In response to Thomas Kingston’s death, Katy Skerrett, the coroner at his inquest, wrote to the MHRA (Britain’s medicines regulator) and to NICE (Britain’s guideline body) suggesting that their communications around antidepressant hazards appeared to downplay the risks of suicidal reactions to SSRI antidepressants, perhaps contributing to his death. See Aunts, Ants and Regulators, and Kingston’s Rule.
Both bodies have responded more or less suggesting that, while over the course of the next year there would be further input on these matters, which might lead to a tweaking of things, they thought their communication was pretty good. MHRA Here – NICE Here.
Here is the key piece from the MHRA response:
The product information for all SSRIs warns that the risk of suicidal behaviour is considered to be greatest in the early stages of antidepressant treatment. This is likely to be related to antidepressants being effective only after a few weeks of taking the medicine and depression itself being associated with an increased risk of suicidal behaviour.
The Kingston family and others bereaved by treatment induced suicide will likely find this response jaw-dropping.
Some of the rest of us are better placed to be disbelieving rather than horrified.
Disbelieving for two reasons. One is that MHRA’s wording looks like it was dictated for them by GlaxoSmithKline (GSK) two decades ago and is unchanged since then. The other is the current wording goes to the heart of how to determine cause and effect and not just raises questions as to whether MHRA should have anything to do with this but positively indicates they shouldn’t.
Scripted in GSK
In 2002 and 2003 a series of BBC Panorama progams put GSK’s SSRI, paroxetine (Paxil/ Seroxat), in the firing line. Regulators like FDA, MHRA, and later EMA were faced with a crisis.
GSK – almost certainly having consulted with other companies – came to the rescue. A review of rates of suicidal events on paroxetine and other SSRIs, along with other problems like dependence on paroxetine, let GSK bundle up their clinical trial data and claim there were no problems. On average, paroxetine and other SSRIs did not cause suicidality or do anything for that matter other than correct a serotonin abnormality.
This claim involved Statistical Lap-Dancing. A not quite statistically significant G String got in between regulators and reality. For just this reason, medical statisticians had been saying for decades that statistical significance tests are completely irrelevant to a hazard like SSRI-induced suicidality.
The G String in this case was used not only to intimate there was no risk from treatment but that the substantial excess of suicidal events on SSRIs compared to placebo was a mirage – a veil between us and reality behind which some might mistakenly think or fantasize there was something.
We now know that in their trials companies had created non-existent placebo suicidal events, breaking regulations in the process and had done so fraudulently in some instances, GSK most notably. Companies do things like this if they expect regulators to turn a blind eye.
It says something about the state we are in that companies could expect to be able to pull a veil over the eyes of pretty well all of medicine.
Professional bodies like the American Psychiatric Association and Royal College of Psychiatrists duly trotted out messages (Suicide Notes) saying Antidepressants Save Lives which they repeat to this day. There is literally no evidence of the kind regulators, companies and APA claim is gold standard, to support this claim – See Professional Suicide and Royal College Suicide Note.
I think antidepressants can save lives but for entirely different reasons to those the Great and the Good are offering us.
GSK embodied one of the Lap-Dance veils in the following submission to MHRA:
It has been proposed that SSRIs, such as paroxetine, may induce agitation or akathisia like events soon after therapy is started and that the distress this causes in an already vulnerable group leads to suicidal behaviour [Healy, 1994]. However this suggestion is not supported by the findings from the adult clinical studies with paroxetine or the postmarketing adverse event data.
Hence, establishing whether paroxetine (or a concurrent medication or underlying psychiatric disorder) is the most likely cause of the onset of akathisia-like symptoms in any individual patient may not be straightforward. However, given that an association between the onset of akathisia or agitation and the development of suicidal behaviour is not supported by the data on paroxetine, there is not an absolute need for therapy to be immediately withdrawn. Rather, the physician will need to consider the range of management options available in the context of the severity of the akathisia symptoms and the potential benefit the patient may derive from continued therapy.
No additional guidance regarding the management of patients presenting with akathisia-like symptoms is considered appropriate, as the prescribing physician should consider each individual patient on a case-by-case basis.
This translates as:
You may be worse after starting treatment, even suicidal when you weren’t before, but in our clinical trials we damped down reactions like this by putting you on benzodiazepines and when we added the data from you and others who were worse right through to the end of the trial, we could still squeak out a teeny-weeny overall on-average benefit on the Ham-D rating scale.
This Ham-D score forced regulators to accept we (GSK) had met the standard for approval agreed with them which we spin as Our Drug Works – It Benefits You. You might have ended up dead but that was down to this terrible illness while our drug was en route to working.
Even if you and your doctor are convinced the drug is making you suicidal, there is no need for the label of the drug to tell either of you that your perceptions might be right. [We have carefully deflected regulatory attention from and told doctors nothing about our healthy volunteer trials where normal people become suicidal on treatment].
Trade-Offs
The wording of the statute governing drug approvals requires companies to demonstrate their drug is effective. Saving lives is the only unambiguous evidence for effectiveness. In the case of the SSRIs, related antidepressants, and many other drugs and vaccines, there is no evidence of lives saved. New treatments mostly show an excess of lives lost and other serious disabilities compared to placebo.
Decades ago, regulators defaulted into agreeing that instead of lives saved companies could demonstrate an effect – on the Hamilton rating scale for instance. An effect that suggests the drug might save some lives. All other rating scales in the trial might show negative results but if there is a bare minimum average drop in a Hamilton score in 2 of several trials done, regulators will license a company to claim their drug is antidepressant.
Not only is there no evidence for effectiveness, and in the case of the SSRIs absolutely minimal evidence for a supposedly beneficial effect, but in the case of sertraline (Zoloft) regulators demonstrated a willingness to license it without meeting the 2 trial criterion. Regulators were also willing to license antidepressant claims for these drugs in minors on the back of completely negative trials.
Companies, as it were, then place this Eucharistic benefit in the weighing scales and claim that even if you are gluten sensitive and killed by gluten in the Eucharist it will still have worked as the body of Xt. You may end up dead but look at it this way – you’ll go straight to Heaven.
Common Sense
A better explanation of what is going on is that SSRIs, created to produce a serenic effect, do so in some but not all of us as Carlsson, their creator, recognized. For some of us nicotine or a benzodiazepine is much better than an SSRI – see Restoring the Magic to Healthcare.
This serenic effect is apparent in roughly half of us taking an SSRI within a day or two of starting – just like the agitation or other effects we might experience. It is not the case that these drugs take 6 weeks to work. Recovery may take 6 weeks, but this is something different. The rates of recovery on placebo are almost indistinguishable from those on an SSRI at the 6 week point. The tiny benefit the entire SSRI group gets from some trial participants showing a serenic benefit, however – with some creative adjustments, was enough to get the entire SSRI arm of the trial onto the gravy train.
The MHRA response to the coroner features another Lap Dancing act. They intimate that children and young adults are particularly at risk of developing suicidality. This is just not true. There is no statistical basis for saying this.
The reason these drugs ended up with Black Box Warnings in the U.S. for children and young adults was because there was no demonstrable benefit on average in the trials against which the risks could be set.
This creates a conundrum. If half of us put on these drugs are not getting the desired benefit, and this is often obvious within a few days of starting, how legitimate is it to keep us on them for 6 weeks – on the basis that these drugs have been proven to produce a benefit by 6 weeks?
- A benefit on one rating scale that is not found on other scales, particularly scales filled by us (patients) such as the Beck scale or Quality of Life scales?
