(First in a series of 7-8 pieces on the IMMDS Review, to include the GMC, epilepsy, misogyny and other reasons for ‘dismissive’ treatment of patients and relatives concerned about drug and device harms. The pieces will be submitted as evidence, with other material.)
The Independent Medicines and Medical Devices Safety (IMMDS) Review is looking at historic and current concerns about three medical products: valproate, surgical mesh, and Primodos (a now discontinued drug to test for pregnancy).
Valproate has been widely used in bipolar affective disorder since the 1980s, and in epilepsy since the 1970s. In March 2018 it was banned in pregnancy in the UK, and throughout the EU, but it is estimated that there have been 20,000 cases of Fetal Valproate Syndrome (FVS, a 30-40% chance of neurodevelopmental problems including severe learning disability and autism, plus a 10% chance of physical abnormalities) in the UK alone.
Many campaigners have suspected that pharmaceutical industry (Pharma) influence has hindered the recognition of FVS, the provision of information to patients, and the tightening of regulation.
Core written submissions to the Review were received in December 2018, and oral hearings have ended. Further submissions are welcomed and there is currently no deadline for those. Nor is there any firm date for its publication, although the end of this year is said to be likely.
I had not heard of the IMMDS review until late April 2019, when I was contacted by FACSaware, an independent Fetal Anti-Convulsant Syndrome group which has had a leading role in regulatory changes and in obtaining the Review. They hope it will recommend the setting up of a Trust similar to Thalidomide’s; but they also want a proper Judicial Inquiry to establish historical responsibilities more clearly and to consider legal and structural reforms.
They have the support of former Health Minister Norman Lamb MP, who used the phrase ‘Hillsborough-style Inquiry’ when he gave oral evidence to the Review.
My own current (non-lawyer’s) view is that such an Inquiry might also gather evidence for Misconduct in Public Office charges against GMC staff. Blog piece(s) on that soon.
The Review panel has already noted the foot-dragging on drug and device harms by the Medical Establishment (the Royal Colleges and other professional organisations). The chair, Former Health Minister Baroness Cumberlege, has stated that past and present patients and parents should not have to take the lead on these issues.
But the Establishment’s failure to tell ordinary doctors about the IMMDS Review is yet another example of this foot-dragging. Non-establishment doctors with concerns could have submitted information anonymously, which might have informed the Review panel’s questioning of Establishment witnesses.
The Royal College of Psychiatrists (RCPsych) emails me several times a month, but did not email me about the IMMDS Review, despite the many clear links with psychiatry: bipolar disorder, epilepsy, learning disability, and autism (ADHD is also increasingly recognised as part of FACS).
Psychiatrist Dr Angelika Wieck MRCPsych (who is not on Twitter and appears not to have a blog) has a serious interest in FACS, has supported regulatory tightening, and presented on FACS at the College’s annual conference in 2018. The RCPsych Tweeted several points from her talk, but none mentioned the Review which had been announced four months earlier.
A recent three-page editorial on valproate in the British Journal of Psychiatry, which is wholly owned by the RCPsych, failed to mention the IMMDS Review. It talked vaguely of ‘the market’ being a factor in the overuse of valproate, rather than the Pharma-influenced behaviour of psychiatrists working in clinical practice, academic research, regulatory bodies, and directly for Pharma itself.
The BJPsych Bulletin regularly contains articles on current policy and practice: again, nothing.
The RCPsych has not posted any IMMDS information on its website or issued any statement. It has not Tweeted at all:
All this indicates that RCPsych leaders do not want ordinary or dissident psychiatrists submitting their own evidence to the Review. And it conforms to a well-established pattern of closing down discussion of drug harms, and conflicts of interests, wherever possible.
Part 2 (Wednesday): the evidence submitted by Dr David Baldwin FRCPsych, chair of the RCPsych Psychopharmacology Committee, and senior British Association for Psychopharmacology member. Plus the questioning of him by the panel on 28th January 2019.