Making medicines safer for all of us

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

1. 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.

2. 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.

3. 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

This post continues the Spotlight on the Suicides series.

There were 8 named people in Stephen O’Neill’s medical record, or who made entries in the record between the time of first admission and his death.  He appears to have told most of them that in his view the sertraline he had been put on and took two doses of had had a disastrous effect on him.  There were likely up to 20 others or more whom he had contact with and probably said much the same thing to.

No-one heeded him.  There was an obvious course of action had they listened – stop all meds, agree with his diagnosis and tell him this would settle.  It would have settled, perhaps facilitated by diazepam or the lorazepam he was briefly given, but even without this it would have settled.

The pharmacist who filled his original prescription was the first person he turned to when things began to go wrong – before going to hospital.  She was the only person who appears to have listened.

At various points over the following 6 weeks Stephen told visiting secondary care staff and others in the day hospital or outpatient settings that he was thinking of suicide following changes in his drugs.  This led to the addition of further drugs and finally Buspirone.

Buspirone is a failed predecessor of the SSRIs and is closely related to them.  One of the surprises in Stephen’s case was that anyone thought to give it to him – it is rarely prescribed now.  Anyone who had reacted with agitation and suicidality to an SSRI was on the face of it more likely to react in a similar way to buspirone than to the mirtazapine or quetiapine he was also tried on.  A few days after being put on buspirone Stephen was dead.

When they came to review what had happened the secondary care services patted themselves on the back.  Every thing they had prescribed was, they said, recommended by NICE Guidelines.  Everyone who had been supposed to liaise with anyone else had all liaised with all the people they should have liaised with.  All boxes had been ticked.  The service had done a wonderful job.  No one seems to have passed on the message they were given by Stephen.

Spotlight

In the 1980s, a concern about abusive clergy emerged in Ireland. It led to the fall of the Irish Government and triggered a crisis that engulfed the Catholic Church worldwide.

Decades later Hollywood in the movie Spotlight twisted the events out of shape – clerical abuse had been discovered by brave journalists in Boston who had gone where no-one else dared go.  The truth was the United States was very late in facing up to what was happening, and has been behind the curve ever since.  Ireland, who might have been thought to be the least likely to face up to the issue, had grappled with it long before Boston.

The crisis came to a head during a visit by Jose Mario Bergoglio to Chile in 2018. Facing anger about the Church’s failure to confront child abuse, Bergoglio responded – if you have faith you believe in us [the clergy] but for us to believe in you [the abused] we need proof.  The powerful are innocent until proven guilty. The powerless have anecdotes but not evidence.

If you have faith you believe in doctors but for us to believe in your claim a drug has wrecked you we need proof.

Unlike the participants in Stephen O’Neill’s inquest, and thousands of other inquests that have unfolded the same way, Bergoglio appears to some extent to have recognised how his response has added to the original damage.

Beyond the Law

In the case of the Church, the tacit understanding seems to be that the authorities figured their personnel, the clergy, were bound by canon law rather than civil law.  Loosely, if the person responsible confessed their sins, God would forgive them and cure them. It was not the place of the authorities to punish them.  Even when the trespassing continued, who gave a bishop, archbishop, cardinal or even pope the right to take the place of God and condemn the trespasser.

For physicians today, Guidelines operate the same way.  They transcend common sense.  If you have adhered to them, you can do no wrong, or no earthly authority is going to find you at fault – “there but for the grace of God go I” as was once commonly said.

Unlike his people beforehand and his church since, God finally figured Guidelines were not the right approach.  But the right approach, as became clear, was likely to be painful. This perception that grappling with the issues might be painful underpins the appeal commandments and guidelines have for good and decent people – and why the greatest problem for Christianity has always been good and decent people.

At the inquest, to give them their due, the secondary services appear to have accepted that some of the medicines Stephen was put on could cause akathisia – agitation.

I can’t be certain how this was put because apparently I am not a person entitled to a transcript of the inquest.  The coroners conclusion suggests that what he picked up is that there was an acceptance the drug might have caused a relatively minor problem – a dissociative problem – which fed into the longstanding mental difficulties Stephen had from bullying at school (which was minor and of no obvious consequence), through loss of a parent, onwards – the memories of which triggered by agitation linked to the drug caused him to commit suicide.

Now we know why healthy volunteers commit suicide on these drugs.  Even healthy volunteers who didn’t know they’d ever been bullied and both of whose parents are still alive.  There’s always going to be something a drug can activate – which is the true cause of the suicide.

Pontius Pilate

What’s a coroner to do when caught between warring factions?

One side saying we have kept to all the commandments. This man clearly had an enduring mental illness.  And the folk on that side are all pillars of the Establishment.

On the other side, the main offering being the word of a man who is now dead.

Sticking with the Establishment also meant not having to get involved in someone else’s politics.  How can he be expected to understand ghost-writing, zero access to trial data – it sounds unbelievable that physicians and their professional bodies would let something like this happen.  Better let the Judaeans sort this out for themselves.

What would you do?

Next week Spotlight on the Politicians

Continuing the Spotlight on the Suicides Series

I have largely avoided naming names and will continue to avoid putting names in the frame but Stephen’s family doctor’s name, Dr Brannigan, is already in the public domain, and I’ve made it clear that the coroner thought highly of him and the whole point behind these posts is to show how even a decent doctor can end up in a nightmare.  These posts are about a rotten barrel not a rotten apple.

Dr Brannigan had his own lawyer present.  The hospital had theirs.

He seemed a decent man. There was a longstanding relationship between him and the family.  Stephen had been his patient for years and the two appeared to get on in a manly way.

He began nervously.

Prozac & CBT

Some years before, Dr Brannigan had spoken to Stephen when he was grieving after the death of a parent.  This conversation led to a prescription for Prozac.  The script was repeated once.

Prozac clearly didn’t work and Stephen may not have taken much of the first course. But like most of us, he took the second script from his doctor – finding it difficult to tell him he’d stopped taking the tablets.

How do I know this?  We know 50% of people stop the SSRI they have been given within a month because it doesn’t suit them or they feel its not really needed.  Stephen’s family mentioned he hadn’t thought it suited him and had stopped it.  Dr Brannigan didn’t renew it after the second script, which he would have done had either he or Stephen thought it been working.

After the second script, Stephen according to Dr Brannigan was better and didn’t need any more.  When pushed on whether he thought the drug had made him better, he declined to say it had helped.

There was no entry in the record saying it had or hadn’t helped.  For lawyers who have no idea what giving an antidepressant means, however, the lack of an entry saying it hadn’t helped meant there was no evidence it hadn’t helped or caused problems in any way.

Some time later, when Stephen was out of sorts Dr Brannigan suggested a course of CBT – rather than more Prozac.  Stephen agreed but again gave this up after a few sessions.  He was a get on with life person rather than someone who liked to pick over things.

Enter Doxycycline

In early 2016, Stephen had a chest infection that didn’t respond to the first antibiotic he was given.  One of Dr Brannigan’s colleagues gave him a prescription for a week’s doxycycline.  The chest infection cleared but almost immediately afterwards Stephen complained of anxiety.  The table here replicates last week’s table – Spotlight on the Coroner

The first point to note is Doxycycline is among other things an SSRI. Dr Brannigan was not to know this – very few doctors do.  But you don’t need to know how a drug works to know what it’s doing.  You just have to listen to and believe the people who have taken it when they tell you what’s happened to them since they took it.

Doxycycline is well known to cause suicide in people who have been given it for acne or malaria prophylaxis or for chest infections.  Only marginally less likely to cause suicide than isotretinoin (Accutane) when given for acne.

Second, the comparison of the two doxycyline sets of figures in the Table above brings out how FDA reports can hide problems.  In addition to reports of depression, there are reports for malaise, asthenia, depressed mood, anhedonia and mood swings, all of which added up make nearly 10% of the reports on doxycycline – even without adding in reports of emotional disturbance, emotional disorder or other events that could conceivably have been depressive.

There are similarly separate reports for anxiety, agitation, panic attack, nervousness, fear, restlessness and stress.  All told over 25% of the reports on this drug are related to suicide or its antecedents.

If you apply the same logic to sertraline, quetiapine, mirtazapine and buspirone that featured in Appendix 1 in last weeks post – the one page of data the coroner decided not to admit as evidence – you can guess what the true profile of the effects of these drugs is likely to be.

In response to Stephen’s anxiety, with no sense it was caused by doxycycline, Dr Brannigan referred Stephen for counselling.  Counselling, CBT, Mindfulness or whatever are only likely to make a problem like doxycycline induced anxiety worse – as the therapist tries to persuade someone their real problems stem from being bullied at school or whatever. Fortunately or unfortunately, the waiting list for therapy was long.

