This Continues the Spotlight on the Suicides series. Astonished by the conclusion of Stephen O’Neill’s inquest, I wrote to Northern Ireland’s Deputy First Minister, copied to the Ministers of Health in Ireland, Simon Harris, in Wales Vaughan Gething, and in England Matt Hancock, along with the Danish MEP, Margrete Auken, the European Ombudsman, Emily O’Reilly and Martina Anderson, a Northern Irish MEP.
Michelle O’Neill MLA
Deputy First Minister
Coalisland Sinn Fein Office
Co Tyrone BT71 4LN
Dear Michelle O’Neill
Re: Stephen O’Neill
I testified recently at Stephen O’Neill’s inquest. Concerned about the conclusion, I have since liaised with several lawyers, one of them a coroner, to explore what might be done to prevent an unfortunate inquest compounding an unnecessary death.
The options available to anyone unhappy with an inquest, primarily review whether there has been a breach of legal process. It is clear to the O’Neill family, and to me, there hasn’t been a breach of legal process, and even a judicial review at this point would be unlikely to contribute to the public safety in the manner the family had hoped for from an inquest.
This leaves the family in a situation resembling that of the relatives of those who died on the recent Boeing 737 Max flights. Had these deaths not been so public, a coroner would likely have concluded they were an unavoidable accident and his/her brief was just to record a death by plane crash. This verdict would have been supported on judicial review.
I am writing to you because there have been thousands of deaths like Stephen O’Neill’s and almost certainly will be thousands more – hundreds of Boeings – and, if a decent coroner like Mr McGurgan cannot see a way to make a difference, no-one will do anything to forestall these further deaths. The situation calls for a political rather than a judicial response.
The problem faced by the O’Neill family is one they would face should the UK remain in Europe or leave it. Given the common issues, I am copying the Ministers of Health for Ireland, England and Wales into this letter, along with the European Ombudsman, Emily O’Reilly, and Margrete Auken, an MEP, who has a longstanding interest in the issue of access to clinical trial data, as well as Martina Anderson MEP.
I attach a prior letter drafted on these issues and will provide a transcript of my inquest testimony, when I have it. I can supply further documents on request. I am happy for this report and everything else to be publicly available.
I list my concerns below and offer suggestions for moving forward.
Bureaucratic Medicine
Mr McGurgan, the coroner, clearly saw both Mr O’Neill’s General Practitioner (GP), Dr Brannigan, and the Craigavon hospital services, as decent and both as keeping to guidelines issued by the National Institute of Healthcare and Clinical Excellence (NICE). Something similar could likely have been said of the pilots and airline staff associated with the recent Boing crashes and perhaps of Boing personnel also.
One of the questions thrown up by the Boing crashes is whether automation has gone too far. Mr O’Neill’s death raises this question also. In my experience, inquests find it difficult to see how doctors and services who claim to have adhered to NICE guidelines could have done anything wrong. But adhering to auto-pilot responses, dictated by guidelines, is fundamentally anti-medical. This adherence embraces a bureaucratic mindset whereas clinical practice until recently was, and today should still be, judicial rather than bureaucratic.
The anti-medical nature of what is happening is compounded by the fact that guidelines like the NICE guidelines, in the case of pharmaceuticals like sertraline, the drug Mr O’Neill was prescribed, are based on a ghostwritten literature, with no access to any of the data from the clinical trials these ghostwritten articles purport to represent.
(Ghostwritten throughout this letter means that writing agencies working to pharmaceutical company marketing departments write articles purporting to represent the results of trials and medical academics allow their names to be appended to these articles for a fee – without ever seeing the data).
Doctors don’t have access to the data from the trials done on the drugs they prescribe. NICE don’t have access to the data on drugs they recommend in guidelines. And the regulators of drugs de facto don’t have access to the data on drugs they approve for use.
These points are laid out in my testimony. I stated that Mr McGurgan would likely find this testimony incredible. My hope was he would recognise that if an expert in his court was making statements that could get him sued if made in the public domain, and that expert had repeatedly make these claims in public without being sued, and the claims, if true, were germane to the cause of death in the case under consideration, that he, Mr McGurgan, would flag up the issues as matters that need addressing by someone. I had some hope that Mr McGurgan was such a man.
There was more that could be said about the evidence NICE and others depend on. Were the data from clinical trials available and all articles written by the people who appear on their authorship lines, there would still be a problem with the interpretation of the trial data. But this further step would have made my testimony unnecessarily complicated.
I will be happy to develop these points, if called on, and will be presenting them in a series of academic forums over the coming months, using Mr O’Neill’s case to illustrate the points.
Treatment Toxicity
In my original report and testimony, I stated that Mr O’Neill had akathisia. This Greek word has been a godsend to the pharmaceutical industry as few doctors even know what it means. While the finer points of akathisia are difficult even for healthcare professionals, the core point is a simple one that anyone can grasp – treatment can turn toxic.
Once treatment turns toxic there are no guidelines and no clinical trials to guide doctors as to what to do next – as the hospital input to this case accepted at the inquest.
This was particularly obvious in Mr O’Neill’s case. Following his catastrophic response to sertraline, his doctors flailed around. He needed a clinician who could reassure him it was best to do nothing and that his agitation would settle. A lay person might have told him this. It seems to have been Mr O’Neill’s first instinct. But his doctors, threw a variety of medicines at him that made things worse, and withheld the one medicine he indicated had helped.
To get things right, Mr O’Neill’s doctors in the Bluestone Unit would have had to recognise they were dealing with an adverse event, a toxic state. They missed this diagnosis, even though he handed it to them on a plate. While later accepting Mr. O’Neill had a catastrophic response to treatment, after the family presented them with the evidence, at the time they treated him as though he was suffering from a mental illness rather than from a toxic state.
