I continue to think this situation has some very exciting possibilities and was dismayed when the previous thread descended into squabbling. But I would like to make one last try to revive it.
Can I first say that some people have taken the view that these reports are likely to have an effect on stopping people from receiving drugs they currently use and value. Mark has made the point several times that this would be a really tragic outcome and is not what will happen. I am absolutely sure that is right. I don’t think anyone need worry about it. But I am hopeful that substantial good may come of this.
The situation we are talking about is in the UK and it involves an incoming UK Govt which is looking keenly for cuts and ways in which to make itself seem more caring and compassionate (in their last administration they were perceived as the party associated with greed and selfishness.)
They have been handed a situation where they can represent themselves as the champions of the NHS and MS patients while at the same time clawing back potentially hundreds of millions of pounds. And they can rightly blame the whole debacle on the last Govt. I can’t see them passing this up. It will be in the newspapers and will provoke public and parliamentary debate.
The recent BMJ article is about the two year report published (late) in Dec 2009. I don’t know when the second two year report is scheduled for publication but it should be about now. Think of the effect if that one came out this month showing the same results as the first.
The scheme as a piece of research is in fact very poor and has been from the beginning. It has attracted continual and accurate criticism and there have been sharp disagreements between the various scientists involved. It was not intended to test efficacy but to adduce data to put a value on the benefits of the drugs. But as has already been published by a critic: how can you work out a measure of cost/benefit when there is no measured benefit? Questions about efficacy will inevitably continue to be asked.
Some scientists from Southampton have already resigned. But that’s not the point. The scheme is huge and rightly or not people are bound to make comparisons with the results of existing research. It is a large contradictory result which will need to be explained somehow. Which is why I posted the comments I already have. I am not saying it will prove anything but it will pose questions about what exactly DMDs do which could impact the very definition of these drugs as disease modifying rather than symptom managing. Most importantly these questions will be in the minds of the politicians involved and their advisers. Again before I get criticism for wild unjustified assertions. I don’t care whether these suggestions are in fact justifiable or not, or what the scientific community may think. It is politicians which will be leading this discussion.
More scientists may bail out of this process but the Drug companies and the Govt side cannot. Some kind of re-assessment has to be made and the Govt will want a clear statement of what is to happen in the future that will make them look good. Remember there are already scientists calling for the scheme to be scrapped.
The second shocker is that most of the criticism levelled at the scheme was because the scientists thought it would overestimate the effects of the drugs. The actual results show the complete opposite. Now before some Smart Alec starts re-analysing the data and telling me I am wrong and there are all kinds of potential biases. I don’t care whether it is right or not. That’s not the point. The point is this is already in the UK news and we should make the most of it.
I think in the dialogue that will happen between them and the Drug companies the govt is bound to be seeking clarification about what they are paying for and what exactly the drugs do. They will be asking questions about the efficacy of the drugs and how you measure them. This scheme measures EDSS scores. The only supporting evidence the Drug companies can show is the existing studies whose outcomes are mostly not measured in EDSS scores. How can that not lead to a discussion about how you reconcile the differences?
I may be wrong but I think this is a golden opportunity for CCSVI. We must write to the ministers involved and the newspapers Liva has already cited urging them to make sure they achieve value for money in this process and pointing out that a viable cheaper alternative treatment already exists and is being considered in Canada and is already in operation in Kuwait. Why should you the UK government be less progressive than Kuwait? Why should you persevere with drugs that are expensive and don’t work when there is such an obvious alternative? This procedure is experimental but could be trialled and implemented before the next review if the political will was there. Your purpose in doing that of course, is to assist the govt in their deliberations but it could result in a headline saying a cheap alternative treatment could be considered. Politicians like headlines. Point them in the direction of the headlines Zamboni has already achieved and they might well think. “Hmm I’d like some of that.”
The fact that there have been so many recent publications about this report also leads me to think this issue will not get buried. Politicians will not be interested in statistical tests and scientific rigor and due process they will want clear common sense answers and are in a position to make decisions that could kick start or even fast track CCSVI research in the UK.
I accept that my judgement may be completely of here and I know this may turn out to be a vain hope but surely it is worth a shot.