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A senior psychiatry adviser to the MHRA, and two other senior medical advisers, are being investigated by the GMC, following my complaints about undeclared conflicts of interest.

I made 9 complaints about Dr David G Owens FRCPsych (GMC number 1329120), Dr Munir Pirmohamed FRCP (3078110), and Dr Anthony Bewley MRCP (3245772), in November 2019. Seven weeks later, the GMC stated they would ‘look into’ them, and in late January a formal investigation was confirmed:

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In response, I sent some further information, mainly to clarify a few of my detailed complaints, but have not heard from the GMC since then. I would have gone public a month or two ago, but delayed doing so because of Covid-19.

My understanding is that the GMC has investigated, and sometimes upheld, similar complaints, in the decade since Andrew Wakefield was struck off for conflicts of interest (COIs) and failing to obtain ethical approval for his MMR research. I quote from Wakefield’s GMC tribunal decision in my complaints, in support of my submission that these doctors should be suspended. In 2019 a complaint about a mesh surgeon who failed to declare funding from a manufacturer was reported.

I came across these undeclared COIs after meeting campaigners concerned about isotretinoin, a drug for severe acne which has prompted reports of serious adverse effects including depression, psychosis, suicidality, and sexual dysfunction, for decades. Reports of permanent adverse effects have appeared in the last decade.

Dr Owens, Dr Pirmohamed and Dr Bewley were the senior authors of a 2014 report on isotretinoin. That report appears to have been seriously defective in the selection and interpretation of published research.

Last year, campaigners managed to obtain a further Review into isotretinoin. The death of a 15-year-old girl, apparently by suicide, may have been an important factor:

Screenshot_2020-06-30 Acne drug ‘linked to at least 14 deaths’ this year

Despite repeated requests, the MHRA has not released the names of the new ‘Isotretinoin Expert Working Group’, which is understood to have had at least one meeting, in March 2020. I informed the MHRA of my GMC complaints shortly after I submitted them.

I will soon be submitting my own analysis, of past published research into isotretinoin, to the MHRA. Given the serious concerns about the failures of dermatologists, and psychiatrists and psychologists working with them, I will be calling for a suspension of isotretinoin in under-18s, and a structured consent form for adults.

The full complaints:

 

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Sonia Macleod PhD has pro-industry, anti-patient views and should not be ‘the researcher’ for the IMMDS Review

Update 28th August: I have now discovered that Sonia Macleod was being paid by leading mesh maker Johnson & Johnson, valproate brands owner Sanofi, other pharmaceutical companies, and two tobacco companies, until late 2018. See bottom of this page for details.

(See my earlier pieces on the Review’s failure to ensure ordinary clinicians were/are informed about its work, and on the false and inadequate evidence given by the Royal College of Psychiatrists)

(The focus in this piece starts as being more relevant to mesh, and then shifts towards valproate and Primidos, but as a whole it is relevant to all three)

(See also a follow-up piece, published four days later)

In the video evidence I have seen, Sonia Macleod (far right in this image) has been

Screenshot_2019-08-12 IMMDSReview ORAL HEARINGS - Tuesday 27th November 2018 - SESSION 1 - YouTube

introduced to witnesses as ‘our researcher’, with an ambiguity as to whether she is part of the ‘panel’ or ‘team’. At least one witness has spoken of her as part of the ‘panel’ without being corrected.

So why are there no biographical details of her on the Review website? Who is she?

Sonia Macleod is an academic lawyer, a qualified barrister, with a PhD in neuroscience. Her entry on the Oxford University Law Faculty website fails to state these last two facts, but a 2014 paper on device industry regulation, co-authored with her head of department Christopher Hodges, does:

Screenshot_2019-08-12 untitled - An Informed Dialogue Supporting Safe Innovation in Medical Technology pdf

Professor Hodges’ own university web page does note that he has worked for industry in the past (the trade bodies EUCOMED and ABHI), and the 2014 paper is markedly pro-industry in several respects. Firstly, the authors only consulted industry and regulators, not any patient groups:

Screenshot_2019-08-12 untitled - An Informed Dialogue Supporting Safe Innovation in Medical Technology pdf(1)

Secondly, Hodges and Macleod clearly express the view that the largely industry-run regulatory system for devices is flawed only in appearance: ‘An outsider might wonder why one should have any trust in a regulatory system that involves public authorities that do not licence or inspect manufacturers, privatized ‘regulators’ in the form of notified bodies that can have variable standards and be purchased by the manufacturers that they contract with, manufacturers who hold considerable personal regulatory responsibility and who do not undertake clinical trials on every product…’. (my emphasis)

As insiders themselves, they see the problem as essentially one of public relations, to overcome ‘the key point’ which is ‘that the system is not readily grasped by a non-expert’:

A culture of pro-active communications should be developed in order to explain the regulatory system for medical devices, to the public, clinicians, patients, politicians, and other stakeholders, so as to clarify how and why it works and can be trusted, its benefits and achievements, and the nature of residual risk.’

‘Residual risk’? What does that mean? A ‘residue’ is something that is usually very small. The term has the ambiguity of PR (which now usually prefers to call itself ‘communications’), advertising, or perhaps a barrister’s advocacy for her client.

