Press releases Monday 22 March to Friday 26 March 2010

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) Study questions whether screening really cuts breast cancer deaths
(2) Guidance about mephedrone urgently needed
(3) Advance care planning improves end of life care and reduces stress for relatives
(4) Leading journals publish new guidance to improve trial reports
(5) Rise in HPV related head and neck cancer has big implications for health services
(6) BMJ backs campaign to reinstate Jenner statue in Trafalgar Square

(1) Study questions whether screening really cuts breast cancer deaths
(Research: Breast cancer mortality in organised mammography screening in Denmark: comparative study)
http://www.bmj.com/cgi/content/full/340/mar23_1/c1241

A study from Denmark published on bmj.com today finds no effect of the Danish screening programme on breast cancer deaths.

Similar results have been seen in other countries, including the UK, leading the authors to question whether screening has delivered the promised effect on breast cancer mortality.

A 2005 study suggested that screening had reduced breast cancer deaths by 25% in Copenhagen. But Karsten Jørgensen and Peter Gøtzsche from the Nordic Cochrane Centre in Copenhagen, together with Per-Henrik Zahl from Folkehelseinstituttet in Oslo, identified important problems in this study and decided to undertake a more comprehensive analysis of the data.

They compared annual changes in breast cancer deaths in two Danish regions offering publicly organised screening programmes (Copenhagen and Funen county) with non-screened regions across the rest of Denmark.

Their analysis covered 10 years after screening could have had an effect on breast cancer mortality. For comparison, they also looked at the 10-year period before screening was introduced.

Data for each area were divided into three age bands. Women aged 55-74 years, who could benefit from screening, and women aged 35-55 years and 75-84 years, who were largely unaffected by screening.

They found that in women who could benefit from screening (55-74 years) breast cancer mortality declined by 1% per year in the screened areas and by 2% per year in the non-screened areas. In women too young to benefit from screening (35-54 years), breast cancer mortality declined by 5% per year in the screened areas and by 6% per year in the non-screened areas during the same period.

For the older age groups (75-84 years), there was little change over time both in screened and non-screened areas.

"We were unable to find an effect of the Danish screening programme on breast cancer mortality," conclude the authors. "The reductions in breast cancer mortality we observed in screening regions were similar or less than those in non-screened areas and in younger age groups, and are more likely explained by changes in risk factors and improved treatment than by screening mammography."

"Our results are similar to what has been observed in other countries with nationally organised programmes. We believe it is time to question whether screening has delivered the promised effect on breast cancer mortality," they add.

Contact:
Karsten Jørgensen, Nordic Cochrane Centre, Rigshospitalet Department, Copenhagen, Denmark
Email: kj@cochrane.dk

(2) Guidance about mephedrone urgently needed
(Editorial: What should be done about mephedrone?)
http://www.bmj.com/cgi/content/full/340/mar23_1/c1605

People with a history of mental health or heart problems, especially those on medication, are likely to be at greatest risk of serious harm from mephedrone, warn senior doctors in an editorial published on bmj.com today.

But we know nothing of its potential toxicity or the long term consequences of its use and guidance is urgently needed, they say.

The recent deaths of two young men who are thought to have taken mephedrone (also known as Miaow, 4-MMC, Meph and TopCat) have prompted urgent calls for the drug to be banned, write Adam Winstock, Senior Lecturer in Addiction Psychiatry at Institute of Psychiatry, King's College London, and colleagues. But, unlike other stimulant drugs such as cocaine and ecstasy, its toxicity and metabolism are still largely unknown.

Like other stimulants, its effects include euphoria, increased energy, feelings of empathy, increased libido, sweating, rapid heart beat (tachycardia), headache, and teeth grinding. And in the days after use, typical comedown symptoms such as lethargy and low mood are common.

Mephedrone is highly likely to be used along with other stimulant drugs or alcohol that moderate or enhance its effects, and this may contribute to an increased risk of adverse effects, warn the authors. A drug induced increase in libido may also lead to risky sexual behaviour.

Credible educational and harm reduction advice about this drug are urgently needed, they say.

In the meantime, commonsense advice should include avoiding regular use to avoid developing tolerance; not using the drug in combination with other stimulants or large amounts of alcohol and other depressants; not injecting the drug; remaining well hydrated when using the drug; and avoiding becoming overheated.

It is likely that the UK government will move to control the manufacture, distribution, and possession of this drug. But the authors question whether controlling mephedrone under the current provisions of the Misuse of Drugs Act is the best public health response.

Recent history suggests that manufacturers will merely turn their attention to the nearest effective but unsanctioned alternative substance, they say. Unfortunately, the list of potential synthetic psychoactive compounds is dauntingly long.

Contact:
Louise Pratt, Acting Public Relations and Communications Manager, NIHR Biomedical Research Centre for Mental Health and Institute of Psychiatry, King's College London, UK
Email louise.a.pratt@kcl.ac.uk

(3) Advance care planning improves end of life care and reduces stress for relatives
(Research: The impact of advance care planning on end of life care in elderly patients: randomised controlled trial)
http://www.bmj.com/cgi/content/full/340/mar23_1/c1345

Advance care planning improves end of life care and reduces stress, anxiety and depression in surviving relatives, according to new research published on bmj.com today.

