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Stem Cell Rogues Hide Out in South Africa
With the help of high-priced lawyers and legal bureaucracy, an
American couple wanted by the FBI for selling unapproved stem cell
treatments are hiding out in South Africa.
The couple, Laura Vanessa Brown and Steven van Rooyen, face a 51
charges of alleged fraud and the distribution of unapproved drugs.
But by the time the indictment was issued in March 2006, they'd
already fled South Africa. Disagreement over the validity of the
nation's extradition treaty has kept the U.S. from bringing them back.
Before leaving the U.S., the couple formed BioMark International and
later Advanced Cell Therapeutics, companies that offered doctors an
intravenously injected concoction of umbilical cord stem cells. Their
patients, who paid $26,000 for treatment, were those with desperate
and incurable medical conditions: multiple sclerosis, Lou Gehrig's
disease, Parkinson's disease and spinal cord injuries.
The couple say the Bush administration and neurologists have
persecuted them for political or profit-driven reasons, and claim
that 80 percent of some 800 patients improved. Some stem cell
recipients have indeed told tales of unexpected recovery. Others have
not been so fortunate; one died shortly after receiving the
injections, and a former employee says that patients "would call in
all the time saying, 'I can't use my hands, I have a high fever, my
doctor doesn't know what it's from.'"
What does it all mean? There's no easy lesson, but the couple are
expected to open a clinic in the Seychelle islands, far from U.S. and
South African law -- and as stem cell therapies become more
sophisticated and more contentious, with patients as desperate as
ever to get them, situations like this will probably become more
common.
Source: Alleged U.S. Stem Cell Fraudsters Shielded by South African
Legal Logjam [ABC News]
Cancer In Exchange For Multiple Sclerosis
BRUSSELS — A private homeopathic clinic in Antwerp has been using
stem cells to treat patients with multiple sclerosis and other
illnesses, BBC reports.
The use of stem cells, proved to cause cancer, is forbidden in
Belgium. Antwerp Prosecutor's Office have launched an investigation.
Piet Vanthemsche, the head of the Fedreal Health Products Agency,
visited the clinic yesterday and said he would keep the prosecutors
updated. According to his information, the clinic had indeed broken
the law.
The stem cells used in Antwerp came from Rotterdam. The PMC clinic in
Rotterdam, headed by Dr. Robert Trossel, had continued their
experiments with stem cells, recently outlawed in Holland, by
transferring them to Antwerp. Twice a week, PMC `s Dr. Aanan took the
train the Antwerp carrying his laptop and two containers with stem
cells.
The Antwerp clinic had been using stem cells since November 2006. The
treatment cost 12,000 euros and involved up to three stem cell
injections.
Dr. Trossel would not comment on the subject.
Source: Expatica News Copyright Expatica News 2007
To watch the BBC Newsnight Report please click here
We're shattered by shutdown of 'MS Cure' clinic
EXCLUSIVE: PATIENTS' HOPES ARE DASHED
A controversial clinic which offered hopes of a "miracle cure" for
multiple sclerosis has been shut down.
The PMC Clinic in Holland was closed after allegations were made that
stem cells used in its treatments were not intended for human use.
Scots who had been pinning their hopes on the clinic have been left
devastated.
MS patient Tom Forrester had been saving to pay for treatment at PMC.
He tried to kill himself when he found out it had closed.
Tom, 54, of Kirkcaldy, Fife, said: "I had had enough.
"I went to bed on a Saturday night and took 70 painkillers.
Tom was found by carers the following day and spent 10 days in
hospital recovering.
The clinic is run by Advanced Cell Therapeutics (ACT).
The Dutch government closed the clinic after ACT were accused of
buying stem cells intended for research and using them to treat
people instead. It has also been claimed that some of the cells used
came from animals.
Many MS patients paid thousands of pounds for stem cell treatment at
the clinic after claims that their symptoms could dramatically
improve or even disappear.
Such treatment is banned in Britain because doctors are not convinced
about how safe or effective it is.
MS patient Amanda Bryson, 20, of Inverness, handed over £12,000 to
the clinic in November last year.
After the treatment, she was able to walk again for the first time in
a year.
But within months, her symptoms had returned and she was immobilised.
Despite Amanda's experience, many MS patients were counting on the
clinic as their only hope of living a normal life.
Margaret Byrne had been on the clinic's waiting list for treatment.
She has been wheelchair-bound since 2003. Margaret, 51, of Buckhaven,
Fife, said: "I thought I would be walking at Christmas. Now I have
nothing to look forward to. I'm devastated."
Between them, Margaret and Tom had raised £14,000 for treatment.
Margaret said: "When the money came in, I thought, great, I'm getting
another chance at life.
"We were signing our lives over to the clinic, believing their
treatment was legitimate."
The Multiple Sclerosis Trust said there are no other clinics in
Europe offering stem cell treatment.
Chief executive Chris Jones said: "We are excited by legitimate
research into stem cell treatment. But there's an awful lot of work
needed before we can talk about delivering stem cell treatment in a
safe, licensed environment.
Storeman Phil Cuthbertson was due to have treatment at the clinic
this month after Daily Record readers donated cash.
He has Lebers, a rare genetic condition which has left him blind.
He hoped stem cell therapy would restore his eyesight.
Now he has had to start the process again at another clinic in
Holland and faces a three-month wait for treatment.
Phil, 24, of Paisley, said: "I'd been so looking forward to seeing my
family opening presents at Christmas."