‘Patients’, ‘the media’ and ‘politicians’ are all enemies of this industry-regulatory-academic alliance. They can only disrupt its claimed (no actual evidence is cited) ‘benefits and achievements’, with their ‘calls by groups of affected patients, magnified by the media and subsequently taken up by politicians, to reform what they see as an inexplicably lax system.’

 

Macleod’s 2018 book, published after the IMMDS Review had started, also contains these views. I have read about half of it in electronic form, in the British Library. Parts of it can

18-Macleod

be read and searched on Google Books.

Throughout the book Macleod promotes a false binary opposition between regulation (good) and litigation (bad), as means of avoiding drug and device harms. Towards the end she states: ‘The transactional costs of the US litigation system are sky high, in large part due to punitive damages awarded as a form of deterrence. If such measures do not make patients safer then a substantial part of their validity becomes questionable.’

The comparison between Europe and the US is often hinted at, but then avoided when it does not suit her argument. In the case history on thalidomide, she points out that strong US regulation led to hardly any cases of fetal injury, and in that on valproate she makes clear that the drug was again resisted by the FDA in the 1970s, only to be introduced after lobbying of politicians by the drug’s US pharmaceutical company.

The implication is that FDA regulation since the 1970s has been subject to political interference and lobbying, so why does Macleod not consider the possibility that that is the reason why patients are not safer in the US (which appears to have been her meaning), rather than the strong litigation culture? She makes no mention of the criticisms of the US system (which of course has a worldwide influence) as industry-dominated, made by the former editor of the New England Journal of Medicine Marcia Angell, and others.

Throughout, the book is negative to the idea that companies and medical professionals should be holdable to account in law by those harmed: ‘access to justice should not be conflated with access to litigation’ is typical. And Macleod often writes of regulation and litigation as though they are fixed natural phenomena, rather than administrative and legal constructs which can be changed at will by government executives and elected lawmakers: ‘…the evidential thresholds for these differ. Evidence of correlation may be sufficient for the former, but proof of causation is required for the latter.’

She suggests that regulatory approaches result in greater transparency, but the evidence is actually rather mixed. The companies responsible for thalidomide only funded trusts after considerable media pressure, and it appears that there are still historical details which are obscure. In his evidence to the IMMDS enquiry Professor John Abraham, another absentee from the 2018 book, stated that the disclosure processes of litigation had provided much material for his own research: I find it hard to believe that Macleod was unaware of his work up to then. Again, governments could legislate to prevent non-disclosure of clinically significant evidence of harms, in civil litigation which does not go to open trial.

If regulators are not always perfect, in Macleod’s version of history pharmaceutical and device companies are the good guys. I found no mention of the substantial criminal and civil fines imposed by the US Department of Justice in the last two decades. She praises the FDA’s loosening of regulation in the 1990s, without adding any caveat that drugs for disorders which substantially shorten life will tend to have many fewer complaining or litigating patients in the event of hyped efficacy claims or suppressed safety data: ‘…typical approval times for drugs for serious and life-threatening diseases such as cancer and AIDS were reduced to less than six months, and sometimes to as little as a few weeks. Rightly, the FDA’s drug review improvements were recognised in October 1997 by the John F Kennedy School of Government of Harvard University, with the Innovations in American Government Award.’

The ‘conclusion’ (provided here in full) to the chapter on valproate paints a rosy picture of the responsible pharmaceutical companies, and of neurologists who resent interference in their clinical freedom: ‘The same safety issue has essentially remained constant throughout, namely that the risks, especially of teratogenicity, are inherent in use of the product as a beneficial treatment for epilepsy. This is a risk-benefit issue, which should be considered by doctors when making prescribing decisions and should be made clear to patients so that they can make informed choices [note 108: H Angus-Leppan and RSN Liu, ‘Weighing the risks of valproate…’, 2018, 361, BMJ]. Throughout the lifespan of the product there has been ongoing updating of the recommendations for prescribers in an attempt to minimise associated risks. In some instances, it has been concluded that the regulatory response was slow to adapt to the increases in knowledge at the time.’

On valproate alone, the presence of someone as ‘researcher’ to the IMMDS Review who has published such a pro-industry (and pro-medical-establishment) opinion, actually while the Review is supposed to be ‘independently’ and open-mindedly gathering evidence, is a serious contradiction.

I have only read a selection of the chapters on individual drugs and devices, but was unable to find any significant weight given to the voices of harmed patients. A passage which selectively, and negatively, considers the behaviour of successful litigants is consistent with the anti-patient stance of the 2014 paper: ‘Some of the compensation [non-medical] personal injury claimants receive is used in ways that bear little relationship to the ‘purpose’ for which it was awarded under specific heads of damage…’.

Macleod is referring to pages 173-4 of a 1994 Law Commission report, ‘Personal Injury Compensation: How much is Enough?’ She claims ‘There is no head of damage for providing gifts or treats for family and friends, but this is a commonly occurring theme when claimants are asked how they had spent their damages.’ What the report actually stated, however, is rather different. The word ‘treat’ did not appear, ‘gifts for family and friends’ were reported by only 19-24% of claimants, and Macleod omits the fact that many claimants were in significant debt, quite possibly as a result of the personal injury itself. If ‘family and friends’ had supported the claimant through difficult times, emotionally and/or financially, it might well have been reasonable for them to have a small share of the award.

