Making medicines safer for all of us

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).

The picture shows Franz Mesmer magnetising a patient.  In between his hands and her head and heart there is a set of little slivers of  metal, capable of being magnetised – shown by the fact they are all lined up the same way.  The therapist was able to influence magnetic fields and could realign bits inside her similarly, undoing whatever blockages were causing her problem – whether she had a paralysis, was hysterical or whatever.

When Mesmer moved from Vienna to Paris, a Royal Commission, put in place by Louis XVI to look into magnetism, concluded there was no evidence for a magnetic influence but a lot of evidence for an influence from the doctor’s suggestions – patients could be mesmerised not magnetised.

Or hypnotised as we’d say now.

The French Royal Commission was set up because Mesmerism suggested the entire social order was held in place by magnetism or hypnosis and we, the sleep-walkers, could conceivably be woken up.  We could be Woke.

Mass Hypnosis

There is an idea out there that only some people can be hypnotised, when in fact we can all be especially when we are in groups – as the Austrians and other German speakers proved in the 1930s and 1940s, and religious revivals and other popular movements repeatedly show.

Whether some of us are more susceptible or not, and whether the hypnosis is being done on an individual basis or not, once induced a key thing is to get the person to do something stupid.  That way the hypnosis deepens.

The very best example of this in the world today happens routinely when people go to a doctor.

When s/he puts you on a medicine, he gets you to focus on just 1 of the 99 things this chemical will do – the essence of hypnosis.  You will not link any of the 99 other things to his drug his voice murmurs – the loss of your ability to make love, your muscle aching, your ruptured Achilles tendon, the feathers you are growing.

If one of those 99 other things is difficult to ignore, maybe you are about to skin yourself alive you are so agitated, or you are compulsively injecting an opioid, the way to deepen the hypnosis is to tell you that this is another illness.

If you are suicidal, this is because you have a bipolar disorder someone missed – here take this as well.  If you are injecting opioids this is because you have an addictive disorder someone missed but we can get the addiction services to treat this while we continue to treat your pain – with an opioid.  If the latest antidepressant doesn’t help, this is because we didn’t realise you don’t have depression, you have an entirely different disorder – Treatment Resistant Depression (TRD).  Here take Spravato – Do Not go Gentle.

What this stupidity should bring home is that it’s your doctor who is under hypnosis not you.

The scene is not your doctor as Mesmer with you as the one mesmerised but the pharmaceutical industry, maybe one of the Sackler brothers, or the health service company your doctor works for in the role of Mesmer – your doctor is the one there in the pink dress.

As with all hypnosis, the spell involves an “If X, then Y”.  In this case if the figures for X  are high, whether cholesterol, glucose, depression scores, give Brand Y – or low as in bone thinning.

Maintaining the Spell

Key to your doctor, nurse, physicians’ associate or pharmacist staying “under” is keeping anything personal out of the interaction.  One way to do this is to encourage him to use rating scales – so much more scientific than just a conversation.  Or as many measuring instruments as possible rather than putting his hands on you or looking closely at you.

Having a computer on his desk, ideally with your record in the form of an electronic medical record (EMR) to occupy his attention is important.  If he’s too occupied with this to spot that you’ve grown feathers, this is ideal.

Another method is group practice, so you rarely see the same person twice and no-one is in a position to notice the change in you from before the drug to after.

The most important thing is to avoid any opportunities for your doctor to make a judgement call.  Hypnosis is like sleep-walking – people can do very complex things but ask them to make a judgement call and they either can’t or they wake up.

Brainwashing

Of course another way to get your doctor is to behave as the powers-that-be want him to behave is to brainwash him – that peculiar form of hypnosis that appeared in the 1950s.  The guideline apparatus is perfect for this. Even the most independent guidelines, are effectively written by pharma.  If pharma run all the trials and ghostwrite the publications, they write the Guidelines – Guidelines work from published trials and nothing else.

But besides the doctors who will faithfully follow the Guidelines because they are guidelines, the rest can also be hypnotised or brainwashed by another function of Guidelines.  As one of the quips about US troops taken prisoner in the Korean War, who went on TV to denounce the USA, had it, you don’t need to brainwash people to get them to say things like this – you just have to aim a gun at them off-screen.

Guidelines are the gun – don’t keep to guidelines doc and you will be out of a job.

Wake Up

How do we get doctors to wake up?

First you need to realise that no matter how awake your doctor appears, he is sleep-walking.

Second, don’t let doctors measure or screen anything unless it has to do with a problem you brought them.  If you happen to be there and they suggest measuring something – your peak flow rate, bone density or whatever – just say No.  If they suggest measuring something linked to a problem you brought them – think about saying No.

Third, don’t go along with your doctor when he suggests something stupid.  If something is going wrong on treatment, its almost certainly the treatment that has caused it.  Don’t buy the line that this is another illness.

Fourth, ask them who they are having an affair with – something, anything that disrupts what might seem like a conversation but it more likely to be a stereotypy.

Fifth, get them to make a judgement call about something that counts – anything.

Something in the Air

The title comes from Macbeth – from the witches one of whose finger-tips start tingling and who says Something Wicked This Way Comes.

