Category: News and events

How much do you weigh?

Barts-MS rose-tinted-odometer  ★

When last have you weighed yourself and calculated your BMI (body mass index)? 

BMI = body mass (kg) / the square of the body height (m) [kg/m2]; to save you time and effort you can simply use the NHS BMI calculator, which takes imperial measurements as well. 

I am not sure if you are aware that childhood and adolescent obesity is an important risk factor for developing MS. We estimate that smoking and obesity could account for 1 in 5 new cases of MS. Obesity is a complex disorder that tends to run in families. The familial link is not only due to the effect of genes but cultural and social factors. If you are obese, or very obese, you need to do something at a personal level that may inform what the next generation does about it; good habits are infectious. 

I have little doubt that obesity impacts on MS outcomes. Obesity affects mobility and is associated with deconditioning and poorer outcomes. I recall a patient of mine with primary progressive MS losing over 30 kg in weight, with his BMI dropping from over 30 to less than 24, and in parallel, his EDSS improved from 6.5 to 5.5. The latter improvement was from him getting fit from his 5-day per week exercise programme and making the effort. 

As you are aware obesity is associated with a metabolic shitstorm that impacts on many disease processes. Obesity causes metabolic syndrome (hypertension, insulin resistance, glucose intolerance, diabetes and dyslipidaemia) and a systemic inflammatory syndrome that may worsen MS. Therefore, there is a good reason why, if you are obese you should consider doing something about it. This is easier said than done. To start I would recommend you read “Why we get fat and what to do about it”, by Gary Taubes or you can watch his lecture on YouTube. Understanding the metabolic issues that underlie obesity will allow you to understand what to do about it. The latest science behind obesity is not rocket science.

Why this post just before Christmas? Christmas is a time of excess and maybe this post will make you mindful of what and how you eat. I was horrified when I read the forecast in this week’s New England Journal of Medicine that by 2030 1 in 2 US adults will be obese. The conclusion of the paper says it all. 

“We project that given current trends, nearly 1 in 2 U.S. adults will have obesity (BMI>30) by 2030, and the prevalence will be higher than 50% in 29 states and not below 35% in any state — a level currently considered high. Furthermore, our projections show that severe obesity (BMI>35) will affect nearly 1 in 4 adults by 2030 and become the most common BMI category among women, black non-Hispanic adults, and low-income adults.”

 Estimated Prevalence of Overall Obesity and Severe Obesity in Each US State, from 1990 through 2030. Image from the NEJM.

I suspect the UK is not far behind the US. What we need to realise that underlying this epidemic in obesity is an MS epidemic. Don’t you think we should do something about it?

Ward et al. Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity. N Engl J Med, 381 (25), 2440-2450 2019 Dec 19.

Background: Although the national obesity epidemic has been well documented, less is known about obesity at the U.S. state level. Current estimates are based on body measures reported by persons themselves that underestimate the prevalence of obesity, especially severe obesity.

Methods: We developed methods to correct for self-reporting bias and to estimate state-specific and demographic subgroup-specific trends and projections of the prevalence of categories of body-mass index (BMI). BMI data reported by 6,264,226 adults (18 years of age or older) who participated in the Behavioral Risk Factor Surveillance System Survey (1993-1994 and 1999-2016) were obtained and corrected for quantile-specific self-reporting bias with the use of measured data from 57,131 adults who participated in the National Health and Nutrition Examination Survey. We fitted multinomial regressions for each state and subgroup to estimate the prevalence of four BMI categories from 1990 through 2030: underweight or normal weight (BMI [the weight in kilograms divided by the square of the height in meters], <25), overweight (25 to <30), moderate obesity (30 to <35), and severe obesity (≥35). We evaluated the accuracy of our approach using data from 1990 through 2010 to predict 2016 outcomes.

Results: The findings from our approach suggest with high predictive accuracy that by 2030 nearly 1 in 2 adults will have obesity (48.9%; 95% confidence interval [CI], 47.7 to 50.1), and the prevalence will be higher than 50% in 29 states and not below 35% in any state. Nearly 1 in 4 adults is projected to have severe obesity by 2030 (24.2%; 95% CI, 22.9 to 25.5), and the prevalence will be higher than 25% in 25 states. We predict that, nationally, severe obesity is likely to become the most common BMI category among women (27.6%; 95% CI, 26.1 to 29.2), non-Hispanic black adults (31.7%; 95% CI, 29.9 to 33.4), and low-income adults (31.7%; 95% CI, 30.2 to 33.2).