Mr McGurgan seems to have missed this point.
The wider public health importance of this is that up to 20% of those who take sertraline, the drug Mr O’Neill was given, or related drugs, have at least a mild form of the reaction he had and a quarter of those have a severe one. As a result, more people die because of sertraline, or similar antidepressants, than are saved by it (them).
Recognising toxicity is critical to safe clinical practice but adverse effects are less likely to be recognised now than a decade or two ago. This is in part because the medical literature, as noted above, is largely written by ghosts who hype the benefits and hide the hazards of treatment, essentially delivering a message that treatment can only do good – a message reinforced by NICE. As a result, the response to toxicity is often to give more meds some of which are at high risk of aggravating the problem.
Life expectancy in the UK is now falling for the first time on record, and adverse events from the ever-growing cocktail of treatments we now take are likely a factor in this. A case can be made that prescription medicines are now our leading cause of death in general and suicide in particular.
Everyone Mentally Ill?
In his conclusion, Mr McGurgan portrayed Mr O’Neill as having a periodic mental illness. There is nothing in his medical record that would support this statement.
The bedrock for this view appears to be a bereavement reaction Mr O’Neill had after the death of parent. But if we are to take a bereavement reaction as evidence of a mental illness, and equally the enthusiasm many parents show at the birth of a child, then it is likely that Mr McGurgan also has a periodic mental illness. I noted this in my testimony, making the point that, if we went down this route, Arlene Foster could be said to have a mental illness (and likely you also) on the basis of the supposed imposter syndrome many successful women have.
None of these states are mental illnesses. Or if they are, then mental illness does not increase the risk of suicide.
A drug like sertraline, in contrast, can be given to healthy volunteers (young people who have never been bereaved, had children or been successful) and can make them suicidal and violent with catastrophic reactions that map directly onto the reaction Mr O’Neill had.
I think it’s unlikely that Mr McGurgan was trying to exonerate the drug, or the pharmaceutical industry, by invoking a mental illness and more likely that he was trying to avoid blaming service personnel. His instinct to think that the staff were decent and, in keeping to guidelines, were doing the best they could is understandable. But it is not appropriate to invoke a non-existent mental illness in order to avoid blaming decent staff.
The response needed was more on the lines of “something doesn’t add up here”. If we get to the point of making all of Northern Ireland mentally ill, then someone needs to point out that the train has come off the tracks.
Mr McGurgan’s response is of a piece with the root-cause analysis conducted by the Bluestone Unit after Mr O’Neill’s death, which gave the service a clean bill of health, but which, as pointed out in my report, like all other root cause analyses of deaths or injuries in health these days, does not include a box for medication induced death and injury. For such a box to be present, our services would have to put a set of processes in place to manage a foreseeable outcome, including plans for when even the best constructed processes run into the iceberg of hazards concealed by ghosts and missing clinical trial data.
Stephen O’Neill should not be the fall-guy for this. He should not be calumniated for the failure of otherwise decent people from doctors to health ministers to take stock of this situation.
Evidence not admitted
On the first day of the inquest, questions came up about the potential of other drugs Mr O’Neill’s was given to cause suicidality. I prepared a Table addressing this issue. It appears in the letter accompanying this letter. The Table was presented to the coroner and his counsel who consulted the Food and Drugs Administration website from where the figures were drawn, based on which Mr McGurgan decided the Table was not admissible. He appears to have misread the website.
An even more important piece of evidence failed to come into play. Mr O’Neill was found with his neck in a noose and Mr McGurgan reported his death as hanging. This might seem reasonable but is misleading in that Mr O’Neill was not dangling from a height. He was closer to kneeling than hanging. This form of death rarely happens when people do intend to kill themselves but is common in people thrown into a state of emotional turmoil by medicines. Plagued by drug-induced thoughts, that can be horrific, the person puts a noose around his or her neck, not realising that in so doing s/he can easily compress the carotid bodies and losing consciousness can slump and strangle.
Mr McGurgan might have contributed to the wider public health by drawing attention to this form of death. Recording a verdict of hanging gives an entirely misleading impression as to what happened and does nothing to reduce the risk to others.
What is Needed
- Coroners: Mr McGurgan was in a difficult situation. While other coroners have directly fingered antidepressants, even buttressed by expert input, non-medical coroners cannot be routinely expected to come to a diagnosis at odds with the one the treating doctors came to.
Perhaps just as surprising to most people as the idea that the greatest concentration of Fake News on earth centres on any prescription medicines our doctors give us is the fact that until very recently coroners had no training. It is only in the last decade they have had some basic training and there has been a push to standardise their conclusions (verdicts).
Since 2013, they also have a mandatory responsibility under Coroners’ Regulations to make a report where such a report might prevent other deaths.
A recently introduced conclusion they can reach is Drug Related Death. This is rarely considered and is almost entirely reserved for drugs of abuse. Prescription drugs cause far more deaths than drugs of abuse. This diagnosis would have been appropriate in this case.
It is not uncommon for coroners to be faced in inquests with a prescription list of 16 different medicines the deceased was taking. More than 5 increases our risk of death.
Given this, a strong case can be made that the medicines all persons subject to an inquest have been taking should be entered into a register. The time taken would be minimal. The data accumulated over time would be informative. This is not now being done.
There are over 200 drugs that companies have conceded, in the small print of drug labels, can cause suicide. These include common drugs given to children for asthma that have led to recent media reports of infants and pre-teenagers changing personality and becoming agitated and suicidal.
Given the role of specific drugs and the effects of drug combinations in causing deaths, hospital services and general practitioners should be asked to offer coroners a view on whether prescription medicines have caused or contributed to a death.
