Yet another story
Posted: Mon Mar 20, 2006 10:32 am
There seems to be a lot of questions and articles regarding some of these "miracle" companies. Click on "Jan Wilks" in the article below for more information about her story.
· Scepticism over treatment for neurological disorder
· Centre took over US firm's activities
Sarah Boseley
Monday March 20, 2006
The Guardian
The anonymous first-floor waiting room overlooking Rotterdam's shopping streets looks an unlikely outpost for miracle cures. It could belong to a building society. Only the stairlift, the wheelchairs and the air of excitement offer clues to what is going on.
Until a few years ago, the Preventive Medicine Clinic, confined itself to acupuncture, aromatherapy and ozone treatment. But it is the new item on the menu - stem cell injections - that has brought increasing numbers of desperate men and women from the UK, in the hope of a cure for multiple sclerosis.
Four Britons arrive with their families or closest friends on the day I visit. Two have come for injections of stem cells from umbilical cord blood, which they want to believe will help them recover from their progressively debilitating disease. The other two have come just to talk it over, but clearly need little encouragement to reach for the credit card. They are different people, from different places, but there's something they share. Hope.
Cells for the procedure are supplied by Advanced Cell Therapeutics, which has a Zurich address and a London telephone number "for new inquiries". It supplies a network of clinics across Europe. The Guardian has learned that ACT has taken over the activities of a US-based company, BioMark International, which became the subject of a fraud investigation and had its accounts frozen by the US Food and Drug Administration in 2003.
Three of the members of ACT's "medical advisory board" are the same, and are described in identical words on the ACT website and that of the former BioMark website, and ACT sends patients to the same clinics that BioMark supplied.
At the Rotterdam clinic Veronika Verden-Anderson, 43, with her friend Julie Jackson, is filling out a form. She can walk with two sticks, but it's a struggle. Her MS is progressive, not the milder relapsing, remitting kind. She has done all she can for herself - moving to the Scottish countryside for a healthier lifestyle, keeping fit and eating well. But there is nothing conventional medicine can offer her.
The MS drug betaferon costs £8,000 a year and it has side-effects, she says. "This is a one-off treatment. If I made any improvement at all, it would be worth it."
Later, Andrew Crichton, his wife, Gillian, and their son arrive. He has just turned 40, but he is in a wheelchair, his hand shakes and his eyesight has been affected. He's registered blind. He is very cheerful and pragmatic. His wife says: "I figure in this life you try anything."
The clinic, run by Dutch GP Robert Trossel who lives in London, used to get its stem cells from Biomark. Now they come from ACT.
The ACT website includes several case studies concerning ALS patients written by Dr Christopher Goddard. Dr Goddard is under investigation by Health Canada and the College of Physicians and Surgeons in British Columbia after the Los Angeles Times published an article a year ago, telling of a patient he allegedly injected on behalf of BioMark. There was no improvement.
The two founders of BioMark appear to have left the US. They were the businessman Stephen van Rooyen and a former model, Laura Brown. Mr Van Rooyen has reappeared in his native South Africa. Mr Van Rooyen said his partner, Ms Brown, was in London where the pair had "established a biotech company that is focusing exclusively on developing a government-approved clinical trials business in providing stem-cell therapies".
He claimed the trial data would "put an end to the smear campaigns and attempts to discredit the potential that cord blood stem cell therapy has to offer".
Jan Wilks, from Liverpool, has primary progressive MS. After stem cell treatment eight months ago, she told national papers she had improved so much that she was able to manage without a wheelchair. She says now that her headaches have gone, her brain feels clearer and she can walk with a stick. "Doctors have said to me it is all in your head and I say where has the pain gone? That wasn't in my head. I was taking paracetamol until it was coming out of my ears."
Doctors are increasingly anxious about the unproven therapy that is attracting so many of their MS patients. Neil Scolding, professor of clinical neurosciences at Bristol University, who is involved in MS research, said: "The stories that one hears of patients in a wheelchair who are walking 10 minutes after receiving this treatment could not be explained by any stem cell therapy mechanism."
Dr Trossel is qualified to GP level, but says he has found a way of adding RNA to the frozen cord blood cells he receives from Switzerland to "instruct" them where to go to mend damage in the human body - a piece of research that would win a research scientist a Nobel prize.
