Thursday, February 23, 2012

Sweden snow: Man 'survives two months trapped in car'

Sweden snow: Man 'survives two months trapped in car'

Survival expert Dale Collett explains how, in theory, somebody could survive for two months with hardly any food or water

A Swedish man has survived being trapped in his snow-covered car for two months without food, police say.

The car was found on Friday at the end of a forest track more than 1 km (0.6 miles) from a main road in northern Sweden.

Police say the temperature in the area had recently dropped to -30C (-22F).

The man, who was too weak to utter more than a few words, said he had been inside since 19 December. He may have survived by drinking melted snow.

Police say they have no reason to doubt his story.

Sleeping bag

The man, who has not been named, is recovering at Umea University Hospital - where staff say he is doing well considering the circumstances.

The 45-year-old was discovered by snowmobilers who initially assumed the car was a wreck until they dug their way to a window and saw movement inside, reported the Vasterbotten Courier newspaper.

The man was huddled in a sleeping bag on the back seat, said policeman Ebbe Nyberg.

"He was in a very poor state. Poor condition. He said he'd been there for a long time and had survived on a little snow.

"He said himself he hadn't eaten anything since December," Mr Nyberg said.

Doctors at the Umea University Hospital said they would normally expect a person to survive without food for around four weeks, said the Vasterbotten Courier.

One doctor told the newspaper that the man might have survived so long by going into a kind of hibernation.

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Male Y chromosome extinction theory challenged

Male Y chromosome extinction theory challenged

Human cells carry 23 pairs of chromosomes
Human cells carry 23 pairs of chromosomes, including one pair which determine gender

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Men may not become extinct after all, according to a new study.

Previous research has suggested the Y sex chromosome, which only men carry, is decaying genetically so fast that it will be extinct in five million years' time.

A gene within the chromosome is the switch which leads to testes development and the secretion of male hormones.

But a new US study in Nature suggests the genetic decay has all but ended.

Professor Jennifer Graves of Australian National University has previously suggested the Y chromosome may become extinct in as little as five million years' time, based on the rate at which genes are disappearing from the chromosome.

Genetics professor Brian Sykes predicted the demise of the Y chromosome, and of men, in as little as 100,000 years in his 2003 book Adam's Curse: A Future without Men.

The predictions were based on comparisons between the human X and Y sex chromosomes. While these chromosomes were once thought to be identical far back in the early history of mammals, the Y chromosome now has about 78 genes, compared with about 800 in the X chromosome.

“Start Quote

The Y is not going anywhere and gene loss has probably come to a halt”

Dr Jennifer Hughes Whitehead Institute, Cambridge, Massachusetts

Jennifer Hughes and colleagues at the Whitehead Institute in Cambridge, Massachusetts, have sought to determine whether rumours of the Y chromosome's demise have been exaggerated.

In a previous Nature paper in 2005, they compared the human Y chromosome with that of the chimpanzee, whose lineage diverged from that of humans about six million years ago.

They have now sequenced the Y chromosome of the rhesus monkey, which is separated from humans by 25 million years of evolution.

The conclusion from these comparative studies is that genetic decay has in recent history been minimal, with the human chromosome having lost no further genes in the last six million years, and only one in the last 25 million years.

"The Y is not going anywhere and gene loss has probably come to a halt," Ms Hughes told BBC News. "We can't rule out the possibility it could happen another time, but the genes which are left on the Y are here to stay.

"They apparently serve some critical function which we don't know much about yet, but the genes are being preserved pretty well by natural selection."

X-Y crossing

Most humans cells contain 23 sets of chromosomes, including one pair of sex chromosomes. In women, this sex pair consist of two X chromosomes, while men have one X and one Y chromosome. It is a gene within the Y chromosome which triggers the development in the embryo of male testes and the secretion of male hormones.

Professor Julian Parkhill visits the Wellcome Collection to unravel the science behind the genome

Genetic deterioration of the Y chromosome has occurred because unlike with the two X chromosomes in women, there is very little swapping of genetic material between the Y and X chromosome during reproduction. This means mutations and deletions in the Y chromosome are preserved between (male) generations.