We are heading toward a creepy MacMedicine, where companies want you on as many drugs as possible every day of the year – none of which save your life or improve your life expectancy.  The lesson that pharma took from AIDS is that cures are bad for business.

Your doctor can’t be hypnotised as easily with something serious like AIDS and or with a treatment like Triple Therapy that saves lives. Better a statin or an antidepressant any day of the week.

Jose Mario Bergoglio in Chile 2018:

To believe in us you have to have Faith, but for me to believe in you you have to bring me proof

Over 150 years ago, describing most of the medicines then available as junk, Oliver Wendell Holmes came up with one of the most famous phrases about medical practice, when he said that:

If all the materia medica (drugs) could be sunk to the bottom of the sea it would be all the better for mankind, and all the worse for the fishes

Recently in Belfast, at a BMA meeting, medical delegates discussed the issue of doctors committing suicide.  There was panic in the air.  Doctors it seems need support.  They should not have to take on an occupational risk like this, delegates said.

There is no evidence that anyone at the meeting was willing to look in the mirror.  Its highly likely most if not all of these medical suicides happened to doctors on pills, a high proportion of which were likely caused by the meds these doctors were on.

A post here some months ago Even Doctors also get killed by Akathisia raised this issue. There have co-incidentally been a number of penetrating comments about this post recently.

The people who are most to blame for this are doctors.  Its doctors who have been handing out these pills and ignoring if not ridiculing patients when they report back that the drug has made them dysphoric, akathisic, suicidal or even homicidal.

Or the treatment has hooked them – See Welsh petition.

Or has caused permanent sexual dysfunction – See Encountering Doctors

A huge proportion of the drugs that every doctor has prescribed during the last ten years have been prescribed on the basis of Fake News – ghostwritten articles and without access to the data from the trials of these drugs.  Doctors could have refused to prescribe without access to the data – but haven’t.

Life expectancy is now falling in America and Britain.  This was entirely predictable given that the science behind prescribing is all Fake Science and given that doctors have been willing to put their patients on 5, 10 or more Fake Medicines every day – where in the 1980s few people were on more than 1 and we had the data behind the one that people were on and the literature was written by who it appeared to be written by.

But there are no BMA resolutions about what we are going to do about our patients’ falling life expectancies. Doctors are worried about themselves – not apparently aware that their patients might hold the answer to what is killing them.

Catholicism

This point can be pushed further. The last year has seen increasing anger about abusive priests and the Church that has sheltered them. This crisis began in Ireland in the 1980s and came to a head in Chile last year.  The Church has been scrambling ever since to manage the fallout. Jose Mario has managed fairly well since his slip in Chile with occasional flips into blaming some of his critics as enemies of the Church.

Its not clear that many people would shed too many tears about the death of an abusive priest or the death of a bishop who had knowingly moved that priest around from parish to parish without getting to grips with the issues.

What is much less well known is that medicine has its share of abusive doctors.  The best known is Harold Shipman but there have been lots of others.  Robert Kaplan’s book Medical Murder tells some of these stories.  A recurrent feature in these cases has been the facility with which the medical authorities have quietly moved doctors from one jurisdiction to another without investigating too closely.

Its not just doctors. The psychologist James Coyne is a very recent example of someone whose shocking behaviors several universities chose to turn a blind eye to and hoped to solve by facilitating a move elsewhere.

But doctors are more dangerous than priests or psychologists.  They openly kill us like Shipman or as Oscar Wilde might have said – lose us carelessly.

The question is how best to treat the profession’s nervous breakdown?  Counselling or mindfulness or even higher rates of pay seem to be the options doctors are lobbying for.

A better bet in terms of restoring morale might be if someone could get the profession to take on a mission – demand access to trial data, believe patients when it comes to adverse events and engage with our falling life expectancies rather than the stressful burn-out inducing handing out meds you don’t believe and wouldn’t take yourself and then ignoring the evidence of harms – because to do otherwise would be “suicide”.

Short of doing this you’d have to say it were better for mankind if doctors were sunk to the bottom of the sea and better for the fishes.

Its not as though anyone will have to push them overboard with their feet encased in concrete to ensure they sleep with the fish – they are busy slipping their own feet into the concrete mix as is.  If medicines are so effective and safe then nurses and physicians associates and pharmacists and robots soon will be a lot cheaper prescribers than doctors

January 28 2019.

Open letter to David Haslam, NICE

Dear David,

Our paths nearly crossed at an IAPT meeting in London in 2016 but you opted not to speak in a session that had me covering “Some Questions for NICE” – a lecture covering issues that have given rise to this letter.

We brushed by each other in May 2018 when Chris Van Tulleken, in The Doctor who gave up Drugs, based on input from me, is shown contacting NICE about antidepressants and children. NICE refused to comment but claimed they were revisiting this topic.

What concerned him (me) was that pretty well everything in the antidepressants and children domain is ghost written and that every single trial including the 2 trials, which had been the basis of approval of fluoxetine for children in the US and the UK, were negative trials.