Another point to note is that this adverse response to a serotonin reuptake inhibitor fits the profile of a poor response to Prozac – another serotonin reuptake inhibitor and antibiotic as it turns out.  In a situation like this, it can be expected that the next serotonin reuptake inhibitor will produce an even worse response.

While waiting for counselling, one day when Stephen came into the surgery, Dr Brannigan decided to give him sertraline.  On the witness stand, he made out that Stephen seemed totally different to the usual Stephen and he Dr Brannigan figured this was more like a real depression than the rather minor nervousness that had led him to prescribe Prozac some years before.

At least this is what he said on the stand at the inquest.  The medical record doesn’t bear this out.

This account is not accepted by Stephen’s family.  Nor is it consistent with his activities at the time that show him continuing to do things such as play in concerts.  They knew he was out of sorts but didn’t notice a dramatic change at this point in time.

Why sertraline?  Well according to Dr Brannigan there is evidence that this is better for dealing with proper depression.  There isn’t.  The sertraline literature is comprehensively fake.  Any hints that it is better for a severe depression is pure marketing copy.

More to the point, whatever change there might have been in Stephen that day paled in comparison to what came next.  Up to the evening he took his first sertraline tablet, Stephen O’Neill was a man who had had no contact with the mental health services and neither he nor his family ever envisaged him having contact.

After he took his first pill, for the remaining 6 weeks of his life he was in constant contact with the services and pretty well every moment of contact made things worse.

Serotonin Pick-up Syndrome

After a catastrophic response to sertraline, Stephen ended up in hospital briefly.  The medical notes are clear – he told people that sertraline had caused all his problems.  This was noted but not heeded.

There he was given lorazepam in a low dose one evening just before discharge and found it tremendously helpful.  His view that it had close to normalised him was recorded in the medical record.

When he returned to Dr Brannigan, the lorazepam was not continued and Quetiapine was introduced instead.  This as a previous post has noted made things worse.  But although Stephen reported being worse, the Quetiapine was not switched back to a benzodiazepine.

Why?

This is because pharmaceutical companies did an extraordinary hatchet job on the benzodiazepines in the 1990s as part of the marketing of sertraline, paroxetine and fluoxeting (Prozac). Most family doctors in the UK ended up quite literally thinking the benzodiazepines are more dangerous than opioids and that in comparison SSRIs are harmless.  They still think this and dish out opioids more liberally than benzodiazepines.

This reputation continues to this day, when prescriptions for benzodiazepines are a fraction of the scripts for SSRIs – with over 10% of the population hooked to an antidepressant.  This reputation persists even though within 3 years of its launch in the UK, there were more reports to the UK regulator of dependence on paroxetine alone than there been in the previous 20 years for all benzodiazepines combined.

This is the case even though when marketing SSRIs in the 1990s, the companies went around telling family docs that in the early phase of treatment with an SSRI there could be a serotonin pickup problem but not to worry this would pass and it could be managed by giving their patients diazepam or lorazepam to take during the first few days of treatment.

The point here is not that benzodiazepines are safe, although I, and I’d imagine most people working in the secondary mental health services, if given a choice between diazepam to take everyday for a year or fluoxetine or sertraline would take diazepam.  The point is that Stephen was handing Dr Brannigan and everyone else who was in contact with him the diagnosis on a plate.

It could not have been more clear. And he could not have been more ignored.  He was ignored by decent and even good people – in much the way that people abused by the clergy in the Catholic Church were ignored by decent and good bishops or other clergy.

This ignoring is a public health hazard. Inquests are supposed to be about trying to minimise risks to the public health.

Next Week: Spotlight on The Hospital Doctor

This continues the Spotlight on Suicides Series –

The photograph is of Patrick McGurgan – the coroner.  Mr McGurgan appeared to be a decent man.  He treated everyone with courtesy and appeared to be listening.  His conclusions at the end of the inquest provoked a correspondence from me that will be posted later in this sequence in its entirety – there is nothing in this that impugns him.

The Hold-Up

The second day started on a strange note.  Dr Brannigan, Stephen O’Neill’s family doctor, the first witness, and I arrived early.  Several hours later nothing had begun and we were both still sitting on the bench for people other than the family, staring across at the family, with me at least wondering what was going on.

Stephen O’Neill had only taken two doses of the sertraline before stopping it and presenting to the hospital telling them he had had a very bad reaction to it.  After a brief admission, nearly 6 weeks later he remained agitated – a series of drugs had been prescribed to him.  Toward the end of this 6 weeks, a junior doctor working in the unit to which Stephen had been briefly admitted had been called to prescribe something to help Stephen who remained agitated.  He prescribed Buspirone without seeing or interviewing Stephen.  A few days later Stephen was dead.

Over the course of the 6 weeks, the hospital system and Dr Brannigan prescribed 4 drugs with the junior doctor in the hospital adding Buspirone (Buspar) into a mix that had included mirtazapine and quetiapine.

The addition of Buspirone led to a question as to whether it could have caused Stephen problems.  The family’s lawyer called me that evening and asked whether there was any evidence it could.  I prepared a Table of the hazards linked to 4 of the 5 different drugs Stephen had been given during this period and gave it to him to produce for the coroner the following morning.

This document shows that a large proportion of the reports on each of these drugs are for behavioural changes consistent with suicide induction.  The rates of  reports of problems triggered by each of these drugs is likely to be between 10-15% of the total of all reports for anxiety and 10-15% for depression and 10-15% for suicidality – perhaps 33-50% of all reports for each of these drugs.  Reports of anxiety to FDA end up being coded under anxiety, stress, nervousness, restlessness etc with depression coded under depression, depressed mood, depressed state, mood disturbance – with no-one in FDA figuring it makes sense to add these up.

This sheet of paper led to a hold-up lasting hours as the coroner and his Q.C decided whether the evidence was admissible.  They apparently consulted the FDA website and based on something they saw there about some reports being from patients, almost by definition without knowing what they were doing and without consulting me, they decided the evidence was not admissible.

The figures for Quetiapine bring out an important point.  Stephen was given Quetiapine by his family doctor Dr Brannigan and by the secondary health services, as in the agitated state triggered by sertraline he was having difficulties in sleeping.  He was told this would help.  When later asked about how he was he made it clear that Quetiapine was not helping his sleep.  His observations were ignored.

The Table however shows that his observations were almost certainly correct.  While Quetiapine can be very sedative and many doctors give it in lieu of a sleeping pill, the FDA figures bring out that many doctors and others report to the companies marketing quetiapine (most FDA data comes from companies not patients) that some patients have just the opposite effect – Q interferes with their sleep.

Stephen was absolutely right when he reported this response but was not heeded.  This was typical of what happened in his case from an initial catastrophic response to sertraline which he reported to the pharmacist who had dispensed it and later to anyone who would listen.  But aside from a mention in the medical record that it was his view that his medication had caused him problems this view was essentially ignored.

A Wonderful Report

Dr Brannigan took the stand once proceedings started.  He appeared nervous to me.  Mr McGurgan welcomed him to the stand.  He made a point of thanking him for his excellent report.  This was a model of clarity and he, Mr McGurgan, indicated an interest to use it if possible as a model of how a report should be done in training sessions he undertook with physicians and others.

It had always been my intention, as per my original report to avoid blaming any of the treating staff but these exchanges made it very clear that viewing Dr Brannigan as anything other than an excellent doctor was not an option.

Dr Brannigan did appear to be a decent man. His testimony took us through till lunchtime.  It features in the next post.

Pay Grades

I was called after lunch.  A great deal my testimony covered details of Stephen’s case, as will become clear as these posts unfold.

Another chunk of testimony centred on explaining how decent doctors like Dr Brannigan and the doctors linked to the secondary care services could end up flailing around, not knowing what to do, and as a result resorting to throwing psychotropic drugs at the problem with their fingers crossed.

The explanation, a substantial proportion of which was delivered looking at Mr McGurgan straight in the eye hinged on the fact that the greatest concentration of Fake News on the planet centres on the drugs that family doctors, like Dr Brannigan, or hospital doctors, like the ones who had prescribed mirtazapine and buspirone, prescribe to you and me or our families and friends.

As I remember it, I more or less said to Mr McGurgan that he was not in a great position to establish the veracity of what I was telling his inquest, but that I had repeated the same message to Ministers of Health and the Chairman of NICE and others with none ever disputing what was being said.  Given this it was rather easy to see how ordinary doctors fed a constant stream of hype about the benefits of treatment with the harms airbrushed out of existence would end up flailing around if a patient’s responses didn’t seem to fit the script.

I say – as I remember it – because I long ago expected to have a transcript of my testimony.  This is available ordinarily for a small fee at the request of a family member or an expert but has been withheld in this case with no explanation offered for this withholding.

