Trial By Error: Current NICE Guidance Stands, For Now

By David Tuller, DrPH

Last week I sent an e-mail with some questions to Sir Andrew Dillon, the chief executive of the National Institute for Health and Care Excellence (NICE). In particular, the questions involved the status of the ten-year-old guidance for CFS/ME, CG53, and of references to the illness elsewhere within the NICE system.

A few days ago, I received Sir Andrew’s response. He indicated that the current guidance remains in effect while NICE undergoes the process of developing the updated version. Whether and how much the NICE recommendations actually change in the updated version is apparently up to the new guideline committee.

Here’s what Sir Andrew wrote:

“The current guideline remains in force until it is replaced by the next version. The decision to update was based on the potential for the evidence published since the guideline was introduced, together with the views put forward by stakeholders to change the current recommendations. Whether that potential is realised is a matter for the new guideline committee to decide, as they apply our guideline development methods and undertake consultation with stakeholders. Other NICE guidance which refers to our CFS/ME recommendations will reviewed [sic] and amended if necessary once the new guideline has been published.”

This was the response I expected, more or less, but it was still disappointing. NICE was remiss in the first place to accept Oxford-criteria studies, including the PACE trial, as legitimate science, given their obvious flaws. The agency has since outlined the reasons why the current guidance is not fit for purpose and needs a full update. Now it has an opportunity—and a moral obligation, really–to take a more proactive stance and alert patients to the concerns raised about these potentially harmful treatments.

If these concerns are truly being taken seriously by NICE, how can the agency stand fully behind CG53 in the interim? Can it really be ethical for NHS clinics and doctors to continue to prescribe CBT and GET based on the current guidance without mentioning that these treatments are up for review and have already been dis-endorsed by the U.S. Centers for Disease Control? Who will be liable for any harms arising from the recommendations going forward, now that NICE has acknowledged the problems?

Whether NICE recognizes it or not, the current guidance has already acquired something of a lame-duck status, especially given widespread international rejection of CBT and GET. Any further argument from the CBT/GET ideological brigades that their approach remains the accepted standard of care can now be readily refuted. And that’s bad news for the public and private disability insurance agencies that have long relied on the CBT/GET paradigm to reject legitimate claims for ME/CFS-related benefits.

Comments on this entry are closed.

  • Brenda Vreeswijk

    So…they keep on recommending a potential harmful therapy, based on manipulated trials conducted by people with a conflict of interest…until 2020 (that was the estimated year if I’m correct)…excellent patient care!!

  • pinklil

    “If these concerns are truly being taken seriously by NICE, how can the agency stand fully behind CG53 in the interim? Can it really be ethical for NHS clinics and doctors to continue to prescribe CBT and GET based on the current guidance without mentioning that these treatments are up for review and have already been dis-endorsed by the U.S. Centers for Disease Control? Who will be liable for any harms arising from the recommendations going forward, now that NICE has acknowledged the problems?”

    Exactly. Simply stating the extant Guideline has to be observed unless or until it is updated is disingenuous at best.

  • Peter Trewhitt

    Presumably this increases the legal liability of NICE for harm resulting from their advice being followed.

    Does this mean they are planning on ignoring the inconsistencies of ME being regarded in the Nice guidelines for functional disorders as a psychological condition and therefor should block from being seen by neurology?

  • Very disappointing. Although as you say, sadly not unexpected.

    I would have thought a precautionary note, highlighting the harms reported by patients from GET would be the minimum. Patients really need to be protected from the potential dangers of exercise. What happened to “First do no harm” !!

  • Oldfarticus

    There’s a limit to how much research I can do, but I still haven’t found a way patients can report harm from CBT/GET independently. Without an official channel to report harm from non-pharmacological treatments, NICE can operate in ignorance. It seems like there’s a huge gap in data collection when it comes to psychological interventions, it’s fairly oppressive all things considered.

    I keep trying to ask around to see if anyone has any idea, but have turned up nothing so far. Maybe a letter to PALS (Patient Liason Service) might be my last step.

    I presume the ambiguity/lack of specialised verification in anecdotal accounts and patient surveys allows them to continue with this madness.

  • Wendy Boutilier

    The best way to get their attention is the legal way. They are knowingly setting standards of questionable health care.

