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³ÉÈËÂÛ̳ BLOGS - Newsnight: Susan Watts

Archives for September 2010

Stem cell doctor GMC decision due

Susan Watts | 18:00 UK time, Monday, 27 September 2010

The London doctor who carried out stem cell injections on British patients at clinics in Holland and Belgium should be "struck off" the medical register, a disciplinary panel of the General Medical Council (GMC) heard on Monday.

Dr Robert Trossel, 56, has already been found to have exploited vulnerable patients. Many of those he was injecting with stem cells were suffering from multiple sclerosis, for which there is currently no cure.

Tom Kark, from Field Fisher Waterhouse, speaking for the GMC, said: "They were all vulnerable patients who already found themselves failed by the medical profession in this country and as a result were searching, some with desperation, for a cure or relief elsewhere, which is why and how they ended up in Dr Trossel's hands.

Stem cells

Dr Trossel used stem cells not designed for human use

"They were given false hope by him and the experience not only cost them financially but for the most part it caused them personal and emotional loss when they realised that the treatment provided to them was not only expensive but pointless."

Mr Kark reminded the panel that Dr Trossel had also injected some of his patients with a material from Germany called Regeneresen, which contained live bovine brain and spinal cord cells, without explaining what he was injecting into them, or getting proper consent.

But the doctor's own lawyer, Robert Jay QC, argued that Dr Trossel should be suspended, not struck off, because the panel had found that Dr Trossel did not act dishonestly.

He described him as a "genuine and compassionate". He said Dr Trossel was "neither driven by love of money nor love of self" and had made it clear to patients that stem cell treatment was an experimental and untested therapy.

The panel is now weighing up this and other submissions behind closed doors, including its own finding in April this year that Dr Trossel was "taking unfair advantage of vulnerable patients and was therefore exploitative of them", and that his behaviour constituted "repeated and serious breaches of the essential tenets of good medical practice" earlier this month.

The GMC placed restrictions on Dr Trossel's work as a doctor in 2007, after a , which revealed that he was injecting patients with stem cells not intended for human use, but for research purposes only.

After a lengthy hearing process, the GMC panel ruled earlier this month that Dr Trossel's fitness to practice as a doctor is impaired, stating that he had "demonstrated little insight into the seriousness of your misconduct and the effects this may have had on your patients", adding that it was not convinced that his misconduct would not be repeated.

His patients paid around £10,000 or more for stem cell injections for a variety of conditions ranging from spinal injury to multiple sclerosis. Families raided pension funds, or organised fundraising events among friends and local communities to find the money.

Many of his British patients had reached Dr Trossel after contacting a web-based company operating out of South Africa, called Advanced Cell Therapeutics (ACT).

Newsnight established in 2006 that ACT was run by a couple called Stephen Van Rooyen and Laura Brown, who are wanted by the FBI for stem cell fraud under an extradition arrangement with South Africa. They failed in an appeal against that earlier this year.

Mr Jay, Dr Trossel's lawyer, argued on Monday that in his dealings with ACT "like Icarus, he flew too close to the Sun" in over enthusiastic pursuit of what he believed to be an exciting new development for his patients.

The GMC has already decided that in its view Dr Trossel "exaggerated the benefits of the treatment, overstated the success rate in treating patients with MS, and failed to inform patients fully of what was contained in the freeze medium in which the stem cells were delivered, namely that it contained bovine calf serum".

The panel said Dr Trossel's offer of such treatments was "unjustifiable on the basis of the available scientific or clinical medical evidence, inappropriate, not in the best interest of the patients and was exploitative of a vulnerable patient. It was therefore an abuse of his position as a doctor".

Dr Trossel has admitted that he did not inform some of his UK patients that he was separately injecting them with additional material which included bovine brain and spinal cord. The panel therefore found that informed consent could not have been given, an omission which the panel on Monday described as "serious".

The doctor had earlier told the panel that he had since had a "change of heart" about stem cell therapy, and that he should have been more careful in the advice he'd given to patients about its efficacy. He also said he regretted not having followed up patients with more scrutiny.

Dr Trossel has admitted many of the facts of the case, but in his defence he has argued that he stopped injections as soon as the Newsnight investigation made the origin of the stem cells clear.

Science brain-drain?

Susan Watts | 16:12 UK time, Wednesday, 22 September 2010

Talk of a new science brain-drain bubbled up again this morning, as science minister David Willetts was given a stark warning that the UK's world class status in stem cell research is under threat.

He was told that a funding gap, between research and commercialisation of stem cell therapies, is already being filled overseas. Leading edge research is at a critical stage in the UK, stem cell scientists said this morning, where it needs money to progress through clinical trials, and then on to commercialisation.

