Devastating drug unleashed killing mental health patients in masses - up to 68,000 dead using standard under-reporting assumption

Mystery in UK as same drug accounts for over 50% of fatal reports globally by physicians and over 90% in Europe - something extra? - and drug is on list of WHO essential medicines

“Why is her face grey?” It was a question I curiously asked as I had never seen anything like this before. A young child I was, visiting a family member in an old haunting Victorian psychiatric hospital standing out in the countryside where only the most ill and difficult to treat patients would wind up. If you were being treated in another hospital, you better not become difficult because you just wouldn’t want to end up in there. The old corridors were claustrophobic, the security doors heavy and the walls surrounding every room no doubt several feet thick. It was a tomb with the occasional jangle of keys held by staff sparking the only promise of release to the outside world and yet as a patient, they were never turned for you.

Mental illnesses such as schizophrenia can be truly devastating and their effects lifelong. With this particular illness, a person’s reality they perceive may break down and their ability to function in the world around them can completely fail. They can become a shell of their former self with family member’s hope to get their loved one back their lifeline to normality. Yet families can’t do it by themselves. Hospitalisations can be numerous and treatment in one capacity or another including reliance on medication often permanent. Suicide is a big risk.

“It’s the Largactil”. She was just standing there, this strange lady with a grey face. My first insight into the shocking side effects which treatment drugs can cause had been laid upon me. We were just sitting around a table as a family, trying to recapture a semblance of normality. Perhaps even on the same visit, in a seeming effort to satisfy my curiosity, I was then pointed to another albeit much younger woman sitting at the far end. She had been admitted after slashing both her and her newborn baby’s throat.

Although an extreme case, and not anything like with the other patients I later met, as you can understand, the stakes with mental illness are often very high. Treatment drugs with heavy side effects have been accepted down the years. If they can get the patient better, it is seen as worth it. However what I discovered the other day, shocked me. Buried amongst the thousands of other drugs profiled in the Interactive Drug Analysis Profiles (iDAPs) was a drug with a radically different safety profile. This particular drug had been released widely not so long ago and one of the more reported side effects is death. Many of them are young. In fact, the number of reports racked up are now nearly triple that of the injurious covid vaccine here in the UK.

Link to full iDAP data

As you can see report numbers are still rising. However their exceptional number isn’t the only striking thing. It’s the number of people on the drug.

Clozapine patients in November 2019

*Table source: An evaluation of the variation and underuse of clozapine in the United Kingdom by E Whiskey, A Barnard, E Oloyede, O Dzahini, D Taylor and S Shergill

Not as many as one would expect. Clozapine is only one of a number of antipsychotic drugs available in the treatment armoury but is seen as a last resort for refractory (hard to treat) psychosis, particularly with schizophrenia and schizoaffective disorder and is known to be beneficial in this capacity. Indeed there are calls to increase the usage. However, although the high risk nature of the drug is apparently known, is it known just how high the risk actually is? Knowledge of the actual danger appears to be in grave doubt.

One way to quantify the danger is to compare with another recent product that has yielded very high numbers of reports, the covid vaccine. With fatal reports per year roughly 1/5 that of the covid vaccine in it’s first year, the group size is astonishingly more than 1000 times smaller. *37,301 patients would rise in number somewhat if measured for an entire year. These November 2019 figures were a snapshot of that month in time although clozapine is a long term medication.

So what is the death rate? In 2019, the actual number of reported deaths from clozapine use from these 37,301 patients (if roughly consistent over the year) was 389, was just over 1%. Yet, it is known that all passive surveillance systems suffer from variable under-reporting (as per the statement from the Commission on Human Medicines) and that 10% of serious reactions are only ever reported leaving the actual number of fatalities at possibility 3,890. If true, a staggering 10% + people on clozapine could be being killed from it each year resulting in a total of 68,000 deaths.

However with this treatment, blood testing and extra monitoring is put in place. Indeed one must even qualify for the treatment and be put on a register. It is therefore reasonable to state that with this extra scrutiny, the level of side effects and fatal outcome reporting would likely increase and hence underreporting would go down. However, given the sheer magnitude of the absurdities being unveiled in the present day, can the possibility of 68,000 actual deaths be completely ruled out?