Phil hopes to have his sight back in time to be best man to his dad
Ian, 53, in 10 weeks.
His own wedding is in August, when he will tie the knot with Yvette
Bruce, 23.
Phil said: "I'm looking forward to enjoying two big weddings when,
hopefully, I'll be able to see."
'I thought I would be walking by Christmas. I'm devastated'
Source: The Daily Record Copywrite 2006 (15/12/06)
Dutch Health Care Inspectorate orders PMC of Rotterdam to stop Stem
Cell Treatment
The Netherlands Health Care Inspectorate has ordered the Preventief
Medisch Centrum (PMC) of Rotterdam to stop performing treatments with
stem cells as from today. The Inspectorate concluded that the PMC is
not providing responsible care, because it is unable to demonstrate
the origin, suitability and safety of the stem cells it uses. This
situation jeopardises the health and safety of patients. Among other
things, it exposes patients to the risk of infection with HIV or
Creutzfeldt-
tumours or rejection reactions.
Last Friday, the Inspectorate received a notification from the
Havenziekenhuis hospital in Rotterdam about a patient who had to be
admitted with serious complications following stem cell treatment at
the PMC. The patient had a serious acute allergic reaction after the
administering of stem cells. After being treated with anti-allergy
medication at the hospital, the patient was allowed to return home.
Under the Care Institutions (Quality) Act, the PMC is required to
provide responsible care. This means care of a good level that is
efficient, effective and suitable for the patient. In the case of
stem cell treatment, the PMC is obliged to demonstrate through
documentation the safety of the entire stem cell supply chain from
donor to recipient. To date, the PMC has been unable to present any
documentation to the Inspectorate concerning the origin, the
suitability for the intended application and the safety of the
products that are used.
The order took effect at 17:00 hrs today and will remain in place for
one week. The Inspectorate will ask the Minister of Health, Welfare
and Sport to renew the order after seven days. The Inspectorate is
further considering bringing disciplinary charges against the
physicians who work at the PMC.
Source: The Netherlands Health Care Inspectorate (02/10/06)
Treatment blow for MS patient Alison
Multiple Sclerosis patient Alison Atkinson has had her stem cell
treatment postponed – days after the screening of a shock TV report.
Alison Atkinson hoped the stem cell injection by Advanced Cell
Therapeutics in Rotterdam on Tuesday, September 26, would change her
life.
But ACT has told her it has temporarily suspended commercial
treatments to engage in clinical trials – following a report on BBC's
Newsnight programme which claimed ACT's treatments were using cells
not fit for use in humans.
ACT says it has started libel proceedings against the BBC and All Out
Productions, who made the programme. The company refused to comment
beyond that.
Alison (48 has raised the £13,500 treatment fee with help from
friends and an appeal launched in the Lincolnshire Free Press in
February.
Alison, of Thary Lane, Surfleet, said: "I am absolutely gutted. But
if it is going to be an improvement in treatment then that is fine. I
have got to wait and see.
"I think that stem cells are the way forward, not just for MS but for
a lot of illnesses."
Alison was among an increasing number of MS patients hoping to
improve their quality of life by having an injection of cells taken
from the blood of donated umbilical cords.
On Thursday she received an e-mail from ACT which states: "ACT will
be engaging in clinical trials for governmental approval over the
next two to three months.
"ACT has decided that it would be in the company's best interests to
temporarily suspend commercial treatments."
The e-mail says clients such as Alison who have already paid for
treatment will be refunded and appealed for people to take part in
clinical trials.
Alison has put her name forward.
Source: Spalding Today All rights reserved © 2006 Johnston Press
Digital Publishing.
BBC Newsnight Programme - The Sale of False Stem Cell Treatments.
29th August 2006 - BBC Newsnight Programme - The Sale of False Stem
Cell Treatments.
You can view the whole programme by clicking here.
Transcript and story below:
Stem cell treatment warning
A company operating out of South Africa is charging tens of thousands
of pounds for stem cell treatments, using cells that should not be
injected into people, putting the lives of their vulnerable and
chronically ill patients at risk, BBC TWO's Newsnight programme has
uncovered
The company, called Advanced Cell Therapeutics (ACT), has been buying
cord blood stem cells from California, storing them in the UK as a
staging post, then shipping them to clinics in Europe and Africa
where doctors inject them into their patients.
ACT claims the cells have a beneficial effect for a host of diseases
and conditions from spinal cord injury, lung cancer, deafness and
HIV/AIDS. But the majority of their patients come from the UK,
seeking help for multiple sclerosis.
Biomark
Newsnight has spoken to former ACT employees, and established that
the two individuals behind the company, Stephen Van Rooyen and Laura
Brown, are the same people being pursued by the FBI for an alleged
fraudulent stem cell business in the United States, run via a company
called Biomark. The pair are living in South Africa, operating under
various aliases, and face an extradition hearing by US authorities on
5 September, 2006.
At a clinic in Rotterdam, run by a doctor called Robert Trossel, who
administers stem cells on behalf of ACT, Newsnight filmed a vial of
cord blood stem cells about to be injected into a two-year old boy.
His mother had travelled from Australia under the impression that the
treatment might ease the severe after-effects of a meningitis
infection in her son, Ethan Regan. The vial was labelled AllCells - a
company based in California.
Legal action
The general manager of AllCells, Jay Tong, told Newsnight he was
shocked that his cells were being injected into people. He made
clear, as does the company's website, that the cells are intended
only for research purposes. They are not guaranteed free from
bacterial and viral contamination to the standard that would allow
them to be used even in animal models, let alone people. He
asked "has anyone died?"