I first got involved in inquests in which SSRI antidepressants were implicated in 1999. After several coroners implicated these drugs in deaths, I wrote to all coroners in England and Wales to appraise them of the issues, not knowing they had no training, or body through which to co-ordinate initiatives in this area. This has now changed and it might help to write to the chief coroner in England and Wales, Mark Lucraft, to draw his attention to suggestions for a register of medicines being taken, greater use of a conclusion of Drug Related Death, and a requirement for services to consider the role prescription medicines might have played in a death. There is no chief coroner in Ireland, but it would be worth writing to the Coroner Service Implementation Team.
- Hospital Services: The Bluestone Unit in this case conducted a root-cause analysis after Mr O’Neill’s death. They gave themselves a clean bill of health. This means that everybody who should have been communicating with others was doing so in a timely fashion. But this analysis missed out on the content of those communications. The doctor who prescribed the drug that may have made things much worse, buspirone, was not told this was a problem of serotonin system toxicity. Briefed properly the situation might have been different.
While it is helpful that services now analyse their processes following a death, in practice in the absence of any effort to tackle the question of medication induced death, perhaps now our commonest cause of death, root cause analyses risk frustrating families by failing to engage with the cause of death.
An increasing number of families are tumbling into the same position as the Hillsborough families, memorably characterised by the Right Reverend James Jones in his report to the House of Commons in 2017, as facing “The patronising disposition of unaccountable power”.
Something needs to be done as the Revd Jones said to ensure this contribution to the pain and suffering of families is addressed.
Having a box for medicine induced death in place would likely have little effect on many services who will remain blind to the role of medication in causing harm, as the services largely were in this case. But having a box will lead some health personnel at some point to grapple with this problem and the associated issues of how we put protocols in place to manage this kind of hazard when there is little but Fake News to go on.
At Mr O’Neill’s inquest, the hospital representative acknowledged there is no professional guidance for the management of adverse events. This acknowledgement needs building on.
It would be helpful to write to the CEO of Craigavon Area hospital and ask whether there are plans for follow up on this point. It would also be helpful to write to a series of Ministers of Health to establish where our current proformas for root cause analyses come from and whether a medication induced death component can be incorporated in these.
- NICE: Central to this and many other cases in my experience was the reliance the hospital service placed on NICE guidelines. It has been widely known since a Lancet editorial in 2004 that NICE guidelines on the role of prescription drugs in treatment are based on a ghostwritten literature and that NICE do not have access to the data from trials or even a database to let them know how many trials there have been. Chief Medical Officers, editors of our major journals, and many experts who have ever had dealings with NICE know about this situation. Even though companies have been fined Billions of dollars for their roles in fraudulently promoting medicines, NICE have not changed tack and refuse to engage with the respectable media such as the BBC on this issue. Earlier this year, I wrote to Professor David Haslam, the Chair of NICE, about this issue but received no reply or even acknowledgement.
It might be worth asking Professor Haslam whether he agrees that if our guidelines are based on ghostwritten articles it is all but inevitable that people will die.
Had Stephen O’Neill not been prescribed sertraline he would be alive today. This letter aims at supporting his family in their hope that some good might be brought from of his death.
Next Week: Spotlight on the Suicides: Serial Killing in the Western European Archipelago and elsewhere
Great letter and suggestions – boing boing bong
It was clear the plane’s new automatic system overrode the pilot and he was unable to switch it off; they are not admitting liability. or confessing.
When I was making funeral arrangements for my mother, I happened across a most entertaining undertaker. He lightened the load and I don’t remember how it came up, but, Seroxat came in to the conversation. May be it was playing on my mind…
He said, I had a…Seroxat, body.
Who was she, I asked.
It was a he, he said.
He would say no more.
What a pity; an undertaker knowing about this person’s demise and the drug, I can only assume it was ‘strictly confidential’ .. Who knew.
“This is where Americans have an advantage. They can take a lawsuit – although its incredibly difficult to do so. Europeans can’t. Winning a lawsuit can make a difference – 20 years later. Tim Tobin won his case against GSK in 2001. The benefits of that win are still making a difference. But for the most part companies have become adept at shutting down any publicity that might stem from a legal loss. Pretty well no doctors have heard that GSK lost the Tobin case or cases against them for dependence on paroxetine or birth defects on paroxetine or even the Dolin case.”
Bong
https://www.missd.co/
According to the FDA:
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
Stephen’s ‘presenting symptoms’ have been presented –
A Toxic State –
She described it as a “landmark” case and said it was extremely difficult for a 26-year-old “to take on the might of the State and a large multinational company GSK” while also coping with her illness.
Settlement reached in swine flu vaccine case
https://www.rte.ie/news/courts/2019/1119/1092827-aoife-bennett/
The defendants in the case were GlaxoSmithKline Biologicals, the Health Service Executive, the Minister for Health and the Health Products Regulatory Authority, formerly the Irish Medicines Board.
All claims made in the case were denied and the settlement was made without admission of liability.
No orders were made against the HPRA or GSK.
BOB FIDDAMAN @Fiddaman 4h
Breaking…
I bet there was not a flicker of concern from any of them – they can even cope with no one believing them providing no one can tell it in court.
David Can I ask How long ago did you send the letter? Did you get acknowledgements of receipt? Are you still expecting responses from any of them? There is a lot to digest in the letter especially if the issues are new to them ,So hopefully a bunch of aides and advisers would go through the points you have made and advise them how to make a serious informed response. I think It would be great if any of the recipients would invite you to meet with them. Is there any chance of that happening?
Excellent letter! Thankyou Dr Healy for all you do.
” it is likely that Mr McGurgan also has a periodic mental illness.”
Brilliant.
In the past when I requested my medical notes so I could see what had been written.
