28 July 2011

ARTIFICIAL ORGANS - We make human spare parts

In a small lab on the ninth floor in the Royal Free Hospital in Hampstead, a technician is watching a vial of clear liquid spin. It's an inexpensive and unremarkable-looking liquid but it can be transformed into a human artery, vein, heart valve, tear duct or trachea. It might in the future be used to make human hearts, bladders, lungs, larynxes, noses, penises, breasts, ears - or most other parts of the human body you can think of. It is the liquid, if you like, of life.

This liquid was developed by Alex Seifalian, professor of nanotechnology and regenerative medicine at UCL Medical School. It is, to get technical, a nanocomposite polymer called - wait for it - polyhedral oligomeric silsesquioxane-poly (carbonate-urea) urethane, POSS-PCU for short. To get less technical, it is a liquid plastic that sets solid when it is heated up or cooled down and contains billions of tiny holes. Earlier this month it was used in an incredible bit of surgery, when a patient in Sweden had a section of his windpipe replaced with a piece built from his own stem cells and the professor's polymer.
This was the first time anyone in the world had received an organ made in a lab. It was a lifesaving operation and it marked the beginning of a new era in medical science. Using the technology, humans can start growing new and replacement body parts to order.
Professor Seifalian works in a small office a few yards from the lab. Aged 53, he has walnut skin and slightly bushy eyebrows. Long nights have given him the beginnings of bloodhound eyebags. But he is seldom far away from breaking into a slightly roguish laugh.
An expert and enthusiast, he has a clear vision of how the work of his small team could change the world. "A lot of organs in the future can be just made in the lab and transplanted," he says. "They will be available 'on-the-shelf'. People will be able to order them, add the patient's stem cell … and put it in the patient. If someone comes along here and says 'make us this', we can spend time and make it. Initially it is difficult to make but once we've made one we can make hundreds."
It sounds like the stuff of science fiction, a comparison he bears with equanimity. "We're not creating humans," he says. "We make human spare parts. We're not making the car, we make the engine, or a piece that has broken."
Seifalian, who began his career as a nuclear physicist, and his multidisciplinary team work at the point where physics and biology, surgery and science, collide. For some time they have made smaller synthetic bits for bodies, such as arteries and tear ducts.
The "spare part" that took Seifalian to the fore of the scientific world this month was a 36-year-old Eritrean man's trachea. Seifalian and his team were given just two weeks by a Swedish team to build him a new one and save the man's life.
It was an incredibly exciting time. "We were working day and night in the lab," says Seifalian. "I live across the road and I was going home to sleep just a few hours a night. My PhD student was sleeping here. My post-doc was here all the time, making the polymer."
Their work was so effective that Seifalian says he now has six more tracheas on order. It is not only the lifesaving aspects of his polymer that are thrilling. There are plenty of cosmetic surgeons, I suggest, who would love to be able to offer their patients new body parts.
Indeed there are. Seifalian says he has just been to a meeting where he has been discussing the possibility of using his polymer for breast reconstructions. For post-cancer mastectomy patients, he suggests, using his polymer would enable more effective breast reconstruction than the fat cells currently used.
But there's a cosmetic purpose, too. The professor delves into a desk drawer and pulls out two breast implants. Both are full of silicone but one is encased in his polymer, the other in the regular material used. He squeezes them, to demonstrate how much stronger his version is - virtually impossible to burst inside an augmented breast.
Is there anything he can't envisage making? "A brain I cannot make," he says. "And the liver is a complex organ, so we won't be able to make that. But the heart is possible. Not tomorrow, but maybe in three years' time."
Seifalian's polymer is incredibly cheap to produce (for around £50 he can make 500ml - enough to make two tracheas) and the possibilities for its use seem endless. It must be an extraordinary feeling, I say. He seems tongue-tied. "It's an amazing feeling … to do something … as a scientist and an academic …" He tails off. But not for long.
"My wife always complains," he laughs. "She says 'how much money will you get?' But it's not a money thing… it's just to see that someone got better from your work."

