Kingston’s Rule

This post is written by Dr Pedro who is watching events unfold from 10,000 miles away – with some extras added at the end.

The UK Royal College of General Practitioners (RCGP) has been asked by Katy Skerrett, Senior Coroner for Gloucestershire, to respond to her Regulation 28 report to Prevent Future Deaths, after the inquest of Thomas Kingston (above). His death seemed to result from an adverse reaction to the SSRI antidepressants he had been prescribed.

See Aunts, Ants and Regulators, and Who Will Make Medicine Great Again.

It is significant news that the opinion of the RCGP has been thought important enough to be sought. The Royal College motto is Cum Scientia Caritas (Compassion with Science).

Here is a once in a generation chance for the leaders of Primary Care in the UK to improve the lives of patients. Between 15 and 20 % of us in most Western countries are taking antidepressants, mostly of the SSRI type that were implicated in Thomas Kingston’s death.

Action

Dr Richard Vautrey is the current President of the RCGP.  He seems to be a reasonable and decent man.  His response to the request must contain details of action taken or proposed to be taken, setting out a timetable.

There are two questions to be answered:

1. Whether there is adequate communication of the risks of suicide associated with selective serotonin reuptake inhibitor (SSRI) medications.
2. Whether the current guidance to persist with SSRI medication or switch to an alternative SSRI is appropriate when no benefit has been achieved and especially when any adverse side effects are being experienced.

Communication of Suicide Risk.

This could be to the doctor or to the patient

Most GPs recognise anaphylactic shock resulting from peanut or penicillin allergy and know what to do. I suspect fewer are aware of the suicidal ideation induced by SSRIs. This I expect is as common as serious penicillin allergy.

We know that printed package inserts, patient information leaflets (PILs) are far too long and most people don’t bother reading them. A dead patient can’t give evidence about what they were told.

The RCGP could announce a plan to provide for training materials or webinars on the subject of “SSRIs and suicide”.

During the initial 4 weeks of treatment should prescriptions be limited to 7 day “starter packs” with review?

SSRI induced suicides are probably more common than valproate induced birth defects. Perhaps reproduce what is now being done to warn of those risks.

Persisting with SSRI Medication

The coroner has an inkling that NICE has got it wrong. Will the RCGP have the guts to agree with her and offer to assist in the urgent rewording of guidance?  See the last paragraph below for more on this.

Kingston’s Rule

A few years ago, a child died in hospital from undiagnosed sepsis. Martha had sepsis. Her parents knew she was seriously ill but couldn’t convince the paediatricians caring for her. As a result of her mother’s lobbying, relatives now have a right to demand a second opinion from a specialist when they are concerned that this potentially fatal diagnosis is being overlooked – this is now called Martha’s Rule.

I don’t know but imagine that the number of deaths each year in children from undiagnosed sepsis is less than the number of suicides associated with taking SSRIs.

It’s time for a ”Kingston’s Rule”.

We need a national 24hr SSRI telephone Helpline, staffed by clinicians, specifically aimed at helping people who develop adverse side effects in the first few weeks of taking this type of medication or when their dosage is changed or discontinued.

The PIL would advertise this. Samaritans, MIND, NHS 111 would be required to transfer referrals immediately. People who work for these organisations would be trained in recognising akathisia and its management.

Handing out a similar leaflet to the ones that must now be given to women taking valproate could be mandatory. This could give akathisia information and advice as to when to call the helpline.

It seems that the RCGP is not in the business of issuing advice at the moment and defers to MHRA, NICE and RCPsych – Mental Health Toolkit.

The RCGP must grasp the nettle and help minimise suicides triggered by adverse reactions to SSRIs.

Putting the clock back

Depression was a rare disease in general practice, when I began there. Instead people complained that they couldn’t sleep. Probably the last time GPs got their act together was in the mid-70s when they proposed a successful voluntary ban on barbiturates – sedatives that commonly led to fatalities in overdose.

The barbiturate gap was filled with -azepams etc. Valium, Librium, Mandrax, Doriden, Dalmane are just some names that come to mind. (These were for the younger patients, the older ones could be fobbed off with “tonics” perhaps with vitamins and iron.)

The tolerance and addictive properties of these drugs were soon realised, GP records were, and still are full of stern warnings – “Diazepam 5mg x7 NOT to be repeated – which they inevitably are by a different doctor.

