Monday, 28 January 2013

Researchers claim NHS drug decisions 'are flawed

Researchers claim NHS drug decisions 'are flawed'

By Jane DreaperHealth correspondent, BBC News

NICE decides which drugs are cost effective on the NHS

The formula used by the NHS to recommend which drugs should be funded is "flawed" and should be scrapped, researchers say.

The European Commission-funded study tested the assumptions of the system used by NICE (the National Institute for Health and Clinical Excellence).

Researchers concluded the watchdog's system failed

to reflect variations in views on illness and disability.

NICE called the study "limited" and said the measure it used was the best.

NICE uses a method called quality-adjusted life years (QALY) for assessing the value of new drug treatments in England and Wales. A similar system is used by the Scottish Medicines Consortium (SMC).

The formula looks at the cost of using a drug for a year and weighs it against how much someone's life can be extended and improved. Generally if a treatment costs more than £20,000-30,000 per QALY, it would not be recommended as cost-effective by NICE.

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"This isn't a scientific way to classify and prioritise the drugs - mathematically, it's totally flawed.”

Ariel BeresniakResearch leader

The European Consortium in Healthcare Outcomes (ECHOUTCOME) researchers will present their findings at a conference in Brussels on Friday.

Their work has already prompted a backlash by UK-based experts, who defended the current system for making decisions.

The researchers analysed a detailed questionnaire with more than 1,300 respondents - including 301 in the UK.

Their findings criticised the QALY system for grading different states of health. The researchers said people varied in their views about the impact of different levels of illness or disability, and in their approach to risk.

They also found that people's willingness to sacrifice remaining years of life in order to have better health varied enormously over different periods of time.

The researchers said 71% of the respondents would prefer to live 15 years in a wheelchair than die after 10 or five years in a wheelchair - but the remaining 29% said they would prefer to die earlier rather than spend 15 years in a wheelchair.

The project leader, Ariel Beresniak, a French doctor and economist who used to work in the drug industry, said: "Important decisions are being made on the basis of QALY, but it produces the wrong results.

"This isn't a scientific way to classify and prioritise the drugs - mathematically, it's flawed.

"We think it is time to open this debate, particularly as some of the newer European countries are trying to organise their health assessment systems and might be considering QALY.

"NICE has made negative recommendations about many major innovative drugs, based only on arbitrary incremental cost per QALY.

"Agencies such as NICE should abandon QALY in favour of other approaches."

Cost-benefit approach

A similar method is used by Canada and Australia for assessing new treatments.

The researchers suggest instead using a cost-benefit approach - such as how many cases of remission a drug can provide, or how many relapses it might prevent.

A NICE representative said: "We need to use a measure that can be applied fairly across all diseases and conditions. The QALY is the best measure anyone has yet devised to enable us to do this.

"It's developing and improving all the time and the criticisms in this rather limited study haven't shaken our confidence in its value to NICE in helping make decisions on the best way to use new and sometimes very expensive drugs and other health technologies."

John Cairns, professor of health economics at the London School of Hygiene and Tropical Medicine and a member of the NICE's appraisal committee for 10 years, said: "QALYs are certainly not perfect and we should be looking for better ways of informing decision making.

"But getting rid of an imperfect system without replacing it with a better one is not the way forward."

Dr Andrew Walker, an economist at the University of Glasgow, with 10 years' experience of reviewing new medicines at the SMC, said: "I am amazed it has taken these authors three years and one million euros to establish what we already know, that QALYs are not perfect.

"Anyone who makes decisions using QALYs and who cannot think of at least three issues with them is not thinking hard enough.

"As an alternative they propose cost per remission in arthritis, but I ask them to tell me how they define remission, how long remission lasts and how much we are willing to pay for one remission.

"If we want to spend more on cancer medicines, it has to come from somewhere. The researchers speak as though there were no budget limits."

Friday, 25 January 2013

Quadruple helix' DNA seen in human cells

'Quadruple helix' DNA seen in human cells

By Jonathan Amos Science correspondent, BBC News

A representation of the four-stranded structure (L) and fluorescent markers reveal its presence inside cells (R)

A representation of the four-stranded structure (L) with fluorescent markers revealing its presence inside cells (R)

Cambridge University scientists say they have seen four-stranded DNA at work in human cells for the first time.