When we put our findings to Dr Trossel, he said: "When confronted
with the evidence yesterday, ACT admitted incorrect product delivery
on this occasion. We are taking legal action against them and have
cancelled all ACT patients until further notice."
Potential health risks
In Cape Town, Newsnight interviewed two former ACT employees, and
spoke to Dr Catherine Orridge, who was the medical director of ACT
until she became suspicious of the source of the stem cells and found
out for herself where they were coming from.
Like Newsnight, she saw the AllCells name on a vial, contacted the
company and was devastated to discover that the cells should be used
for research purposes only. She is anxious about potential health
risks to patients posed by the cells because they contain animal
protein. Patients are not told this, so are put at risk of an
allergic reaction - including anaphylactic shock, which can be fatal,
she says.
Stem cell scientists see enormous potential benefit for medicine from
stem cells in the future. But they say it is simply a false hope to
use cord blood stem cells in the vast majority of the range of
conditions ACT claims.
Professor Colin Blakemore, chief executive of the Medical Research
Council told Newsnight:
"I'm shocked. I am taking what you tell me as true, and my first
concern is for the patients, very vulnerable, obviously desperate for
treatments and that desperation is being exploited by charlatans it
seems to me."
UK role
Newsnight has also uncovered that the UK has been performing a vital
role in ACT's business. A company called CryoStore was holding the
frozen stem cells in its Greenwich warehouse.
CryoStore's manager, Malcolm Wilkinson, said in a statement:
"We were advised by ACT that the material was for research purposes.
We were not aware of what form this research took."
He said he was seeking advice from the UK's Human Tissue Authority
(HTA). When we informed him of the FBI's interest in the individuals
behind ACT (known to him as Biomark) he told us he had severed his
links with them. He sent ACT's stem cells to another storage facility
in the UK and informed the HTA. When we told him our findings he
confirmed that that all the material he had held for ACT was from
AllCells...
The stem cells are now being stored at Thermo Electron Biorepository
Services in Hertfordshire, who say they will probably not continue to
store them. They are waiting for written confirmation of what the
company in South Africa they've been dealing with, BioCell, has told
them verbally - namely that the material is for research purposes
only.
"We wouldn't want to condone any unethical treatment," head of
operations Robert Jones told us. "Injecting into people would be a
clinical purpose, not research."
The HTA said it's done everything it can within the limits of current
legislation to advise them about the wisdom of storing cells if they
know they are intended for use in people when they are not fit for
that purpose.
Consent form
Newsnight has spoken to Stephen Van Rooyen, who has so far declined
our offer of an interview on camera and has not confirmed or denied
that ACT's stem cells come from AllCells.
He has pointed out that ACT's patients sign a consent form in which
they are told about the risk of an allergic reaction. But that form
does not mention animal protein.
When we asked him if his cells come from AllCells, Mr Van Rooyen
said:
"I'm sure you understand where I'm coming from here. This is a highly
sensitive business, the number of companies around the world that
have the technology to produce this kind of cell is very limited and
by us going out on the BBC and explaining where our source is is
equivalent to commercial suicide. Every single company, individual,
doctor, would then be able to go directly to the source."
"In terms of patients having an issue with the safety of the cells
and their origin. The most important thing there is that the cells
are supported with a certificate of analysis provided to the doctors.
The doctors review that. We have a five year track record with not a
single negative side effect and the vast majority of people having
benefited. That surely matters more than anything. We're not talking
about people with minor conditions. We're talking about people who
have been sent home to die."
Newsnight contacted Ethan Regan's mother, Sybil, and told her about
the origin of the stem cells used in her son's £13,000 injection. She
said she was:
"Really disappointed, deceived, duped. What can I say? There are a
lot of colourful words I can use but I am not going to. I am really
disappointed if the allegations I have heard are true, then it's not
fair... the financial perspective doesn't concern me but from a
health point of view for Ethan it really does."
Susan Watts' report was shown on Newsnight on Tuesday, 29 August,
2006.
Source: BBC NewsNight online Copywrite BBC 2006
Patients warned over dangers of untested stem-cell wonder cures
Patients warned over dangers of untested stem-cell wonder cures
Patients with crippling diseases such as multiple sclerosis should
beware of expensive stem-cell "wonder cures" that have never been
properly tested, leading medical research groups say today.
While stem cells offer great promise for treating many disorders,
extravagant claims made for therapies costing more than £10,000 a
time do not stand up to scientific scrutiny, they say.
In a letter to The Times, 14 medical charities and research funders
warn patients that there is no evidence to support the benefits
attributed to unorthodox stem-cell treatments, which could carry a
risk of infection, immune system rejection and even cancer.
Premature use of stem cells to treat disease, before safety and
effectiveness have been evaluated in clinical trials, also threatens
to set back mainstream research that promises genuinely better
therapies, they say. The signatories include Professor Colin
Blakemore, chief executive of the Medical Research Council, Lord
Patel, of the UK Stem Cell Bank, and the heads of the MS Society, the
Parkinson's Disease Society, the Juvenile Diabetes Research
Foundation and the Alzheimer's Society.
Stem cells have the capacity to form a wide variety of tissue types,
and could be used to replace cells and organs that are damaged or
destroyed in conditions such as MS, diabetes and Parkinson's disease.
The most powerful are found in embryos, but other less malleable
types can also be extracted from the adult body and from umbilical
cord blood.