There is something strange happening in the UK with this drug. In a recent letter funded by the UK Mental Health Research Center by Jose de Leon, ominously titled “According to the WHO clozapine pharmacovigilance database, the United Kingdom accounts for 968 fatal outcomes versus 892 in the rest of the world”, he cited clozapine as being the most lethal drug in the UK. Based on the parameters of over 18’s and report by physician (for the highest clinical validity), he warned that it was responsible for over half the death reports in the previous decade in the nation and revealed that the 968 fatal reports in that period dwarfed the 105 fatal outcomes in the rest of Europe.

He need not have stopped there. A look at the main paper he referenced by Montastruc et al shows clozapine as the most dangerous drug in the world for the 18-64 age category and dramatically bolstered into position by UK reports numbers placing it ahead of oxycodone, a drug which Montastruc goes on to state as “known as a major cause of death within the framework of the so-called opioid crisis, occurring mainly in USA”. What crisis is clozapine then when they outnumber oxycodone reports in excess of 2 to 1?

Having effectively almost single-handedly inflated the treatment drug to the most dangerous in the world by any reasonable measure (if 18 - 64 year olds dying is not a danger then what is?), to parse out just how abnormal report numbers in the UK must be to support that, out of 9 European countries, only 3 times a drug shared greater than 10% of fatal reports per country. The 52% share of clozapine in the UK dwarfs that even of relative outlier wayfarin, an anticoagulant, coming in at second place at 31% in Norway. Wayfarin is also used as rat poison.

If someone left these numbers to accumulate in a forgotten spreadsheet somewhere they wouldn’t look much different such is their lack of attention. They are glaring. And it’s not as if there are many greater problems. Instructively, Montastruc states that “Adverse drug reactions (ADRs) are the most common cause of hospital admission and the fourth or sixth leading cause of death” but makes the damning observation that “However, relatively few studies have described the main drugs involved in these fatal ADRs”. How on earth has this been allowed to happen?

Despite the agonisingly severe disparity, Montastruc waves off the extreme clozapine numbers suggesting that the far higher reporting in the UK “is related to the need for all patients receiving clozapine to be registered with mandatory patient monitoring service” - a casual dismissal smacking of not wanting to upset the applecart.

This actually led to a rebuttal by de Leon stating that “The UK has a clozapine national registry for haematological monitoring, as do many countries. In a review of clozapine regulations in eight countries besides the UK, Nielsen et al. described the existence of national registries in four other countries: Ireland, the United States, Japan and New Zealand”.

Very very strange. At best the reporting issue is unclear, at worst, something endemic to the UK is causing a massive increase in death. Indeed de Leon proposes pneumonia and sudden death as the manifest of such. I should point out that clozapine use in the UK appears to be well within the range of other European nations with Germany for example, a more populous country, experiencing greater use per head. Even if one was to claim that the problem is that the UK doesn’t underreport but everywhere else does, with the selected criteria in the WHO database considered, if the UK had instead underreported to it’s norm by 10 fold for example, that would still leave 97 death reports in the UK versus 105 in Europe.

What is going on?

* UPDATE: A new study has just been released listing de Leon as one of the authors and which attempts to get to the bottom of the matter: Adverse drug reactions and their fatal outcomes in clozapine patients in VigiBase: Comparing the top four reporting countries (US, UK, Canada and Australia)

In the new study, with wider parameters focusing on death reports by all reporters (not just physicians) and a longer timeline, it reveals problems in the US, UK, Australia and Canada, these four accounting for 94% of all death reports for the drug worldwide despite the WHO database being open to over 170 countries. Despite incomplete data, the paper warned of a similarly high fatality rate in Canada compared to the UK. Usefully, infection was also found to be associated with UK clozapine deaths.

Despite being currently associated with a reduction in mortality (due to reduced suicide), the utterly absurd and devastating number of ongoing death reports absolutely demand clozapine be urgently sent back and rectified and should not be seen as safe because it somehow, despite these numbers, might be “relatively safe”. It certainly wasn’t for those who died unecessarily because of a failure to return the product back to the manufacturer.