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Sunday 2 October 2011

Plastic surgeons warn over 'stem-cell' breast surgery

The procedure involves grafting fat harvested from the patient by liposuction

Senior plastic surgeons have issued a warning over a breast enlargement procedure being offered by private UK clinics.

The British Association of Aesthetic Plastic Surgeons (BAAPS) say "stem-cell breast augmentations" are unproven and should not be offered commercially.

The warning came at the group's annual conference in Birmingham.

One Harley Street clinic offering the surgery responded by saying they were "confident" the treatment was safe.

Research 'hijacked'

The surgery involves using fat harvested from the patient's stomach or thighs via liposuction and using it to build up the breast.

Prior to transplantation, around half of of the fat is processed to enrich the stem-cell content - naturally occurring regenerative cells found within the fat.

The hope is that this enrichment process can improve the prospects for the fat graft.

The same technology is being used in reconstructive surgery where "cell-enriched fat grafting" is now being offered in several centres around the world to reconstruct breasts following cancer surgery.

Trials are currently under way at NHS centres in London, Glasgow, Swansea, Norwich and North Tyneside.

But BAAPS believes more clinical testing needs to be done to establish its safety before it is used commercially on healthy women.

“Start Quote

We have to make sure whatever treatment we offer for breast augmentation is safe in the long-term”

End Quote Eva Weiler-Mithoff Consultant plastic surgeon

"To think that this unproven research is hijacked and used in the commercial sector is really an appalling thought," former BAAPS president and consultant plastic surgeon Adam Searle told the BBC. "Not least when it's being utilised by inadequately trained practitioners."

Private London clinics, The Harley Street Skin Clinic and The Private Clinic of Harley Street, have been advertising stem-cell breast augmentations for some time. The latter says they will have treated some 200 patients by the end of this year.

In a statement, Dr Valentina Petrone of the The Private Clinic, said the views of BAAPS were welcome, but insisted the surgery was safe and every precaution was taken.

"The Private Clinic, is confident in respect to the safety of this treatment. Furthermore ongoing studies reassures us even more. We have strict patient selection criteria and clinical protocols in place.

"We, of course, look forward to completion of studies and any other findings as they become available over time and will, if necessary, adapt our protocols accordingly."

Cancer concern

The BAAPS warning came the same week new clinical data on cell-enriched fat grafting was presented to an conference in Nottingham.

Eva Weiler-Mithoff, a consultant surgeon at Canniesburn Plastic Surgery Unit in Glasgow, presented details of a 12-month trial to a meeting of the Oncoplastic Reconstructive Breast Surgery group.

The trial involved around 70 patients in seven centres in four countries. The data is yet to undergo peer review and was sponsored by Cytori Therapeutics, the US makers of a machine which can enrich the fat.

Consultant plastic surgeon Eva Weiler-Mithoff discusses the findings of a 12-month clinical trial

Ms Weiler-Mithoff told the BBC the procedure appears to be effective in cancer patients in filling in defects in the breast and in improving the appearance and feel of the breast. Nor were there any serious side-effects or recurrence of breast cancer to date.

"Traditional fat-grafting (in breast reconstructive surgery) does not work terribly well because there is not enough circulation to support the survival of the fat graft," she said.

"We know if we augment the fat graft with the naturally occurring regenerative cells in fat tissues we can improve the circulation around the fat graft and the survival of the fat graft."

But she said longer-term results were needed - at least five to10 years of data - before the technique could be deemed safe for use in cosmetic surgery.

"We still don't have enough long-term outcome data to say it's safe in the sense that it doesn't encourage the cancer to come back or new breast cancer to develop," she said.

"Because breast cancer is such a common disease we have to make sure whatever treatment we offer for breast augmentation is safe in the long-term."

A previous Japanese study involving 40 Japanese women undergoing cosmetic stem-cell breast augmentation also deemed the procedure to be effective, but also called for additional study.

Wednesday 6 July 2011

IVF procedure 'may increase risk of Down's syndrome'

Down's syndrome is caused by one too many copies of chromosome 21

Drugs used in IVF for older women may increase their risk of having a baby with Down's syndrome, experts say.

Doctors already know that the chance of having a baby with the genetic condition goes up with the age of the mother, especially for those over 35.
Now UK researchers, who looked at 34 couples, think drugs used to kick-start ovaries for IVF in older women disturb the genetic material of the eggs.
Work is now needed to confirm their suspicions, a meeting in Sweden heard.
And they do not yet know the magnitude of risk, but say it could also cause many other genetic conditions, not just Down's.
The findings, presented at the European Society of Human Reproduction and Embryology's annual conference, come from a UK study of 34 couples undergoing fertility treatment.

“Start Quote

It raises the concern that some of the abnormalities might be treatment-related”

End Quote Mr Stuart Lavery Consultant obstetrician

All of the women in the group were older than 31 and had been given drugs to make their ovaries release eggs ready for their IVF treatment.

