BMJ -- Press Releases

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Press releases Monday 7 December to Friday 11 December 2009

Please remember to credit the BMJas source when publicising an article and to tell your readers that they can read its full text on the journal's website (http://www.bmj.com).

(1) Exclusive: Experts say no clear evidence that Tamiflu prevents flu complications
(2) 26 deaths for every 100,000 cases of swine flu, say experts
(3) 20 mph traffic speed zones associated with 40% drop in road injuries in London/a>

An updated expert review says there is no clear evidence that the antiviral drug most commonly used against influenza - oseltamivir (Tamiflu) - prevents complications like pneumonia in healthy people, according to a joint investigation by the BMJ and Channel 4 News.

The claims about the effectiveness of oseltamivir against complications have been a key factor in decisions by Governments around the world to stockpile these drugs as part of global pandemic preparedness plans. The UK Government has spent an estimated £500m.

The expert review published on BMJ.com today has led to a joint investigation by Channel 4 News and the BMJ into oseltamivir. A feature article is published on bmj.com and a film detailing the investigation will be broadcast on Channel 4 News tonight from 7pm ( www.channel4.co.uk/news ).

The study, which updates a 2006 review published in The Cochrane Library ( www.thecochranelibrary.com ), acknowledges that oseltamivir and other neuraminidase inhibitors have a modest effect in reducing flu symptoms and infectivity in otherwise healthy adults by about one day, but the researchers say that there is insufficient published data to know if oseltamivir reduces complications in otherwise healthy adults.

Dr Fiona Godlee, Editor in Chief of the BMJ, warns that this updated review leaves important questions about effectiveness unresolved. "Governments around the world have spent billions of pounds on a drug that the scientific community now finds itself unable to judge," she says.

Roche, which produces oseltamivir, has estimated sales of £1.6billion (CHF 2.7bn) this year alone from the drug.

The use of neuraminidase inhibitors, especially oseltamivir, has increased dramatically since the spread of the influenza A/H1N1 (swine flu) pandemic began in April 2009. In the absence of an effective vaccine and because of resistance to previous drugs used against flu, neuraminidase inhibitors were seen as the answer to the pandemic.

The research team, led by Professor Chris Del Mar from Bond University in Australia, analysed 20 published trials that focused on prevention, treatment and adverse reactions.

But their investigation was hampered by the "paucity of good data" available from authors and Roche (the company that produces oseltamivir). Hence the team dropped eight key trials which were never fully published that were included in the earlier review because they were unable to independently verify the results. As a result, they conclude that they have no confidence in claims that oseltamivir reduces the risk of complications of influenza in otherwise healthy adults, and believe it should not be used in routine control of seasonal influenza.

This inability to access the data means that previous evidence on the effects of oseltamivir on flu complications may be unreliable, and they call on governments to set up studies to monitor the safety of neuraminidase inhibitors.

Professor Nick Freemantle and Dr Melanie Calvert from the University of Birmingham reviewed observational studies based on a list provided to the Cochrane authors by Roche. They conclude that "oseltamivir may reduce the risk of pneumonia in otherwise healthy people who contract flu. However, the absolute benefit is small, and side effects and safety should also be considered."

They are critical of the data and say: "Interpretation of the studies was difficult - It seems likely that some patients were included in more than one study, which undermines the ability of these studies to provide independent estimates."

Professor Freemantle says he sees "very little evidence to support the widespread use of oseltamivir in the otherwise healthy population who are developing signs of influenza like illness." He adds: "We have remarkably few resources in this country to spend on pharmaceuticals on health and it’s surprising to see such widespread use of oseltamivir. But I suppose that once you’ve gone and bought lots of doses then it’s a bit like the situation with gun control in the US. If you have a gun in the house it’s much easier to use it. But it does not mean it’s the right thing to do."

Dr Fiona Godlee and Professor Mike Clarke, Director of the UK Cochrane Centre, say this updated review is important because it calls into question "not only the effectiveness of oseltamivir but the whole system by which drugs are evaluated, regulated and promoted."

In an editorial in the BMJ, they call for new global legislation to ensure that "once a trial is completed, there needs to be ready access to the raw data behind any analyses used to licence and market a drug."

