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Press releases Saturday 6 October2007

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(1) Fears about complications shouldn't drive antibiotic prescribing for colds, sore throats, and ear infections
(2) European drug regulations need to change, say experts
(3) Genetic screening would prevent hearing loss caused by antibiotics
(4) Call for doctors to become MPs

(1) Fears about complications shouldn't drive antibiotic prescribing for colds, sore throats, and ear infections
(Protective effect of antibiotics against serious complications of common respiratory tract infections, assessed using the UK General Practice Research Database)
(Editorial: Antibiotics for respiratory tract infections in primary care)
http://www.bmj.com/onlinefirst_date.dtl

Antibiotics are not justified to reduce the risk of complications after upper respiratory tract infection, sore throat, or ear infection, finds a study published on bmj.com today.

But they do substantially cut the risk of pneumonia after chest infection, particularly in elderly people.

Most antibiotic prescribing is in primary care, and most of it is for common respiratory tract infections. Guidelines advise against the routine use of antibiotics in patients with upper respiratory tract infection, sore throat, and ear infection, but do recommend them for pneumonia.

Although rates of antibiotic prescribing for acute respiratory infections in UK general practice declined by 45% between 1994 and 2000, in 2000 antibiotics were still prescribed to 67% of patients with respiratory infection, including over 90% of those with chest infection, 80% with ear infections, 60% with sore throat, and 47% with upper respiratory tract infections.

On the basis of the evidence in this BMJ study, there seems to be a substantial gap between evidence based guidance and general practitioners' prescribing behaviour, say the authors.

So, they identified 3.36 million episodes of respiratory tract infection recorded between 1991 and 2001 in the UK General Practice Research Database and determined whether complications were less common in people who were prescribed antibiotics than in those who were not.

Risk of serious complications in the month after diagnosis were recorded: mastoiditis (infection of the mastoid bone of the skull) after ear infection, quinsy (an abscess at the back of the throat) after sore throat, and pneumonia after upper respiratory tract infection and chest infection.

The number of patients needed to treat to prevent one complication was also recorded.

Serious complications were rare after upper respiratory tract infections, sore throat, and ear infection. Antibiotics reduced the risk, but over 4,000 courses were needed to prevent one complication.

In contrast, the risk of pneumonia after chest infection was high, particularly in elderly people, and was substantially reduced by antibiotic use. The number needed to treat to prevent one case of pneumonia was 39 for those aged 65 and over and between 96 and 119 in younger age groups.

The risks were not appreciably different in smokers, those with chronic respiratory disease, or those with cardiac disease.

The authors conclude that general practitioners should not base their prescribing for sore throat, ear infection, or upper respiratory tract infections on a fear of serious complications. However, antibiotic prescribing to reduce the risk of pneumonia after chest infection is justifiable, particularly in elderly patients in whom the risk is highest.

This view is reiterated in an accompanying BMJ editorial by researchers at the University of Antwerp, who say that most infections can be managed by watchful waiting.

Contact:
Andrew Hayward, Senior Lecturer in Infectious Disease Epidemiology, UCL Centre for Infectious Disease Epidemiology, University College London, UK
Email: a.hayward@pcps.ucl.ac.uk 

(2) European drug regulations need to change, say experts
(How can we regulate medicines better?)
www.bmj.com/cgi/content/full/355/7624/803

European drug regulations need changing to ensure they meet the needs of patients and doctors, argue experts in this week's BMJ.

Licensing of new drugs in Europe is increasingly controlled by the European Medicines Agency (EMEA), yet new drugs have only to show they are equivalent to current treatments rather than show superiority.

This favours the interests of drug companies, say Silvio Garattini and Vittorio Bertele from the Mario Negri Institute for Pharmacological Research in Italy. They believe that new drugs should be required to have some added value to current treatments or be cheaper.

One way to ensure this would be to introduce some element of independent research by a non-profit organisation, they say. At present, manufacturers prepare the reports seeking approval for a new drug or a new indication and independent research occurs only after approval.

Another concern with the European agency is transparency, they write. Unlike the US Food and Drug Administration, the EMEA keeps almost all its information secret, yet there is no reason to hide toxicological and clinical information, which is essential to understand why a new drug has been approved or a new indication granted.

Other information they suggest should be made transparent includes the size of the majority that approved a given drug, the reasons of the minority for opposing approval, conflicts of interest, and post-marketing commitments and their fulfilment.

They also believe that the regulatory system is subject to bias and suspicion and call for the European pharmacovigilance system to be implemented.

They conclude: "Some of our suggestions will make the approval of new drugs and new indications more difficult and prolong the time needed for their introduction into the market. We may therefore need to be more flexible to encourage industrial research.

One possibility would be to prolong product patents in exchange for better, safer, more trustworthy, and more affordable innovation. We believe the changes will not only be important for patients but will help stimulate innovative research by drug companies."

