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.
Being out on a limb; cross-examined, in these cases, the plaintiff is likely to become ‘the accused’ as the defendant has the power and the glory and an endless train of ‘hearsay’ medical pro supporters …
The Sixth Amendment to the United States Constitution provides that “In all criminal prosecutions, the accused shall enjoy the right … to be confronted with the witnesses against him”.
As is said, here, Political Pills, Psychopharmaceuticals and Neoliberalism as Mutually Supporting…
The Sedated Society pp 189-225 | Cite as
Political Pills: Psychopharmaceuticals and Neoliberalism as Mutually Supporting
This chapter argues that a core explanatory variable in the spread of psychopharmaceuticals has been the ability of such products since the 1980s to serve key aims of the neoliberal political economy. Thus to understand the expansion of psychopharmaceutical consumption since the 1980s, we must go beyond the machinations of the pharmaceutical industry and psychiatric profession, to inspect the deeper neoliberal interests, aims and logics to which both profession and industry have been responsive and beholden.
Psychopharmaceuticals, in other words, have enjoyed rapid ascent by being configured as consistent with key neoliberal aims of increasing ‘labour productivity’ and of furthering ‘commodification’ while themselves benefitting from ‘deregulation’. While reform of psychiatric and pharmaceutical practices certainly is long overdue, unless political will grows sufficiently to tackle systemic corruptions and excesses in the research, regulation and distribution of psychopharmaceuticals, little may transpire in the form of tangible change.
A still-popular and beloved son of England, one of the judges at his less than fair trial later said
“The justice of England has never been so degraded and injured as by the condemnation of the honourable Sir Walter Raleigh.”
https://www.historyhit.com/sir-walter-raleigh-executed/
Unless it’s a criminal court then it’s the other way round. Sorry Annie just reading the first sentence made me make this comment.
The state will always make sure it’s looked after first even when they are wrong.
The other wonderful thing about Raleigh is that while awaiting execution he wrote a History of the World – I fear I never read it but I recall being shown the first edition by a book collector friend of the family as a child, and being left in an appropriate state of wonder.
I agree very much about the bureaucracy – I do think COI is important on occasion and should be disclosed. But it is the people locked into a set of practices which is deadly to truth. Truth becomes a thing which is settled by committees which are actually more interested in dogma, control and covering their backs from decades of malfeasance and which in turn is perhaps itself a kind of COI and it is more potent for being administrative. My guess is in the Wakefield case we see the Department of Health and the licensing agency shaking in their shoes. And I am sure on the other that the people who have dribbled the contaminated blood for haemophiliacs scandal or the Camelford scandal up the field for decades have regarded themselves as particularly honourable public servants. But, of course, you are right that RCTs are a particular effective means of rendering the experimented on faceless (apart from anything else). If you can avoid recognising the individual then perhaps you can avoid recognising the mass.
To me a random controlled trial is like a bunch of people deciding it’s worth sacrificing the few, or the many, like bombing the hell out of a city ‘for the greater good’. It.s not moral it’s accepted expediency chosen by those who have been appointed to a committee by their brethren and who will not die themselves. An RCT surely will ensure that some are harmed when the randomly chosen are all different not just from me but from each other as well..making the use of it even less scientific or true or fair.
One reason for defending some bits of bureacracy though is that pre-neo -liberalism there was too little accountability by doctors. They could and some did practice based on what they were taught often decades earlier without any obligation to further education. Also clinical judgement is fallible, human behaviour is not always honourable – people have not always received equal and fair treatment so although bureacracy is not the answer unless we are all transformed into machines, I think there needs to be some safeguards to ensure honourable, benevolent treatment is assured for everyone (as far as possible given human nature)..
I agree with this post; however, I would still consider myself as someone who believes RCTs to be superior method to anecdotes. I think the real issue here is not the method of RCTs, but rather how industries are manipulating the study designs and misrepresenting the findings to paint whatever picture they want. Some examples would be like those antidepressant trials where the patients were given benzodiazepines beforehand to combat the akathisia, or trials that have completely fake patients. These are clearly broken study designs. Industries will manipulate trials in their favor, conduct several of them, and then cherry pick the ones that suit them and bury the rest. That is the core issue with RCTs. They are easy to fool people with because we do not always have full access to data, and we also do not have populations that are educated on how to properly analyze scientific research. However, in the absence of non biased RCTs, it is wise to look at clusters of case reports. This is where your method has really come into play. A single claim made by some random person IS a mere anecdote; however, if you have many of these claims that are consistent and have been documented into case reports, then I believe that is when it transcends a state of being “anecdotal”. It’s like you said, if a person has a documented reaction to a drug that starts on usage, stops or changes when halted, and has a varying degree of severity that matches the dose variation, then what other explanation is there? This is where case reports become invaluable at establishing specifics, and I believe they should be valued almost as much if not just as much as any other form of evidence in this particular context. However, I would still say that appropriately designed RCTs are superior for discovering the overall efficacy of something in most cases. The issue with pharmacy drugs is that the RCTs for them are poorly designed on purpose in the interest of the pharmaceutical companies.
