Editorial Note: The image that was here will be repeated and explained next week
Who will Rid me of …
Events from Washington to London and elsewhere surrounding the gruesome death of Jamal Khashoggi at the hands of the Saudi hierarchy link well with the difficulties everyone of us has when things go wrong on a medicine or after a vaccine.
The Saudi “who us?” fell apart almost instantly. The day after the murder there were photographs of Khashoggi entering the embassy but none of him leaving, along with images of a hit squad arriving in Istanbul, armed with bone-saws, and then leaving. And there was, if not an obviously compelling motive for murder, a clear desire to sort Khashoggi out.
American gangsters, at least as in Breaking Bad or The Wire, would likely have avoided something that risked being so bad for business. A touch medieval, they’d likely have said, or at least 1930s.
What has followed since has seemed like an episode from Breaking Bad. Much of what normally happens behind the scenes, is for whatever reason, whether power-politics among the leading players or the new style of the current American administration, playing out in public.
The President makes it clear business comes first. There is no pretending otherwise. Saudi explanations branded credible by the administration only to be retracted almost immediately as the watching public refuses to buy them, are replaced with other “credible” accounts.
This can continue indefinitely until we find a point where at least some of the public find it within themselves to suspect disbelief, or the news cycle goes stale.
The basis for obfuscation lies in the lack of a body, and the recordings apparently made, and any recordings made in Riyadh of the Crown Prince issuing instructions to bring him Khashoggi’s fingers or testicles or just wishing perhaps that, as with Henry II, someone would rid him of a turbulent journalist, not realising he had such numbskull courtiers.
The less clear the details, the more clear the message – don’t mess with us.
Don’t Use the C…. Word
The BMJ recently ran an extraordinary article by Peter Doshi, followed by an editorial from Fiona Godlee, that hinged on the fact that GSK’s swine flu vaccine Pandemrix causes narcolepsy. For lots of people this wasn’t new. For the many takers of the vaccine who were tortured by it and left unable to function afterwards, if not actually dismembered, particularly children, there was little doubt as to what had happened.
But MHRA, EMA, and GSK rode in to the debate claiming they had nothing to hide, indignant at any hint they had been anything other than utterly transparent.
In the Rapid Responses to the BMJ article and editorial, Clifford Miller, a lawyer who has successfully taken on vaccine and related cases, took issue with MHRA denials of responsibility. He quotes some of MHRA’s response here:
“Most reports of narcolepsy after exposure to Pandemrix vaccine came from Finland and Sweden. In September 2010, the European review concluded that the available evidence was insufficient to confirm a link between Pandemrix and narcolepsy, and that further studies were necessary to fully understand this issue. No restrictions on use of the vaccine were recommended.
After use of more than 6 million doses of Pandemrix vaccine in the UK, we have received 4 unconfirmed reports of narcolepsy following vaccination. These were received after the reports from Finland came to light. The reports so far in the UK are no more than we would expect to see by coincidence after vaccination.
After review of all of the available information, the case remains that a link between Pandemrix vaccine and narcolepsy has not been confirmed. Epidemiological studies are ongoing to further evaluate this.”
Sounds more credible than the Saudi account or at least smoother but there’s a rub.
Ordinarily, when patients present with what is later diagnosed as narcolepsy, on average there is a wait of 15 years before the diagnosis is made. This is well known. Initially doctors diagnose fatigue syndromes or somnolence disorders and all sorts of other things. The average doctor will have seen very few cases of narcolepsy if any.
Against this background, thanks to Clifford we know that here is what was spotted arriving at Istanbul airport, before any reports of narcolepsy from Finland.
- As early as December 2009, under the heading of Narcolespy and Hypersomnia, MHRA had 6 reports of hypersomnia within 67 days of Pandemrix being rolled out. (There are 10 new cases of narcolepsy per million people per year. Hypersomnia is not as rare but 6 cases in 67 days is striking when under-reporting is taken into account and the events were largely among children).
- Under Disturbances in Initiating and Maintaining Sleep, MHRA had 30 reports of Insomnia, 3 reports of Abnormal Dreams (a classic feature of narcolepsy), 7 reports of Nightmares (ditto), 1 report of Sleep Terror (ditto).
- Under Sleep disorders Not Elsewhere Classified it had 9 reports
- Under Disturbances in Consciousness Not Elsewhere Classified it had 73 reports of lethargy, 5 reports of loss of consciousness, 1 of sedation, 27 of Somnolence, and 22 of syncope.
Given how few events are ever reported to MHRA or FDA or any regulator (most doctors figure there is no point reporting) and given that most but not all of these events were happening in minors, there was as good a case that Pandemrix Caused narcolepsy as there was that Khashoggi was Murdered by some Saudi.