Then word got out that these patients were depressed and needed a short course of antidepressants and the -azepams must be stopped. First a month’s treatment was needed. Then we were told 6-12 months was better to prevent relapse. Tricyclics were best. Amitriptyline gave a dry mouth, so patients knew they were on a real drug. We learnt never to refer a patient to a psychiatrist until they had tried that doctor’s personal favourite. So I issued prescriptions for a fair bit of clomipramine – Anafranil.

Although we never used them it was about this time that various depression rating scales came in. These were invented by pharma as research tools. True family doctors needed no such thing to determine whether their patient was depressed.

Then scientists discovered that depression was due to brain serotonin levels being abnormal. The great news was this could be corrected by SSRIs and make patients great again.

In the early part of my career we could refer patients to Community Psychiatric Nurses. They indulged in talking therapies – although that term was not used in those days. These poorly paid sensible people had minimal training and used common sense and sympathy to help people. This was before counselling and CBT came on the menu.

My impression, throughout my career, was that from the effectiveness point of view – all the treatments – tablets or talking were about as good or useless as the others.

We know that one of the best antidepressant treatments is placebo. At least 80% as good as any drug it has been compared with, and a safety profile to die for. In the 1960s GPs could prescribe aspirin flavum – yellow aspirin – when they didn’t know how to help someone, and I remember a trial which showed that red placebos were better than other coloured analgesics.

What did I learn?

• Most people got better
• Depression often affected a family – you only had to treat one person in the family and all would improve. Relatives were relieved that something was being done
• “Depression” can be the first sign of Parkinson disease or cancer
• Young people with learning difficulties often appear depressed but aren’t.
• I have no idea what compliance was like
• Male impotence was occasionally discussed “temporary” and PSSD did not exist.
• I still don’t understand how antidepressants help depressed people with cancer regardless of their serotonin levels. Give me a glass of wine, preferably ice-cold with bubbles.
• If consulting a certain patient makes you feel depressed s/he probably has social problems

There was a recent article in the British J of General Practice – What are the Challenges to Quality in modern hybrid General Practice?

The (young) editor of the journal, Euan Lawson, clearly thought it was great and that it should have what is apparently a new buzz word linked to it – Enshittification – see this link for where this word came from and what the editor sees in the article.

The article is jargon-overloaded but states what we all know – that general practice is extinct and what’s on offer is not fit for purpose. Sadly, todays GPs don’t realise what they’re missing by not getting to know their patients.

It reminds me of a tour I did in 1972 of the Soviet Union where the Intourist guide told us that men became Orthodox priests because the job paid well, implying they had no religious faith..

How would I advise Dr Vautrey?

I wouldn’t be surprised if he didn’t recognise the word akathisia.  I wouldn’t have until recently.  I would still not be sure how to treat SSRI induced suicidality – akathisia.

He might like to survey the membership and patient organisations to gather evidence of the SSRI problems and gather suggestions to prevent future deaths. It would be good if there was a “family members– bereaved by suicide group” he could contact, although the risk is that these all now promote the use of antidepressants.

Readers of this blog could send him suggestions. His email is in the public domain.

The RCPsych has led the way in its rearguard action to delay acknowledging SSRI problems and has done little to minimise overdiagnosis and overtreatment of “low mood”. Does Dr Vautrey feel strong enough to stand up to his opposite number in RCPsych?  Almost all new antidepressant prescriptions are initiated in primary care.

Assuming that he knows that virtually all the literature about SSRIs is ghostwritten by industry employees – would it help to explain this to the coroner?

Could he ask the Coroner to persuade Government to legislate so that raw data from clinical trials is made freely available?

Could he suggest to the Coroner that whatever NICE says, the advice they give is unhelpful.

In particular – in the case of a depressed young person who already feels suicidal and is prescribed an SSRI – a warning that during the first few days your symptoms may get worse can at present only lead to a doubling of the dose.

Could he suggest that organisations like NHS111 and Samaritans are made aware and receive training about SSRI suicide risk?

One of the tricky bits is the question about wandering into territory when the lawyers say don’t say it looks like the drug caused the death.

Coroners need to insist that the GP who issued the prescription gives evidence in court. Doctors will of course develop PTSD or depression, maybe even dementia.

Still – the question needs to be asked. Do you think it is possible that the SSRI triggered suicidal thoughts?

The Coda here was not written by Dr Pedro. Apologies for the change in tone.

CODA

It usually takes parents or families to create a Martha’s Rule but in this case the central people may be Katy Skerrett or Richard Vautrey.  Ms. Skerrett’s report joins over 40 Other Coroners concerned about the drugs Tom Kingston was on.

