http://www.dailymail.co.uk/pages/live/a ... _a_source=
Can goats' blood help beat MS? My mother is walking proof it can
By VICTORIA LAMBERT - More by this author »
Last updated at 11:08am on 19th June 2007
Trial: Jackie Llewellyn-Bowen with her husband Laurence
When her mother, Diana, began taking an unlicensed experimental drug made from
goats' blood for multiple sclerosis, you might imagine Jackie Llewellyn-Bowen
would have had a few nagging doubts.
But if she did, these were quickly allayed. 'Three weeks after she started
taking it, I went to my parents' home. My mother was standing in the hallway,'
says Jackie, wife of Laurence Llewellyn- Bowen.
'She beamed at me and said: "Look - no stick!" She wasn't using a frame,
hobbling or grabbing at furniture to find her balance. She had gone back to the
mobility she had the year before.'
All over the country, sufferers of MS and their families were hearing of Aimspro
and clamouring for it. Some were able to get hold of it, although no one has
ever established how many.
Yet, just three years later, its true value is being challenged by medical
experts and charities, many of whom are unable to speak publicly because they
are involved in complicated litigation with Daval International, the
pharmaceutical company behind the drug.
Most significantly, the MS Society has just revealed it is concerned that users
of Aimspro, a potential anti-inflammatory treatment, are spending their life
savings and placing too much faith in a drug that is untried and not properly
tested. As the drug has not been formally evaluated, it is impossible to judge
whether it works.
Moreover, the Society is raising concerns that the drug is being promoted in an
evangelical fashion by the charity Proventus (set up to lobby for wider access
to drugs such as Aimspro).
MS is a debilitating and incurable neurological condition - the result of damage
to the nervous system. Vital messages are not transmitted properly from the
brain to the body. There are 85,000 people diagnosed with it, with varying
degrees of severity.
There are four types of MS. Benign MS accounts for 20 per cent of cases and
causes a few mild attacks but no longterm symptoms. Relapsing remitting MS
causes sporadic attacks from which there are periods of total remission.
Secondary progressive MS often starts with these clear-cut attacks and
remissions, but over ten to 15 years becomes more disabling.
Finally, primary/progressive MS affects 12 per cent of sufferers and has a slow
onset, beginning with walking difficulties but progressing steadily.
Authorised treatments include betainterferon and Copaxone, disease-modifying
drugs, which some patients find reduces the likelihood of relapse by one-third.
A cannabis spray called Sativex recently became available to be prescribed on a
'named patient' basis: it is not licensed for general use but can be made
available for a specific patient or need.
Some sufferers find it alleviates the worst symptoms. But most find day-to-day
management of their condition a challenge. And for those with
primary/progressive MS, no drugs are available to help.
Aimspro is derived from purified serum extracted from the blood of goats, which
have been injected with dead, harmless HIV-infected cells created in the lab
rather than taken from humans. It is thought this creates antibodies, which
appear in the serum and can help reduce the inflammation likely to be at the
root of many major illnesses including MS.
The stories about its efficacy that first emerged seemed miraculous: men and
women were apparently throwing down their walking sticks and turning over their
Alan Osmond of Seventies pop fame tried it and abandoned his leg brace, saying:
'Almost immediately I could walk faster, better, quicker.'
A trial got under way at St George's, Tooting, a leading London hospital. GPs
sought ways to get their patients a free course from Daval. And patients
clamoured for a chance to try it, even if they had to pay for the £180-a-time,
twice-weekly injection privately.
Those who did get the drug couldn't wait to tell their stories: they were
feeling less pain, their eyesight improved, they had more energy, some found
physical sensations were renewed, others just felt better in themselves. Perhaps
this drug really was the breakthrough all had hoped for.
The Llewellyn-Bowens thought so. Diana had fallen ill three years previously,
aged 65. After suffering a slipped disc in her back, she had felt increasing
pain in her left leg which was causing her to limp.
She was diagnosed with primary/ progressive MS, which meant her condition was
likely to decline rapidly. Jackie discovered the trial at St George's and tried
to get her mother on it.
When told it was full, she found Dr David Maziels, a Kent GP, who agreed to
prescribe it as part of another trial group.
There was just one thing missing - the link that meant Aimspro could be assessed
by the National Institute for Clinical Excellence and become available to all: a
clinical peer-reviewed trial. Instead, the trial under way at St George's was
suddenly brought to a halt by Daval and without explanation.
A hospital spokesman said: 'A trial to establish the safety of a drug consisting
of HIV-inoculated goat serum on patients with secondary progressive MS was
stopped by Daval in March 2005, without consultation or investigation, after
nurses found a small number of treatments were defrosting too rapidly to be
given to patients.
'The trial was not endangered in any way, as back-up supplies of the drug were
given to the patients.
'The trial had been conducted according to an agreed clinical protocol and
without problems for nearly a year.
'We were surprised by the abrupt decision to withhold supplies of the drug based
on this one instance after so many months of work without discussing it with us
Daval has continued to supply the drug privately. Doctors are still able to
prescribe Aimspro because it is produced under a specials licence under the
Medicines and Healthcare products Regulatory Agency (MHRA).
It does not approve the medicine itself, but gives a licence to a pharmaceutical
site, its staff and approves its basic ingredients.
The responsibility for ordering the drug is then down to a GP who is comfortable
to prescribe it.
The MHRA is clearly not happy with the current situation. It has an ongoing
investigation into Daval for offences under the Medicines Act 1968, including
illegal sale, supply, manufacture and advertising of an unlicensed medicine.
The lack of a clinical trial is a concern for the MS Society. Dr Lee Dunster,
head of research for the Society, says: 'There have been no safety and efficacy
trials which runs against standard practice for a company that wants to bring a
therapeutic agent to market.
'We have been told that the company intends to get trials under way but there is
a huge difference between intention and action.'
Dr Dunster is not attempting to prejudge the results of any trial - he is aware
that many MS sufferers are happy with the drug.
He said: 'If it is safe and proven, that is great for everyone. Until then we
cannot support it. We know there have been some adverse reactions to the drug.
What we don't know is what this might do to the body over time.'
However, Brian Quick, managing director of Daval International, denies the
suggestion the company is dragging its heels over testing or trying to abuse a
'All I want to do is the get the trials under way and done,' he says.
'The MS Society know that we are trying to do this; and that we concluded a
small one in Oxford which found the product safe. We stopped the trial at St
George's, as we felt the product was not being handled carefully enough, which
would have affected both its efficacy and the trial results.
'It's not in our interests not to do trials; we want to get this drug on to the
'The application is with the MHRA, we hope to have a positive response within
three to four weeks, and we are lined up now to begin clinical trials in
September or October this year.'
The MHRA investigation, he says, is 'a minor matter'.
'We would like the MHRA to pursue their investigations and get this over with.
We are not selling the product illegally.'
It's been two years since Diana took Aimspro - the family took a joint decision
that it was too difficult to get hold of and too expensive for the results it gave.
Jackie is sure her mother got some benefit, but says it's impossible to know
what would have happened if they hadn't gone down that route. But she is glad
'Aimspro has no serious side effects, no toxicity, so why shouldn't people give
it a go? 'My mother is still getting around now. But you can't say if it is a
longterm effect of the Aimspro.'
Where she and Dr Dunster agree is on the need to examine the serum more closely.
She says: 'From what I have seen, this drug offers hope. Why not investigate it
further and then judge it?'