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Press releases Saturday 16 October 2004

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(1) URINARY INCONTINENCE RUNS IN THE FAMILY

(2) DRUG COMPANIES SHOULD DISCLOSE ADVERSE EVENTS BEFORE LICENSING

(3) THE DANGERS OF NHS REORGANISATION


(1) URINARY INCONTINENCE RUNS IN THE FAMILY

(Familial risk of urinary incontinence in women: population based cross sectional study)
http://bmj.com/cgi/content/full/329/7471/889

Women are more likely to develop urinary incontinence if their mother or older sisters are incontinent, finds a study from Norway in this week's BMJ.

These findings add weight to the theory that a genetic predisposition may play a part in the development of this common and burdensome condition among women.

The research team investigated the risk of urinary incontinence in the daughters, granddaughters, and sisters of over 2,000 incontinent women compared to the risk for almost 6,000 women with continent relatives.

Daughters of mothers with urinary incontinence had a 1.3-fold risk of being incontinent. If mothers had severe symptoms then their daughters had a close to 2-fold risk of such symptoms.

Female siblings had a 1.6-fold increased risk of urinary incontinence if their older sisters were incontinent. The familial risk found in the study was present for both symptoms of stress and urge incontinence.

"The symptoms of urinary incontinence are likely to have a complex cause, and known risk factors such as increasing age, pregnancy and childbirth, and high body mass index may further increase the risk among women with a genetic predisposition," conclude the authors.

Contact:

Yngvild Hannestad, Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway
Email: yngvild.hannestad@isf.uib.no


(2) DRUG COMPANIES SHOULD DISCLOSE ADVERSE EVENTS BEFORE LICENSING

(Editorial: lessons from the withdrawal of rofecoxib)
http://bmj.com/cgi/content/full/329/7471/867

Following the withdrawal of the painkiller and anti-inflammatory drug rofecoxib (Vioxx), researchers in this week's BMJ argue that patients would be safer if drug companies disclosed adverse events before licensing.

Single phase III drug trials are simply not big enough to detect relatively uncommon but important adverse events, which may affect large numbers of people in routine clinical use, writes Paul Dieppe and colleagues.

Furthermore, the impact of undetected adverse events is likely to be made worse if widely marketed new drugs are prescribed haphazardly and rapidly to large numbers of people. Within five months of the launch of rofecoxib, more than 42,000 patients had been prescribed the drug in England.

To prevent further similar episodes, drug companies should be legally required to make all data on serious adverse events from clinical studies available to the public immediately after completion of the research, say the authors. This will allow independent, timely, and updated systematic reviews of serious adverse events.

They also suggest phased introduction of new drugs in independent, large-scale, randomised trials before licensing, together with better postmarketing surveillance.

"Although these measures will not be popular with pharmaceutical companies, they will limit the numbers of patients exposed to unknown hazards and provide robust and unbiased evidence on adverse events before a drug is fully licensed," they conclude.

Contact:

Paul Dieppe, MRC Health Services Research Collaboration, University of Bristol, UK
Email: p.dieppe@bristol.ac.uk


(3) THE DANGERS OF NHS REORGANISATION

(Editorial: Primary care trusts)
http://bmj.com/cgi/content/full/329/7471/871

The NHS should resist the temptation to reorganise and merge primary care trusts in the belief that it would bring benefit to patients, argue researchers in this week's BMJ.

Just over two years ago, 303 primary care trusts were created in England, each with responsibility for providing primary health care, improving health, and commissioning secondary care services for a population of around 180,000.

Hopes were high that these new organisations would be powerful agents for change in a more devolved and locally responsive NHS. But some in the NHS now believe that primary care trusts have failed to fulfil these expectations and are suggesting a further reorganisation, with mergers, to reduce their number to 100-150 across England.

So what would these mergers achieve?

There is no good evidence to show that a structural reorganisation of primary care trusts would bring benefit to patients, write Professor Kieran Walshe and colleagues. The rush to reorganise and merge also fails to recognise that many primary care trusts have already made some progress.

Reorganisations are a clumsy reform tool, and research shows that they seldom deliver the promised benefits, they add. Every reorganisation produces a transient drop in performance, and it takes a new organisation at least two to three years to become established and start to perform as well as its predecessor.

Yet the NHS is reorganised every two years or so, which probably means it sees all of the costs of each reorganisation and few of the benefits.

To propose making structural changes to primary care trusts is premature. What they need instead is the space to work on implementing current policy initiatives and seeing their effects, building relations in local healthcare communities, and securing much needed clinical engagement and improvement in service.

The Department of Health and NHS managers should resist the temptation to reach for the old panacea of reorganisation, they conclude.

Contact:

Keiran Walshe, Professor of Health Policy and Management, University of Manchester, UK
Email: kieran.walshe@man.ac.uk

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