By David Tuller, DrPH
I met Valerie Eliot Smith a year or so before I published my 15,000-word investigation of the PACE trial. As an experienced lawyer familiar with how libel and related torts are handled in the UK, she provided invaluable advice on legal issues. (She and her husband also suggested the name “Trial By Error,” for which I remain indebted.)
Valerie routinely posts her sharp commentary about legal issues and ME at her blog, Law and Health. Earlier this week, she posted a blog about the impact of the pandemic on the current guideline review that the National Institute for Health and Care Excellence (NICE) is conducting, as well as what that might mean for patients and the possibility of litigation. (The discussion is based mainly on UK law.)
Below is the first half of Valerie’s post.
COVID-19, NICE and ME: towards litigation?
Since that tweet, the COVID-19 crisis has continued to escalate worldwide. Given that the disease myalgic encephalomyelitis (ME) often has an infectious onset, inevitably there is already a considerable amount of discussion about whether or not the current pandemic is likely to trigger a rise in the number of cases of €œME€ in due course. Unfortunately, this discussion is not always as well-informed as one might hope.
At this critical time, the world is rightly focused on dealing with the immediate impact of the COVID-19 pandemic. Nevertheless, the need to continue advocacy work on behalf of the international ME community remains essential. ME is seriously misunderstood as an illness and the patient community remains devastated by decades of stigma and neglect.
National Institute for Health and Care Excellence (NICE) review of €œCFS/ME€ guidance
If there is an increase in the number of people in the UK diagnosed with ME (or, more likely, the misleading and inaccurate term €œchronic fatigue syndrome€ or €œCFS/ME€), then there is a serious risk that they will be directed to undertake Graded Exercise Therapy (GET).
In the UK, most medical professionals follow the treatment options recommended in the NICE Guidelines. In the Guidance for €œCFS/ME€, GET remains a recommended treatment. The current guidance has been in place since 2007. Since 2017, it has been undergoing an urgently-needed update which was due for publication in December 2020. However, on 27 March, an email was sent to the stakeholders who are participating in the update process. The email stated the following:
During this period of emergency, NICE has adapted its priorities to support the NHS, local authorities and the wider health and social care sector to tackle COVID-19. We will only publish guidance that is therapeutically critical or focused on COVID-19-related issues.The stakeholders and advisory committees involved in the development of our guidelines include a large number of frontline staff. We know that their priority in this crisis is caring for patients. We do not want to draw them away from this vital work.For this reason, we have cancelled all guideline committee meetings and we will not be publishing any draft or final guidelines until further notice (except for COVID-19 rapid guidelines €“ see below).At present we are not able to confirm the revised timelines for each guideline. We will be in touch to provide further information as soon as possible.
So the long-awaited update of the €œCFS/ME€ guidance has been delayed yet again, having been already postponed from the original publication date of October 2020 (see final page of document).
Does this delay matter?
Yes, it does. The current guidance is outdated, ill-conceived and founded on misinformation. The patient community has been lobbying for many years for the guidance to be reviewed and updated. A further delay in publication means an increased potential for newly-diagnosed patients to be subjected to GET, a treatment which is likely to be actively harmful. On top of that, the guidance is sometimes used as a weapon by the Department for Work and Pensions to deny benefit applications (refusal of treatment -> refusal of benefits)*.
In 2019, a patient survey was presented to the Chairman [sic] of the NICE Guideline Development Group. It was compiled in great haste, thanks to NICE’s tardiness in calling for the evidence. The Executive Summary states the following:
€œThe results show clearly that cognitive behavioural therapy [CBT] and graded exercise therapy are unsuitable treatments or management approaches for ME/CFS [sic]. The changes in severity and the worsening of symptoms are clear indications that the therapies being offered are having adverse effects on the health of individuals.€
Members of the ME patient community have been warning of the dangers of the NICE-recommended treatments for ME for many years. As of April 2019, when the patient survey was submitted, it is no longer tenable for NICE to claim that it was unaware of the potential harms which could be caused to ME patients who undertook GET as a result of expert medical advice.