When the researchers studied these now fertilised eggs they found some had genetic errors.
These errors could either cause the pregnancy to fail or mean the baby would be born with a genetic disease.
A closer look at 100 of the faulty eggs revealed that many of the errors involved a duplication of coiled genetic material, known as a chromosome.
Often, the error resulted in an extra copy of chromosome 21, which causes Down's syndrome.
But unlike "classic" Down's syndrome which is often seen in the babies of older women who conceive naturally, the pattern of genetic errors leading to Down's in the IVF eggs was different and more complex.
And this led the researchers to believe that it was the fertility treatment that was to blame.
Lead researcher Professor Alan Handyside, director of the London Bridge Fertility, Gynaecology and Genetics Centre, said more research was now needed.

Down's syndrome risk with the mother's age:

20 years - 1 in 1,500
25 years - 1 in 1,300
35 years - 1 in 350
40 years - 1 in 100
45 years - 1 in 30

"This could mean that the stimulation of the ovaries is causing some of these errors. We already know that these fertility drugs can have a similar effect in laboratory studies. But we need more work to confirm our findings."

If more tests back up their suspicions then it would mean that doctors should be more cautious about using these treatments, he said.
The researchers believe their work could also help identify which women might be better off using donor eggs for IVF instead.
Co-investigator Professor Joep Geraedts, of Bonn University in Germany, said: "This in itself is already a big step forward that will aid couples hoping for a healthy pregnancy and birth to be able to achieve one."
UK fertility expert Mr Stuart Lavery said: "There's a huge increase in the number of women undergoing IVF at later ages as people delay the age of starting a family.
"Previously we have always thought that these chromosomal abnormalities were related to the age of the egg.
"What this work shows is that a lot of the chromosomal abnormalities are not those that are conventionally age-related. It raises the concern that some of the abnormalities might be treatment-related.
"It's a little unclear as to whether it's the medication itself that is affecting the egg quality or whether it's the medication that is just forcing the issue and allowing eggs that nature's quality control system would have otherwise excluded, to arise."

Friday 24 June 2011

Warning over combining common medicines for elderly

Taking multiple common drugs has been linked to brain decline and death

Combinations of commonly used drugs - for conditions such as heart disease, depression and allergies - have been linked to a greater risk of death and declining brain function by scientists.

They said half of people over 65 were prescribed these drugs.
The effect was greatest in patients taking multiple courses of medication, according to the study in the Journal of the American Geriatrics Society.
Experts said patients must not panic or stop taking their medicines.
The researchers were investigating medicines which affect a chemical in the brain - acetylcholine. The neurotransmitter is vital for passing messages from nerve cell to nerve cell, but many common drugs interfere with it as a side effect.
Eighty drugs were rated for their "anticholinergic" activity: they were given a score of one for a mild effect, two for moderate and three for severe. Some were given by prescription only, while others were available over the counter.

Some of the drugs examined

Category one, mild

Codeine (painkiller)
Warfarin (blood thinner)
Timolol maleate (eye drops)

Category three, severe

Piriton (antihistamine)
Ditropan (incontinence drug)
Seroxat (antidepressant)

Full list of drugs investigated

A combined score was calculated in 13,000 patients aged 65 or over, by adding together the scores for all the medicines they were taking.

A patient taking one severe drug and two mild ones would have an overall score of five.
Deadly consequences
Between 1991 and 1993, 20% of patients with a score of four or more died. Of those taking no anticholinergic drugs only 7% died.
Patients with a score of five or more showed a 4% drop in ratings of brain function.
Other factors, such as increased mortality from underlying diseases, were removed from the analysis.

“Start Quote

Do not stop your medicines without taking advice first”

End Quote Dr Clare Gerada Royal College of GPs

However, this study cannot say that the drugs caused death or reduced brain function, merely that there was an association.

Dr Chris Fox, who led the research at the University of East Anglia, said: "Clinicians should conduct regular reviews of the medication taken by their older patients, both prescribed and over the counter, and wherever possible avoid prescribing multiple drugs with anticholinergic effects.
Dr Clare Gerada, chairman of the Royal College of GPs, said the findings of the study were important.
She told patients: "The first thing is not to worry too much, the second thing is to discuss it with your doctor or the pharmacist, and the third thing is do not stop your medicines without taking advice first."
She said doctors reviewed medication every 15 months and were aware of the risks of combining different drugs.
Dr Fox said he wanted to conduct further research to investigate how anticholinergic drugs might increase mortality.

Electrical signals cannot cross the gap between brain cells; neurotransmitters pass the message on

A more modern study is also thought to be desirable. Practices and drugs have changed since the data was collected two decades ago.
Ian Maidment, an NHS pharmacist in Kent and Medway, believes the situation may now be even worse.
He said the use of anticholinergic drugs had "probably increased as more things are being treated and more drugs are being used."
Brain decline
Reduction of the neurotransmitter acetylcholine has already been implicated in dementia.
The drug Aricept is given to some patients with Alzheimer's disease to boost acetylcholine levels.
Dr Susanne Sorensen, head of research at the Alzheimer's Society, said a 4% drop in brain function for a healthy person would feel like a slow, sluggish day.
"If you are at a level where one little thing pushes you over into confusion, then that is much more serious," she added.
"However, it is vital that people do not panic or stop taking their medication without consulting their GP."
Rebecca Wood, chief executive of Alzheimer's Research UK, said: "This comprehensive study could have some far-reaching effects. The results underline the critical importance of calculated drug prescription."