File on Four covering the same issue had the same material and message from me. They were rivetted but then claimed they couldn’t fit the material into their programme, opting instead, like Dr van Tulleken, to feature Andrea Cipriani, despite being made aware that Dr Cipriani’s work is necessarily based on ghost written material and that he had had no access to any of the data behind the studies he worked on.

Faced with difficulties in moving some substantial concerns forward, I opted for publication in a peer reviewed journal – the article is attached.

I have given a TedX talk on this topic – https://www.youtube.com/watch?v=vpTqei5hZ3g

And presented the issues in the Welsh Assembly –  https://youtu.be/oku_8t8MLek

Both talks cover material presented in several national and international fora – including how the NICE process fails us – to which I can now add the following for future talks.

On January 23^rd, an email from NICE informed me that a draft guideline on depression in children and young people was up for consultation. I was not surprised to find physicians advised in the case of more serious disorders to consider a turn to fluoxetine, or combining fluoxetine and CBT, before turning to sertraline and citalopram if these treatments fail.

Then on the afternoon of the 24^th, a follow-up email indicated that sections of the guideline were blocked off from comments. These sections included those I might have commented on. Hence this open letter to you, as you personally may be unaware of the issues.

The fluoxetine trials, which were used for paediatric approval in 2001, just like the paroxetine trials a year later, were negative on their primary outcomes. FDA recognised this for both fluoxetine and paroxetine and were willing to approve paroxetine and not mention in the label that the trials were negative, leaving an unchallenged ghost-written article in the public domain to claim paroxetine worked well and was safe. Essentially the same applies to fluoxetine.

Following the fluoxetine approval, a Panorama programme made it difficult to approve paroxetine, sertraline and other SSRIs.

I am not saying these drugs should never be used. There is evidence they may produce a benefit in paediatric OCD. I can envisage using them in conditions other than OCD. But these drugs cannot be used safely unless clinicians are aware of the true state of the evidence as regards both benefits and hazards, which include making young people suicidal, wiping out their ability to function sexually, perhaps forever, or hooking them to treatments forever.

The guidance mentions that in the case of fluoxetine the risk benefit ratio has proven favourable. This seems to mean provided there might be some benefit any risks can be taken. The data do not indicate that on balance the benefits outweigh risks. There are more negative trials for fluoxetine than any other SSRI.  In the case of the only notionally independent trial (TADS), the study that underpins your recommendation to combine fluoxetine and CBT, there were 34 suicidal acts on fluoxetine against 3 on placebo. I appreciate that this isn’t stated clearly in any of the 7 TADS publications but it is readily ascertained – see Hogberg et al, attached.

The guidance mentions sertraline, perhaps because Dr Cipriani recommended this for adults – on the basis of ghost-written articles and a lack of access to the data. FDA assessments suggest sertraline may be the weakest of the SSRIs for adults.

Citalopram is also mentioned as an option.  Again, the data are inaccessible, the articles ghost written, and one of the key trials has I believe the highest rate of suicidal events in paediatric SSRI trials. The company then marketing it, like GSK, ended up resolving a Department of Justice action against them for a substantial amount of money.

This situation echoes 2004/2005 when NICE personnel compiling the first guideline in this area, wrote an editorial in the Lancet, Depressing Research, questioning whether it was possible to produce guidelines when trial data is inaccessible and the published literature all ghost written.

I’m not clear what the Care in National Institute for Health and Care Excellence means. It may just refer to Care of the Elderly Services. I take Care to mean there is more to Health Care than just another Service Industry – something more like taking responsibility for others as when in the care of people with diabetes we used to tell patients they needed to prick the sides of their finger when taking a blood sample as they might need the pulp of their fingers should their eye sight fail later. As a family doctor, I expect you would agree that there is always going to be a need for those of us on the coalface of clinical care to be alert to the way those who seek our Care integrate technologies, such as a drug that might make you suicidal, into a life that has to be lived.

I have not added any honorifics to your name or mine. This letter is from one person to another, not one office to another.

Yours sincerely,

David Healy

The recent moral panic around the Death of MR and the involvement of Instagram and Facebook in her death and maybe that of others is intriguing. Worthy of John Le Carre – at his Tinker, Tailor, Soldier, Spy best.

This may be a cynical attempt by the old media – the BBC or NBC, the New York Times or the Guardian to put pressure on new media like Facebook and Google. There are appearances of concern for the Russell family but no evidence of real concern about anything other than getting a story – or making a point. If there was real concern for the families of any of these teenage girls a lot more would have been done about the hazards of antidepressants before this.

Despite the appearances, it’s entirely possible that this crisis has been engineered by Facebook to gain an advantage. It brings to our attention the possibilities that Facebook or Google might be able to flag up people who are actively suicidal and be able to intervene.

Shortly before the Russell brouhaha began unfolding in the UK, the New York Times reported that Facebook and other media companies have been using their surveillance methods to pick up people who may be actively suicidal and intervening – Minority Report like – for instance sending Tom Cruise around to save a life .

