Press releases Tuesday 1 June to Friday 4 June 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) MS drugs scheme "a costly failure" for the NHS
(2) Low dose HRT patches carry less risk of stroke than tablets
(3) Low IQ scores in early adulthood increase the likelihood of attempted suicide in men
(4) Special care plan does not slow decline in patients with Alzheimer's

(1) MS drugs scheme "a costly failure" for the NHS
(Analysis: Multiple sclerosis risk sharing scheme: a costly failure)
http://www.bmj.com/cgi/content/extract/340/jun03_1/c1672
(Analysis: Continuing the multiple sclerosis risk sharing scheme is unjustified)
http://www.bmj.com/cgi/content/extract/340/jun03_1/c1786
(Commentaries: Scheme has benefited patients / Outcome measures were flawed)
http://www.bmj.com/cgi/content/extract/340/jun03_1/c2693 (Editorial: The multiple sclerosis risk sharing scheme)
http://www.bmj.com/cgi/content/extract/340/jun03_1/c2882

The multiple sclerosis risk sharing scheme is “a costly failure” and should not be continued, according to researchers on bmj.com today.

They argue that the biggest losers are the other NHS patients who would otherwise have benefited from the money spent on the scheme, estimated to be around £50m per year since it was set up in 2002.

They also point out that, if an assessment had been completed after the first two years, the NHS could have already saved around £250m.

The risk sharing scheme was set up by the Department of Health to make sure disease-modifying drugs were available on the NHS after the National Institute of Health and Clinical Excellence (NICE) ruled that they were not cost effective.

Under the terms of the scheme, the government agreed to provide these drugs on the NHS while research was carried out to assess their long term cost effectiveness. The NHS would then gradually stop paying for the drugs if patients did not appear to be benefiting.

In 2009, seven years after the scheme was set up, the first analysis of the data showed that patient outcomes were much worse than predicted, but the scheme’s scientific advisory group judged that it was premature to reduce prices without further analysis.

Why did this happen and what can we do to prevent it recurring?

Christopher McCabe, a health economist at the University of Leeds, and colleagues argue that none of the reasons for delaying the price review withstand critical assessment. They raise concerns about the independence of the group, which includes representatives from the drug manufacturers, patient groups, clinicians and the Department of Health. The delay in the publication of the first results is a further cause for concern, they add.

James Raftery, Professor of health technology assessment at Southampton University, supports these concerns and raises further questions about the independence of the advisory group, and the overall governance of the scheme.

The scheme was a success for the drug companies, who sold at close to full price to the NHS, says Raftery. For the NHS, however, it can be judged only “a costly failure,” he writes. “Monitoring and evaluation of outcomes in future patient access schemes must be independent of the companies involved. Transparency is essential, involving annual reports, access to data, and rights to publish. Any of these might have helped avoid the current fiasco, he concludes.”

McCabe and colleagues add: “When the key uncertainty in the evidence base for a new product relates to its effectiveness, a randomised controlled trial is likely to be the quickest, most efficient, and most ethical strategy.”

But in an accompanying commentary, Alastair Compston, Professor of Neurology at the University of Cambridge argues that the scheme has benefited patients, though he acknowledges that its governance was inadequate and that its terms of reference were not delivered. He also warns that attempts to force the drug companies to repay costs would be likely to trigger complex legal arguments.

And in a second commentary, George Ebers, Professor of Clinical Neurology at the University of Oxford, believes that the outcome measures used in the scheme were flawed. He also says that the scheme’s findings raise questions about industrial-academic relationships and their governance. “The scheme may have been well intentioned, but perhaps the public interest would be served by an independent inquiry,” he writes.

And in an editorial, Neil Scolding, Professor of Clinical Neurosciences at the University of Bristol and Frenchay Hospital, describes the scheme as a clever achievement, which despite being flawed, has had unintended beneficial consequences.

Scolding argues that the scheme has spawned an extremely successful infrastructure of specialist multiple sclerosis care in the UK and that the drugs prescribed will have prevented thousands of relapses. He also says that “it leaves a platform for introducing new treatments and executing clinical research that is second to none in the world.”

