Prof Malcolm Hooper and Margaret Williams call for donations to UK Rituximab trial

[Sasha]

Posted by lilpink on another thread (good catch, lilpink!):

Permission to Repost:

The UK Rituximab Trial for ME

Professor Malcolm Hooper Margaret Williams

2nd August 2013


The charity Invest in ME has provided a truly remarkable opportunity to address one of the biggest medical scandals in history and to remove what in 2007 Alex Fergusson, Presiding Officer (Speaker) of the Scottish Parliament, referred to as “the cold grip of psychiatry” on myalgic encephalomyelitis (ME), which he said was “still far too deeply rooted in the world of ME” (http://www.meactionuk.org.uk/Defiance_of_Science.htm).

Now, however, despite the power and control of the psychiatric lobby, thanks to Invest in ME and the invaluable support of Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College, London, (world-renowned for his work in B cell immunology and as lead researcher in the clinical trials of rituximab for rheumatoid arthritis), the neuro-immune disease ME is at last about to enter the realm of mainstream medicine in the UK under the guidance of Professor Edwards himself.

Invest in ME are at the forefront of international biomedical research and have by sheer determination and effort managed to put things in place for a trial of rituximab to begin on ME patients in the UK. They recognise the urgency of the situation and know that many ME patients do not have the luxury of time. The charity already has the facilities in place, including suitably experienced researchers (Professor Jo Cambridge is now principal researcher at UCL, and the ME trial will involve the same team working under her that carried out the rituximab research in RA).

The Clinical Trials Unit at UCL is already working on the protocol, and Invest in ME have agreed with Professor Edwards that the protocol will be externally reviewed even though the UCL team will make sure it is cast-iron by their own internal reviewers.

Invest in ME have been told this trial could start relatively quickly if the charity had funds available. Such an opportunity must not be lost. However, this will not happen without substantial funding.

We therefore ask everyone who is able to do so to donate whatever they can afford, in order that the UK rituximab trial can get under way as quickly as possible whilst the excellent facilities and committed staff at UCL and the active support of Professor Edwards remain available, so that ME can finally be recognised as the devastating multi-system neuro-immune disease that it is and – most importantly -- so that sufferers may at last have some hope of alleviation of their suffering.

Invest in ME have assured us that all donations to the rituximab fund will sit in a separate account which is totally ring-fenced, and should the trial not proceed, the following statement on the IiME website will be honoured –

What Happens With These Funds If The Project Does Not Go Ahead:
If the rituximab project does not go ahead for some reason then the funds raised will be transferred to the IiME Biomedical Research Fund to fund other biomedical research projects which are attached to our proposal for an examination and research facility based in Norwich Research park in Norfolk, UK. These funds will only be used for biomedical research into ME.
- http://www.investinme.org/IIME Statement 1306-01-faq.htm

A UK trial of rituximab is essential to move ME out of the realm of psychiatric dogma and into the realm of medical reality.

Information on how to donate can be found on the Invest in ME website: www.investinme.org​

 

[sproggle]

Great statement from Prof Hooper and MW - as always!

 

[Bob]

I appreciate the enthusiasm from Hooper and Williams, but I think we all need to be careful to also express caution, perhaps especially when fundraising. I don't want to bring negative energy to the issue, but I do suggest that we don't over-play expectations. We've all been here before: Massive expectations with no guaranteed outcome. And if it ends without the result we want, many people might understandably find it difficult to deal with. It might be the case that Rituximab doesn't lead us anywhere meaningful. But even if 10% of patients experience a dramatic recovery, the NHS probably wouldn't approve the drug, because of its safety profile and its expense. So we should perhaps prepare ourselves for a long and bumpy road.

Edit: I'm not suggesting that people shouldn't donate. I think it's a very important trial, and it has the potential to transform the field of ME. But I think that people should be aware that the results from Norway do not suggest that a majority of patients will experience dramatic improvements, as far a as I understand the results.

Edit 2: I haven't seen the results from the latest Norway study, so that might give reasons to be even more optimistic.

 

[biophile]

"All funds for the Rituximab project will be isolated from the rest of the Biomedical Research Fund."

There are so many different options to help mentioned on the website, but I cannot find an obvious method on the website for donating specifically to the Rituximab project. Are people supposed to specify it when using PayPal?

Here is the URL to the Biomedical Research Fund:

http://www.investinme.org/IIME Campaigning-Can Do Biomedical Research Fund.htm

[Edit: specific links are kindly provided by others in following posts.]