An article by Mason Marks in the Yale Journal of Health Policy Law and Ethics recently – HERE – outlined a number of the hazards involved in this, ranging from compromising peoples credit records to detention and forced medication or triggering death by cop.  Forcing Facebook to delete images in the Molly Russell case helps make a case for using the technology to intervene in other cases and making it even more of a policeman in all of our lives.

The latest big thing are Home Hubs, Personal Assistants like Alexa, intelligence units aimed at making homes smart.  These units will register every emotional nuance we have, all our contacts and activities. We could drift very quickly into an uncomfortable position.  Not just those of who buy them but those who don’t – what have you to hide then?

If the Police can…

As things stand, as an expert witness in cases where a drug may have played a part in triggering a suicide or homicide, I have for years been presented with police searches on their computers showing the sites people have visited before and after going on an antidepressant.  This is a powerful aid in working out whether the homicidal or suicidal thinking began before or after treatment – or whether it changed in character.  If the police using old tech have been able to do this for years, its unquestionably the case that Facebook and Google and other companies can do it.

They unquestionably could contribute evidence as to the rates at which people going on antidepressants become suicidal or have a malignant change in their thinking.  They can easily establish whether the kind of imagery Molly Russell may have viewed was provided by people who had gone on an antidepressant and become suicidal even if she hadn’t.

But were not hearing about this.  Why not?

What we’re getting is a confected fuss that looks like it suits the interest of government for greater surveillance capabilities and the new media – no one is particularly worried about the old media these days, except putting them to some good use before saying adieu.

One more aspect to this story though is the indifference of Facebook and Google to whether any of us lives or dies. Their argument is that it’s not their brief to worry about things like this.  This would be an invasion of our sacred privacy.

The links we make and the traces we leave provide material that can be put to use (and they can make money from) but it’s exactly to same traces and links that are on the one side being blamed for MRs death but on the other side could be used to help save her. The argument is we cannot get one without the other.

Of course you can – you might respond. It’s a matter of making a judgement, a diagnosis, coming to a verdict. But judgements and verdicts are exactly what Google and Facebook do not do. For them everything is equivalent – there is no evil – there is no good. They operate like a thermostat that will turn off the heating at a certain temperature and on at another but do so without making a judgement about whether a higher or a lower temperature is good or not. It’s a function.

But still we set our thermostats as Google and Facebook set theirs with theirs designed to avoid making any changes that reduce their revenue stream.

And the money always comes from the herd rather than any individuals within it.

This is the scenario Lily, Pfizer and Merck depend on when they claim that anecdotes are not data and that whether clinical trials show a problem or not is the only thing that counts. An individual making a good case for a connection between an antidepressant and suicide is a voice crying in the wilderness.

Curious that a business that depends on the plural of anecdote being data doesn’t disrupt that.

All Muslim Now

The image above shows an outfit designed to avoid surveillance – to avoid being tracked around town. There is a growth industry in people buying anti-surveillance gadgets like shields to block their webcams on computer and phones – they can be bought on amazon.

It seems a younger generation are much more savvy and already taking steps to create ways of living with some freedom in our new surveillance states.

One of the cute things about the outfit above is it offers us all a chance to look Muslim, or perhaps the way Catholic nuns used to look 50 years ago.  We may be all KKKing yet or Hijabbing.  There’ll be a premium on a good pair of ankles, for men as well as women.

Dead Contact

Following last week’s post Are Old or New Media to Blame for Suicide, I had the following email from papyrus:

Ged.Flynn@papyrus.co.uk

David
I’d be happy to have a discussion with you. Perhaps you could contact me. Many thanks
Ged

Ged is apparently a little more senior within the organisation than Chris.

Ged

David

There was nothing from Ged – no call, no email, NADA.

Bridgend

The post Left Hanging in Bridgend seems to have triggered Papyrus to make contact.  Bridgend remains a mystery.  Like finding the Marie Celeste – a ship drifting at sea with no-one on board.

There are a lot of comments after the post – some of which get quite vituperative and even I who have glanced through them prior to posting have lost track of what is exercising people.

It appears that Madeleine Moon the Member of Parliament for the area got the local papers to stop reporting on inquests in Bridgend just after there was a succession of inquests where antidepressants were mentioned – not by coroners,  or GPs, but by relatives or police officers.

Of the suicides 13% were reported to be on antidepressants, 0% were reported not to be taking antidepressants and 87% remain unreported.  See HERE.

Somewhat surprisingly in the aftermath, Madeleine Moon went on to be Parliament’s leader on suicide prevention. Bridgend got a large pharmaceutical facility (Biotec).  No public enquiry was ever held.

Swansea University’s Department of Psychiatry were supposed to investigating the Bridgend deaths and I had the impression some account would be given of what happened, but I’ve never seen anything.

Maria Bradshaw from CASPER in New Zealand later reported that their research found that 87% of children who took their lives in New Zealand did so after having been prescribed antidepressants.  This is a lay organization keeping track of things.

In the UK Louis Appleby and the National Suicide Prevention Programme is supposed to keep track but its never possible to work out from their reports the proportion of people who are taking meds at the point of death.

It is also impossible to work out what the UK suicide rates are as coroners now have discretion to return narrative verdicts, or open verdicts or other options.