Screenshot_2019-08-13 Personal injury compensation HC 666 - 0666 pdf

Arguably, whether Macleod is part of the panel or not may be less important than the filtering influence she has, on the evidence going to the four panellists who the patient groups have been provided some information about. It might have been appropriate for her to provide evidence as a witness, alongside industry and establishment medical organisations.

(In a future Blog piece I will touch on Macleod’s failure to bring her legal qualification and experience to bear on the questioning of the GMC by the panel).

 

Update 28th August: eight days after the above piece, a ‘register of interests‘ appeared on the IMMDS Review website. It stated the funder of Macleod’s 2018 book was the ‘European Justice Forum‘, which appears to be an anti-group-litigation lobby group

Screenshot_2019-08-29 IMMDSReview-Register-of-Interests pdf

dominated by pharmaceutical and device manufacturers including Johnson & Johnson (makers of mesh) and Sonofi (valproate). This clearly shows undisclosed industry influence at the heart of the Review. Remarkably, the group also includes two tobacco companies, which raises an additional question for Professor Chantler, as he studied the behaviour of the tobacco industry in his review of plain cigarette packaging.

Screenshot_2019-08-28 About us - European Justice Forum (EJF)

 

 

Next blog piece: questions put to the IMMDS Review Team, four days before they provided the ‘register of interests’.

 

 

 

 

 

 

‘Request for Review under Rule 12’ of the GMC’s decision that Dr Jessen’s ‘dick head’ and ‘bullshit’ is just ‘free speech’

Screenshot_2019-12-10 Dr Neil MacFarlane MRCPsych on Twitter DoctorChristian gmc letter to Hollysvaccine amp; me, 3rd Octob[...]

(Update above, 10th December)

(See my previous blog piece, which was my initial complaint)

(Letter to GMC below, 7th August)

From: Dr Neil MacFarlane BA MBBS MA MRCPsych GMC 3205688 and Mrs Vicky Oakley (Please reply to both)

In the GMC’s responses to the initial complaints it stated:

(To Mrs Oakley, 23rd July, initial response): ‘We appreciate you feel that Dr Jessen’s comment was insulting towards you and that his use of language was not appropriate…His use of the term ‘dick head’ to describe you may be considered insulting.

In making this comment Dr Jessen however appears to be exercising his human right to free speech. Whether you or members of the public disagree, or find offense, with his viewpoint or comments is not a matter for us…we do not find there have been any serious breaches of our guidance.’

(To Mrs Oakley, 23rd July, further response): ‘You have…questioned whether use of such language in the workplace would be acceptable. The short answer to your question is no. We expect doctors to act in nothing other than a courteous manner with their patients and I hope I can assure you that if a doctor’s behaviour and attitude puts patient safety and public confidence at risk we would take action.’

(To Dr MacFarlane, 2nd August): ‘…we appreciate that you find the comments made by Dr Jessen to be insulting and inappropriate […] We appreciate Dr Jessen’s choice of words [the complaint included a Tweet describing Mrs Oakley’s concerns as ‘the bullshit you spread’, and others calling members of the public ‘loon’, ‘loony’ and ‘lazy fuck’] may be considered insulting and are not condoned or endorsed by the GMC, however we do believe his comments are him exercising his human right to free speech. (our emphases).

 

Our requests for review

(we reserve the right to make additional requests for review, including requests on the basis of how other regulators restrict ‘free speech’.)

‘Free speech’ is ‘Freedom of Expression’ in Article 10 of the The Human Rights Act 1998, which states: ‘The exercise of these freedoms, since it carries with it duties and responsibilities, may be subject to such formalities, conditions, restrictions or penalties as are prescribed by law and are necessary in a democratic society…for the protection of health [and] for the protection of the reputation or rights of others’. (https://www.legislation.gov.uk/ukpga/1998/42/schedule/1/part/I/chapter/9)

1. The GMC has a statutory duty (Medical Act, 1983) ‘to protect, promote and maintain the health, safety and well-being of the public’. This duty must include the encouragement of reporting, and public discussion, of adverse events which follow medical treatments. The GMC itself has stated that adverse events are ‘under-researched’ and, by implication, under-reported:

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Therefore, given that Dr Jessen has a prominent and powerful position substantially arising from his GMC registration, the ‘insulting’ and abusive Tweets that we complained of are likely to suppress reporting and discussion of adverse events, and be detrimental to public health and safety. It follows that the restriction of his free speech rights, here, is reasonable.

The GMC has stated (second response to Mrs Oakley, above) that ‘…if a doctor’s behaviour and attitude puts patient safety and public confidence at risk we would take action.’ We submit that there is no basis in law for this to apply to a doctor’s language to his own patients, but not a doctor’s language to a person identifying as a member of the public (and, in fact, in this case as a parent carer) on social media or in any other context.

2. The GMC has a statutory duty to ‘to promote and maintain proper professional standards and conduct for members of that profession’. Dr Jessen’s prominent and powerful position results in his ‘insulting’ and abusive language impairing Mrs Oakley’s ‘reputation and rights’. Therefore, it is reasonable for the GMC to restrict his free speech on that ground also.

3. The GMC has taken a highly restrictive approach to ‘free speech’ in at least one other case involving a registered doctor, therefore its refusal to investigate Dr Jessen is inconsistent. As a body with statutory duties and powers, the GMC must carry out its duties and apply its legal powers consistently.