  • John Peters

    The big question and concern is over the people who will be on the guideline committee. If Esther Crawley, Bavinton, Downes etc are on the committee again, then everyone knows what the guidance will be. This gets a bit recursive, but we need to know who will decide who is on the guideline committee and what procedures they’ll follow. Will they exclude those who have a financial interest (Bavinton etc) and those who have a researcher allegiance (eg Crawley)? How will they determine the balance of the committee? If they simply select again a bunch of psychiatrists, psychologists, physiotherapists and occupational therapists who are involved in delivering CBT-GET, guess what they’re going to recommend?

  • Paul_Watton

    Following this response, for NICE to then take in excess of 2 years to complete the review process, is utterly irresponsible. They know that they are neglecting the interests of patients, but clearly they don’t care.

  • Jen

    Depressing. It’s not just a case of GET & CBT being ineffective, they are actively harming a great number of patients. It’s disturbing a health body that is there to supposedly protect patients Is willfully sitting on their hands in this matter. Over 15,000 patients signed the MEA petition to NICE citing harm from GET, I just don’t understand how they can just ignore patients in this way. If this was a drug significantly harming such a large number of patients so severely it would be immediately withdrawn. I really don’t understand it.

  • Graham McPhee

    And, of course, everything hinges on the composition of that committee: it’s not looking good from my perspective.

  • Steve Hawkins

    Once again Sir Andrew is being rather misleading when he talks about the guidance ‘remaining in force’. This encourages people to believe it is a legal document, which it is not. As I’ve noted before, NICE, used to publish a statement on the legal status, but they don’t publicise it now, and everyone seems to think they are impelled to follow what is clearly *just guidance* to *help* doctors make choices–which they have to make after considering *all* the evidence, and then deciding *in discussion with their patients*, what is best for them.

    If doctors follow this guidance, and do harm, NICE can still say, it wasn’t their fault the GP didn’t keep up with developments that made the guidance obsolete:

    “Implications for clinical practice 

    Once NICE guidance is published, health professionals are expected to take it fully into account when exercising their clinical judgment. However, NICE guidance does not override the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and/or their guardian/carer.  

    In particular, guidance that does not recommend a treatment or procedure, or that recommends its use only in defined circumstances, is not the same as a ban on that treatment or procedure being provided by the NHS.  

    If, having considered the guidance, a health professional considers that the treatment or procedure would be the appropriate option in a given case, there is no legal bar on the professional recommending the treatment or on the NHS funding it. 

    For example, if an individual patient is known or is likely to suffer a serious adverse reaction to a recommended drug it would be appropriate for their health professional to prescribe an alternative.  

    Any health professional who is considering departing from NICE guidance may wish to discuss the issue fully with the patient and/or their guardian or carers and should keep a record of his/her reasons for taking such a decision in the patient’s notes”‎

    Thus they don’t even have to ask other doctors: they just have to explain properly to the patient and their carers. So long as they document their actions and can show good reasoning behind them–such as ‘the definition of M.E requires post exertional malaise’, therefore I do not consider GET to be in her best interest–there should be nothing for any doctor to worry about, and much for Chalder and her cult to answer for, as they blindly follow guidelines‎ that are very out of date–esp after the IOM report.

    Thus Sir Andrew is wrong to tell people that the guidelines are ‘in force’: they are *current*: that is all. And, what is more: they are obsolete, and doctors who follow them are on legally shaky ground.

    http://www.forward-me.org.uk/Letters/Legal_context_nice_guidance.pdf

  • Paul_Watton

    Their refusal to do the right thing has to be viewed in the context of their longstanding defence of the flawed guideline.

    I’m guessing, but it’s reasonable to assume that the circumstances surrounding their victory at the judicial review and their repeated refusal to review the guidance, have ramped up the stakes to the point where they felt unable to back-down and admit that they got it wrong. Whilst they won the relatively short-term battle, the emerging evidence means that (sooner or later) they will inevitably lose the war

    They’ve created a really bad position for themselves, which they feel compelled to defend, so they’re now trying to navigate a face-saving way out. Taking 2+ years to do it, just makes things worse.

  • mesupport

    Einstein once said that insanity is doing the same thing over and over and expecting a different result. Can we take it that NICE subscribes to Albert Einstein’s definition of insanity: “doing the same thing over and over and expecting a different outcome.”

  • mesupport

    CDC are facing a similar scenario in making changes whilst unable to acknowledge previous failings of policy within the organization stretching back decades.

  • Steve Hawkins

    Where did yesterday’s posts go? Mine has disappeared. It was important. :/

  • Steve Hawkins

    Still says in Disquss ‘detected as spam: we’ll try to do something about it’. 🙁