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Press releases Saturday 19 January 2008
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(1) Increased risk of heart attack or stroke for patients who are resistant to aspirin
(2) Risk of falling is overlooked as the major cause of fractures in the elderly
(3) Value of drugs for pre-osteoporosis exaggerated
(4) NICE guidelines on breast cancer follow-up need urgent revision
(5) Recalled toy beads still available in the UK, warn doctors
(1) Increased risk of heart attack or stroke for patients who are resistant to aspirin (Aspirin "resistance" and risk of cardiovascular morbidity: systematic review and meta-analysis) http://www.bmj.com/cgi/content/short/bmj.39430.529549.BEv1 (Editorial: Aspirin resistance in cardiovascular disease)http://www.bmj.com/cgi/content/short/bmj.39405.635498.80v1
Being resistant to aspirin makes patients four times more likely to suffer a heart attack, stroke or even die from a pre-existing heart condition, according to a study published on bmj.com today.
The study relates to patients who are prescribed aspirin long term as a way of preventing clots from forming in the blood.
Patients who are labelled "aspirin resistant" have blood cells (platelets) that are not affected in the same way as those of patients who are responsive to the drug, ie people who are "aspirin sensitive."
There is currently no agreed method of accurately determining who is and isn't aspirin resistant and the reasons why someone might be aspirin resistant are currently a cause of controversy.
Relatively few studies have looked at whether aspirin resistance has any impact on clinical outcome so the Canadian authors carried out a review of all the available data to better understand the relationship between the two.
They identified 20 studies, involving 2,930 patients with cardiovascular disease, all of whom had been prescribed aspirin as a way of preventing clots from forming in the blood. 28% were classified as aspirin resistant.
They found that all aspirin resistant patients, regardless of their underlying clinical condition, were at greater risk of suffering a heart attack, stroke or even dying. In particular they found that 39% of aspirin resistant patients compared to 16% of aspirin sensitive patients suffered some sort of cardiovascular event.
They also found that taking other drugs to thin the blood, such as Clopidogrel or Tirofiban, did not provide any benefit to these patients.
The authors conclude that there needs to be further studies on aspirin resistance to identify the most useful test to determine the condition. They also say aspirin resistance: "is a biological entity that should be considered when recommending aspirin as antiplatelet therapy."
Contact:
Michael Buchanan, Department of Pathology & Molecular Medicine
Thrombosis & Haemostasis, McMaster University Health Sciences Centre, Canada
Email: jtrehm@aol.com
Neil McKeganey, Professor of Drug Misuse Research, University of Glasgow, Scotland
Email: mbuchan@mcmaster.ca
(2) Risk of falling is overlooked as the major cause of fractures in the elderly
(Shifting the focus in fracture prevention from osteoporosis to falls)
http://www.bmj.com/cgi/content/short/336/7636/124
An elderly person's risk of falling is too often overlooked when trying to prevent them from getting serious fractures, for instance of the hip or wrist, according to an article published in this week's BMJ.
The Finnish authors says studies show that if the focus were to be switched to how at risk someone is of falling, rather than whether they have the bone disease osteoporosis, then considerably more fractures in elderly people could be prevented. However, many important publications completely overlook falling as a risk factor and it is still very poorly recognised and assessed by doctors.
Dr Jarvinen and colleagues say current fracture prevention methods have serious limitations. At the moment an individual is screened to see whether they have osteoporosis, and is then treated accordingly with medication. Yet the test which determines whether someone has the disease is flawed. It assesses bone mineral density (BMD) and can often either over and under-estimate that density. BMD is therefore a poor predictor of whether a person is likely to suffer a fracture and is of little diagnostic value to a GP.
The cost of using drugs to prevent fractures in the elderly is also extremely high. For example the researchers calculated that 577 postmenopausal women would have to be treated with osteoporosis drugs (known as bisphosphonates) for one year to avert one hip fracture, at a cost of about £120,000. Among a high risk population (women over 80), for whom drug prevention would theoretically be most effective, prevention of one hip fracture costs about £28,500. Yet 80% of hip fractures would still occur.
