Press releases Monday 17 May to Friday 21 May 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) BMJ investigation raises concerns over NHS whistleblowing policies
(2) Antibiotic resistance lasts up to a year
(3) Young infants are not sufficiently protected against measles
(4) No clear evidence that major sport events benefit local people
(5) Some statins have unintended effects and warrant closer monitoring
(6) Vitamin deficiency linked to diabetes drug "increases over time"

(1) BMJ investigation raises concerns over NHS whistleblowing policies
(Feature: Whistle while you work: an analysis of NHS foundation trust policies)
http://www.bmj.com/cgi/content/extract/340/may18_2/c2350

Despite laws to protect NHS workers who wish to raise concerns about patient care, a BMJ investigation reveals that some NHS trusts still make it hard for staff to speak out.

The BMJ obtained whistleblowing policy documents valid up to November 2009 from 118 of the 122 NHS foundation trusts.

The documents were then compared against six standards set out in guidance produced by Public Concern at Work, an independent authority on public interest whistleblowing that also runs a helpline for NHS staff. These include taking malpractice seriously, giving staff the option to raise concerns outside of the trust, and respecting the confidentiality of staff raising concerns.

The results, published on bmj.com today, show that some trusts do not have measures in place to protect whistleblowers.

Twenty two of the 118 trust policies do not give examples of types of concerns to be raised, while four do not mention the option for a person to raise concerns outside of the trust.

More than a third of trust policies say staff can go outside the trust with a concern, but insist that a person goes through management first. Some mention that staff must go to an outside organisation "in good faith" but warn that there may be disciplinary action if they go to them unjustifiably.

A fifth of trust policies do not specifically say they will respect the confidentiality of the whistleblower, or it is not clear that they will do, and 106 trusts mention sanctions against any malicious or false claims made.

Twenty two trusts mention "disciplinary" in their policies, a term unlikely to make potential whistleblowers comfortable in coming forward with a concern, while 30 trusts mention staff have a duty, implied duty, or loyalty to the trust as well as to patient confidentiality.

Commenting on the results, Peter Gooderham, a law lecturer at the University of Manchester, says trusts should give assurances of protecting the whistleblower's confidentiality. "It should be made clear that the finger won't be pointed at them if they take steps to raise a genuine concern," he says.

He argues that policies need to be user friendly and encourage people to raise concerns. "We need some positive recognition for people who have raised concerns ... they shouldn't be treated as troublemakers, ostracising them, suspending them from work, and so on," he writes.

To address these issues, Public Concern at Work will launch a policy pack, developed in conjunction with a Social Partnership Forum working group, on whistleblowing for distribution throughout the NHS in June. It also recommends that trusts audit, review, and check how their whistleblowing policies are performing in practice and promote their use to staff regularly.

The BMA is also aware of the problems that some whistleblowers can face. Dr Mark Porter, Chairman of the BMA Consultants' Committee, says: "We get very concerned about doctors who fall foul of these whistleblowing policies while following their professional duty. Members continue to raise examples with us, and there are high profile cases, some of which take place in organisations that have good policies. The BMA will support members before, during and after they raise concerns."

According to a BMA survey, around 1 in 7 hospital doctors in England and Wales who reported concerns said that their trusts had indicated that by speaking up, their employment could be negatively affected.

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

(2) Antibiotic resistance lasts up to a year
(Research: Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis)
http://www.bmj.com/cgi/content/full/340/may18_2/c2096
(Analysis: Stoking the antibiotic pipeline)
http://www.bmj.com/cgi/content/full/340/may18_2/c2115

A community based falls prevention service reduced the rate of falls among older people by 55%, finds a study published on bmj.com today.

The service also led to increased levels of activities of daily living and reduced fear of falling.

Falls are a common and serious problem in older people. Many people who fall call an emergency ambulance, but are not transported to hospital and are not referred to a falls prevention service. Yet they remain at high risk of falling again.

So a team of researchers in Nottingham set out to evaluate whether falls could be reduced in this high risk group by a community falls prevention service.

The study involved 204 adults aged more than 60 living at home or in residential care who had fallen and called an emergency ambulance but were not taken to hospital.

Participants were given a thorough assessment at the start of the study and then randomly split into two groups. The intervention group received support from community fall teams including strength and balance training, a home hazards assessment and adaptations for the home, and practice in getting up from the floor. They also attended regular group sessions on fall prevention for further strength training and advice.