Coroners are in a tricky position.  They are not medical experts and cannot readily come to a view that contradicts the medics who testify.  Mr McGurgan had one doctor saying one thing and a number of others essentially saying they had done a good job.

However he did not have anyone contradicting the Fake News point. I didn’t expect he could solve a matter like this but I thought if I was in his position, I’d have written a conclusion (coroner’s verdicts are called conclusions) that bumped the matter up to a Minister of Health or First Minister saying “look I can’t come to a conclusion here without your involvement”.

One function of inquests is to advance the public health.  There was another public health issues at stake here which was that Stephen O’Neill had died essentially kneeling rather than hanging.  This is not uncommon in people plagued with drug induced thoughts of harming themselves who have no natural inclination to do so.  They commonly put their head in a noose – experimenting as it were – not realising that quite minimal pressure from a rope on both sides of a neck can lead to a person losing consciousness and the noose tightening.  This is very different to the person who attaches a noose and drops from a height.  It’s something the public need to be warned about.

My testimony took up most of the afternoon of Thursday June 19th. The coroner was due to go on holiday that weekend.  So the only day he could come to a conclusion was on the Friday.  Conclusions are delivered in print but are then posted online.

A written conclusion was delivered before Mr McGurgan went on holiday but nothing has been put online as of the time of writing this post and no explanation has been offered as to why not in response to queries from the family or from me.

I wrote to Mr McGurgan, offering him the courtesy of letting him know that I would be writing to Ministers of Health and others about this case and would be embarking on a series of posts.

Next week – Spotlight on the Family Doctor.

This is part 2 of Spotlight on the Suicides.

In February 2017, I received the email below.  The email address gave no hint of where it came from – it could have been any English speaking country but the word Trust in the second and fourth paragraphs suggested England.

The details seemed clear enough for me to respond that the coroner would have to request my input and I would need access to all the medical records of the man in question.  And I asked where the emailer was based.

Email

My family and I are hoping that you can provide us with an expert opinion in relation to my uncle’s suicide. Currently, we have requested an inquest into Stephen’s death and have provided the coroner with a file of documentation to support our concerns, that is, that Stephen died as a result on an adverse reaction to anti-depressant medication he was taking. To us, the evidence is clear cut. Stephen first took the medication on 16th June 2016 and within 6 weeks of suffering severe symptoms and constantly telling his family and professionals the medication had ‘done something to my head’ and begging for help, he was found hanging in his brother’s backyard.

We have also received a “root cause analysis report” from the Trust that confirms that prior to starting the antidepressant on 16/06/16 he had difficulty sleeping and possibly mild anxiety from time to time but no suicidal thoughts or depression. However, this is a draft report and we are due to meet with the Trust soon to discuss some gaps and information that has not been included, such as Stephen telling the crisis team that during first day or two on Sertraline he had put a belt around his neck and also, three days before his death his sister called the psychiatric unit and told a doctor that Stephen had “woke up” with a rope around his neck and wanted to come off all the medication immediately (he was advised to stay on the medication for another few weeks).

Stephen was a pioneer, he never in his life drank alcohol, smoked or took drugs. He was a very fit man and lead a healthy lifestyle. In retrospect, it is clear to us that Stephen suffered a severe reaction to the medication. Some of his symptoms included: an inability to sit still (pacing/walking); twitching/shaking; over sensitive to noises; feeling of mice crawling up his legs; insomnia; diarrhea; retching/vomiting, to name a few.

Please note, we are not interested in pursuing any civil action against the Trust. Stephen meant the world to us and we were unable to help him whilst he was with us. We truly believe had we listened to him and took him off the medication, he would be with us today. Ultimately, we are eager to have Stephen’s reaction to the antidepressants recognised, the true cause of death reflected in his death certificate and hopefully, in the future, other untimely deaths like Stephen’s, prevented.

If I were to provide you with all the information we have so far, are you able to provide us with your view on Stephen’s death?  We would really appreciate your expert input.

Stephen

Stephen  turned out to an O’Neill who had been living in Northern Ireland.  Whether he was Catholic or Protestant didn’t feature for me. Northern Irish politics can be complex with Terence O’Neill  and Martin Smyth being part of the Unionist establishment and John Hume and Gerard Adams leading Nationalists.

Stephen’s medical records were sent to me along with a Root-Cause Analysis undertaken by the secondary health service he had been referred to when things began to go wrong. There were two things that were interesting about this.  One was the family seemed to be the people putting akathisia on the map for the professionals.  The second was the people from the service side involved in meeting the family seemed to be decent people.

There appeared to be a good case that treatment had played a part and some reason to believe that health service personnel were open to recognising this.

On October 2017, I submitted a straightforward report saying that but for the sertraline he had been given Stephen O’Neill would not have committed suicide but that no-one on the service side was to blame for this suicide – the key issues lay with the lack of access to clinical trial data which meant doctors were in the dark when they prescribed these drugs.

It was to take over 18 months for the inquest to be heard.  It was originally scheduled for Belfast but it was transferred to Omagh – the site of the most terrible bombing during the Troubles.  A place where the coroner still arrives to an inquest in an armour-plated vehicle and with an armed escort.

The coroner was Patrick McGurgan, one of three N Irish coroners, and the one whom the lawyer for the family suggested was probably the best person for the case.

The hearing lasted two days.  Seven family members were in seats facing into the well of the Court on one side facing the coroner and his staff on a raised bench with the various lawyers for the coroner, the secondary services, the family doctor and the family in the middle.  Experts and the press and other observers were on a bench on the opposite side facing across the lawyers and coroner to the family. The witness box, a tight uncomfortable affair was perched on the experts side in a place that made it difficult to look anyone in the face.

On the first day there were statements from the family and witness statements read into the record along with witness testimony from some of the secondary care medical personnel involved in the case during two brief admissions over a 6 week period and outpatient and community reviews.  One of these offered the view that Dr Healy has an agenda.  This line of questioning was blocked off and I’ve never found out what the agenda was – in part because of an extraordinary later development – it has proven essentially impossible for the family to get hold of a transcript of the hearings.

Northern Ireland has been at the centre of European, even world politics, over the last three years, as a result of a referendum in Britain that was held with little, if any, thought of the possible consequences for Ireland.

If an alien zooming towards Earth burst through the atmosphere and was faced with the Western European Archipelago (WEA), it might figure these islands should be an obvious Free Trade area or if not that each of the two main islands should be Free Trade areas.  And in 1660 the world’s first Free Trade proposal covered Ireland and Britain – a Britain that at the time was trying to shake off European influence.

When Free Trade works, everyone should benefit.  But it can go wrong and suck life out of regions, concentrating wealth centrally.  Pressure then builds to re-balance the system. Ireland’s Protestants initially led the push to re-balance but a century ago when the system finally broke open and created the conditions for re-balancing, things went wrong.

Northern Ireland emerged and quickly became a failed political entity.  Success was always likely to be difficult given its location and size. An all-island entity was a better bet.  A WEA entity with differences within it could work as could a European entity but not two small entities on a small island owing allegiance to two different polities.  These are the points where visionary leadership is needed rather than a scrambling for political advantage.

Spotlight

Unless you live on the island, Northern Ireland likely looks like a backwater,  Even the English barely know where it is, or knew where it was had it not been for the regular place it occupied in news bulletins. A place to avoid if you were a tourist.

A currently ongoing 7 part BBC series – Spotlight on the Troubles: A Secret History – might change your views about whether the N Irish issues were just local. This extraordinary retelling of the story of the Troubles (1966 to 1998) raises the most profound issues about the role of the State in any of our lives – anywhere in the world.  Those who are now worried about the treatment of the Uighurs by China would do well to look at this series – its well worth trying to find pirated copies if you live outside the BBC remit.

While it might seem obvious why a program about N Ireland should be shown at this critical juncture in the Brexit debate, it’s difficult to avoid the question – why is this program being shown now.

Even taking into account that States have right and left hands with one not necessarily knowing what the other might be doing, there is a pressing question as to why or how a program about the murky, likely illegal, depths to which the State seems willing to descend could be made and continue to air

In lectures and other settings over a 20 year period, I have regularly used the example of the Guildford Four as an illustration of what is going on in the case of suicide on antidepressants or other deaths linked to on-patent drugs.  Following bombs in a Guildford pub, 4 innocent Irish people were locked up.  After this became clear, senior British jurists argued on the record they should remain in jail forever as otherwise the public would lose confidence in the rule  of law.

See In the Name of the BBC and In the Name of the BMJ.

Its the same with drugs.  For some, a link between death and injuries and treatment has to be denied for fear the public will lose confidence in medicine.