The get out of jail card for British regulators was that no British doctors used the word narcolepsy for problems linked to a vaccine produced incidentally by a British company.
This not just a narcolepsy issue. There is a vanishingly small number of doctors who will send a report of PSSD (post SSRI sexual dysfunction), or PRSD (post retinoid sexual dysfunction) or PFS (post finasteride syndrome) to the regulator in their country. They’ve never heard of these conditions. They will send reports of sexual dysfunction of one sort or the other on antidepressants and other drugs.
They don’t send reports of any old sexual dysfunction because everyone knows that happens on antidepressants and regulators don’t want reports of things already in the label. If doctors report at all it will be because there is something striking about what their patients are saying to them. So how many reports do the regulators have of significant sexual dysfunction on antidepressants? Over a thousand in the UK alone. There are reports of permanent sexual dysfunction going back to 1987 – before Prozac.
If in the future the BMJ feature this issue as evidence of the kind of thing that’s going wrong with out pharmacovigilance systems, MHRA and EMA and others will doubtless ride in and claim to be whiter than white.
The one thing they will be hoping for is that no idiotic company or other courtiers will have done anything silly like attempting to assassinate someone like Peter Goetzsche.
What Kind of People Are We?
There is a lot of spluttering about the Khashoggi murder. Realists figure business comes first. Others (non-Saudis of all stripes) figure a message has to be sent that this is not who we are even if it means loss of business.
In the case of lives destroyed by Pandemrix, Clifford’s take is that the regulatory apparatus has been bought by Pharma.
It appears a complex web is woven. The longstanding problems of what appears to me to be drug industry bias amongst personnel in the Department of Health, [and] MHRA, appears by inference to be in some way associated with anonymous senior civil servants. If it were otherwise one might argue that the problems could not continue and should be less likely to exist. That is coupled with the influence the pharmaceutical industry has invested heavily in acquiring throughout Government, the civil service, medical schools, the medical professions, medical societies, health charities and medical publishing. Generous donations and grants are known commonly and to be made on a routine basis. Throw in for good measure manipulation of the media, and daylight is less than likely to be shone to illuminate the darkness.
This greasing of palms scenario is meat and drink to conflict of interest afficionados, who will happily debate how many conflicting angels can be set on the head of a pin until the cows come home.
But this is not the way power operates today. The Crown Prince or whoever is unlikely to have greased palms in the Khashoggi case. Its usually the threat of violence that does the trick. Along with the violence meted out to those who screw things up. The carrot is we won’t use the stick.
Its not a greasing of palms that achieves results in the Pandemrix case. Its Pharma’s business model – pay us what we want or we will stop bringing new pills on the market and you will die. Coupled to – and we will move our jobs out of your country.
This is nothing if not just as macho as the CP.
None of it would work today in Henry IX’s world though without a magic ingredient – the causal link. Unless you can show Pandemrix specifically causing narcolepsy, how can you expect a bureaucrat to take action? This is not the kind of people they are. If doctors report somnolence and not narcolepsy, is a bureaucrat going to disagree?
And if the bureaucrats don’t step up to the plate it would be irresponsible of doctors to start alarming anyone – this is not the kind of people they are.
We don’t now live in a Top-Down world like Saudi is still or Britain was until recently. Its not a Bottom-Up world either. Its a Faceless world, with no complaints departments, and no redress. Activism is like water into sand.
There should be no need to execute people – the Goetzsche affair was a touch medieval. A dead phone-line or online access is more effective. Carrots and sticks may break bones but anonymity is much more painful.
Also just published in BMJ Rapid Responses (my letter)
Re: A tale of two vaccines and the “spectre of Andrew Wakefield”
Re: A tale of two vaccines Fiona Godlee. 363:doi 10.1136/bmj.k4152
https://www.bmj.com/content/363/bmj.k4152/rr-22
The “spectre of Andrew Wakefield” certainly should not be allowed to deflect from this important issue [1,2].