Of course conflicts of interest are important…that’s why so often they are hidden from public view…
The poor trusting general public has no idea how vaccination policy is being manipulated by vested interests, operating behind a facade of authoritative-sounding ‘doctors’ and ‘professors’ with conflicts of interest.
For a perspective, see this recent article by Children’s Health Defense: ‘The Pharmaceutical Industry’s Front Men’, 23 July 2019: https://childrenshealthdefense.org/news/the-pharmaceutical-industrys-front-men/
Galileo said that “In questions of science, the authority of a thousand is not worth the humble reasoning of a single individual”.
It’s easier for Seroxat victims of this Church, even with the evidence and the facts from an expert, to reason with an evangelical Christian or Flat Earthers than to convince others that their doctor is far from omniscient and that ‘medicine’ does not revolve around science and health-care.
In fact, that forces have conspired so that they are no longer in the same universe.
You are guilty, like Socrates, of two charges: asebeia (impiety) against the pantheon of Athens, and of corruption of the youth of the city-state.
And thank God for the next generation of children and teens like my step daughter:
Prescribed Sertraline before I came on the scene, this young lady is still out of school; she has since suffered from ‘obesity’ and apathy, sexual ‘dysfunction’ (no interest in the opposite sex at all in puberty) and from suicidal akathisia (also acting out violently on the same day) after missing one pill.
I repeat her plight all the time as it’s just shocking to me (working now to get her safely off it with support at the right time).
Post a needless prescription for Seroxat as a young adult in 1999 (and all the follow up offending drugs to function), the legacy of Corporate abuse and Standard Care has left me struggling with seemingly permanent physical, cognitive, and emotional damage. Since 1999, my life has been about survival and self defense.
And even after I had made it clear in 2005 (albeit incapable of saving myself, an utter mess and not equipped at the time with what would be the most important word in my life: “akathisia”) post the Panorama Programmes who my trusted abuser had been: GSK.
Still, a psychiatrist (and the first psychiatrist I saw after being prescribed Seroxat ten years prior – terrified after Seroxat of ever going again) had noted no abuse in my childhood and that she could not make “head nor tail” of what was wrong with me.
This post reminds me that I’m soon on a State Disability Claim Appeal Hearing/Trial where I also argued my iatrogenic Disabilities (as Annie says, it does feel to the victim like they are always on trial. Even more frustratingly when the damage has compromised the victim’s ability to think much less make their best case/defense).
A box long on the packet (and more and evidence of the disabilities caused post long term prescription and post a severe withdrawal) there’ll be no corresponding tick box in State Claims. What a doctor says…
No matter that what a doctor said (on the basis of what they were effectively told to believe/say) almost killed me a few times, ruined my health, my life – and did kill too many.
I hear my deceased father and my partner, although knowing the time and costs that would be involved in getting more State pleasing tick box false diagnoses and inappropriate and damaging drugs for false diagnoses and when suffering from MCS, say “just play the game”.
Both survivalists, and where the cost has already been too much, they are not wrong:
“The King” is always safe in the State’s hands.
There can be not even a rumour of plot against him (even if you were a good citizen, he almost killed you a few times and left you disabled). The victims of the golden word of third parties, of even the King, are the only ones who will be cross examined by the State.
All Seroxat victims have to them their epic little battles. And which they always lose to their further detriment.
If the State rep also sits in judgement (albeit their own hands tied behind their back), I’m hoping I won’t lose my head.
The ‘Crown of Thorns’ … for D’s..
Market 2019-2023 Featuring Allergan, Eli Lilly and Co, GlaxoSmithKline, H. Lundbeck AS, Pfizer – ResearchAndMarkets.com
July 26, 2019 10:55 AM Eastern Daylight Time
https://www.businesswire.com/news/home/20190726005346/en/Global-Selective-Serotonin-Reuptake-Inhibitors-SSRIs-Market
This analysis also considers the sales of selective serotonin reuptake inhibitors in Asia, Europe, North America, and ROW. In 2018, the depression segment held the highest market share, which is expected to remain prevalent over the forecast period. Factors such as the rising incidence of depression, easy absorption of the drugs through the gastrointestinal tracts, and their selective activity toward 5-HT receptors will significantly help the depression segment in maintaining its leading market position.