"When vast quantities of public money, and large amounts of public trust, are placed in drugs, the full data must be accessible for scrutiny by the scientific community," they conclude. "Pending full disclosure and independent review of the raw data from Roche, the risks and benefits of oseltamivir remain uncertain."

A BMJ feature article and a film to be shown on Channel 4 News tonight details the investigation undertaken jointly by the BMJ and Channel 4 News, which exposed a complex interplay between politics, public health planning, poor trial data, publishing and drug regulation. It raises questions about the use of ghostwriters in some of the manuscripts, as alleged by former employees of the medical communication company hired by Roche, and why one of the largest trials of oseltamivir was not published.

In a response Roche said that they "firmly believe in the robustness of the data". They point out that full access to data has been granted to Governments and regulatory authorities.

As a result of this investigation, Roche has committed to make all study summaries of oseltamivir - including key data - available on a password-protected site. But until then, the Cochrane authors say that "any claims regarding a reduction in risk of serious complications from influenza in healthy adults still cannot be verified."

Editors' Notes
Please click on the links below for the full text of papers, and contact the authors direct for further comment.

Channel 4 News
The film was broadcast on Channel 4 News on Tuesday 8 December 2009 from 7 pm
For further information about the story please go to www.channel4.com/news . The site will carry a range of articles and video interviews to accompany the story and will be asking people for their questions and views on their experiences of Tamiflu.

Contacts:

Dr Fiona Godlee, Editor in Chief, BMJ, London, UK
Email: fgodlee@bmj.com

Deborah Cohen, Assistant Editor, BMJ, London, UK
Email: dcohen@bmj.com

Philip Carter, Producer Independents Fund, Channel 4 News
Email: Phil.carter@itn.co.uk

Sophie Bickford, Press Office, Channel 4 News
Email: Sophie.bickford@itn.co.uk

Other contacts:

Chris Del Mar, Coordinating editor of Cochrane Acute Respiratory Infections Group, Faculty of Health Sciences and Medicine, Bond University, Australia Email: cdelmar@bond.edu.au

Tom Jefferson, Researcher, Acute Respiratory Infections Group, Cochrane Collaboration, Rome, Italy Email: jefferson.tom@gmail.com

Analysis: Nick Freemantle, Professor of Clinical Epidemiology and Biostatistics, School of Health and Population Sciences, University of Birmingham, UK Email: N.Freemantle@bham.ac.uk

(2) 26 deaths for every 100,000 cases of swine flu, say experts
(Research: Mortality from pandemic A/H1N1 2009 influenza in England: public health surveillance study )
http://www.bmj.com/cgi/doi/10.1136/bmj.b5213

New data, published today on bmj.com, reveal that there were 26 deaths out of every 100,000 cases of swine flu in England (a fatality rate of 0.026%). The authors conclude that "the first influenza pandemic of the 21 st century is considerably less lethal than was feared in advance." However, they emphasise that this is not a justification for public health inaction when death, serious illness and admission to hospital can be prevented.

This paper will be published on bmj.com at 15:00 hrs UK time, Thursday 10 December, to coincide with the Department of Health's weekly H1N1 update, hosted by the Chief Medical Officer for England , Sir Liam Donaldson.

After the pandemic was announced, from June 2009 the Department of Health in England compelled all primary care trusts and acute hospitals to collate data on individuals who were believed to have died from swine flu. Today’s study is the first analysis of this material and includes all known deaths in England from swine flu up until 8 November 2009.

The research, which was carried out by Sir Liam Donaldson’s research team, reveals that two thirds of the patients who died (66.7%) from swine flu would now be eligible for vaccination. The authors say that this demonstrates the importance of getting high risk groups vaccinated.

Donaldson and his team also argue that there is a case for extending the vaccination programme to the wider population given that a substantial minority (38%) of deaths occurred in non-high risk groups.

While the over 65’s had less chance of contracting swine flu, the study reveals that this group were more likely to die from the disease if they developed it. The authors argue that perhaps older people were less likely to become infected with swine flu because they had already been exposed to similar strains and that "without this previous exposure, the pandemic might have caused many more deaths in this age group."

The researchers say their fatality rate estimate compares well with the other three 20 th century influenza pandemics – the rate for the 1918 Spanish flu was 2-3% and subsequent pandemics (1957-8 and 1967-8) had rates of around 0.2%.