"The X is fine because in females it gets to recombine with the other X but the Y never gets to recombine over almost its entire length, and shutting down that recombination has left the Y vulnerable to all these degenerative forces," said Dr Hughes, "which is why we're left with the Y we have today."

Commenting on the paper, Professor Mark Pagel, an evolutionary biologist at the University of Reading and author of Wired for Culture: Origins of the Human Social Mind, said that while there might be some squabbling in academic circles over the timings of the events, the paper told us there was a future for males in the very long term.

"It's a very nice piece of work, showing that gene loss in the male-specific region of the Y chromosome proceeds rapidly at first - exponentially in fact - but then reaches a point at which purifying selection brings this process to a halt."

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How to get America to walk

How to get America to walk

Help

US cities built in the 20th Century have long catered for a population that prefers to take the car to shop, dine and work. But an ageing population and a young professional workforce looking for an urban lifestyle have forced city planners to reconsider the existing road and pavement infrastructure.

But how do you remake a city into a pedestrian dream, and how do you re-educate the public about its transportation choices?

The BBC's Franz Strasser went to Raleigh, North Carolina, where an unsanctioned street sign campaign called Walk Raleigh caught the attention of city officials and pedestrians alike.

Night video courtesy of Matt Tomasulo.


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New York police 'spied on' New Jersey Muslims

New York police 'spied on' New Jersey Muslims

NYPD Police Commissioner  Ray Kelly speaks at a press conference 3 February 2012
New York's police commissioner has come under fire for appearing in a documentary about Muslims

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New York City police secretly collected information on Muslim communities in nearby Newark, New Jersey, police records have shown.

Newark Mayor Cory Booker said he was not informed of the surveillance, revealed by the Associated Press.

"This raises a number of concerns," Mr Booker said, promising to investigate. "It's just very, very sobering."

Earlier this week university officials in the US north-east protested against NYPD monitoring of Muslim students.

Administrators at Yale and Columbia protested about the police department's activities, which the NYPD said were justified in an effort to identify possible campus radicalisation.

Earlier this month, civic groups from around the US called for a legal investigation into intelligence-gathering on Shia Muslims in New York.

NYPD's demographic unit compiled information on mosques and Muslim-owned businesses in Newark in 2007, AP reported.

The secret police report obtained by the news agency mentions no evidence of terrorism or criminal behaviour.

"These locations provide the maximum ability to assess the general opinions and general activity of these communities," the report said.

Similar reports were prepared for two counties in Long Island, in New York state.

Jersey unsure

In a statement, the NYPD told the BBC that they had informed Newark officials of their operations.

Newark's former police director, Garry McCarthy, told the Associated Press that the NYPD had contacted his police department "as a courtesy" before sending the officers.

“Start Quote

The police department goes where there are allegations. Remind yourself when you turn out the light tonight”

No Newark police officers were involved in the surveillance, according to Mr McCarthy.

But New Jersey Governor Chris Christie said he had knowledge of the operation, which he called "disturbing".

Newark Mayor Cory Booker said the extent of the reported surveillance came as a surprise to him.

"If anyone in my police department had known this was a blanket investigation of individuals based on nothing but their religion, that strikes at the core of our beliefs and my beliefs very personally, and it would have merited a far sterner response,'' he said.

"We're going to get to the bottom of this."

The report notes Newark's large Portuguese and Brazilian communities, but says that only information about "Islamic religious centers" and Muslim-owned businesses were gathered.

However, polls show that most New Yorkers strongly support the NYPD's counter-terrorism efforts.

On Tuesday, New York City Mayor Michael Bloomberg strongly defended the city's police department after university leaders protested over campus monitoring.

"The police department goes where there are allegations," Mr Bloomberg said.

"And they look to see whether those allegations are true. That's what you'd expect them to do. That's what you'd want them to do. Remind yourself when you turn out the light tonight."

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Is English or Mandarin the language of the future?

Is English or Mandarin the language of the future?