As for the Instagram side of this story, there was no Instagram then.  Now 10 and 12 year olds, as comments on last week’s post suggest, know more about sex than I know or would want to know, may have watched snuff movies or real torture. Its likely there is a lot of material on many phones that an older generation would never cope with.  But they desensitize just as their parents generation (Ged and Chris included) became erotically desensitized, perhaps helped by material from Google and Facebook.

That said, there are well documented accounts of SSRI takers who have deliberately watched snuff movies and executions in order to be able to feel something – such is the emotional numbing these drugs can produce – and who recoil in horror from these things once they stop their drug.

Cui Bono

Its perhaps perverse to mention it but the only people who profit after a child dies by suicide is an organisation like Papyrus.

More next week.

Your Worst Horror

The week of January 22 to 27 a series of stories of the death of a 14 year old young woman (MR) horrified many people in Britain.  This was first item on the BBC news for several days and on the front page of newspapers like the Guardian pushing Brexit, the US Government closure, Venezuela and Huawei aside.

The way the story ran the new social media were to blame. Instagram helped kill my daughter. It had pretty well caused her to die by suicide by all but forcing imagery of suicide onto her phone and into her mind.  Facebook bosses were called to account. The Secretary of State for Health appeared on prime-time television saying the State might have to act to ban social media unless Instagram and Facebook got its house in order.  Coverage of the events mentioned a group called Papyrus.

The story, along with the photographs of the young woman, was heartbreaking as the death by suicide of any 14 year old would be.  While the extent to which it became a media event might have left some wondering, it was not a story anyone would want to ask questions about. But an email from Papyrus reproduced below with my response left me more than wondering – particularly as she had died two years before.

The Greatest Failing

As outlined in this recent TedX talk and in a talk to the Welsh Assembly, there has been great concern about children’s mental health recently.

This crisis – the greatest failing of the NHS according to the Secretary of State for Health – has also been an occasion for the Old Media like the BBC and Newspapers to make a whipping boy of the new media.  Great if their efforts improve children’s mental health, but its not clear that this flaying of social media won’t do more harm than good.

Was this sad event just an occasion for the Old Media to be even more cynical than the New Media?  Given its timing, was it an event that suited the Conservative Party – get Brexit off front-stage?

The single greatest cause of suicide and suicidality in young people is likely to be the medication they take.  But despite being repeatedly handed a story about how the entire literature on these pills is ghost-written and the data inaccessible and that regulators have approved drugs on the back of negative trials and Guidelines bodies like NICE recommend these same drugs despite knowing the trials are negative, the BBC have repeatedly flunked handling the story and the Guardian and other newspapers are as bad.

In the face of fewer suicides and suicidal events than the clinical trial evidence would point to, one has to wonder if social media sites like Instagram might not even be saving lives.  The only place teenagers are likely to hear that it might be their meds that are giving them horrific thoughts of mutilation and death is on social media platforms.  It is only there they are likely to pick up strategies to minimise the problem – perhaps by pretending to take the pills.

They won’t hear it from the BBC or the Guardian – all they will hear about is take the pills and don’t believe the Fake News on social media.

We don’t know what medicines this young woman was on.  There are a hundred medicines that might trigger suicidality in a young woman from antidepressants to antibiotics to oral contraceptives and others.

In the case of people posting horrific images on Instagram, it has to be a racing certainty that many of these are on meds that can induce horrific images they would never have otherwise had.  So even if MR was on no pills, someone else’s pills may have helped to do her in.

Open for Business?

A leitmotif of the Brexit debate has been that Britain is open for business.

Being open for business in the Caring Business seems to mean a willingness to tolerate suicides and suicidal events, homicides, birth defects and endless other problems.  It means a willingness to tolerate close to the entire medical literature about on patent drugs being ghostwritten.  A willingness to have a set of Guidelines about the sequence in which to take out on-patent meds that are based on “junk” (difficult to find a better word).  A willingness to turn a blind eye to the fundamental scientific norm which is you don’t make claims if you don’t have data that others can scrutinise to back up your claim.

Papyrus

I had an email from Papyrus on Monday January 28 after the Secretary of State had been on weekend television.

chris.prendergast@papyrus-uk.org

Dear Dr Healy,

I’m contacting you on behalf of PAPYRUS, the UK charity for the prevention of young suicide. Part of the work we do involves raising awareness of our media guidelines around safe and sensitive discussion of suicide. We came across an article you have published on suicide in March 2013, which includes extensive discussion of suicide method – particularly with regards to hanging. We are concerned that vulnerable people might come across this article via a similar search and that it could introduce a method of suicide to them which they weren’t previously aware of. We understand that this would not have been your intention in writing the blog, and we were wondering if you’d be open to a conversation about taking some of this information down/editing some details out? We’d be happy to discuss this more, either by email or telephone if you prefer, and can provide more detail over the parts we feel would be unsafe for a vulnerable person.

