Press releases Monday 1 November to Friday 5 November 2010

Please remember to credit the BMJ as 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 about the post-approval surveillance of medical devices
• (2) Could ‘low risk’ pregnancies in the Netherlands be more dangerous for newborn babies?
• (3) Hidden costs of applying to medical school will deter poorer students
• (4) Doctors call on governments to use evidence in making clinical decisions
• (5) Calling all journalists to enter the BMJ Group Awards 2011
• (6) Risk of haemorrhagic stroke rises with use of vitamin E

(1) BMJ investigation raises concerns about the post-approval surveillance of medical devices

(Feature: Why the FDA can't protect the public)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5504
(Research: A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5370
(Editorial: Regulation of devices)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5730

A BMJ investigation published today raises concerns about the ability of the US Food and Drug Administration (FDA) to monitor the ongoing safety of medical devices through post-approval surveillance.

The report by Jeanne Lenzer, a medical investigative journalist in New York, and Shannon Brownlee from the Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire, looks at the FDA's approval of a device to prevent or reduce seizures in patients with epilepsy who do not respond to drug treatment.

The device, manufactured by Cyberonics, is implanted under the skin and sends electrical impulses to stimulate the vagus nerve in the neck. It was approved by the FDA in 1997 on the condition that Cyberonics carried out a post-approval study to examine the safety of the device.

"However, in the 13 years since the device was approved in the US, more than 900 deaths have been reported to the FDA, and it is still not clear what impact, if any, the device has had on patient mortality," say Lenzer and Brownlee. They point out that, although Cyberonics conducted the requisite post-approval study, the FDA did not specifically require the company to submit mortality data.

Lenzer and Brownlee argue that the FDA's failure to request and rigorously monitor mortality data related to the vagus nerve stimulator "is but one example of the gap in post-approval surveillance of medical devices." A recent review showed that less than one third of devices approved under FDA's premarket approval process had been evaluated in a randomised study.

They also question the FDA's ability to detect potentially unsafe devices through its harms database and cite a finding that many post-approval studies "are not conducted or conducted so poorly as to be meaningless."

The FDA gave the BMJ references to five additional post-approval studies as evidence of the device's safety. But Lenzer and Brownlee say that these studies do not establish that the device wasn't responsible for deaths because none of them reported mortality data.

In 2005, the FDA approved the vagus nerve stimulator for the treatment of depression, despite the recommendation against approval by its own scientists. The company has also suggested that the stimulator might have a role in treating obesity, stroke, traumatic brain injury, and other conditions, and has taken out patents for these potential therapies.

The gaps in post-approval monitoring of the vagus nerve stimulator are emblematic of the FDA's surveillance of all devices, say the authors. Yet they believe many of the problems have relatively easy fixes. For example, the FDA could make better use of the FDA's database to detect potential safety issues by requiring manufacturers to regularly submit data on the number of active devices.

An independent review panel could also be appointed to decide whether certain adverse outcomes could be excluded from reporting, instead of allowing the manufacturer to make those decisions. And, as the FDA has suggested, mechanisms to limit widespread uptake of new devices could be put in place so that fewer patients are harmed if it ultimately turns out that newly approved devices are flawed, they conclude.

In an accompanying editorial, Professor Jerry Avorn from Harvard Medical School argues that "the standards for device approval and surveillance have fallen far below those for drugs, and even those that would be dictated by common sense."

He points to a "notoriously inadequate approach" in the vital area of postmarketing safety surveillance, and calls for surveillance activities to be placed at a higher and more independent position within regulatory bodies.

Important lessons can be learnt from drug regulation, he says, including mandatory recording of all installed devices on clinical databases and better systems to review new products.

Contacts:
Feature: Jeanne Lenzer, medical investigative journalist, NY, USA
Email: jeanne.lenzer@gmail.com
Editorial: Jerry Avorn, professor, Department of Medicine, Harvard Medical School, Boston, MA, USA
Email: javorn@medsoc.harvard.edu

(2) Could 'low risk' pregnancies in the Netherlands be more dangerous for newborn babies?
(Research: Perinatal mortality and severe morbidity in low and high risk term pregnancies in the Netherlands: prospective cohort study)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5639
(Editorial: Place of delivery and adverse outcomes)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5560

Infants in the Netherlands born to mothers who have been classified as low risk, are more than twice as likely to die during or shortly after birth than babies born to high risk mothers, finds a study published on bmj.com today.

While the risk remains low the authors are surprised at the results and say "a critical evaluation of the obstetrical care system in the Netherlands is urgently required."