Mandarin-English dictionary

English has been the dominant global language for a century, but is it the language of the future? If Mandarin Chinese is to challenge English globally, then it first has to conquer its own backyard, South East Asia.

In Malaysia's southernmost city of Johor Bahru, the desire to speak good English has driven some children to make a remarkable two-hour journey to school every day.

Nine-year-old Aw Yee Han hops on a yellow mini van at 04:30. His passport is tucked inside a small pouch hung around his neck.

This makes it easier for him to show it to immigration officials when he reaches the Malaysian border.

His school is located on the other side, in Singapore, where unlike in Malaysia, English is the main language.

It's not your typical school run, but his mother, Shirley Chua thinks it's worth it.

"Science and maths are all written in English so it's essential for my son to be fluent in the language," she says.

The assumption that Mandarin will grow with China's economic rise may be flawed. Consider Japan which, after spectacular post-war economic growth, became the world's second-biggest economy. The Japanese language saw no comparable rise in power and prestige.

The same may prove true of Mandarin. The character-based writing system requires years of hard work for even native speakers to learn, and poses a formidable obstacle to foreigners. In Asia, where China's influence is thousands of years old, this may pose less of a problem. But in the West, even dedicated students labour for years before they can confidently read a text of normal difficulty on a random topic.

Finally, many languages in Asia, Africa and the Amazon use "tones" (rising, falling, flat or dipping pitch contours) to distinguish different words. For speakers of tonal languages (like Vietnamese) learning the tones of Mandarin poses no particular difficulty. But speakers of non-tonal languages struggle to learn tones in adulthood - just ask any adult Mandarin-learner for their funniest story about using a word with the wrong tone.

An estimated 15,000 students from southern Johor state make the same bus journey across the border every day. It may seem like a drastic measure, but some parents don't trust the education system in Malaysia - they worry that the value of English is declining in the country.

Since independence from the British in 1957, the country has phased out schools that teach in English. By the early 1980s, most students were learning in the national language of Malay.

As a result, analysts say Malaysian graduates became less employable in the IT sector.

"We've seen a drastic reduction in the standard of English in our country, not just among the students but I think among the teachers as well," says political commentator Ong Kian Ming.

Those who believe that English is important for their children's future either send their kids to expensive private schools or to Singapore, where the government has been credited as being far-sighted for adopting the language of its former colonial master.

Nearly three-quarters of the population in Singapore are ethnic Chinese but English is the national language.

Many believe that this has helped the city state earn the title of being the easiest place to do business, by the World Bank.

Lost in translation

Notes saying Merry Christmas in different languages
  • Up to 7,000 different languages are estimated to be spoken around the world
  • Mandarin Chinese, English, Spanish, Hindi, Arabic, Bengali, Russian, Portuguese, Japanese, German and French are world's most widely spoken languages, according to UNESCO
  • Languages are grouped into families that share a common ancestry
  • English is related to German and Dutch, and all are part of Indo-European family of languages
  • Also includes French, Spanish and Italian, which come from Latin
  • 2,200 of the world's languages can be found in Asia, while Europe has 260

Source: BBC Languages

However, the dominance of English is now being challenged by the rise of China in Singapore.

The Singapore Chinese Chamber Institute of Business has added Chinese classes for business use in recent years.

Students are being taught in Mandarin rather than the Hokkien dialect spoken by the older Chinese immigrants.

These courses have proved popular, ever since the government began providing subsidies for Singaporeans to learn Chinese in 2009 during the global financial crisis.

"The government pushed to provide them with an opportunity to upgrade themselves so as to prepare themselves for the economic upturn," says chamber spokesperson Alwyn Chia.

Some businesses are already desperate for Chinese speakers.

Lee Han Shih, who runs a multimedia company, says English is becoming less important to him financially because he is taking western clients to do business in China.

"So obviously you need to learn English but you also need to know Chinese," says Mr Lee.

As China's economic power grows, Mr Lee believes that Mandarin will overtake English. In fact, he has already been seeing hints of this.

"The decline of the English language probably follows the decline of the US dollar.