Yours sincerely,   Chris Prendergast, Marketing and Communications Officer, PAPYRUS

This email seems to refer to a post Left Hanging about suicides in Bridgend in Wales.  It doesn’t contain any imagery. There are many other posts that contain suicide imagery – one of which The Spectre of Dissent contains a compelling image – that disturbed many from JFK 50 years ago to Facebook who blocked the circulation of this post.  Facebook not Papyrus. In the light of this, I took care not to include an image of Jan Palach in flames in the last post here Rest in Dissent.

I emailed Mr Prendergast back on Tuesday January 28, when I had calmed down.

Chris

I’m not sure what word to apply to your email – bizarre, suspicious, or laughable.

The issue of media reporting of suicides has concerned me for decades and I appreciate Papyrus more recently have been doing work in this area but in my opinion the way you are going about it risks doing more harm than good especially when you get to the point of sending emails about this post you have targeted.

I know Papyrus are aware of the suicide risk antidepressants pose.  This is a much greater risk that anything that appears in the media – whether new or old media – but you have done nothing to warn people of these risks.  Whatever about the new and old media romanticising suicides and doing harm in the process, the media as they currently operate are doing greater harm by totally ignoring the risks of treatment, which they will continue to do while organisations like Papyrus opt to stay silent rather than press for change or give them the impression that the key thing is not to talk about suicide rather than face up to what is happening.

If Papyrus is open to a conversation about spreading the word about the risks that some of the most commonly used drugs pose, I’d be happy to discuss this more, either by email or telephone if you prefer, and can provide more detail over the points I think you could make and the organisations I think you should be approaching.

In the meantime, I will be discussing the issues in a post this week, including your email and my response.

David

Simony and Sanctimony

There is an organisation – the American Foundation for Suicide Prevention – that almost vampire like preys on parents and partners and children who have been bereaved by suicide.  They sell a message that if only the disease had been recognised earlier and treatment instituted earlier this death would not have happened.

A large proportion of those they recruited to their “Cult” (hard to find a better word) are people whose children or partners or parents have been taking an antidepressant or other drug.    See How Pharma Captures Bereaved Mothers.

AFSP gets support from Pharma. Papyrus claims not to.  For pharma the very best groups are those that get no obvious support – like NICE.

Under cover of keeping to ethical codes, organisations like the Samaritans block discussion about the suicide risk of antidepressants or related drugs.  Anyone working for organisations like the Samaritans who suggests to someone their medication may be making them suicidal is likely to be fired without comeback.  Judgement calls like this supposedly have to be left to doctors – whose minds like those of the BBC and Guardian are close to completely colonised (hard to find the right word).

Cui Bono?

MR looks like a beautiful young woman.  But what’s happening now looks terribly contrived.  To whose end?

Fifty years ago today, January 19, Jan Palach died.  He had set fire to himself 3 days earlier in Wenceslas Square in Prague in protest against the Soviet occupation of Czechoslovakia. The spot was close to Charles University where Jan Hus had begun a resistance to religious oppression 5 centuries before that helped ignite the Reformation.  He may have fallen as he began to die on cobblestones made from Jewish gravestones, following the obliteration of Prague’s Jewish community in the 1940s.  There doesn’t come a much greater concentration of history in a few square metres.

I have resisted posting some of the images of Palach that can be found on Google as posting similar images of a Buddhist monk mounting a similar protest in Saigon against an American occupation a few years earlier led to Facebook blocking the post in which those images appeared.

Dissent

Jan Palach’s death played a part in creating what was later called the Velvet Revolution which 20 years later helped “liberate” Eastern Europe. Vaclav Havel was among the key figures who picked up Palach’s challenge and channelled it into a movement that rather like ACT-UP in the US some years later was neither a movement of the Left or the Right but one that took a stand on the value of individuals and their right to live the lives they chose to live.

Faced with a new dictatorship East of the Elbe, that unlike prior dictatorships ruled in the name of the people and looked permanent, Havel framed the issues as follows:

“A specter is haunting Eastern Europe, the specter of dissent… You do not become a ‘dissident’ just because you decide one day to take up this most unusual career. You are thrown into it by your personal sense of responsibility, combined with a complex set of external circumstances. You are cast out of the existing structures and placed in a position of conflict with them. It begins as an attempt to do your work well and ends with being branded an enemy of society. … The dissident does not operate in the realm of genuine power. He is not seeking power. He has no desire for office and does not gather votes. He does not attempt to charm the public. He offers nothing and promises nothing. He can offer, if anything, only his own skin—and he offers it solely because he has no other way of affirming the truth he stands for. His actions simply articulate his dignity as a citizen, regardless of the cost.”

Havel V.  Power of the powerless.  In Living in Truth, Faber Books London 1978. P 83

Strikingly, while protesting against the new dictatorship in Eastern Europe, Havel and others didn’t look to the West for salvation. And if we look at what has happened, especially in healthcare, since the Velvet Revolution and the End of History, a good argument can be made that what was happening in Eastern Europe was a managerialism that was pioneered there but developed and improved on in the West since then so that we are even more imprisoned that the Czechs were then.

Dissent Now

In the late 1990s, Pfizer ran clinical trials for a new antipsychotic Geodon.  In one of these trials, a person on active treatment set fire to themselves.  They died several days later.  The death was coded as death from burns rather than suicide.