In my case (Dr MacFarlane, Case number: C1-2141764902) the ‘Decision to refer to an Interim orders tribunal’ of 4th March 2019 alleged: ‘He has made antagonistic tweets about other psychiatrists and has caused distress to service users. The GMC has been tagged by others in response to his tweets, illustrating the concern that his tweets are causing and the public belief that he should be prevented from tweeting in this way.’

Leaving aside the fact that the GMC presented no evidence for the ‘antagonistic’ (as opposed to reasonably critical) allegation, the allegation of ‘distress’ was not based on ‘insulting’ or abusive language towards members of the public, or indeed on any language towards the public.

Mrs Oakley is not basing her complaint on an unreasonable expectation that she will not suffer any ‘distress’ as a result of being presented with evidence or reasoning concerning health issues, or witness robust discussion between professionals. As a competent person (Mental Capacity Act, 2005), she accepts that risk.

Her complaint (and my repetition of her complaint, with additional examples of Dr Jesson’s language directed at members of the public) is based on a reasonable expectation that she does not suffer a specific kind of distress: that caused by ‘insulting’ and abusive language directed towards her, from GMC-registered medical practitioners, especially one with a prominent public profile.

 

(I have not made an appeal under ‘Rule 12’ before, so at this stage am not sure what the next step will be, if the GMC does not significantly change its position.

This blog piece will be brought to the attention of various individuals and organisations for comment, including Doctorcall (Dr Jessen’s Harley Street employer, who provided a very limited comment, which avoided the issue of ‘abusive language’, on my previous blog piece), Sanofi (who have failed to comment but have stopped Tweeting their travel advertisment featuring Dr Jessen), the Vaccine Confidence Project, the Independent Doctors Federation, and the Patients Association).

Complaint to the GMC: Dr Christian Jessen’s ‘dick head’ and ‘bullshit’ abuse of a parent carer

(As submitted to the GMC 18th July. See also the 7th August appeal against the initial decision not to investigate, which the GMC stated was due to Dr Jessen having ‘free speech’.)

Dr Jessen (GMC 6028241) has been a prominent media doctor for many years. His website states that he currently works for Doctorcall in Harley Street, London, offering ‘general medical and sexual health’ consultations.

He has recently been abusive to the parent carer of a teenager who has experienced a range of symptoms, and I understand to have received a range of diagnoses, after HPV vaccination. I have had a limited conversation (on Twitter) with the parent, who has stated that she has already made a complaint to the GMC.

 

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In fact, drug ‘insert sheets’ are not 100% reliable, as the IMMDS Review has recently found in the case of valproate (see Session 1 of the MHRA’s evidence, at 98 minutes).

I have not attempted to establish whether Dr Jessen has publicly expressed a formal opinion on this teenager’s diagnoses, without his seeing the patient. However, I submit that for many members of the public his abusive Tweets do imply such an opinion.

I submit that Dr Jessen has used abusive and derogatory language on Twitter since (at least) 2016. I hope that the GMC does not require me to spell out exactly why ‘loon/loony’ is abusive towards people with mental health problems.

 

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There have also been dozens of other ‘bullshit’ Tweets.

Aggravating factors

‘Holly’s Mum”s concerns about Dr Jessen being paid by the pharmaceutical industry to promote vaccines appear reasonable, given his appearing in Tweets by Sanofi, and promoting Sanofi in his own. I have pointed out (in my own Tweets) that Dr Jessen directs his Twitter followers to this drug company’s website, rather than the NHS’s.

Sanofi is currently under scrutiny by the IMMDS Review (above), following serious injury to 20,000 children in the UK alone, due to valproate.

There is no declaration of interest in Dr Jessen’s Twitter profile or on his website.

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Only last year Dr Jessen was promoting an online pharmacy which, according to the Royal Pharmaceutical Society, was ‘directly promoting’ prescription drugs, contrary to UK regulations.

I was unable to find any expression of regret from Dr Jessen concerning this.

 

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(Thanks to Emma Friedmann, of FACSaware, whose Tweet about Dr Jessen’s ‘dick head’ Tweet drew my attention to this).

Twitter response as of 24th July:

Screenshot_2019-07-24 Dr Neil MacFarlane MRCPsych ( NMacFa) Twitter

 

Next piece: the 7th August appeal against the initial decision not to investigate, which the GMC stated was due to Dr Jessen having ‘free speech’.

Pharma-psychiatry, bipolar disorder, and the IMMDS Review (2 of 3: COI)

(See the previous piece on the IMMDS Review and the RCPsych’s failure to promote it)

In October 2018 Dr David Baldwin FRCPsych, appearing for the Royal College of Psychiatrists (RCPsych), provided written responses to the Review Panel’s written questions. The last of those questions (p. 214) concerned conflict of interest (COI):

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It is false to claim the declarations on the RCPsych website are ‘full’ when they only go back three years. The Review is public, so the meaning of ‘full’ should be as the public would understand it, rather than professionals or academics.

And Dr Baldwin was clearly aware that the IMMDS Review is substantially ‘historical’: in his oral evidence he talked about valproate’s elevated risks being known since the mid-1990s. Therefore his answers about COI should contain information covering decades, not just a few years.

