· Remedy 'promoted like a religion' by charity
· Patients paying £19,000 a year for unproven product
Sarah Boseley, health editor
Monday June 11, 2007
The Guardian
Multiple sclerosis sufferers are spending their life savings and running up large debts to pay for a treatment derived from goats' blood that is being sold in Britain without any scientific proof that it works.
The MS Society is concerned about promotion and sales of the treatment, called Aimspro, to people with the progressive disease who have few other options. It has called on the firm selling it, Daval International, to put the drug through trials.
There are also concerns about a registered charity called Proventus, which was set up to lobby for greater access to Aimspro, but now says that it has broadened its field to a range of largely alternative products for MS.
Proventus, many of whose trustees and officers have small shareholdings in Daval, organises road shows to talk about Aimspro to people with MS. A recent event in Wimborne, Dorset, was described by one man who attended as reminiscent of a religious rally. "It was a very evangelical meeting. Others who were there said it was like a Billy Graham sermon," said Tim Worner, who runs a support group in Bournemouth for people with MS and invited Proventus to speak to it.
"A guy at the back of the hall stood up and said he took Aimspro once a week and was better. He said he had been in a wheelchair and used two sticks. He walked to the front and gave us a short talk on how he spent £180 to inject it once a week and how he wished he could afford to spend twice that. That's a good-sized mortgage payment."
Aimspro is made of the blood of goats that have been injected with killed HIV virus. The theory is that the antibodies produced stimulate the body's immune system against MS and other neurological and inflammatory diseases.
In the seven years since Daval was set up only two very small trials of Aimspro have been done. One was inconclusive and the other was stopped early.
Daval insists it will soon launch another small-scale trial, but in the meantime supplies of the drug - which has to be kept in a freezer until just before it is injected under the skin - are being shipped around the country to patients who pay £180 a vial. Two injections a week are recommended, which means some patients are paying out almost £19,000 a year. Proventus estimates that around 300 people are taking Aimspro, although as many as 500 may have tried it. "The society has always said that Daval International, like any other organisation that wishes to bring a therapeutic product to market, has to go through the current processes like anybody else," said Lee Dunster of the MS Society.
"There is a structure in place to protect people. There has been almost a flat refusal to go down that route. To make this available off-licence to people who are vulnerable borders on exploitation."
The MS Society accuses Daval of exploiting a loophole in the law to sell the drug. Aimspro has a "specials" licence, which means it can be supplied to an individual named patient if the patient's doctor agrees to write a prescription. It received the licence because it has an "orphan drug" status in Australia - granted after it was tried in four children with a rare and fatal disease called Krabbe's, for which there is no treatment. But a "specials" licence exists so that a drug can be manufactured to the specific needs of a single patient at the behest of a doctor - and is not intended for general marketing.
The Medicines and Healthcare Products Regulatory Authority, which grants licences and oversees drug safety, said that the company was under investigation, but could not comment further.
Bryan Youl, Daval's clinical director, told the Guardian that he had applied to the MHRA for a trial in January to study the effects of Aimspro in alleviating bladder symptoms of MS. "It has taken a long time. The documentation is pretty complex." He was waiting for a response from the MHRA, and planned further studies. "It has not been through lack of intention that we haven't trialled this."
Dr Youl added Aimspro was not an MS cure, but a palliative medicine, intended to treat symptoms. He said it was not unusual for medicines to be made available to patients "off-label" - outside the terms of the licence. "It is up to the doctor prescribing it to decide whether the patient truly requires the medication," he said.
The Charity Commission is looking into Proventus. Concerns have been raised with the commission over its administration and management, and possible conflicts of interest. In a statement the commission said: "We are currently considering these concerns to determine what action, if any, it might be appropriate for us to take." It is understood to have particular concern about the role of Proventus in public appeals for funds by MS patients who desperately want to buy Aimspro.
A Dorset newspaper ran a story about a woman who was dependent on benefits and had spent all her savings on the drug. At the foot of the article a request was made for cheques to be sent to Proventus.
Dr Dunster also went to a Proventus rally. "It clearly was a sales pitch - no bones about it at all."
"They had someone in the audience who talked about how much of a difference goat's serum makes to them. The guy walked to the front and said that was not possible a few years ago. I am really sad and disappointed that this kind of activity goes on. When you are sitting in an audience of 50-60 people, the majority of whom have a progressive condition, with inexorable decline in mobility ... it gives a very hopeful message for individuals who have very little else at the moment."
John Slack, Proventus's chairman of the trustees, was diagnosed with MS 15 years ago and says he believes Aimspro helped him. "We are a group of volunteers who are desperately trying to find a treatment for MS sufferers. There is virtually nothing out there - that is the sad thing. There are 100,000 people with MS in this country. We feel as if we are totally forgotten. If we are promoting Aimspro, we're simply saying there is a future out there because there is something on the horizon." He had a few shares in Daval - but had bought them out of gratitude when he was supplied with Aimspro for nothing as one of the earliest patients by the managing director, David Shotton. He now has to pay.