What Spotlight exposes as happening in Northern Ireland was of a piece with the Guildford Four scenario – but worse – an elimination of the innocent.  Many among the media and politicians had a very clear idea about what was going on over 30 years ago but did nothing.

If even States claiming adherence to the law are prepared to sponsor the elimination of their own citizens, or write off their deaths when convenient, what might they do when it comes to drug (or vaccine) induced injury and death?

It has taken the BBC and some elements of the British State over 20 years to even hint at what appears to have been a policy  of extra-judicial executions of innocent people.

In avoiding the issues surrounding antidepressants and suicide – executions of innocent people – the BBC and other major media outlets have done more than almost anyone to create the epidemic we now have – and continue to do so.

Suicide

There were 3,600 deaths linked to the Troubles.  As of 2018 there had been over a thousand more suicides since the Troubles (4,600+) than deaths in the Troubles.  Efforts were being made in civil society to draw attention to these deaths.  Deaths that are being attributed to nervous problems, anxiety, PTSD and related problems now attributed to the Troubles – see Here.

What is not mentioned is that Northern Ireland has one of the highest rates of antidepressant consumption in the world – see Here.

It suits the interests of the Democratic Unionist Party (DUP), the largest “Protestant” party, and Sinn Fein, the largest “Catholic” party, to milk this one for political gain.  More money for more mental health services and more drugs – none of which is likely to help but for which politicians can take credit. This is a time for cross-party, and cross-community leadership, not scrambling for political advantage.  Neither community is spared these senseless killings – SSRIs are neither Catholic nor Protestant.

Stephen O’Neill’s death in 2016, and the reaction of the “system” to his death, makes visible the failures of basic decency and leadership deaths like his involve.  The next few posts will shine a Spotlight on these Troubles.

(Editorial Note: There is always breaking news about drugs and health which lead to comments. The comments after these posts will be restricted to the topics that come up – linked to death from treatment and the cover-up by the authorities.  Other comments should go to posts on DH or RxISK dealing with pertinent topics).

Study 329 is the most famous clinical trial of all time – see Study329.org.  The only trial with two diametrically competing versions of what happened in print at the same time.

329 (March 29) was the date Britain was supposed to leave the European Union – but didn’t – with close to GUBU consequences.

And its 329 years since the Battle of the Boyne, which effectively ended 50 years of upheaval that began with a clash between the then King (Executive), Charles I, and Parliament.  This clash now seems to many pundits, commentators and experts to be echoed in the current clash between the British Executive (King Boris) and UK Parliament playing out this week. Will Boris get the chop, the way Charles did?

The Battle of the Boyne secured the reign of King Billy, the price of which was a triumph of Parliament.  This Battle is celebrated every 12th of July in Northern Ireland – the marching season – when towns are bedecked in Orange regalia and pavements painted red, white and blue.  It has become a symbol of Protestant triumph, even though the year before King Billy had made an alliance with Catholic Austria.

This Battle set the scene for the later partition of Ireland, in 1922, into Cis-Ireland and Trans-Ireland – with Trans-Ireland designed to be tribal. There would be a Protestant majority, which was initially around 55% to 45%, but is now closer to 52% to 48%.

The 2016 Brexit referendum has since produced the exact same split in England.  And a descent into the same tribalism.  Two groups marching past each other, unable to find common ground.  We’re all Nor’n Irish now.

This is not just a story local to the Western European Archipelago; the United States has been intensely and increasingly tribal for the last 30 years at least.  It may not be entirely unconnected to the WEA story, in that broadly speaking the WASPs are on one side facing off against the others.

The original WASPs were a bunch of Puritans, some of whom figured on leaving England and setting up a less sullied polity in America, while others stayed put but figured on purifying England (of European influence).

The Forgotten Man

On all sides now, everyone seems to feel forgotten or overlooked and is busy asserting an identity, increasingly an individual one with a bodily focus – such as neurodiverse or transgender.

When campaigning Trump pitched it in terms of the forgotten man – that too many of us now feel enmeshed in the tentacles of a Deep State, which he promised to roll back.

The Deep State is largely a set of rules, regulations, a bureaucracy.  One that cuts numbers into people’s arms and processes them without ever paying heed to who they are.  It is growing.  It encroaches on our lives more and more, facilitated by the internet which requires us to tick innumerable boxes before we can access anything.

Europe is a domain of regulations par excellence.  It’s where rule by rules began.  But exiting Europe won’t mean exiting regulations.  It will mean a double-dose of regulations – those Britain requires and those Europe requires.  And the grip of regulations will be no less in Britain than in Europe.

In both Britain and Europe anyone who gets injured by a drug or a vaccine will be forgotten.  There is no greater chance of access to clinical trial data in Britain than in Europe.  The people who have done most to push for access to trial data have been recent European Ombudspersons – a Greek man and then an Irish woman.

Because there is no access to trial data, if you are injured by a drug in Britain or Europe, your identity is not that of a citizen or a consumer, or even as a patient as it once was.  Your identity now is as a loser.  And not even other losers like the company of losers.  Neither Trump nor Johnson have ever shown a scrap of interest in losers.

I Daniel Blake

It took 50 years for England to find a middle ground after the stand-off between Charles and Parliament.  It was a shaky middle-ground – unlike America and Canada, which were as WASP dominated as Britain through to the 1960s, the British prime minister for instance still cannot be a Catholic.

In Norn’ Ireland, there are hints of voters beginning to endorse a middle ground, over a century after the difficulties became formally entrenched.  The priest-ridden, Rome dominated South meanwhile has become one of the most liberal states in Europe.

America shows just the opposite – the loss of common ground – and a sense that the descent into division may have a long way to run before it bottoms out and people begin to find a way back.

Ken Loach’s movie I Daniel Blake speaks to these issues.  It shows a decent man trapped in and ground down by an impersonal bureaucratic apparatus.  No one in the apparatus is able to engage with any of the people they see.  The horror grows steadily and leads to a blow-out.  Blake doesn’t pick up a gun and spray bullets around the place.  He has a stroke.

This would have struck a chord ten or twenty years ago but no-one now gives a fuck about the English working class.  They are beyond forgotten.  The problem our rulers now have is that the same impersonality is encroaching on middle class or upper middle class folk in their dealings with their banks, the government, the education and health systems and increasingly everything else.

Everything works, sort of, provided nothing goes wrong.  But once you hit a snag that requires discretion to sort out, the system can’t cope.  It calls on you to do the administration to sort your own problem, while often making the problem impossible to solve because there is no tick box that corresponds to just what has happened to you.  We are left screaming in impotent rage “I David Healy would like to speak to a human being”.

What we have here is government by algorithm and process.  Every process is made up of bunches of algorithms – If X, then Y.

Around 1990 – 300 years after the Boyne , giving drugs became algorithmic – as a consequence of EBM and pharmaceutical companies persuading doctors and governments to treat risk factors as though they were medical disorders – If your cholesterol is high, given X, if a rating scale score is high, give Y etc.

Except drugs are not algorithms.  They are chemicals whose safe use depends on information and discretion and giving the same information to Catholics, Protestants, Jews and Muslims.  And even with the information, drugs defeat algorithms – you should not be consuming 5 or more algorithms or you will die earlier, end up in hospital more often and have a worse quality of life.

Drugs and the injuries they cause may point a way forward.  Everyone should have access to all the data behind any drug they take and very very few of us should be on 5 or more drugs.

But drugs don’t come without doctors.  So very very few of us should be seeing 3 or more partialists (specialists) because each partialist will want to chuck drugs at us and many will get staggeringly nasty if we demur.

Until recently the ideal was to have a family doctor, a generalist, with occasional recourse to a specialist.  The problem now is that its increasingly difficult for any of us to have a family doctor – we may go to one clinic but will see a different doctor each time and this is just as bad as being fed to partialists.

The logic extends one step further.  We probably need to limit the number of processes in our lives.  I’ve no idea what the optimal number is but it would seem self-evidently true that the greater the number of processes we are exposed to, no matter how intelligible the elements of these process are, unless meaningful discretion (oversight) is built into the system, the riskier for all of us.

Macrocosmically this is obvious.  The environmental problems we now have is at least in part because too many things are happening automatically without anyone in a position to take stock.

Its not just the injuries drugs and processes can cause, its the passivity they induce. A thermostat means that we don’t have to get up and adjust the heating.  This can be convenient and useful from time to time.  When it becomes automatic it contributes to a passivity, just as all remote controls do.  And to an impersonality even impersonal killing as in death by drone.

We need Citizen’s Assemblies and Co-operatives rather than, or at least to supplement, government by regulation.

PS This evening in Parliament the British Executive got defeated by a group termed the Rebel Alliance (largely not from Eton) – the tally being 300 votes for the Executive and 329 for the Alliance.