The famous "molecule of life", which carries our genetic code, is more familiar to us as a double helix.
But researchers tell the journal Nature Chemistry that the "quadruple helix" is also present in our cells, and in ways that might possibly relate to cancer.
They suggest that control of the structures could provide novel ways to fight the disease.
"The existence of these structures may be loaded when the cell has a certain genotype or a certain dysfunctional state," said Prof Shankar Balasubramanian from Cambridge's department of chemistry.
"We need to prove that; but if that is the case, targeting them with synthetic molecules could be an interesting way of selectively targeting those cells that have this dysfunction," he told BBC News.
Tag and track It will be exactly 60 years ago in February that James Watson and Francis Crick famously burst into the pub next to their Cambridge laboratory to announce the discovery of the "secret of life".
What they had actually done was describe the way in which two long chemical chains wound up around each other to encode the information cells need to build and maintain our bodies.
Today, the pair's modern counterparts in the university city continue to work on DNA's complexities.
Balasubramanian's group has been pursuing a four-stranded version of the molecule that scientists have produced in the test tube now for a number of years.
It is called the G-quadruplex. The "G" refers to guanine, one of the four chemical groups, or "bases", that hold DNA together and which encode our genetic information (the others being adenine, cytosine, and thymine).
The G-quadruplex seems to form in DNA where guanine exists in substantial quantities.
And although ciliates, relatively simple microscopic organisms, have displayed evidence for the incidence of such DNA, the new research is said to be the first to firmly pinpoint the quadruple helix in human cells.
'Funny target' The team, led by Giulia Biffi, a researcher in Balasubramaninan's lab, produced antibody proteins that were designed specifically to track down and bind to regions of human DNA that were rich in the quadruplex structure. The antibodies were tagged with a fluorescence marker so that the time and place of the structures' emergence in the cell cycle could be noted and imaged.
This revealed the four-stranded DNA arose most frequently during the so-called "s-phase" when a cell copies its DNA just prior to dividing.
Prof Balasubramaninan said that was of key interest in the study of cancers, which were usually driven by genes, or oncogenes, that had mutated to increase DNA replication.
If the G-quadruplex could be implicated in the development of some cancers, it might be possible, he said, to make synthetic molecules that contained the structure and blocked the runaway cell proliferation at the root of tumours.
"We've come a long way in 10 years, from simple ideas to really seeing some substance in the existence and tractability of targeting these funny structures," he told the BBC.
"I'm hoping now that the pharmaceutical companies will bring this on to their radar and we can perhaps take a more serious look at whether quadruplexes are indeed therapeutically viable targets."

Prof Shankar Balasubramanian in front of a painting by artist Annie Newman that represents quadruplex DNA

Why are the British revolted by the idea of horsemeat?

In today's Magazine

Horsemeat has been found in beefburgers on sale in UK and Irish Republic supermarkets. But why do the British have such a revulsion over the idea of eating horsemeat?

The discovery of horse DNA in burgers in major supermarkets such as Tesco and Iceland has been met with alarm among consumers.

Horse-eating, or hippophagy, spread in Europe in the 19th Century, after famines caused several governments to license horse butcheries.

The meat is still commonly consumed in France and Belgium, as well as parts of Central Asia and South America.

So why are the British so squeamish about eating horse?

The answer

Horses are seen as pets
Historically, they were useful for transport and war
There are emotional connotations

There is no real logic as to why plenty of Britons are perfectly willing to eat cows, pigs, and chickens, but see horses as taboo, according to Dr Roger Mugford, an animal psychologist who runs the Animal Behaviour Centre.

"I'm a farmer and there is an irony. Why are horses different from pigs and lambs?" he says.

Part of the reason is people frequently see horses as pets, and humans tend to put "extra qualities and values" on animals they call pets, he says.

"As soon as you give an animal a name, how can you eat it? I've got lambs, sheep, with names - they live forever. I don't name the commercial flock, which won't," he says.

Quite the fashion

From Curiosities of Food by Peter Lund Simmonds, published 1859

At Paris, where all eccentricities are found and even encouraged, one of the latest gastronomic innovations is the use of horse-flesh.

This social phenomenon of making the horse contribute to the nourishment of the human race is not altogether new. The ancient Germans and Scandinavians had a marked liking for horse-flesh. The nomad tribes of Northern Asia make horse-flesh their favourite food.