If the UK misses the opportunity successfully to translate and commercialise such therapies, scientists will start to be attracted to other countries, according to Sir Richard Sykes, chairman of the UK Stem Cell Foundation, newly-appointed head of the Royal Institution and former chairman of the pharmaceuticals giant GlaxoSmithKline. "We will see British scientists move away if that happens, and crucial benefits that we could exploit will be exploited by other people," Sir Richard warned.

As if to back up his fears, professor Peter Coffey of the London Project to Cure Blindness, at University College London, said other countries are already looking "very attractive". He is working on a stem cell-based therapy for the eye condition age-related macular degeneration. He cited Californian investment of $3bn in stem cell science, and Singapore's announcement two weeks ago of a $10bn stem cell research fund - one area of which is the eye.

Professor Coffey clearly wants to resist the lure of overseas facilities and money. Speaking to journalists in London he said: "I'm loyal to where I was born. I was educated here, I have family here, I don't see why I should move out of the UK."

But if funding fell by a certain level, he feared having to make people unemployed. "The pressures are becoming huge," he said. And professor Coffey may be one of the luckier researchers. His research has backing from Pfizer and AstraZeneca.

The government's spending review is clearly at the back of everyone's mind. Asked how much of a cut would make a serious dent in his ability to carry on, professor Coffey said a 10% cut in research council money or in the infrastructure that supports stem cell science in this country would mean he'd be looking at laying people off.

Sir Richard said charitable money is available to be tapped - perhaps as much as £100m - but that most investors want the security of knowing that their money is matched by government investment.

Scientists say stem cell therapies could reach clinical practice sooner than some regulators had expected. Therapies to treat liver and heart conditions, and perhaps bone and joint disorders could come in under five years, depending on investment, though therapies for neuro-degenerative disorders such as Parkinson's and Alzheimer's Disease are likely to be 10 years out or more.

David Willetts said the government recognises that stem cells have enormous potential for health benefits, and for contributing to our wealth and economic growth, describing this as "an exciting area of scientific advance."

He announced the go-ahead for two competitions for companies seeking to bring new therapies to the marketplace. These are expected to be worth about £10m though, as with so much else, scientists will have to wait for the spending review before the exact amount available will be clear.

Stem cell doctor Trossel faces being struck off after GMC hearing

Susan Watts | 13:12 UK time, Friday, 10 September 2010

The London doctor who carried out stem cell injections on British patients at clinics in Holland and Belgium faces being struck off at the end of the month after a panel at the (GMC) found this morning that his behaviour constituted "repeated and serious breaches of the essential tenets of good medical practice".

The GMC placed restrictions on Dr Robert Trossel's work as a doctor in 2007, after a which revealed that he was injecting patients with stem cells not intended for human use, but for research purposes only.

After a lengthy hearing process, the GMC panel said today that Dr Trossel's fitness to practice as a doctor is impaired, stating that it is concerned that he had: "demonstrated little insight into the seriousness of your misconduct and the effects this may have had on your patients," adding that it was not convinced that his misconduct will not be repeated.

A decision on whether or not Dr Trossel will be "struck off" or face lesser sanctions, such as suspension, is expected at the end of September. His patients paid around £10,000 or more for stem cell injections for a variety of conditions ranging from spinal injury to multiple sclerosis. Families raided pension funds, or organised fund-raising events among friends and local communities to find the money.

The GMC case involves nine such patients, some of whom gave evidence during the hearing. Many had reached Dr Trossel after contacting a web-based company operating out of South Africa, called Advanced Cell Therapeutics (ACT).

Newsnight established in 2006 that ACT was run by a couple called Stephen Van Rooyen and Laura Brown, who are still wanted by the FBI for stem cell fraud under an extradition arrangement with South Africa. They failed in an appeal against that earlier this year, and patients in South Africa are currently pursuing their own case against the pair.

In April, in its "findings of fact", the GMC found that Dr Trossel was "taking unfair advantage of vulnerable patients and was therefore exploitative of them"

It ruled that he: "exaggerated the benefits of the treatment, overstated the success rate in treating patients with MS, and failed to inform patients fully of what was contained in the freeze medium in which the stem cells were delivered, namely that it contained bovine calf serum".

The panel also concluded that given Dr Trossel's state of mind and his "actual belief" at the time, his actions were "not dishonest".

The panel said Dr Trossel's offer of such treatments was "unjustifiable on the basis of the available scientific or clinical medical evidence, inappropriate, not in the best interest of the patients and was exploitative of a vulnerable patient. It was therefore an abuse of his position as a doctor".

Dr Trossel has already admitted that he did not inform some of his UK patients that he was separately injecting them with additional material which included bovine brain and spinal cord. The panel therefore found that informed consent could not have been given, an omission which the panel today described as "serious".

The doctor had earlier told the panel that he had since had a "change of heart" about stem cell therapy, and that he should have been more careful in the advice he'd given to patients about its efficacy. He also said he regretted not having followed up patients with more scrutiny.

Dr Trossel, whose wife is admitted many of the facts of the case, but in his defence he has argued that he stopped injections as soon as the Newsnight investigation made the origin of the stem cells clear.