Conclusions: Our analysis indicates that the prevalence of adult obesity and severe obesity will continue to increase nationwide, with large disparities across states and demographic subgroups. (Funded by the JPB Foundation.).

CoI: multiple

Sorry to disappoint

Many of you who have requested an opinion from Barts-MS, and don’t live in the Barts-MS catchment area, have discovered that your referral to our service has been rejected. I have a handful of complaints from patients wanting to see me in the last week or so. The reason is that we can’t cope and we are now putting our existing patients at risk!

We have just completed a review of our MS Services and have come to the conclusion that without more resources we are unable to cope with the rising demand.

As you can see from the graph above the number of patients on DMTs at Barts-MS has quintupled in the last 7 years. Hidden in these figures is the fact that we have had no increase in staff to manage this increased caseload. In addition, close to 70% of our patients on DMTs are out-of-area. These out-of-area patients are being managed by our service rather than their local MS team. The consequences of this are that the quality of our MS service is suffering and we are now having difficulty looking after our ‘own patients’.

Another factor that is going to have a big impact on our service is the licensing of DMTs for active progressive MS, i.e. ocrelizumab for PPMS and siponimod for SPMS. This means more visits, more MRI monitoring and many more patients on DMTs. Something has to give!

Increasing our staff complement is not easy either. Barts Health NHS Trust has been under special measures for several years and has one of the largest deficits in England. Business cases to expand our MS Services get submitted and are held-up for years. For example, it has taken us over 3 years to get our Trust to support an MS clinical nurse specialist in Newham. This is despite the fact that the salary of this post will be covered by the MS Trust for the initial two years and that 50% of the salary after that will be covered by the local clinical commissioning group or CCG.

To try and address the service issues we have just submitted a grant to the Big Lottery Fund to transform our service into a distributed network. The configuration of the service will be a co-design project with patients, GPs and HCPs working with people with MS. The good news is that we are doing this with All-Together-Better, an innovative NHS team, who have experience in transforming services.

So Barts-MS would like to apologise to you all that we are not going to be able to take on the management and treatment of any more out-of-area patients with MS unless something drastically changes with the funding model in the NHS.

We hope you understand.

CoI: multiple

Rose-tinted-ometer

In response to a request from one of our reader’s I will be testing out a new feature on the blog; the so-called Barts-MS rose-tinted-ometer.

The rose-tinted-ometer derives its name for having a rose-tinted view of the world. Someone with a rosetinted view of the world has an unduly idealistic, optimistic, sentimental, or wistful perspective on or about something.

In future, my blog posts will be rated from zero to 5-stars on the rose-tinted-ometer. The reader can then choose whether or not to read the post, based on whether or not they want good, bad or other news.

When I started thinking about rating my posts I was considering making an ostrich-ometer, i.e. a rating scale on how far you wanted to bury your head in the sand. However, I soon realised this is really a binary scale; you either have your head in the sand or you don’t 😉

Time-poor

I want to apologise to my patients for running late in clinic yesterday. Since reducing my NHS, or clinic time, from 50% to 20% of my work week and moving onto a yearly job plan I stopped cancelling clinics. I now move them to ‘ad hoc’ slots at a different time of the week. This may increase my workload, but it also means that I don’t have to overbook clinics, which I used to do in the past whenever I would cancel a clinic.

This means that occasionally I have extra clinics with more complex patients. Yesterday was one of these clinics. A clinic with patients who simply needed time. Time to discuss and deal with complex problems. Time to formulate complex management solutions. Time to spread hope. Time to try and be a good doctor. Time to build trust. Time to get to know the patient in front of you. Time, time, time …… a most precious commodity.

When I went back to my office in the afternoon I estimated that in addition to the 4.5 hours of face-time in yesterday’s clinic I will need another three to four hours of administrative work to implement all the actions points resulting from the decisions taken in the clinic. For example, one medical report I agreed to write for a patient to support their employment tribunal, will take me at least an hour as it will need to be researched and well-referenced; it needs to be comprehensive so as to be lawyer-proof. 

Coincidently, I read the Shattuck lecture in this week’s NEJM on the tube this morning. It was written by John Noseworthy, a colleague and fellow MSologist. The theme is on how to preserve the patient-doctor relationship in the current work environment. Although this was written from an American perspective all the issues raised are relevant to the NHS. The core theme of his lecture is time. John mentions ‘time’ a remarkable 27 times in the lecture. I would urge you to read it. I think John is highlighting an existential crisis for physicians and the relationship they have with their patients. The crisis can be summed up in one phrase, ‘time-poor’. 

