A surgical treatment for multiple sclerosis is to be offered privately in the UK, despite warnings that it has not been proved safe or effective.
A clinic in Edinburgh will begin operations within weeks that involve a package of screening, consultation, day surgery under local anaesthetic and a six-month follow-up, costing £5,950 in all. As the medical establishment advised caution, the NHS made it clear it would not offer the treatment in its present state, however frustrated patients may be.
The Essential Health Clinic says the procedure, meant to improve the blood flow from the brain and central nervous system, will be carried out by a surgeon, Donald Reid, and “an internationally recognised” expert from Bulgaria responsible for more than 300 procedures.
The company’s owner, Tom Gilhooly, a Glasgow GP with an interest in MS, admitted the procedure was unproved. “But we are not going to get proof unless we look for it.”
MS experts and surgeons are deluged with requests for screening and treatment, while people with MS in Britain, the US and Canada are spending thousands on packages to countries such as Poland, Bulgaria, Greece, Mexico and India, where the procedure is being performed.
There are concerns about monitoring the progress of patients after they come home, although UK bodies will not stop people travelling for treatment.
Gilhooly said: “We have a pretty good safety net [in the NHS] but unfortunately it also stifles innovation. Anything new has to be proven, but we cannot prove [anything] until we have done it.”
If health providers offered only established procedures, “you won’t understand what you are trialling. What differentiates this from other so-called breakthrough treatments is that there is a growing body of significant, serious scientists and doctors who are getting involved.”
Patients would face questionnaires before and after the procedure, which typically might take 45 minutes to an hour.
The clinic has screened about 300 people without offering the procedure. It found between 70% and 80% had vein problems, said Gilhooly.
MS charities and research bodies have advised people with the condition – there are an estimated 100,000 in the UK, more than 10,000 of them in Scotland – to have treatment only as part of a properly controlled trial. So far, a handful of such trials are under way or planned.
The procedure, first outlined by an Italian team last year, is similar to the angioplasty treatment for heart problems. It involves inserting a device with a deflated balloon into a blood vessel in the groin and guiding it to affected areas, where the balloon is inflated.
“The hypothesis is plausible and we don’t want to miss an opportunity to help people,” said Ian Franklin, a council member of the Vascular Society. But he added: “Internationally, there are only a handful of units that have published results so far and there has to be a properly randomised trial which can be the benchmark for treatment. No one outside the handful of units has reliably confirmed the diagnosis. When you cannot even agree on diagnosis, it is very difficult to agree treatment.”
Franklin, a surgeon at Charing Cross hospital, London, said doctors there recently had to operate on a patient who had had the treatment in eastern Europe. “There are people getting nasty complications. We don’t know whether these anatomical anomalies are incidental or contributory to MS.”
Doug Brown, head of biomedical research at the MS Society in Britain, said MS societies were funding projects in the US and Canada to see if there was an association.
“Within the next year or two we should have a wealth of information and [know] if there is a connection. It is very early days. It is important to get the answers we need before we move on to the clinical trials stage.””
The DoH said “carefully controlled research” was vital. “While the pace of this process may seem frustratingly slow, it is critical to producing the very best results for people living with MS.”
Helen Yates, chief executive of the Multiple Sclerosis Resource Centre, another UK charity, was more supportive. “The screening is non-invasive, pretty straightforward, and the treatment has been performed for other conditions for decades,” she said, adding that no procedure was risk-free.
“Would we rather people could get scanned and treated on the NHS, with appropriate follow-up? Of course. If it is not available [on the NHS] we would rather see people treated in this country privately with appropriate follow-up.”
The Guardian