I was horrified at the covertly written crap written one saying I was autistic/aspergers simply because I didn’t smile at the doctors (offensive) comment when I was there simply to lay a complaint against them.
So I wrote back and asked for my comments to be attached to my file and that I diagnosed the doctor as having autism/aspergers because he wasn’t able to read peoples feelings appropriately and further more he was suffering a severe case of I.E.D. (impervious to the evidence disorder).
They never replied. They can sure hand it out but they cant take it when someone does diag-nonsense on them.
I also agree that doctors have no idea what akathisia is or what it is like. Yet we all assume they do. Until doctors can get it and change their sanguine thoughts about akathisia they will continue to be a serious danger to others. Forget the hypocratic oath that was vapourized long ago. Doctors are now the most dangerous people anyone could talk to.
Ugandan Ministry of Health got its epistemology wrong
https://observer.ug/viewpoint/62681-ministry-of-health-should-quickly-deal-with-the-vaccination-confusion
https://observer.ug/viewpoint/62680-measles-rubella-why-ministry-ought-to-have-involved-some-anthropologists
Coroner warns lack of guidance on co-prescribing oxycodone and amitriptyline
19 November 2019 Beth Gault
A coroner has criticised the lack of guidance on prescribing oxycodone and amitriptyline after a patient died after he was prescribed both of these by health professionals.
at St Pancras Coroner’s Court. Ian had jumped in front of a train at Finchley Road tube station (right).
An account of the inquest appeared in the Camden New Journal, under the headline: ‘Wonder drug’ played a part in man taking his own life – coroner.
Ian’s widow Maria told the court that Ian had been prescribed Citalopram for a month before his death, and “had expressed a wish to come off it, complaining of confusion and anxiety.” She said that “until he began taking Citalopram he had only been suffering from mild depression, brought on by retirement from his Royal Mail job and a foot injury. She added that Ian’s action was completely out of character, and said: “I felt Citalopram was to blame for my husband’s death.”
Delivering a narrative verdict, Coroner Andrew Reid (left) ruled that Ian had taken his life, adding: “I’m satisfied he did so while the balance of his mind was disturbed while suffering the adverse effects of Citalopram.”
What is significant about this inquest is that it is the most recent account that I have managed to find online where a British coroner has admitted that Lundbeck’s SSRI antidepressant Citalopram can induce suicide.
The reason why, for the past ten years, coroners have been in denial over the propensity of Citalopram and other SSRI antidepressants to induce suicide may well have emanated from events in Cumbria earlier that year.
In March 2008, an inquest in Cumbria heard that retired bank manager Nigel Woodburn had deliberately driven his car into a tree, four days after having been prescribed Citalopram. Coroner Ian Smith (left) told Nigel’s relatives that he would write to the Committee on the Safety of Medicines (CSM) as “he knew of several other suspected suicides involving the same group of antidepressants, known as selective serotonin re-uptake inhibitors (SSRIs).” He said: “I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past.”
The following month, Mr Smith presided over the inquest of 56-year-old farmer Philip Morton, who had been prescribed antidepressants a few days before his death by hanging. Once again, Mr Smith “criticised the use of antidepressants and expressed concerns over a pattern of people taking their own lives days after being prescribed the drugs.”
The report concluded with this extraordinary sentence: “Mr. Smith went on to say that he had dealt with six to eight cases in a short period where people had taken their lives days after starting antidepressant drugs and he had reported these concerns to the health authorities, despite coming under criticism for speaking out.”
“Life expectancy in the UK is now falling for the first time on record, and adverse events from the ever-growing cocktail of treatments we now take are likely a factor in this. A case can be made that prescription medicines are now our leading cause of death in general and suicide in particular.” – Healy
It’s not only the UK
In the US – “there’s a pattern of ‘deaths of despair’ related to drug overdose, alcohol related deaths and suicide. The death rates for all these causes have increased over the past 15 years, with white men aged 45-54 years especially affected.” Acciai, F. et al. Why did life expectancy decline in the United States in 2015? A Gender specific analysis Soc Sci Med. 2017;190:174-180.
So the proposed solution?
“To diminish deaths of despair, we first need policies to combat these causes and offer help to those left out of the American dream.” Acciai, et al.
So let’s talk about crashings of American Dreams – The Great Depression. Never a time for more collective despair in American history in my opinion with the exception of our Civil War. As the story goes, the suicide rate in the US increased from 17 per 100K in 1929 to 21.3 per 100K in 1932 during the worst of he financial calamity. Galbraith. – The Great Crash 1929.
In comparison -at a time when there is more “mental health care” and wonderful drugs to treat these problem and the economy is not slumped, per captured CDC statistics, this is where we stand. Not far off from the Great Depression.
1.CDC.gov – ’99-’17-the age adjusted suicide rate increased 33% from 10.5 to 14 per 100K
2.Suicide rates were significantly higher in 2017 compared with 1999 across all age groups of females males starting from ages 10 thru the 65-74 age group.
3.Since ’08 suicide ranked 10th as leading cause of death for all ages in the US.
In ’16 suicide became the 2nd leading cause of death for ages 10-34 and the 4th leading cause for ages 35-54.
Healthy People 2020 seems to be missing it’s target to reduce suicide death rates to 10.2 per 100K.
A good clinician told me once, “if your patient keeps coming back with the same complaint, you’ve missed something or your initial premise is wrong. Time to reassess.”
Perhaps, a “Great Depression” should be trialed against some of our miracle cures for statistical significance related to increasing causes of death?
The problem is systemic.
Your average clinician is too busy. In addition, for many, not even on their radar is the fact that guidelines are based on trials that have little oversight from actual researchers and that data is being interpreted in large part primarily for profit masqueraded for patient benefit. This is hard to believe but it is a reality. The infestation of profit into care has been insidious, like an aspergillus of healthcare. The disease is tenacious, treatments long and messy, tons of many side effects.