Why synthetic?

Hundreds of thousands of patients require organ donations every year. Those who survive must take drugs for life to suppress their immune system. Since it is seeded with a patient's own stem cells, Professor Seifalian's polymer is not rejected by the body.
The operation
The first transplant of a fully synthetic organ took place on July 9 at the Karolinska Hospital in Sweden.
The patient was Andemarian Telesenbet Beyene, who had advanced cancer of the trachea, which would have killed him. The medical team was led by Professor Paolo Macchiarini.
To build a new trachea, Macchiarini sent Professor Seifalian a 3D CT-scan of his patient's chest. Seifalian commissioned a glass-blower to make a perfect model of the damaged organ. This model was then dipped into liquid polymer, which set to form a plastic mould of the trachea, covered in millions of tiny holes in which new cells could grow.
The mould was sent to Sweden and placed in a bioreactor with nutrients and stem cells from the patient's bone marrow. It was rotated slowly at body temperature. As it rotated, the stem cells attached to the plastic mould and began to form themselves into a new trachea. After two days a new organ was ready. It was lined with cells from the inside of the patient's nose, and implanted in his body during long surgery. He has made a full recovery.

23 July 2011

Young people should not take flu vaccine, watchdog says

Children should no longer be given a widely-used flu vaccine over concerns it is linked to a rare sleep disorder, the European drug regulator has recommended.

Youngsters Receive Childhood Immunization: Young people should not take flu vaccine, watchdog says
Young people who were given the vaccine were at increased risk of developing narcolepsy, which causes sufferers to fall asleep unexpectedly Photo: GETTY
The European Medicine Agency said that Pandemrix should only be given to the under-20s if they are at risk of contracting swine flu and alternative jabs are not available.
Its announcement comes after studies showed that young people who were given the vaccine were at increased risk of developing narcolepsy, which causes sufferers to fall asleep unexpectedly.
But the British drug watchdog said it would not ban Pandemrix in the young and pointed out that the country’s stocks expire in a few months anyway.
Pandemrix, manufactured by the British pharmaceutical giant GlaxoSmithKline, was given to 30million people across Europe after the outbreak of swine flu – the H1N1 strain of the virus - that started in Mexico early in 2009.
It was approved by the European regulator in September that year but by the following August its safety was being reviewed after health officials in Finland claimed it had been linked to narcolepsy.
In total 335 cases of the sleeping disorder in people vaccinated with Pandemrix have been reported to GSK, with 10 suspected cases out of the 6million doses given in Britain.
In its review, the European watchdog said it looked at all the data as well as taking advice from experts, and found that the results of studies in Sweden and Finland suggested a six to 13-fold increased risk of narcolepsy among vaccinated children.
This means that for every 100,000 adolescents who are given the injection, up to seven are likely to develop narcolepsy.
However it added that a similar risk has not been confirmed in other countries, and the vaccine is likely to have interacted with “genetic or environmental factors” such as local infections in Scandinavia that might have raised the risk. Adults do not appear to be at greater risk, and overall its effects are said to remain positive.
As a result of the study, the agency said that Pandemrix should only be given to under-20s if they still need protection against swine flu but normal seasonal flu vaccines are unavailable.
The European Medicines Agency said: “The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that in persons under 20 years of age Pandemrix may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed (e.g. in persons at risk of the complications of infection). The CHMP confirmed that overall the benefit-risk balance of Pandemrix remains positive.”
But the Medicines and Healthcare products Regulatory Agency, Britain’s drug watchdog, said the recommendations were not binding and that Pandemrix would not be restricted in this country.
A spokesman said: “The annual seasonal flu vaccines have not been associated with the development of narcolepsy, and there are no new safety concerns associated with these vaccines. These vaccines remain recommended for protection against seasonal influenza.
“The MHRA has been fully involved in the European safety review of Pandemrix vaccine. It is possible that other geographical factors in Sweden and Finland, at the time of the pandemic, have contributed to the cases of narcolepsy seen after vaccination with Pandemrix. These factors remain unknown, and further studies are ongoing to explore this.
“The regulatory action for Pandemrix vaccines recognises the potential seriousness of H1N1 infection and ensures that the vaccine remains a licensed alternative to protect children and adolescents in need of protection against H1N1, if seasonal vaccines are not available.”
The MHRA added: “As the shelf-life of remaining UK stocks of Pandemrix expires in October this year, the vaccine will not be used in the 2011/12 flu vaccine campaign.”
It is not yet known if new stocks of Pandemrix will be ordered this winter.
The drug’s manufacturer said: “GSK is committed to patient safety and will continue to work closely with the EMA and other national regulatory organisations in the best interest of patients.
“Further information from ongoing studies, including the final data from the VAESCO (Vaccine Adverse Event Surveillance and Communication) study and an epidemiological study in Canada being supported by GSK, is however still needed in order to gain additional insight into the cause of the reported cases of narcolepsy.
“In addition, GSK has committed to conduct further research into any potential association between Pandemrix and narcolepsy and will seek independent expert advice on this research activity, as agreed with the EMA.”