Only a handful of treatments based on adult and cord blood stem cells
have been licensed in the UK, principally for treating leukaemia and
eye and skin disorders. But some foreign clinics offer stem-cell
injections for other conditions, chiefly MS, and for cosmetic
surgery.
Several dozen British MS patients have travelled to a centre in the
Netherlands to receive cord blood stem cells from a Swiss company
called Advanced Cell Therapeutics (ACT) at a cost of up to £13,500.
The Dutch clinic is one of two under investigation by the
authorities. The ACT procedure was banned in the Irish Republic this
year, prompting the company to consider offering it in international
waters on the Swansea to Cork ferry.
While some patients have claimed dramatic improvements and provided
glowing testimonials, no scientific evidence has been published
showing that the treatment works.
Most mainstream researchers are sceptical that the grafts perform as
they are purported to, and ascribe apparent benefits to a short-lived
placebo effect.
Scientists are concerned that desperate patients are being
exploited. "We advise those who are desperate for cures or attracted
to cosmetic surgery to be wary of claims being made by clinics
offering these treatments," the letter says.
An accidental death from a treatment that has not been adequately
assessed for safety could also turn public opinion against more
carefully regulated stem-cell research. "We worry that those cutting
corners risk discrediting the field as well as betraying patients,"
the letter says.
Professor Blakemore said that the potential of stem cells would best
be realised by cautious progress and rigorous clinical trials. "This
is a delicately poised field of research, with a difficult ethical
background. Just one application of maverick stem-cell science that
leads to cancer could set back the legitimate field by years, if not
decades."
Professor Robin Lovell-Badge, a stem-cell expert of the National
Institute for Medical Research, said that there was preliminary
evidence that cord blood stem cells could form other kinds of cell,
but these did not appear to have a long-term therapeutic effect. It
was also hard to see how injecting them could ensure they reached the
parts of the body where they were needed.
RISKS ATTACHED TO TREATMENT
Stem cells are precursor cells that grow into other specialised kinds
of tissue
Those from human embryos are the most malleable and can form any body
tissue. Less powerful versions are found in adults' and umbilical
cord blood
Stem cells of all three types have potential for growing "spare part"
tissue to treat conditions such as Parkinson's, diabetes, MS and
spinal injury
Cord blood and bone marrow stem cells are licensed in Britain to
treat leukaemia. Bone marrow is destroyed and replaced with donated
stem cells
Stem-cell therapies have been licensed for use in skin and cornea
grafts
Several foreign clinics offer cord blood stem-cell injections for
treating MS and for cosmetic surgery
There are anecdotal reports of success, but no published clinical
trials showing either safety or effectiveness
Treatment typically costs £10,000 to £13,500 for one injection of
about a million stem cells. They are injected into the blood or under
skin, not into organs
Stem-cell therapy has three main risks. The cells have the potential
to cause cancers, they can introduce infection, and they can be
rejected by the body's immune system
Source: The Times Online Copyright 2006 Times Newspapers Ltd.
Couple in court for 'miracle stem-cell cures'
Biomark two finally in court.
They allegedly raked in millions of rands by offering terminally ill
and paralysed patients miracle cures.
On Thursday, Stephen van Rooyen and his American girlfriend Laura
Brown were involved in a bid in the Kempton Park magistrate's court
to stave off an extradition order requested by US Secretary of State
Condoleezza Rice.
The couple have been on the run from the FBI for allegedly running an
international stem cell scam. Van Rooyen, 44, and Brown, 35, of the
upmarket Cape Town suburb of Llandudno, allegedly offered the fake
medicine to terminally ill and paralysed patients across the US and
Europe.
They made their second appearance on Thursday after their arrest by
Interpol at Johannesburg International Airport in June as they
returned from Seychelles. They are out on R100 000 bail each.
The hearing got off to a shaky start for the state on Thursday
because of the lack of original extradition papers.
According to a treaty signed by South Africa and the US, the papers
must be handed in within 60 days of a person's arrest. Thursday was
day 61.
However, senior state advocate Beverly Edwards argued that the US
government had hand-delivered the extradition papers to the
Department of Foreign Affairs on August 1 and that while she did not
have an original copy, she had been sent an electronic one.
She said she would be able to have the original document by next week
and requested a postponement.
But the couple's high-powered defence team, led by advocate Willie
Vermeulen SC, was having none of it.
Vermeulen argued that the onus was on the state to produce the papers
timeously.
He told magistrate Steven Holzen that because the state did not have
the original extradition papers, he should dismiss the matter.
"The effect of this delay in the interest of fairness and balance...
would have a dire effect on my clients. If the state is granted a
postponement, the postponement would merely be a prelude to
incarcerating my clients. Where is the evidence (original extradition
paper)? What is the reason for the delay? It should have been
produced a long time ago. The extradition party had more than enough
time," he said.
In response, Edwards argued that the absence of the papers was not
the fault of the state, and was an administrative delay.
She said the original papers were in the possession of the Department
of Foreign Affairs, which was supposed to hand them to the Department
of Justice, which then sends them to the Directorate of Public
Prosecution before it landed on her desk.
"It is somewhere in this chain. The US is absolutely bona fide. The
papers were signed by Condoleezza Rice on July 17. We are well within
our 60 days. They were correctly and timeously handed in," she said.
The hearing, which was taking place in court E, had to move to the
civil court next door because the prosecutors and magistrates needed
the room for an isiZulu lesson.
