Dr Esther Crawley: Transcript of Presentation: The Future of Research in CFS/ME

[Dolphin]

Fred maybe the patients spirits at least could be helped by being allowed to spit elsewhere other than in the pot (i.e. at some of these people)?

They do say we have (sleep) hygiene problems so maybe we could blame it on that!

 

[SDP]

Can someone please explain why the population wide genome study is not a good idea?

 

[Snow Leopard]

OK and their results, you might all remember, they didn’t find any out of 186 patients – none of them had chronic fatigue [Ed: corrects herself] – XMRV.

Freudian slip?

Later edit - By the way, 4.7% of the population is simply nutty, but higher incidence rates in the 1-2% range might be true if you consider the (increasing) aged population who may fit in to the less strict Empirical CDC or Oxford definitions.

In children, I'm willing to bet that at least in my area, CFS incidence was well under 1%.

 

[Enid]

Has she caught up yet ?

 

[Dolphin]

In children, I'm willing to bet that at least in my area, CFS incidence was well under 1%.

Yes, figures for children should be lower - I think under 1% also while she often quotes high figures for them and adults. I think I recall her saying giving prevalence rates of <some number> to 9%. Even with the Oxford criteria or empirical CDC criteria, they're under 3%. She consistently quotes figures much higher than pretty much anybody else.

 

[kermit frogsquire]

A transcript is great ME Agenda - but pictures are better than a thousand words as they say - see Crawley creep and crawl in the flesh -

http://www.youtube.com/watch?v=FGtChQPNUQw

Anyone and everyone that can, would do well to write a letter, see their MP, and demand that this trial be stopped. Please help get this trial stopped! Crawley is claiming that this trial can be done on children because

"CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children."

Under the rules trials cannot normally be done on children unless there is no other option. But lightning process practitioners are claiming there is an 85% success rate in adults and that children respond equally well - so Dr Esther Crawleys statement is absolutely misleading in this instance.

Letters should go to the National Regional Ethics Service. Please help!

Joan Kirkbride
Head of Operations, England
National Research Ethics Service
National Patient Safety Agency
Darlington Primary Care Trust
Dr Piper House
King Street
Darlington
Co. Durham
DL3 6JL

 

[fred]

Kermit, there is no such thing as a National Regional Ethics Service. There are Regional Ethics Committees (RECs), one of which may have approved the trial. Then there is the National Research Ethics Service (NRES) which is the national administration which oversees the RECs. The first port of call has to be to the REC which may have approved the trial and there are five of these in the South West (assuming that this is where Dr Crawley filed the application).

 

[Dx Revision Watch]

A transcript is great ME Agenda - but pictures are better than a thousand words as they say - see Crawley creep and crawl in the flesh -

http://www.youtube.com/watch?v=FGtChQPNUQw

Anyone and everyone that can, would do well to write a letter, see their MP, and demand that this trial be stopped. Please help get this trial stopped! Crawley is claiming that this trial can be done on children because

"CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children."

Under the rules trials cannot normally be done on children unless there is no other option. But lightning process practitioners are claiming there is an 85% success rate in adults and that children respond equally well - so Dr Esther Crawleys statement is absolutely misleading in this instance.

Letters should go to the National Regional Ethics Service. Please help!

Joan Kirkbride
Head of Operations, England
National Research Ethics Service
National Patient Safety Agency
Darlington Primary Care Trust
Dr Piper House
King Street
Darlington
Co. Durham
DL3 6JL

In order not to waste the time and energy of those whom you are urging to write letters, have you taken the time to establish directly from the NRES (and note it is the "National Research Ethics Service" not the "National Regional Ethics Service" as you have it above):

a) What classes of stakeholder might make representations following the handing down of a favourable opinion by a regional research ethics committee and the granting of research ethics approval?

b) What the correct procedure for making representations is?

c) What types of information might be drawn attention to and to whom these should be addressed in the first instance?

If you haven't bothered to do so, then I suggest that you first establish what the procedure is - otherwise a good deal of energy is likely to be expended to very little effect.

