Action for ME: The PACE trial and behavioural treatments for M.E. [position statement]

I note you haven't addressed the factual error about AfME's involvement only starting in 2007 which I raise here.

https://www.s4me.info/threads/actio...s-for-m-e-position-statement.5532/#post-99817

If you want evidence, I can provide you with the 2002 application to the MRC made by the Principal Investigators which includes a letter of support from AfME. I also have minutes of the second meeting of the TSC (September, 2004) that list Clark as attending on your behalf.

Since this is a question of fact, I would appreciate if you could alter your statement so that it is accurate.

 

As one of the people making suggestions to AfME on this thread I am as keen as anyone to get answers, and to get them quickly. However, I am also realistic I think in saying that it is likely to take time. It's less than 2 weeks since we last heard from the AfME representative. I imagine detailed and quite radical suggestions some of us have made will need to be taken to the directors of AfME for consideration if they are to be acted on. I wouldn't be surprised if that process of discussion and decision making (if it is happening) will take a month or two. On the other hand our ideas may have been set aside. All we can do is wait.

 

Some of us have written to @Action for M.E. about this statement. The exchange is below.

While it's not everything we wanted, I think it is a good reply from Sonya.

Thanks to all those involved, including one other who helped with the drafting.


Dear Sonya,

We are writing to thank Action For ME for its recent statement on the PACE trial. We, and many other patients, welcome what has been said. None of what follows should be seen in any way to detract from our appreciation for that statement.

We would first ask you to address a factual error. AfME was involved with PACE from at least 2002 when a letter of support from the charity was included in an application to the MRC for the grant for the trial (1). Minutes (attached) for the Joint meeting of the Trial Steering Committee and Data Monitoring and Ethics Committee on 27th September, 2004, show Chris Clark attended as an observer on behalf of AfME. It is clear, then, that AfME's involvement did not begin only in 2007. AfME was involved from the application stage onwards. In the interests of accuracy and as we are sure the charity would not want knowingly to make a misleading statement, we hope this error will be corrected promptly.

We would also ask that you consider four matters arising out of the statement.

First, as you are aware, much of the work in revealing the flaws and poor conduct of the trial was undertaken by patients. These patients were vilified in the media, painted as unreasonable and science-deniers, compared to anti-vaxxers and the wilder, violent, militant fringes of the animal rights movement. This portrayal was deeply damaging and was personally upsetting to the patients involved. Patients feel AfME did not stand up for them on this issue and engaged for many years with those who were involved in painting this false, disparaging picture of them. We would hope that following on from AfME's statement about the trial and the implicit acknowledgement that these patients were in fact right all along, it would be possible also to make a statement that the allegations were false and caused considerable hurt to the patients.

Second, minutes (copies can be provided) of the Trial Steering Committee show that the Science Media Centre was asked to manage publicity for the trial publications. The SMC played a leading role in making the false allegations against patients and continues to brief journalists about them every time any paper on ME is published. When the reanalysis by Wilshire et al, which AfME quotes in its statement, was released, the SMC tried to undermine the paper by using 'experts' with a conflict of interest. It also published a factsheet on ME and an analysis of the reanalysis. All were criticized for making errors (Forward ME reaction on ME Association website here). It is known that individuals within the SMC have a particular view of the illness. It is no longer possible to consider the Science Media Centre as neutral on the subject of ME, and we would ask AfME to cut all ties with the organization and to issue a statement saying it has done so and why.

Third, all the faults in the PACE trial outlined in the statement apply to the SMILE trial. The intervention being tested is based on a false assumption about the nature of the illness; it seeks to persuade patients to ignore concerns about the consequences of activity; the criteria for inclusion in the trial were too broad; the main outcome is subjective in an unblinded trial; the outcomes were switched. We cannot see how AfME can make such a strong statement on PACE and not consider the same to be true about SMILE. We would also ask, then, that AfME makes a similar statement pointing out the same flaws in SMILE and disassociating itself from the trial and its claimed findings.

Fourth, we welcome AfME's rejection of GET and of any therapeutic approach that assumes ME is based on deconditioning. We would note that patient surveys, including AfME's own, consistently find large numbers of reports of harm caused by GET. We would ask finally, then, that AfME calls on NICE to change its guidelines immediately and stop recommending GET.

We would stress again how much we welcome the statement on PACE.

Please note we consider this email to be an open one and shall be sharing it and any response with other patients.

Thanks for your help.

Best wishes,


The Management Committee of the Science for ME forum

Graham McPhee

John Peters

Robert Saunders



Reply:

Dear John

Many thanks for your email, and for your feedback about our PACE statement, which I will share with the team. I appreciate the opportunity to respond to the further issues you have set out, and I’m going to address each one in turn.

With regards to the factual error in our statement, I understand that Clare has removed the 2007 date from this story so it is no longer misleading – many thanks for flagging this.

With regards to making an additional statement regarding the vilification of patients, this is something we are considering in the wide-ranging review of our digital and printed resources (ie. the update we refer to in our statement). You’ve referred to us engaging “for many years with those who were involved in painting this false, disparaging picture” and I am guessing here that you mean the researchers who led the trial, and the media. I have always tried to take a collaborative approach to moving the field forward and sometimes this means working with and/or alongside those who hold views I do not share. I apologise to those patients who feel they the charity did not stand up for them on this issue.

With regards to the Science Media Centre, we have no connections or relationship with the SMC. The only relationship we had was as part of the CMRC Board but, as they are no longer members, we have no contact with them.

With regards to the SMILE trial, we do not have any plans to undertake a critique of this or any other research in which we have had no involvement. While I question how likely the SMILE trial results are to have any meaningful impact on healthcare policy, I understand it has the potential to reinforce the stigma and misunderstanding around M.E. – something we strongly addressed in our statement on SMILE, along with the trial’s methodological limitations (eg. that the research team acknowledges they do not know which aspects of the treatment administered were the most effective).

With regards to asking NICE to change its guidelines immediately and stop recommending GET – As part of Forward ME, we have supported the Countess of Mar’s repeated requests to NICE to issue clear interim guidance, highlighting the risks associated with GET, while guideline CG53 is under review. NICE has repeatedly explained that they will not do this, and I see no value in committing more of our limited resources and capacity to this. Instead, we are engaging directly with healthcare professionals (eg. at the RCGP conference next month) to increase their knowledge and understanding of M.E. and the limitations/risks of the current guideline.

I thank you again for taking the time and energy to contact me directly, and I hope you and any other S4ME members feel welcome to do so in the future with any questions or feedback you have about our work. I understand that this response will be shared with other patients.

With best wishes

Sonya Chowdhury, Chief Executive, Action for M.E.


Response:

Dear Sonya,

Thank you for your reply, and for the correction about the date of AfME's involvement with PACE. We're glad to see the CMRC conference went well.

We look forward to reading your additional statement and hope you will be able to mention the hurtful vilification of patients. We welcome your apology.

We are glad that AfME no longer has any dealings with the SMC and hope also that you will not do so as long as the same people remain in position at the Centre.

We understand your position on SMILE and agree that the trial is not likely to have any impact on policy. We would note that, before it was folded into AfME, AYME played a prominent role in support of the trial. The fact that SMILE is being used to sell the Lightning Process causes us considerable concern and we would welcome a stronger statement from the charity stating clearly that there is no evidence for the effectiveness of the LP.

While we would prefer that pressure was maintained on NICE not to continue recommending GET, once again we understand your position.

Thank you for the offer to patients to contact with you with questions and feedback.

Best wishes.

Yours sincerely,

The Management Committee of the Science for ME forum

Graham McPhee

John Peters

Robert Saunders