During this adjournment, Edwards received a phone call to say that
the original extradition papers had arrived at the National
Prosecuting Authority's offices in Pretoria.
"I have just spoken to a person named Dolly - I don't have a surname -
who has said that the documents have arrived," Edwards told the
court.
After a brief argument on whether to postpone the hearing to next
week, the magistrate decided to postpone the matter until Friday.
A lengthy international investigation by US authorities against the
couple culminated in a 51-count indictment handed down by a federal
grand jury in Atlanta in March this year.
Van Rooyen and Brown were accused of distributing untested stem cell
treatment drugs "without any basis in science".
The couple had allegedly been paid thousands of dollars by
individuals suffering with motor neuron disease, multiple sclerosis,
and other serious and incurable diseases.
Source: IOL © 2006 Independent Online. All rights strictly reserved.
Clinic peddles false hope of cure
People with life-threatening illnesses are being swindled out of
thousands of pounds by a UK company making offering them false hope,
says an expert. Advanced Cell Therapeutics says it can treat people
using stem cells taken from umbilical cords.
But stem cell expert Dr Stephen Minger told the BBC there was no way
the treatments could work.
Sarah Smith finds it harder on her eyes to use the internet.
Her eyesight is getting worse because of her MS. Two years ago she
learned about a company called Advanced Cell Therapeutics on the
internet where she read glowing testimonies from other customers.
She was so convinced about unfounded claims that eight out of ten
customers saw their conditions improve after being injected with stem
cells from umbilical cords, that she paid 9,000 euros to be treated.
She had to travel to their Rotterdam clinic because such injections
would not be legal in the UK.
Placebo effect
"I had it done in June and about September time I felt that I might
be getting better but in hindsight I think it was the placebo effect.
"I think if you have got the money and it's not going to have a
massive change to your life to use that money then go for it, try it
but I certainly would not recommend people going into debt for this."
But for Sarah - and many others we have spoken to - the treatment
just did not work.
Stem cells are our bodies' remarkable own repair kit, able to develop
themselves into other cells within the body.
But one of the country's leading stem cell experts, Dr Stephen Minger
of King's College and Guy's Hospital, has told us there is no
plausible way ACT's treatment would work.
Dr Stephen Minger said: "This is trafficking in tissues. We take
tissues very seriously after Alder Hey, so the idea that this is
going on and that this completely unregulated and underground therapy
is going on I find disturbing.
"I like to think that people can come and regulate this on an
international level."
No medical background
ACT was set up by the one of the founders of a company called Biomark
in the US.
This untested treatment was the brainchild of Laura Brown, a media
student and former catwalk model from North Carolina and her
boyfriend, Steve Van Rooyen, a South African businessman.
And despite no medical background or qualifications they moved to
Atlanta and set up Biomark.
They bought the stem cells from labs around North America.
Then, through a network of compliant medical professionals and
clinics plus a webpage of flawed and plagiarised testimonies from
real experts, they lured sufferers of illnesses like Parkinson's and
multiple sclerosis into paying thousands of dollars for treatment,
which some of the world's foremost scientists have described as
ineffective and possibly dangerous.
Brown and Van Rooyen by this point were making hundreds and thousands
of pounds from their flawed "miracle treatment".
Chat rooms and blogs were feverishly alive with the news that Biomark
could be the answer to the prayers of sufferers across the US, but
back in rural Pennsylvania their claims were to be challenged for the
first time.
Nerve deterioration
Nelson Lauver's radio show is syndicated across the US.
He is "The American Storyteller"
lives.
There was nothing ordinary about the story he had to tell, though.
Nelson's brother Craig developed an incurable deterioration of the
nervous system, called ALS.
After Craig found out he had the illness, it was a familiar pattern:
hours spent on the internet, hopes raised by the dozens of quack
remedies on offer only for them to come crashing down when the
treatment did not work.
Craig clicked onto the Biomark site to be seduced by the bold but
unfounded claims and the testimonies taken out of context, as Brown
and Van Rooyen intended. It was just too good to miss.
Craig was told that he to would have to fly to Canada for treatment.
As it turned out, he was never well enough to do so.
Home visit
Nelson persuaded someone calling herself Dr Diana Krause from Biomark
to turn up at the family home.
But it was not just Craig who was waiting for them. The vase in the
corner did not hold just a bunch of flowers and the radio did more
than just play out Craig's favourite music.
The room was swarming with electronic bugs.
The family, suspicious of Brown, had contacted the FDA who had the
room covered with secret cameras and microphones while agents lay in
wait next door.
Nelson Lauver said: "The night before Dr Kraus turned up, I rang
Laura Brown and said, 'Hi, I'm Craig's brother and I really want to
thank you for this good work and for helping us.'
"She went on about people throwing their wheelchairs away and people
who couldn't walk running up and down the steps. It was obvious that
this was a scam."
Allowed to go free
The FDA had wired $10,000 from a bogus trucking company they had set
up into Nelson's account to pay Biomark using the evidence they had
gathered in the sting in Craig Lauver's house.
They then raided Biomark's office.
Although they seized assets of around $250,000, crucially and
strangely Laura Brown was allowed to go free.
Brown's whereabouts after the FDA let her go were a mystery, not
least to the FBI who in March placed both her and Van Rooyen on their
wanted list, issuing a 51-count indictment against them.
Randy Chartash is the FBI's Assistant Attorney in Atlanta, at the
courthouse downtown.
In the first interview the FBI have done about Biomark, Mr Chartash
told me just how serious these charges against Brown and Van Rooyen
are, with the couple facing a very long jail sentence if found
guilty.