Help! 

John Noseworthy. The Future of Care — Preserving the Patient–Physician Relationship. N Engl J Med 2019; 381:2265-2269

Excerpts: 

….. First, it is critical to enable physicians to spend adequate time with patients who need extra time, such as those with diagnostic uncertainty, those whose treatment plans are failing, and those at the end of life….. 

…… At the same time, Americans are grappling with vast societal problems, such as unacceptably high maternal mortality, the tragedy of gun violence, and the opioid crisis, as well as disparities in access to such essential services as early childhood education and healthy nutrition. When their own health is affected, they seek answers from many sources, including the Web, social media, walk-in clinics, pharmacists, and others — or end up adrift in a fragmented health care system, where they don’t get enough time with their clinicians and they suffer from the lack of a single trusted professional who can help them bring together disparate data points to arrive at unifying answers and a plan….. 

…… Attending to the business and financial aspects of health care is necessary, but this focus too often overshadows the human side of medicine. A key attribute of physicians is the commitment to caring for others — the desire to reduce suffering and make a meaningful difference in the lives of patients, often at their time of greatest need…..

….. Many physicians struggle to use technology in a way that enhances their enjoyment of their practice, and they resent spending more time doing clerical work than seeing patients….. 

…… I would suggest ….. allowing more time with patients when needed and designating coordinating physicians to reduce the fragmentation of health care — merit similar consideration. 

……. I believe the patient–physician relationship will remain fundamental to the future of health care and that we therefore need to invest in it once again. Healing begins when patients and their physicians build trust — a process that often takes time, especially when the patient’s health and future are in jeopardy. There is no app for that. The medical profession will have to be creative in finding ways to serve our patients better….. 

…….. Insufficient time with patients in need and the lack of care-coordinating physicians are emblematic of the fragmentation of health care, which leads to massive waste, delays, missed opportunities for cure, medical errors, and enormous dissatisfaction on the part of patients and physicians alike….. 

…… “The best interest of the patient is the only interest to be considered, and in order that the sick may have the benefit of advancing knowledge, union of forces is necessary.” These two principles — which map directly to my “adequate time with patients who need it” and “coordinated care” — have guided the Mayo Clinic since its inception….

….. Patients who have complex medical issues or multiple coexisting conditions frequently fall through the cracks in our health care system. They often express frustration that no one is taking responsibility for their total care. At the same time, all physicians understand that patients who require extra time present a challenge in a busy practice. Without a system that anticipates this need, either time is granted and the patients who are waiting to be seen next are inconvenienced or time is not granted, which both frustrates the patient who has a complex problem and delays answers…… 

…… The leaders who are responsible for fostering an institution’s culture can take the principles of adequate time and coordinated care into account when they contemplate practice redesign, management of schedules, institutional support for various types of visits, and expectations of physicians. …

….. With the pervasive emphasis on costs and efficiency, physicians have seemingly given up on unhurried time with patients. But we can rethink this norm and fight for our patients. A sound clinical and business case can be made for spending more time with certain patients. ….. 

…… Having adequate time is often essential for reaching an accurate diagnosis and developing an appropriate treatment plan, and conquering those tasks efficiently can ultimately help bend the cost curve in health care….. 

…… But having the flexibility to spend more time with patients who need it reduces their suffering and helps both health care organizations and patients save money. It also boosts satisfaction for physicians. …..

….. The work of refocusing medicine on humans rather than finances needs to happen within individual practices, specialty groups, and hospitals. Physician leaders can work to achieve a consensus that problems involving issues of time and coordination are worth addressing and provide opportunities to identify innovative solutions….. 

….. Involving all the members of a team and rethinking the purpose of their work and the skills they bring to the practice. The amount of time and effort needed to change a practice’s workflow depends on the team’s maturity…..

……  Everyone, from the appointment secretary to the nurses and physicians, brings perspectives and insights that can contribute to effective change and collaboration, given sufficient time and trust in the team-building process. …. 

…. If the care team is empowered to collaborate on solutions, then technology can take its rightful place as a tool, rather than being a barrier, and tasks such as record review, order entry, and documentation can be offloaded from physicians, allowing them more time with their patients….. 