Contact:
Silvio Garattini, Director, Mario Negri Institute for Pharmacological Research, Milano, Italy
Email: garattini@marionegri.it 

(3) Genetic screening would prevent hearing loss caused by antibiotics
(Ototoxicity caused by aminoglycosides)
http://www.bmj.com/cgi/content/full/335/7624/784

Hearing loss caused by a group of antibiotics called aminoglycosides could be prevented if patients were screened for a genetic mutation before treatment, say experts in this week's BMJ.

Aminoglycosides are most useful for the treatment of serious infections, such as septicaemia, complicated urinary tract infections, and tuberculosis.

Their potential for ototoxicity (damage to the ear) is well known, but less well known is that some people have an inherited predisposition that renders them highly sensitive to these effects and can result in severe and permanent hearing loss, write Maria Bitner-Glindzicz and Shamima Rahman at the Institute of Child health in London.

The mutation, known as m.1555A-G is thought to cause up to 5% (1 in 40,000) cases of deafness in children in the UK. This is low compared to other countries. Studies from New Zealand and the US, for example, found between 1 in 206 and 1 in 1,161 positive cases in newborns.

Even in the absence of exposure to aminoglycosides, some families carrying this mutation may also develop deafness, albeit at a later age and with a lower penetrance.

In Spain, for example, 27% of families with at least two deaf individuals were positive for this mutation and everyone with the mutation who was exposed to aminoglycosides became deaf. By the age of 30, the probability of becoming deaf if an individual had received such antibiotics was 96.5% compared with 39.9% if they had never been treated.

Thus aminoglycosides are a major environmental modifier of the m.1555A-G mutation, say the authors.

But is it cost effective to screen for this mutation before aminoglycosides are given? The current cost of testing for this mutation in the UK is about £35 per test. However, this is based on a small number being performed and demand for more tests would reduce the costs. In contrast, the cost to the health service for a child who becomes deaf is estimated to be £61,000 over a lifetime, and an additional £18,000 a year in educational costs.

In the US, the total lifetime cost to society for a child who becomes deaf before acquiring language has been estimated to exceed $1m.

Hearing loss induced by aminoglycosides in individuals with the m.1555A-G mutation is preventable, they say. The mutation is well known among doctors who see patients who already have hearing loss. However, the general medical community is not aware of this susceptibility and that mutation testing is available.

They recommend in this BMJ editorial that the true prevalence of the mutation in the UK be ascertained to determine the cost effectiveness of screening everyone prescribed aminoglycoside antibiotics. In the meantime, patients who are likely to receive multiple courses of aminoglycosides - for example, patients with leukaemia and newborns admitted to special care baby units - should be screened.

Genetic testing needs to be turned around rapidly and consideration should be given to using an alternative antibiotic until the result of genetic testing is known, they conclude.

Contact:
Maria Bitner-Glindzicz, Reader in Clinical and Molecular Genetics, University College London, Institute of Child Health, London, UK
Email: mbitnerg@ich.ucl.ac.uk 

(4) Call for doctors to become MPs
(How to become an MP)
http://www.bmj.com/cgi/content/full/335/7624/826

In this week's BMJ, Steven Ford, a general practitioner in Northumberland, appeals for healthcare workers to stand as MPs and offer the electorate a better choice of health and other policies than those on offer from the established parties.

He himself intends to stand at the next general election.

Ours is a participatory democracy, he writes in this BMJ article. Membership of the hopelessly debt laden political parties is at an all time low, and the esteem in which parliament is held is likewise low. Could we make a change, he asks?

It is often noted that the public has more trust in doctors and other healthcare workers than in politicians. This is the right time, a last chance perhaps, to take our approval ratings out for a psephological test drive, he says.

We have witnessed problems arising from the healthcare "reforms" and can predict more of the same, he adds. And as a group we have been on the receiving end of much government inspired unpleasantness. If we are sincere in our reservations about the course proposed for health care in the United Kingdom, is it legitimate or excusable to do nothing, he asks?

With few exceptions, healthcare workers - not just doctors - are hard working, dynamic, committed, disposed to serve the community, of broadly liberal outlook, and of beneficent intent, he writes. These surely are the sorts of values that the electorate might care to see more widely represented in parliament. By comparison, parliamentarians are increasingly narrowly confined in their views on policy and preoccupied with party matters to the exclusion of governing effectively.

MPs are not better than the rest of us, he says, and do not deserve the unopposed scope for harm that the electorate has so far given them. Acquiescence is complicity - examine your conscience before discounting yourself as a candidate in your own constituency, he urges.

At the least, he concludes, an all constituency health professional candidacy will push the health issue up the political agenda, and that might promote fresh thinking and debate. It's time to put up or shut up.

Contact:
Steven Ford, General Practitioner, Haydon and Allen Valleys Medical Practice, Hexham, Northumberland, UK
Email: mail@stevenford.co.uk 

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