 

[Firestormm]

"All funds for the Rituximab project will be isolated from the rest of the Biomedical Research Fund."

There are so many different options to help mentioned on the website, but I cannot find an obvious method on the website for donating specifically to the Rituximab project. Are people supposed to specify it when using PayPal?

Here is the URL to the Biomedical Research Fund:

http://www.investinme.org/IIME Campaigning-Can Do Biomedical Research Fund.htm

Apparently it is here, Bio:

https://www.paypal.com/uk/cgi-bin/w...63663d3faee8d92b37e35c82a7c965120dd5a9b6ad0e3

And the page is here.

 

[sproggle]

"All funds for the Rituximab project will be isolated from the rest of the Biomedical Research Fund."

There are so many different options to help mentioned on the website, but I cannot find an obvious method on the website for donating specifically to the Rituximab project. Are people supposed to specify it when using PayPal?

Here is the URL to the Biomedical Research Fund:

http://www.investinme.org/IIME Campaigning-Can Do Biomedical Research Fund.htm

All donation links here on the IiME Ritux Trial page are specific for the Ritux Fund -
http://www.investinme.org/IIME UK Rituximab Trial Home.htm#How_To_Donate

We have links also on the ldifme site but have to redirect to IiME for monthly donations due to the restrictions of Wordpress. It may be simpler for some to use though as it's the donation options only and so hopefully fairly simple to navigate - http://ldifme.org/donate/

Hope that helps

 

[biophile]

OK thanks. I donated small amounts to both the Rituximab project and the general Biomedical Research Fund.

Last time I donated was to the WPI (early days) and now I would not mind having my money back for this instead!

Bob. Good points. I do not expect Rituximab to be any sort of silver bullet, but the research may help to uncover mechanisms of the disease process. I am very weary of trying it myself.

 

[Sasha]

I appreciate the enthusiasm from Hooper and Williams, but I think we all need to be careful to also express caution, perhaps especially when fundraising. I don't want to bring negative energy to the issue, but I do suggest that we don't over-play expectations. We've all been here before: Massive expectations with no guaranteed outcome. And if it ends without the result we want, many people might understandably find it difficult to deal with. It might be the case that Rituximab doesn't lead us anywhere meaningful. But even if 10% of patients experience a dramatic recovery, the NHS probably wouldn't approve the drug, because of its safety profile and its expense. So we should perhaps prepare ourselves for a long and bumpy road.

Edit: I'm not suggesting that people shouldn't donate. I think it's a very important trial, and it has the potential to transform the field of ME. But I think that people should be aware that the results from Norway do not suggest that a majority of patients will experience dramatic improvements, as far a as I understand the results.

I don't want to cross-post too much but I responded to this here:

http://forums.phoenixrising.me/inde...tatement-8-july-2013.24123/page-2#post-375415

I understand caution - we've all been a bit battered in the past - but I think this is overly pessimistic (sorry, Bob!).

 

[Jonathan Edwards]

Difficult to know where to post! But since Bob's comment is here, I will comment here. Bob is right to advocate caution. If a UK rituximab trial was going to be easy and the outcome obvious it would have been done long ago. People need to take a long term view. However, a few points come to mind. I do not personally consider rituximab to be especially dangerous. I doubt it is more so than even something like voltarol. Unlike most pills it rarely causes stomach ache, nausea, headache, dizziness etc etc. There was a lot of disinformation about rituximab for rather curious commercial reasons at one time. There are also problems with inexpert administration. It needs to be treated with respect but I have always been more worried by drugs like steroids, methotrexate or non-steroidals. The cost is also not so very high and may come down after November when the patent runs out. So I doubt that safety and cost would have much to do with a NICE decision (more likely just bureaucracy). If it only benefits a small proportion of patients that is a real issue, which is why I think research should focus on finding out who those people are.

 

[Bob]

Jonathan Edwards
Thanks again, Jonathan, for your information. It's reassuring to hear your thoughts re safety. I've also read that Rituximab is safer for non-cancer patients, in terms of fewer dangerous reactions. (I can't remember the reason, but it might have been to do with the concurrent treatments that cancer patients receive. But I'm sure you know the details.)

Sasha
Perhaps my post was a too pessimistic, as I was trying to present the reasons to be cautious. But I wasn't suggesting a pessimistic approach. I was simply suggesting a cautious and balanced approach. But that doesn't rule out enthusiasm and optimism.