With the high ruling prices of butcher's meat, what think you, gentlemen and housekeepers, of horse flesh as a substitute for beef and mutton?

Banquets of horse-flesh are at present the rage in Paris, Toulouse and Berlin. The veterinary schools there pronounce horse-bone soup preferable beyond measure to the old-fashioned beef-bone liquid, and much more economical.

History is also responsible for attitudes towards horses, according to Mugford.

"Horses helped out in warfare. There have been huge sacrifices alongside riders in historic battles. And there are sentimental depictions like War Horse," he says.

Their widespread use as working animals has had a lasting effect, argues food historian Ivan Day.

"We have to remember at one point, before railways, horses were the main means of transport. You don't eat your Aston Martin," he says.

Food historian Dr Annie Gray agrees the primary reasons for not eating horses were "their usefulness as beast of burden, and their association with poor or horrid conditions of living".

She suspects the practical considerations have become so embedded in culinary norms that horseflesh has garnered emotional connotations.

But all of the above reasons apply as much to France as they do to the UK. There must be more to it.

"It enables us to have yet another point of difference with the French," says Gray.

"Beef has long been symbolic of Englishness and therefore anything we can do or say to put British beef on a pedestal is usually done - ergo the thought that the French eat horse while we eat good beef becomes a chauvinistic way of asserting national identity," she says.

Horsemeat production levels in 2009

China - 168,000 tonnes
Mexico - 81,749 tonnes
Kazakhstan - 71,387 tonnes
Russia - 48,936 tonnes
Argentina - 37,712 tonnes
Mongolia - 35,582 tonnes

Source: United Nations' Food and Agriculture Organisation

Gray, who lived in France for three years, says for her, it is completely natural to eat horsemeat as it was sold at her local butcher.

"I am far more concerned with where the food is from. I would far rather eat ethically sourced, well-cared for horse, than battery chicken, for example," she says.

So are attitudes changing at all?

Peta says the thought of unexpectedly tucking into a horse burger has "rightly shocked the nation". But it says Britons who say "neigh" to horsemeat do so only because they find ponies "cute".

Who, what, why?

A part of BBC News Magazine, Who, What, Why? aims to answer questions behind the headlines

"Why is one species cherished while another is spurned? If this story has shocked people, they should consider leaving all flesh off their plates and going vegan," it says.

Rather than seeing them as "cute", others may be more inclined to think of horses as majestic, or associate them with nobility.

The killing of horses for meat is still an emotive subject as many people see them as companion animals rather than a food source, according to the RSPCA.

But the proliferation of horsemeat jokes on Twitter suggests other people are seeing the lighter side of the story.

Contaminated horsemeat sold for food, FSA admits

Mary Creagh has called for action to stop any more horses with bute entering the food chain

The Food Standards Agency has admitted five horses which tested positive for a drug harmful to humans were exported to France for food.

Earlier, shadow environment secretary Mary Creagh said "several" UK-slaughtered horses with phenylbutazone, or bute, may have been sold for food.

The FSA said it identified eight cases of bute-positive horsemeat in 2012, none of which was for the UK market.

The drug is banned from being consumed by humans within the EU.

The FSA added that the other three horses which tested positive did not enter the food chain.

"Where the meat had been exported to other countries, the relevant food safety authorities were informed," it said. "None of the meat had been placed for sale on the UK market."

The news comes after traces of horse and pig DNA was recently found in some burgers.

Some of these were sold in Tesco, Iceland, Lidl, Aldi and Dunnes stores in the UK and Irish Republic. Tesco took out adverts in British newspapers apologising for selling some of the burgers.

There is no suggestion that these burgers contained phenylbutazone.

'Right to know'

Phenylbutazone is an anti-inflammatory drug which is given to horses for the treatment of lameness, pain and fever.

It is thought to cause bone marrow disorders in rare cases - and horses that have been administered the drug should have the information recorded on their passport.

AnalysisDavid ShukmanScience editor, BBC News

For horsemeat containing bute to get into the food chain, several safety processes have to fail.

First the horse's passport tracking its drug history has to be misleading - an illegal act in itself.

Then the horse has to get past the spot checks - relatively easy because not many are carried out.

Finally, the meat has to end up being processed and sold for human use - almost always on the Continent, very little being eaten here.