- A benefit that does not on average translate into lives saved, disability avoided or function restored?
Experts in What if Anything?
MHRA and FDA are not staffed by people who are treating us. If they have treated people like us in the past, they have ended up as regulators because they don’t like meeting us or aren’t any good at treating us. And they may be asked to deal with submissions on drugs they have no experience of giving for conditions they know nothing about.
Yet FDA and EMA claim they can decide these drugs cause cures and decide that they don’t cause harms or if they do it’s impossible for them, or anyone else, to decide if the drugs caused a harm in someone.
Faced with a coroner reporting that a doctor (me) and the family in the Kingston case believed his treatment had harmed Tom and stood no chance of curing him, the MHRA are refusing to face the obvious – that these drugs have the capacity to cause suicide – as evidenced by the healthy volunteers who’ve committed suicide on them. They pay no heed to company documents saying our drugs can do this.
This doesn’t mean that an SSRI has caused a suicide in someone who was on it and committed suicide. A doctor or family members who believe the drugs can cause suicide are much better placed than FDA, MHRA or EMA to say ‘we knew him and what else was going on and saw what he was like on the treatment, and we can say the drug did not cause him to commit suicide”.
Ditto for can save a life. If the doctor and family and patient know the desired effect is a serenic effect visible in 24-48 hours and they have clear evidence it was present and things work out well, it is not unreasonable then to say this drug likely saved or contributed to saving this life (if the depression was severe) and if it did so in this case, it has the capacity to do so in others.
If this isn’t the case medicine isn’t possible. If the combination of a doctor and the person on treatment is not mostly correct when we decide it is likely the drug is causing the problem and reducing the dose or stopping the treatment is the correct answer – medicine cannot be safe.
Regulators and Doctors
The chances of keeping you safe fall drastically if your doctor believes company and regulator endorsed propaganda that her view of what is happening you is misguided. If she has been seduced by Statistical Lap-Dances into viewing you as being over-emotional.
Regulators give the impression they are responsible for deciding on Cause and Effect. Ask them what doctors do in this respect and they fudge. They mumble that of course doctors have to treat you but regulators do not concede that in order to treat you safely doctors have to make cause and effect judgement calls and that their decisions on cause and effect in individual cases have or should have implications for what regulators do/think.
If Dr Morgan had turned up at Tom Kingston’s inquest, she could have been asked about all the professional literature, convincing cases, that SSRIs can make people like Tom suicidal. If she is quizzed about this and says she didn’t access it or have time to read it, she will be held liable for not being a responsible professional – she will be blamed.
The more successful company marketing, the more likely it is that, in addition to the drug label and NICE guidelines based on a ghostwritten literature, companies have shaped the culture so that people on Twitter or Tik-Tox will tell someone in Tom’s position, s/he needs to grit her/his teeth and persist until the drug starts working in perhaps 6 weeks time – see Restoring the Magic.
The more successful the company, the more at risk Dr Morgan and other doctors are, yet companies can still depend on professional medical organizations to trot out Antidepressants Save Lives rather than Doctors Save Lives messages.
Off-Piste Regulators
But here is the most extraordinary thing of all.
The regulations state companies should inform and warn when there are serious events that are life threatening, might land you hospital or cause other serious problems. Proven cause and effect is not needed for a clear warning in the case of a serious hazard. The regulations state that if there good grounds to think there might be a problem, there should be warnings.
Up to about 2000, knowing regulators were no good at, and neither in a position to nor trained to determine cause and effect, companies got their doctor to interview you if you or a family member had a serious problem. When they figured, as they often did, that there was no other way to explain what had happened other than their drug had caused the problem, they added this to the label of the drug.
But then, knowing regulators were no good at and not trained to do this, they began passing your reports or coroner reports to regulators and put an additional stumbling block in front of regulators. They also suggested to the regulators that it was not enough to decide there was a risk, the regulator really had to be sure that they wouldn’t kill people by warning. They might save some lives, but if suicide warnings deterred people from taking an antidepressant might the regulators be responsible for more deaths than they saved?
This company masterstroke depends on the fact that no studies have been done to explicitly see if antidepressants save lives. All the data points the opposite way. Even if there was pertinent data, there is no metric into which to put any data that might yield an answer that regulatory bureaucrats could use to create a paper trail in the event you or I were to question their judgement to warn or not warn.
Without a paper trail regulators are sunk. There is no place in their systems for a free standing act of judgement.
We make judgement calls when our lives are at stake. Doctors, like Dr Morgan, made the same calls once upon a time but now they have essentially become bureaucrats who stick to a paper trail.
Worse again, Tom Kingston was privileged in being able to access the same doctor every time. Most of us now get a different doctor every time and this makes it harder for the doctor to work with us when they can’t see that we clearly look and sound different to how we looked just a few days ago before we started the drug. A doctor who doesn’t know you is in a worse position to make a judgement call – and keeping to the paper trial becomes ever more appealing.
As a colleague looking at this put it recently – medicine has become a word-game rather than a place where lives are enhanced or saved. If we had a blood test that shows raised blood sugar levels, we get diagnosed with diabetes – adjudged to have diabetes – when we may not have diabetes at all even with a raised A1C level. This judgement call is almost impossible to eradicate from a record.
If we make a solid case we have SSRI induced suicidality, the record will read ‘patient thinks he has a treatment related problem’. This may even, ludicrously, become a bipolar diagnosis which has all sorts of implications for us.
The paper trail – the drug label or NICE guidance – doesn’t say that if the patient feels worse on treatment and like Tom Kingston stops a treatment he clearly believes is causing him to feel this way you should trust his judgment and not put him back on essentially the same drug.
The fact that the label doesn’t say this is a breach of regulations and at the very least breaking the spirit of the law. There is a regulation about warning if the hazard is serious, there is none creating a duty for regulators to consider what outcome a warning about a hazard will have on average.
As things stand, no-one, not even God, can make an on-average Benefit-Risk calculation. Weighing Benefits and Risks in the balance is an individual matter. It is a critically important duty for us and our doctor, more critically important than voting, paying taxes or almost anything else we do. It is up there with marrying and having children (along perhaps with choosing to die, our ‘rights’ to which are currently being debated in many countries).
Regulators have no place here other than to make all the information available. Legislators have not permitted regulators to be Censors. Companies have seduced them into this.
This post will be followed next week by Signal for the Goose is Signal for the Gander.
It maps onto recent RxISK posts that outline a rapidly deteriorating state of affairs.
- Deciphering the Web we have Woven
- Who Will Make Medicine Great Again
- Restoring the Magic to Healthcare
- Repairing Ruptures in Clinical Care
- The Future of Health App-Ointments
RCGP
Since the above was written, the Royal College of General Practitioners who were also invited to respond, have done so – the RCGP Response is Here
‘No additional guidance regarding the management of patients presenting with akathisia-like symptoms is considered appropriate, as the prescribing physician should consider each individual patient on a case-by-case basis’.
If the prescribing physician, or her colleagues had ever heard of AKATHISIA, and if our loved one had been afforded fair full and informed consent; the subsequent misdiagnosis of ‘Psychotic Depression’ (in one who was never ever depressed) could have been avoided.
When we returned to the GP it would appear that there was no consideration, knowledge or awareness of AKATHISIA.
It appears that this life-threatening, life-destroying ADR had been deliberately hidden from antidepressant prescribers?
