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
Inequality
Prof G why the sudden and recent fixation with inequality?
There is overwhelming evidence that many health outcomes, including life expectancy, infant mortality, obesity, cancer survival rates, suicide, addiction and many more are linked to the level of economic inequality within society. In short, greater economic inequality leads to worse health outcomes.
Inequality does not necessarily refer to poverty, but relative poverty in society. For example, somebody in the lowest decile of the income distribution of a rich country such as the UK may not be considered poor by international standards, but relative to other people in the UK they are poor.
If you are interested in understanding more about this can I suggest you read Danny Dorling’s book “Injustice: Why social inequality still persists”. In this book, he uses the example of not be able to go on a family holiday as been a good indicator of the ‘have-nots’. The corollary is being able to afford an annual family holiday in modern Britain defines you as being one of the ‘haves’.
Why inequality results in poor health outcomes is complex. Michael Marmot argues in “The Health Gap: The Challenge of an Unequal World” that it causes chronic stress that results in poor outcomes. Please note stress is a biological response and can be measured; when people are stressed they produce excessive cortisol (a steroid) that then triggers a biological cascade that drives many disease processes and behavioural responses. The implications of this are that at a population level stress is bad and to improve outcomes you need population-based interventions to reduce stress. The latter is easier said than done when you have at least half the political establishment pushing a neoliberal (market) agenda that has been shown to increase inequality.
How does this relate to MS? At the moment we are not sure if inequality affects MS outcomes, but we suspect it does. Many comorbidities associated with inequality, such as smoking, obesity, hypertension, diabetes, stroke and myocardial infarction are associated with a worse MS prognosis. In addition, healthcare literacy and healthcare utilization are also linked to inequality and this is very relevant to MS.
To address this data gap we are starting a programme of work in the UK to investigate inequality and whether or not it is impacting on MS practice, MS outcomes and access to MS services. Although we started this at Barts-MS the main body of work will be done under one of the MS Academy workstreams we have defined as part of our ‘Raising the Bar’ initiative. Please note this is not just about defining and measuring inequality in MS Service provision and use, but implementing service change to make sure no MSers are left behind.
I note many commentators on this blog don’t like us highlighting political issues and would prefer us to focus on science. I would argue healthcare is politics and politics is health. If you are an HCP you can’t practice your trade without getting involved with politics or at least having a position on political issues.
The one positive outcome for me from the Brexit debacle is that it has made me realise that I didn’t have the background knowledge to have an informed opinion on Brexit and the reasons for Brexit. As a result of the self-exploration Brexit triggered (see Medium post), I have become an amateur economist, behavioural psychologist and geopolitician. All this has changed my worldview. This is why we have launched our #ThinkSocial campaign to raise awareness and make sure every HCP working in the MS space understands how inequality impacts on their patients and rather than accepting the status quo they should do something about it.
CoI: multiple