 

[kermit frogsquire]

All letters should go to the address given - Joan Kirkbride - Nation Research Ethics Service - They are doing an ethical review on the trial due to work undertaken by people that have taken the time to write to secure such a review. The word "regional" above should be considered a typo, and it is clear that the full address stated could not have been a typo therefore I hope to most it was obvious. Thanks Kermit

 

[kermit frogsquire]

In answer to points a) b) and c) everyone should write politly to the above address with any concerns about the trial as the regional decision is now being reviewed. Anybody with any cogent points or comment should write as we all have a stake in stopping this biased trial for if it goes ahead it could legally be sold here and in the US as a cure for ME. There would be no stopping Phil Parker! Professor Robin Gill makes some very good points - anything along those lines will help.

 

[Dx Revision Watch]

All letters should go to the address given - Joan Kirkbride - Nation Research Ethics Service - They are doing an ethical review on the trial due to work undertaken by people that have taken the time to write to secure such a review. The word "regional" above should be considered a typo, and it is clear that the full address stated could not have been a typo therefore I hope to most it was obvious. Thanks Kermit

What confirmation do you have that a review of the decision is being undertaken, by whom was it signed and when was it received?

I asked:

c) What types of information might be drawn attention to and to whom these should be addressed in the first instance?

That is, not what you consider would be useful information but what is set out by the procedure.

 

[Dx Revision Watch]

A couple of weeks ago, you were circulating a "Form letter" via Facebook urging people to send letters to South West 2 Regional Ethics Committee.

What has happened between then and now that provides documentary evidence that a review of the decision of South West REC 2 to hand down a favourable opinion is now in progress or is about to be undertaken?

Who will be responsible for undertaking this alleged review, what is the procedure and what is the timeline for the review process?

--------------------------

Form letter that was being circulated on Facebook:

Edited on 24 October.

"Kermit Frogsquire's" template letter had been posted on Action for ME's (publicly accessible) Facebook Wall on or around 11 October by a third party (that is, not by me). The posting was subsequently deleted from Action for ME's Facebook Wall by that poster on 11 October.

This morning (24 October) I have received a request to delete content of "Kermit Frogsquire's" template letter from this forum, including quotes from his template letter.


Content deleted at the request of "Kermit Frogsquire"

 

[kermit frogsquire]

I have been informed just today that a letter was recently received, stating that the National Research Ethics Service will be launching an investigation to undertake an ethical review of the project. That is as much as I know. No doubt the result of the work of many people, including yourself, our MP's and academics, that have worked together to help bring the attention of this terrible biased and unethical project to the attention of those that can review the decision. The only important point is that we now have an opportunity to write to someone that will be reviewing the decision.

 

[kermit frogsquire]

PS There is no procedure, information that would be reasonably considered cogent to the ethical viability of the study is all that is needed. If one knows the specific GMC/BMA or MRC requirements for ethical studies on children with examples of their application then all the better. All polite and clear input that makes reasonable arguments with respect to the flaws in the original ethics decision are welcome. I assume this reply has come from Joan Kirkbride as that is the contact I have been told to write to by the person that contacted me.

 

[Dx Revision Watch]

Have Neil Riley and Dr Charles Shepherd (Trustees ME Association) been advised that you have been informed that a review of the decision to approve is underway/about to be set in motion and have you provided them with written confirmation that this is the case and have they been appraised of the review procedure and the timeline for the review process?

Forgive the scrutiny, "Kermit", but you will understand, from your legal studies, why I need to ask for these clarifications.

Suzy

 

[Dx Revision Watch]

I have been informed just today that a letter was recently received, stating that the National Research Ethics Service will be launching an investigation to undertake an ethical review of the project. That is as much as I know. No doubt the result of the work of many people, including yourself, our MP's and academics, that have worked together to help bring the attention of this terrible biased and unethical project to the attention of those that can review the decision. The only important point is that we now have an opportunity to write to someone that will be reviewing the decision.

By whom was this letter signed, please, and when was it dated and is the recipient intending to make this development public?