Although I was a hospital doctor, and prescriber for 39 years – (and for 1 year in General Practice) – I would never have heard the word, or understood its presentation and management, if it had it not lead to our loved one’s serial misdiagnosis, and serial deprivation of liberty – (in the complete absence of any mental illness).
Incarceration accompanied by a forced cascade of toxic psychotropic drugs, cruel and sadistic abuse by ‘nurses’, and now: continuing dreams of physical, psychological, emotional, and other forms of abuse.
Despite the invaluable, meticulous re-assessment, case re-analysis and reports from those who founded RxISK, residual Rx injuries and the loss of all life’s opportunities remain a source of constant family sorrow.
Without RxISK, we believe that she would most likely have been eventually killed by, or died later from obsessional psychotropic drugging.
In retrospect, this whole experience might seem to justify a concept of ‘Medical Terrorism’, but perhaps this is too extreme???
Then we read above:
‘— but in our clinical trials we damped down reactions like this by putting you on benzodiazepines —–‘
How many destroyed and terminated lives, how many heartbroken and bereaved families have resulted from this outrageous example of Economy With The Truth?
Truthfulness and integrity could have prevented this, and so much other suffering for so very many years.
Isn’t the aspiration to reduce human suffering the reason we studied and practised medicine?
Surely such mass suffering merits financial ACCOUNTABILITY?
(Am I correct in my belief that the Prevention of Future Deaths Report was also sent by the Coroner to the R.C.G.P.?)
Incarceration accompanied by a forced cascade of toxic psychotropic drugs, cruel and sadistic abuse by ‘nurses’, and now: continuing dreams of physical, psychological, emotional, and other forms of abuse.
Despite the invaluable, meticulous re-assessment, case re-analysis and reports from those who founded RxISK, residual Rx injuries and the loss of all life’s opportunities remain a source of constant family sorrow.
Without RxISK, we believe that she would most likely have been eventually killed by, or died later from obsessional psychotropic drugging.
A lot of the public will think this crazy and over the top. But it’s not it fits my own experience.
This is what happens in a psychiatric situation in the UK when someone has a serious adverse drug reaction that is neurological and looks like mental illness’.
You’re reading the truth it’s horrific and more a form of torcher.
At the moment no lawyer can stop a psychiatrist from doing this. I watched as people desperately called their lawyers to get them out and off the neuroleptics and the shock and panic when they were told they could not.
Psychiatrists utterly refuse to accept what they are doing is drug abuse.
Tim
The Royal College of GPs have responded. It is something of a non-response. I will insert a link to their response in the post and you can read it
David
Thank you for the RCGP link.
This response to the Prevention of Future Deaths Report is also published on-line together with the responses From NICE and the MHRA. (judiciary.uk website).
These publicly available documents will afford little reassurance that adequate, accurate and unbiased antidepressant drug ADR safety information might become available to protect both patients and prescribers from avoidable deaths and life-changing injuries.
Perhaps I can refer to the NICE and MHRA responses initially, and in a following comment, make some observations on the RCGP response?
In the NICE reply to the Coroner’s PFDR it is stated:
‘Given that the matters of concern relate to the side effects and safety of medication, specifically selective serotonin re-uptake inhibitors (SSRIs) we believe that the key issues raised are best addressed in the first instance by the MHRA —‘
So, referring to the on-line published MHRA response (12 February 2025):
‘Patients (and care-givers of patients) should be alerted about the need to monitor for any worsening suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms persist’
What is the point of ‘immediate medical advice’ if the prescriber has never seen or heard of SSRI induced AKATHISIA, and believes this to be a ‘revealed’ Serious Mental Illness. (SMI)?
Our loved one was neither depressed nor suicidal before a locum G.P. prescribed an SSRI for normal pre-exam/new temporary job anxiousness.
No ADR warnings. “If I were you I’d take them” is hardly shared decision making and consent.
(Please see RCGP Response).
“The MHRA is aware that some patients and families have ongoing concerns about the effectiveness of the current wording in the patient information leaflets”.
WE MOST CERTAINLY DO MHRA:
TO PREVENT FUTURE DEATHS AND DESTROYED LIVES: –
We urgently need: – A bold black Box PRECISE warning of AKATHISIA without the meaningless term: ‘restlessness’ and with a description of the extreme, unrelenting AGITATION, inability to explain what is happening, writhing, contorted ceaseless movement, tearing out of body hair in desperation induced by agony, disinhibition, emotional blunting and risk of violence to self or others.
AKA: – HONESTY.
Would anyone misdiagnose this unique, drug induced, acute life-threatening emergency as serious mental illness if the PIL gave the ADR-information necessary to maintain safety and preserve life?
Absolutely unforgivable.
Patients, families and prescribers were more likely to learn about akathisia on the London Underground (MISSD) – than from those whose duty it is to protect us from prescription drug induce harm.
Financial accountability for destroyed lives might motivate the provision of adequate PILs?
Do 18 – 25 year olds suddenly develop immunity to AKATHISIA on their 25th birthday?
“The considerations of the Expert Working Group are anticipated to complete in 2025′.
In the meantime, the MHRA refer to NICE Guideline NG222: –
‘—- — a person with depression started on antidepressants, aged 18 – 25 years should be reviewed in one week after starting antidepressant treatment or increasing the dose.
Some may already be dead before this review.
Tim do you think this maybe worth a go?
Reply from NICE regarding akathisia.
Thank you for your further email to NICE.
We understand the importance of this issue, however, we are unable to investigate or intervene in complaints about healthcare or concerns for individual NHS trusts, doctors, or services (including where NICE guidance is not followed) as this is not part of our role.
The Medicines & Healthcare products Regulatory Agency (MHRA) are responsible for issuing the licence for medications and have ongoing responsibility for monitoring the safety of medicines. A healthcare professional would be expected to refer to appropriate guidance when prescribing medication. They would need to consider and weight up the potential risks and benefits of a treatment on a case by case basis, in discussion with the individual, before deciding whether it is an appropriate treatment for them.
As you are aware, NICE are not asked to develop guidance on all conditions and our recommendations do not cover all clinical circumstances. We have not published any specific guidance on akathisia.
Topics for new or updated guidance are considered through the NICE prioritisation process. In 2024 we updated our guideline review, update, and prioritisation process which means a move away from a review at fixed points after publication to a more responsive process that reacts to the publication of new evidence, and the requirements of those working in the health and social care sector, when appropriate.
We continue to operate an active surveillance programme and when new evidence emerges, we proactively consider whether existing guidance should be reviewed and, if appropriate, updated. We also work to understand the current needs and priorities of the health and care system, and key stakeholders within it. Decisions as to whether NICE will create new, or update existing, guidance are overseen by an integrated, cross-organisational prioritisation board, chaired by NICE’s chief medical officer.
Section 7 of our topic prioritisation manual (PMG46) shows the eligibility criteria that we consider when making decisions on whether new guidance or updates of current guidance are appropriate. When there is not enough information to assess a new topic against the eligibility criteria, it is not progressed further. The new topic can be reconsidered when NICE is alerted that further information is available.
After considering the information above, if you would like to suggest a new topic for guidance, or feel that an update to any of our current guidance is warranted, you are welcome to complete the form on the prioritisation page of our website.
I hope this further information is useful.
https://www.nice.org.uk/about/what-we-do/prioritising-our-guidance-topics
Chris,
I don’t know the answer to your question.