Recap

When it comes to assessing the benefits of drugs randomised controlled trials (RCTs) are over-rated, rarely if ever objective, and easily gamed.  If you don’t know what you are doing to begin with, RCTs won’t find an answer and in practice will make the situation worse.  The operationalism of RCTs helped tee up a Neo-Medicalism.  Neo-liberalism is another word for this.

For the full background see Something Happened to Science,  and Neo-medicalism .

Judgement Sidelined

This is the state of affairs for the supposed strong point of RCTs – rating a treatment’s benefits. When it comes to assessing the adverse effects of treatment, things are much much worse.  The exclusive focus of RCTs on a primary outcome (the benefit) means that the 99 other effects every drug has – some of which may be commoner than the primary outcome – are neglected and vanish.

The sexual side effects of SSRI antidepressants demonstrate this.  Within 30 minutes of taking an SSRI, there is some degree of genital change in close to 100% of people but when the drugs came on the market, their labels reported sexual dysfunction as happening in 5% of people taking an SSRI.

The disappearance of something as obvious as sex can happen innocently in part; investigators spend so much ticking the boxes linked to benefits, they may only have minutes to ask about problems and are unlikely to register as an adverse event something they have been primed to think of as a feature of the illness – depression affects sex.

But something that would be disastrous for marketing purposes, severe sexual dysfunction had been seen in over 50% of healthy volunteers in preclinical trials.  One of things about testing a drug in healthy volunteers first is that a company has years to work out how to “manage” the issue.  It can be as blunt as telling investigators in later patient trials not to ask about sex.

But then to compound the problem, the academic glove puppets on company trials in “their” articles apply statistical significance tests and/or confidence intervals to these adverse effects and claim there is nothing significant here – so the problem isn’t happening or isn’t happening with any degree of frequency.  This isn’t just garbage in and garbage out of statistical tests, this is garbage, lies and fraud in and garbage, lies and fraud out.

The Myth of the Rare Side-Effect

Once a drug is on the market, there is inevitably then a mismatch between what the trials published in the NEJFM or other Fake News outlets show and our experience taking or prescribing these drugs. In response to this mismatch, we are told there are indeed rare side effects of treatment that RCTs don’t pick up and for this we need post-marketing surveillance.

Rare side effects are not the problem. The pressing problem is that because of RCTs we are now missing the most common effects of drugs, ones like dependence on and withdrawal from SSRI drugs that now affect roughly 5 million people in the UK, 30 million in the US, and 50 million across Europe.  This is a public health problem on a grand scale – and the problem was obvious from healthy volunteer studies done even before the drugs came on the market.

Sixty years ago, the problems new drugs caused were picked up within a year or two of coming into use.  The problem now is that common effects of drugs are denied 20 or 30 years after the launch of drugs like the SSRIs, leukotriene antagonists, dopamine agonists, or fluoroquinolone antibiotics.

This is no accident. Companies have worked out how to disconnect us and our doctors from the harms their drugs can cause.  Central to these efforts is the RCT.  If it hasn’t been shown to happen in an RCT then it either isn’t happening or we don’t know that it is happening. This is a procedural, a bureaucratic, rather than a medical answer.

Every week of the year, I get emails from people making a good case that their relative or friend was injured or killed by treatment but running into a response from the health service they were treated in that the doctors concerned kept to the Guidelines.  This is bureaucracy.  This is not medicine.

Things have got so bad that doctors with a patient right in front of them who has turned blue and grown feathers, after being given a drug and whose problem improves after the drug is removed, will still not say the drug has caused the problem but will defer to a bureaucrat in FDA or EMA or MHRA who is there because they don’t like meeting people, who may have briefly practiced medicine, orthopaedics perhaps when the problem is being produced by an oral contraceptive.  The bureaucrat turns to the RCTs and doesn’t find the problem there – although it might there coded in a way that fools most people, or the report he reads says there is nothing statistically significant there.  The bureaucrat says there is no evidence this drug causes this problem and doctors tell patients the problem is in their mind.

This turns medicine upside down. Its supposed to be doctors telling bureaucrats the problems a drug causes.

Walter Raleigh

And doctors do appear to report to bureaucrats, using MedWatch in the US or Yellow Cards in Britain and other reporting systems elsewhere.  But crucially the patients name, Walter Raleigh, doesn’t appear on the form.

So if I David Healy am having sexual difficulties after an SSRI and try to take a lawsuit against a company or doctor or take my case to the media, and say I know the regulators have thousands of these cases on file, the company response, or their lawyers response in Court, is “Ah but, this is hearsay”.  These are anonymous reports.  Nobody can be brought into Court to be cross-examined and so because of Walter Raleigh, the regulator might have a million pieces of paper on file, but this is all they are – pieces of paper.

This is at least semi-deliberate on the part of the system.

When reports go to companies, they are legally obliged to track down the patient and their medical record and cross-examine them.  They do this in an attempt to find the ingrown toenail at the age of 2 they can point everything on.  Despite their best efforts company reviewers often end up unable to explain the problem away and have to conclude their drug has caused it and list the problem in the label.

The problem then appears in a section of the label called Other Reports or Post-marketing Experience, which is small print and comes a long way after the section of the label that lists the adverse events noted in RCTs and most laughably lists their frequency.  It’s the RCT section doctors read as offering the best evidence.  They assume anything listed in Other Reports are things that have been reported to companies from flat-earthers and other whackos and this wonderfully transparent company is listing these events for the sake of completeness.

Regulators in contrast never follow you up or make an effort to determine if the drug has caused the problem.  You will not be surprised to hear that companies are doing their damnedest to get doctors to report to regulators rather than to them.  To many observers this looks like a step in the direction of transparency.  It’s just the opposite.

The Vanishing

But the biggest problem of all is that both we and our doctors have lost confidence in our own judgement – and this is the key condition for the emergence of cults.

The issues of deciding whether a treatment is worth it or not, or whether it is causing problems or not and then deciding whether to trade possible benefits against inevitable hazards are as delicate as the challenge to teenagers grappling with how to shape an identity in our very messed up world. RCTs trample across these issues and rather than support nuance and give time for reflection create a scenario for doctors and the rest of us in which we have to Choose – to be part of the damned or the saved, the rational or the woolly, male or female – and we have to choose right now.

These are the conditions that lead to the creation of cults.  From the psychoanalytic cult from 1920 to 1960, to the Nazis in the 1940s, the Children of God and a plethora of religious cults in the 1960s, and now medical cults from EBM and Vaccine cults to an emerging cult affecting adolescent girls who are being bounced into gender transitioning.  In all these cases, the cult-masters seek to abolish individual judgement.

Those who don’t sign up to the message are branded unbelievers, irrational, or phobics.  Their resistance to joining becomes evidence that the cult’s members are on the right track.  Any internal doubts a member of the cult has are branded neurosis, or internal transphobia, or blamed on scaremongerers.  If you want to spot a cult look for the people calling others phobic or irrational or neurotic – as those riding shotgun on the vaccine stagecoach do.

One of the features of cults until recently is that they were a minority interest. Christianity is not a cult but the Christian and other religious cults of the 1960s circling around it were. Psychodynamic psychology is not a cult, but psychoanalysis became one.  The Nazis came close to changing the game.  While only a minority of Germans were members of the party close to all became de facto members. Vaccines are not a cult, but the current mandatory vaccine scheme come very close to making us all Germans now.

A growing body of the “truths” that both the highest echelons of medicine and medical rank and file now endorse are Fake.  Even more important is that hemmed in by Guidelines, and a risk of referral to regulatory bodies, it is understood that physicians will not now exercise their own judgement or support a patient in doing so.

Saved by Drug Wrecks

This is why Drug Wrecks are so important. One of the key differences between justice and bureaucracy lies in establishing Facts.  Bureaucrats don’t do this.  Justice has to.  If those of us working in health don’t take a stand on the facts, we are working in a health system and collecting our pay rather than delivering Healthcare.

In the case of Drug Wrecks, the details that need assembling into facts are right in front of our noses.  Our conversations with family and friends are a first step in doing this.  The conversation with a doctor or another person in the health system is a potential next step – can we get them to Care.  Can we get the jury – us and them – to reach a common verdict, a diagnosis, that moves things forward?

Decernimus Ergo Summus

We need to replace Credo Ergo Sum and Cogito Ergo Sum with Decernimus Ergo Summus – it’s in working together to establish facts, that we are.

When we have a doctor blow us off by telling us an enduring sexual dysfunction after treatment is all in our minds, both we and s/he come out of the encounter reduced.