The control group received no such support and were advised to use existing social and medical services as usual.

All participants completed monthly falls diaries to monitor the rate of falls over 12 months.

The results show a 55% reduction in the rate of falls over the study period (3.5 falls per year in the intervention group compared with 7.7 falls per year in the control group). Results were similar when adjusted for factors such as sex, age, medication use, previous falls and residential status.

The intervention group were also better able to carry out usual daily activities and were less fearful of falling than the control group.

The number of participants admitted to hospital with a fracture, and the number of times an emergency ambulance was called because of a fall were also lower in the intervention group.

The authors believe this reduction to be clinically important and they call for a study of the economic consequences of these findings to be conducted.

In an accompanying editorial, Lindy Clemson, Associate Professor in Ageing at the University of Sydney, says that, although such interventions are successful in trial settings, their uptake in practice has been remarkably slow and inconsistent. She concludes: "Further studies are needed to assess the barriers and facilitators to implementing falls prevention programmes in the community, and how to make these programmes sustainable."

Contacts:
Research: Philippa Logan, Postdoctoral Researcher and Occupational Therapist, School of Community Health Sciences, University of Nottingham, UK
Email: pip.logan@nottingham.ac.uk
Editorial: Lindy Clemson, Associate Professor in Ageing, Faculty of Health Sciences, University of Sydney, NSW, Australia
Email: lindy.clemson@sydney.edu.au

(3) Are enhanced pharmacy services value for money?
(Analysis: Community pharmacy: moving from dispensing to diagnosis and treatment)
http://www.bmj.com/cgi/content/extract/340/may11_1/c2298

Recent changes to the NHS community pharmacy contract in England and Wales have led to a range of services, like smoking cessation and supervised methadone administration, which were once the reserve of general practitioners but which will now be provided through a private market dominated by large corporations.

But are these enhanced services value for money and what are their implications for patient care? Two public health specialists discuss the issues in a paper published on bmj.com today.

In 2005, the government argued that expanding the range of services provided by private for-profit community pharmacies would increase access and patient choice, reduce general practitioner workload, and lower costs to the NHS. The UK general medical services contract and the pharmacy contract allows a shift of NHS services from general practice to private for-profit community pharmacies in England.

But Elizabeth Richardson and Allyson Pollock from the University of Edinburgh say that a lack of centrally collected data "makes it difficult to draw general conclusions about their effectiveness and efficiency."

"Value for money is also difficult to determine," they add, "because the true costs of providing pharmaceutical services are obscure, especially in relation to premises and staff."

While good evidence supports the provision of some extended services, like smoking cessation and emergency hormone contraception supply, the evidence base on value for money and effectiveness of more complex services - such as opportunistic screening and minor ailment clinics - is limited and more research is needed, they argue.

They point to commercial conflicts of interest which, they say, are at odds "with public health priorities" and could undermine pharmacists' professional role. There is a risk too that, as more services are contracted out from the NHS, the boundaries between public and private funding and provision will also become blurred and difficult and costly to monitor and regulate.

As the health systems of Scotland, England, and Wales diverge it will be important to monitor these market oriented changes and their implications for the NHS and its patients, write Richardson and Pollock.

They conclude: "The absence of national data, central monitoring, and research into these changes means that the effectiveness, equity, efficiency, value for money, and above all the implications for access, safety, and quality of patient care are not known."

Contact:
Allyson Pollock, Centre for International Public Health Policy, University of Edinburgh, Scotland, UK
Email: allyson.pollock@ed.ac.uk

(4) No clear evidence that major sport events benefit local people
(Research: The health and socioeconomic impacts of major multi-sport events: systematic review (1978-2008))
http://www.bmj.com/cgi/content/abstract/340/may19_4/c2369
(Editorial: How will we know if the London 2012 Olympics and Paralympics benefit health?)
http://www.bmj.com/cgi/content/extract/340/may19_4/c2202

There is insufficient evidence to show that major multi-sport events like the Olympics benefit or harm the health and economy of the host population, according to research published on bmj.com today.

The authors are now calling on decision makers to ensure that robust evaluations are in place for the London 2012 Olympics and Paralympics and the Glasgow 2014 Commonwealth Games so that it is clear that costs "can be justified in terms of benefits to the host population."