"The indictment alleges that they made misrepresentations to people
about the effectiveness of the stem cell therapy they were offering.
"This type of fraud is especially harmful as it victimises people in
the most vulnerable situations and individuals who are suffering or
have loved ones who are suffering from an incurable disease.
"They were preying on people at their most vulnerable point."
Stunnning home
It is many months since they were last seen at their apartment, but
we have tracked Stephen Van Rooyen down to where he now lives in his
native South Africa.
His spacious house perches on top of dramatic cliffs, overlooking the
idyllic white sanded beach. This is the area of Cape Town where the
beautiful people live.
Van Rooyen has never responded to our letters or emails and no one
answered when we knocked on the door.
Like the FBI, we also want to talk to Laura Brown.
She has failed to respond to any of our approaches and we have good
reason to think she may be in Pakistan. As a consequence of the FDA
letting her slip through their fingers, she was free to set up her
fraudulent scheme again, which alarmingly she did here in the UK.
London clinic
But their brand of untested treatment is still being peddled through
a London clinic for ACT which sends customers abroad for treatment.
Sarah Smith received her treatment from one doctor, Robert Trossell.
"With all new developments in medicine there are always new groups
who are not used to the new concept and they cry like this is
impossible.
"They said this of penicillin, insulin and life cell therapy. In the
meantime everyone is studying stem cells because everyone knows it is
the future."
The Dutch authorities have told us they are investigating the
legality of ACT's clinic.
Another centre in Cork is also being investigated by the Irish
Medicine Board.
Benefits
One customer we have spoken to who claims real benefit from the
treatment is Jan Wilks from Liverpool.
The 45-year-old MS patient claims her condition has improved and she
is now able to get about the house without the wheelchair she has
relied on.
Scientists are convinced stem cells will eventually be a treatment
for previously incurable diseases. Indeed a proper clinical trial on
MS patients begins very soon in Canada.
But anything like a miracle advance is, they say, still many years
away.
The Stem Cell Swindle will be broadcast on Tuesday, 16 May, 2006 at
8pm on BBC Radio 4.
Source: BBC News Copywrite BBC 2006
Radio 4 - The Stem Cell Swindle.
Radio 4 - The Stem Cell Swindle.
"The Stem Cell Swindle"
Tuesday 16 May 2006 20:00-20:40 (Radio 4 FM)
Repeated: Sunday 21 May 2006 17:00-17:40 (Radio 4 FM)
Award-winning medical journalist Matthew Hill investigates the people
and the companies offering stem cell treatment. He hears from
patients who have risked thousands of pounds on the slim chance that
stem cells will cure them. Matthew also asks how companies are able
to offer this untested and costly treatment in Britain.
www.bbc.co.uk/
Doctor calls for an urgent legal review of the rules governing
international waters
03/05/06
A LEADING doctor has called for an urgent legal review of the rules
governing international waters after a company offered to provide
unlicensed stem cell jabs on board a Welsh ferry.
Dr Dai Lloyd, a Swansea GP and AM for South Wales West, said he
feared other private companies could seek to circumvent strict rules
governing the use of medicines by offering them on makeshift clinics
in the middle of the ocean.
His comments come after it emerged a Swiss-based firm had told its
clients it would provide injections of stem cells - a new but
unproven treatment for Multiple Sclerosis - on the Swansea-Cork ferry
after a doctor in Ireland was forced to stop offering such
treatments.
The controversial treatment, which many believe could be a miracle
cure for MS, is illegal in the UK and has been suspended in Ireland,
following an investigation by the Irish Medicines Board.
Swansea Cork Ferries, which operates the overnight crossing, said
yesterday it would not allow any medical procedures to be carried out
on board its ships under any circumstances.
It is understood the plan by Advanced Cell Therapeutics (ACT) to use
the sanctity of international waters to administer the injections,
has now been abandoned.
But Dr Lloyd, a Plaid Cymru AM, said, "This therapy is illegal in the
UK and Ireland so it is vitally important that we know what happens
in international waters, beyond the jurisdiction of the UK and
Ireland.
"It would appear this private pharmaceutical enterprise is riding
roughshod over how we licence and make treatments available.
"We know there is a lot of concern about MS but this treatment is
being pushed as a miracle cure without the recognised evidence base
to back it up.
"If that evidence base was available then presumedly it would be
legal in the UK and Ireland and the company would not have to resort
to such desperate measures. We need a review of the use of stem cells
in MS and a legal review of what can be done in international waters
as a matter of urgency."
The controversial stem cell treatment, which comes from umbilical
cord blood, costs £12,000 a time and is claimed to repair the spinal
damage caused by MS. But many experts are sceptical about the claims,
which they say have not been backed up by any trials in the UK.
Dr Richard Lewis, Welsh secretary of the British Medical Association,
said, "The BMA cautions both doctors and patients about participating
in the provision of care in conditions that are not appropriate for
serious medical treatment.
"Innovative procedures in particular must not only be subject to
close scrutiny and regulation but should only attempted after
appropriate trials and in clinical settings which minimise all risks
for patients."
A spokesman for Swansea Cork Ferries last night said, "Swansea Cork
Ferries Ltd was astonished to learn that a company was proposing to
offer stem cell treatment on board its ship, mv Superferry, while the
ship was in international waters.
"The promotion of the treatment which is prohibited under EU law was
done without any reference to Swansea Cork Ferries.