I wrote to this journal in February 2010 explaining why the GMC findings against Royal Free doctors were defective [3], and no one challenged me. The Wakefield Lancet paper had nothing to do with the Legal Aid Board commissioned protocol; investigations were carried out according to clinical need; the order of referral was a red-herring – all of which anticipated the views of the High Court judge, Sir John Mitting, when exonerating the senior clinician and senior author of the paper, Prof John Walker-Smith, two years later [4]. Mitting dismissed the central contention the of the GMC prosecution that the authors of the paper were executing the Legal Aid Board sponsored protocol (172/96):
“Its conclusion that Professor Walker-Smith was guilty of serious professional misconduct in relation to the Lancet children was in part founded upon its conclusion that the investigations into them were carried out pursuant to Project 172-96. The only explanation given for that conclusion is that it was reached ‘in the light of all the available evidence’. On any view, that was an inadequate explanation of the finding. As it may also have been reached upon the basis of two fundamental errors – that Professor Walker-Smith’s intention was irrelevant and that it was not necessary to determine whether he had lied to the Ethics Committee, it is a determination which cannot stand ….” [para 20]
The case that Walker-Smith was undertaking research was dismissed:
“..their case was that he was in fact undertaking research, which required Ethics Committee approval, without realising that he was doing so. This is an untenable proposition, as the analysis of the letter of 11th November 1996 above demonstrates. In consequence, not only was the panel invited by the GMC not to determine Professor Walker-Smith’s intention, it was also invited not to determine his truthfulness in his dealings with the Ethics Committee.” [Par. 18]
“It is in its findings on the clinical issues in the individual cases of the Lancet children that the most numerous and significant inadequacies and errors in the determination of the panel occur. In no individual case in which the panel made a finding adverse to Professor Walker-Smith did it address the expert evidence led for him, except to misstate it. The issues to which this evidence went were of fundamental importance to the case against him. Universal inadequacies and some errors in the panel’s determination accordingly go to the heart of the case. They are not curable. Unless the remainder of the panel’s findings justify its conclusion that Professor Walker-Smith was guilty of serious professional misconduct, its determination cannot stand.”
Mitting rejects the idea that there was any misrepresentation over referrals:
“This paper does not bear the meaning put upon it by the panel. The phrase “consecutively referred” means no more than that the children were referred successively, rather than as a single batch, to the Department of Paediatric Gastroenterology. The words did not imply routine referral.”[par. 157]
Finally, Mitting states:
“For the reasons given above, both on general issues and the Lancet paper and in relation to individual children, the panel’s overall conclusion that Professor Walker-Smith was guilty of serious professional misconduct was flawed, in two respects: inadequate and superficial reasoning and, in a number of instances, a wrong conclusion….The panel’s determination cannot stand. I therefore quash it. Miss Glynn, on the basis of sensible instructions, does not invite me to remit it to a fresh Fitness to Practice panel for redetermination. The end result is that the finding of serious professional misconduct and the sanction of erasure are both quashed.” [para.186-7]
It remains concerning that the chairman (Surendra Kumar) of the fitness to practice panel in the case against the three Royal Free doctors sat on two MHRA committees and owned shares in GSK [5].
All this time Cochrane has been far from clear about MMR, finding safety studies in successive reviews (2003, 2005, 2012) to be “largely inadequate” [6]. Nor do we seem to be able to rely on the MHRA and the EMA to guard the public’s safety – either with sufficient rigour or with sufficient distance from the industry.
[1] Fiona Godlee, “A tale of two vaccines”, BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4152 (Published 04 October 2018)
[2] Philip Bryan, June Raine, Ian Hudson, ‘MHRA response to BMJ Editor’s Choice – ‘A tale of two vaccines’’, r 2018, 18, https://www.bmj.com/content/363/bmj.k4152/rr-11
[3] John Stone, “The unexplained puzzle of the GMC verdict (and responses to Peter Flegg) 10 February 2010, https://www.bmj.com/rapid-response/2011/11/02/unexplained-puzzle-gmc-ver…
[4] In the High Court between Prof Walker-Smith and and the General Medical Council, http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWHC/Admin/2012/5…
[5] John Stone, ‘Re: Financial conflicts -shock horror’, 22 October 2008, https://www.bmj.com/rapid-response/2011/11/02/re-financial-conflicts-sho…
[6] John Stone, ‘Response to David Oliver II (Risks of Vaccines)’, 28 August 2018, https://www.bmj.com/content/362/bmj.k3596/rr-11
My husband and I recently received in the post from our GP practice, letters reminding us to go to a certain location at a certain time to get our flu inoculations. At the bottom of the letters is a tear off strip, which we have to fill in with our reasons for not attending, if we decide to decline the kind offer of these vaccines. Like naughty children handing in their lines. I wrote mine easily, saying I react badly to most medicines, have therefore always avoided flu vaccines and intend to keep doing do. (If I get flu, being relatively well preserved for my advanced age, I will go to bed with a hot water bottle, honey and lemon, and sleep it away). My husband, however, in filling in his ‘naughty slip’ was more anxious not to rock the boat. What could he write? In the past when much younger he often used to fall asleep suddenly at embarrassing moments, as he said, he was unaware of it, it was like someone flipped a switch and he was gone, off into oblivion. He hasn’t been like that for years. But he sure doesn’t want a recurrence. Narcolepsy may be something he is prone to. In filling in his lines however, he doesn’t want to upset his doctor 😊 so he wrote words to the effect that he is not a frail elderly man, he doesn’t mix a lot in public, so is unlikely to catch flu, hasn’t had it for years, and would like his vaccine shot therefore to go to a more deserving recipient…. very diplomatic. Several friends and relations who have had their shots this year have instantly gone down with flu. It happened to them last year too. But Big Brother is obviously eyeing us up like errant youngsters, wanting to keep us on the straight and narrow.