As it happens, Dr Baldwin’s current RCPsych declarations are nearly two years out of date:

Screenshot_2019-06-25 About the psychopharmacology committee

Further, it is absurd to claim that these statements are ‘full’, given that they are unquantified. We actually have Dr Baldwin’s recent quantified declarations on the ABPI’s ‘Disclosure’ site:

Screenshot_2019-06-25 Disclosure Search

I have never seen the RCPsych, any NHS website, or any mental health charity mention the ABPI Disclosure site, so the chances of any patient looking at it before they consult a psychiatrist seem slim. And because disclosure in UK law and GMC guidance and regulation is voluntary, these may only be part-disclosures.

I think the few patients who would look this up in advance would be more wary of psychiatrists who had not disclosed. But because of the law and the GMC’s soft approach, that information is not available.

A patient with FACS, or a relative, researching a psychiatrist who prescribed valproate to a mother, will be unable to find even this incomplete information beyond three years.

 

Dr Baldwin claimed the RCPsych produces ‘clear guidance’ on COI. It is not ‘clear’. Good Psychiatric Practice states that COI declarations must be made when engaging in ‘college activity’: it does not state whether such declarations should go beyond the usual three years, or whether they should be quantified. In my experience they do not and are not.

For clinical work Good Psychiatric Practice simply refers to the GMC’s Good Medical Practice: to be dealt with in a future piece here.

As for Competing Interests: Guidance for Psychiatrists, I was unable to find such a document on the RCPsych website.

 

In the oral evidence on 28th January 2019 it is disappointing that the IMMDS Review panel asked Dr Baldwin no questions about COI.

NHS psychiatrist Dr Peter Gordon has been campaigning for compulsory COI declaration laws for years. The RCPsych has refused to comment on the issue, stating that it is ‘a matter for the government’. The GMC failed to respond to his enquiries. In my view these are expressions of contempt towards people experiencing drug and device harms. In late 2018 Dr Gordon resigned his membership of the RCPsych and he later revealed he had been ‘gaslighted’ by the RCPsych, but that his NHS employer supported him.

Dr Gordon has documented Dr Baldwin’s long history of involvement with Pharma, including his promotion of the allegedly ‘defective’ SSRI Seroxat, and its dubious UK licence for ‘Social Anxiety Disorder’, which I recall many ordinary psychiatrists in the 1990s sceptically viewing as a Pharma construct.

It seems likely that my own campaigning on Pharma COI was a factor in my GMC-MPTS suspension, on very dubious grounds. The GMC has still not disclosed the nature of its anonymous psychiatrist investigator’s links to the RCPsych, and it has not interviewed me, seven months after it received the first anonymous complaint about me.

Dr Baldwin mentioned Dr Thomas Barnes FRCPsych, in relation to the POMH survey(s) of prescribing rates of psychiatric drugs in the NHS. Dr Barnes is a member of the psychopharmacology committee and his current COI declaration is even more out of date:

Screenshot_2019-06-25 psychopharmcommittee-doi-thomasbarnes pdf

 

Finally (for this piece on COI), Dr Baldwin mentioned the British Association for Psychopharmacology (BAP) several times, as having views and policies on valproate in line with the RCPsych. The editor of the Journal of Psychopharmacology (BAP’s main journal) is Dr David Nutt FRCPSych. It is interesting to see that Dr Nutt’s latest paper has Dr Baldwin as a co-author. I have criticised Dr Nutt in my ‘Manifesto‘:

 

Screenshot_2019-06-25 Prescribed Harm Manifesto learning disability and autism now included

Dr Nutt’s recent ABPI COI voluntary declaration supports the idea that Pharma payments to doctors correlate with a ‘dismissive’ attitude towards patients experiencing drug harms:

 

Screenshot_2019-06-25 Disclosure Search(1)

Dr Peter Gordon (see above) has published this mildly satirical image of Dr Nutt, based on past drug company interests:

professor-david-nutt-psychiatry-scientist21

I have defended this use of satire, against the accusation that it is unfairly ‘ad hominem’.

Next week (or, possibly, the week after): Dr Baldwin’s failure to submit evidence on the range of opinion on bipolar disorder within the RCPsych, especially the opinion that milder forms of bipolar (‘bipolar 2’) have been promoted under Pharma influence.

 

 

 

 

 

 

 

 

Pharma-psychiatry, bipolar disorder, and the IMMDS Review (1 of 3)

(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.

Screenshot_2019-06-24 S0007125019001375jed 1 3 - sodium_valproate_in_psychiatric_practice_time_for_a_change_in_perception pdf

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:

 

RCPsych-IMMDS-Tw

 

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.

Screenshot_2019-06-24 IMMDSReview ORAL HEARINGS - Monday 28th January 2019 - SESSION 2 - YouTube

‘Recovery Narrative’ as a ‘genre’: some uninvited comments

This academic paper (open access) was published two months ago (when I was rather busy being suspended by the GMC/MPTS, for reasons which remain unclear):

Screenshot_2019-05-15 The Recovery Narrative Politics and Possibilities of a Genre

However I did find time to gently ‘troll’ its lead author about her links to the pharmaceutical industry, and my piece published today attempts to say why I think that might be relevant for the ‘Recovery Narrative’ and ‘genre’ paper, and the so-called ‘Medical Humanities’ more widely.