"On learning of the proposal, Swansea Cork Ferries contacted the
promoters of the treatment and categorically informed them that such
treatment was absolutely prohibited on board the vessel.
"The captain and crew captain of mv Superferry have been informed of
the company's position and have been instructed to prevent the
treatments from taking place should attempts be made to undertake
them.
"It is wholly inappropriate that non-emergency medical treatments
take place on board passenger ferries and we are appalled that our
company was connected in any way with this treatment offer."
Source: icWales copywrite owned by or licensed to Trinity Mirror Plc
2006
Stem cell firm uses Swansea ferry to evade Irish block on
controversial treatment
01/05/06
Hundreds of UK patients book £12,000 injections
Irish Medicines Board acts to stop treatment in Cork
A company offering controversial "stem cell" injections to hundreds
of people from the UK with multiple sclerosis and other neurological
diseases is planning to get around a ban on treatment in Ireland by
carrying it out in international waters on an overnight ferry.
Advanced Cell Therapeutics (ACT), which has an address in Geneva and
a London telephone number, has been supplying stem cells from
umbilical cord blood to 12 clinics around the world, of which two are
in the Netherlands and one in Spain. Demand from the UK - where the
treatment is illegal - has been huge, following tabloid newspaper
stories about apparent remarkable recoveries and an interview with a
clinic doctor on television's Richard and Judy programme.
Scientists, however, dismiss ACT's claims, saying that nobody has yet
been able to trick stem cells into repairing the spinal nerve damage
that causes MS.
The Guardian recently revealed that ACT has taken over the business
of a US company called Biomark International, which closed in 2003
during an investigation by the drugs regulatory agency. Biomark's
founders now face a 51-count indictment for allegedly obtaining
thousands of dollars by making fraudulent claims about the
effectiveness of their treatments.
The Irish Medicines Board has now acted to stop the treatments,
costing up to £12,000, that have recently begun at the Cork Road
Medical Centre in Carrigaline, which had 400 patients from the UK
booked for the coming weeks. In a statement the board confirmed "that
it is aware of the stem cell therapy being conducted in the Cork
region ... [It is] conducting an investigation into this practice."
But the Guardian has learned that ACT plans to continue treating
patients from the UK this week by booking them on to the Cork to
Swansea ferry which will take them into international waters, outside
Irish jurisdiction. "ACT is offering a convenient alternative, which
involves an examination and preliminary consultation at the Cork
clinic on the scheduled day of your treatment," it wrote to booked
patients. "Administration of stem cell therapy will take place in
international waters aboard the ferry. The cost of the return ferry
and one night's accommodation will be covered by ACT."
Investigation
It goes on to say that the ferry "is fully handicap accessible and
has an array of entertainment on board". It also offers the
alternative of treatment in the Rotterdam clinic where most patients
from the UK have to date gone for their injections.
The doctor who runs the Cork clinic, John Dunphy, is being
investigated by the Irish Medical Council - the doctors' disciplinary
body which is the equivalent of the General Medical Council in the
UK. Speaking to the Guardian, he said this was routine. "When there
is any controversy like this, you usually will be called before
them," he said. He denied that he would be treating patients on the
ferry, but added: "You will have to speak to ACT. I'm merely
facilitating ACT. We are looking for any legal way to treat them."
ACT declined to answer the Guardian's questions.
Dr Dunphy said he became involved because his sister has multiple
sclerosis and wanted stem cell treatment, but was faced with a long
waiting list for the procedure at the Rotterdam clinic. Asked what
scientific evidence he had that the treatment worked, he was unable
to give specifics, but said: "Obviously I wouldn't be using it if I
thought there wasn't any."
The Rotterdam clinic, run by Dr Robert Trossel who is based in London
and carries out initial consultations in Harley Street, is also under
investigation by the Dutch authorities, the Guardian has learned. The
Dutch healthcare inspectorate is concerned that the clinic has not
submitted any proposals for its experimental work on humans to ethics
committees.
"We are doing this because we have had complaints from Dutch
neurologists about the way the doctors are treating the patients,"
said Karen Donk of the inspectorate. The investigation is expected to
be concluded by the end of the summer, she said. It would include
inquiries into ACT, the supplier of the stem cells.
The clinic has been allowed to stay open during the investigation
because there have been no reports of anybody suffering harm, she
said.
In the UK, the Department of Health says that although the government
is putting £100m into stem cell research, the science is in its
infancy. "We would urge caution against seeking treatment or
procedures that have not been subjected to rigorous clinical trials
and assessment of safety and potential efficacy. Patients with
multiple sclerosis are advised to speak to their consultant about
their best treatment options," it said in a statement.
US indictment
The two founders of Biomark International, the US company which used
to supply clinics with stem cells and which shared members of its
advisory board and patient case histories with ACT, are now facing a
51-count indictment from a federal grand jury in Atlanta.
Stephen van Rooyen, 44, and Laura Brown, 35, are accused of
distributing untested stem cell treatment drugs "without any basis in
science". US state attorney David Nahmias said in statement that Mr
Van Rooyen and Ms Brown "provided false and misleading information"
about the effectiveness of stem cell treatment.
"This type of fraud victimises people in the most vulnerable
situation," said Mr Nahmias. "The allegations in this indictment are
serious and will be prosecuted vigorously."
The US department of justice said it would take steps to bring the
two to trial. Mr Van Rooyen has returned to his native Cape Town,
while Ms Brown is thought to be in England.