Also, our global selective serotonin reuptake inhibitors report has observed market growth factors such as the increased drug dependency associated with SSRIs, rising prevalence of mental illnesses, and favorable drug purchasing policies for patients. However, challenges such as side effects of antidepressants, advent of biologics, and stringent US FDA regulations and approval of psychotropic drugs may hamper the growth of the selective serotonin reuptake inhibitors industry over the forecast period.
re Open Consultation to Green Paper : Maximising our Health; Prevention in the 2020’s (nice rounded number); Pub 22nd July 2019 Dept Health and Social Care Gov.UK. Closed Oct 14th Oct (2 months to handle a massive doc with citizens responses – maybe it just goes straight to the shredder). ) ‘Online for responses ‘Advancing Our Health’
In Iceland citizens’ data is stored on a massive database without choice. In UK there is a more covert patronising nudge nudge approach to persuade us to be good boys and girls and provide our data for the common good of the country and of course for our own personal benefit. But it hides that much is already grabbed without our consent Another consultation document has been issued which shows the aims of relyinh much more heavily on the collection of data and use of ‘intelligent’ devices, especially those attached to our personal devices and actual bodies. It can be seen as progressive but is also very creepy.
Much is made of intelligent gathering of data in this Green Paper which is out for so called consultation. There is room for responses but when you get to the end the site hasn’t been ‘switched’ so need to save. So we can all rely on intelligent collection of data then,!,
Now and then I grap an opportunty to hightlight the issues on DH and Rxisk on ‘consultations’ -who knows someone might get curious..- We don’t need to guess what’s left out of the document – untrustworthy promises about how our data will be protected by this and that regulation ,obfiscates that there is no mention of research data, just what is proposed to be researched . In an attempt to make us feel this all a great partnership between citizens and politicians and ‘stakeholders’ they just infantalise and paternalise or maternalise people in ways we never imagined. Every corner of life is intruded upon and cleverly using psychological research tries to influence society by these pretence of consultations that we all have chosen to buy into it. Anyway ,3 of the aims;- targeted support; tailored lifestyle advice; x Greater Protection Against Threats x Theydon’t just threaten our health but the whole concept of a free society.
Channel 4 Dispatches @C4Dispatches
“We’re promoting the idea that it’s ok to have a mental health problem – but it’s made us afraid of our emotions” Dispatches looks at claims that de-stigmatisation campaigns are having unintended consequences, leading some to wrongly believe they have a mental health problem.
Channel 4 Dispatches @C4Dispatches
Britain has a youth depression crisis. More and more are now asking for help – but 2 out of 3 people aren‘t getting the treatment they desperately need.
WATCH: Young, British and Depressed – tonight at 8 on @Channel4 #Dispatches
James Moore Retweeted
Lucy Johnstone #FBPE @ClinpsychLucy 58m
‘Young, British and Depressed: we need way more TV like this.’ Review of last night’s #Dispatches @C4Dispatches in @guardian
Young, British and Depressed: we need way more TV like this
There’s a crisis in mental health among young people – and anyone who questions it is viewed as deeply controversial. Thankfully, this documentary asked all the right questions
https://www.theguardian.com/tv-and-radio/2019/jul/30/young-british-and-depressed-we-need-way-more-tv-like-this
30 Jul 2019
…..about what’s going on.
dr Healy, you say it is very unlikely that any doctor would distrust RCT’s, even when explained that RCT’s are not to be trusted?
What am I missing here? Isn’t it just in the doctors favour to keep believing in RCT’s?
A doctor that can point to a RCT, is a doctor that can’t be blamed.
I would say it is almost foolish to even try to change the doctors opinion.
A RCT is ordered by the pharmaceutical manufacturer, carried out with oversight from the manufacturer,(and in some ‘mysterious cases’ seen through court litigation where manufacturers seemingly hide adverse events and buff benefits through clever manipulation), commonly performed by Universities who rely on the manufacturers endorsement for the RCT, and published in medical journals that gladly publicise, who also needs to use in-house attorneys if they feel obliged to publicise negative reviews (like 329 re-vamped) in fear of(!!!!!!????) manufacturers that can sue them!
(Not even considering politics and legislation that also agree that RCT’s are ‘gold standard’)
The system is in place, and it’s run by the manufacturer in each step. It is silently agreed upon. The doctors benefit from this, the patients don’t.
If doctors stood to gain from exposing lies, they most likely would.
Ove2019