What to do? Some ideas I’m not really sure how to accomplish.
1. Harnessing the power of those affected – patients and clinicians
(Decreasing life expectancy rates going up with the “miracle” of modern medicine should not be happening. Linked causes need to be studied and teased out. You can’t treat something that’s not in the differential. Facts, unlike fake news don’t lie.)
2. Educating patients and clinicians about drugs, reporting, less is more etc.
3. Listening to patients and linking SEs ADRs to drugs – reporting to Drug Companies
4. Related to 1. is how take back power for trials, research? re-frame the paradigm for evidence/care initiatives including patient case reports specifically in the area of harms.
“As systemic as steroids in baseball”…
Unlike baseball, everyone is playing this game
https://www.nytimes.com/2009/08/05/health/research/05ghost.html
In my experience, the only way to get behavior to change is when the consequences of that behavior become less desirable than the gains. Perhaps efforts need to be legally directed to those who contribute to actual harms of patients by establishing direct links to ghostwritten authored studies purporting benefits. Seems quite appropriate on many levels.
“Fiona Godlee, editor of the British Medical Journal, said the practice continues to be a problem in the medical literature.
“Guest authorship and ghostwriting is absolutely unacceptable and we have been saying this for a long time. It is misleading, a form of fraud, and it would be good to see much stiffer penalites and legal liabilities for people who involve themselves in this,” she said.
“The benefits of being a guest author are still substantial. You get a piece of work under your name that you didn’t have to bother writing, the company involved will push to get it published in a high-profile journal, and visibility, promotion and all sorts of things come your way, not to mention international travel and speaking at conferences.”
– I. Sample. Scientists credited on ghostwritten articles ‘should be charged with fraud.’ The Guardian. Tues 2 Aug 2011
Fiona G editor of thebmj is also responsible for allowing countless numbers of adverts by pharmaceutical companies to sully l the pages of thebmj for a hefty price -and which interfere with reading it without having to blank them off. F.G has defended this by saying they are a result of historical decisions to allow advertising and cannot be disallowed retrospectively – – thebmj has condemned advertising in med journals and does not allow new advertising. As if this could not be stopped! Readers have called on thebmj to stop this hypocritical practice and conform to their own moral position on advertising
David
Do you know whether in cases of sucide/homicide when psychiatric drugs have been prescribed, whether at post mortem, blood toxicology is tested for all the drugs taken? Together with the person’s metabolism genotype, this would determine if psychiatric drugs would have been over prescribed, even though inadvertantly.
Followers of your postings may be unaware of this recently published review: https://www.ncbi.nlm.nih.gov/pubmed/31370036 ” Treatment Emergent Violence to Self and Others: A Literature Review of Neuropsychiatric Adverse Reactions” The review explains why neuropsychiatric side effects arise and steps that can be undertaken in order to keep patients ‘safe from harm’ before psychiatric drugs are prescribed. A draft version can be sourced in psychiatric-drug-effects.com.
Catherine
These tests are not done post-mortem. I suspect many of the readers of the blog are aware of the paper – but its not one that I put great store by.
As I told the inquest, the reaction Stephen O’Neill had could have led to him turning a gun on his family rather than thinking about killing himself. For all I know the coroner might have a similar reaction – as Don Schell did to paroxetine when he did kill his family. Rapid reactions like this almost certainly have no link to poor metabolism and the worry is that a negative pharmacokinetic test might lead an inquest to discount the role of the drug
D
Catherine – you say
‘In this website you will find a variety of information regarding anti-psychotic and antidepressant medication.
The purpose is to assist service users, carers and health and social care practitioners in achieving a fuller understanding of the impact of medication than is commonly taught in under-graduate and post-graduate university’
I have only read small sections of your web site so far and I will not be qualified to agree or not with some of the more ‘scientific’ details but especially admire the aims of your intention.
My hesitation in general though is I wonder how often you update the information in the light of new information and research findings ? Most of the references are quite dated . I imagine this is a problem with all publications though so I am wondering if there might be a way to flag up the need for readers to access more recent publications /information including on other sites where people are documenting their experiences themselves, such as Rxisk.org as well as those on your site? A lot has happened in the last few years so I realise you might have a job to keep updating the website.
Thank you David for responding.
May be rapid reactions are related to rapid titration of psychiatric medications or sudden discontinuation. In either case akathisia worsens along side mental health deterioration.
Hopefully the research at Addenbrookes Hospital will bring genetic matters to the fore as a spokes person there informed me there was a ‘high drive’ to ensure the genotype will be taken prior to psychiatric drug prescribing.
This below possibly shows the point. That our individual metabolism is important isn’t denied – but in published papers there seems to belittle reference to the composition of the drugs which were used by people diagnosed with depression and other conditions, which led to suicide or aggression , Even after researchers had conducted post mortems they make no references to drugs which had been prescribed -by name. They surely have that information? Or are the pharma companies allowed to withhold data even in these kind of investigations. If so the research is very flawed and there should be reference to how much data they were given by the companies. Those lucky enough to have discovered information on line would likely be able to refuse eg sertraline when the risk is so high The drug should be banned and researchers must be realising that by now when their effect is part of the studies. The push is for populations to get genetic tests and brain scans – even for very young babies in ‘baby labs’ to predict their future behaviour. It is dangerous to be linking a possible genetical bias to violence and suicide when that could lead to more surveillance on thier lives. Family studies are still popular – not just an individual is effected by these propositions.Social policies can also be effected – it was medical records which were used in many cases of identifiying Jewish people for extermination and for those deemed unfit in UK to be incarcerated and used in research – It all sounds more benign these days but there is still an underbelly of a wish to eliminate unwanted behaviours and illnesses The information gleaned from current research into genetics whether ultimately correct or not into genetics of suicidal and violent behaviour is unlikely to stop there. Wonder how many of the researchers actually met the people they experiment on or their relatives.? Doubt if they are wanting research into their loved ones’ brains or genetics – they know that the drugs are the primary cause.