Have you been affected by the issues raised in this story? Send us your comments using the form below:

Friday 21 January 2011

antibiotics can increase risk of irritable bowel syndrome

Giving children antibiotics can increase risk of irritable bowel syndrome and Crohn's disease later in life, the Daily Mail has reported. The newspaper article says that “scientists believe the drugs may encourage harmful bacteria and other organisms to grow in the gut, which trigger the conditions”.

This study looked at the medical records of over 500,000 children in Denmark, and found that children who had been prescribed antibiotics were more likely to develop inflammatory bowel disease (IBD) than those who had not received such prescriptions. IBD is a group of diseases which includes Crohn’s disease, but not (as suggested by the Mail) irritable bowel syndrome (IBS).

While this study has found a relationship between antibiotic use and IBD, it is not possible to say for certain why such a relationship exists. It might be that antibiotics do raise the risk of IBD, or that the infections being treated with them cause or trigger IBD, or that in some cases antibiotics were being used to treat symptoms of undiagnosed IBD that was later identified. These findings are worth further investigation.

It is important to remember that the risk of IBD in children is very low. In this study of more than half a million children, only 117 were diagnosed with the disease, despite almost 85% of the subjects taking at least one course of antibiotics.

Where did the story come from?

The study was carried out by researchers from the Statens Serum Institut in Denmark and funded by Danish Medical Research Council and the Danish Agency for Science, Technology and Innovation. The study was published in the peer-reviewed medical journal Gut.

This study was reported by the Daily Mail, which has confused inflammatory bowel disease (investigated by this study) with irritable bowel syndrome, which is not an inflammatory bowel disease (and was not investigated in this study).

What kind of research was this?

This was a nationwide Danish cohort study looking at whether there was a link between the use of antibiotics and inflammatory bowel disease (IBD) in childhood. The balance of microorganisms in the intestine has been suggested to be important in the development of IBD. As antibiotics can alter this balance, one suggestion is that their use could potentially affect the risk of IBD.

The main limitation of this type of study design is that the groups being compared (in this case, children exposed and unexposed to antibiotics) may differ in ways other than their use of antibiotics. Any such differences might potentially affect the results and therefore obscure the true relationship. Researchers can try to reduce the likelihood of this by taking such factors into account in their analyses.

Limitations of this nature could potentially be avoided by looking at the risk of IBD in children who had participated in randomised controlled trials of antibiotics, although the practical constraints of such studies mean they would not be likely to include the very large number of children that this study had.

What did the research involve?

The researchers looked at the healthcare records of all Danish children born between 1995 and 2003 who were not part of multiple births (e.g. twins or triplets). They obtained information on collections of antibiotic prescriptions, diagnoses of IBD and other factors that could affect results. They then looked at whether children who had received antibiotics were any more or less likely to subsequently develop IBD compared with children who had not received antibiotics.

The researchers drew data from various national registries to locate eligible children, their filled prescriptions and medical history. The researchers identified:

all prescriptions for systemic antibiotics antibiotics for internal rather than external (topical) use, given between 1995 and 2004
the type of antibiotic given, and how many different courses of antibiotics were given in the study period
all recorded diagnoses of IBD, which includes Crohn’s disease and ulcerative colitis. These diagnoses were identified using records of hospitalisations, emergency department visits and outpatient hospital visits.

The researchers also obtained a range of information on factors which could affect results, including gender, birth order (whether the child was born first, second or third), level of urbanisation of the place of birth, birth weight, length of gestation, mother’s age at the child’s birth, educational level of mother in the year preceding the year of birth, and socioeconomic category of father in the year preceding the year of birth.

However, none of these factors were found to be independently associated with the risk of IBD, so they were not taken into account in the main analyses. These only took into account the child’s age and year of the diagnosis.

What were the basic results?

Overall, the researchers collected data on 577,627 children, with an average follow-up time of about 5.5 years. This provided over 3 million years of data in total. Most of the children (84.8%) had received at least one course of antibiotics.

Across both study groups 117 children developed IBD – 50 of these children had Crohn’s disease and 67 had ulcerative colitis. On average, diagnosis of these conditions was first recorded between the ages of three and four years old.

The researchers reported their outcomes using a measure called the "incidence rate ratio" [iRR], which is the relative proportion of people given a new diagnosis in two different groups within a specified period of time. They found that children who had collected an antibiotic prescription were 84% more likely to develop IBD during follow-up than those who did not [iRR 1.84, 95% confidence interval [CI] 1.08 to 3.15].

When looking at the different types of IBD separately, antibiotics were only associated with an increased risk of Crohn’s disease [iRR 3.41] but not ulcerative colitis. The risk of being diagnosed with Crohn’s disease was greater in the first three months after the prescription collection [iRR 4.43], and greater in children who received seven or more courses of antibiotics [iRR 7.32].