In view of our collective adverse drug reaction experiences with ADs (and other prescription drugs) inducing AKATHISIA and its misdiagnosis: – It would seem reasonable for us to advocate for greater prescriber knowledge, awareness and understanding, wherever an whenever an opportunity arises?
I appreciate that our efforts may often appear to be unwelcome to
“Defenders of The Faith”.
I searched the NICE Website for ‘SSRI Induced AKATHISIA’: – “No results found”.
BNF Search Result for ‘SSRI induced AKATHISIA’ : – “We couldn’t find any results for SSRI induced akathisia”.
Will be interested in Tim’s comments, as a medical professional.
My immediate reaction was one word – boilerplate. Two more words – cut ‘n paste.
The response from the RCGP seemed to cover every conceivable issue. Except the key one – clearly – what you need to do to protect your patients from SSRI induced suicidality.
This does indeed seem to be something of a non-response. It would also appear to be a possible missed opportunity to augment: “The curriculum recognises the emerging issue of suicide prevention in mental health care”.
I am not without bias in favour of the RCGP, in view of the exemplary Teaching and Learning experience that I received during my own Vocational Training in General Practice before returning to Hospital Medicine.
The Report to Prevent Future Deaths asks for specific comment on two matters of concern.
However, most of the RCGP response is comprised of ‘General Comments’.
Who could not support the emphasis on shared decision making?
The RCGP Scotland Joint Chair is quoted:
“As with any medication, GPs carefully consider the benefits and risks when prescribing antidepressants’.
How is this possible when the most dangerous and life-threatening antidepressant harm of akathisia apparently remains largely unwritten and unspoken?
There is complete agreement with the following statement:
“GPs are highly trained to have frank and sensitive conversations with our patients” —
My hospital department, and our patients, benefitted greatly from the outstanding consultation skills that our attached GP Trainees/Registrars had acquired in their teaching practices.
The above quotation continues: – “conversations with our patients, and this includes any potential side effects which may occur from taking antidepressants`’. .
This was not our loved one’s experience, nor does it appear to have been the experience of those who record their antidepressant outcome tragedies here.
It is recognised that in the very brief consultation time available in General Practice, it would not be possible to address all of the many ADRs of this class of drugs, but surely we should be warned about an ADR which can kill?
An akathisia alert would save so much misery, loss, bereavement and, in some cases, unforgivable, inappropriate incarceration. Deprivation of liberty for suffering a common ADR.
Primum non Nocere.
Returning to: “The curriculum recognises the emerging issue of suicide prevention in mental health care”; – we also need to address prescription drug induced suicidality in those who have no mental health condition/s whatsoever, solely an adverse drug reaction (ADR).
So, having discussed some of the General Comments; what of the specific questions?
My personal preference would be for more direct and brief responses: –
Q. Is there adequate communication of the risks of suicide with SSRI medication? A. NO.
Q. Is current guidance to persist with SSRI medication or switch to an alternative SSRI medication appropriate when no benefit has been achieved and/or especially when any adverse side effects are being experienced? A. NO.
( Persisting or Switching can induce akathisia, with emotional blunting and disinhibition which, it is reported, can result in precipitate suicide).
It is accepted that many physicians are committed advocates of the benefits of SSRIs/ADs.
This should not prevent a meticulous scientific analysis and debate.
Finally, reference in the specific answers is made to a Shared Decision Aid. (SDA).
Surely an SDA specific for prescription drugs which can induce suicide would be an asset to safer prescribing, and to suicide prevention?
Although I shamelessly skimmed and you have meticulously analysed the RCGP response, Tim, I think we ended up in the same place. They failed to focus on and answer the significant questions – but you did:
Q. Is there adequate communication of the risks of suicide with SSRI medication? A. NO.
Q. Is current guidance to persist with SSRI medication or switch to an alternative SSRI medication appropriate when no benefit has been achieved and/or especially when any adverse side effects are being experienced? A. NO.
Obviously, the SDA (shared decision aid) they touch on would be a good idea- not least of all because it might inform prescribers, some or even many of whom seem to know as little about SSRI risks as their patients. As you rightly ask would they even recognise akathisia – odds are it would more likely be misdiagnosed as ‘agitated depression’ or even psychosis?
Plenty of us have, in one way or another, mooted SDAs. The key moment when risks have a chance of being avoided, or at least anticipated, is the initial interaction with the prescribing doctor, ideally in the presence of a significant other – family, friend etc.
As I’ve mentioned before – and referenced to the MHRA – The Ollie Foundation (a suicide prevention charity started by 3 bereaved parents of teens) and run by a fabulous woman, Debi Roberts, has developed its own SDA – My Prescription Safe Plan. https://theolliefoundation.org/wp-content/uploads/2024/09/My-Prescription-Safe-Plan-%E2%80%93-Herts-%E2%80%93-editable.pdf
Imo it’s too long-winded – but Debi et al are producing a crisper version. Thinking of a consult between stressed patients and time pressed GPs – we need something short, visual and to the point.
Yes Harriet, Definitely in the same place. Thank you.
Why does it appear impossible for accurate and succinct answers to be provided by the ‘Great and The Good’ to these two critical questions?
Re The Ollie Foundation:
Great concept with the Prescription Safe Plan. I hope that Debi et al may be able to produce a final version which is short and visual enough to be addressed in the few minutes available to patient and prescriber when considering Rx with SSRIs/ADs. (and other prescription drugs).
“If Dr Morgan had turned up at Tom Kingston’s inquest, she could have been asked about all the professional literature, convincing cases, that SSRIs can make people like Tom suicidal. If she is quizzed about this and says she didn’t access it or have time to read it, she will be held liable for not being a responsible professional – she will be blame”
A lawsuit against his GP, what about Pfizer and can any other organisation be held responsible NHS, NICE ?
I don’t get the feeling Tom’s family would do this, no idea about Lady Gabriellea.
Chris
There was a marvellous doctor in the US Erling Oksenholt who in 1981 had a patient who went on a Pfizer myambutol that caused her to go blind. She sued him – maybe even encouraged by him to do so and was paid $100K back then. He then sued Pfizer for not informing him properly about this risk and I think got something like $1M. This is what I would have advised Dr Morgan to do – but her insurance lawyers would have tried to talk her out of this – which for the insurance company would have been risky.
David
“The product information for all SSRIs warns that the risk of suicidal behaviour is considered to be greatest in the early stages of antidepressant treatment. This is likely to be related to antidepressants being effective only after a few weeks of taking the medicine and depression itself being associated with an increased risk of suicidal behaviour.”
Tom didn’t have depression he had anxiety inducing insomnia.
“being effective only after a few weeks of taking the medicine ”
They also state to review in one week ages 18-25.
I disagree it’s any age and anytime. Akathisia needs to be named and far more fully understood. Most important thing to understand in this case is that akathisia can switch on like turning a light on and be intensely horrific, so it’s a second, one second you are pretty much normal next second horrific and it’s not ruminations and thoughts of suicide it’s a horrific feeling of horror that you need to escape from and that escape means death; your body tells you there is no other way out. It’s not suicidal thoughts you do not want to die.
“This is likely to be related to antidepressants being effective only after a few weeks of taking the medicine”
No. Tom didn’t want to die, the drugs and what the GP did caused what happened by introducing more drugs that also cause akathisia.
Chris
Tom Kingston’s case is pretty clear cut and I agree that MHRA played a part in killing him
David
Prof,
That is a harsh criticism of MHRA and I don’t question the strength of your upset but I do wonder if it is misplaced and that we, by that I mean the UK general public, are being given the full picture on this sad event by the surviving people involved, including yourself as the expert witness..