"If the renminbi is becoming the next reserve currency then you have to learn Chinese."

More and more, he says, places like Brazil and China are doing business in the renminbi, not the US dollar, so there is less of a need to use English.

Bilingualism

Indeed, China's clout is growing in South East Asia, becoming the region's top trading partner.

But to say that Mandarin will rival English is a "bit of a stretch", says Manoj Vohra, Asia director at the Economist Intelligence Unit.

Find out more

  • Listen to Jennifer Pak's two part documentary English in the East on the BBC World Service

Even companies in China, who prefer to operate in Chinese, are looking for managers who speak both Mandarin and English if they want to expand abroad, he says.

"They tend to act as their bridges."

So the future of English is not a question of whether it will be overtaken by Mandarin, but whether it will co-exist with Chinese, says Vohra.

He believes bilingualism will triumph in South East Asia.

It is a sound economic argument, but in Vietnam's case, there is resistance to learning Mandarin.

The country may share a border with China, but the Vietnamese government's choice to not emphasise Mandarin is an emotional one, says leading economist Le Dang Doanh.

Aw Yee Han and his mother Shirley Chua fears her son's English will suffer in the Malaysian school system

"All the streets in Vietnam are named according to generals and emperors that have been fighting against the Chinese invasion for 2000 years," he says.

Tensions flared up again last May over the disputed waters of the South China Sea.

Anti-Chinese sentiment means that young Vietnamese are choosing to embrace English - the language of a defeated enemy. Many families still bear the psychological scars from the Vietnam War with the United States.

Yet there is no animosity towards English because the founding father of Vietnam, Ho Chi Minh, made a clear distinction between the so-called American imperialists who were bombarding Vietnam and the American people, says Le Dang Doanh.

Many Vietnamese who have lost family members during the war are now studying in America, he says.

"We never forget any victim in the past but in order to industrialise and normalise a country, Vietnam needs to speak English."

The Vietnamese government has an ambitious goal to ensure all young people leaving school by 2020 will have a good grasp of the English language.

Bboy dancer Ngoc Tu Vietnamese Ngoc Tu only listens to music in English

But it's not hard for young Vietnamese to accept English. For some, the language offers a sense of freedom in Vietnam, where the one-party communist state retains a tight grip on all media.

In a public square in central Hanoi, a group of young men are break-dancing to the pulsing beats of western hip hop. Ngoc Tu, 20, says he only listens to English music.

"The Ministry of Culture has banned a lot of [Vietnamese] songs and any cultural publications that refer to freedom or rebellion but... English songs are not censored."

It is debatable whether English or Mandarin will dominate in South East Asia in the future. There are arguments for both on the economic front.

But culturally, there is no dispute.

Even Mandarin language enthusiasts like Singaporean businessman Mr Lee, says that English will remain popular so long as Hollywood exists.

The success of movies such as Kung Fu Panda, an American production about a Chinese animal, has caused a lot of anxiety in China, he says.

There have been many cartoons in China about pandas before, but none had reached commercial success, says Mr Lee.

"The moment Kung Fu Panda hit the cinemas everybody watched it. They bought the merchandise and they learned English."

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Barack Obama seeks to change US corporate tax code

Barack Obama seeks to change US corporate tax code

Barack Obama addresses the audience at the White House, Washington, DC 21 February 2012.
The US president has seen recent success on extending the payroll tax cut

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US President Barack Obama is proposing cutting the US corporate tax rate from 35% to 28%, and closing loopholes, as part of a larger push for tax reform.

Announcing the plan, the US treasury secretary called the tax code loopholes "fundamentally unfair".

Republicans also propose lowering rates, but Mr Obama's plan is thought to have few chances of becoming law.

Correspondents say the president is using the plan to spark a debate on tax reform in an election year.

The plan does not include any overhaul of the individual tax code.

"Our current corporate tax system is outdated, unfair, and inefficient," Mr Obama said in a statement.

"It is unnecessarily complicated and forces America's small businesses to spend countless hours and dollars filing their taxes."

Treasury Secretary Timothy Geithner also called the current system inefficient, describing it as bad for job-creation.