……… Building a partnership with administration for long-term support. Redesign efforts are always more difficult and time-consuming than expected. Even the Mayo Clinic, where teamwork is a bedrock principle, must provide constant support, resources, and institutional prioritization for taking time to work in teams — time that is always in short supply in today’s climate focusing on productivity and volume….

….. Revamping payer reimbursement so that it covers time spent with patients and performance of the coordinating physician role will require validation of new metrics, including the speed and accuracy of diagnosis to reduce fragmentation, the appropriate use of diagnostic services to reduce costs, and the use of innovative follow-up visits with various members of the care team, including assembled groups of specialists (using telemedicine and other digital connections as necessary), to improve adherence and outcomes, as well as new measures of patient and physician satisfaction……

CoI: none

Not diagnosing MS

Last night when I got home I was emotionally burnt-out. I had done an all-day clinic and saw many difficult and challenging patients with MS, both new and follow-up patients. My wife asked me if I had a good day. I replied that it had been exhausting and that I felt numb. She said there must have been something rewarding in my day’s activities? On reflection, there were a lot of small moments that made me feel I was doing something worthwhile. This is highly relevant because my clinical director has recently recommended I stop seeing patients so that I can focus on research for the last decade of my academic career. The question is am I ready to auction off my vintage patella hammer and ophthalmoscope and not see another patient?

The most satisfied patient I saw yesterday was a young woman in whom I was able to not make the diagnosis of MS. Her white matter lesions were non-specific, her CSF was clear (no oligoclonal IgG bands and normal neurofilament levels), she had a full set of evoked potentials, which were normal, and her neurological examination was entirely normal. She has a positive family history with her mother and aunt having died of the MS-related complications. After presenting with visual and sensory symptoms her previous neurologist had been influenced by the family history and raised the possibility of her having MS. The non-specific white matter lesions on MRI had cemented the possibility in both the referring neurologist’s and the patient’s minds. 

The tragedy of this case is that this patient has been living with the possibility of having MS for the last 6 months. Her anxiety levels were sky-high and she had already internalised the diagnosis and had started to behave like someone with a chronic disease. She developed ‘MS-fatigue’, which on reflection was due to anxiety and depression and had tragically turned down a promotion at work that required her to transfer to her company’s office in New York. On reflection, her symptoms were almost certainly due to migraine aura. She was not the only patient to cry in clinic yesterday, the only difference was that her tears were tears of joy. 

Not diagnosing MS is easier than undiagnosing MS, which is a topic I teach on frequently. There are many reasons why people are misdiagnosed as having MS, but it is much commoner than you realise. I am not sure if you are aware that if you have MS there is a 1 in 20 chance that you have another disease; if you are interested I have already covered this issue in a previous blog post. 

Time is Brain

So what has the UK’s poor performance in relation to cancer survival has to do with MS? A lot. These cancer statistics are collected as part of a national audit and are a bellwether for NHS services in general. If we had national MS statistics they would indicate similar problems, i.e. delays, delays, more delays and poorer outcomes. This is why we wrote a policy document ‘MS Brain Health: Time Matters’ to try and get the MS community to treat MS more urgently and effectively. This is also behind the motivation of our ‘MS Service Provision – Raising the Bar’ initiative to improve MS services and outcomes across the country. 

I would be interested to know if the same issues exist with MS as the do with cancer diagnosis and treatment? 

How long did it take to see your GP?

Did you feel you were wasting your GP’s time?

Did your GP interpret your initial symptoms correctly?

Were you promptly referred to see a neurologist?

How many GP visits did it take to get a neurology referral?

Were you forced to go via accident and emergency to see a neurologist?

How long did you wait to see a neurologist?

How long did it take to get a diagnosis of MS?

How long did it take to be started on treatment?

Are you being monitored for subclinical MRI activity with annual MRI scans?

Have you been offered escalation therapy or an immune reconstitution therapy?

Were you involved in the decision making around your treatment?

Etc. 

These are the kinds of data we need via a national MS audit to benchmark MS services. The idea is to use the data to get rid of unnecessary variation in the provision of MS services. 

Ruth  Thorlby. UK’s poor performance on cancer survival. BMJ 2019;367:l6122

Excerpts:

…. the UK had the lowest five-year survival rates for four out of seven cancers….

…. If international variations in cancer survival are real and represent important differences in healthcare systems, what have ICBP studies revealed about their causes? A 2015 survey of around 19 000 people aged ≥50 found that public knowledge of possible cancer symptoms was not substantially worse in the UK than in other countries, but people in the UK were more likely to worry about wasting their general practitioner’s time (34% agreed with this in the UK compared with 9% in Sweden)…..

