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.