Given your background, I am surprised that you should leave anything to assumption.

 

[Dx Revision Watch]

So unless or until "Kermit's" informant is prepared to place a copy of his or her communication in the public domain, we have no evidence that a review has been set in motion.

 

[kermit frogsquire]

All the information I know has been posted - as was stated Joan Kirkbride is doing the review. It is sufficient for me to make my own contribution to hopefully stopping the trial. Should you consider or anyone else know of someone that could more usefully contribute such as Dr Shepherd then please feel free to contact them. All you need to know, as I do, is that a a decision to review has been set in motion, by Joan Kirkbride.

(If you want to know specifics then PM me and I will gladly forward your email to the the person that sent me the info and I will ask them to message you if that helps. Its very important that the best people with most influence such as Shepherd/Robin Gill follow this up, if you have any connections with such people please do all you can)

 

[Dx Revision Watch]

All the information I know has been posted - as was stated Joan Kirkbride is doing the review. It is sufficient for me to make my own contribution to hopefully stopping the trial. Should you consider or anyone else know of someone that could more usefully contribute such as Dr Shepherd then please feel free to contact them. All you need to know, as I do, is that a a decision to review has been set in motion, by Joan Kirkbride.

(If you want to know specifics then PM me and I will gladly forward your email to the the person that sent me the info and I will ask them to message you if that helps. Its very important that the best people with most influence such as Shepherd/Robin Gill follow this up, if you have any connections with such people please do all you can)

No, I'm afraid that that is "not all I need to know".

I have been liaising with the MEA for months in connection with this issue and with others, for example, Annette Brooke, MP, and Vice-Chair of the APPG on ME, and they have been kept abreast of FOI developments and my researches into this issue.

In order to act on this information, they will need more than hearsay - and so do I.

I would not be prepared to pass on information to either the MEA or Annette Brooke unless I had documentary evidence that it has been confirmed by a named person at NRES that a review is in progress and what the timeline is.

So yes, I would like to be put in touch with your contact.

You already have my email address. You may pass this on to your contact and ask him/her to contact me.

Suzy

 

[fred]

I asked:

c) What types of information might be drawn attention to and to whom these should be addressed in the first instance?

That is, not what you consider would be useful information but what is set out by the procedure.

kermit frogsquire

There is no procedure, information that would be reasonably considered cogent to the ethical viability of the study is all that is needed. If one knows the specific GMC/BMA or MRC requirements for ethical studies on children with examples of their application then all the better. All polite and clear input that makes reasonable arguments with respect to the flaws in the original ethics decision are welcome.

I share Suzy's concerns about the bases on which people are challenging this trial as I do not believe that anything "reasonably considered cogent to the ethical viability of the study is all that is needed" (even if that is the 'official' line from NRES itself). I also do not believe that there is "no procedure", based on my own contact with NRES.

The arguments for requesting a review have to be compelling, totally unequivocal and based on (a) the REC's own approval and review standards and (b) empirical evidence (such as previous research studies) that challenges the contention of Crawley's application.

Has anyone acquired Crawley's submission documents so that the arguments she used to gain ethics approval can be assessed fully? Bear in mind that (a) the rationale for ethics approval posted on the Uni of Bristol website is just a sound bite and (b) Crawley runs workshops on how to gain ethics approval for 'CFS' research. It is likely that she will have provided multiple rationales to support the application and all should be properly challenged by those requesting a review.

Has anyone acquired the RECs' and/or NRES' approval and decision reviews processes? Unless these are known, how can a request for an appeal be targeted effectively? It will take more than simply a large number of letters from outraged patients to force a change of decision, as so clearly demonstrated by the weight of correspondence sent to the GMC about Sarah Myhill's case.

For a challenge to be taken seriously and stand a chance of succeeding, the evidence on which it is based must be relevant, accurate and compelling and, so far, I have not seen in this thread how this is to be achieved.

If a review is being launched, then it is likely there will be only one chance at it and the risks of failing do not bear thinking about. For this reason, and none other, it has to be done properly and thoroughly and not rushed through in a panic.