….. A parallel study of GP referral practices across countries found an association between higher survival rates and GPs’ willingness to investigate or refer quickly, which led some to argue that health systems where GPs have a gatekeeping role were more likely to have poorer cancer outcomes….

…… Although differences between countries existed in the time it took for patients to see their GP for the first time and in time to onward referral, diagnostic tests, initial diagnosis, and start of treatment, these were not obviously associated with survival differences. Each country had a long “tail” of patients waiting many months to start treatment…..

….. Closing the gap between the UK and other countries will require further progress in all four devolved countries. In England, the NHS Long Term Plan, published in early 2019, contains a comprehensive plan for improving cancer services, including multiple strategies for earlier diagnosis with the aim that by 2028, 75% of cancers will be diagnosed at stage 1 or 2. This is ambitious in the current climate….. 

……  Interviewees for our 2018 report Unfinished Business were clear that the 2012 Health and Social Care Act brought unwanted organisational upheaval—for example, to cancer networks. A period of relative austerity in the English health service since 2012 has magnified other problems too. These include worsening workforce shortages in essential professions (such as general practice, diagnostics, and specialist nursing), the diversion of capital funding into everyday expenditure at the expense of maintenance and investment in new equipment, and, more broadly, a short term approach to planning services. Without tackling these fundamental problems, England will struggle to make its contribution to closing the survival gap between the UK and other countries…

CoI: multiple

Adios Mexico

A big thank you to my Mexican friends and hosts for such a wonderful experience at the annual meeting of the Mexican Academy of Neurology. Your hospitality and friendship were truly special, not to mention the food, tequila, weather and the Pacific ocean. As promised I have uploaded my presentations onto my SlideShare site for you to download and use.

Talk 1 – Case studies

Talk 2 – Treatment algorithms

Talk 3 – Maintenance/Escalation vs Immune Reconstitution Therapies

CoI: multiple

Brave dreams, or not

A blast from the past. Just when we thought CCSVI had died a quiet death the Brave Dreams trial is reported. It is clear that venoplasty in pwMS with “CCSVI”, a non-disease, are not cured of having MS. 

However, it appears that venoplasty may have some weak antiinflammatory effects.  A secondary assessment in subjects with favourable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavourable venograms. The interesting question is how does stretching your veins have an anti-inflammatory effect in MS.

One hypothesis would be via the stimulation of the parasympathetic afferent or sensory nerve fibres that innervate cerebral veins and venous sinuses. There is an extensive literature on the potential mechanisms of how parasympathetic stimulation, using the vagal nerve, could be anti-inflammatory. 

I suspect exploring the mechanisms of how venoplasty is anti-inflammatory is academic because the treatment effect is so small and is nowhere close to the effectiveness of licensed DMTs. Why would you have venoplasty if you could be on a more effective DMT?

I hope this will finally be the last we hear about CCSVI. I want to stress when you apply medical philosophical principles, CCSVI is not a disease; it does not fulfil the contemporary definition of being a disease entity. In short, there is not clinicopathological correlate that defines CCSVI as being a disease. A better descriptor for CCSVI would be that it is a meme.

Definition: A meme an image, video, piece of text, etc., that is copied and spread rapidly by Internet users, often with slight variations.

Zamboni, et al. for the Brave Dreams Research Group. Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial. J Endovasc Ther 1526602819890110 2019 Nov 17.

Purpose: To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI).

Materials and methods: The Brave Dreams trial ( ClinicalTrials.gov identifier NCT01371760) was a multicenter, randomized, parallel-group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a secondary assessment, venograms of patients who underwent venous angioplasty were graded as “favorable” (n=38) or “unfavorable” (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared.

Results: Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005).

Conclusion: Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. The secondary analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from the accumulation of new cerebral lesions at MRI.

Bonaz et al.  Anti-inflammatory Properties of the Vagus Nerve: Potential Therapeutic Implications of Vagus Nerve Stimulation. J Physiol, 594 (20), 5781-5790 2016 Oct 15.