What Ms. Skerrett and Dr. Vautrey are up against is caught in the famous image below.

That was 1962.  Today the BMJ, the journal of the British medical profession, whose pages are festooned with adverts selling a Camel Veoza getting through the eye of a needle, are scared to even hint at the fact that treatments may have harms. So much so that they can run an ‘educational’ article on Assessment and Management of Self-Harm in Young People by Mughal et al that mentions nothing about keeping an eye out for adverse responses to SSRIs and how to manage them.

I heard about this article which appeared between Thomas Kingston’s death and his inquest, because the parents of some teenagers, who had been put on SSRIs and died, drew it to my attention. I’ve just read it today.

Marion Brown, Tim Moss and Vincent Schmitt submitted some truly Great Responses to the article which can be seen in full in the GR link.  BMJ were very slow to publish any of them. Then bizarrely a week ahead of Tom Kingston’s inquest, BMJ sniffily added its own extraordinary response and have resolutely refused any follow up responses:

Adverse effects of medication were not the focus of this education article. It was based on the new NICE guidance for self-harm, which was primarily focused on psychosocial factors and care rather than pharmacological treatment.

BMJ Editors. Competing interests: No competing interests

BMJ editors who avoid putting their names in the frame have the gall to write no competing interests when its almost impossible to read BMJ these days without being interrupted by pop up and other adverts or educational sessions for Veoza, rapid responses to which they have also been refusing to publish, and for Lilly’s Kisunla – see Hope, Hype, Consent and Alzheimer’s.

Worse again BMJ recently featured an in the circumstances deeply hypocritical editorial on Predatory Journals: what can we do to protect their prey?  Their Prey?  It is difficult to avoid the impression that this is all about money – BMJ and the other journal editors who wrote this want the money that goes with Open Access publication.

Open Access does not mean you get to see the company data behind a publication as the norms of science suggest you should be able to – it means you or your institution hand over thousands of dollars so others can download this article for free and get told they really must get put on this drug which can only benefit and is close to completely free of adverse effects.  Of course pharma have more money to hand over than anyone else in order to get messages like this out branded as ‘science’.

The appalling predatory journals, BMJ etc complain about, have arisen because some smart folk have looked at BMJ and NEJM’s no-brainer business model.  The predators Prey?  They at least will publish anything for money – even the adverse effects of treatment.  They may be keeping some people safer than BMJ/NEJM etc.

BMJ and NEJM and other major journals should be designated as Zombie Journals – perhaps both Zombie and Predatory.  It may be time to face the fact that we don’t really have any decent medical journals these days – we have businesses that have a journal front but we do not have journals – see Silencing Doctors, Silencing Safety.

The result is Clare Gerada a former president of RCGP and Tony Blair (giving medical advice) have just featured in a Daily Mail article about Britain drowning in a tsunami of labels and psychotropic meds. C and T are blaming patients for seeking out meds and labels. Portraying medicines as sacraments – something that can only do good and cannot harm – cannot result in anything other than this outcome.  But neither Clare nor Tony mention this.

Luther Terry, the Surgeon General in America, the kind of doctor we had before1991 when Richard Smith and BMJ told doctors their views were anecdotal, helped turn the tide on a comparable problem in 1964 by openly stating in a way that could not be ignored that Smoking can Kill.

Dr Pedro sees SSRI induced deaths as relatively rare.  I think deaths from these and related drugs rival smoking induced deaths from lung cancer and heart attacks combined in frequency.

Two more BJGP snippets.  One was close to a repeat BMJ Mughal et al article, also by Mughal et al – How GPs can help young people avoid future self-harm. This interviewed 15 family doctors none of whom seem to have heard about possible adverse responses to antidepressants.  This came out nearly 5 months after the BMJ article by the same authors and the responses from Marion, Tim and Vincent pointing to its problems. There is not a hint that anything has penetrated through.

A second snippet in BJGP this week covered Antidepressant Follow Up a point that concerned Katy Skerrett. Its author mentions a survey of 17000 people starting an antidepressant which reported that:

• 28% of patients were followed up within 14 days,
• 51% within 30 days,
• 67% within 90 days of first drug dispensing.

The other 33%?  At least 33% will have had the wit, as Tom Kingston had, to stop a treatment that was not suiting them and fortunately, unlike him, will have opted not to report back to their doctor. Among the 67%, some will have had the sense to lie to their doctors – even doctors like the 15 Mughal et al interviewed who rather smugly seem to think they do a pretty good job.