The numbers involved in this scenario cannot be large since only around 8,000 horses are slaughtered each year.

But checks since 2007 do show bute turning up in small but consistent quantities. And the stuff is best avoided.

A specialist Defra committee says it has "serious adverse effects". Real harm is very unlikely, but the episode once again raises awkward questions about the international meat trade.

Read more from David

But Labour claims the issuing of horse passports in the UK is fragmented, as there are 75 approved issuing organisations in the UK, with no national database to track the information.

Speaking prior to the FSA's statement, Ms Creagh told agriculture minister David Heath in the Commons: "I am in receipt of evidence showing that several horses slaughtered in UK abattoirs last year tested positive for phenylbutazone, or bute, a drug which causes cancer in humans and is banned from the human food chain.

"It is possible that those animals entered the human food chain."

When Ms Creagh asked if Mr Heath was aware of the phenylbutazone cases to which she referred, the minister replied: "The Food Standards Agency carry out checks in slaughterhouses to ensure that equine animals presented for slaughter are fit for human consumption in the same way as they do for cattle, sheep and other animals.

"In addition, the FSA carry out subsequent testing for phenylbutazone and other veterinary medicines in meat from horses slaughtered in this country.

"Where positive results for phenylbutazone are found, the FSA investigates and takes follow-up action to trace the meat."

Ms Creagh then asked if that meant Mr Heath was aware of the issue.

"I'm astonished that you have not raised this and I think the public have a right to know," she said.

'No evidence'

She also said the news was a "very serious development" and demanded action to ensure that "illegal and carcinogenic horsemeat stops entering the human food chain".

And she called on the government to reverse a "reckless" decision to end the National Equine Database.

But Mr Heath replied: "There is no difficulty in tracing the use of a horse passport. To suggest the National Equine Database was required to do that is simply erroneous."

Alastair Hay, professor of environmental toxicology at the University of Leeds, disputed Ms Creagh's claims about the drug causing cancer in humans.

He said there was "no convincing evidence" of phenylbutazone's carcinogenicity in humans "because in the individuals studied many other drugs had also been taken and any one of these might have caused the cancers seen".

And there is no animal evidence either that it is a carcinogen, he added, saying that "phenylbutazone is not classifiable as to its carcinogenicity" according to the International Agency for Research on Cancer.

"The reason the chemical is not for human consumption appears to be rare and idiosyncratic responses in humans to the chemical. These include aplastic anaemia and some other disorders of the bone marrow. But these are not cancer events."

Antibiotic 'apocalypse' warning

By James GallagherHealth and science reporter, BBC News

Drug resistance is a problem in tuberculosis

The rise in drug resistant infections is comparable to the threat of global warming, according to the chief medical officer for England.

Prof Dame Sally Davies said bacteria were becoming resistant to current drugs and there were few antibiotics to replace them.

She told a committee of MPs that going for a routine operation could become deadly due to the threat of infection.

Experts said it was a global problem and needed much more attention.

Antibiotics have been one of the greatest success stories in medicine. However, bacteria are a rapidly adapting foe which find new ways to evade drugs.

MRSA rapidly became one of the most feared words in hospitals wards and there are growing reports of resistance in strains of E. coli, tuberculosis and gonorrhoea.

Prof Davies said: "It is clear that we might not ever see global warming, the apocalyptic scenario is that when I need a new hip in 20 years I'll die from a routine infection because we've run out of antibiotics."

She said there was only one useful antibiotic left to treat gonorrhoea.

"It is very serious, and it's very serious because we are not using our antibiotics effectively in countries.

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We have to be aware that we aren't going to have new wonder drugs coming along because there just aren't any.”

Prof Hugh PenningtonUniversity of Aberdeen

"There is a broken market model for making new antibiotics, so it's an empty pipeline, so as they become resistant, these bugs, which they would naturally but we're breeding them in because of the way antibiotics are used, there will not be new antibiotics to come."

Possible solutions will be included in her annual report to be published in March.

Empty arsenal

The World Health Organization has warned the world is heading for a "post-antibiotic era" unless action is taken.

It paints a future in which "many common infections will no longer have a cure and, once again, kill unabated".

Conservative MP Stephen Metcalfe warns that research is not happening quickly enough.

