The title of this post borrows a famous line from Monty Python:
No one expects the Spanish Inquisition
This is an advance notice of things to come rather than a post per se.
To get a sense of the things to come, it is worth reading the Antidepressants, Homicide and a Challenge post and the comments that come after it where many regular contributors to RxISK pick up aspects of the challenge. The challenge is how can we get a fair trial for a drug induced problem like homicide because if we cannot get a fair trial the very same factors that mean we cannot get justice also mean we cannot get good clinical care.
A bunch of different opinions are put forward in the comments – some appealing to what Harriet Vogt calls the emotional approach as opposed to a strategic approach. The emotional approach is what both Trump and Harris are now taking. There is very little solid evidence as to the strategy they plan to implement.
In responses to some of the comments, semi-reluctantly I offer to add a strategic response. Reluctantly because it is not easy to get the Ducks to line up. The effort will be difficult and tiring. Nothing has been done so far but I’m committing to doing it in a series of No One Expects the Reformation posts.
A post today on DavidHealy.org – Friendly Fire – reprises some of the Antidepressant and Homicide details while introducing a new player to the game – the US military or perhaps militaries more generally.
US Veterans are uniquely placed as a group to deliver a strategic option if between us and them we can agree on the right strategy. This post sketches a possible strategy and offers some tactics, if picked up by Vets, might get us somewhere.
In terms of strategy, anyone who has been injured needs to remember that their injuries have not happened in isolation. There are a larger set of forces in play that need to be understood and shaped if we hope to get anywhere.
A catchphrase for this might be:
War is Surgery on a Grand Scale
RxISK will feature a return to some vaccine thoughts for the next week or two.
DH meanwhile will try laying out some emotional and strategic aspects to the dilemmas antidepressant induced homicide reveals in a series of posts about possible Reformations to the System.
In the meantime, the Q and A after the Mad in America Webinar version of Antidepressants and Homicide brought the Clancy case into the frame. This involved Lindsay Clancy’s killing of her 3 children and attempted suicide two years ago.
As chance would have it, the New Yorker has just published an account of this case A Husband in the Aftermath of his Wife’s Unfathomable Act.
For those unable to access the piece, there is a readable version HERE.
annie says
No one expects the Spanish Inquisition –
But ‘Something is rotten in the state of Denmark’ is a significant line in Hamlet because it ushers in what will become a whole array of references to rotting, decay, corruption, and festering.
It is remarkable how the FDA allowed the Fraudulent clinical trials by want of a peculiar reasoning, how the medical journals went along with it, how ‘off-piste’ go the Guidelines, how doctors are succoured in, how ghostwriting became normal, and since 1999 which was my introduction to Seroxat, how little things have changed or got a whole lot worse.
Take the weight-loss drugs which have become Party Political. For the last two days you can’t move for politicians, journalists, tv and radio, increasing the market share of fatty farma – Clare Gerada on BBC Today, Evan Davis on PM yesterday giving out at least ten minutes of pharma spin.
So many famous faces taking the jab, give it to the poor to get them back to work, give it to little children for their obesity epidemic – it’s like 1984 with bells on.
Like SSRIs, no long term trials. Plenty of horrific side-effects.
War is Surgery on a Grand Scale
GSK Suing over vaccines for Covid and RSV
https://www.fiercepharma.com/pharma/gsk-takes-mrna-patent-fight-moderna-suing-over-vaccines-covid-rsv
DH meanwhile will try laying out some emotional and strategic aspects to the dilemmas antidepressant induced homicide reveals in a series of posts about possible Reformations to the System.
Friendly Fire –
Slide 28: Marilyn Lemak
Janet Lagerloef
https://rxisk.org/janet-lagerloef-responds-to-eric-zorn/
Harriet Vogt says
I don’t blame you being ‘semi-reluctant ‘ for one second – the ducks are all over the shop. Please don’t force yourself. A fundamental problem – that you have revealed to me more clearly than anyone – is that ‘The System’ believes itself to be rationally driven by ‘evidence based medicine’. But is, in fact, emotionally driven by the notion of evidence based medicine – when the RCT evidence base bears little or no relation to the patient in front of them and is largely marketing.