How did the researchers interpret the results?

The researchers concluded that their study is the “first prospective study to show a strong association between antibiotic use and [Crohn’s disease] in childhood”. This suggests that antibiotics or the conditions for which they are prescribed (infections) could potentially increase the risk of IBD or trigger the disease in people who are susceptible.

However, they note that as with all studies of this type, it cannot prove that antibiotics or the illnesses they were prescribed to treat cause IBD. They say that a possible explanation might be that the children had been prescribed antibiotics to treat intestinal symptoms caused by undiagnosed Crohn’s disease that would later be identified.

Conclusion

Overall, this large study has suggested a link between antibiotic use and IBD, although it should not be assumed that antibiotic use is necessarily the cause of the condition. There are a number of alternative explanations for the association, such as the possibility that antibiotics had been given to the children to deal with symptoms of Crohn’s disease that had not yet been diagnosed. Further research will be needed to clarify the situation.

The strengths and limitations of this research must also be considered when interpreting its results:

The large size of this study, its ability to include most of the children of the relevant age group in the entire country and the level of data available on antibiotic prescriptions are all strengths.
As exposures and outcomes were based on medical records, the reliability of the findings may depend on the accuracy of the records.
Standard diagnostic assessments of each child were not carried out, therefore some cases of IBD may have been missed and some children may have been misdiagnosed. However, the authors report that the hospital registers used have previously been found to have a high level of validity and completeness in identifying individuals with IBD.
Although the prescriptions were filled out, not all of the antibiotics may have been taken by the children. However, this would tend to reduce any link between antibiotics and IBD, rather than make it stronger.
In this type of study, the groups being compared – children exposed and unexposed to antibiotics – may differ in ways other than their use of antibiotics, and these differences may be affecting the results. Although the researchers took into account factors that they thought could affect results (as the causes of IBD are not well understood), it is difficult to know whether all the important factors have been accounted for.

As the authors acknowledge, it is not possible to say whether the link found is due to the antibiotics, the infection that prompted the need for antibiotics or treatment of existing but undiagnosed IBD.

Friday 7 January 2011

animal feed has been contaminated by dioxins

7 January 2011 Last updated at 09:20

German dioxin contamination eggs exported to UK

Contaminated animal feed was sent to poultry and pig farms in Germany

Eggs from German farms where animal feed has been contaminated by dioxins have found their way into processed products destined for British food.

The EU executive said 14 tonnes of the liquid food had been exported to the UK but stressed there was a very low risk to human health.

The UK's Food Standards Agency agreed, saying the eggs would have become diluted with other products.

The FSA said it was trying to trace the shipment in the UK.

It said that following the distribution of affected eggs to the Netherlands they were mixed with non-contaminated eggs to make pasteurised liquid egg.

This product has been distributed to the UK.

'Product for consumption'

The FSA said in a statement: "The mixing of the eggs will have diluted the levels of dioxins and they are not thought to be a risk to health.

"The FSA is currently liaising with the industry and will provide further updates as information becomes available."

Dioxins

Dioxins are a group of chemicals commonly formed as by-products of industrial combustion and chemical processes, such as manufacturing of chemicals, pesticides, steel and paints, pulp and paper bleaching, exhaust emissions and incineration
The main source of dioxin contamination of food for human consumption is contaminated animal feed
Dioxins are absorbed by fatty tissue of cattle, poultry, pork and seafood. Foods high in animal fat, such as milk, meat, fish and eggs (and foods produced with them) are the main source of dioxins although all foods contains some
Dioxins are found throughout the industrialised world, in air, water and soil, as well as in food
Dioxins can cause problems for people if they are absorbed at high levels for long periods
They have been shown in lab tests to cause a wide range of effects in certain animals, such as cancer and damage to the immune and reproductive systems, including low sperm count and learning difficulties

The alert began when it was discovered thousands of tonnes of animal feed contaminated by highly toxic dioxins had been sent to more than 1,000 poultry and pig farms in Germany.

Eggs from those farms were sent to the Netherlands for processing and then on to the UK where they are likely to have been used in the production of a variety of foodstuffs including mayonnaise and pastries.

European Commission health spokesman Frederic Vincent told a news conference how the problem had now reached the UK.

"Those eggs were then processed and then exported to the United Kingdom... as a 14-tonne consignment of pasteurised product for consumption," he said.

"Whether it went into mayonnaise, pastries, I don't know. So we will probably take a look at this with the UK authorities and see what was done with these eggs."

Farms closed

The problem has been traced to oils intended for bio-fuel becoming mixed with oil destined for animal feed.

The dioxin was discovered in late December but the extent of the problem was only revealed earlier this week when German officials said 3,000 tonnes of feed had been affected.

Germany has closed more than 4,700 farms, mostly in the Lower Saxony region in north-west Germany.

German officials will brief their EU counterparts next week and the incident could lead to new rules on animal feed.

