IiME write to Prof Mark Baker of NICE: Battle lines are drawn

[Countrygirl]

http://www.investinme.org/IIMER-Newslet-1801-01.shtml#MBaker-reply


IiME have been in correspondence with Prof Baker over the past 48 hours.

The first letter is from IiME to Prof Baker.

The second is Prof Baker's totally unsatisfactory response.

The third is IiME's reply

There is heavy use of the word 'negligent' and the suggestion that each patient keeps a record of these letters on file so in the event of being harmed by the medical profession as they impose the suggestions of the NICE guidelines on us we can use it to sue.

Letter to Professor Mark Baker
Centre for Guidelines Director, National Institute for Health and Care Excellence

15 January 2018



Professor Mark Baker
Centre for Guidelines Director
National Institute for Health and Care Excellence

NICE Guidelines for Myalgic Encephalomyelitis (ME)
15 January 2018

Dear Professor Baker,

Invest in ME Research is a UK charity (charity nr 1153730) that seeks to educate and campaigns for biomedical research into myalgic encephalomyelitis (ME). The charity also facilitates and funds biomedical research into ME.

Although Invest in ME Research is a stakeholder in the NICE Guidelines review process, and will contribute to those discussions, we feel there is an urgent matter that needs to be addressed immediately, irrespective of progress with a NICE Guidelines review and separate from the full review process.

This concerns the continuing recommendation for use of Cognitive Behaviour Therapy (CBT) and Graded Exercise Treatment (GET) for ME which are still held in NICE Guidelines and still, apparently, being used by doctors treating people with ME.

It must surely be realised by all now that CBT and GET are inappropriate for treating ME and in many cases have proven to be deleterious to the health of patients.

The PACE Trial) [1], which was supposed to prove the efficacy of CBT and GET for ME, has been proven to be flawed [2], possibly fraudulent [3] and a complete waste of tax payers’ money.

Reanalysis of PACE Trial results by Matthees et al (once the data was forced to be released from the authors following a legal challenge) stated -


"This re-analysis demonstrates that the previously reported recovery rates were inflated by an average of four-fold." [4]




The PACE Trial is now being used as an example of how not to perform research – and it is widely seen as flawed and is ridiculed. Several articles by David Tuller academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley, have exposed these flaws and demonstrated that the PACE Trial cannot be considered valid [5]

NICE cannot use PACE for anything other than to reject its previous guidelines comments. Continuing to use PACE Trial references to justify CBT and GET will invalidate any further review.

The reason for sending you this letter now is that we believe a full review of the NICE guidelines that may take two years or more will leave patients exposed to these harmful treatments (CBT and GET) and it is not acceptable.

We stated this in our submission in July 2017 [6] -


“NICE will be accountable if it ignores the advice to withdraw this unsound recommendation. NICE would be negligent.”

“NICE must be accountable for damages, and costs, relating to the burden brought on to patients by this erroneous and negligent recommendation.”

“By ignoring the recent IOM, NIH, AHRQ and CDC decisions to remove CBT and GET from their recommendations and stipulate that the Oxford criteria and research using those criteria need to be abandoned then NICE are negligent.”


You stated yourself [9] that " … the ME/CFS Guideline specifically, …… did not meet our [patients’] needs and it did not meet theirs (NICE’s) either.".

By removing the recommendations for CBT and GET from the existing guidelines now, with an addendum or correction of some sort, it could go a long way to establishing some trust in NICE from patients that was forfeited when the previous guidelines were published and the views of patients were ignored.

It would publicise the fact that NICE are responsible and would avoid future possible litigation from those adversely affected by CBT and GET in the intervening period before a new set of guidelines have been published.

The full review of the guidelines for ME will take time. There would be no excuse not to remove what is already known to be faulty recommendations.

Thank you for taking the time to consider this request,

Yours Sincerely,

Kathleen McCall

Chairman Invest in ME Research
and the Trustees of Invest in ME Research

References

Dear Ms McCall

Thank you for your letter.

As you are, I’m sure, aware the NICE guideline on ME/CFS was published before the PACE trial was seriously under way. Our recommendations were based on a body of research which preceded the PACE study. In our most recent review of the guideline, and cognisant of the controversies regarding the interpretation of the PACE results and methods, we assessed the evidence with, and without, the PACE results and the trial made no difference to the conclusions. Therefore, I cannot accept at this stage that reports of flaws in one study invalidate the results of all the studies in this area.

I appreciate that the existing recommendations are a matter of concern to some patients and groups and we will give some consideration to whether we need to modify or omit any of the existing recommendations during the development of the new guideline. We will certainly consult the new Committee members, when appointed, on this and a number of other issues.

In the meantime, I will keep your letter on file for future consideration and reference.

Best wishes

Mark

Professor Mark R Baker
Director, Centre for Guidelines
National Institute for Health and Care Excellence

Invest in ME Research feel this reply is not consistent with expectations from a public body which is responsible for the health and welfare of sick and vulnerable patients who could be affected by flawed guidelines.

We have therefore given this response to Professor Baker -

Invest in ME Research Reply to Professor Baker - 16th January 2018

16 January 2018
Professor Mark Baker
Centre for Guidelines Director
National Institute for Health and Care Excellence

NICE Guidelines for Myalgic Encephalomyelitis (ME)
16 January 2018

Dear Professor Baker,

Thank you for your prompt reply on this matter. You state in your reply that –

“the NICE guideline on ME/CFS was published before the PACE trial was seriously under way. Our recommendations were based on a body of research which preceded the PACE study. In our most recent review of the guideline, and cognisant of the controversies regarding the interpretation of the PACE results and methods, we assessed the evidence with, and without, the PACE results and the trial made no difference to the conclusions”.