We are told Tom had worries at work but also that these had passed and they were no longer to be considered a factor. We are expected to take his two partner’s word for it (one personal, the other business) yet the evidence now freely available online points to that being very much not the case.
Chris has the sort of certainty that many of us don’t share, leaning instead more towards the “common sense” interpretation that something circumstantial rather than something chemical tipped Tom over the edge that Sunday afternoon a year ago.
I expect the authors of the two responses agree with me but are not prepared to challenge the coroner in public, if at all. But if you and others repeatedly assert in public that the relevant regulatory bodies “played a part in killing him” then that could well change, The GP, who lost a patient, might eventually feel the same way too.
From the above, you will recognise that I don’t share your view that the case is clear cut but then, unlike you, I didn’t hear the evidence in court. Perhaps it addressed the extent and nature of those worries but I haven’t found any reporting to suggest that they were even classified let alone discussed..
Gary
Gary
You are missing the point. The issue is not do we know with absolute certainty that his meds killed Tom Kingston. We do know with close to absolute certainty that
1/. The meds can kill people – even healthy volunteers.
2/. We Know Pfizer have terminated healthy volunteer trials with sertaline when all of those on sertraline became agitated around 4 days like Tom Kingston and Pfizer said our drug can cause this – drugs like this can cause this.
3/. We know there is an excess of suicidal events in clinical trials of SSRIs drugs.
4/. We know companies broke regulations in their efforts to hide this and committed fraud.
The issue is whether the labelling of these drugs should give the impression that it is only depression that cause cause suicide. The issue is why does the labelling not clearly indicate the drugs can cause suicide in their own right?
A medicine is a chemical we can all expect to be hazardous along with information that we used to think would help to keep us safe when using this chemical. The current labels of these drugs put people like Tom Kingston at greater risk than if people bought the drug over the counter and you used natural caution and stopped the drug when you began to feel worse – as he did – but then was essentially put back on the same drug.
Perhaps there were other factors but the chemical and its unfortunate labelling increased the risk the outcome would be death whether or not he had no other worries in his life, no other factors of any sort, or whether he had some heavy duty other worries (which no-one has told me about).
David
This shows that people.. the general public do not know the important history specifically related to the case and other such cases re sertraline nor have our experience and it is difficult for them to grasp. How can we change this?
Prof,
I take your points but I ask myself a similar question: (Perhaps) the risk was increased but if he had not gone to the GP and struggled on or had their RCGP joint decision making led to a non-chemical treatment plan would he, on the balance of probabilities, still have taken his own life?
To answer that we would have needed to learn more detail about his personal and professional life than many would consider seemly for a coroner’s court involving a grieving family and friends.
The responses from the three authorities suggest to me that the Coroner’s concerns, legitimate as they are, were about a singular and complex circumstance and were arrived at in a selective way that together mean they won’t be allowed to tip the scales against the existing policies (both informational and switching within treatment lanes) on their own.
Having said that, I think RCGP were a bit insensitive in their response. I for one got an uncomfortable feeling there may have been some patient blaming/GP protecting going on in the author’s mind when drafting and releasing it.
Gary
Gary
You are still missing the point I think. Of course if he never got put one of these drugs or if he did get put on one but had a good response so he felt no need to stop it because it was clearly making him feel worse, attention would focus on other factors. There do not appear to have been significant other factors in this case.
These are hypotheticals. The details that need to be explained in this case are that all sides agree he became malignantly agitated after going on sertraline – and pfizer say sertraline can cause this in healthy volunteers who are under no known stress – and not just an occasional healthy volunteer but 100% of the volunteers in one study – and then after he stopped sertraline and went back to his doctor she put him on essentially the same drug although not called sertraline.
Do you not think that the most likely factor causing his death was his SSRI drugs. No one has said there are no other possibilities but with the current state of the evidence everything else appears much less likely and much less contributory.
D
Below you ask “Do you not think that the most likely factor causing his death was his SSRI drugs. No one has said there are no other possibilities but with the current state of the evidence everything else appears much less likely and much less contributory”
As I have suggested previously, while it is clearly true that no evidence was presented to the coroner in open court, either by her officer or on behalf of any other interested party, that is not to say there weren’t facts, readily discernable between February and December 2024, that pointed to ongoing problems in his life. Here is not the place to try to correct the record but I hope a simple example will suffice.
Look at the Devonport Capital entry at Companies House (link at end), as the coroner’s officer must surely have done. You will see immediately that the last set of accounts for this “credit granting by non-deposit taking finance houses and other specialist consumer credit grantors” company were filed back in 2023 for 2022 and that the next are now overdue by a month. This despite the remaining director being granted an additional three months leeway in August 2024. Download the last accounts and you will see that this two man team had made or borrowed and then lent out £23m as at January 2023. This was a red flag waving over the business partner’s testimony that there were no longer any financial worries to be explained. In late December 2024 this was risk was substantiated in the first of two Devonport related Regulatory News Service announcements by GoldStone Resources Ltd.
Then there is the very human question of why it was that a middle aged man was moving stuff, without his wife, from a house in London to his parents’ home for storage. A more risk averse coroner’s officer might also have asked why a borrowed gun and ammunition were available together in the back of a car, even in an off-road property, just before a planned deaprture. To be frank, I think there were at least equal grounds for a coroner’s report to the Home Office, BASC and CLBA on that one.
But, yes, you are right. In the absence of evidential disclosure of any other of the usual factors for middle age male ideation and action (eg the Samaritans personality traits, masculinity, challenges of mid-life, relationship breakdown, emotional illiteracy and socio-economic factors) the use of SSRI drugs does indeed provide the most likely explanation.
https://find-and-update.company-information.service.gov.uk/company/09741181
Gary
Decades back Eli Lilly approached me about some cases they had on their books. I made it clear to them about some of these cases that I was likely the best expert they could have – something who believed Prozac could cause suicide but was willing to say that in the case of this or that person who had committed suicide or homicide that it was unlikely that it had caused the problem and even unlikely that it had played a part.
If someone goes on an SSRI and has a clearly beneficial effect – usually apparent within 48 hours, certainly in the first week, as one colleague put it when they seem happy as a clam on it if under the kinds of stress you hint at they commit suicide – I’d be happy to be a witness for the company.
I’ve repeatedly made it clear I’d be happy to be an expert for a Doctor in a negligence case where someone commits suicide on an SSRI the doctor has prescribed – I find it hard to blame doctors who don’t realize NICE Guidelines are based on a largely fraudulent literature, that MHRA have not seen the data from the trials done on drugs they license – that they have licensed a drug without warnings for suicide and homicide that with a little bit of digging they could have found the company and lots of folk knew could cause homicide – a mother killing her children and trying to kill herself.
Its worth reading the posts on the Lemak case on RxISK. There are a lot of other homicide cases of mothers killing children and trying to kill themselves and succeeding or not. You can as the prosecutor did in the Lemak case say this was a women seeking revenge on a husband who was leaving her rather than a homicide caused by the drug she was on – sertraline. But again if you look at the details of the case, this was not a happy as a clam on this pill woman, it was a woman who had all the stigmata of a drug induced state at high risk of eventuating in the outcomes we had – a women unlikely to do anything like this had she not been on the drug. The prosecutor had little option in this case but to pursue a revenge story because she was clearly not insane. The defense could not raise the drug because Illinois law didn’t allow,
Coroners in the UK are in the same bind. The law does not allow them to finger the drug as the likely trigger to death – even those these drugs are more likely to cause suicide or homicide that pretty well anything available on the street when coroners can finger the drug as the cause.