He said the White House and Treasury plan would make the tax system more globally competitive and eliminate "fundamentally unfair" loopholes.

"We want to restore a system in which American businesses succeed or fail based on the products they make and the services they provide, not on the creativity of their tax engineers or the lobbyists they hire."

Loophole tax rate

The US currently has one of the top corporate tax rates in the world, but loopholes and other subsidies mean many companies pay a much lower effective tax rate.

According to the Congressional Budget Office, total corporate federal taxes represented 12.1% of US profits in 2011.

US media analysis

Washington Post's Wonkbook argues the plan is a challenge to businesses who have called for reform: "In a sense, their document is as much about showing how hard corporate tax reform will be as it is about getting corporate tax reform done."

Fox Business's Elizabeth MacDonald says that under the White House's plan, business such as utilities and car manufacturers would benefit, while the internet and biotech sectors could see higher taxes.

Writing in the National Review, Douglas Holtz-Eakin says: "Credit where credit is due," but adds that the rate is not competitive enough and that a minimum tax on foreign profits puts the US "out of step" with other developed countries.

Republican Representative Dave Camp and presidential hopeful Mitt Romney have proposed a 25% rate, while other Republican candidates have suggested rates as low as 12.5%.

While both parties have expressed interest in removing tax loopholes, there is disagreement on which subsidies will be need to be cut in order to make up for revenues lost through lowering the standard rate.

Removing the tax loopholes would be likely to raise tax revenues overall, with some companies paying more or less under the current system.

As part of the proposed plan, Mr Obama has suggested lowering the tax rate to 25% for manufacturing businesses and continuing research and development-based tax credits.

While the announcement fleshes out promises made in Mr Obama's January State of the Union address, it leaves certain key details, like the percentage of a minimum tax on foreign profits, up to Congress.

Correspondents say that the tax proposal - and the deliberate lack of detail in some areas - is a move by Mr Obama to shift responsibility to Congress.

Republicans in the House of Representatives have routinely opposed Mr Obama's legislative plans since winning control of the chamber in the 2010 elections.

Source

Wednesday, February 22, 2012

Lab-grown meat is first step to artificial hamburger

Lab-grown meat is first step to artificial hamburger

Lab grown meat
The first strips of muscle have been grown in a project to develop a new way to produce meat

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Dutch scientists have used stem cells to create strips of muscle tissue with the aim of producing the first lab-grown hamburger later this year.

The aim of the research is to develop a more efficient way of producing meat than rearing animals.

At a major science meeting in Canada, Prof Mark Post said synthetic meat could reduce the environmental footprint of meat by up to 60%.

"We would gain a tremendous amount in terms of resources," he said.

Professor Post's group at Maastricht University in the Netherlands has grown small pieces of muscle about 2cm long, 1cm wide and about a mm thick.

They are off-white and resemble strips of calamari in appearance. These strips will be mixed with blood and artificially grown fat to produce a hamburger by the autumn.

The cost of producing the hamburger will be £200,000 but Professor Post says that once the principle has been demonstrated, production techniques will be improved and costs will come down.

At a news conference, Prof Post said he was even planning to ask celebrity chef Heston Blumenthal to cook it.

“Start Quote

In the beginning it will taste bland. I think we will need to work on the flavour”

Prof Mark Post University of Maastricht

"The reason we are doing this is not to show a viable product but to show that in reality we can do this," he told BBC News.

"From then on, we need to spend a whole lot of work and money to make the process efficient and then cost effective."

So why use such high tech methods to produce meat when livestock production methods have done the job effectively for thousands of years?

It is because most food scientists believe that current methods of food production are unsustainable.

Some estimate that food production will have to double within the next 50 years to meet the requirements of a growing population. During this period, climate change, water shortages and greater urbanisation will make it more difficult to produce food.

Prof Sean Smukler from the University of British Columbia said keeping pace with demand for meat from Asia and Africa will be particularly hard as demand from these regions will shoot up as living standards rise. He thinks that lab grown meat could be a good solution.