Screenshot_2019-05-15 from NMacFa angela - Twitter Search

Regular readers of my blog will know that in January I suggested a co-author of the ‘Narrative’ paper, Professor Helen Spandler, was running Asylum Magazine as ‘a self-censoring academic front for establishment psychiatry’.

As a psychiatrist long interested in English Literature, who spent much of 2013-17 drafting proposals for a self-funded MD or PhD, I had come across Angela Woods’ work before. She co-edited a 700-page 2016 book on the ‘Critical Medical Humanities’ but, alas, as with so-called ‘Critical Psychiatry’, the claim to be broadly ‘critical’ is questionable.

If one probes for key words on Google Books (and I have also searched the whole text in the British Library), one gets the impression that ‘Western biomedicine’ (for example) is something undesirable ‘practised historically by white males’ etcetera. But the nature of its undesirability, and how it maintains its ‘hegemony’, is circled around rather than stated.

There is no mention of Ivan Illich’s Medical Nemesis, let alone more recent critics such as Marcia Angell, or David Healy. Yes, Nikolas Rose is referenced, but in my view he is more of an observer and chronicler of biomedicine than a critic of its downsides and excesses.

So Pharma-dominated medicine (including Pharma-psychiatry) has little to fear from this kind of academic ‘output’. And that may be partly a consequence of how most ‘Medical Humanities’ in the UK is funded.

Some more fact-checking is required, but most humanities academics I have talked to over the last 6-7 years have believed it to be overwhelmingly backed by the Wellcome Trust, a 26 billion pound charity which mostly invests on the stock market (excluding tobacco, which might put the #Pharma proportion of the portfolio up a bit from the usual 10% or so of the FT 100 benchmark) but also develops its own vaccines and other pharmaceutical products. (Full disclosure: at one point I explored whether funding for my own MD or PhD might be available from the Trust).

Professor Woods appears to be still part of a major Wellcome project and, interestingly, one of her colleagues at Durham University is a Wellcome-funded anthropologist, with an interest in ‘narrative’, who researches ‘health conspiracy theories. These include beliefs about secret agendas behind vaccination programs, the side effects of medical treatments, and cover-ups by the government or pharmaceutical industry.’

On his University page, professor Tehrani simply makes a much vaguer reference to research on ‘conspiracy theories’ (dropping ‘health’), and does not mention his Wellcome funding. However, scrolling down does show his most recent paper was on ‘antivax attitudes’.

Coming back to the paper on ‘Recovery Narrative’ as a ‘genre’ (the first link in this piece), how might Wellcome’s ‘#Pharma-loaded’-ness be relevant?

Well, the role of the pharmaceutical industry, in promoting biomedicine while marginalising psychosocial understandings and interventions, is completely absent.

Take the semi-fictional ‘Ben…a young person struggling with unusual experiences’ in the second paragraph: ‘When he becomes part of a dynamic mental health charity, his world transforms. He grows in confidence and…he becomes an ambassador for a major national anti-stigma campaign…’.

There is no mention of the degree of funding of the charity by Pharma. Some charities disclose the names of companies, but there is no obligation to do so, and I am not aware of any that itemise exact figures. There is also the issue of industry disclosure, by professionals with formal or informal charity roles, being only voluntary (see No. 4 of my ‘manifesto’).

Ben’s ‘narrative’, as told by the two Wellcome-funded professors and their co-author, continues with his audience getting bored with him, and eventually ‘From hospital, where he has been sectioned, he speaks of a painful ebbing away of his sense of self-worth.’

The suggestion, as I read it, is that ‘Ben’ is more a victim of the media’s general tendency to build up ‘fresh faces’ and later knock them down, rather than of Pharma-psychiatry which has a vested interest in mental health services being poorly funded, so that drugs are used rather than more expensive person-delivered support and psychotherapy.

In the 10,000 words of the whole paper the word ‘drug’ does not appear, and even ‘medication’ only does so twice, with the mildest (if any) of ‘critical’ inflection: ‘The Recovery Narrative can…suggest multiple pathways to recovery (including therapy, medication, familial or peer support, religious counselling, and mental health activism)…’.

I suggest a ‘genre’ for this paper, sadly not a new one: ‘Academic Output Disguising Industry Interests’.

 

 

 

Seroxat on trial again, in 2019

I first mentioned Seroxat (generic name paroxetine, US brand name Paxil) as an example of a problematic psychiatric drug in 2011. More recently, it appeared in my pieces on Dr David Baldwin’s resignation from the ‘Prescribed Drug Dependence Enquiry’, and the ‘Prescribed Harm ‘Manifesto”.

Its developers GlaxoSmithKline (GSK), who still own these brand names for the patent-expired drug, are listed for a civil trial in London’s High Court, to start on Monday 29th April and projected to last eleven weeks:

2019-04-26_Queen's_Bench_Division_daily_cause_list

For lawyers the trial is interesting because the judge who has case managed it since 2015, but will not actually be sitting, increased the financial liability of the hundred or so claimants’ ‘litigation funders’, in the event of the case being lost (perhaps this means that the funders will receive a greater proportion of the claimants’ damages if they win). Much of the recent ‘case management’ has concerned this issue.

As a psychiatrist, my perspective on Seroxat is that despite much having been written about it, there may be more to productively explore about how it was introduced in the UK. My own recollection is that there was a good deal of ‘word of mouth’ negativity among psychiatrists, many of whom felt it was being aggressively marketed to GPs, in a way which covered up both the poor side effect profile (compared with other SSRIs) and the dubiousness of its licence for ‘Social Anxiety Disorder’. There was also some talk of discontinuation problems.