Dioxins are toxins formed by industrial processes and waste burning.

They have been shown to contribute to higher cancer rates and to affect pregnant women.

Thursday 30 December 2010

GPs report flu cases rose again last week

29 December 2010 Last updated at 14:24

GPs report flu cases rose again last week

By Helen Briggs Health reporter, BBC News

Officials are urging patients in high-risk groups to get immunised

Flu cases have risen again in England and Wales, according to figures from GPs.

Levels of flu - including H1N1 swine flu - have gone up by almost 50% in the past week, says the Royal College of GPs.

The flu tally reached 124 per 100,000 people in the week to Christmas, up from 86 cases in the previous week.

Health officials in England define an epidemic as 200 cases per 100,000.

Wednesday's figures come amid political debate over the decision not to give all young children a flu jab this winter.

Labour has criticised the lack of protection for healthy under-fives, but the government says they were excluded on medical and not cost grounds.

The latest figures show the highest rates are in children aged under five - at 184 cases per 100,000.

Professor Steve Field, a former chairman of the Royal College of GPs, said there was no indication in the current expert advice that across-the-board vaccination of young children is necessary.

Click to play

Professor Steve Field, the former the chairman of the Royal College of GPs, said those children at risk should be vaccinated as soon as possible.

He told the BBC: "Looking at the evidence - looking at where we are in this early epidemic, there doesn't seem to be any indication.

"But we do need to do better in those children who have asthma, who've got heart disease or other diseases and particularly pregnant women.

"I'm worried about the number of sick pregnant women who haven't been vaccinated. And we can prevent this illness by vaccination, which is safe."

The latest figures give an indication of the extent of this winter's flu outbreak, based on people visiting GP surgeries in England and Wales with flu-like symptoms.

Flu cases have risen steadily in England and Wales from 32.8 per 100,000 in week 49, to 85.8 in week 50, to 124.4 in week 51.

The latest figures for Scotland, released on 23 December, show a rate of GP consultations for flu of 45.8 per 100,000.

In Northern Ireland, the latest figures available - for week 50 - show an increase from 28.1 to 64.6 per 100,000.

New figures for flu cases in Scotland and Northern Ireland will be released on Thursday.

A Department of Health spokesperson said the figures for England and Wales were "in keeping with what we would expect during a winter flu season".

Flu advice

Symptoms of seasonal flu include sudden onset of fever, cough as well as sore throat, aching muscles and joints
Antivirals are drugs given to high risk patients who become ill with seasonal influenza
They are most effective if taken within 48 hours of onset and may help limit the impact of some symptoms and reduce the potential for serious complications
Source: Health Protection Agency

The spokesperson added: "But everyone can do their bit to help keep well - simple measures like washing your hands help stop flu spreading.

"The Chief Medical Officer has issued clear advice to get the seasonal flu jab if you are in a vulnerable group, particularly pregnant women and people with underlying health conditions, as well as those aged 65 and over."

The vaccine protects against H1N1, the same strain of flu behind last year's swine flu pandemic, and also protects against the H3N2 and B strains.

Meanwhile, managers at a hospital on Merseyside have suspended visiting until further notice to minimise the chances of visitors passing on colds and flu.

Restrictions apply to relatives of patients at Arrowe Park Hospital in Birkenhead, Wirral.

French 'epidemic'

A flu outbreak has also been reported in France.

French health experts said on Wednesday the country was officially in the grip of a flu epidemic, with 176,000 people sick, two of whom have died.

In the UK, 27 people have died from flu this season, of which nine were children. Among the fatalities, 24 had swine flu. Three suffered from another strain, flu type B.

According to the World Health Organisation, flu epidemics result globally in about three to five million cases of severe illness per year and 250,000-500,000 deaths.

Friday 24 December 2010

Swine flu vaccine safety probed over link to rare sleep disorder

The safety of a swine flu vaccine is to be investigated by European drugs regulators after it was linked to a rare condition that causes people to fall asleep suddenly.

An investigation has been launched after a swine flu vaccine was linked to a condition that causes people to fall asleep suddenly. Photo: Getty Images

By Rebecca Smith, Medical Editor 2:38PM BST 27 Aug 2010

4 Comments

The investigation has been prompted after health officials in Finland announced they were suspending the vaccination programme there following reports of narcolepsy in people who had received the jab.

So far there have been 27 reports of suspected narcolepsy in people across Europe who had previously been vaccinated with Pandemrix, the H1N1 swine flu vaccine made by GlaxoSmithKline.

No cases have been reported in Britain.

In total more than 30m people in the European Union have been vaccinated with Pandemrix.

Narcolepsy is a rare condition and its causes are unknown. It can be dangerous if sufferers fall asleep while driving or operating machinery. It is thought there are 25,000 people with the condition in Britain but experts have estimated that 80 per cent of sufferers have not been diagnosed.

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Once diagnosed with the condition, which is long-term and has no cure, people are not allowed to drive.

The investigation will examine if Pandemrix was the likely trigger for the condition or whether it was a coincidence.