This scenario is pretty standard for most of the drugs used in medicine today.  The degree of mismatch between what patients experience and what the authorities claim about the reality of treatments is as comprehensive in medicine now as any mismatch between the claims of the State and lives of its citizens ever was in Eastern Europe in the 1970s.

Just as Czechs in 1970 never met those who were the Engineers of Human Souls in Eastern Europe, so patients and even doctors don’t meet the people responsible for the forces that are making encounters in healthcare worldwide today increasingly miserable.  Doctors meet managers who insist they keep to guidelines that are based on junk. Patients meet doctors who are keeping to the guidelines.  Neither managers nor doctors nor patients get to meet those who engineer the guidelines.

This is a scenario in which the only thing that doctors learn from patients who are injured or killed on treatment is not that there might be something wrong with the guidelines but instead perversely that any questioning of the guidelines risks the loss of a job.  Every death of every patient ratchets up the pressure not to question the guidelines – if need be by coding suicides as death by burns.

What’s going on?  For Havel, the problem centred on responsibility.  Its our willingness to hand over responsibility, willingness to let important things slide by while we tread water (get on with life),  willingness to hide in the herd and behind slogans that is the root of the problem.

In 2010, just before he died, after the Czech Republic had been free for twenty years, Havel’s view was that the situation, our situation, was worse now than it had been in the 1980s.

Between Good and Evil

When times are good it can seem to make sense to go along with things as they are.  But this being sensible all too easily slides into getting on the train when you are told to do so.  Losing the ability to resist is a recipe for death when resistance is called for.

There is a resistance that is non-violent that can seem to transcend the politics and struggles of men and can apparently lead to success as with Gandhi in South Africa, turning the other cheek, or Havel and Walesa in Prague and Gdansk. This looks like it can work when we stand together but we rarely stay standing together for long – without our “leaders” having to bribe us with something.

The morality of this way of doing things sits in the balance along with what can be for some a more psychologically fitting way – a turn to violence. Rather than set fire to yourself, bring the fire down on them.   But whether with violence or without, the enduring problem is how to ensure that after the Revolution things don’t end up worse than they were before.

How do restore caring to health, and how do we ensure it remains at the heart of what happens there?

There has been increasing brouhaha about Fake News of late. In the general media, Facebook are apparently going to introduce panels of reviewers to take down posts that contain fake material. In the academic media, doctors are told not to believe what they hear in the media about the adverse effects of drugs – See Fake News and the Great Purple Pill as well as this article passing off concerns about PPIs as nothing to see here.

As regards medical and health-related issues, there is more than a vague sense that under cover of efforts that some would see as reasonable to block claims for instance that Hilary and Bill Clinton are really Martians who abuse and cannibalise children, politicians – more often on the Left than the Right – intend to brand and block what they declare to be Fake News about the adverse effects of vaccines or drugs – anything that might scare people away from treatment.

Its absolutely fine for pharmaceutical companies to scare the bejaysus out of people as This Video shows.

But its not fine for a prescriber like me to remind people that you can only get prescription drugs from someone like me because we have every reason to think once we know more about them they will turn out to be more dangerous than alcohol or tobacco.

Added to this legitimate concern about drugs we know little about, you’d have thought medics like me would be pitching these drugs as risky and needing expertise.  If these drugs aren’t dangerous and work wonderfully well then nurses and pharmacists and others would make cheaper prescribers.  The reason for not going the whole way and having them over the counter is that industry want a fall-guy in between them and us who can be blamed if anything goes wrong.

Keeping the Herd Together

Then there is the surreality of the recent Golden Globes shenanigans.  What is going on here?

While vaccines have been around since 1800 and the basis for them came into view in the 1860s, and public health focused on sewers and food adulteration had been around since the 1850s and grew in force in the 1890s on the back of germ theories, around 1900 something else took shape. Several inputs from the picture school inspections revealed of the health of children to the work of Josephine Baker on infant mortality created a preventive medicine centered on building up resilience – on engineering individuals rather than the environment.

Baker’s work led to the greatest ever jump in life expectancies.  This led public health departments to embrace what some have since termed pronatalism and others refer to as “gardening”.  It seemed increasingly possible to shape the population – removing the weeds and generally getting the human garden in a shape pleasing to the gardener’s eye.  The new ethos fuelled a push to eugenics in the US and UK and Scandinavia.

It led to a later German effort to purify the Volk that turned in the first place to eliminating the mentally ill and mentally handicapped along with the removal of non-nationals from the national territory and then their later elimination when complete removal proved impractical.

The need to tend the national garden seemed obvious to most people.  German doctors were at the time the most advanced scientifically, and the most philosophically oriented, in the world.  Few of them objected.  Doctors like Hans Asperger, featured here, continued to go to Church while screening children for relatively minor oddities, knowing that in many instances this would lead to their elimination.

Just as the Vatican’s show a reluctance to get involved in anything medical now (other than bullying women about abortion), few of the hierarchy in any of the Churches spoke out about “gardening”.