22 July 2011

Beware 'Planet of the Apes' experiments that could create sci-fi nightmare

It sounds like something from a Hollywood science fiction film: a race that is half human, half ape.
But leading scientists are today demanding tough new rules to prevent the nightmare scenario becoming a reality.
In a hard-hitting report, they warn  that research is close to pushing ‘ethical boundaries’ and that extreme attempts to  give laboratory animals human attributes must be banned.

A scene from the latest Planet of the Apes film Rise of the Planet of the Apes
Summer blockbuster: A scene from the latest Planet of the Apes film Rise of the Planet of the Apes
In the film scientists search for an Alzheimer¿s cure create a new breed of ape with human-like intelligence
In the film scientists search for an Alzheimer's cure create a new breed of ape with human-like intelligence
Another scene from the film out in August. Last year, more than one million experiments were carried out on genetically modified animals
Another scene from the film out in August. Last year, more than one million experiments were carried out on genetically modified animals
While talking chimpanzees and gun-toting gorillas are currently confined to movies, the academics say the dangers of disturbing animal-human experiments are real.
Professor Martin Bobrow, a medical geneticist at Cambridge University and co-author of the report, said society needed to set rules before scientists began experiments that the public would find unacceptable.
He added: ‘We are trying to get this out in the open before anything has happened.’

Science fiction: Image from the new film Rise of the Planet of the Apes
Out for justice: Scientists claim chimps can be trained to wield weapons like this animal in a viral ad for new prequel Rise Of The Planet Of The Apes
Academics say the dangers of disturbing animal-human experiments are real
Could it happen? The clips, shot to look like fly-on-the-wall documentary footage from Africa, appear scarily real
The warnings have echoes of the new movie Rise Of The Planet Of The Apes, in which scientists searching for an Alzheimer¿s cure create a new breed of ape with human-like intelligence
After taking the AK47 the chimpanzee fires it towards onlookers who goaded it into pulling the trigger


  • Mice modified to carry human genes are widely used to study diseases including cancer, heart disease, osteoporosis and anxiety.
  • Goats created with a human gene are used to produce a human protein that treats blood clotting disorders.
  • Mice implanted with pieces of human tumours are used to test cancer drugs.
  • Rat brains are injected with human stem cells to study how the brain deals with stroke damage.
  • Researchers add human cells to mice immune systems or livers to study hepatitis.
The Academy of Medical Scientists review was set up to look at the growing number of experiments in which scientists add human genes or tissue to animals.
Last year, more than one million experiments were carried out on genetically modified animals – mostly mice and fish carrying human DNA.
These ‘transgenetic’ laboratory animals are used to develop new drugs for diseases such as cancer and Alzheimer’s, or to investigate the role of individual genes.
Researchers also create humanised animals by inserting human stem cells into animal embryos. These ‘chimeras’ are used to shed light on conditions such as stroke, hepatitis and cancer.
Today’s report says that most of these experiments raise no ethical or legal concerns.
But it argues that the fast pace of science means researchers could create  ‘animals containing human material that approach ethical or regulatory boundaries’, and calls for a new body of experts within the Home Office to monitor the experiments. 
It also demands some research is banned outright, including injecting human stem cells into the brains of primates if it ‘engenders human-like behaviour’. 
That would prevent scientists creating apes with human-like memories or the ability to speak.
Pugh: I wish you'd stop doing that, George!
The warnings have echoes of the new movie Rise Of The Planet Of The Apes, in which scientists searching for an Alzheimer’s cure create a new breed of ape with human-like intelligence. 
Report co-author Professor Thomas Baldwin said: ‘The fear is that if you start putting very large numbers of human brain cells into the brains of primates suddenly you might transform the primate into something that has some of the capacities that we regard as distinctively human – speech, or other ways of being able to manipulate or relate to us.
‘These possibilities that are at the moment largely explored in fiction,  we need to start thinking about now.’