Prof Hugh Pennington, a microbiologist from the University of Aberdeen, said drug resistance was "a very, very serious problem".

"We do need to pay much more attention to it. We need resources for surveillance, resources to cope with the problem and to get public information across.

But he said it was not a problem entirely of the UK's making.

"People are going abroad for operations, going abroad for, let's say, sex tourism and bringing home gonorrhoea which is a big problem in terms of antibiotic resistance - and then there's tuberculosis in many parts of the world.

Prof Pennington said the drugs companies had run out of options too as all the easy drugs had been made.

"We have to be aware that we aren't going to have new wonder drugs coming along because there just aren't any."

Thursday, 24 January 2013

Islamic diet in US

McDonald's settles $700,000 suit over Islamic diet in US

Published January 22, 2013

Associated Press

DEARBORN, Michigan – McDonald's and one of its franchise owners agreed to pay $700,000 to members of the Muslim community to settle allegations a Detroit-area restaurant falsely advertised its food as being prepared according to Islamic dietary law.
McDonald's and Finley's Management Co. agreed Friday to the tentative settlement, with that money to be shared by Dearborn Heights resident Ahmed Ahmed, a Detroit health clinic, the Arab American National Museum in Dearborn and lawyers.
Ahmed's attorney, Kassem Dakhlallah, told The Associated Press on Monday that he's "thrilled" with the preliminary deal that's expected to be finalized March 1. McDonald's and Finley's Management deny any liability but say the settlement is in their best interests.
The lawsuit alleged that Ahmed bought a chicken sandwich in September 2011 at a Dearborn McDonald's but found it wasn't halal -- meaning it didn't meet Islamic requirements for preparing food. Islam forbids consumption of pork, and God's name must be invoked before an animal providing meat for consumption is slaughtered.
Check out the latest news of the fast food industry on FoxNews.com
Dakhlallah said there are only two McDonald's in the United States that sell halal products and both are in Dearborn, which has one of the nation's largest Arab and Muslim communities. Overall, the Detroit area is home to about 150,000 Muslims of many different ethnicities.
The locations advertise that they exclusively sell halal Chicken McNuggets and McChicken sandwiches and they have to get those products from an approved halal provider, Dakhlallah said. He said there was no evidence of problems on the production side, but he alleges that the Dearborn location on Ford Road sold non-halal products when it ran out of halal.
Dakhlallah said he was approached by Ahmed, and they conducted an investigation. A letter sent to McDonald's Corp. and Finley's Management by Dakhlallah's firm said Ahmed had "confirmed from a source familiar with the inventory" that the restaurant had sold non-halal food "on many occasions."
After they received no response to the letter, Dakhlallah said, they filed a lawsuit in Wayne County Circuit Court in November 2011 as part of a class action.
The AP left messages Monday afternoon for attorneys representing the corporation and the franchise.
In the settlement notice, Finley's Management said it "has a carefully designed system for preparing and serving halal such that halal chicken products are labeled, stored, refrigerated, and cooked in halal-only areas." The company added it trains its employees on preparing halal food and "requires strict adherence to the process."
He said although Ahmed believes McDonald's was negligent, there was no evidence that the chain set out to deceive customers.
"McDonald's from the very beginning stepped up and took this case very seriously," Dakhlallah said. "They made it clear they wanted to resolve this. They got ahead of the problem."
The lawsuit covers anyone who bought the halal-advertised products from the Ford Road restaurant and another Dearborn McDonald's with a different owner between September 2005 and last Friday. Since that would be impossible to determine, Dakhlallah said both sides agreed to provide money to community-based charities that benefit members of this group.
The other location on Michigan Avenue wasn't a defendant or a focus of the investigation, Dakhlallah said.
He said the final hearing will ultimately determine who gets what and how much, but roughly $275,000 is expected to go to the Huda Clinic, about $150,000 to the museum, $230,000 to attorneys and $20,000 to Ahmed.
Dakhlallah said he believes it's the first lawsuit of its kind related to McDonald's and halal food.
In 2002, McDonald's agreed to donate $10 million to Hindu and other groups in the U.S. to settle lawsuits that accused the chain of mislabeling french fries and hash browns as vegetarian. The vegetable oil used to prepare the items had contained traces of beef for flavoring purposes.

mengele plus

Monday, 28 January 2013