Brain and viscera interplay within the autonomic nervous system where the vagus nerve (VN), containing approximately 80% afferent and 20% efferent fibres, plays multiple key roles in the homeostatic regulations of visceral functions. Recent data have suggested the anti-inflammatory role of the VN. This vagal function is mediated through several pathways, some of them still debated. The first one is the anti-inflammatory hypothalamic-pituitary-adrenal axis which is stimulated by vagal afferent fibres and leads to the release of cortisol by the adrenal glands. The second one, called the cholinergic anti-inflammatory pathway, is mediated through vagal efferent fibres that synapse onto enteric neurons which release acetylcholine (ACh) at the synaptic junction with macrophages. ACh binds to α-7-nicotinic ACh receptors of those macrophages to inhibit the release of tumour necrosis (TNF)α, a pro-inflammatory cytokine. The last pathway is the splenic sympathetic anti-inflammatory pathway, where the VN stimulates the splenic sympathetic nerve. Norepinephrine (noradrenaline) released at the distal end of the splenic nerve links to the β2 adrenergic receptor of splenic lymphocytes that release ACh. Finally, ACh inhibits the release of TNFα by spleen macrophages through α-7-nicotinic ACh receptors. Understanding of these pathways is interesting from a therapeutic point of view, since they could be targeted in various ways to stimulate anti-inflammatory regulation in TNFα-related diseases such as inflammatory bowel disease and rheumatoid arthritis. Among others, VN stimulation, either as an invasive or non-invasive procedure, is becoming increasingly frequent and several clinical trials are ongoing to evaluate the potential effectiveness of this therapy to alleviate chronic inflammation.

CoI: nil

Unaccountable

The European Union and its Institutions have been heavily criticised as part of the Brexit debate as been undemocratic and unaccountable to the man or woman on the street. However, it is only when their decisions impact on you, or your patients, that you realise that these critics have a valid point. 

Last week the European Medicine Agency’s safety committee (PRAC or Pharmacovigilance Risk Assessment Committee) did something that makes me despair. They railroaded through changes to alemtuzumab’s SmPC (summary of product characteristics) against the advice of experts and without data to support their position. Their advice is therefore not evidence-based and as a result, it is likely to deny many pwMS access to one of our most effective DMTs. 

The PRAC states “Alemtuzumab should no longer be used in patients …. who have autoimmune disorders other than multiple sclerosis”. There is no evidence to support this statement. PwMS who have a pre-existing autoimmune disease are not at an increased risk of developing complications from alemtuzumab or secondary autoimmune disease when compared to pwMS who don’t have a pre-existing autoimmune disease. 

The problem I have is that the PRAC made this decision despite robust evidence to the contrary being presented by Genzyme and advice from experts in the field. I even co-signed a letter that Prof. Alasdair Coles penned to the PRAC, CHMP and MHRA, which clearly fell on deaf ears.

The behaviour of the PRAC reminds me of the Michael Gove interview with Faisal Islam on Sky News that took place on the 3rd June 2016 in the run-up to the Leave-Remain EU referendum: 

Gove: I think the people in this country have had enough of experts, with organizations from acronyms, saying—

Faisal Islam: They’ve had enough of experts? The people have had enough of experts? What do you mean by that?

Gove: People from organizations with acronyms saying that they know what is best and getting it consistently wrong.

Faisal Islam: The people of this country have had enough of experts?

Gove: Because these people are the same ones who got consistently wrong what was happening.

Faisal Islam: This is proper Trump politics this, isn’t it?

Gove: No it’s actually a faith in the —

Faisal Islam: It’s Oxbridge Trump.

Gove: It’s a faith, Faisal, in the British people to make the right decision.

Does the EMA expect us to have faith in their decision-making?

As an MSologist looking after pwMS this upsets me and worries me immensely. The implications of ignoring experts is one thing, but what are the implications for my patients? What impact will this PRAC decision have in practice?

I estimate that about a third of pwMS will have a comorbid autoimmune disease and may even be more than a third. The latter depends on how you define autoimmunity. This means many people with MS will be denied access to alemtuzumab because of EU officials who ignored the evidence presented to them and without any transparency around their thought processes and why they made this decision. This is no way for EU officials to be acting when we are trying to argue the case for Britain staying in the EU. 

Lack of transparency with the EMA is not new. I have been involved with many EMA-CHMP decisions and it really depends on the whim of rapporteur or co-rapporteur. Unlike the FDA which holds its meetings in the open, with the EMA and its various sub-committees you have no idea of the decision-making processes that go on behind closed doors. I am often asked why the British voted to leave the EU. The elephant in the room is the EU itself and how it functions; its decisions impact the lives of its citizens and this is another example of very, very, poor decision making with many downstream ramifications. 

CoI: multiple