18 July 2011

End of the World? Debt stalemate invokes language of Armageddon

End of the world? Debt stalemate invokes language of Armageddon

But instead of scaring GOP into action and breaking deadlocked talks, Obama's biblical rhetoric has had the opposite effect

With time quickly running out to raise the U.S. debt ceiling, the Obama administration is turning to biblical rhetoric to underscore the disastrous consequences if the United States defaults.
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For weeks Treasury Secretary Timothy Geithner and other administration officials have been warning of an economic "catastrophe" if the $14.3 trillion debt ceiling, which caps the amount Washington can borrow, is not raised by August 2.
Merriam-Webster dictionary defines catastrophe as "a momentous tragic event ranging from extreme misfortune to utter overthrow or ruin."
That definition appears to chime with the view of most economists, who agree that a U.S. default on its obligations would plunge the United States into a new recession and send shockwaves through international financial markets.
In interviews, speeches and news conferences, administration officials have used the word again and again.
But instead of scaring Republicans into action and breaking deadlocked debt talks it has had the opposite effect.
Scaremongering? Republican lawmakers accuse the Obama administration of scaremongering and many refuse to budge from their firm belief that a default will not happen, that the United States can keep paying its creditors simply by cutting back on spending.
Americans also do not appear to share the Obama administration's sense of doom. Polls show a majority of Americans are happy for the debt ceiling not to be raised, although it's not clear that those being surveyed are fully aware of the consequences of such a step.
Story: Fallback plan gains momentum in debt talks
So, the White House has upped the ante, eschewing catastrophe for a word more reminiscent of the "Cold War" stand-off between a nuclear-armed Soviet Union and United States —Armageddon.
Obama used the biblical reference last week at a White House news conference when he talked about a complicated Republican plan that seeks to pin the blame for raising the debt ceiling on him. He said then it could avert economic Armageddon.
Obama's budget director, Jack Lew, repeated it during a television interview on Sunday.
"Notwithstanding the voices of a few who are willing play with Armageddon, responsible leaders in Washington are not, he told ABC's "This Week" program.
Story: Tea Party debt plan takes center stage
To be fair, it was a Republican, Senator Kay Bailey Hutchison, who first warned way back in April that the debt ceiling negotiations would be a cataclysmic event, although at the time her warning was dismissed by many in Washington as hyperbole.
"The debt ceiling is going to be Armageddon," she said, trying to explain that while a just-ended budget dispute between Republicans and Obama had brought the government to the brink of a shutdown, the debt talks would be even worse.
Merriam-Webster's definition makes clear that while a catastrophe would be bad enough, Armageddon would be positively apocalyptic: "The site or time of a final and conclusive battle between the forces of good and evil; a usually vast decisive conflict or confrontation."
Around the country many Americans seem to agree that neither side in the standoff looks good as the talks grind on without resolution.
"They're all boneheads," Steve Ruzika, 55, told The New York Times.
"This has been brewing for a long time," the Boca Raton, Fla., entrepreneur said, adding that he's tired with both sides. "They should have solved it before now."