The authors say falling is the major cause of nine in ten hip fractures and drug therapy would not prevent more fractures because the drugs cannot be expected to work on fall-related risk factors. Eight in ten fractures also occur in people who do not even have osteoporosis.
The authors go on to say it is important for GPs to identify at-risk individuals and assess their needs. Current evidence-based recommendations for preventing falls include regular strength and balance training, taking Vitamin D and Calcium supplements and an assessment of the possible hazards in the homes of at-risk people. There is evidence that fall prevention efforts can reduce the incidence of falls by up to 50% in the elderly.
Contact:
Teppo Jarvinen, University of Tampere, Tampere, Finland
Email: teppo.jarvinen@uta.fi
(3) Value of drugs for pre-osteoporosis exaggerated
(Drugs for pre-osteoporosis: prevention or disease-mongering?)
http://www.bmj.com/cgi/content/short/336/7636/126
A series of recent scientific publications have exaggerated the benefits and underplayed the harms of drugs to treat pre-osteoporosis or "osteopenia" potentially encouraging treatment in millions of low risk women, warn experts in this week's BMJ.
The authors believe that this represents a classic case of disease-mongering: a risk factor being transformed into a medical disease in order to sell tests and drugs to relatively healthy people.
Osteopenia or "pre-osteoporosis" is said to affect around half of all older women and, in at least one country, drug companies have already begun to market their drugs to women with osteopenia, based on re-analyses of four osteoporosis drug trials.
But the authors of this week's BMJ paper argue that this move raises serious questions about the benefit-risk ratio for low risk individuals, and about the costs of medicalising and potentially treating an enormous group of healthy people.
These reanalyses tend to exaggerate the benefits of drug therapy, they say. For example, the authors of one reanalysis cite a 75% relative risk reduction, though this translates into only a 0.9% reduction in absolute risk.
In other words, up to 270 women with pre-osteoporosis might need to be treated with drugs for three years so that one of them could avoid a single vertebral fracture.
Most of the reanalyses also play down the harms of drug therapy, they add. For example, the reanalysis of data for the drug raloxifene focuses solely on the potential benefits, with no mention of an increased risk of blood clots.
Finally, like much of the published literature on osteoporosis, these analyses have potential conflicts of interest, they write. For instance, all of the original drug trials being re-analysed were funded by industry and, in three out of four cases, drug company employees were part of the team conducting the reanalyses.
The World Health Organisation is currently developing guidance on how to deal with women categorised as having osteopenia. Whether this will stop industry efforts to encourage treatment in low risk women is, however, questionable, they say.
"We need to ask whether the coming wave of marketing targeting those women with pre-osteoporosis will result in the sound effective prevention of fractures or the unnecessary and wasteful treatment of millions more healthy women," they conclude.
Contacts:
Ray Moynihan, Conjoint Lecturer, University of Newcastle, Australia
Email: ray.moynihan@newcastle.edu.au
Pablo Alonso-Coello, Family Practitioner, Department of Clinical Epidemiology and Public Health, Hospital de Sant Pau, Barcelona, Spain mail: palonso@santpau.es
(4) NICE guidelines on breast cancer follow-up need urgent revision
(Editorial: Follow-up after breast cancer)
http://www.bmj.com/cgi/content/short/336/7636/107
The NICE guidelines on follow-up for breast cancer patients need urgent revision, warn experts in this week's BMJ.
More than 1.2 million women and men worldwide are diagnosed with breast cancer each year and it is now recognised as a chronic disease that can recur even after 20-30 years.
Survival continues to improve, so new cancers are now more common in many patients than recurrence because the treatments of the first cancer are so effective. However, follow-up protocols still vary widely both within and between countries and are not always evidence based.
The National Institute for Health and Clinical Excellence (NICE) in England and Wales state that the aims of breast cancer follow-up are to detect and treat local recurrence, to deal with adverse effects of treatment and to provide psychological support.