Advance care planning has the potential to improve end of life care by enabling patients to discuss and document their future health wishes, and appoint a substitute decision maker (surrogate), thus increasing the likelihood of patient wishes being known and respected at the end of life.

But no randomised controlled trials have investigated whether advance care planning improves end of life care.

So researchers based in Australia set out to test the theory that coordinated advance care planning would improve end of life care, the perceptions of the quality of care, and levels of stress, anxiety, and depression in surviving relatives.

Their study involved 309 competent patients aged 80 or more who were admitted to a large university hospital in Melbourne between August 2007 and March 2008.

A total of 155 patients received usual care (control group) and 154 received usual care plus advance care planning from trained non-medical facilitators (intervention group). Advance care planning aimed to assist patients to reflect on their goals, values, and beliefs; to consider future medical treatment preferences; to appoint a surrogate; and to document their wishes.

All patients were followed for six months or until death.

Of the 56 patients who died by six months, end of life wishes were much more likely to be known and followed in the intervention group (86%) compared with the control group (30%).

In the intervention group, family members of patients who died had significantly less stress, anxiety, and depression than those of control patients. Patient and family satisfaction was also much higher in the intervention group.

This trial shows that advance care planning carried out properly by trained non-medical staff improves end of life care by enabling patients' wishes to be determined, documented, and respected at end of life, conclude the authors.

It also improves such care from the perspective of the patient and the family, and diminishes the likelihood of stress, anxiety, and depression in surviving relatives.

Contact:
Karen Detering, Respiratory Physician and Clinical Leader, Respecting Patient Choices Program, Austin Health, Heidelberg, Victoria, Australia
Email karen.detering@austin.org.au

(4) Leading journals publish new guidance to improve trial reports
(Research: The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed)
http://www.bmj.com/cgi/content/full/340/mar23_1/c723
(Editorial: The new CONSORT statement)
http://www.bmj.com/cgi/content/full/340/mar23_1/c1432

New guidance to improve the reporting of trial findings is published simultaneously today (24 March 2010) by the BMJ and eight other leading journals around the world.

Full and transparent reporting of trials is crucial to ensure that decisions about health care are based on the best available evidence.

The guidance, known as the Consolidated Standards of Reporting Trials (CONSORT) statement, was first published in 1996 and revised in 2001. It includes a checklist to help authors write reports of randomised controlled trials so that others can judge the reliability and validity of the results.

More than 400 journals and three leading editorial groups across the world have now given their official support to CONSORT.

The latest version, CONSORT 2010, improves the specificity and clarity of the previous checklist. Several new items will also make it easier for decision makers to judge the soundness of trial results. A separate explanatory paper, also published by the BMJ today, provides published examples of transparent reporting.

Speaking on behalf of co-authors, Douglas Altman and David Moher, and for the CONSORT Group, Kenneth Schulz, Distinguished Scientist and Vice President of Family Health International in the US emphasises that CONSORT 2010 represents an evolving guideline. He says: "In the future we will further revise the CONSORT material considering comments, criticisms, experiences, and accumulating new evidence. We invite readers to submit recommendations via the CONSORT website."

A study also published by the BMJ today to accompany the guidance shows that, although the quality of trial reporting has improved since publication of the revised CONSORT statement in 2001, it remains well below an acceptable level. The researchers conclude that more journals should endorse CONSORT and, most importantly, they should do more to ensure adherence.

This view is supported in an editorial which says that the guidance is clear, but awareness and endorsement are lagging behind. Author Gerd Antes, Director of the German Cochrane Centre, believes that journal editors should do more to incorporate the CONSORT checklist into the peer review process. He also warns that, although CONSORT has been translated into 10 other languages, not much is known about endorsement and adherence in those areas.

Contacts:
Kenneth Schulz, Scientist and Vice President, Family Health International, NC, USA
Email kschulz@fhi.org
Research: Sally Hopewell, Senior Research Fellow, Centre for Statistics in Medicine, University of Oxford, UK
Email sally.hopewell@csm.ox.ac.uk
Editorial: Gerd Antes, Scientist and Director, German Cochrane Centre, Freiburg, Germany
Email antes@cochrane.de

(5) Rise in HPV related head and neck cancer has big implications for health services
(Editorial: Oropharyngeal carcinoma related to human papillomavirus)
http://www.bmj.com/cgi/content/full/340/mar25_1/c1439

The rapid rise in cases of oesophageal squamous cell carcinoma – a type of head and neck cancer that begins in the middle part of the throat - that are related to human papillomavirus (HPV) infection has serious implications for health services around the world, warn researchers in an editorial published on bmj.com today.

They suggest that sexual transmission of HPV might be the reason for the rise.

Head and neck cancer is the sixth most common cancer, with about 640,000 new cases each year worldwide. Despite an overall marginal decline in most head and neck cancers in recent years, the level of oropharyngeal squamous cell carcinoma (OSCC) has increased greatly, especially in the developed world.