That was years before the first ‘Secrets of Seroxat’ programme. I never had a patient ask to try it, as happened with other antidepressants (especially Prozac in the mid-1990s).

My reading of this trial’s case management is that the claimants lawyers were seeking to explore some aspects of these wider issues of GSK’s behaviour, which are ‘on the record’ from other civil and criminal proceedings, and perhaps in non-legal settings. The case managing judge has determined that the focus should narrowly be on the UK marketing claims, and information submitted to UK regulators, but only in respect of discontinuation problems.

One interesting aspect of the trial is that Seroxat is apparently alleged to be ‘defective’, compared to other SSRIs, in the opinion not only of the anti-establishment David Healy, who has been associated with such a view for nearly two decades (see link above). The claimants’ other experts include prominent establishment psychiatrists.

Healy took over in 2016 from Malcolm Lader, who had requested withdrawing as an expert due to his age: Lader was first engaged on the case in 2005. He was then a professor at the Institute of Psychiatry (IoPPN) and is still an Emeritus.

Dr Matthew Hotopf FRCPsych is also an IoPPN professor, and is the director of the Maudsley Hospital’s National Institute for Health Research (NIHR) centre. The scope of his expert contribution has been narrowed from ‘epidemiology and statistics’ to just ‘epidemiology’.

‘Statistics’ has been taken over by Dr Glyn Lewis FRCPsych, professor at University College London, who has moved through the IoPPN as well as that other bastion of UK Pharma-psychiatry, Oxford.

So the idea that no establishment UK psychiatrist ever dares to undermine the interests of pharmaceutical companies appears incorrect, given the experts lined up against the UK’s largest.

Both complainants to the GMC are supporters of Dr Paul Morrison FRCPsych and Dr Samei Huda MRCPsych

(See my piece of 19th March for a brief background. The issues have always been wholly public. Most of this piece was made available to the GMC a day in advance. The GMC has informed me that ‘the complainants are being well supported and have regular update and contact’.)

I have no problem with the supporters of those I have criticised making anonymous complaints. It is up to the GMC to take that into account. The GMC have known for weeks that the second complainant is a supporter of both of these ‘Pharma-psychiatrists’, as I sometimes call them: my term includes those who are not significantly funded by Pharma, but ignore, deflect from, or minimise such conflicts of interest. However, given the UK’s lack of compulsory disclosure, it is impossible to know who is truly unfunded.

The first complainant focused on the issue of registered-but-unlicensed practice. This Twitter account has now identified itself, but still appears to be

190322-RAF-1-of-7

essentially anonymous. Again, I have no problem with that, but it is relevant to the question of whether these complaints reflect the general concerns of ‘patients and the public’, as the GMC has implied. More on that in later blog pieces. On the issue of ‘vulnerable patients’, see my notes to the Decision, 1/3 down.

Two (undeleted) tweets by the first complainant are supportive of Dr Morrison. The first is just four days after my blog piece of September 6th on Dr Morrison. Hundreds of this complainant’s tweets have been in Twitter threads with Dr Samei Huda, who has been closely aligned with Dr Morrison.

Screenshot_2019-03-24 RoseAnnieFlo on Twitter It's very odd peterkinderman made such a song dance about his complaint re Pa[...]

In the second, ‘Lucy’ is Lucy Johnstone, who complained (with Peter Kinderman and others) about Dr Morrison’s alleged ‘bullying, harrassment and misogyny’ in February 2018 (see my same September 6th blog piece). ‘DCP’ is the British Psychological Society’s (BPS’s) Division of Clinical Psychology:

Screenshot_2019-03-24 RoseAnnieFlo on Twitter SPECIAL PLENARY SESSION How to retract a power-point slide Special BPSOfficia[...](1)

Screenshot_2019-03-24 RoseAnnieFlo on Twitter SPECIAL PLENARY SESSION How to retract a power-point slide Special BPSOfficia[...]

The second complainant Tweeted in support of Dr Morrison and Dr Huda, a day after my piece criticising both. :

Screenshot_2019-03-26 C1-2141764902 Dr MacFarlane- Documents to be presented to the IOT_Redacted pdf

I discussed the above in the tribunal hearing (it was in the GMC’s evidence bundle): it has been deleted, along with many others. But it is still possible to find evidence of this Twitter account’s support for Dr Morrison by showing its ‘likes’ of Tweets such as this abusive one (also discussed in the tribunal):

181228-Morrison-Bag-of-Sh

181228-Morrison-Bag-of-Sh-Likes

The second complainant also continues to be active in many Twitter threads with Dr Huda, who promotes them both by re-Tweeting, as here shown with consecutive re-Tweets (image made 26th March 13.15 pm):

Screenshot_2019-03-26 Samei Huda ( SameiHuda) Twitter

To repeat again, I have no problem with anonymous complaints, but if it is claimed they represent ‘patients and the public’, then bodies (the GMC and others) investigating them must consider the wider context.

In contrast, Dr Huda and establishment psychiatrists have repeatedly expressed their hostility towards anonymous complainants. This is very worrying, given the fears that many patients and members of the public have that NHS psychiatrists are in positions of power, regularly work with the police, and might be able to uncover the identity of anonymous complainants, or even punish them with Mental Health Act detention and/or forced treatment.