In terms of a larger politics, these conversations are a prototype for Citizens’ Assemblies, which have come to the fore recently as a means of tackling a series of seemingly intractable issues such as those linked to climate change or inequality or child abuse. These assemblies seem to have some potential to help us find ways of bridging rather than deepening divisions.

What is happening here is a replacing of a hierarchy with a democracy. With a hierarchy, the moral order was imposed from the top-down.  This was lost with the execution of kings and we have been seeking ever since to find a way to restore a moral order.  There has been a reluctance to entertain the idea of an order that arises from the bottom up.

Athens had citizens assemblies. But the citizens were all property holding men.  This was androcracy rather than democracy, just as the hierarchy was de facto a patriarchy.

Unlike Germans in the 1940s, faced now with a falling life expectancies and Drug Wrecks rapidly becoming our leading cause of death and disability, we have no opportunities to emigrate.  The new bureaucratic medicine is a global phenomenon.  No armies are going to arrive from elsewhere to save us.  The unfortunate among us will get on the train as we are told.  Others will keep their heads down.  Some will take advantage of the situation.

We need a new moral order arising from the bottom up.  Incorporating women is critical to any idea about how such a moral order might arise.  The desperate emails I get from people wondering how to get justice for a loved one who has been killed or injured come from women, not men. The people who take on doctors and the system for the sake of a loved one are women.  Pharma already know this – it leads them to target women as a way to get drugs into men, children and older people.

One example of how a citizen’s assembly might work would be the creation of pregnancy registries where every woman getting pregnant would log every med taken, every health issue and perhaps many other things.  To this would be added all outcomes in respect of the child, perhaps out to their teenage years.

When it comes to interpreting what the data mean, the key people at the table would be women – ordinary women. Sure, it would help to have some experts too and industry should also have a seat the table – we need people who will do their utmost to explain away possible links to a med or vaccine.  At the end of the day though, the purpose of the exercise is to leave it to ordinary women in the light of genuine data to decide what to take or what to do when pregnant, figuring that they are best placed to decide what hazards are acceptable to risk and what aren’t.

It Takes a Community

It takes a community to sustain complexity. Healthcare used to be a community, albeit a rather top-down one.  Now it has no citizens.  When we control medical techniques, we can have healthcare.  When they control us, we have health services – a bureaucracy.  This is what we now have – a system that doesn’t trust its people.

Upholding facts is a precondition for sanity and citizenship as Tiananmen Square shows. Facts lead to justice.  The good thing about the horror of Drug Wrecks is that it is still in our hands to establish the facts. No doctors are trained in how to establish these facts.  No-one is. But the facts can be readily established and a failure to engage diminishes each and every one of us that is party to that failure.

Key to establishing facts are our names.  Whether as doctors or patients we need to put our names to the events on a drug we are seeking to establish.  We need to be willing to come into court to be cross-examined if need be – a pharmaceutical company might threaten this but would never want to carry it through.

Our names are key to restoring HealthCare.  If a doctor and a person affected both put their names to a report indicating they have considered the issue in detail, this is the essential act of solidarity that can restore the moral order we have now lost. But it won’t be easy.  RxISK was set up to build RxISK Maps of doctors and patients willing to do this but it has proven almost impossible to get it to happen – other than in the case of a small number of people with PSSD.

RxISK partly needs a revamp to make it clear we are anything but anti-medical but this doesn’t account for why so many have been so reluctant to approach doctors with a request to consider their adverse effect with them.  It doesn’t account for doctors reluctance to co-operate with something that in my opinion is their single best chance for staying in business.

One more thing needs doing.  We need to designate RCTs, at least when it comes to adverse events, as hearsay. Unless the people affected can be brought into the assembly to be cross-examined, the numbers purporting to represent their experience can make no contribution to establishing facts.

Last Night

Who knows what Walter Raleigh would have made of all this.  Below is his epitaph, penned the night before his execution.  He lived in a time when it was impossible not to believe in the hierarchy.  Who knows what he might have written now.

Even such is time that takes in trust
Our youth our joys our all we have
And pays us with but age and dust
Who in the dark and silent grave
When we have wandered all our ways
Shuts up the story of our days
But from this earth this grave this dust
My God shall raise me up I trust

This continues a Something Happened Series,

A Western moral order fractured between Luther’s nailing of his Credo Ergo Sum, I believe therefore I am, to the door of Wittenberg Cathedral in 1517, and Descartes’ Cogito Ergo Sum, I reason therefore I am, in 1649 the year of Charles I’s decapitation.

Justice

Justice and benevolence were central to the moral order monarchs held in place – bureaucracy is central to the moral order now.  The interaction between human beings in Justice settings differs from that in bureaucratic settings.  Law and regulation are different things.  Justice is not an application of bureaucratic rules.

While a lot what now happens in courts is about whether we have infringed rules and while one side to an interaction in court might be able to bring more resources than the other to the interaction, and something hinges on the exercise of human wit on the part of advocates for either party, what we celebrate when we celebrate justice is the ability of a judge or jury to reach beyond the argument and exercise judgement, or discretion – their ability to make a diagnosis that moves things forward in the right way.

The trial of Walter Raleigh in 1603 produced a moment critical to our ideas about justice.  Raleigh was convicted of treason, and later executed – on the basis of claims made by third parties who did not appear in court and could not be cross-examined. The judiciary recognised a problem and put in place a Hearsay Rule – evidence would not be admitted if the people offering it could not be cross-examined.  Justice involves an exercise of judgement grounded in an interaction between people rather than an appeal to technique.

In contrast to justice, bureaucracy has a set of procedures that ideally are applied without discretion. It aims at sidelining judgement.

Medicine

Medicine was one of the routes through which benevolence has traditionally been delivered. It made moral sense to tend to the ill and heal where possible – and later made what would be called economic sense as having people fit and able rather than drawing on welfare should all things being equal enrich a country.  It also made sense when disorders were contagious – treating you might save me and my family.

Until recently, medical thinking was essentially the same as judicial thinking.  Doctors faced with patients able to be cross-examined came to a view as to what was likely happening and both patient and doctor hoped the judgement call, the diagnosis, worked out.

When modern drugs came on stream in the 1930s, detecting adverse effects, Drug Wrecks, were one of the easier medical jobs – easier than diagnosing many illnesses. If a problem happens soon after a drug is given, and clears up if the drug is removed, perhaps reappearing if it is reintroduced, or varying with the dose of the drug, and if there is no other obvious way to explain what has happened, then it makes sense to diagnose the drug as the cause.  This is still the standard view on how to go about establishing cause and effect in the case of drugs in judicial settings as laid out in the Federal Judicial Reference Manual for applying science to drug induced injuries.

When drugs later became precious commodities, worth more than their weight in gold, that changed. Before that point, if a doctor prescribed us a drug, there were only two of us in the room – the doctor and us.  After that among others there were company marketing departments whose job it is to ensure our doctors don’t have a thought in their tiny little heads other than the thoughts put there by them or their competitors (this really is their view of doctors).  The others included bioethicists, medical journals, medical academics, and politicians who were all singing from the same song-sheet as pharma.

The problem we have now is not caused by pharmaceutical company marketing – the lunches, the trips to conferences, the glad-handing, the making of second-rate medics into opinion-leaders.  Pharma actively want you to think this glad-handing is the problem and are pleased when their critics rant on and on about conflict of interest.

RCTs

Central to our difficulties is the bureaucracy we thought we had tied Pharma up in with the 1962 amendments to the FDA Act and especially a then new and poorly understood invention – randomized controlled trials (RCTs) – which were built into the regulations governing the licensing of drugs.

RCTs don’t work for the purpose intended, which was as a means to ensure Pharma could only bring drugs that worked on the market.  They work for Pharma – nothing better has ever been invented for hiding Drug Wrecks.

And we have no easy back from what we did in 1962 – it would be easier to get doctors to believe the earth was flat that to get them to accept that RCTs are the source of their and our problems.

It’s not difficult to get doctors and pharma critics to believe conflict of interest is an issue, a little harder to get them to accept that ghostwriting of trials and sequestration of trial data is problem, but it will be like getting the Pope to give up Xtianity to get them to forsake RCTs.

The ghostwriting and data sequestration are a problem but pretty well all doctors and others, including the Chair of NICE, Chief Medical Officers in the UK and US, Ministers of Health in US, UK and Europe, the BBC in all its manifestations, New York Times in all its manifestations, the Pope and others, while accepting this is a problem can seemingly continue taking the sacraments as though there was nothing wrong, and where once they encouraged us to do so as well, they now seem to be gearing up to force us to do so.

Both JAMA and the New England Journal of Fake News two weeks back came out with articles claiming that being anti-statin was the same as anti-vaxx and that mistrust of the Fake News they publish (they call it Science even though they know its ghost-written and there is no access to the data) is a threat to the physician patient relationship.

