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.
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 Boeing crashes and perhaps of Boeing personnel also.
One of the questions thrown up by the Boeing 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.
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