The guidelines suggest that these aims can be met by two to three years of follow-up, and that routine long term follow-up is ineffective and unwarranted. They also claim that the yield from mammography is low.
But Michael Dixon, Consultant Surgeon at Edinburgh Breast Unit and David Montgomery, Clinical Research Fellow at Glasgow Royal Infirmary, argue that the NICE guidelines do not meet their stated aims.
Although true local recurrence after breast conserving surgery falls with time, the development of new cancers in the treated breast increases, so the overall rate of ipsilateral breast events is constant at 0.5 to 1% each year for at least the first 10 years and probably for the rest of the patient’s life.
If "recurrences" in the treated breast and armpit are combined together with new cancers in the opposite breast, the annual incidence of treatable disease is constant at 1 to 1.5% for at least the first 10 years, and 70% of such events occur after the first three years.
If NICE is to achieve its aim of detecting and treating local recurrence it clearly cannot be achieved with a three year follow-up, they say.
Data also show that mammography is a very effective way to detect treatable local disease, and fully funded mammographic surveillance programmes specifically for patients with breast cancer are urgently needed, they add.
In contrast to NICE guidelines, they recommend that clinical examination should be annual for two years and surveillance by mammography thereafter.
Ongoing psychological support should also be available, and in between visits for mammograms, patients should have direct access to a named breast care nurse, specialist nurse or doctor and access to prosthesis advice and fitting.
Timely investigation of symptoms and communication of test results is also vital to reduce anxiety and improve ongoing care.
Patients' needs vary, so follow up programmes for patients with breast cancer patients need to be evidence based, flexible, and tailored to their lifelong needs, they conclude.
Contact:
Jane Runnacles, Paediatric Specialist Registrar, University Hospital Lewisham, London, UK
Email: j_runnacles@hotmail.com
(5) Recalled toy beads still available in the UK, warn doctors
(Letter: Poisoning from toy beads)
http://www.bmj.com/cgi/content/short/336/7636/110
Toy beads that were internationally recalled last year, after concerns that they may be coated with a dangerous chemical, are still being advertised on toy shop websites for purchase in the UK, warn doctors in this week's BMJ.
They want to bring this serious public health concern to the attention of all doctors involved in the care of children.
They report the case of a 7 year old girl who presented to their emergency department with an acute life threatening event after swallowing Bindeez toy beads given to her as a Christmas present.
Paramedics found her with a reduced level of consciousness, and she had a respiratory arrest requiring bag and mask ventilation. On arrival at hospital, she had a dangerously slow heart rate and needed cardiopulmonary resuscitation.
Initial concerns were that she may have choked on the beads. However, further investigations did not identify any beads.
Once stabilised, she was able to tell doctors that, thinking they were sweets, she had eaten approximately 80 beads, and they had tasted of marzipan.
Toxicology tests showed that the beads were coated in the chemical 1,4-butanediol, which when digested in the body, is metabolised to gamma hydroxylbutyric acid (GHB), a potent sedative and anaesthetic agent.
In November 2007, Bindeez beads were internationally recalled after two similar cases were reported in Australia. However, they are still advertised on toy shop websites for purchase in the UK, say the authors.
When they drew this to the attention of the UK distributor, it stated that it was not aware of this and would be launching a further investigation.
It is essential that all paediatricians, emergency department doctors, anaesthetists, and general practitioners are aware of this extremely serious public health hazard, they write.
And they recommend that GHB intoxication from toys should be considered in all children presenting with depressed level of consciousness.
Contact:
J Michael Dixon, Consultant Surgeon and Senior Lecturer in Surgery, Edinburgh Breast Unit, Western General Hospital, Edinburgh, Scotland
Email: jmd@ed.ac.uk
Embargoed press releases and articles are available from:
Public Affairs Division, BMA House, Tavistock Square London WC1H 9JR
(contact: pressoffice@bma.org.uk)
and from:
the EurekAlert website, run by the American Association for the Advancement of Science (http://www.eurekalert.org)
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