Robin Lovell-Badge, a stem cell scientist with the National Institute for Medical Research, says: "I certainly cannot see how adding mRNA to frozen cells would instruct them to do anything, except die."
Between patients, Dr Trossel does admit that the chances of long-term improvement for people with progressive MS are not so good. "Even if you repair all the nerve damage it doesn't mean they won't have another attack," he says. He admits that many who say they feel better at three months find that at six months "they feel back to the same situation". He also acknowledges that "the placebo effect is part of medicine".
A month after the injections, Mr Crichton says he feels "really well. My hands don't shake nearly as much and my walking is definitely a bit better and the same with my eyesight". He puts it as a 10% improvement. Ms Verdon-Anderson says: "I've had no improvement at all."
ACT requested that a list of questions be emailed to its medical director, Catherine Orridge. A reply came from Sean Castle, who describes himself as the managing director. He promised to answer the questions, including some on the relationship between Biomark and ACT, but failed to do so.
Foot notes
Stem cells
The basic building blocks of the human body. Embryonic stem cells, the tiny cluster that develops in the first days after fertilisation of a human egg, divide and divide again to become blood, nerves and tissue as required. Scientists hope one day to find a way to direct them to become specific cells, for instance to repair the damaged myelin sheath around the nerves in people with multiple sclerosis.
Multiple sclerosis
A disabling neurological condition affecting 85,000 mostly young adults in the UK. The cause is unknown and there is no cure. The immune system is wrongly triggered to attack the protective myelin layer around nerves that send messages to the brain. Movement becomes progressively more difficult. Some people have flare-ups followed by periods of recovery ( relapsing remitting MS) and some deteriorate steadily (progressive).
Cord blood
Umbilical cord blood contains stem cells. They are not thought to have the same potential as embryonic stem cells but they have been successfully transplanted into patients with blood diseases, such as leukaemia, thalassaemia and sickle cell disease. Cord blood is an alternative to a bone marrow transplant. A very close match is needed between patient and donor, however, which is why some parents with sick children want to have babies through test-tube fertility techniques, to select a perfect match sibling.
mRNA
Stands for messenger RNA, one form of ribonucleic acid, a chemical similar in structure to DNA. It transmits genetic information from DNA to proteins.
Source: Guardian Unlimited © Guardian Newspapers Limited 2006
· Scepticism over treatment for neurological disorder
· Centre took over US firm's activities
Sarah Boseley
Monday March 20, 2006
The Guardian
The anonymous first-floor waiting room overlooking Rotterdam's shopping streets looks an unlikely outpost for miracle cures. It could belong to a building society. Only the stairlift, the wheelchairs and the air of excitement offer clues to what is going on.
Until a few years ago, the Preventive Medicine Clinic, confined itself to acupuncture, aromatherapy and ozone treatment. But it is the new item on the menu - stem cell injections - that has brought increasing numbers of desperate men and women from the UK, in the hope of a cure for multiple sclerosis.
Four Britons arrive with their families or closest friends on the day I visit. Two have come for injections of stem cells from umbilical cord blood, which they want to believe will help them recover from their progressively debilitating disease. The other two have come just to talk it over, but clearly need little encouragement to reach for the credit card. They are different people, from different places, but there's something they share. Hope.
Cells for the procedure are supplied by Advanced Cell Therapeutics, which has a Zurich address and a London telephone number "for new inquiries". It supplies a network of clinics across Europe. The Guardian has learned that ACT has taken over the activities of a US-based company, BioMark International, which became the subject of a fraud investigation and had its accounts frozen by the US Food and Drug Administration in 2003.
Three of the members of ACT's "medical advisory board" are the same, and are described in identical words on the ACT website and that of the former BioMark website, and ACT sends patients to the same clinics that BioMark supplied.
At the Rotterdam clinic Veronika Verden-Anderson, 43, with her friend Julie Jackson, is filling out a form. She can walk with two sticks, but it's a struggle. Her MS is progressive, not the milder relapsing, remitting kind. She has done all she can for herself - moving to the Scottish countryside for a healthier lifestyle, keeping fit and eating well. But there is nothing conventional medicine can offer her.
The MS drug betaferon costs £8,000 a year and it has side-effects, she says. "This is a one-off treatment. If I made any improvement at all, it would be worth it."