Chunks from –
Chapter 14Genetics of Suicidal Behavior in Children and Adolescents
Gil Zalsman.
Currently, it is believed that the most plausible biological system related to suicidality, impulsive violence, and anxiety is the serotonergic system (Apter et al. 1990, 1993b; Mann 2003; Zalsman et al. 2006c).
Go to:
14.2. RISK FACTORS FOR SUICIDE IN PEDIATRIC AGE GROUP
Risk factors for suicidality are discussed elsewhere in this clinical book and are not specific for children and adolescents. S
14.3.6. Postmortem Studies
Pandey et al. (2002b) examined the right prefrontal cortex (Broadmann area 8/9) in 15 teenage suicide victims compared with 15 matched normal subjects. They found that 5-HT2A receptor protein and mRNA levels were higher in the prefrontal cortex and hippocampus but not in the nucleus accumbens of adolescent suicide victims; these higher levels were restricted to the pyramidal cells of layer V. In adults, most autopsy studies of suicide victims reveal various abnormalities in serotonin function in the brain stem and prefrontal cortex, where more 5-HT1A and 5-HT2A binding and lower serotonin transporter bindings are reported, mostly in the ventral prefrontal cortex (Arango et al. 1995). Serotonergic function may be a mechanism whereby genetic factors influence the suicide threshold. Its stability as shown by genetic studies of CSF 5-HIAA over time suggests that serotonergic function is a trait and may contribute to its potential use as a predictor of suicide and suicide attempts (Traskman-Bendz et al. 1992
two factors (gene–environment interaction [GXE]) (Brent et al. 1996; Brent and Mann 2005; Mann et al. 2001; Zalsman 2010). The next paragraphs will review the evidence for each of thesesuicide attempts (Roy et al. 1995) are higher in monozygotic versus dizygotic twins. Adoption studies (Schulsinger et al. 1979) have shown a higher reported rate of suicide in the biological parents of adoptees who commit suicide compared with biological relatives of control adoptees, even after controlling for rates of psychosis and mood disorders. Heritability of suicide and suicide attempts is comparable to the heritability of other psychiatric disorders, such as bipolar disorder and schizophrenia (Statham et al. 1998). Several studies have shown a higher rate of suicidal behavior in families of children and adolescents who have attempted or completed suicide, compared with controls, independent of the diagnosis of depression (Pfeffer et al. 1994; Shafii et al. 1985).
These results could be caused by the genetic transmission of underlying psychiatric illnesses or nongenetic family influences, such as imitation or exposure to violence in the family. Brent et al. (1996) conducted a family study of adolescent suicide victims and 55 demographically similar controls. The rate of suicide attempts in first-degree relatives of suicide victims was higher than the controls, even after adjusting for differences in rates of Axis I and II diagnoses in the families, including depression, which suggested that suicidal behavior may be transmitted as an independent factor from Axis I and II disorders. Several studies have attempted to locate genetic markers for suicide, and interest focused on genes for serotonergic systems.
Although genetic factors account for ∼45% of the variance in suicidal thoughts and behavior, the specific genes that contribute to vulnerability for suicidal behavior are unknown despite numerous candidate genes association studies, especially relating to the serotonergic system (Mann 2003; Zalsman et al. 2002).
The family-based study design, collecting case-parent triads and other available first-degree relatives, will enrich genetic loading of the sample population and guard against potential population substructure (Zalsman et al. 2001a).
Another strategy that is wildly used in adults is the postmortem studies of suicide victims. This allows a combination of the most serious form of suicidal behavior, genotyping, and use of tissue analyses to determine biological intermediate phenotypes such as the gene transcription and proteins. Postmortem studies in adolescent suicide are still rare (Pandey et al. 2002b). Studies in adolescent population using such combined opportunities may add to our understanding of this fatal behavior
In the future, it is hoped that utilizing a combination of neurobiological tools such as genetic vulnerability, environmental factors, and maybe levels of 5-HIAA in the CSF will help recognizing populations at high risk for suicide.
Reading these comments about Citalopram and Sertraline I feel even more sickened, knowing that my son was on both of these drugs not long before he died by suicide. I’ve been trying every which way since then to get people to sit up and listen when I try to tell them about the effects of akathisia, and how the wise thing to do is never to touch these meds unless you absolutely have to, like it’s a matter of life or death.
But now, listening this week to Winifred Robinson presenting a phone-in on Radio 4’s ‘Your and Yours’ midday Tuesday, I see hope at last. Because they can’t get their medications owing to uncanny shortages, patients were ringing in in droves to say they’d had to stop their drugs cold turkey, and were feeling terrible. One lady reported that her elderly mother had been on Nardil for 45 years, a drug which apparently should never be stopped suddenly, but now it’s unavailable, her mother had no choice, and is feeling terribly ill. If there is such a shortage of antidepressant and antipsychotics, (as well as epilepsy drugs etc etc) there is going to be an epidemic of AKATHISIA. Surely this will wake people up, with so many affected, and rising…. no one mentioned the magic word, but it’s only a matter of time, they can’t hide it forever. I’m sorry to feel gleeful at others’ expense, but I can’t help it.
Yes this is concerning. Discontinuation or shortages of these drugs. Another reason to taper people to least needed dose or off if able. Less is more. I am very sorry you lost your son.
Further to my last comment, about drug shortages and AKATHISIA, I forgot the best bit….