Despite the high level of medical care in the Netherlands, the perinatal mortality rate (death of fetus or new born baby) is one of the highest in Europe, says the study.

The management of childbirth delivery in the Netherlands is divided into two independent systems – midwife-led care for low risk pregnancies and obstetrician-led care for high-risk pregnancies. This differs to all other obstetric care systems in the industrial world. Home birth in the low risk group is popular and 22% of this group deliver their babies this way.

The authors, led by Dr Annemieke Evers from the University Medical Center in Utrecht, investigated whether the obstetric care system in the Netherlands contributes to the high perinatal mortality rate.

Evers and colleagues assessed the data of 37,735 births from a region in the middle of the Netherlands covering 13% of the Dutch population. The overall perinatal death rate in the study group was 2.62 per 1,000 babies delivered but this risk more than doubles for infants of low risk pregnant women.

The authors were also concerned to note that this risk more than triples for babies of women who were referred during labour by a midwife to an obstetrician.

The results also show that there was no difference in the admission rate of babies born to low and high risk women to neonatal intensive care units (NICU).

Dr Evers believes this study puts "severe question marks by the supposed effectiveness of the Dutch obstetrical system that is based on risk selection and obstetrical care at two levels." She says "the Dutch system of risk selection in relation to perinatal death at term is not as effective as once thought ... this implies as well that the high perinatal death in the Netherlands compared to other European countries is among other factors possibly caused by the obstetrical care system itself."

In an accompanying editorial, Mr Derek Tuffnell, Consultant Obstetrician at the Bradford Royal Infirmary, believes women at low risk of complications should be given a choice of having their baby at home or in a midwifery unit.

While Tuffnell acknowledges that Evers' study suggests that the higher rate of perinatal mortality in the Netherlands may be "because women were inappropriately booked for labour care under a midwife," he adds that "risk assessment is an inexact science" and that no birth is without risk.

He says "low risk does not equal no risk, and high risk women who are away from consultant care are a particular risk."

Mr Tuffnell concludes that the study is welcome but it can only provide estimates. He argues that the debate about how to manage low risk and high risk pregnancies will continue and that "women will have to make individual choices."

Contact:
Research: Department of Internal and External Communication at University Medical Center (UMC) Utrecht, Netherlands
Email: press@umcutrecht.nl
Editorial: Derek Tuffnell, Consultant Obstetrician, Bradford Royal Infirmary, Bradford, UK
Email: derek.tuffnell@bradfordhospitals.nhs.uk

(3) Hidden costs of applying to medical school will deter poorer students
(Personal View: Selecting tomorrow’s doctors – not a level playing field)
http://www.bmj.com/cgi/doi/10.1136/bmj.c6108

The costs of a medical school application may deter young people from poorer backgrounds from applying to medical school, argue a father and daughter in an article published on bmj.com today.

In the UK, medical students are 4.5 to 7.2 times more likely to come from the wealthier socio-economic groups 1-3 than 4-7, write Professor Terence Stephenson, president of the Royal College of Paediatrics and Child Health, and Lucy Stephenson, a medical student.

Selection to a medical course should not depend on the applicants' financial status. However, with "grade inflation" at A level, choosing between applicants can involve other criteria that may depend on ability to pay, they say.

They calculate that the activities required as part of the selection process for many medical courses comes to over £1,600.

The costs include travel to attend UKCAT and BMAT exams, and a residential course to familiarise applicants with the medical career and the complex application process, and to have interview coaching and guidance.

It also includes the cost of attending six open days, as far afield as Exeter and Edinburgh, and an average of two interviews, usually accompanied by one or both parents. If offered a place, students may also pay for vaccinations essential to commencing the course.

Adding all these costs together comes to £1609.60, they say.

But this figure doesn't include non-academic activities, such as music, sport, or work experience that can also influence whether an applicant is offered a place, but that often require significant financial assistance over many years.

They also point out that a school pupil from a poor background may have a part-time job evenings and weekends in addition to their four A level subjects competing for their time and resources.

They conclude: "In addition to the greater opportunity that professional parents have to arrange appropriate work experience, and the lesser debt aversion of wealthier families (medical students finish the course with average debts of £35,000), the costs described here may further disadvantage young people from poorer backgrounds in the process of selection for medical school."

Contact:
Terence Stephenson, former medical school dean, president of the Royal College of Paediatrics and Child Health, and a member of the GMC
Email: claire.brunert@rcpch.ac.uk

(4) Doctors call on governments to use evidence in making clinical decisions

At a major international conference held in London today, doctors from around the world called on governments to base policy decisions on health care using current available evidence.