In this case I knew about the business dealings, and chased them. I chased other possibilities also. But I also looked at the medical record which did not seem constructed a priori to lead someone like me to come to the conclusion I came to. There was an unambiguous fingerprint of hypnotic and later SSRI induced problems. These were unambiguous enough and severe enough to be able to separate them from any other stressors that might have led TK to see input for something that initially he figured would resolve with a few nights good sleep.
There was the account by his business partner – not about the financial state of the business which has problems now because TK out of character didn’t put things in place that would have prevented later problems had he accidentally been run over by a bus – but about an episode his partner and a business colleague witnessed that they could have had no idea would be important to me in coming to a view as to what was happening.
Still with very clear evidence of drug induced problems, I remained open to the possibility that I was being mislead. Getting s ‘smell’ of the people involved – parents, partner, lawyer – were all important. ‘Smell’ like this is an important part of my job and I didn’t detect anything that added to suspicions I should have and you clearly have.
The case throws up things you aren’t dealing with. First why do lawyers for doctors, like Dr Morgan’s in this case advise their clients never to blame the drug. We can set aside anything extra you think Dr Morgan might have known about but is not telling us for the sake of the family – all doctors are advised by all defense lawyers not to blame the drug.
Why do the warnings for these drugs not tell doctors that you should be able to tell in the first week if an SSRI is suiting your patient and if its not you should stop it and not prescribe another SSRIs. Why do the warnings not say these drugs can cause suicide and have done so even in healthy volunteers?
If you think I have some agenda and am part of a conspiracy to mislead people – spell it out,
David
I should add that I wrote my last comment before discovering that Companies House had been updated earlier today to reflect an announcement that Devonport Capital commenced insolvency proceedings on 27 February.
I think it’s probably best to leave it at that.
Except you havent opted to leave it at that – you have made a snide comment for some reason. No-one knows who you are or whether you have good grounds to make a comment.
In respect of your comment, TK’s business partner PD made a lengthy statement to the coroner in this case stating there was very little problem with the business. He and TK had been discussing things like Director’s Insurance and it was on the agenda to being put in place. Against this background, he saw TK’s death as not just unforeseeable but as very unlikely to be related to the business. I quote
It is relevant to note that the death of Mr. Kingston has upended the business of Devonport. Lenders to it fear that Mr Kingston’s actions were related to the state of the business and are concerned that their funds may be lost. I have faced what is akin to a ‘run’ on the bank. At the same time some borrowers see a weakness and have ceased to engage, holding out a hope that Devonport will cease to exist before they are forced to repay.
Lender confidence can only be restored by replaying them as soon as is practicable. This can only be done by closing down the loans business of Devonport.
Such an outcome is reasonably foreseeable following a shareholder and director taking one’s own life when one is responsible for the money of others.
This fact would have been reasonably foreseeable to Mr Kingston, if he had contemplated taking his own life. He would have foreseen the damage that would do to the value of his estate and thus any benefit that passes to those that inherit. He would also, I not just hope but honestly believe, not have placed me in such a position whereby I am forced to close down our business whilst dealing with nervous lenders (some of whom are threatening litigation) and opportunistic borrowers.
Unless you can offer anything other than snide comments, best to leave it at that
D
You’ve segued from lap dancing to veil dancing in this piece. How appropriate.
The key para from the MHRA’s written response to the Coroner, Katy Skerrit, and GSK’s MHRA submission are far more sinister moves than the sheer sleaziness of lap dancing, respectively:
‘The product information for all SSRIs warns that the risk of suicidal behaviour is considered to be greatest in the early stages of antidepressant treatment. This is likely to be related to antidepressants being effective only after a few weeks of taking the medicine and depression itself being associated with an increased risk of suicidal behaviour.’
‘Hence, establishing whether paroxetine (or a concurrent medication or underlying psychiatric disorder) is the most likely cause of the onset of akathisia-like symptoms in any individual patient may not be straightforward. However, given that an association between the onset of akathisia or agitation and the development of suicidal behaviour is not supported by the data on paroxetine, there is not an absolute need for therapy to be immediately withdrawn’.
They actively obscure the risk of suicide.
I’ve been reading up on veil dancing – ‘today, the veil has become a dance prop used provocatively as a coy decoy’. The analogy could not be more apt.
https://suhaila.com/uncovering-the-mystery-behind-the-veil/
As you know too well, the fundamental problem is that information that should enable good doctors to keep their patients safe, is dominated by those whose primary objective is returns to investors. And they’ve hobbled hard working regulatory bureaucrats into playing their game – or they won’t engage. The values of business and safe care just don’t mesh.
You touch on ‘breaking the spirit of the law’. If we look at the Medical Defence Union’s own advice to doctors on the law around Informed Consent, post Montgomery, it is clear that the information about SSRI induced suicidality – as expressed in the MHRA and GSK responses you quoted – FAILS to enable doctors to deliver informed consent – legally as well as ethically:
‘Before Montgomery, a doctor’s duty to warn patients of risks was based on whether they had acted in line with a responsible body of medical opinion. (Bolam test).
Instead, doctors must provide information about all material risks; they must disclose any risk to which a reasonable person in the patient’s position would attach significance. (Suicide seems essentially material to me – as does PSSD)’.
MDU also quote the GMC guidance on how to deliver informed consent:
‘Any risk of serious harm, however unlikely it is to occur….sharing information in a way they (patients) can understand… You must use clear, simple and consistent language when discussingrisks with patients.’
https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informed-consent
Veil dancing makes informed consent impossible. It’s high time – way past time – that doctors looked to Erling Oksenholt’s example – rather than blindly believing they are ‘following the science’ – and thereby putting their patients at risk.
The Dance of the Three Veils
The three bureaucratic responses (from NICE, MHRA and RCGP) can be seen here
https://www.judiciary.uk/prevention-of-future-death-reports/thomas-kingston-prevention-of-future-deaths-report/
(links at the bottom of that page)
My interpretation is
1 Is there adequate communication of the risks of suicide associated with SSRI’s?
RCGP “probably not enough”
NICE – no answer from its “Patient Safety Leads” who defer to MHRA
MHRA – “we’re reviewing this”
2 Whether the current guidance to persist with SSRI medication or switch to an alternative SSRI medication is appropriate … when any adverse side effects are being experienced?
RCGP dodges the question and defers to NICE
NICE no answer from its “Patient Safety Leads” who defer to MHRA
MHRA “if no or limited response – discuss further treatment options”
At least, a year after Thomas Kingston’s death, MHRA have created a Yellow Card report for an adverse reaction to SSRI medicines.
Brutal – but fair, Dr Pedro. The dance of the three veils – otherwise known as – ‘pass the veil’.
This sort of bureaucratic, self-justification – is precisely the sort of behaviour that contributed to the Grenfell tragedy:
‘Moore-Bick used the 1,000-page report to criticise the LFB’s commissioner Dany Cotton for “remarkable insensitivity” for claiming in evidence to the inquiry that she wouldn’t change anything the brigade did on the night. It showed “the LFB is an institution at risk of not learning the lessons of the Grenfell Tower fire”.