Finland suspended its national vaccination programme on Tuesday after eight suspected cases of narcolepsy following administration of the jab. A further ten cases have been reported in Sweden, six in France, and one each in Germany and Norway.

The European Medicines Agency will now investigate if there is any link, including how many people would normally be expected to suffer narcolepsy so this 'background rate' can be compared to with the number of cases observed after vaccination.

The Agency is also liaising with the European Centre for Disease Prevention and Control, other drugs regulators and the World Health Organisation.

A spokesman for GlaxoSmithKline said: "Information surrounding the reported cases remains limited at the current time. GSK is conducting its own investigation in an effort to gather as much additional data as possible regarding the observed cases and is working closely with the regulatory authorities, including the European Medicines Agency (EMA)

"Global experience with previous large-scale immunisation programmes has shown that it is likely that a certain level of adverse events will be reported. The adverse events that are reported may be the result of underlying conditions, or new conditions that occur in temporal association with the vaccination, and some events may be related to the vaccine.

"Having reviewed the currently available data and information regarding the reported cases of narcolepsy, which remains limited at this time, as well as GSK’s own safety database, the Company has concluded that the currently available information is insufficient to assess the likelihood of a causal relationship between Pandemrix and narcolepsy."

Saturday 27 November 2010

Cloned cattle food safe to eat, say scientists

26 November 2010 Last updated at 07:17

Cloned cattle food safe to eat, say scientists

Click to play

The BBC's Pallab Ghosh looks at how cloned meat reaches the dinner table

Meat and milk from cloned cattle and their offspring are safe to consume, independent scientists have said.

The Advisory Committee on Novel Foods and Processes said it believed the food was unlikely to present any risk.

The Food Standards Agency will discuss the conclusions in December before providing further advice to ministers.

Questions raised by reports over the summer that meat from cloned animals' offspring was sold to consumers "remain unanswered", the Soil Association says.

However, the committee's scientists said there was no substantial difference between meat and milk from cloned animals and produce from conventional livestock, in line with a number of other scientific assessments.

Three cases had emerged of meat linked to a cloned cow being sold in the UK, according to the Food Standards Agency (FSA).

Two involved Highlands farm bulls grown from embryos of a cow cloned in the US, while the third involved meat from a male calf being sent to a London butcher's shop.

Disadvantage claim

The FSA said the calf was the offspring of one of eight animals born in the UK from embryos produced by the US cloned cow.

FSA chief scientist Andrew Wadge said: "The Advisory Committee on Novel Foods and Processes has confirmed that meat and milk from cloned cattle and their offspring shows no substantial difference to conventionally produced meat and milk, and therefore is unlikely to present a food safety risk."

“Start Quote

Not only does cloning have a negative impact on animal welfare, we also have no long-term evidence for the impacts on health”

End Quote Soil Association

Send your comments

In the US, South America and Asia, farmers can breed from cloned cows, sheep and pigs in order to increase milk and meat production.

However, farmers in Europe who want to introduce the products of cloned animals into the food chain require specific authorisation because they are considered "novel foods".

BBC science correspondent Pallab Ghosh says this is in effect a ban. Breaches of the Novel Food Regulations can attract a fine of up to £5,000.

Some European farmers believe they are being put at a disadvantage by being denied the option of using the technology, our correspondent adds.

Critics say there are strong ethical and animal welfare reasons to ban its use in European agriculture.

"There are many unanswered questions on the issue of cloning animals - both ethical and practical - and insufficient regulation," said a Soil Association spokeswoman.

"Not only does cloning have a negative impact on animal welfare, we also have no long-term evidence for the impacts on health."

The European Commission proposes to ban meat and milk from clones and their offspring. The FSA board will discuss this at its December meeting, with the outcome influencing Britain's negotiations on the issue in Europe.

A spokesman said the board had asked for clarity from Europe but that any change in position was unlikely to come in the short term.

"It is for individual member states to interpret European law but, obviously, we differ from the commission on this," he said.

Monday 15 November 2010

Cosmetic surgeon concerned over 'guinea pig' patients

14 November 2010 Last updated at 07:45

Cosmetic surgeon concerned over 'guinea pig' patients

By Adrian Goldberg Presenter, 5 live Investigates

surgeon working on patient with hip x-ray in background.

Some medical devices and implants used in the UK do not have to undergo independent clinical trials

A leading UK cosmetic surgeon claims patients are treated like "guinea pigs" because medical implants do not need to undergo independent clinical trials.

Nigel Mercer spoke out after complaints about problematic breast implants and hip replacements.

Speaking to BBC 5 live he described current regulation as weak, saying the regulator needed to "have teeth".

The Medicines and Healthcare Products Regulatory Agency (MHRA) said it takes its role "very seriously".

Mr Mercer, who is a former president of the British Association of Aesthetic and Plastic Surgeons, says one of the key areas of concern is a breast enhancer called a Poly Implant Prosthesis (PIP). This has been fitted to more than 50,000 women in the UK since it was introduced in 2004.