A great X friend and iatrogenic warrior, Alyne Duthie, pointed me to this essay you and Dee wrote, capturing the rxisk in a sentence:
‘When it comes to detecting harms related to drugs, clinicians’ and patients’ judgment trumps trials, say David Healy and Dee Mangin. Failure to realise this is the greatest threat to the safety of medicines’
https://www.bmj.com/content/367/bmj.l5777
My thoughts on how campaigning elements seem to work – emotive affecting change vs instrumental effecting change – aren’t meant to be a straightjacket – just one way of seeing – and balancing expectations.
My simple observation is that the tipping points of 20-30 year campaigns (thanks to the defective reporting systems, thanks to you also for clarifying that mystery) tend to be the instrumental elements, because, pretty obviously, that’s how you ultimately change a fixed system – by penetrating its own ‘thought’ processes.
Examples being the Read Davies ‘systematic review into the incidence, severity and duration of antidepressant withdrawal effect’, the fact that Adele Framer’s Surviving ADs was being used even by HCPs as the authority on AD withdrawal, Rxisk’s 2018 Citizen Petition on PSSD and 2019 recognition by the EMA. All kosher system behaviours, if you like.
This sort of schematic clearly does NOT work for drug-induced homicide – for the complex reasons you explored in your talk the other weekend. More of that, briefly, in a moment – reflecting on The New Yorker piece you posted, ‘ A husband in the aftermath of his wife’s unfathomable act’
But, before commenting – it was ofc wholly, tragically, fathomable – one piece of ‘instrumentally effected’ positive news. I made a new GP friend on X the other day, after he made this statement,
https://x.com/jamie_wallis/status/1845207327462314028
‘As a GP I would never start an antidepressant in this age. There have been coroners warnings galore about the risks. For context, I’ve had 17 year old patients in practices who I’ve taken to clinical meeting and none of the other GPs would prescribe either. How is a PA even thinking of starting antidepressants in this age group? Dangerous.’
A really good guy, who was shocked and genuinely affected by Dexter’s terrible death – I told him about that. Which raises another HUGE issue – you touched on in the Drug Dysregulation Sybdrome talk – toxic dosage levels being the norm. So much work to do .
I read Lindsay’s story quickly this morning – with a sinking heart. This poor woman is a perfectionist, almost ‘Stepford Wife’ Mom – completely exhausted by trying to combine mothering of three small children with night shifts in maternity, drugged both insensiible and insomniac. When I read this sentence, I thought, OMG, that’s it, that’s the evidence that the drugs have driven her to kill her beloved children.“I have thoughts of wanting to die, and I feel numb to them.”
The defence was precisely right – horrific overmedication. But the way the system could only conceive of her actions as those of a mad person not as a poisoned, involuntarily intoxicated person, was an action replay of many of the cases you worked on and discussed. I keep meaning to look further into the case of David Hawkins, the one person you mentioned who got off – not a jury trial I seem to recall.
It also showed how little psychiatrists and prosecutors understand about motherhood and the psychological effects of sustained sleep deprivation – generalized anxiety disorder, what nonsense. The unthinkable nightmares antidepressants can cause seemingly by disrupting natural REM sleep patterns are surely connected.
There is no logic either. I was appalled to read that Lindsay has now been prescribed an antidepressant that renders her numb and prevents her from crying. Wouldn’t you think they’d join the dots? No, of course not – that’s not in the algorithm.
For sure, as you say, ‘The challenge is how can we get a fair trial for a drug induced problem like homicide because if we cannot get a fair trial the very same factors that mean we cannot get justice also mean we cannot get good clinical care.’
Actually my algorithm specialist, problem solving No 2 son, had a neat and focussed strategy. But it’s unprintable. You’ll know.
Dr. David Healy says
One of the strategic issues you are missing here perhaps because only lately encountering what is going on is that Charles Medawar with Social Audit in the 1990s played the MHRA, the ABPI, the Royal College and others at their own game – filed complaints and won.
Paxil Progress was there long before Surviving Antidepressants and alerted a generation their dependence issues without claiming it knew how to solve them. Bob Fiddaman was very active on this front from 2000 onwards, and helped establish the need for liquid versions of these meds in order to be able to Taper.
Baum Hedlund took a legal action against GSK for dependence in 2004 and won.