"There are three-quarters of a million clinical trials and thousands of systematic reviews around the world on which to base decisions on health care", said Professor Paul Glasziou, from the Centre for Research in Evidence-Based Practice at Bond University in Australia.

Half of the clinicians at the conference agreed that clinicians have enough evidence to make decisions on commissioning. However, with GP commissioning planned to take place soon in the UK, Professor Glasziou warned that many GPs may not have the right skills to find, evaluate and act on the available evidence.

Delegates registered unanimously their concern that missing or unreported data presented huge problems for the integrity of the healthcare evidence base and Dr Fiona Godlee, Editor-in-Chief, BMJ, called for greater access to data on which published medical research is based.

300 clinicians and healthcare professionals from the UK, North America, Scandinavia, Western Europe, the Middle East and Australia are attending a two day conference, "Evidence 2010", a collaboration between the BMJ Evidence Centre, part of the BMJ Group, and the Centre for Evidence Based Medicine at Oxford University.

(5) Calling all journalists to enter the BMJ Group Awards 2011

BMJ Group is calling on journalists to submit their entries for the Health Communicator of the Year Award at groupawards.bmj.com This award celebrates an individual who has shown excellence in promoting understanding of medicine and health through the media. Closing date for entries is 4 January 2011.

The annual BMJ Group Awards recognise individuals, organisations and initiatives that have demonstrated outstanding and measurable contributions to health care. Established in 2009, the Awards are now the most highly sought after awards in the medical world, attracting high calibre entries for 13 categories from across the globe.

(6) Risk of haemorrhagic stroke rises with use of vitamin E
(Research: Effects of vitamin E on stroke subtypes: meta-analysis of randomised controlled trials)
http://www.bmj.com/cgi/doi/10.1136/bmj.c5702

People should be cautious about indiscriminate widespread use of vitamin E due to an increased risk of a certain type of stroke, warns a new study published on bmj.com today.

An international team of researchers found that taking the vitamin increased the risk of haemorrhagic stroke (where bleeding occurs in the brain) by 22 per cent but reduced the risk of ischaemic stroke by 10per cent.

However, they stress that the absolute effects are small (0.8 more haemorrhagic strokes and 2.1 fewer ischaemic strokes per 1,000 treated persons). In other words, there is the chance of one additional haemorrhagic stroke for every 1,250 people taking vitamin E in contrast to one ischaemic stroke prevented per 476 people taking vitamin E.

They also point out that other preventive strategies, such as blood pressure and cholesterol lowering drugs and living a healthy lifestyle, have far stronger effects on reducing ischaemic stroke than intake of vitamin E.

Previous studies have suggested that taking vitamin E has a protective effect on coronary heart disease and around 13 per cent of the US population takes this vitamin as a supplement. Other studies have found the vitamin has no such effect and in high doses, might increase the risk of death.

Researchers from the US, France and Germany carried out a review of existing studies that had looked at vitamin E and its reported effect on different types of stroke.

They studied nine trials that had investigated the effect of vitamin E on stroke totalling 118,756 participants (59,357 of whom took the vitamin and 59,408 who took a placebo).

Among these, some trials just reported data for total stroke and others had data on both haemorrhagic and ischaemic stroke.

None of the results from the individual trials suggested that vitamin E significantly altered the risk for total stroke. However, the researchers found there were stark differences when looking at the effect of the vitamin by type of stroke.

In the overall analysis, a total of 223 haemorrhagic strokes occurred among 50,334 people assigned to take vitamin E and 183 such strokes among the 50,414 people taking placebo, meaning the group taking the vitamin were 22 per cent more likely to have this kind of stroke.

For ischaemic stroke, the analysis showed that of the 45,670 people taking vitamin E, 884 had this form of stroke, compared with 983 of the 45,733 people taking placebo – meaning people taking the vitamin were 10% less likely to have a stroke.

The researchers conclude: "Given the relatively small risk reduction of ischaemic stroke and the generally more severe outcome of haemorrhagic stroke, indiscriminate widespread use of vitamin E should be cautioned against."

Contact:
Markus Schurks, Instructor of Medicine, Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
Email: claire.brunert@rcpch.ac.uk

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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

and from:

the EurekAlert website, run by the American Association for the Advancement of Science (http://www.eurekalert.org)
http://intranet.bmj.com/departments/dept-bmj/bmj-team-resources/web-team-resources/General_blogging_principles.doc