Screenshot_2019-03-15 from SameiHuda anonymous - Twitter Search(1)

Screenshot_2019-03-26 Dr Kate Lovett on Twitter Anonymous accounts (cowards), photoshopping images (lack of respect and dig[...]

Screenshot_2019-03-26 Wendy Burn 🌈 on Twitter Particularly from the anonymous accounts Cowards as DrKateLovett says …

Finally, it emerged yesterday that Dr Wendy Burn appears to have contacted the first complainant privately. I have previously complained about Dr Burn to the GMC, and named her twice in my submission to the MPTS tribunal on March 20th.

As evidence from both complainants was considered by the tribunal both are potential witnesses. Dr Burn must have known that, and must have known that her action was potential interference with a witness and with evidence. I am likely to call on Dr Burn to suspend herself from RCPsych office, or resign, and will be adding this interference to my other GMC complaints about her.

190327-RAF-WB-support-cr-1

[…]

190327-RAF-WB-support-cr-2

 

(Next piece: the GMC’s false and misleading submission on ‘unlicensed practice’.)

Andrew Solomon’s The Noonday Demon: two decades of #MedHums marketing

(Note for readers new to my blog: although I argue for much greater Pharma-psychiatry regulation and scrutiny, I also oppose pillshaming and anti-diagnosis purism.)

This proposal (lightly edited here) has been accepted, and will be delivered as a twenty minute paper at the July 2019 biennial conference of Symbiosis: A Journal of Transatlantic Literary and Cultural Relations, in Dundee, Scotland. The deadline for proposals has been extended to 25th March.

 

Andrew Solomon’s The Noonday Demon (2001, new edition 2015): an example of US-UK BioPsychiatry marketing through #MedHums (Medical Humanities)

TND

In January 1998 the New Yorker published an autobiographical account of depression by one of its regular writers. Three years later the greatly expanded piece appeared in book form, and it would become arguably the single most impactful Anglo-American work, in any genre or discipline, to promote biopsychiatry in the last two decades.

The Noonday Demon received immense media attention and won over twenty book prizes. I have found only one review which dared to express any significant scepticism, by Joyce Carol Oates, who noted the hypnotic use of ‘mellifluous brand names: Celexa, Xanax, Viagra, Zyprexa, Effexor, Wellbutrin, BuSpar, Depakote, Klonopin, Halcion, Restoril, Zoloft, Paxil et al’.[1]

Andrew Solomon had just published his first (and only) novel, well reviewed in both the UK and the US, when he became depressed. He had a BA from Yale and an MA from Cambridge (England), both in English Literature, and he wove multiple literary quotations and biographical facts through his uplifting account of historical and contemporary neuroscience and psychopharmacology. The depressed and ultimately suicidal Virginia Woolf appears on the second page of the first chapter, and later the reader learns that Solomon was held in high regard as a Woolf scholar by culturally-informed New Yorkers.[2] Shakespeare, Sylvia Plath, and many other canonical writers are employed in the narrative which ends, in the 2015 edition, with an account of the author’s ongoing medications, monitored by both a psychiatrist and a ‘psychopharmacologist’, supplemented by visits to a third specialist, a psychotherapist.[3]

While there is no evidence that Solomon or anyone else ever employed deliberate deception, it is interesting that his father, a businessman, was the CEO of the company which came to license Celexa (under the brand name ‘Cipramil’ it was the UK’s bestselling antidepressant of the mid-2000s) in the US.[4] In 2010 the company, Forest Laboratories, pleaded guilty to criminal overmarketing to children, and was fined $313 million.[5]

I argue that mental health is especially vulnerable to a problematic notion of imbalance between The Two Cultures, potentially leading to an indiscriminate prescription of Humanities in order to counteract overactive Biomedical Science within the mental healthcare body.

As some Humanities scholars have pointed out, quite often ‘humanists can end up privileging medical understandings of health and wellbeing issues’.[6] While not disputing the truth of Andrew Solomon’s account, I explore how that may have occurred in The Noonday Demon and in its transatlantic reception.

 

[1] Joyce Carol Oates, Review of The Noonday Demon, The New York Times 24th June 2001: http://www.nytimes.com/books/01/06/24/reviews/010624.24oatest.html

[2] The Noonday Demon (Scribner, New York, 2015) pp. 87-8

[3] pp. 445-7

[4] https://www.bloomberg.com/news/articles/2002-05-26/a-ceo-and-his-son

[5] https://www.nytimes.com/2010/09/16/health/16drug.html

[6] Maria Vaccarella, Review of Paul Crawford et al., “Health Humanities”, BMJ Medical Humanities Blog (2015) http://blogs.bmj.com/medical-humanities/2015/05/05/the-reading-room-a-review-of-health-humanities/; Anne Whitehead,‎ Angela Woods (Editors) The Edinburgh Companion to the Critical Medical Humanities (Edinburgh University Press, 2016)

 

(Since submitting this abstract I have found a feisty review by Solomon, of James Davies’ Cracked, which defends biopsychiatry while acknowledging some downsides of Pharma’s behaviour. He accuses Davies of ‘pompous psychic Marxism’ and having a ‘smug view of human suffering’.)

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