Butcher Demand for meat will increase at a time when it will be harder than ever for farmers to boost production

"It will help reduce land pressures," he told BBC News. "Anything that stops more wild land being converted to agricultural land is a good thing. We're already reaching a critical point in availability of arable land," he said.

Lab-grown meat could eventually become more efficient than producing meat the old fashioned way, according to Prof Post. Currently, 100g of vegetable protein has to be fed to pigs or cows to produce 15g of animal protein, an efficiency of 15%. He believes that synthetic meat could be produced with an equivalent energy efficiency of 50%.

So what is the synthetic burger likely to taste like?

"In the beginning it will taste bland," says Prof Post. "I think we will need to work on the flavour separately by trying to figure out which components of the meat actually produce the taste and analyse what the composition of the strip is and whether we can change that."

Prof Post also said that if the technology took off, it would reduce the number of animals that were factory farmed and slaughtered.

The BBC's Pallab Ghosh reports from Duggie's Dogs hot dog restaurant in Downtown Vancouver

But David Steele, who is president of Earthsave Canada, said that the same benefits could be achieved if people ate less meat.

"While I do think that there are definite environmental and animal welfare advantages of this high-tech approach over factory farming, especially, it is pretty clear to me that plant-based alternatives... have substantial environmental and probably animal welfare advantages over synthetic meat," he said.

Dr Steele, who is also a molecular biologist, said he was also concerned that unhealthily high levels of antibiotics and antifungal chemicals would be needed to stop the synthetic meat from rotting.

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Surprise in store for Republican race? Surprise in store for Republican race?

Surprise in store for Republican race?

People in South Carolina look at sand sculpture depicting Republican presidential candidates (L-R): Mitt Romney, Newt Gingrich, former candidate Jon Huntsman, Rick Perry, Rick Santorum and Ron Paul
Will there be a hot political night this summer in Florida's Tampa?

The Republican party's rolling roadshow of internal democracy known as the primaries has many surreal aspects.

One of the oddest is that it is all about winning votes for a contest that no-one thinks is going to happen.

Except now things are so feverish that there is chatter that the vote might actually take place.

If Mitt Romney loses the Michigan primary on 28 February, that talk will reach a new and shriller pitch.

There will be desperate calls for a new candidate to enter the race. One anonymous but apparently senior senator has told ABC that he will lead the charge.

That would inevitably lead to a political brawl in Florida's summer heat.

Let me explain.

The state-by-state caucus and primary contests are all about winning delegates to vote at the Republican Convention in Tampa, Florida, in August. That is in theory.

In practice it hasn't actually reached a vote since 1972, although that contest was pretty sewn up.

But further in the past, conventions were nail-biting affairs with all the decorum of a wild-west cattle sale.

Desperate and sweaty men pace around each other in hotel suites, threatening and tempting by turns.

City and state power brokers dangled "their" delegates, holding out for more bourbon and bigger bribes.

In every race since then it has operated on a "it's-a-knockout" principle.

The convention hasn't had to choose because long before the summer one candidate has emerged as a clear winner, and the others have dropped out.

This time it is possible that neither Mitt Romney, nor Rick Santorum, nor Newt Gingrich nor Ron Paul will have enough votes to look like a clear winner.

Equally, none may look so much like a loser that they are forced out. That is partly down to the personalities and dynamics this time around.

But it is also compounded because the Republicans have moved from "winner takes all" to "proportional representation". So states divide up their delegates between the candidates making a knockout victory less likely.

There's also the separate, but linked, theory that if none of them looks like a winner someone else, like Jeb Bush, will emerge and take them all on.

This is hard to do, playing by the rule book, but anything is possible if the political will is there.

Wise heads now point out that every four years someone will write up the "brokered convention" story, but it doesn't happen.

This is true. But it is not a prediction.

In every British election I have covered, there has been a flurry when someone talks up the chances of a coalition with the Lib-Dems, or at least highlighted the dilemma for the party.

In the 20 years I reported on British politics it never happened. Then in 2010 it did.

There is very little smart money on a Florida showdown.