Conflict of Interest was the stick critics (let’s say Puritans) used to beat the industry with some two decades ago but industry is no more bothered about this than Donald Trump by an association with Stormy Daniels or Jeffrey Epstein.

With Puritanism making little headway, a few took to pushing for access to the data.  This however feels a touch like Catholic or Protestant pastors in Germany in the late 1930s and early 1940s making it clear they were not entirely happy with an elimination of the unfit – a move that was too little and too late.  If industry are forced to grant access to the data, there are ways to ensure what becomes the data delivers the message that industry wants.

But even beyond this, the deeper problem here is the declaration that RCTs are infallible – that they offer gold-standard knowledge.  Sure there are problems brought about by industry use of RCTs, many critics will say, but RCTs themselves are the best source of knowledge we have.  This is the problem.

History of RCTs

The first RCT was of streptomycin in tuberculosis.  Prior to that there had been a standard clinical evaluation of streptomycin in tuberculosis that produced a much more accurate picture of this drug than the later RCT.  Both showed the drug worked.  But the standard evaluation also showed that patients became tolerant to streptomycin pretty quickly and some went deaf.

The RCT showed randomisation could be used as an aid to evaluating drugs but it would not necessarily get as good answers as standard clinical evaluations.

The first RCT of a drug before it came to market was done on thalidomide which sailed through this trial and came out on the far side as safe and effective.

Still the mantra took hold that no doctors would ever be able to work out if a drug worked were it not for RCTs.  This gets repeated every hour of every day even though every hour of every day, patients, or doctors or both combined decide if a drug is working or not and medicine simply would not be possible if one or other of them weren’t right pretty well always.

We might say “To err is human, To really foul things up needs an RCT.  And we are totally screwed if RCTs are given an infallible status.”

Objectivity

The idea is that RCTs deliver objective knowledge, which doctors on their own or patients can’t.  Compared with clinical judgements, RCTs aren’t objective. The idea that they are is a myth. They are mechanical and impersonal.

One basis for their supposed objectivity lies in Ronald Fisher’s first thought experiment involving randomisation in 1925 which he expressed in terms of statistical significance.  Fisher’s original idea was that statistical significance would indicate we knew what we were doing so well that only chance could get in the way of the outcome we predicted.  But when a doctor today figures on giving an antidepressant to someone, there is no better than a 50-50 chance it will suit them (never mind work).  Despite a statistically significant result in trials, giving an SSRI is no better than a crapshoot.

Imagine walking into an emergency department with a broken arm, being told they are randomly applying plaster casts to broken limbs and ending up with a cast on your leg.  This RCT would show randomly applied casts beat placebo (one in 4 times the case would be on the right limb versus 0 in 4).  But to practice medicine this way would be obviously nuts.  This however is increasingly the modern practice of medicine.

In response, some defenders of RCTs – and most defenders are non-industry folk who figure RCTs are the one true way to knowledge if we could just get industry’s hands off them – will say pooh to statistical significance, we use confidence intervals.

Confidence intervals come from efforts in astronomy around 1810 to come up with a way to decide whether the differing measurements we ended up with came from two different stars or one star imprecisely measured.  The bright idea was that measurement errors would cluster predictably around a mean – a distinguishable second star would fall outside this cluster.

This works for stars but not for human disorders, where diabetes, depression, back pain, breast cancer, parkinson’s disease and pretty well everything else can be forty different conditions rather than one. And it works even less well for trials of drugs, where even if the condition were one my response to a beta blocker might be exactly the opposite to yours.

The Gold Standard

The only reason RCTs are a gold-standard is that they are the standard through which industry makes gold.  They work for industry – and not just because industry work them.  Within 3 years of RCTs being built into regulations in 1962 as the way to keep ineffective drugs off the market, company salespeople were encouraging doctors to prescribe in accordance with RCT evidence – RCTs that the companies had not run.  Companies did a lot to create and have been the biggest promoters of Evidence Based Medicine (EBM) ever since.

RCTs are not totally worthless. They are like a microscope or telescope – helpful in seeing things that are not obvious to the naked eye such as how many people on active treatment end up dead compared to those on placebo when treatment extends 5 years and needs thousands of people recruited to the trial to spot a very distant or miniscule difference. But just as you wouldn’t use a microscope or telescope to work out who it was you were talking to, any more than you’d have this kind of lens on your eyes when walking down the street, so RCTs can get badly in the way of dealing with someone right in front of you – or with yourself.

All of the above applies to the benefits of RCTs, which is where RCTs are supposed to be particularly helpful in shielding us from bias.  Their intense focus on one thing to the neglect of everything else, is clearly risky, but this might be a risk worth taking if they got the right answer to the question of whether there is a benefit to this drug but more often than not they don’t.

When it comes to adverse events, Drug Wrecks, things get exponentially worse. We’ll deal with this next week.

Neo-Medicalism

But cutting across the effect of RCTs in helping us get a handle on either the benefits or the hazards of treatment is the effect of RCTs on our confidence in ourselves and our judgement calls.

And this is of a piece with a removal of judgement from everyday life that picked up pace in the 1960s.

This sequence of posts would be interminably long if our turn to procedure was explored in detail but in brief what gets called neo-liberalism emerged at exactly the same time as neo-medicalism – in the mid-1970s. Neo-medicalism is typified by the operationalism of DSM III – with blood pressure, blood sugar and other measurements playing the same role in the rest of medicine.

Both neo-medicalism and neo-liberalism embody thermostat functions – simple algorithms – that reduce complex problems that should call for judgement to simple functions – if X do Y.  If the supply of money grows to a certain point, cut it – regardless of the damage this will do to a country and its people.  If someone can tick 5 out of 9 boxes, they have depression regardless of whether the boxes they tick all stem from a flu or a pregnancy.

This is a bureaucratic – procedure-based – approach to complex problems.  Judgement and benevolence are replaced by a slot-machine – if 3 lemons line up you are entitled to an antidepressant without anyone intervening to ask whether this is “wise” or not, “honorable” or not –  any call to judgement based on any of the virtues (pagan or religious) that used to guide us at important moments involving justice or benevolence or other things is sidelined.

RCTs fit into this bureaucracy perfectly and did more than anything else to ensure a triumph of neo-medicalism in the 1980s.  Its this that I think the Roy Porter review glaringly misses.  Porter and others, especially those writing history, were very aware of neo-liberalism and were at the vanguard of those raising concerns about it but they missed its manifestations in medicine in a manner that suggest they and perhaps others never understood what neo-liberalism is  – and to this day the word is a piece of jargon that few people ever try to define.

Understand neo-medicalism and how to get to grips with it and we might understand and be able to roll-back neo-liberalism.

This too long post will continue next week – returning to the decapitation of Walter Raleigh and why this matters now more than ever before.

Editorial Note: This post will be an easy and obvious read if you’re Irish.  If you’re not, with Google or whatever it should be accessible and indeed the little bit of extra effort may make it a more rewarding read.  There is a warning below in respect of one item you might choose to Google. There is also one made up word that won’t appear in Google – until after this post is published.  A closely related word does appear – which is just fine.

Study 329

Study 329 was the most famous Randomized Clinical Trial (RCT) in history.  This study of paroxetine given to children and adolescents, who were supposedly depressed, led to a publication in 2001 in the Journal with the highest impact factor in Child and Adolescent Psychopharmacology.  The paper had an authorship line to die for including Marty Keller, Neal Ryan, Stan Kutcher and others.  Its claim that paroxetine worked well and was safe led to mass sales of the drug.

Turns out the study was ghostwritten, there was no evidence the drug worked and there were triple the number of suicidal events on paroxetine compared to placebo – along with other problems. It also became clear that several years before, in 1998, GSK had internally conceded their drug didn’t work for children but figured they would pick out the good bits of the study and publish them.

FDA were happy to overlook the fact the drug didn’t work, it would seem, but New York State weren’t and took a fraud action against GSK, the marketers of paroxetine.

One consequence of this fraud action, resolved in 2004, was that in 2014 a team got access to the data behind the trial and published a reanalysis of the data.  Study 329 became the only trial in history for which there are two contradictory published articles.  The restoration of 329, to something like what the original publication might more appropriately have said, was finally published in the BMJ in 2015.

The BMJ ordinarily publishes articles within weeks but in this case there was a year long extension to the 329 date.   The British medical establishment essentially had a nervous breakdown over 329. The details of what happened can be found on Study 329.org and even more detail will be available in a racy pacy juicy book later this year – telling you who was sleeping with who behind the scenes.

329 a Study

After a referendum in 2016, Britain was supposed to leave the European Union on 329.  329 has come and gone. A process that was supposed to be efficient and smooth has led to a nervous breakdown. There are claims of fraud and lies, scaremongering and ghostwriting on all sides.  What’s up?