So none of the recent efforts are new. They also seem amnesic to what has gone before. If there is a degree of success now compared to before it can’t be down to these efforts but is much more likely to be a case of pharma wanting to get rid of SSRIs because they are dirt cheap so they have opened the door to regulators and others agreeing there is a problem that needs handling.
What’s the strategy that might change this – other than resign yourself to living a life dictated by the patent life of meds? And when it comes to pointing out the hazards after a certain point, accept that you are now working for the pharmaceutical industry?
D
Harriet Vogt says
We have different perspectives. You, amongst many other talents, uomo universo and all that, are an historian. I’m a commercial world analyst of consumer and market dynamics – with a patient safety obsession. You’ve written scholarly works on the pharmacological evolution of ADs and lived all the history. But – I’ve done a lot of background research digging, much of it inspired by leads from my friends in the prescribedharm community.
The only piece of history you mention that I haven’t explored and didn’t know about – is Charles Medawar suing the MHRA. Would be interested to learn more.
Ofc, the commercial reality is that antidepressants have been relegated to cashcow unimportance by pharmacos for years. There are still some high value, old niche products, but there are ‘blockbuster’ rich picking elsewhere, as we all know.
I suppose the big question is how does history evolve or even flip into change? What are the tipping points? It’s Kuhn meets Malcolm Gladwell, ( for us populist readers – I’ve read Kuhn too!).
In my iatrogenesis aware lifetime, pretty narrowly UK based, system recognition of antidepressant withdrawal has been the big change. Part of it is critical mass – there comes a time when the scale of suffering even unto death for some can no longer be dismissed.
Alto/Adele herself started as a member of Paxil Progress, as you probably know, that being the drug that nearly killed her. But, ferocious citizen scientist and personality (and wit) that she is – we’ve connected a lot on X- it seems to me that she transformed Surviving ADs from a major peer support forum into a political force for change, building on the past in a transformative way.
And, Mark’s hyperbolic tapering – I entirely understand its flaws from a simple minded, lay perspective – if going up creates fundamental changes in a system, then going down isn’t necessarily going to reverse those changes – has added a scientific or ‘scientific’ flourish to the system’s understanding of and belief in the reality of AD withdrawal. It’s interpreted as ‘slow and careful’ which seems progressive to me – and pushing this through into autopilot practice is the big test.
So, in a sense, the most prevalent harm is now recognised and embedded in the UK system, albeit not yet practice. But what about all the others? Just because one decent GP is well aware of suicidality risks in young people and actually follows the guidance, AD scrips are still rising for this cohort, as are actual patient numbers.
From a simple strategic pov, you could say there’s a spectrum of harms – ranging from tolerable adverse effects through long term disabilities to death. The awful truth is that the system is able to dismiss the very worst – iatrogenic homicide – as extremely rare. Although I see from Wisner Baum’s website, cheecked out the other night after your talk trying to get a fix on legal aspects, that iatrogenic mass homicide is a business area for them. They’re still quoting Rxisk figures from 2015 highlighting a hierarchy of drugs causing violent reactions where varenicline tops the list. I’ve worked on OTC medical devices for stop smoking so was aware of that vile drug. Equally, I’ve come across quite a lot of smokers it helped to quit.
Laying aside emotion – which is hard – PSSD, assuming a deliberate move on your/ Rxisk’s part – is a powerful strategic direction. Because its prevalence is unknown and to some extent unknowable, it is unpredictably life destroying – and patients will have had a sample of it . Viz charismatic Lewis Capadli talking in the Daily Mail about sertraline’s ADE, that he can’t come to save his ******* life.
But the real game changer, the market disrupter as I see it , is your MOA revelation- Drug Dysregulation Syndrome. A tangible explanation of what these drugs are actually doing to human beings, how they work for some and harm others. Incredibly – the chemical imbalance baloney is still extant – an example the other day from Sam Cook writing for walesonline that we jumped on https://x.com/shvogt/status/1845779691883368605. It’s a heinous lie, as we all know, because patients believe there is something fundamentally wrong with their brains, not their lives, and imagine that the drugs are keeping them on an even keel, not the fact that they are staving off withdrawal.