But it isn't at all obvious how, and when, this race will end. I wouldn't rule out the answer being a hot night in Tampa.

Source

FDA Sets Path for Biotech Drug Copies

FDA Sets Path for Biotech Drug Copies

The Food and Drug Administration on Thursday created the first shortcut to the U.S. market for "biosimilar" drugs—cheaper versions of expensive and complex medicines made from biological matter.

Examples of such blockbuster drugs are erythropoietin for anemia, Remicade for rheumatoid arthritis and the cancer drug Herceptin. Erythropoietin alone costs the federal medical system an estimated $4 billion, and the FDA's guidelines for cheaper knockoffs are designed to put a dent in such ballooning medical costs. Versions of erythropoietin are made by Amgen Inc. and Johnson & Johnson. J&J sells Remicade in the U.S., and Roche Holding AG makes Herceptin.

The FDA's release of guidelines for the cheaper drugs sets out a series of steps that companies must comply with. It will be "an abbreviated pathway that will depend on existing data" on the already-existing, more-expensive drug, said Rachel Sherman, FDA associate director for medical policy.

"Instead of starting from scratch, these companies will be starting in the middle of the process," said Dr. Sherman. The new guidelines add details to the original proposal for introducing biosimilar drugs, contained in President Barack Obama's 2010 health overhaul.

The FDA action lags those in the European Union, which already has more than a dozen biosimilar drugs on the market.

Biologics are among the biggest-selling medicines today. In 2010, seven out of the top 20 selling drugs in the U.S. were biologics, led by anemia fighter erythropoietin, which has $3.3 billion in U.S. sales, according to Morgan Stanley Research. Biologics with $30 billion in U.S. sales are expected to lose patent protection by 2020, according to Bernstein Research.

Given the stakes, drug makers including Merck & Co., Novartis SA and Pfizer Inc. have stepped up efforts to develop knockoffs and tap into the market. Most recently, biotechnology giant Amgen said it was partnering with generic drug maker Watson Pharmaceuticals Inc. to develop unspecified biosimilars treating cancer.

Biologics are far more complex than other drugs generally, and so producing a true generic version—one that is chemically identical to the brand drug—isn't possible with today's technology. Left unanswered in the FDA's latest guidelines is whether the bio-knockoffs can use the same name as the original brand drug.

Sales of the knockoffs could reach $8 billion by 2020, Bernstein Research estimates. And they might be more lucrative than generic versions of small-molecule drugs, if the complexity of developing these larger molecules limits competition. Payers who were surveyed by Bernstein said they expect biosimilars to cost 10% to 20% less than the brand products. (Traditional generics can be as much as 90% cheaper.)

Yet companies must overcome technical, financial and commercial challenges. Amgen sought a partner in Watson because it wanted to share the $150 million to $200 million cost of developing a biosimilar, and because it lacked the skills a traditional generic drug maker like Watson had selling lower-cost medicines to health plans and hospitals.

"There are so many unknowns commercially," said Scott Foraker, who heads Amgen's year-old biosimilars unit. "We don't know what the competitive environment will look like. We don't know what the pricing will be. And there still is regulatory uncertainty."

Many of the knockoffs will be classified as comparable to branded biologics, but not copies that a pharmacist could automatically substitute. As a result, manufacturers expect they will have to do more than sell the therapies based on price, as companies do with traditional generics. They will have to promote biosimilars to doctors, as they do for brand-name drugs.

"The essence is not going to be a typical generics business," said Michael Kamarck, who's heading Merck's biosimilars effort. He said the brief history of biosimilars in Europe, where the medicines are approved, showed the need for "actively promoting" the medicines in order to get them used.

The market share for biosimilar versions of anemia therapy erythropoietin is less than 13% in France, while in Germany it is 72%, according to IMS Health, a data firm.

Manufacturers will have to get doctors to overcome their comfort and experience with using branded biologics and persuade them to prescribe something comparable, said Gillian Woollett, a biosimilars expert at consulting firm Avalere Health.