A large poll of voters’ statements about why they voted the way they did, taken as they exited from referendum polling booths in 2016, found that sovereignty was the most commonly cited issue by leave voters.

If you’re Irish, you might wonder about this. Britain was still able to bomb Iraq, Libya and Syria without anyone in the EU stopping them.  Sovereign to do what exactly?

Choclatistas

Britain joined the EU on January 1 1973.  This was the day the Chocolate Wars began. Other European countries argued British “chocolate” contained vegetable fats rather than just cocoa and couldn’t be called chocolate. A Thirty Years War followed that contributed to British perceptions that Europe meant rule by Brussels’s bureaucrats. European choclatistas on their side saw nation based artisanal enterprises threatened by multinationals bent on replacing wholefoods with processed foods.

Retrospectively, even if these moral high-ground arguments were being put forward by people who brought us the Mafia and other locally sourced movements, many people would probably concede European chocolate was just better.

But whatever you think of the chocolate, behind this War lay the role of regulation in modern life. When regulators license a drug, they apply criteria in just the same way as they apply criteria to butter or chocolate. Meet the criteria and you can claim your product is butter, chocolate, an analgesic or an anti-hypertensive.

Your product might kill people, be an inferior butter or bone-thickening drug but it’s not the role of the regulator to keep people alive (other than through any contribution banning egregiously false advertising claims might make), nor to mediate between artisanal and multinational sectors of the market, nor to do politics. The role of regulators is to apply criteria.

When trading blocs such as China, America or Europe rub up against each other now, the issues to be negotiated are rarely about politics, and all about achieving regulatory alignment.  The criteria applied to feta cheese, diesel emissions and drugs determine the room to move an American, Chinese or European president has.

Where both liberals and communists in the 19th century envisaged the State withering away, by the time we hit the 1960s we had nuclear bomb proof regulatory systems that seem unlikely ever to wither away.  America’s FDA is a good example of this. Having no regulations for food or drugs is no more an option than removing all signage from roads and junking driving codes.

While companies have preferential access to the regulatory apparatus through appeals and other processes, and regulators are encouraged to partner industry, and consider the impact of regulations on jobs, this is not a global capitalist conspiracy in the sense of deals that no-one else could support done behind closed doors and imposed on us.  The initial drive to regulation came from us, the people, and our effort to control the power of the sovereign.

There is input from experts, including some representing consumer interests, to the regulatory process and the resulting regulations are publicly available, even if industry discussions with regulators are not.  In the case of drugs, FDA advisory panels are composed mostly of notionally independent doctors and the meeting transcript is publicly available.

Somehow though in the case of recent antidepressants, everyone on FDA panels appraising Spravato and Brexitanalone, bar Kim Witczak, who is not a doctor, and Julie Zito, who is not a prescriber, voted in favour.  Even though Brexitanalone is an ancient drug being hyped up 20 years ago as something that would transform Snow White into a bronzed, skinny, Libidy-chasing third millennium woman.  Me too and three and four might have been her motto – at least that’s the way the pre-marketing hype was tending 20 years ago.  (For Spravato see here and here).

Its not as though we don’t notionally have our guys on these panels.  The panel was stuffed full of what you might imagine were our guys.  Yet somehow….

Our guys never get to see the data.  They depend on FDA to look over it, which at best FDA do literally – they look over it. If we got to see the data afterwards, or at least some scientists did – this after all is supposed to be science and science hinges on data – and our guys knew we could see it, they might man up, other than at those exceptional times that call for political maturity – when faced with a dwarf-eating Snow White.

Its the lack of access to the data that’s key and the myth that RCTs are a good way to evaluate drugs – they aren’t but they provide good boxes to tick.  Clinically RCTs are useless.

With drugs and foods, industry score in another way.  Once a drug is approved they can deploy armies of lawyers to work on possible meanings of “organic”, “artisanal”, “locally sourced”, “chemical imbalance” or “mood-stabilizer”.

Sovereign

In the 1980s, Pharma was among the first industries to push for a global harmonization of regulations. This underpinned a globalization of the industry. The general view was, and may still be, that any problems with this necessary feature of modernity are balanced in health, that most sensitive of areas, by the presence of physicians to act as a counter-weight to industry and as advocates for consumers.

The bottom line though is that even Europe is not sovereign.  It does what America decides.  FDA approved fluoxetine (Prozac) for kids despite recognising the trials showed it didn’t work and that it caused suicidality.  The European Medicines Agency (EMA) and Britains MHRA followed suit and approved fluoxetine for kids.  WHO included fluoxetine in its list of essential drugs for children.  NICE and other guidelines recommended and recommend fluoxetine and other SSRIs for children despite there never having been a single positive trial.

Sovereignty would mean being able to say – look none of these (mostly chlorinated) drugs have been shown to work for children. That doesn’t mean they can’t be used but if we’re going to keep people safe, in this case children, we have to at least be able to call it as it is. Put like this, the idea that Britain is somehow going to regain some lost sovereignty by leaving Europe is clearly nuts.

It is probably unfair to say MHRA is about as craven as a regulator can be.  Its not the job of a regulator to be brave. It is more accurate to say British physicians as about as craven as physicians can be – well at least as craven as European and American physicians.  If physicians stood up to be counted they could make a difference – regulators would have to listen.  But if British physicians did this, there’d be a lot less Sir’s around the place.

The British have a wonderful system to keep people in place – offer to give them letters after or before their name.  Works a treat and costs nothing.

The Backstop

Back when Absolute Monarchs were still the in-thing, England invaded Ireland.  A doctor, William Petty, was given the job of surveying Ireland and its people. Petty created the first GDP for any country anywhere, created the first public health and hints of Evidence Based Medicine and proposed the first Free Trade agreement between any two countries – Ireland and England. Given the Brexit mess now, and all the claims about Free Trade, this is an irony like no other.

Petty’s ideas gave rise to liberalism and public health. His influence came to head, as it were, with the decapitation of Louis XVI in the French Revolution and the replacement of absolute power by regulated power.

It once seemed that this regulated power could always be undone.  There are no better illustrations of this than the 19th century interplay between Ireland, then Europe’s most destitute country, and England, the world’s most powerful. After Ireland was forcibly absorbed by Britain in 1800, Daniel O’Connell, realizing that power in this new world was constrained by laws, and boasting he could drive a Horse and Carriage through any English law, campaigned to get the Irish to hang together peaceably.

His campaign demonstrated a weakness inherent in England’s apparent strength and led to Catholic emancipation in Ireland (not yet in England) and on to a series of Irish inventions including the boycott, and the hunger strike that (give or take a little bit of violence) against the odds delivered freedom to the Irish to oppress themselves – even to the extent of handing over sovereignty to others.  (Its probably not for nothing that the abbreviation for Ireland – IRL – also stands for In Real Life)

But since somewhere in the 1980s, in medicine anyway, the regulatory apparatus has become as it were a learned intermediary between us and industry. Just as companies invoke doctors as learned intermediaries when things go wrong, they now claim to have adhered to all the rules and regulations and that those who work in industry are more rule-abiding and ethical than the average doctor or regulator – just as German soldiers were at least as ethical and professional as American troops in 1944.

The more we drift toward Google cars and away from Horses and Carriages, the worry has to be that piercing this System will be harder and harder.

In terms of drug wrecks, the key factor has been losing access to the data from the RCTs in which we have participated. This data should be as inalienable as our vote. Industry power stems from its seizure of our data. If we take our data back so that our consent must be sought for its use, and we decide when and under what arrangements it is in our interests to co-operate, we take back not just data but power.

We need a medical version of that recent Irish invention – the backstop.  Bottom line is doctors shouldn’t prescribe drugs for which they don’t have access to the data.  There should be a hard border between us and chemicals like this. We have nothing to lose by getting our doctors to insist on this.  Since the 1980s, there have been vanishingly few drugs that industry has produced that we need – Triple Therapy for AIDS, Gleevec for certain leukemias and maybe Solvadi for Hep C.  As things stand there won’t be many more as industry have figured that making drugs that cure disease is bad business.

We could learn something from Study 329 and 329 a Study.  Lets put a backstop in place and see who blinks first.  We wouldn’t need to take the drastic cutting off their eyelids measures that DUP politicians contemplated in the build up to Brexit 329.  Industry would blink first.

(Google “DUP cutting off eyelids” if this is not familiar to you.  Make sure you put DUP in the search term – I take no responsibility for the consequences if you don’t.  The DUP are a Northern Irish unionist party whom most English people think want a union with the South of Ireland.  They are seen by most English people as causing them endless Troubles).