He concluded many lives could have been saved if her officers had identified sooner that the fire was out of control and told residents to evacuate. He found that the LFB failed to train its incident commanders and firefighters in how to recognise the need for evacuation or in the dangers of combustible cladding.’
https://www.theguardian.com/uk-news/2019/oct/28/grenfell-inquiry-finds-fire-brigade-gravely-ill-prepared-for-blaze
The comparison is highly relevant. What is SSRI induced suicidality – but an emergency event in the person?
Bulletin from the front.
Just before the CHM meeting this Wednesday re SSRI safety communications – focusing on suicidality and PSSD – RCPsych has issued revised information on antidepressants. https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/antidepressants
PSSD is finally given official recognition – a triumph for Team PSSD. Though ‘rarity’ is assumed, despite the many obstacles to it quantification. Posted your/Dee’s paper in response to Wendy Burn:
https://www.cambridge.org/core/journals/epidemiology-and-psychiatric-sciences/article/postssri-sexual-dysfunction-barriers-to-quantifying-incidence-and-prevalence/EF502A763704810C127E2561CFB52FD2
‘RARELY people can experience more persistent sexual side-effects after they have stopped taking SSRIs. The term ‘post SSRI sexual dysfunction’ (PSSD) has been used by some people to describe these symptoms. For these people, PSSD can have a significant and distressing impact on their lives.
More research is needed to understand why this happens and how common it is. It is important that people experiencing ongoing sexual side-effects receive appropriate and timely support’.
Suicidality has dropped the delayed action /’feel worse before better’ veil – and language is quite urgent. But clarity is still compromised by conflation with ‘depression causing suicidality’:
‘Depression can cause you to feel suicidal. Some people also experience increased suicidal thoughts when they start taking antidepressants. The risk of this happening may be higher in children and adolescents. Because of this, if they are prescribed antidepressants they should be closely monitored for suicidal thoughts by the prescribing doctor or another healthcare professional.
It is very important that if you are experiencing suicidal thoughts or feelings, you report these to your doctor straight away. They might suggest that you stop taking your antidepressant.’
How hard is it to communicate drug induced suicidality clearly and simply? it should be as direct as any warning about a threat to life. Rough draft:
Some people have a dangerous adverse reaction to SSRIs. The drugs make them feel acutely suicidal – literally like they want to kill themselves. If you feel even slightly suicidal on an SSRI take emergency action – call 999 and explain you are having a suicidal reaction to the drug,,call your doctor and tell them, stop taking the drug.
“(Perhaps) the risk was increased but if he had not gone to the GP and struggled on or had their RCGP joint decision making led to a non-chemical treatment plan would he, on the balance of probabilities, still have taken his own life?”
This is so important to understand from people who have no concept of what akathisia actually is which is a horrific form of torture.
Gary you seem very interested in all this, maybe you can take the time to watch these, it’s important to really grasp what this is all about:
John Virapen 7mins in
https://www.youtube.com/watch?v=9Eet4x5_8tE
38mins in
https://therehab.com/kendra-campbell-m-d-free-range-psychiatry/
“We know that thousands of people commit suicide every year because of akathisia.”
“I have seen hundreds probably thousands of times someone get started on a psychiatric medication let’s say an anti-psychotic or something and they have akathisia and the akathisia is not recognised by the person who prescribed that medication or by other prescribers and it is assumed to be a new mental illness right – oh my god they’re so agitated, now they have bi-polar disorder or this and that. Literally they get a new label and they get another medication added. I have seen this in the emergency room, I have seen it so many times”
Antidepressants and Mass Shootings/Murder Suicide: An interview with Dr. David Healy:
https://www.youtube.com/watch?v=CLgt3zhJ0hk
Prof
In response to your challenge and without being at all snide I offer you and others a single factual counter to TK’s business partner PB’s stating there was very little problem with the business prior to 25 February 2024.
https://www.mincom.gov.gh/category/press-releases/
As you can see by reading the press release above, by August 2023 there was already a problem developing over the loans to Blue International Holdings Limited/Future Global Resources. These had been advanced by Devonport in January 2021 and 2022 just as its turnover was starting to fly. It was also in the public domain that Blue/FGR had themselves loaned funds to another gold miner in Ghana, GoldStone Resources, in January of 2023. It’s not unreasonable to suggest that Blue/FGR were already experiencing operational difficulties at their mine by then and that Devonport’s directors were fully aware of the developing threat to both the liklehood of repayment and the security on which their investment in Prestea-Bogoso rested. Subsequent events confirmed that the concerns were well founded.
This is the Devonport loan series (there were four loans to the Blue/FGR group as declared to Companies House) with the clearest evidence of associated problems available to the public. Other investments also appear to have developed problems between August 2023 and February 2024 but rather than speculate about those here and now I thought it more appropriate to draw a line in order to wait for the statutory report to identify them with all the authority and independence of the office of an insolvency administrator.
If the phrase I used earler sounded snide then I do apologise but it wasn’t intended to. I also regret that you detected a personal and adversarial tone in my comments. although it does appear to have led to you quoting PB’s testimony extensively. For that and for your other detailed explanations I am very grateful to you.
Gary
Gary
It is difficult for me or any reader to know if you are a conspiracy theorist or whether you have genuine information that needs taking into account. So far you haven’t mentioned anything. It was very clear to me that TK was in a risky business but also that he had gone into it because the prior very well compensated business role he had was much less entrepreneurial – risk taking. The new business was one where some loans were almost certain to fail without failures being catastrophes. You either don’t know this and are not in a position to factor it into account when considering the point you have just made – or you do know it and are choosing not to factor it into account – or are mentioning this as a conspiracy theorist seeking to influence readers here and others – to induce a Holy Shit reaction in them – yes of course that would make me suicidal.
I don’t know how much else you know about the man but he had a track record of seeking out risks prior to this and things going wrong leaving him with consequences that did not lead to suicide or attempted suicide or mood disorders of any sort – and I should stress he did not have a mood disorder of any sort on this occasion. There are other elements to his life that I am not prepared to delve into here as they are none of the business of readers.
I mention this only to repeat that when looking at a case like this or any case, I take as full a picture into account as I can get hold of and in many more cases – inquests and others – I have given a view that the drug likely did not play a part or at least it is not at present sufficiently obvious from the details made available that a case can be made that would persuade a coroner or many other reasonable folk – including me.
In contrast, there are many people who term themselves critical psychiatrists, or such like, who mostly do not have the nerve to get involved in a medico-legal case but if they do are all too likely to blame the drug – this man was on a drug that can cause suicide and he committed suicide therefore the drug likely caused it. Even when colleagues I otherwise respect have offered views like this, I have said that I was pretty certain the drug did not cause this suicide or homicide.
I gave the Kingston family a blunt message about retaining me, that from a skim through the initial material sent to me I was quite likely not to implicate the drug in this case. I changed my mind on digging deeper. The coroner was initially not inclined to credit the drug as playing a part from toxicology reports which said there was no or almost no SSRI in TK’s body and it could not therefore be playing a part.
Why mention this? I do so in order to allay fears some readers may have in the light of details you’ve brought into the frame that I took into account – I do not want the case that SSRIs can cause suicides or worse homicides to be compromised in some eyes by innuendo.
What neither readers nor I know is whether you are a conspiracy theorist feeding on details which you can always find in a case involving a well-known person. Or whether you have grounds to think the drugs in this case did not play a significant role in this death – likely the critical role in this death happening at this time.
Another option is you are someone who like our suicide Tsar Louis Appleby simply doesn’t believe the drugs can cause problems like this. There are many doctors and large sections of the public who believe this. I could be here till the cows come home and not be able to persuade them. Is this the case with you?