Donaldson argues that "improvements in nutritional status, housing and health care availability might explain some of the apparent decrease in case fatality from one pandemic to the next" and that "since the most recent pandemic there have been major advances in intensive care medicine."

The authors conclude that "many more patients may have died in England without the ready availability of critical care support, including mechanical ventilation."

Contacts:

Liam Donaldson, Chief Medical Officer for England, Department of Health, Richmond House, London, UK
Tel (via Kate Pike or Peter Graham): +44 (0)20 7210 5703
Out of hours: +44 (0)7050 073 581 (DH duty press officer)

(3) 20 mph traffic speed zones associated with 40% drop in road injuries in London
Research: Effect of 20 mph traffic speed zones on road injuries in London, 1986-2006: controlled interrupted times series analysis
http://www.bmj.com/cgi/doi/10.1136/bmj.b4469
Editorial: Traffic speed zones and road injuries
http://www.bmj.com/cgi/doi/10.1136/bmj.b4743

The introduction of 20 mph traffic speed zones in London has reduced road injuries by over 40%. The greatest benefits were found among younger children and in the numbers killed or seriously injured, finds new research published on bmj.com today.

The authors estimate that 20 mph zones prevent 203 casualties each year, and they support the case for extending 20 mph zones in London with the potential of preventing a further 692 casualties each year.

Road injuries are among the leading causes of death and disability worldwide. It is well known that reducing the speed of traffic in urban areas using traffic calming measures such as speed humps and chicanes can reduce injury rates. There is some evidence to suggest that 20 mph zones are effective in reducing traffic speed, but their impact on road casualties is not clear.

To address this issue, researchers from the London School of Hygiene and Tropical Medicine assessed the effects of introducing 20 mph (32 km an hour) traffic speed zones on road collisions, injuries, and deaths in London over 20 years.

They linked geographically coded police data on road casualties in London between 1986 and 2006 to a detailed database of road segments. After adjusting for background reductions in road injuries, they found that relative to other roads, 20 mph zones were associated with a 40% reduction in casualties and collisions.

Casualties as a whole were reduced by 41.9%, with killed or seriously injured casualties in children reduced by half. Pedestrian injuries were reduced by a little under a third and cycling casualties by 16.9%.

Reductions were greatest in younger children (0–5 and 6–11 years), and higher for the category of killed or seriously injured casualties than for minor injuries.

The authors found no evidence of casualty migration to areas bordering the 20 mph zones. Indeed, in areas adjacent to the zones casualties also fell by an average of 8%.

“The additional effect of the 20 mph zones was that of a step reduction in casualties and collisions by an amount that has taken over 20 years to achieve on roads without 20 mph zones,” say the authors.

They conclude: “This evidence supports the rationale for 20 mph zones not just in major cities in Britain but also in similar metropolitan areas elsewhere. Indeed, even within London, there is a case for extending the currently limited provision of such zones to other high casualty roads.”

Speed management is key, says Associate Professor Shanthi Ameratunga from the University of Auckland in an accompanying editorial. This includes setting and enforcing speed limits, “engineering treatments” (such as road humps and roundabouts), and public education. She believes that, as witnesses to the consequences of road injuries, clinicians have a responsibility to evaluate the links between decision making in transportation and the effects of these choices on public health and equity.

Contacts: Research: Chris Grundy, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK Tel: +44 (0)207 927 2441 Email: chris.grundy@lshtm.ac.uk

Editorial: Shanthi Ameratunga, Associate Professor of Epidemiology, School of Population Health, University of Auckland, New Zealand Tel: +64 (0)9 373 7599 ext 86354 Email: s.ameratunga@auckland.ac.nz

FOR ACCREDITED JOURNALISTS

For more information please contact:

Emma Dickinson
Tel: +44 (0)20 7383 6529
Email: edickinson@bma.org.uk

Press Office telephone : 020 7383 6254 (Weekdays : 0900hrs - 1800hrs)
British Medical Association
BMA House, Tavistock Square, London WC1H 9JP

and from:

the EurekAlert website, run by the American Association for the Advancement of Science (http://www.eurekalert.org)
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