My comment here is trivial in comparison, when one realises the extremely serious implications of this post. It does seem that every opportunity for balanced open judgement has been closed off to us by Pharma. Every possible exit is barred. This is terrifying. Even the media has been nobbled. Profit and survival of Governments and their masters Pharma, come before all else.
The fact that more and more human beings (and wild life) on this planet are becoming weaker due to pharmateceutical poisons damage, doesn’t seem to concern anyone. Or is this coming through like Darwin’s survival of the fittest? Is it all part of a plan? Those who can tolerate the meds with virtually no side effects can go on to pass their trendy genes down the line, creating the next generation of believers and happy drug takers, whereas those who can’t, fizzle out and die whilst lamely protesting about how they were got rid of. If they can be understood through their AKATHISIA. But what happens when there are too few of the toughies left? Too few to do the necessary jobs to keep things running? To few to keep Pharma in profit? The wheel may then have turned full circle. Unless we somehow find a way to wake the world up, before it’s too late. And just maybe we are starting to see the first seeds of this, with the APPG Report.
Let’s do the All Souls Day vigil of candles like we did the last two years. No one can say it hasn’t been working. We need a really big push now, to break the side of the dam. And we need publicity for it ahead of time.
In response to your call Heather may I suggest that this year we all do exactly the same as we did the last two years – and send our pictures and messages to Rxisk facebook page as last year ( I hope that will be acceptable to the rxisk team?)
It would have been good to set things in motion earlier as you say – but it seems that time constraints, due to health or other matters, have got the better of us this year. I feel that to repeat last year’s effort is far better than doing nothing at all.
That sounds good Mary. We will be doing something to commemorate all those who died having suffered terrible side effects from RoAccutane/ isotretinoin, and therefore from AKATHISIA, which includes all those who died because of ADRs from psychotropic prescribed medications.
And we will be thinking very much at around 10 pm on All Souls Night of all those incredibly brave people who have suffered terrible mental and physical damage from these drugs, who struggle to regain their former selves, and, worst of all, who suffer the horror of not being believed when they try to convey what has been done to them by a medical profession that has failed them, who are bewitched by Big Pharma, and they, bewitched in turn by a lust for profit at all costs.
We hold these brave people too in our thoughts and salute them for their enormous courage. May they all be restored eventually to good health and happiness, and regain their human right to do so, and may RxISK continue to crusade for answers and solutions to facilitate this. Our candles will be posted on the Facebook page of Olly’s Friendship Foundation additionally.
Terrorism Inc.
http://claredaly.ie/latest-pandemrix-revelations-we-need-answers-from-government-and-justice-for-narcolepsy-sufferers/
http://us.gsk.com/en-us/media/press-releases/2011/glaxosmithkline-european-regulatory-update-on-pandemrix/
https://www.gsk.com/en-gb/media/press-releases/reports-of-narcolepsy-in-europe-following-vaccination-with-pandemrix/
‘I do believe Tom Jefferson makes an unwarranted assumption:
“As Healy pointed out, openness and clarity are the enemies of vaccine hesitancy. Non response and obfuscation are gifts to those who are ideologically opposed to vaccines and their use.”
Leaving David Healy aside
https://www.bmj.com/content/362/bmj.k3948/rapid-responses
‘it might be reasonable to ask whether the EMA, MHRA and GSK lack of response to Doshi’s initial enquiries and tackle the main responses to his article are manufacturing the very hesitancy they blame on him.
David Healy
GlaxoSmithKline put out two press releases in 2010 and 2011 and have since gone all Kashoggi …
Clifford Miller finds another 172 Pandemrix reports received by the MHRA within 67 days:
https://www.bmj.com/content/363/bmj.k4152/rr-23
Vaccine Confidence Project and EU move to root out misinformation about vaccines:
https://www.telegraph.co.uk/news/2018/10/23/young-people-sceptical-vaccinations-getting-worse/amp/
Next are ‘super-spreaders’ …
The biggest pandemic risk? Viral misinformation
Heidi Larson | 16 Oct, 2018
https://www.nature.com/articles/d41586-018-07034-4
’emotional contagion, digitally enabled, could erode trust in vaccines so much as to render them moot. The deluge of conflicting information, misinformation and manipulated information on social media should be recognized as a global public-health threat’