I wrote to my MP last week. I do hope as many of us as possible can write to MPs. It will have an effect if Andrew Lansley is inundated with MPs correspondence about it. Here is what I said (with a few gaps where I have taken out words to prevent my MP being identified here because I do not want to cause him any embarrassment - he is a first class constituency MP):
"You probably will not remember but you did kindly take up my request in March last year to try to get the Department of Health and NICE to get on with appraising two new drugs for the treatment of chronic myeloid leukaemia (CML). My wife has CML.
I am really sorry to bother you again but I so very much need your urgent help for a very real and personal reason, as well as more generally for CML patients. If my wife develops problems (such as lack of response or mutations) with the first line therapy that is presently prescribed (Glivec), in the absence of availability of Dasatinib and Nilotinib, she will almost certainly die. I have spent most of today trying to calm down so that I could write a reasonably sensible and cogent letter to you and I hope that I have managed that. If I have managed it, you should not assume that I am not very angry indeed with NICE. I am. I could not be any angrier about what they are proposing.
NICE has just produced provisional guidance. To my complete horror, they have concluded that these two drugs are not to be permitted to be used. Their decision is not final and I beg your support to try everything to get NICE to reverse its decision before the 27th May deadline they have unfairly imposed for responses (after delaying making their decision for years). .....I hope you will feel able to take this up urgently in correspondence with the Secretary of State for Health. You are more than welcome to copy this letter and its two enclosures to him if you wish.
The NICE guidance is perverse and irrational (meaning that it is potentially open to legal challenge – I am a lawyer by profession) because NICE acknowledges the clinical effectiveness of both drugs but says, in effect, that it needs a “four arm trial” to prove how effective. NICE (and the Department of Health) must know that these drugs are prescribed in all of Western Europe, the USA, Canada, Australia, New Zealand and even Mexico. Most insulting and bizarre of all, these drugs are approved for use in Scotland by the NICE equivalent in Scotland, the Scottish Medicines Consortium. You can probably imagine how angry CML patients south of the border are about that, particularly now the SNP have an overall majority and will probably use it to make no change to the advice in Scotland. That will result in me paying taxes in England to help fund the Scottish Assembly to pay for the use of a drug in Scotland that CML patients in England and Wales will not have if this provisional guidance comes into force. Surely the Coalition Government does not want to preside over such a farcical and bizarre situation and do nothing about it. Kafka could not have written that story line any better.
Incidentally, these two drugs (and higher dose Glivec) are presently prescribed and in use in England and Wales in the very circumstances which NICE now intend to stop. This is not a huge cost issue either in the overall NHS budget, at least in terms of the small numbers of patients affected, even though the drugs are themselves expensive. Further, the cost difference between Glivec, Dasatinib and Nilotinib is not huge.
NICE must also know that a four arm trial will not be funded by the two drug companies involved because they have no financial incentive to do so for a very small number of patients in England and Wales compared with their huge world-wide sales arising from approvals all over the world. In any event, it is impossible to see how such a trial could be done with the small number of available patients to take part in England and Wales. This decision is, accordingly, lacking any moral base because NICE is saying that these are effective drugs but we are not going to let you have them until there is a further trial, which they must know will never happen. In short, it is both a perverse and an amoral decision that will lead directly to the otherwise avoidable deaths of CML patients.
Mr Dillon, the head of NICE was quoted in the Daily Telegraph today (copy enclosed) as saying “The evidence for the effectiveness of dasatinib, high-dose imatinib and nilotinib is very weak. When we recommend the use of very expensive treatments, we need to be confident that they bring sufficient additional benefit to justify their cost.” If that is an accurate quotation, Mr Dillon, with respect to him, does not know what he is talking about. His comment flies in the face of the reality of day to day existing practice, for example, at the specialist Hammersmith Hospital in London, where my wife’s treatment is monitored, and in most parts of the world. If ever NICE and Mr Dillon were totally out of touch with reality, this really is it.
So far as I can see, there was not a single person with specialist knowledge of leukaemia on the NICE Committee that has produced this provisional guidance. Whilst there were, of course, specialist consultees, a decision made by the people on this Committee must be questioned because they do not have the necessary specialist expertise in this narrow part of the field of haematology and it shows in the provisional decision.
A petition was started on line yesterday and by this evening it already had over 700 signatures. You may care to draw that to the attention of the Minister of Health: http://www.gopetition.com/petitions/nice-i-don-t-think-so.html You might ask him (not a civil servant) to read the comments that people have left there, some of which are heart breaking. That will give him a flavour of the reaction that has already been generated to NICE’s provisional decision.
It is highly significant for the Secretary of State for Health and NICE that Professor Goldman has signed that petition. Professor Goldman is the former head of the leukaemia unit at the Hammersmith Hospital, Emeritus Professor of Haematology at Imperial College and a highly respected and world renowned authority on leukaemia. Further, in the enclosed Daily Telegraph article, he is quoted as saying “This may put clinicians in England and Wales in a very difficult position, and clearly puts us behind Scotland and the majority of the western world where these treatments are reimbursed.” He is so very right. I imagine that the highly skilled and dedicated consultants at the Hammersmith Hospital and other hospitals are in complete shock about this perverse NICE view. Are we to be a third world country in cancer treatment, contrary to what David Cameron and Andrew Lansley have been consistently asserting? Really, that must not be allowed to happen and NICE must be put back in its box.
At the very least, NICE’s provisional guidance should be suspended indefinitely by the Secretary of State so it can listen more carefully to CML patients and real haematologists in the real world of that specialist area of medicine.
Finally, I enclose a copy of a press release from the CML Support Group that explains what is happening more eloquently than I feel able to do today.
I do hope you can find time to move quickly on this and I apologise for adding to your burdens. If you feel it might help for me to pop in to your office in .... to talk to you briefly about this, I would be pleased to do so, but I will not unless you feel it necessary. Could I ask that you try to get real answers from the Secretary of State? By that I mean that I do not want a “civil service” type standard response that is rooted in the allegedly careful procedures that have been followed. Procedure here is not the point. I would very much like a response that deals with the substantive issues that I have raised in this letter.
I thank you in advance for anything that you feel able to do to help my wife, her family, me and other CML patients."