PIP implants are no longer recommended for use in Britain amid growing evidence that it is prone to rupture, leaving patients in pain and uncertain about the long-term effects.

“Start Quote

I have to live with that in my body for the rest of my life. No-one can actually tell me if that's going to be a problem in the future or not”

End Quote Catherine Kydd Breast implant patient

Catherine Kydd, from Dartford in Kent, only realised her implant had split after being sent for a mammogram and ultrasound scan when she found a lump in her breast.

Her relief at being told she did not have cancer was tempered by anger at the discovery that the silicon in her implants had leaked and spread into her lymph nodes.

"I'm outraged and upset," she told the BBC's 5 live Investigates programme.

"I have to live with that in my body for the rest of my life. No-one can actually tell me if that's going to be a problem in the future or not."

Ms Kidd says she raised her concerns with the MHRA in 2009 but no action was taken at the time.

'Designed for mattresses'

It was only in April this year, after France banned PIP implants, that the MHRA followed suit and advised doctors in the UK not to use them.

The Poly Implant Prosthesis breast enhancement is no longer recommended for use in Britain

Since then, it has emerged that after winning approval for the implant, the manufacturer changed the gel inside the device to one designed for mattresses.

Tests have shown that the strength of the gel-filled shells is not up to standard, increasing the chance they could rupture.

For surgeon Nigel Mercer, this highlights the regulatory confusion surrounding medical devices - a broad-ranging category which includes orthopaedic beds, artificial joints and medicine bottles.

He says unlike drugs, which have a strict testing regime, companies making medical devices have to get a European CE safety mark, which then allows their products to be sold in Britain, often without independent clinical trials.

“Start Quote

The public are being used as guinea pigs”

End Quote Nigel Mercer Leading plastic surgeon

Mr Mercer said: "A medicine has to be tested very rigorously, it has to go through different levels of testing before it goes to market and that process can sometimes take years.

"It means at every step along the way it's tested for toxicity, to see if people are allergic and it's tested for how it's delivered and how good it is.

"That process costs tens of millions of pounds and takes years to do. With a medical device you go to the two bodies in Brussels who produce CE marks.

"There are existing standards as to how any medical device is produced. As long as you follow those standards, and you have that inspected, you produce that device and sell it."

The result, he says, is that, "the public are being used as guinea pigs."

The MHRA, which is responsible for the regulation of medical devices and equipment used in healthcare, as well as the investigation of harmful incidents, responded by saying:

"The MHRA takes its role very seriously and works with other member states to ensure that only compliant devices are placed on the market."

'Rotting away'

A similar row has also erupted over the use of a new kind of artificial hip manufactured by DePuy, a French subsidiary of the respected manufacturer Johnson and Johnson.

A new artificial hip used in the UK was not required to undergo independent clinical trials before use.

The DePuy ASR hip has now been withdrawn following reports that metal shards broke off and lodged themselves in patients' bodies after being fitted.

Charlotte Bird from Suffolk was one of those who suffered as a result: "It had been rotting away and I had been rotting away around it.

"I couldn't work. It never felt right. It just held me back completely.

"It was completely depressing. Friends were worried about me - it was misery and never getting better."

DePuy has told 5 live Investigates that it was not required to carry out a clinical trial, but says that its artificial hip was subjected to numerous laboratory tests.

These included tests on the materials used, as well as the product's performance using hip simulators which looked at how well the device wore over time.

LISTEN TO THE FULL REPORT

Hear the full report on 5 live Investigates, on Sunday 13 November at 2100 GMT on BBC Radio 5 live.

Since the product was launched, DePuy says it continued to evaluate the ASR hip system.

That is little comfort to Charlotte, who condemned the lack of vigilance among the regulators.

She said she was not told it had not been subject to independent clinical trials.

"I was just told it was marvellous and it was the new way of doing it," she said.

The MHRA says it investigates all reported adverse incidents involving medical devices, where there is a risk of death or serious injury to patients, and takes action when it becomes clear that there is a need to do so. In a statement, the MHRA said:

"We encourage everyone - the public and healthcare professionals, as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action."

However, surgeon Nigel Mercer says recent evidence relating to problems with a number of medical devices suggests this is not good enough:

"The regulator needs to have teeth and be able to regulate these businesses."

You can hear the full report on 5 live Investigates on Sunday, 14 November at 2100 GMT on BBC Radio 5 live.

You can also listen again on the BBC iPlayer or by downloading the 5 live Investigates podcast.

Send your comments and stories to 5 live Investigates

Saturday 13 November 2010

Painkillers, pregnancy and male reproductive problems

Fergus Walsh | 15:35 UK time, Monday, 8 November 2010

The use of painkillers such as ibuprofen, aspirin and paracetamol during pregnancy could be linked to male reproductive disorders according to new research. A study in the journal Human Reproduction (opens pdf) found that women who took more than one painkiller at the same time during pregnancy, or who took the drugs during the second trimester, were at increased risk of giving birth to boys with undescended testicles.

The condition, known as cryptorchidism, affects about one in 20 boys in the UK. It is known to be a risk factor for male fertility problems later in life and an increased risk of testicular cancer.