Decision makers often bid for big global sport events because they claim that such events generate a wide range of benefits for the host population, says the study. These benefits include improvements in employment, skills, the economy, housing, national and local pride, the environment and sport (collectively termed the 'legacy').

Lead author, Dr Gerry McCartney, a specialist in public health from Glasgow, is now questioning whether events like the Olympics do help local people.

McCartney and colleagues reviewed 54 studies that assessed the health and socioeconomic impacts of major multi-sport events. The authors say that the quality of the majority of studies were poor and at risk of bias. They add that there were large gaps in a number of outcomes evaluated, especially health.

The authors conclude that "there is not sufficient evidence to confirm or refute expectations about the health or socioeconomic benefits for the host population of previous major multi-sport events ... future events such as the 2012 Olympic Games and Paralympics, or the 2014 Commonwealth Games, cannot be expected to automatically provide benefits."

They argue that better long-term evaluations are needed before justifications about costs can be attributed to host population benefits.

In an accompanying editorial, Professor Mike Weed from Canterbury Christ Church University, writes that the London 2012 Olympic and Paralympic Games will cost over £9 billion, £150 for every man, woman and child in the United Kingdom.

Weed argues that "the risk for the UK population is not that we will not get the benefits for our £150 a head investment in London 2012, but that there will be no robust evidence of what we have paid for."

Contacts:
Research: Gerry McCartney, Specialist Registrar in Public Health, MRC Social and Public Health Sciences Unit, Glasgow, Scotland
Email: gmccartney@nhs.net
Editorial: Mike Weed, Professor of Sport in Society, Centre for Sport, Physical Education and Activity Research (SPEAR), Canterbury Christ Church University, Kent, UK
Email: mike.weed@canterbury.ac.uk

(5) Some statins have unintended effects and warrant closer monitoring
(Research: Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database)
http://www.bmj.com/cgi/content/abstract/340/may19_4/c2197
(Editorial: Balancing the intended and unintended effects of statins)
http://www.bmj.com/cgi/content/extract/340/may19_4/c2240

The type and dosage of statin drugs given to patients to treat heart disease should be proactively monitored as they can have unintended adverse effects, concludes a new study published on bmj.com today.

Researchers found that some statins can lead to an increased risk of liver dysfunction, acute renal failure, myopathy and cataracts in patients.

Cardiovascular disease is a leading cause of premature death and a major cause of disability in the UK. The use of statins is often recommended to reduce the risk of cardiovascular disease among high risk patients.

Julia Hippisley-Cox, professor of clinical epidemiology and general practice and Carol Coupland, associate professor in medical statistics at the University of Nottingham, wanted to measure the unintended effects of statins on certain clinical outcomes, taking into account the type, dose and duration of use.

They studied data collected from 368 general practices contributing to the QResearch database on 2,004,692 patients aged 30-84 years including 225,922 patients who were new statin users and prescribed a range of statins. The patients' adverse outcomes were studied from January 2002 to June 2008.

The researchers estimated the effects of type, dose and duration of statin use on clinical outcomes that have been associated previously with statins and then calculated the numbers needed to treat and harm.

They found there was no significant association between use of individual statins and risk of Parkinson's disease, rheumatoid arthritis, venous thrombo-embolism, dementia, osteoporotic fracture, or many cancers including gastric, colon, lung, renal, breast or prostate. There was a reduced risk associated with statin use for oesophageal cancer.

There was, however, an increased risk associated with using statins for moderate or serious liver dysfunction, acute renal failure, moderate to serious myopathy and cataracts and evidence of a dose response for acute renal failure and liver dysfunction with higher doses being associated with greater risk.

Adverse effects were similar for all of the different statins taken except for liver dysfunction, where the highest risks were found for fluvastatin. All of the increased risks persisted during the treatment, but were highest in the first year.

Overall, for every 10,000 high risk women treated with statins, there would be approximately 271 fewer cases of cardiovascular disease, 8 fewer cases of oesophageal cancer; 74 extra patients who experience liver dysfunction; 23 extra patients with acute renal failure, 307 extra patients with cataracts, 39 extra patients with myopathy, Similar figures were found for men except rates of myopathy were higher. Some of the effects might be due to better detection rates since patients taking statins will consult their doctor more.