If these drugs are being either withheld in the EU, or because of the drop in the value of the pound, they are being sold by the Pharma companies out of stockpiles in U.K. to Europe and the USA to make them higher profits (both theories mentioned by phone in callers to Radio 4’s ‘You and Yours’ programme), then they will have finally shot themselves in the foot, (or in the money) because once people become affected in huge numbers, the negative effects of their drugs will at last be obvious. Enforced AKATHISIA will hurt. Deaths by suicide will rise. Questions will be asked (at last) in the House. It was only a matter of time. Greed never pays in the end. Let’s hope the rationing goes on long enough to really work its miracle. I’m sorry to sound heartless, but I lost my heart a long time ago, when these medications murdered my son.
Thanks Heather – I didn’t hear that programme. Do yo think this might be an unintentional opportunity for someone to to do a massively important piece of ‘research’ by collecting information somehow on the consequences of being without the drugs. This will be – hopefully- documented on medical records which individuals could consent to access, Also ,looking for a light somewhere in this – could it be that those who do successfully get off them and at last begin to feel well again – will find how shocking the drugs effect has been then spread the word and warn others of the potential harms and suicides via the media etc. But as you say, sadly many will not recover. As neither will those close to them stop suffering their loss.
A Rapid Reaction is key.
How many people have had ‘Impulse’ written down in their medical records as the By-Line for impromptu self-inflicted suicide/homicide, when the drug had a hugely significant role?
One case discussed dated back to 2001, when Dr Healy testified at a wrongful death trial in Wyoming, after a 60-year-old man on Paxil shot and killed his wife, daughter and infant granddaughter before turning the gun on himself in 1998.
https://www.lawyersandsettlements.com/features/drugs-medical/ssri-suicide-akathisia.html
At trial, the jury returned a verdict for the man’s son-in-law after Dr Healy presented the jury with a summary of an unpublished company study that found incidents of serious aggression in 80 patients on Paxil, including 25 that involved homicide, and proved that the drug maker knew about the violence and suicide risks before the 1998 shootings.
Dr Healy points out a rechallenge study by Rothschild and Locke in McLean Hospital where the authors found Prozac-induced emergent suicidality associated with akathisia in several patients. In order to test whether suicidality was coincidental or associated with Prozac, they withdrew Prozac, then re-administered it, and in all three cases, the patients experienced the exact same effect. “All three patients developed severe akathisia during treatment with fluoxetine and stated that the development of the akathisia made them feel suicidal and that it had precipitated their prior suicide attempts.”
However, even more alarming, one set of patients who became suicidal on Prozac were described as follows: “[n]one had a history of significant suicidal behavior; all described their distress as an intense and novel somatic-emotional state; all reported an urge to pace that paralleled the intensity of the distress; all experienced suicidal thoughts at the peak of their restless agitation; and all experienced a remission of their agitation, restlessness, pacing urge, and suicidality after the fluoxetine was discontinued.”
F.D.A. 22nd November 2019.
“FDA approves new treatment for adults with partial-onset seizures”.
XCOPRI ( cenobamate tablets).
“Antiepileptic drugs (AED)s, including XCOPRI, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication”.
“Patients taking an AED for any indication should be monitored for the emergence, or worsening of depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour”.
I received this information as an email.
Why are these notices not emailed to coroners?
Surely this would facilitate greater knowledge, factual accuracy, and awareness in their reaching, where appropriate, the correct conclusion of: – (Prescription) “Drug Related Death?
This may also improve compliance with the Coroner’s MANDATORY RESPONSIBILITY TO MAKE A REPORT, WHERE SUCH A REPORT MIGHT PREVENT OTHER DEATHS.
This might, in addition, result in greater knowledge, skill, awareness and understanding of the fundamental importance of an Expert Witness Report, presented to The Court by an Independent Specialist with a professional lifetime of fastidious research, publication and monitoring of prescription drug induced AKATHISIA and prescription drug induced violence against self and/or others.
Yes not much to review yet on this. Nothing up on the phase 3 trial as far as results on Clinicaltrials.gov. The drug works on INaP a persistent Na+ current that is implicated in flow after the transient current has been inactivated. Increased INaP enhances neuronal excitability which may contribute to the repetitive generation of action potentials that can occur during spontaneous seizures in epilepsy. This is taken from a study from Neurology 4/26/2018 called Mechanism of Action of Cenobamate: Preferential Inhibition of the Persistent Sodium Current (P5.278). This is interesting. So we’ll see what the actual study design and effects look like related to relative risks. Personally I think if the trial is up before the drug hits the market the info should be readily accessible on the Clinicaltrials site. I think they have a year. Not everyone needs drugs but sometimes people do. All drugs are poisons given in the right amount. It’s about access to information to make informed decisions in the best interests of patients.
Hi Susanne
Yes – the website is dated due to ongoing personal cirucmstances. However finding are findings what ever the date.
Some considerable time was spent on the recently published review:
‘Treatment Emergent Violence to Self and Others: A Literature Review of Neuropsychiatric Adverse Reactions ‘. This is more up to date – which is accessible via myself – obtain my email from this site.
Hi Catherine – I have a problem with your statement that ‘findings are findings whatever the date’ In science Findings are not fixed but provisional, they are open to revision in the light of new ‘information’ /findings.- that is something too few practitioners and those who write guidelines to advise them take too little account of unfortunately. Those who experienced the consequences of dated opinions/research/practices are documenting information and collating information which is often way ahead of the game. eg collaborators on Rxisk.org, but find it impossible to obtain funding to progress their research data, The way research is being carried out is being challenged by clinicians/researchers such as Peter Gotzche and many colleagues (see website) who are setting up new institutions or ways of conducting research – not only but importantly qualative research – it is of course a huge task for anybody to keep abreast of all research and to make decisions about it’s usefulness or reliability – As far as the Addenbrokes project is concerned there are also serious ethical questions to be asked when any kind of genetic testing is considered.