The business factors you bring up are pretty well irrelevant when the drug is the primary factor in a suicide. The business factors may be relevant in cases where there is no drug or for people who think a drug cannot do something like this. Do you think these drugs can’t do this? If they can do it they will do it in some healthy volunteers under no stress and in some other people who may be under stress (healthy volunteers like TK). The stress may contribute in these latter cases but mostly would not, absent the drug, have caused this outcome at this time.
In this case the stigmata of drug induced suicide are present to see. This man had a relatively minor problem before being put on what turned out to be a poor choice for him and the situation escalated from there. I wonder Gary if you have any expertise or biases in this area?
Whether you have expertise or not or are biased or not, this case whether it is a drug induced suicide or not sheds light on regulatory communication close to dictated for the UK regulators by GSK 20 years ago – a company who at the time were charged with Fraud. A regulator who went on to appoint Ian Hudson an ex GSK employee as its CEO – a man who stated under oath that paroxetine has no adverse effects at all. How acceptable do you find this – should the wider public find this?
It sheds light on the fact that the NICE guidelines for close to all drugs are based on a ghostwritten, likely fraudulent in many cases, literature with neither you nor I nor the guideline makers having access to the data from the studies they are purporting to synthesize into guidance. How acceptable do you find this?
In their submissions to regulators for these drugs, most of the companies in this area breached regulations – a matter that was pointed out by staff in FDA, MHRA etc – but those in charge turned a blind eye. Senior regulators put their names to articles based on regulation breaching manipulations of the data. How should we view this?
The upshot is probably innocent doctors like Dr Morgan faced with someone who appears to have a disastrous response to sertraline instead of knowing that she should applaud him for having stopped it and should not have put him back on essentially the same drug goes ahead and does just this.
We both might think perhaps Dr Morgan knew more and her view at the inquest might have fed into the points you are making but what you perhaps haven’t know is that doctor’s lawyers in cases like this tell them not to blame the drug and if it seems all too obvious the only way to explain this is that the drug did it and the doctor is uncomfortable denying this, they advise her not to be present – advice she took.
Why are we in this situation when the man who created SSRIs, Arvid Carlsson, believed SSRIs can cause suicide and the way to avoid this is to listen to patients – they are not supposed to feel worse after starting an SSRI. But MHRA listening to GSK rather than Carlsson have wording in the label which will say to many if you feel worse keep on taking the drug because it doesn’t start working for up to 6 weeks.
Carlsson would have told you that TK might have done a lot better on nicotine than an SSRI – in his case this was an evidence based rather than an idiosyncratic view – he tested it out.
How have we managed to stray so far from basic common sense? Can you answer some of these points or do you prefer celebrity gossip?
David
Prof,
Your assertion: “The business factors you bring up are pretty well irrelevant when the drug is the primary factor in a suicide.”
It seems, from my perspective, to come down to an irreconcilable difference of opinion on the nature and impact of the worries facing two very different people, PB and TK, before 25 February 2024. The first insolvency report should shed some light, on the former at least.
My counter assertion: “The past use of a drug is pretty well irrelevent when a noxious cocktail of personal worries combined with ready access to a firearm and ammunition is the primary factor in a suicide”.
Gary
Gary
This is not a matter of an irreconcilable difference of opinions. You are completely avoiding serious and genuine (honest) engagement for whatever reason.
I’ve suggested you might be a conspiracy theorist but contrarian may be a better word. Another option is you are a front for MHRA, or NICE, or Britain’s supposed Suicide Czar – Louis Appleby – all of whom in my opinion have played a dismal, sometimes shocking, part not just in this case but for several decades that has in my opinion led to many more deaths than would otherwise have happened.
The issue is not – was there a business stress. There appears to have been some stress, part of which may have been linked to the business, but whatever the cause TK initially figured a few nights better sleep would sort it. The first treatment aggravated things further. A second treatment dramatically aggravated things. A third preceded the suicide. This is all very clear in the medical record and is not a matter of some distant prior history but is a continuous series of events where each intervention ramped up the problem.
In one sense no surprise – these are not treatments for business stress. And no surprise in that the treatments given do not suit more than 50% of those who get them. There was a 50-50 chance there might have been some help and very clear evidence that this possibility of help was not being realized in TK’s case.
A declaration of insolvency nearly a year later is irrelevant to all this. I’m linked to RxISK.org and one of my business partners has been pushing for us to declare insolvency for some years. What many readers here may not realize is insolvency is very different to bankruptcy. Technically amazon could have filed for insolvency for a period of a decade or more. Businesses can be insolvent in order to avoid paying taxes. Or may end up insolvent some time later because of a run on the bank that TK’s death triggered – as his partner outlined but also outlined that he never envisaged TK ordinarily doing anything like this, even under stress – so what happened remained inexplicable to his partner without invoking another factor.
In the case of RxISK, my accountant resisted the efforts of my business ‘partner’. Just as well. It turns out he appears to have being breaching his fiduciary duty to the rest of us for several years and his suggestion about declaring insolvency now looks like one more instance of this.
This constituted a profound betrayal of a group of us who otherwise were primarily aiming at helping people survive and better again avoid treatment induced injuries. A shocking betrayal also in that this partner had a son whom he claimed was killed by treatment.
I’ve got good grounds to know about the stress business factors like this, including the betrayal element, can cause but it hasn’t caused me to attempt to kill myself and I am much less battle-hardened than Tom Kingston was. I didn’t get into this figuring risk taking was better than a quiet life as he did, and I have far less resources to call on than TK.
Unlike your disregard of a drug-induced element, I haven’t for one minute disregarded a stress element.
You haven’t given any indication you have a health background, so let me explain. Likely close to every day in the week, certainly every week of the year, doctors dealing with nervous problems – either mental illness or stress – are called on to decide if the worsening picture they are witnessing is stress or illness linked in which case the answer might be to increase the dose.
If it is treatment related, the answer is to reduce the dose or stop the treatment – a reasonable option if you bear in mind that 50% of us are unlikely to have a good response to the treatment we have been put on.
This is not a matter of an irreconcilable difference of opinion. Doctors and ideally patient and doctor together have to choose against a background where making the wrong choice can cost a life. Medicine cannot work unless they mostly get this right.
From the very start many patients were often forced to get it right on their own – they smiled sweetly at their doctor when he asked if the pills were helping, saying yes they were when in fact the patient, like TK, figured they weren’t and had stopped them.
TK was more open and made it clear sertraline had made things worse in the clearest way he could possibly have made it clear – this was long before the final events so there is no reason to believe he was part of a conspiracy. The accounts of his business partner and wife all support a view that there was some business stress but a dramatic change in TK after starting the meds that appeared out of all proportion to the business stress.
There is no indication you have any sense as to the high stakes game that can be involved with some of these drugs. You are sounding like a scratched record returning to the business factors alone.
Unless you are willing to engage with the treatment issues we are left with a situation where you are making no effort to reconcile different observations – efforts that good clinical practice and all of science requires you to make. This is why your input does not look genuine – for whatever reason.
It casts aspersions on a man not here to defend himself. Why not cast aspersions on me who can respond – other than your snide approach of suggesting I didn’t know what I was doing?
Which of the many Gary Bullivants who can be found on the web are you? Do you have any background in assessing medication induced problems? Are you being fed lines?
You are making this a non-conversation. I think you need to start answering questions.
David