Are we closer to a 'theory of everything'?

Susan Watts | 12:09 UK time, Wednesday, 8 September 2010

The physicists' ultimate dream is the search for a "theory of everything", a unifying explanation that can make sense of the infinitely tiny as well as the infinitely large.

From the strange particles that are the terrain of atom-smashing machines such as the Large Hadron Collider (LHC) at Cern, to galaxies beyond our own, about which we're learning more and more through increasingly powerful telescopes and observatories.

Much of Stephen Hawking's new book, The Grand Design, makes his case for so-called M-Theory as the prime contender to be that elusive theory of everything.

The Large Hadron Collider

The Large Hadron Collider is helping in the quest

But it's esoteric stuff. So, in his first television interview, Newsnight asked him how he would explain the importance of M-theory to the many people in the UK who have little interest in theoretical physics.

"M-theory is the theory of everything. It explains how the universe was created out of nothing in the Big Bang, and how it behaves now. It governs everything we think and do. Isn't that of interest?" Hawking asks.

Though he hasn't really tackled the important part of the question, it's clear from his answer that Professor Hawking is as dogmatic about M-theory as he is about God. Recall his quote from the book: "It is not necessary to invoke God to light the blue touch paper and set the universe going."

He deals with M-theory in a similar tone: "M-theory is the only (sic) candidate for a complete theory of the universe." He adds later: "M-theory is the unified theory Einstein was hoping to find."

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But not all physicists agree that M-theory is the answer. The blogosphere has been almost as alive with chit chat from critics of his support for M-theory as it has over his views on God.

The thing about M-theory that most people find confusing is that its maths implies extra dimensions - not yet observed - that exist alongside the four dimensions of space and time that we have become familiar with in our everyday world.

The trouble with theories of everything, including M-theory, is that testing them in the laboratory is tricky - and that leaves them open to the charge that they're as much a leap of faith as religion. Theoretical physicist and broadcaster, Jim Al-Khalili, suggested as much on Newsnight last week.

But experimental evidence may be closer than some think. Atom smashers such as the LHC may one day "see" the extra dimensions that M-Theory implies, and London's Imperial College has published a paper in Physical Review Letters with a press release making the bold claim: "Researchers discover how to conduct first test of 'untestable' string theory."

Lead author Michael Duff tells me it's not quite as black and white as that and that the "test" is an indirect one, but it could have important implications for both string theory and M-theory - effectively an umbrella theory that embraces all five leading string theories.

The team from Imperial say they've found that string theory predicts the behaviour of entangled quantum particles - another mind-boggling area of physics. As this prediction can be tested in the laboratory, researchers say they can now test string theory.

"This will not be proof that string theory is the right 'theory of everything' that is being sought by cosmologists and particle physicists," Professor Duff explained.

"However, it will be very important to theoreticians because it will demonstrate whether or not string theory works, even if its application is in an unexpected and unrelated area of physics."

But Professor Hawking is not alone in his attachment to M-theory, or to the idea that our universe is just one world in a "multiverse" of worlds.

This is an idea which echoes work by the physicist Hugh Everett III in the 1950s on quantum theory. This was roundly dismissed while he was alive, but has enjoyed a late renaissance in recent years. Everett described the universe as having not one single history, but multiple histories, in his so-called Many Worlds, or Parallel Worlds, theory.

Though there's no direct link between Everett's many worlds theory and M-theory, Professor Hawking does describe how M-theory "allows for 10 to the power of 500 different universes, each with its own laws".

Hugh Everett's son, the musician Mark Everett, more famously known as E of the rock band Eels, has tried to grapple with some of this physics in an effort to better understand his difficult relationship with his father.

E, promoting his latest album Tomorrow Morning, tells me how he believes his father's withdrawn character was down to the early dismissive reaction to his work from other physicists.

"He was a 24-year-old genius that was brushed under the carpet, and that ruined his life," he tells me.

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But Professor Hawking explains how Hugh Everett III contributed to our knowledge of the universe.

"Hugh Everett made an important contribution to our understanding of quantum theory," he said. "In classical theory the universe has a definite history but this is not the case in quantum theory, Instead Everett suggested we could think of it as if the history kept branching into alternative histories."

The struggle to understand our world, or worlds, will continue, and the concluding paragraph of Professor Hawking's book sets out a seductive insight into the drive behind that search.

"The fact that we human beings - who are ourselves mere collections of fundamental particles of nature - have been able to come this close to an understanding of the laws governing us and our universe is a great triumph... If the theory is confirmed by observation, it will be the successful conclusion of a search going back more than 3,000 years. We will have found the grand design."

Incidentally, the M in M-theory is variously said to stand for "membrane", or according to Professor Hawking, possibly "master", "miracle" or "mystery". And mystery it may well remain for those of us still trying to make sense of it all.

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