I would put it to them to ask can repurposing occur without pharma and the answer is increasing clear I think, it is no. So let's not kid ourselves otherwise.
I always knew it but was prepared to give it a go.
10:4:2015. Get quotes from companies that do the data monitoring for trials and there quotes are up to £50,000,000 (apparently that is a discounted rate if we sign up within 30 days) so they are having a laugh with Pharma... Funny thing is they pay it. Get one quote at a few million.
21:4:2015. One of the companies we talked to about data monitoring have been blabbing everything to Pharma (Merck), They probably have known everything anyway . What to you do take it on the chin or take legal action about a confidentiality agreement being broken.
We hear on the grapevine again that the giant is waking and Merck are planning on bringing Movectro out of mothballs, we have known this for months. This says something about the risk as they would not do this if they thought the risk profile was real.
So the ultimate way to stop the knights is occurring, as Cladribine comes back on the table. However, on the plus side ProfG and QMUL will get a an impact outcome if the drug comes back for the next REF:-)
1:5:15 Have meeting with Innovate UK about business prospects of Cladribine. Interesting but I suspect too much effort..this is taking up too much of our time.
5:5:15 Have meeting in the Wellcome Trust Cafe, which is where the fly (Forensics Exhibition) comes from for a debrief about the failed application. There is a view that the idea of developing a DMT is not dead with the NIHR, but we have to bin the science and reduce cost substantially. Personally I don't buy this. You can't get a cheap and good trial. Plus they are going to pull the lack of medical need card. There is a need for a smaller trials to establish dosing which puts us back to two years ago. There is option discussed of PPMS study maybe we can get something from this project.
11:5:15 White Goes Grey as we begin talks with Merck about oral Cladribine. If we can help them get it back on the agenda we will.
It seems decision time is looming with the EMA
26:6:2015: A cryptic post appears - Is there a shimmer of light in the darkness? Are we looking down a tunnel with light at the end? Or is it just an illusion, some sweaty dream during a restless night at full moon? After supposedly throwing the final blow against the knights some influential voices at the NIHR have apparently returned to the battle field to search for survivors and say ??sorry?? we didn't fully understand what you said before hacking off your limbs. Can we sit down and talk over afternoon tea? We err... would consider some prosthetics for you and help you learning to run again, to fight for another day...
30:6:2015. Get a word that we may be able try again with NIHR, if we can show that our study is feasible and we can cut costs.
So this helps us to Re-Arm an recharge our batteries. This post is so ambiguous and readership thinks this is something that it is not. i.e. it is not a mechanical exoskeleton.
20:7:2015 Paper on cancer risk nearly accepted but now we have to find £2,000 for the open access fee. We had got pharma lined up to pay for it but medical student on the paper can't be seen to be associated with pharma or they will loose their job. Nothing is straight forward with this project.
This paper is the information that Merck need for their EMA submission, so we give them that and don't sign the confidentiality agreement that they want us to sign.
Meetings take place and we get powering for an MRI trial.
11:9:2015. News leaks that Cladribine is going back to the EMA
01:10:2012. More problems with CTU...We need Jack Baurer to get them sorted. They have been on board for 1.5 years and now we have to go to them and explain the trial. They (including a guy from the NIHR) say they don't think the NIHR will fund the phase II and want a phase III with two arms instead. I despair.
This is too much, no support anywhere. Head of NIHR says "quick and dirty study with a few people"....This simply will not work as would be too small to be useful.
02:10:2015. Cladribine paper published suggesting the risk of cancer was probably a fluke due to no cancers in the placebo arm.
10:10:2012 DrK posts the Cladribine story. Is there a donor out there?
The case is put there for all to see why this is a worthwhile cause and details of the trial laid bare.
13:10:2015. UK MS Society want to support the drug repurposing bill. But we are second choice in their eyes, they want to support simvastatin though Cladribine is much closer to the finish post.
This is taking too much time for no reward and we are swimming in treacle. Any chance of going back to the NIHR in the near future is delayed because we are getting pushed back down the pecking order by a trial of DMT supported by the MS Society's Clinical Trials Network, that we would need to co-ordinate any trial.
Our plan to get proper people to do the trial monitoring is scuppered by cold feet by our people in the NIHR, who are now worried about the re-awakening of the Movectro programme
The teutonic knight looses it...
"The NIHR should stop wetting their pants .........Please tell Tom (Tom Walley Director of the NIHR) the NIHR is in danger of turning into a giant smoke screen for a public that believes his organisation could facilitate real change in and for the NHS should they shy away from reasonable, evidence-based and solid science with - yes - potential for significant impact, and only because an unpredictable company expresses "the intent" of doing something (nothing has really happened on the ground!)".
The teutonic knight will not do a placebo controlled trial and therefore you need the NIHR support as who will pay for the drug comparator. The NIHR won't support such a trial. So catch 22.
29:10:2015 Hear that the Department of Health will not support the Repurposing Bill so it is essentially dead irrespective of what happens
Give up on the idea of NIHR for the time being unless we get your support we will not get this going in the UK, until patent life of DMT dies. Mercks plans wins?
The only way to make this happen is either a change of mind by the MS Societies or a Philantrophic benefactor.
We request that NICE undertake a single technology appraisal to provide guidelines on how to prescribe generic Cladribine...NICE reply they will only do this for licenced drugs and if Pharma ask them to do it....After all pharma under-write much of the cost of NICE...
2:11:2015 Kill off the White Knights on the Barts MS Blog-Sorry
You can take part and push the agenda or you can let it die.
If you let it die you are part of the collective problem and don't say we can't do anything, because you can.
We tried and failed. If you are a mega donor maybe we can do something. Contact us.
Has it been worthwhile. Many say it has been a waste of time, we did not raise hopes for you as you did not know what was going on.
However on the plus side...
1. We have learned a lot more about the drug development process and some of the details that Pharma have to do to get drugs approved.
2. We have identified failings in the system in the UK that will stop academic neurologists developing treatments, yes it could be done in yesteryear but that time has passsed
3.We have kept Cladribine alive and may have contributed in some small way to Merck bringing it back or trying to bring it back.
4. Importantly we have developed our own Cladribine protocol to give people with MS a treatment, where currently there is none.
People with PPMS and gadolinium enhancing lesions will respond to this type of treatment and until and if Ocrelizumab is approved there is nothing in the UK, as our hospital has stopped funding Rituximab. For people in wheelchairs with brains full of lesions there are no treatments for them either, but there is now...for the time being.
What does the future hold?
The Second Crusade? Anyone up for it?