‘Pause’ of MHRA isotretinoin Review: letter to chief executive June Raine

To: Dr June Raine MRCP CBE

Chief Executive, MHRA

10 South Colonnade

Canary Wharf

London

E14 4PU

From: Dr Neil MacFarlane MRCPsych (email address held by the MHRA)

26th August 2020  (by email, & paper copy – ‘signed for’ delivery)

Re: MHRA Isotretinoin Review  

Dear Dr Raine

Many patients and relatives who have been campaigning for years were very disappointed to have been informed by the MHRA last week, with minimal explanation, that ‘after much deliberation we have decided to delay launching a call for information’.

However, the work of the MHRA must continue, and I point out that my submission (21st July, acknowledged by the MHRA)[1] shows the previous 2014 Review, and in particular the Sundstrom et al 2010 study which you, in person, cited in Dying for Clear Skin in 2012, to have been wholly unreliable.

Roche appear to have already acknowledged this by failing to directly cite Sundstrom et al, in the Daily Mail piece of 10th August, by Jonathan Gornall.[2] I will be asking them to clarify what the ‘three reviews’ they refer to are, but it seems likely that all rely heavily on Sundstrom et al.

Therefore, I repeat my submission that isotretinoin’s licence for under-eighteens be immediately suspended, and that a mandatory consent form be introduced for adults, which properly highlights the risks of potentially permanent serious adverse effects, and lack of evidence for efficacy.

I also request that you clarify whether a meeting of the ‘Expert Working Group’ has already occurred (that is the widespread understanding), and provide the names of its members.

One aspect of the Cumberlege Review that has not received attention is the fact that the stakeholder campaigning groups often sought and obtained that kind of information, and used it (sometimes in cooperation with sympathetic professionals and academics) to make reasonable criticisms of individual professionals and academics. The Review praised the campaigners’ behaviour as responsible, without exception; indeed the strong implication was that campaigners were substantially more responsible than most ‘establishment’ professionals and academics, including those in the MHRA.

I would be grateful if you could also provide a target date for the Review’s resumption.

It is a reasonable assumption that some campaigners will be sharing this letter with their members of parliament.

Yours sincerely

Dr Neil MacFarlane MRCPsych

Cc

Sam Ward, Derek Jones, Helen and Simon Wright

British Association of Dermatologists (BAD), RCPL, RCPE, RCPI, RCPsych, GMC

Roche

Published openly at https://acneawareuk.com/


[1] https://acneawareuk.com/2020/07/23/2020-mhra-isotretinoin-review-submission-suspension-of-licence-for-under-eighteens-and-a-mandatory-consent-form-for-adults/

[2] https://www.dailymail.co.uk/health/article-8613003/Two-bereaved-mothers-share-shattering-warning-acne-drug.html

Published by AcneAwareUK

Information about isotretinoin (Roaccutane) toxicity, since November 2019

2 thoughts on “‘Pause’ of MHRA isotretinoin Review: letter to chief executive June Raine

  1. The MHRA are a law unto themselves and the whole show of reconvening an EWG has been just that. They do not care about patients, especially children who deserve that extra level of protection. The MHRA are corrupt and they put profits ahead of patient safety. June Raine in particularly is amoral and lacking any sense of integrity by accepting a CBE while allowing the prescribing of Isotretinoin which is killing teenagers. There has been a complete lack of transparency surrounding the Isotretinoin EWG which is very troubling indeed. Questions now need to be asked and answered.

    Like

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