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