Source

Friday, February 17, 2012

'Pharmacy on a chip' gets closer

'Pharmacy on a chip' gets closer

Implant device
The clinical trial reports the working of the implant device in seven women from Denmark

The futuristic idea that microchips could be implanted under a patient's skin to control the release of drugs has taken another step forward.

US scientists have been testing just such a device on women with the bone-wasting disease osteoporosis.

The chip was inserted in their waist and activated by remote control.

A clinical trial, reported in Science Translational Medicine, showed the chip could administer the correct doses and that there were no side effects.

The innovation has also been discussed here at the annual meeting of the American Association for the Advancement of Science (AAAS).

One of the designers, Prof Robert Langer from the Massachusetts Institute of Technology (MIT), claimed the programmable nature of the device opened up fascinating new avenues for medicine.

"You could literally have a pharmacy on a chip," he said. "This study used the device for the treatment of osteoporosis. However, there are many other applications where this type of microchip approach could improve treatment outcomes for patients, such as multiple sclerosis, vaccine delivery, for cancer treatment and for pain management."

The work is described as the first in-human testing of a wirelessly controlled drug delivery microchip. The technology at its core has been in development for more than 15 years.

Programmed to dose

It sees the fingernail-sized chip connected to an array of tiny, individually sealed wells of a drug product - in this case, a parathyroid hormone, teriparatide, which is used to counter bone density loss. Fully packaged, the device is about the size of a heart pacemaker.

"The whole device is approximately 3cm by 5cm, and 1cm thick," explained co-author Dr Robert Farra.

"Like other medical implants, it's made out of biocompatible materials. It has a housing with the electronics on the inside, together with the microchips that contain the discrete doses of the hormone."

The drug wells are capped by a thin membrane of platinum and titanium. A dose can only get out when a well membrane is broken, which is achieved through the application of a small electrical current.

“Start Quote

Although it was a very small study, the findings are certainly exciting”

Julia Thomson National Osteoporosis Society

The chip controls the timing, and because it is programmable, the dosages can be scheduled in advance or - as in the newly reported study - triggered remotely by a radio signal.

"When the microprocessor decides to pass current through a particular membrane, that membrane decomposes in about 25 microseconds," colleague Prof Michael Cima told BBC News.

"The drug is then available for pick up in the capillaries that surround the device to go into the bloodstream."

The device was tested on seven women between ages of 65 and 70 from Denmark. In their paper, the scientists report that the implant delivered the drug teriparatide just as effectively as the injections pens that often used to administer such treatment, and that there were indications of improved bone formation (although drug efficacy was not formally assessed in the trial). Critically, no side effects were noticed.

The innovation started out as a research project in MIT but is now being developed by a spin-off company, Microchips Inc.

The firm is trying to scale up the system so that more doses can be included. In the trial, only 20 wells were present. Microchips Inc believes drug delivery devices containing hundreds of wells are possible.

However, the team acknowledges that a marketable product is still at least five years away.

'Clinical promise'

Commenting on the research, John Watson, a professor of bioengineering at the University of California, San Diego, listed areas where improvements would be needed.

"In the study, the device failed in one patient (an 8th patient, not included in their analysis), and the manufacturing process yielded only one device with all 20 reservoirs of drug," he said.

"Nevertheless, all doses present were released from the seven devices. Several years are still needed to bring this technology to approval by the US Food and Drug Administration (FDA) and to the clinical promise reflected in this small study."

Automated drug delivery systems are likely to prove popular with patients who currently have a daily regimen of self-administered injections. Julia Thomson, a nurse with the UK's National Osteoporosis Society, said such innovations could improve compliance among patients, some of whom will stop injecting because of the hassle.

"These implants form a new and novel approach to the way in which parathyroid hormone is administered, and although it was a very small study, the findings are certainly exciting," she said.

"The downside with parathyroid hormone has always been that women have to inject themselves on a daily basis so a new implant, like this, would certainly address compliance issues."

Ultimately, say the Massachusetts researchers, one could envisage sensors being combined with chips that hold reservoirs of different kinds of drugs, creating a system which could adapt treatments in response to changing conditions in a patient's body.

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