Source: Guardian Unlimited Guardian Unlimited © Guardian Newspapers
Limited 2006
Dr suspends his use of stem cell therapy as treatment
26/04/06
A DOCTOR who has used unlicensed stem cell therapy to treat multiple
sclerosis patients has claimed he has had to turn hundreds of
patients away because of new EU regulations.
Dr John Dunphy, who is under investigation by the Irish Medicines
Board (IMB) for providing the treatment at his clinic in Carrigaline,
Co Cork, said 400 patients, all from Britain, were due to be seen
over the next four weeks.
"All of them had paid for their flights and hotels, and now they must
all cancel. There is a major loss financially to people who can ill
afford it," he said.
Dr Dunphy had to suspend his use of stem cell therapy a treatment
which is not licensed by the Irish Medicines Board since the signing
into domestic law on April 7 of new EU regulations.
The GP, who used stem cells supplied by Swiss company Advanced Cell
Therapeutics, also claims he is the victim of an orchestrated
campaign by British neurosurgeons annoyed at losing patients to him.
In an interview in the Irish Medical Times, Dr Dunphy defended his
use of the therapy, used mainly to treat multiple sclerosis and
spinal injury.
He said all stem cells he used were:
Derived exclusively from umbilical cords (no right-to-life issues).
Donated by informed consent.
Tested for infectious diseases HIV1, HIV2, Hep B, Hepatitis C,
syphilis and CMV (herpes virus).
Traceable from donor to recipient.
Used to treat 80 different disease types, with clinical benefits
reported in over 80% of patients treated.
He said he had decided to speak out now to expose those conducting
what he called a campaign of vilification.
"I presume that senior neurologists in the UK were irritated that
their patients were coming to Paddyland for advanced therapy."
He said reports about exorbitant costs €30,000 were "total and
complete garbage", adding some patients were charged nothing and
others between £1,000 and £5,000 (roughly between €1,400 and €7,200).
Dr Dunphy said that by turning its back on stem cells Ireland was
wasting an opportunity.
"This is an extremely important field of medicine. If Ireland does
not get involved, we are going to lose out, both from a medical and
commercial point of view," said Dr Dunphy.
He added that he has applied to the IMB for a licence to administer
stem cell treatment under the new EU regulations.
A spokesperson for the IMB said an investigation into the use of stem
cell therapy is ongoing.
Source: The Irish Examiner © Irish Examiner, 2005, Thomas Crosbie
Media, TCH
Advanced Cell Therapeutics issues notice of postponement of treatment
at their Cork Clinic.
12/04/06
Advanced Cell Therapeutics today issued the following notice of
postponement of treatment at their Cork Clinic.
"We are pleased to announce that the Irish Medical Board has invited
ACT to comply with the new EU Directive (2004\27\EU) that was
transcribed into law on 7 April 2006 (governing all establishments
using tissue and cells products).
The ACT executive body has recommended that treatments at the Cork
facility be postponed for a short period pending our expedited
approval. This is necessary to enable the Cork clinic management and
the Irish government to comply fully with the new EU Directive."
It is understood that patients who were booked into the Cork clicnic
are being offered alternative arrangements at ACT's Rotterdam
Facility.
City man faces 51 charges in US over 'fake' Stem Cell Treatments
A Cape Town man and his former model girlfriend are facing a possible
20 years in a US prison for allegedly offering fake medicine to
terminally ill patients across the US and Europe.
In a 51-count indictment handed down by a federal grand jury in
Atlanta on March 28, Stephen van Rooyen, 44, and Laura Brown, 35, are
accused of distributing untested stem cell treatment drugs "without
any basis in science".
The couple had allegedly been paid "thousands of dollars by
individuals" suffering from multiple sclerosis and other incurable
diseases.
US State Attorney David Nahmias said in statement that Van Rooyen and
Brown "provided false and misleading information" about the
effectiveness of stem cell treatment.
The grand jury's decision to prosecute the couple followed an
intensive three-year probe by the FBI and Special Agents of the Food
and Drug Administration.
Charges against the duo include fraud and distributing unapproved and
misbranded drugs.
The US Department of Justice said they will announce steps later this
week in an effort to get the couple to stand trial.
Van Rooyen is believed to be in Cape Town while Brown is thought to
be living in England.
The couple had allegedly marketed their products online
internationally to desperate patients in several countries including
Switzerland, Holland, Germany, Spain, India, Trinidad, Argentina,
Brazil, Mexico, Turkey, Saudi Arabia, Pakistan, China and the
Ukraine.
Nahmias said the couple's alleged scam posed a grave threat to
patients' health. "This type of fraud is especially harmful because
it victimises people in the most vulnerable situation," Nahmias said.
"The allegations in this indictment are serious and will be
prosecuted vigorously."
The allegations against Van Rooyen and Brown date back to September
2002 when hopeful patients started flocking to clinics and paid
thousands of dollars for relief from the supposed miracle cure.
The couple had met in Los Angeles in the late 1990s.
In 2002 they joined an osteopath, Mitchell Chen, in his business in
Atlanta.
They learnt for the first time about stem cell treatment when Chen
told them about his interest in umbilical cord blood and stem cells.
After a few months, they broke away from Chen and formed a company,
Biomark, which soon fell foul with US authorities.
The couple left the US late in 2003 after authorities had raided
their offices in Miami.
But their operation appeared to have re-emerged under another name in
Europe.
Source: Cape Argus ©2006 Cape Argus & Independent Online (Pty) Ltd.
All rights reserved.
http://www.msrc.
fuseaction=show&
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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