IPAC (NICE) meeting of the 13th October.
Anyone expecting guidance encouraging the treatment of people with an MS diagnosis would be disappointed with the conclusions that the committee came to yesterday.
Five people from the CCSVI community attended: Kevin Campbell, Michele Findlay, Khris Martick, Cyndi Tunstead, Jane Longley.
In essence the draft guidance document was not changed greatly by this second meeting of the committee. The most encouraging aspect of the whole proceedings was the strength of response from the consultees, (as they called the people who wrote to give them the benefit of their experience and their suggestions). Four hundred and forty (440) people wrote in, most of them in support of PTA for the treatment of CCSVI.
The issue of equality was discussed extensively and the committee had to agree that the procedure could not be described as anything but safe and that there was no reason why people with an MS diagnosis should not be treated via a venoplasty procedure, however they felt that the most import question not answered so far was whether this was an effective treatment for MS symptoms. Although there was plenty of evidence about the safety of the procedure, no one had published anything regarding its efficacy. The only evidence they had that this was making a difference to people with MS symptoms is what they had read from the responses, and this was not the level 1 evidence that they required.
There was quite a lot of discussion regarding the design of a research with some of the committee thinking it was important to mention the need of sham procedures in a Randomised Clinical Trial, but in end Bruce Campbell said that they do not tell researchers how to conduct a clinical trial and that it was up to them to design something that would show whether this treatment was effective or not.
Bruce Campbell also spoke of the need for urgency in this matter as there was little effective treatment for Multiple Sclerosis. There was also a discussion about the definition of MS as a disease, a description several consultees disagreed with. Bruce Campbell turned to one of his administrative assistants whom he had charged with finding out whether MS was a disease or a syndrome (a syndrome is a collection of symptoms) and she explained that from her research for which no reference or data was quota, she was sure that this was a disease. But as Kevin would tell you, MS is a collection of infinitely diverse symptoms affecting all the systems of the body: circulatory, neurological, endocrine, immunological, metabolic and how they interact: ie the entire physiology. To call it a disease is like saying that coughing, headache, sneezing , vomiting and diarrhoea (a collection of symptoms) are the disease whereas the disease causing the symptoms could be anything from the flu virus to HIV. Differential diagnosis was not explored.
Many consultees mentioned the need for follow up care which was practically impossible to obtain if people were treated abroad. Amongst ourselves later on, we thought that one of the reason nothing had been published about effectiveness was because treatment was not available locally.