While we have the spotlight on suicides lets not forget that many tragedies are going on literally every day scratch the surface and you will find ssri involvement.
This is a little off topic so if moderators want to shift it that’s ok. But this week in New Zealand we as a country have been fixated with the Grace Millane murder trial. No doubt Britain has been glued to it as well. I feel so sorry for the Millane family. When I first heard of this case and the dreadful string of events that unfolded I couldn’t help as you always do but wonder if there was an ssri drug involved. As I read more and more I started to sense this could be the case things like no previous criminal record and the terrible post death behaviour of the murderer. His callousness and inability to feel or reason. Well now I have confirmation as a piece was posted from the murderer to his family that police dug out, in it he talks about turning over a new leaf. Clearly he was a ratbag but he talked about taking escitalopram a double strength ssri. Sadly this little somewhat insignificant thing was missed by the defense team and no one mentioned it. No disrespect to the Millane family and my heart goes out to them but this smells to me like another ssri tragedy.
https://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=12287282
With paroxetine liquid, 10ml is equivalent to a 20mg tablet.
Key facts
It usually takes 4 to 6 weeks for paroxetine to work.
Side effects such as feeling sick or sexual problems are common. They are usually mild and go away after a couple of weeks.
If you and your doctor decide to take you off paroxetine, your doctor will probably recommend reducing your dose gradually to help prevent extra side effects.
Paroxetine is also called by the brand name Seroxat.
https://www.nhs.uk/medicines/paroxetine/
Page last reviewed: 13 December 2018
Next review due: 13 December 2021
BOB FIDDAMAN @Fiddaman 3h
This is deeply concerning. I anticipate many are going to be put through sheer hell without the liquid. Dr’s will be forced to reinstate the pills. Shortage Notice: #Seroxat (paroxetine) 20mg/10ml oral solution
https://psnc.org.uk/our-news/seroxat-paroxetine-20mg-10ml-oral-solution-out-of-stock-until-january-2020/
Shortage Notice: Seroxat (paroxetine) 20mg/10ml oral solution
UK Medicines Information (UKMi) have advised that tablets can be crushed and mixed with water for administration, however this would be an off-label use. The crushed tablets are bitter and have a slight local anaesthetic effect.
Down to your last few ml. Or working out the arithmetic, dose of tablet to dose of liquid –
The tablets, ‘plural’ and mixture of water, ‘indeterminate’, and you, could be, on the,
Highway To Nowhere …
Correction – before drug hits the market trial info results should be accessible period.
Prof. Peter Gøtzsche @PGtzsche1 Nov 22
Prof. Peter Gøtzsche Retweeted TranspariMED
Excellent information on your website!
https://www.scientificfreedom.dk/2019/11/22/more-drug-deaths-merck-and-ptc-therapeutics-want-clinical-study-reports-to-be-secret/
Access to information on medicines under threat in Europe
The documents, called Clinical Study Reports (CSRs), provide a highly detailed picture of the design, conduct, analysis and findings of a trial, including data on the positive and negative effects experienced by patients. CSRs thus allow far deeper insight into a trial’s methodology and findings than other information sources do.
https://www.transparimed.org/single-post/2019/10/09/Access-to-information-on-medicines-sold-in-Europe-under-threat
Several large-scale incidents of harm to patients in the recent past could have been averted if data contained in Clinical Study Reports had been accessible at the time.
In 2016, the European Medicines Agency drew applause from numerous patient and transparency advocates by making a radical break with regulators’ traditional opacity and proactively releasing CSRs for newly approved drugs, as well as continuing to providing access to older CSRs on request.
This victory for patients is now under threat. Recently, in the context of an ongoing court case, an Advocate General issued a legal opinion warning that the previous court judgements might have been flawed, and that CSRs should no longer be released.
“This will mean that data secrecy will over-ride the public interest of disclosure which is now the default option. It will be a major blow to patient safety, scientific progress, and society at large. Pharmaceutical companies—one of the most secretive business sectors—have long fought against clinical trial transparency, harming patients. The public interest needs to prevail over narrow commercial interests.”
Health Canada has recently started proactively releasing CSRs. To date, the U.S. Food and Drug Administration still refuses to release CSRs.
https://www.belfasttelegraph.co.uk/news/northern-ireland/tyrone-musician-suffered-bad-reaction-to-antidepressant-inquest-is-told-38239133.html
By Anton McCabe
June 21 2019 7:00 AM
‘The coroner at the inquest into the tragic death of a Coalisland musician has acknowledged that he suffered an extreme adverse reaction to an antidepressant about six weeks before he died.
Mr McGurgan ruled that Mr O’Neill took own life ‘when the balance of his mind was disturbed.’
Seems McGurgan’s mind was not altogether clear or he could not have made the first statement and then made the ruling ignoring what he had initially acknowledged himself about the effect of the drug. The evidence was documented in the newspaper report as he must have known it would be..so why give a judgement which many people would feel suspect?.Thinking it would just blow over? It doesn’t seem likely the two psychiatrists named in the paper would be found guilty of anything as Mcgurgan seems to have accepted they were correctly following guidelines . I think the use of the archaic ‘balance of mind disturbed’ should be disallowed in rulings unless a coroner makes it clear – balance of mind disturbed – by what.
The headline in another paper was https://www.belfasttelegraph.co.uk/news/northern-ireland/musician-feared-antidepressant-was-poisoning-him-inquest-told-38236154.html
Nasty eyecatching headline to suggest delusional thinking when it is exactly what many people do rightly feel and make the ‘mistake’ of saying – adding to the crass entries on a medical record by using jargon instead of teasing out meanings.