In a way, Drug Dysregulation Syndrome removes the medical mystery from SSRIs and turns them into a more physically understandable class of drug that could be sold OTC. We agree on this point – I think – perversely OTC is likely to be safer than Rx ever was. How many patients would persist with a drug that made them feel dizzy and numbed their genitals, if a medical authority hadn’t informed them that it would cure their chemical imbalance , the source of their woes?
I suppose there’s also the political context in the UK. Arguably space cadet Wes Streeting’s plans for sending job advisors into hospitals. I fear that this is more likely to increase patients’ self-perceived need for drugs to help them cope. But theoretically it could segue into more of a social prescribing. ‘beyond pills’ culture. With scrips for ADS and stimulants on the increase – expect that’s probably wishful thinking.
https://www.thecanary.co/uk/analysis/2024/10/06/dwp-nhs-co-working-job-advisors-hospitals/
A few thoughts to throw into your whopper hopper.
Dr. David Healy says
Forget trying to flatter me. We have articles appearing regularly saying SSRIs don’t cause suicide and warnings need to be removed. We have children in Canada, Britain, France and elsewhere being put on SSRIs and committing suicide and parents cannot get an expert willing to get involved. Some of the academics and doctors approached are better academics than anyone you’ve mentioned and intensely critical of the pharmaceutical industry but claim to be unable to write reports on cases like these – not unwilling but not knowing how to be an expert. It is quite notable that critical psychiatrists in the UK seem in the same position either unable to unwilling to get their hands dirty.
In my opinion, having been around for a long time and over 30 years in this game – things are getting grimmer not better. If there are openings it is because it suits industry not because any medics or academics on our side has developed a backbone or worked out how crack things open.
What some folk with PSSD have done is magnificent – and what is particularly magnificent is their articulation of the growing vacuum at the heart of modern healthcare but it is not leading at the moment to any research that makes a difference or altering a fraction of the ghostwritten medical literature and lack of access to trial that means doctors who are adherent to the guidelines are the ones who pose the greatest threat to us.
Negligence used to be about the doctor who did unorthodox things. The greatest threat now is the orthodox doctor. This would have been unimaginable 20 years ago even to a President of the Royal College but doesn’t cause an eyebrow to lift now.
D
Dr. David Healy says
Harriet
25 years ago Lilly were openly running adverts saying my SSRI causes less discontinuation syndrome than yours. They were sponsoring symposia at academic meetings including the College and journal supplements on the dependence and discontinuation topic. Almost all psychiatrists 25 years ago freely acknowledged SSRIs caused dependence.
The Panorama programs ran from 2002 to 2007 – first time Panorama ever repeated a program on a topic. Can you see anything like that happening now?
D
annie says
Does the perpetual ask for Informed Consent, fall at the wayside, when most of the stuff, has been off-limits, and does it help along David’s intriguing question?
https://x.com/woodymatters/status/1846607457470079436
We can say definitively that GSK paying $3B fines made no difference to Paroxetine being prescribed and has led to further destruction of lives of children and adults. GSK know this. It takes ‘hard-nosed’ types to walk away from it and pursue their careers despite it.
Paroxetine was a very dirty trick.
GSK thought they could indent themselves in the SSRI market; it didn’t destroy them.
Instead a young boy recently died in France.
So, it’s not all stopping.
Shelley Jofre and Karen Barth Menzies, in a Malibu beach house, looking through all the folders and finding details of horrific deaths of youngsters.
Secret emails reveal that the UK’s biggest drug company distorted trial results of an anti-depressant, covering up a link with suicide in teenagers.
http://news.bbc.co.uk/1/hi/programmes/panorama/6291773.stm
Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials.
And that GSK-employed ghostwriters influenced ‘independent’ academics.
GSK told Panorama: “GSK utterly rejects any suggestion that it has improperly withheld drug trial information.”
Read a statement from GSK
Your stories and views
Read transcript
GSK faces action in the US where bereaved families have joined together to sue the company.
As a result, GSK has been forced to open its confidential internal archive.
Karen Barth Menzies is a partner in one of the firms representing many of the families.
She has examined thousands of the documents which are stored, box upon box, in an apartment in Malibu, California.
She said: “Even when they have negative studies that show that this drug Seroxat is going to harm some kids they still spin that study as remarkably effective and safe for children.”
