications for pharmacovigilance)
http://www.bmj.com/cgi/content/short/334/7606/1233

The current drug surveillance system needs to be fixed, argues an editorial in this week±s BMJ.

The call follows a recent analysis of the diabetes drug rosiglitazone (Avandia) which raised serious questions about the drug±s safety.

Rosiglitazone was approved by the US Food and Drug Administration (FDA) in 1999 and by the European Medicines Agency (EMEA) in 2000. Its popularity has increased steadily, with more than one million prescriptions written in the one year period ending March 2006 in England alone.

But last month an analysis of 42 trials of rosiglitazone, published in the New England Journal of Medicine, found that the drug was associated with an increased risk of heart attack and death from cardiovascular causes.

These emerging safety concerns highlight the need for a better system of drug evaluation both before and after approval, says Dr Dhruv Kazi from the London School of Economics.

He argues that the current approach relies heavily on passive surveillance and is based on reports of unusual adverse events from consumers, practitioners, manufacturers, and national regulatory authorities. Alternatively, the regulatory authorities may require further (phase IV) trials after approval, but these are often not completed in a timely manner, he says.

This results in a fractured regulatory process, where postmarketing surveillance falls short of the standards the agencies set for themselves.

This is exemplified by the case of rosiglitazone, which comes from a family of drugs with well documented side effects, he writes. However, postmarketing safety data seven years after regulatory approval consist of a patchwork of heterogeneous manufacturer sponsored trials, many of which are unpublished.

The system needs to be fixed, he says. This will require systematic rethinking of the existing regulatory and funding processes, and expediting changes currently in the pipeline.

In the meantime, doctors will need to revisit the indication for the drug on a case by case basis, bearing in mind that several alternatives are cheaper, supported by robust evidence, and now perhaps safer, he concludes.

Contact:
Dhruv Kazi, Internal Medicine Physician, London School of Economics, London, UK
Email: d.s.kazi@lse.ac.uk

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