As you will be aware Invest in ME Research challenged that.

It seems very strange that you can state categorically that NICE found no evidence to change the conclusions and, therefore, did not alter the recommendations of using CBT and GET for ME.

However, you are now aware that the NIH, CDC, AHRQ and IOM in USA are not only downgrading CBT and GET but have removed them from as recommendations.

Finland’s Valvira has also now removed the suggestion that CBT and GET be used for ME.

We have to state that we are somewhat shocked by your lack of action.

It is unfathomable why you continue to allow these recommendations for CBT and GET to stand.

The existing recommendations from NICE are hardly “a matter of concern to some patients and groups”! They are, in fact, a matter of life and death for sick and vulnerable patients – those whom even you have admitted have been ill served by NICE guidance.

Perhaps it might be of use for you and your team to read the last post from Anne Örtegren – a brave, severely affected yet articulate patient in Sweden who suffered enormous damage caused, in part, by poor medical advice http://www.investinme.org/AnneÖrtegren.shtml

We wonder if this is the outcome you, and NICE, really wish to risk imposing on ME patients.

To ignore completely the evidence that is in front of you makes you directly responsible for any harmful effects administered by practitioners of CBT and/or GET following referral by any doctor who follows NICE guidance.

Whilst you may be providing cover for establishment organisations and individuals, you are not protecting patients – surely that should be your overarching concern.

What you must do, at the minimum we feel, is to issue an addendum to the existing NICE guidelines which states that not only are patients wanting to remove the recommendations for use of CBT and GET for ME but also that the USA agencies have removed CBT and GET from their recommendations. This will not only give some protection for your own liability but you could actually be saving lives.

We also urge you to rethink your decision.

In the meantime we will advise all patients and their carers to retain a copy of your reply on their files so that, in the event of their being adversely affected by the NICE recommendation to use CBT and GET for ME, they may be able to use your statement to show the abrogation of responsibility by your organisation.

We would also state that this does not bode well for the forthcoming review of these flawed guidelines,

Yours Sincerely,

Kathleen McCall

Chairman Invest in ME Research
and the Trustees of Invest in ME Research

 

[Jonathan Edwards]

'Therefore, I cannot accept at this stage that reports of flaws in one study invalidate the results of all the studies in this area.'

Point 1: PACE invalidates the results of all the previous studies because it has brought to the attention of people who know something about trial design that all the other studies have been carried out with methodology so poor that they are meaningless.

Point 2: Whereas previous studies may have given weak evidence for a positive effect of CBT and GET, as Kindlon (and others) has cogently pointed out, PACE actually gives strong evidence for no effect. Objective measures did not change. Recovery was minimal. Extended follow up at two and a half years showed NO BENEFIT AT ALL over the null comparator (not to be confused with a control).

 

[Deepwater]

Confirms my worst suspicions - that agreeing to a review was simply an attempt to take the steam out of the patient campaign and that it is not intended that anything substantial will change.

Mark Baker writes: "Our recommendations were based on a body of research which preceded the PACE study."

As if the public sector would have coughed up £5M for further research on a subject for which adequate evidence already existed! I'm actually pretty sure that the official reason given for doing the PACE trial was that there was a lack of empirical data for these existing treatments. The relevant quotation needs to be brought out in response, and Mark Baker also needs to be made to state explicitly what studies the 2007 GET/ CBT recommendations were based on.

I'd be hopping mad if I could still hop without falling over.

 

[Countrygirl]

Following the stakeholder meeting IiME have forwarded a strong(er) letter to Prof. Baker:

17 January 2018



Professor Mark Baker
Centre for Guidelines Director
National Institute for Health and Care Excellence

NICE Guidelines for Myalgic Encephalomyelitis (ME)
17 January 2018

Dear Professor Baker,

Thank you again for your reply to our letters.

We apologise for taking up more of your time but there is one issue that has now arisen which we feel needs clarification and action.

At the Stakeholder engagement workshop meeting yesterday you were reported as saying that the existing NICE guidelines would be “torn up” and new guidelines developed.

Yet yesterday, just a few hours before that meeting, you wrote to us and stated –

“In our most recent review of the guideline, and cognisant of the controversies regarding the interpretation of the PACE results and methods, we assessed the evidence with, and without, the PACE results and the trial made no difference to the conclusions”

and that you would

“give some consideration to whether we need to modify or omit any of the existing recommendations during the development of the new guideline”

These remarks seem to us to be contradictory.

If you are now telling participants at yesterday’s meeting that the existing guidelines will be torn up then you are effectively stating that they are of no value.

Therefore, there is no logic in retaining the existing guidelines any longer, which you have previously stated were not effective and which you are now alleged to have said will be completely removed in any case.

If you decline to take action in issuing the addendum that we have requested then the most logical action that NICE must now take is to withdraw the existing guidelines completely, immediately, and inform all doctors across the UK that the existing guidelines are not fit for purpose and the recommendations in those guidelines are not to be used.

This notice should also be communicated around the world to any foreign organisations that have misguidedly used the existing NICE guidelines for their own healthcare systems.

It is better to have no guidelines than to have guidelines that will potentially harm patients.

Although withdrawal of the guidelines may be embarrassing for NICE this action would avoid the need to add the addendum that we previously requested and would serve patients – the very people that the guidelines should help at the end of the day.

This action could also demonstrate that your words mean more than the meaningless platitudes that patients in UK have long been accustomed to from establishment organisations over the last decades. You can change that – Tear It Up!

Failure to withdraw these now would invite speculation that you are leading patients down one of the longest garden paths in history,

Yours Sincerely,

Kathleen McCall

Chairman Invest in ME Research
and the Trustees of Invest in ME Research