GSK’s biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.
Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.
In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.
He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.
In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.
She also found an email from a public relations executive working for GSK which said: “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.
“Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise.”
But the article was published in the Journal of the American Academy of Child and Adolescent Psychiatry which says it ranks as number one in child mental health in the world.
The editor in chief of the British Medical Journal, Fiona Godlee, said that what she calls the “blind-eye culture of medicine” should be exposed by professionals.
She has written in response to the Panorama film: “We shouldn’t have to rely on investigative journalists to ask the difficult questions.
“Reputations for sale are reputations at risk. We need to make that risk so high it’s not worth taking.”
Read Fiona Godlee’s reaction to Panorama
The Medicine and Healthcare Products Regulatory Authority (MHRA) began a criminal investigation into GSK three years ago but no action has been taken yet.
A spokesperson told Panorama that the investigation has been given substantial additional resources and remains a high priority.
Seroxat was banned for under 18s in 2003 after the MHRA, revealed that GSK’s own studies showed the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children.
Do GSK define themselves, as a World Leader, by the behaviour of their opponents?
Dr. David Healy says
Annie
A few years later – that same BMJ with Fiona G as editor featured Andrew Witty, CEO of GSK as the acceptable face of the pharmaceutical industry with him on the Front Cover in an Obama like image suggesting he was a figure of hope
David
annie says
I know, in fact, I was trying to find it. Study 329 was beset by problems with the BMJ who took over a year, finding fault with Study 329, and putting up many objections.
“The controversy will not end if they simply stop talking about it. If anything, it will get worse.”
“Behind the scenes, Nardo’s letter had impact.”
No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility
https://www.bmj.com/content/351/bmj.h4629.full?ijkey=00ZjcBlMGct6aDR&keytype=ref
18 September 2015
Kristina K. Gehrki
17 September 2015
David Healy
https://www.bmj.com/content/351/bmj.h4629/rapid-responses
Mickey Nardo
That was just a quick run through, but the point is that the whole history of the story is in that “grain of sand” – again, hidden in plain view. We owe a debt of gratitude to the people like David Healy, Robert Whitaker, Casper, Bernard Carroll, Paul Thacker, Allen Jones, and the countless others who smelled this rat and gave us the tools to begin to read between the lines [from the top down as well as the bottom up]. The only way to make a dent in this sorry edifice is to keep linking the elements until denial is no longer even possible. I guess my Freudian roots are showing here, but unconsciousness is how all this works, and in this case, it’s been the enemy from the start – actively maintained by people with something to gain from it…
The HOPE front page was utterly ridiculous – Andrew Witty
This is part 4 in Health Care’s Colossus, a series about how UnitedHealth Group wields its unrivaled physician empire to boost its profits and expand its influence.
https://www.statnews.com/2024/10/16/united-health-optum-care-medicare-advantage-strategy-dashboard-emails-documents/
The emails from UnitedHealth Group managers were filled with exclamation marks and pleasantries about the weather. But the underlying message to doctors in late 2020 was persistent and urgent: Hit your targets to see more patients. We need to bring in more money.
At the time, deaths from Covid-19 were surging, and no vaccine was available. But inside a UnitedHealth practice, the “#1 PRIORITY” became documenting older patients’ chronic illnesses to generate more revenue from the federal government, the emails show.
HOPE – some things never change…
mary H. says
Annie, would you please remind me how Shelley Jofre first suspected that there was a story to uncover – which resulted in the excellent Seroxat programmes in 2002? Took one plucky woman to push her way through the mire that she found, once looking, for sure. At the time, it felt as if it would cause a breakthrough didn’t it – did to me anyway as I’d no idea that such corruption was present anywhere, least of all affecting prescriptions from doctors who we had always been taught were trustworthy. Was an eye-opener for sure – but was it a game-changer?
Dr. David Healy says
She read the published article. Almost no doctors, psychiatrists or otherwise, spotted what retrospectively was obvious – there were lots of children described as emotionally labile. A simple question to ask GSK – what does this mean?
There used to be an old conservative party jibe about Tony Blair – how do we know he’s lying – when his lips move. All she did was apply the same technique to companies but also the academics who appeared on the authorship of articles and the editors of good journals.
D
D