The authors say: "At national level, our study is likely to be useful for policy and planning purposes. Our study may also be useful for informing guidelines on the type and dose of statins."

A companion paper by the same researchers, also published today in the journal Heart, shows that their newly-developed and validated risk prediction algorithms could be used to identify patients at high risk of adverse events from statins so that they can be monitored more closely. A web calculator suitable for use by doctors can be found at www.qintervention.org

In an accompanying editorial, two senior cardiologists say that, like any intervention in medicine, statins are not entirely free of adverse events, but that when used according to current guidelines, the benefits outweigh the risks.

Contacts:
Research: Julia Hippisley-ox, Professor of Clinical Epidemiology and Clinical Practice, University of Nottingham, UK
Email: julia.hippisley-cox@nottingham.ac.uk
Editorial: Alawi A Alsheikh-Ali, Consultant Cardiologist, Institute of Cardiac Sciences, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates
Email: aalsheikhali@alum.mit.edu

(6) Vitamin deficiency linked to diabetes drug "increases over time"
(Research: Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial )
http://www.bmj.com/cgi/content/abstract/340/may19_4/c2181
(Editorial: Reduced serum vitamin B-12 in patients taking metformin)
http://www.bmj.com/cgi/content/extract/340/may19_4/c2198

Patients treated over prolonged periods with metformin, a common drug for diabetes, are at risk of developing vitamin B-12 deficiency, which is likely to get progressively worse over time, according to a new study published on bmj.com today.

Symptoms of B-12 deficiency include fatigue, mental changes, anaemia and neuropathy, which can easily be misdiagnosed as being due to diabetes and its complications or to ageing.

Because vitamin B-12 deficiency is preventable, the researchers suggest that regular measurement of vitamin B-12 levels during long-term metformin treatment should be strongly considered.

Metformin is the most commonly prescribed first-line therapy for patients with type 2 diabetes. It is already known that taking metformin can lead to vitamin B-12 deficiency and could be associated with decreased folate concentrations, which might, in turn, result in an increase in homocysteine levels - a functional marker of vitamin B-12 and folate deficiency.

So researchers from the Netherlands led by Professor Coen Stehouwer set out to study the effects of metformin treatment on levels of vitamin B-12, folate, and homocysteine in 390 patients with type 2 diabetes.

They gave 850 mg of metformin to 196 of the study's participants and a placebo to the other 194 people three times daily for more than four years. Measures were taken at regular intervals of the patients' vitamin B-12 levels, folate, and homocysteine levels.

People who had taken the metformin were found to have a 19% reduction in their vitamin B-12 levels, compared with people who had taken a placebo, who had almost no change in their levels during the study.

In addition, the reduction of levels of vitamin B-12 by metformin was not temporary, but persisted and became more apparent over time.

There was also a significant rise in the number of people with deficient levels of vitamin B-12 over the period of the study if they had been taking metformin, from three patients to 19. The equivalent number for the placebo group rose from four patients to five.

Compared with people taking a placebo, people taking metformin also had a 5% increase in homocysteine, but their folate levels were the same once the researchers took body mass index and smoking figures into account. Homocysteine levels increased especially in individuals in whom vitamin B-12 levels decreased - showing that the decrease in vitamin B-12 levels were functionally meaningful.

The authors say: "Our study shows that it is reasonable to assume harm will eventually occur in some patients with metformin-induced low vitamin B12 levels."

Current guidelines indicate that metformin is a cornerstone in the treatment of type 2 diabetes, but make no recommendations on the detection and prevention of vitamin B-12 deficiency during treatment, they add. "Our data provide a strong case for routine assessment of vitamin B-12 levels during long term treatment with metformin."

Researchers from Cardiff, writing in an accompanying editorial, say: "We first need to determine whether simple dietary counselling when metformin is started and at medication reviews will solve the problem. If it does not, a trial of screening for vitamin B-12 deficiency in patients taking metformin would be needed."

Contacts:
Research: Coen Stehouwer, Professor and Chair, Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, Netherlands
Email: cda.stehouwer@mumc.nl
Editorial: Josep Vidal-Alaball, Honorary Research Fellow, Department of Primary Care and Public Health, Heath Park, Cardiff, Wales
Email: vidal-alaballj@cf.ac.uk

FOR ACCREDITED JOURNALISTS

For more information please contact:

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

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