Contacts:
James Raftery, Professor of Health Technology Assessment, Southampton University, Southampton, UK
Email: j.p.raftery@soton.ac.uk
Christopher McCabe, Academic Unit of Health Economics, University of Leeds, Leeds, UK
Email: c.mccabe@leeds.ac.uk
Alastair Compston, Professor of Neurology, Department of Clinical Neurosciences, University of Cambridge, UK
Email: alastair.compston@medschl.cam.ac.uk
Neil Scolding, Professor of Clinical Neurosciences, University of Bristol and Frenchay Hospital; Bristol, UK
Email: n.j.scolding@bristol.ac.uk

(2) Low dose HRT patches carry less risk of stroke than tablets
(Research: Transdermal and oral hormone replacement therapy and the risk of stroke: nested case-control study)
http://www.bmj.com/cgi/content/abstract/340/jun03_1/c2519

Hormone replacement therapy (HRT) skin patches containing low doses of oestrogen carry less risk of stroke than oral therapy and may represent a safer alternative to tablets, suggests a study published on bmj.com today.

However, the risk increases significantly with high dose patches.

HRT is regularly prescribed to women suffering from the effects of the menopause. However, most studies have shown an increased risk of stroke associated with taking HRT. There is also evidence that different routes of administering HRT may be associated with a different risk of cerebrovascular events.

So researchers in Canada and Germany assessed the risk of stroke associated with oral and transdermal (through the skin) HRT in post-menopausal women in the UK.

Their findings are based on data from the General Practice Research Database (GPRD), which holds the anonymised medical records of millions of patients registered with family doctors across the UK.

From a population of over 870,000 women aged 50-79 between January 1987 and October 2006, they identified 15,710 cases with a first recorded diagnosis of stroke occurring in the study period. Each case was matched to 59,958 controls.

Exposure to HRT was categorised into oestrogens only, oestrogens plus progestogen, progestogen only, and tibolone. Oestrogens were further subdivided according to the route of administration (oral or transdermal) and to the dose (high or low).

The risk of stroke was not increased with use of low oestrogen dose patches compared with no use, whereas the risk was increased by up to 88% with high dose patches.

Use of oral HRT increased the rate of stroke by around 25-30% compared with no use, regardless of the oestrogen dose or when combined with progestogen.

There was no risk increase with short-term use (less than one year) of the oral formulations, but longer-term users (more than one year) of the oral agents had a 35% increased risk.

The authors conclude: “Our study suggests that the use of transdermal oestrogen replacement therapy containing low doses of oestrogen could be associated with a lower risk of stroke than the oral route of administration.”

They add: “Although these results alone do not represent definitive evidence to promote the use of the transdermal route over oral administration of oestrogen replacement therapy, this study should encourage further research on the importance of the route of administration to define the role of transdermal oestrogens in the therapeutic arsenal for the treatment of menopausal symptoms.”

Contact:
Samy Suissa, Center for Clinical Epidemiology, Jewish General Hospital, and the Departments of Epidemiology and Biostatistics and of Medicine, McGill University, Montreal, Canada
Email: samy.suissa@mcgill.ca

(3) Low IQ scores in early adulthood increase the likelihood of attempted suicide in men
(Research: Psychosis alters the association between IQ and future risk of attempted suicide: cohort study of 1,109,475 Swedish men)
http://www.bmj.com/cgi/content/abstract/340/jun03_1/c2506

Men with the lowest intelligence in their youth are almost nine times more likely to attempt suicide then those with the highest IQ, finds a new study published on bmj.com today.

The large-scale study of more than 1.1million men living in Sweden, found a direct association between lower IQ and attempted suicides.

Suicide is a major cause of morbidity and mortality in young adults. Attempted (non-fatal) suicide causes many emergency hospital admissions and such attempts are a strong predictor of subsequent fatal suicides.

There is growing evidence that intelligence (cognitive function) may have a role in the causes of attempted suicide, but the nature of the relationship is uncertain.

An international team of researchers from the UK, Australia and Sweden, led by Finn Ramussen of the Karolinska Institutet in Stockholm, Sweden, decided to look at a possible link between intelligence and suicide attempts.