1,463 pregnant women in Finland completed written questionnaires and 834 women in Denmark did the same or took part in a telephone interview. The researchers found that women significantly under-reported the use of painkillers in the written questionnaire because they did not consider mild painkillers to be "medication".

The study showed that women who used more than one painkiller simultaneously (such as paracetamol and ibuprofen) had a seven-fold increased risk of giving birth to sons with some form of undescended testes compared to women who did not take the drugs.

The second trimester appeared to be a particularly sensitive time. Any analgesic use at this point more than doubled the risk of the condition. Simultaneous use of more than one painkiller during this time appeared to increase the risk 16-fold.

The scientists behind the research believe painkillers may be part of the reason for the increase in male reproductive disorders in recent decades, possible by interfering with the role of the male hormone testosterone. Research carried out on rats in Denmark and France found that painkillers disrupted androgen production, leading to insufficient supplies of testosterone during the crucial early period of gestation when the male organs were forming. The effects of the painkillers on the rats was comparable to that caused by similar doses of known endocrine (hormone) disrupters such as phthalates - a family of chemical compounds used in the manufacture of plastics such as PVC.

Dr Henrik Leffers, senior scientist at Righospitalet in Copenhagen, who led the research, said: "If exposure to endocrine disruptors is the mechanisms behind the increasing reproductive problems among young men in the Western World, this research suggests that particular attention should be paid to the use of mild analgesics during pregnancy, as this could be a major reason for the problems".

But the study is not without limitations. The researchers could not find a statistically significant effect among the Finnish women, which was the larger group, but did find significant effects among the Danish women.

Dr Leffers said: "We do not quite understand why the Finnish cohort does not show the same associations as the Danish cohort." However, he said the telephone interviews used in Denmark gave the "most reliable information" and this may explain some of the differences. He added: "The prevalence of cryptorchidism is much lower in Finland (2.4%) compared to Denmark (9.3%) and, therefore, this would require a larger cohort to find the same number of cases."

Pregnant women in the UK are already advised to avoid taking ibuprofen or aspirin, unless they are advised to do so by their doctor.

Instead they are told they can take paracetamol. The NHS Choices website puts it like this:

Paracetamol has been used routinely through all stages of pregnancy to reduce a high temperature (fever) and relieve pain. There is no clear evidence that paracetamol has any harmful effects on the baby.

As with any medicine that is used during pregnancy, paracetamol should be taken at the lowest effective dose for the shortest possible time.

This raises a further concern with the research. Of the individual painkillers, ibuprofen and aspirin approximately quadrupled the risk of cryptorchidism. Paracetamol doubled the risk, but this was not statistically significant. This suggests that a link between paracetamol use alone in pregnancy and male fertility problems is not clear-cut.

Dr Leffers said: "Although we should be cautious about any over-extrapolation or over-statement, the use of mild analgesics constitutes by far the largest exposure to endocrine disruptors among pregnant women."

Prof Richard Sharpe of the Medical Research Council's Human Reproductive Sciences Unit at the University of Edinburgh, said:

"The studies are top quality from groups with considerable expertise. The association between painkiller (paracetamol) use in early pregnancy and increased risk of cryptorchidism in sons has been independently confirmed in another study from Denmark (MS Jensen et al. November 2010, Epidemiology). Painkillers/paracetamol are likely to be one of several factors that cause cryptorchidism - some environmental chemicals are also implicated - it is probably the sum of all such exposures that determines the outcome.

Pregnant women who are alarmed by these studies should note the following:

It is only prolonged use that has an effect - taking occasional painkiller for a headache will have no adverse effect (and the stress, worry and sickness from not taking something for a bad headache may be worse for the mother and baby).

Most women in this study who used paracetamol did not have a baby boy with cryptorchidism.

Prolonged use of painkillers in pregnancy should not be contemplated without medical approval. For certain, taking paracetamol as a 'feel good' factor should be avoided (by all of us!).

It is sound common sense to minimize your exposure (and therefore your baby's exposure) to all drugs, environmental (pesticides, paints, household chemical exposures) and lifestyle (smoking, alcohol, cosmetics usage) chemicals during pregnancy wherever possible."

Update at 17:00

Basky Thilaganathan, Spokesperson for the Royal College of Obstetricians and Gynaecologists, said:

"The findings need to be interpreted with caution. Firstly, the study shows an association rather than causation; it is entirely possible that mothers took these analgesics for an ailment (for example, a viral infection) in pregnancy that may have been the real cause for the noted problems. Secondly, the dose-dependent effect was seen in one study cohort but not another, raising the possibility that this preliminary study may be prone to inadvertent bias of patient recruitment and ascertainment. Furthermore, the definition of cryptorchidism is broad and clinical, rather than specific and the overall number of cases is so small that a small change in affected numbers would have nullified the findings.

"Given these limitations, the findings of the study should be interpreted with caution and it would be inappropriate to spread alarm to pregnant women on this basis."

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Painkillers, pregnancy and male reproductive problems

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