For instance, in the United States, cases increased by 22% between 1999 and 2006, after showing no change between 1975 and 1999, while the United Kingdom has seen a 51% increase in oral and oropharyngeal cancer in men between 1989 and 2006.

This increase seems to be accounted for by a rise in HPV related tumours, say the authors, led by Hisham Mehanna at the Institute of Head and Neck Studies and Education, University Hospital, Coventry.

A recent study showed a 70% increase in the detection of HPV in biopsies taken to diagnose oropharyngeal carcinoma in Stockholm since the 1970s. HPV related oropharyngeal carcinoma has also been reported in 60-80% of recent biopsy samples in studies conducted in the US, compared with 40% in the previous decade.

HPV related oropharyngeal carcinoma seems to be a new and distinct disease entity, explain the authors. It has a better prognosis than non-HPV related oropharyngeal carcinoma, particularly in non-smokers, but the reason for this improved survival is not fully understood.

They suggest that sexual transmission of HPV might be the reason for the rise. A recent study found that the risk of developing oropharyngeal carcinoma was associated with a history of six or more lifetime sexual partners, four or more lifetime oral sex partners, and - for men - an earlier age at first sexual intercourse.

But, whatever the reason, the rising rate of HPV related oropharyngeal carcinoma has implications for health service providers and commissioners, they warn.

For instance, patients are typically younger and employed, and - because outcomes seem to be more favourable than for patients with non-HPV related carcinoma - they will live longer. Consequently, they need prolonged support from health, social, and other services, and may require help in returning to work.

There are also public health implications, they add. For example, including boys in HPV vaccination programmes before they become sexually active.

"At present, we have no good evidence to support managing patients with HPV related head and neck cancer differently from those whose tumours are not HPV related, although several studies are being planned to evaluate different treatment options," they write. "Until data from such studies are available, we suggest that clinicians should not change their current treatment policies, but should aim to offer all patients with oropharyngeal cancer the opportunity to enrol in an appropriate clinical trial."

Contact:
Hisham Mehanna, Director, Institute of Head and Neck Studies and Education (InHANSE), University Hospital, Coventry, UK
Email hisham.mehanna@uhcw.nhs.uk

(6) BMJ backs campaign to reinstate Jenner statue in Trafalgar Square
(Editorial: Put Edward Jenner's statue back in Trafalgar Square)
http://www.bmj.com/cgi/content/full/340/mar25_2/c1582

The BMJ is backing a campaign by the Edward Jenner Museum to reinstate a statue of Edward Jenner in London's Trafalgar Square. This is timely - 2010 is 30 years after the World Health Organisation’s formal declaration of the eradication of smallpox.

Edward Jenner is widely known for developing a vaccine against smallpox. His statue was unveiled in 1858 by Prince Albert. But four years later, following pressure from anti-vaccinationists, it was relegated to Kensington Gardens, where it remains.

A BMJ report of 1862 said: "The pitiful memorial ... to Jenner had been banished even with ignominy from that honourable neighbourhood of men esteemed great because they killed their fellow creatures whereas he only saved them."

In an editorial in this week's journal, Professor Gareth Williams from the University of Bristol explains how Jenner tested and proved his theory that infection with cowpox gave immunity to smallpox, "thus dragging vaccination into mainstream medical practice."

At the time, smallpox was greatly feared. It attacked one person in three and killed one in 12. Even in the 20th century it killed 300 million people and survivors were often left severely scarred or blinded.

Williams, the author of a new history of smallpox, describes how "worldwide admiration for Jenner flooded in" but that back in England, Jenner faced "concerted opposition" from anti-vaccinationists.

"Leading doctors, jealous or dismissive of the provincial surgeon, set out to undermine vaccination," he writes, while churchmen "appalled by people being infected with 'bestial' pus, bent Biblical texts to prove that vaccination was the Devil's invention."

But his opponents had little to offer as an alternative and “ultimately, vaccination was the decisive weapon that eradicated smallpox in 1978, nearly 180 years after Jenner voiced his aspiration that his invention would achieve that aim,” says Williams.

As such, he believes that Jenner's statue deserves to be reinstated alongside the other Trafalgar Square heroes "for his role in the defeat of an enemy of all mankind ... which killed far more people than all human wars combined."

In defeating smallpox, Jenner also opened the door for immunisation against many other infections, and vaccination has proved to be one of medicine's most transferable technologies, he adds.

Williams urges people to sign a petition to persuade the government to put Jenner's statue on the empty fourth plinth in Trafalgar Square, at http://petitions.number10.gov.uk/Jenner2010/

A BMJ podcast to accompany the campaign will also be available from Friday at http://www.bmj.com/podcasts

Contacts:
Gareth Williams, Faculty of Medicine and Dentistry, University of Bristol, UK Via Cherry Lewis, University of Bristol Press Office
Email cherry.lewis@bristol.ac.uk

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)
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BMA House, Tavistock Square, London WC1H 9JP

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