While what happened in Germany and Austria looks horrific in retrospect, and the recorded efforts of some parents to save their children by writing and visiting regularly are heart-wrenching, most of us stayed away and hearing that our child had died wrote letters to the authorities thanking them for doing the necessary in the case of these lives not worth living.

This is what we would do again – we are no different to the Germans. This perhaps is what we are doing now.

Anti-Vaxx

The authorities express alarm at the growing number of anti-vaxxers in our midst.  There may be some died in the wool anti-vaxxers, but I’ve yet to meet one.  There may be some libertarians who believe in vaccines but not in compulsion.  But the vast majority of people I have met – it feels like 80% plus – who are engaged on the issues were pro-vaccine and pro-drug and are engaged on these issues because of an injury to their child.

It seems inordinately cruel to brand them and deride them as anti-vaxxers. There is no basis in good science or good religion for doing so.

Its worth repeating the greatest concentration of Fake News on the planet centers on the drugs and vaccines doctors dish out – See HERE.  When it comes to drugs, the articles underpinning medical practice are almost entirely ghostwritten and the data from studies are entirely inaccessible. Doctors are now and for thirty years have been the greatest consumers of Fake News. When it comes to exercising discrimination, teenage boys do better in respect of designer clothes or gadgets than doctors do in respect of designer drugs, vaccines and devices.

Fake What

One of the functions of religion is to keep the herd or the tribe together.  Loyalty is an important “virtue” in this respect.  A tribe or herd can cope with occasional dissent but not with a split.  The vaccine struggles seem religious in this sense – down to talk of herd immunity when herd immunity in fact applies to very few vaccines.  In practice herd immunity seems to mean we need to inoculate all members of the herd so they believe the same things and are protected against any deviations from the one true faith and give straight arm salutes.

But good religion has also been about equipping us to look steadfastly at realities from our individual insignificance to the plight of others and the need to overcome the effects of evil.  Its about standing up for things that count rather than running with the herd.

Good science equally is not about a blind acceptance of what the authorities say.  Its about recognising that when it comes to spotting a phenomenon or an anomaly that needs explaining a high school drop-out or page 3 model may do just as well as a Nobel Prize winner and it may be a better idea to pay heed to motivated high-school dropouts than to most guideline committees whose commitment is to ghostwritten pap.

So what should the scientific response be to a 15 month old child who is developing fine until vaccinated and after that shows a regression?

Its not scientific to respond by saying we have no studies that show an increased rate of regression, autism, call it what you will, after MMR, and therefore the vaccine hasn’t caused the problem.  The studies we have are all seriously flawed but even if they weren’t this would not be a scientific response.  The point is that science aims at explaining what is in front of us.

It may be that lots of 15 month old children regress but this doesn’t just happen for no reason.  In each case there will be a reason.  Listening to all sides of the story, from parents and other family members to the doctors or other healthcare personnel, and any other interested parties, there is a need to make a judgement call in each case as to what has happened and what may have caused it to happen.

If there is a mismatch between the view that emerges as to what has happened to this child and the apparent result of studies, while many will find it more convenient to ignore the child and her parents, even if current studies were done by angels and were not contaminated by Fake Evidence, the scientific thing is to wonder how come the studies are not reflecting what has happened in the case of this child.

The case of people becoming suicidal on antidepressants brings home the point.  When the case is convincing, the scientific question is not how has this patient fooled us or what bias does her doctor have, but rather why do the studies that claim to show no problem not show a problem.  In the case of the antidepressants it turned out that the reason the studies show no problem is that companies went out of their way to hide the problem using a variety of illegal and unethical and unscientific maneuvers.

But even if these had been studies done by angels, there would still be the same need to work out how the studies were failing to find things they should find.

If it isn’t the case that we start by attempting to explain the individual case, the justice system could no longer function.

But the logic of the justice system is not the logic of drug and vaccine regulators who, as Ian Hudson the current CEO of MHRA put it, faced with compelling cases that, having looked at all angles and heard testimonies from all points of view, you or I or a jury would figure had a drug induced problem, argue there is no issue if controlled trials haven’t shown the drug causes the problem.

This is logically incoherent.  If we haven’t some reason from individual cases to think the drug can produce a benefit, we wouldn’t have done any trials at all and there would be nothing on the market.

Since 1990 or thereabouts, modern medicine where it involves drugs or vaccines or devices has been increasingly incompatible with natural justice and with science.  Its difficult to know what to say about religion.

What do we need?

Perhaps a Facebook review process banning adverts and related material in the public domain as for example on HPV vaccines instanced above and on PPIs as shown on the Great Purple Pill.

Media – especially the “liberal” media who are the greatest purveyors of Fake News – need to look carefully at how they have been hoodwinked by the False Balance strategies they have adopted and need to scrutinize the role of bodies like the Science Media Centre.

Medical journal editors need to Woman Up.  The greatest failure in this area has come from Cochrane which appears beyond reform.

Meanwhile, whether we think its science or religion or whatever, the greatest concentration of Fake News on the planet centers on any drug, vaccine or device our doctor proposes giving us. We need to look her in the eye and ask him what s/he figures on doing about this.