Later, Andrew Crichton, his wife, Gillian, and their son arrive. He has just turned 40, but he is in a wheelchair, his hand shakes and his eyesight has been affected. He's registered blind. He is very cheerful and pragmatic. His wife says: "I figure in this life you try anything."
The clinic, run by Dutch GP Robert Trossel who lives in London, used to get its stem cells from Biomark. Now they come from ACT.
The ACT website includes several case studies concerning ALS patients written by Dr Christopher Goddard. Dr Goddard is under investigation by Health Canada and the College of Physicians and Surgeons in British Columbia after the Los Angeles Times published an article a year ago, telling of a patient he allegedly injected on behalf of BioMark. There was no improvement.
The two founders of BioMark appear to have left the US. They were the businessman Stephen van Rooyen and a former model, Laura Brown. Mr Van Rooyen has reappeared in his native South Africa. Mr Van Rooyen said his partner, Ms Brown, was in London where the pair had "established a biotech company that is focusing exclusively on developing a government-approved clinical trials business in providing stem-cell therapies".
He claimed the trial data would "put an end to the smear campaigns and attempts to discredit the potential that cord blood stem cell therapy has to offer".
Jan Wilks, from Liverpool, has primary progressive MS. After stem cell treatment eight months ago, she told national papers she had improved so much that she was able to manage without a wheelchair. She says now that her headaches have gone, her brain feels clearer and she can walk with a stick. "Doctors have said to me it is all in your head and I say where has the pain gone? That wasn't in my head. I was taking paracetamol until it was coming out of my ears."
Doctors are increasingly anxious about the unproven therapy that is attracting so many of their MS patients. Neil Scolding, professor of clinical neurosciences at Bristol University, who is involved in MS research, said: "The stories that one hears of patients in a wheelchair who are walking 10 minutes after receiving this treatment could not be explained by any stem cell therapy mechanism."
Dr Trossel is qualified to GP level, but says he has found a way of adding RNA to the frozen cord blood cells he receives from Switzerland to "instruct" them where to go to mend damage in the human body - a piece of research that would win a research scientist a Nobel prize.
Robin Lovell-Badge, a stem cell scientist with the National Institute for Medical Research, says: "I certainly cannot see how adding mRNA to frozen cells would instruct them to do anything, except die."
Between patients, Dr Trossel does admit that the chances of long-term improvement for people with progressive MS are not so good. "Even if you repair all the nerve damage it doesn't mean they won't have another attack," he says. He admits that many who say they feel better at three months find that at six months "they feel back to the same situation". He also acknowledges that "the placebo effect is part of medicine".
A month after the injections, Mr Crichton says he feels "really well. My hands don't shake nearly as much and my walking is definitely a bit better and the same with my eyesight". He puts it as a 10% improvement. Ms Verdon-Anderson says: "I've had no improvement at all."
ACT requested that a list of questions be emailed to its medical director, Catherine Orridge. A reply came from Sean Castle, who describes himself as the managing director. He promised to answer the questions, including some on the relationship between Biomark and ACT, but failed to do so.
Foot notes
Stem cells
The basic building blocks of the human body. Embryonic stem cells, the tiny cluster that develops in the first days after fertilisation of a human egg, divide and divide again to become blood, nerves and tissue as required. Scientists hope one day to find a way to direct them to become specific cells, for instance to repair the damaged myelin sheath around the nerves in people with multiple sclerosis.
Multiple sclerosis
A disabling neurological condition affecting 85,000 mostly young adults in the UK. The cause is unknown and there is no cure. The immune system is wrongly triggered to attack the protective myelin layer around nerves that send messages to the brain. Movement becomes progressively more difficult. Some people have flare-ups followed by periods of recovery ( relapsing remitting MS) and some deteriorate steadily (progressive).
Cord blood
Umbilical cord blood contains stem cells. They are not thought to have the same potential as embryonic stem cells but they have been successfully transplanted into patients with blood diseases, such as leukaemia, thalassaemia and sickle cell disease. Cord blood is an alternative to a bone marrow transplant. A very close match is needed between patient and donor, however, which is why some parents with sick children want to have babies through test-tube fertility techniques, to select a perfect match sibling.
mRNA
Stands for messenger RNA, one form of ribonucleic acid, a chemical similar in structure to DNA. It transmits genetic information from DNA to proteins.
Source: Guardian Unlimited © Guardian Newspapers Limited 2006