They looked at 1,109,475 men born in Sweden from 1950 to 1976. As part of military service conscription, these men all had physical and mental examinations including their mental health and intelligence.

The men were followed up over 24 years and the researchers used hospital admissions data to monitor their hospital attendances and the reasons for those.

They found there were 17,736 (1.6%) cases of men being admitted to hospital for attempted suicide.

Hospital admissions for psychosis occurring before any suicide attempts were identified because the researchers also wanted to examine the role of psychosis. A total of 12,328 (1.1%) of the men were identified as psychotic.

After adjusting for age and socioeconomic status, the researchers found that men with lower IQ scores were more likely to have attempted suicide by any means.

Analysis adjusted for age showed that men in the lowest IQ group were almost nine times more likely to have a hospital admission for attempted suicide as men in the highest IQ group.

Further analysis showed that IQ-attempted suicide associations were restricted to study members without psychosis and there was no marked impact of IQ on attempted suicide risk on those with psychosis.

Of the 12,328 men identified as psychotic, 1,607 (13%) had at least one subsequent admission for attempted suicide compared with 16,129 (1.5%) of men free from psychosis.

The researchers said there were many reasons for the association such as the fact that people with a lower IQ tended to have lower socioeconomic status and lower income so might experience more social and financial hardships leading to an increase in suicidal thoughts and behaviours. Low IQ has also been linked to poor health behaviours such as binge drinking, which increases suicide risk.

They conclude: “A greater understanding of mechanisms underlying these associations may provide opportunities and strategies for prevention.”

Contact:
David Batty, Wellcome Trust fellow, Medical Research Council, Social & Public Health Sciences Unit, Glasgow, Scotland
Email: david-b@sphsu.mrc.ac.uk

(4) Special care plan does not slow decline in patients with Alzheimer's
(Research: Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study))
http://www.bmj.com/cgi/content/abstract/340/jun03_1/c2466
(Editorial: Care plans for people with Alzheimer's disease)
http://www.bmj.com/cgi/content/full/340/jun03_1/c2626

A special dementia care plan, involving regular assessments of patients with Alzheimer's disease in specialist memory clinics, does not slow functional decline compared with usual care, finds a study published on bmj.com today.

Guidelines for the care of patients with Alzheimer's disease recommend regular evaluation and follow-up. However, questions remain over the feasibility and real impact of these guidelines, and whether assessments are better carried out in primary care or specialist memory clinics.

So a team of researchers in France tested the effectiveness of a comprehensive care plan in reducing the rate of functional decline in patients with Alzheimer's disease compared with usual care.

The study was conducted over two years at 50 memory clinics in France and involved 1,131 community dwelling patients with mild to moderate Alzheimer's disease. Patients were randomised to either a comprehensive care plan (intervention group) or usual care (control group).

Patients in the intervention group received regular 6-monthly assessments, while the control group received only an annual consultation.

After two years, there was no significant difference in functional decline between the two groups. There was also no difference in the risk of being admitted to an institution or death between the two groups.

The authors say: "This finding underlines the fact that this kind of broad intervention does not convey benefit in activities of daily living and may have little public health value."

They add: "it may be that interventions must be targeted towards patients at particular risk of decline or we may need to develop a more effective intervention and ensure that it is correctly implemented in all patients."

Future research is needed to determine whether functional decline can be improved by more direct involvement of general practitioners or by using case manager programmes, they conclude.

In an accompanying editorial, Professor Lon Schneider from the University of Southern California acknowledges that care plans are not simple to implement, but says the trial "provides an important basis from which to assess the feasibility and effectiveness of care plans delivered by doctors. It also highlights the need to develop effective comprehensive care plans that can be integrated into practice."

Contact:
Research: Fati Nourhashemi, Geriatrician, Service de Médecine Interne et de Gérontologie, Toulouse University Hospital, Toulouse, France
Email: fatinour@orange.fr
Editorial: Lon Schneider, Professor of psychiatry, neurology, and gerontology, University of Southern California Keck School of Medicine, Los Angeles, USA
Email: lschneid@usc.edu

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

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