Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Author Archive for David Healy

Clinical Trials Are Unsafe

This is the first of  3 linked lectures given to family doctors in Stockholm on September 9 2021.  The meeting was organized by André Marx, a family doctor in Stockholm who also runs Sweden’s first and only public health care-funded withdrawal clinic for psychiatric drugs.

The alternate title of this talk is Girl with a Clinical Trial Tattoo. It will be followed by Girl who Catches Ghosts and Girl who Eats Salt.   All will feature on the Politics of Care Forum.

Thomas Hultgren who works in  Equal – a patient organization in Stockholm – made a video recording with occasional Zoom effects – children talking. The Video is HERE

Slide 1

I come from a very orthodox, conservative medical background. I believe in the medical model and the value of pharmacological and other medical treatments. Despite this you may be disturbed by what you hear. Disturbed by the distance we seem to have travelled from what They Used to Call Medicine to what is happening now.

I won’t be offering many answers. But I have two questions – What are RCTs and What is Data. My answer to Data is in this talk. My answer to RCTs is in the third talk.

Slide 2

Here is our patient. It’s not clear if it is a woman or a man.  I can tell you s/he is smelly. You might initially feel s/he is not very bright. How do we Help here?  What would Help look like? Help surely cannot be the same as telling someone what to do.

Slide 3

Our problems knowing what to do for our patient start here. Any discussion of randomized controlled trials (RCTs) starts with Ronald Fisher, a cantankerous character. Fisher thought the idea that smoking causes lung cancer was ridiculous – views the tobacco industry were happy to fund. Fisher wasn’t a doctor or a scientist.  He never ran an RCT. He was a mathematician who was interested to mathematically characterise the views of experts.

Fisher assumed experts knew what they were doing. For him experiments were a way to demonstrate that – not a way to find out new things.  Only two things could get in the way of an experiment turning out the way the expert said.

Slide 4

There might be some unknown factor, but Fisher thought this would be rare – experts knew nearly everything.  Randomization could take care of unknown unknowns.

Fisher’s experts were like Robin Hood. Unless chance intervenes, like Robin Hood they would split the first arrow 19 times out of 20.

Slide 5

If you can any medical condition where the RCTs turn out like Fisher’s scenario – let me know. Trials of antidepressants and most drugs look more like this – all over the place.

If medical experts were like Fisher thought, you wouldn’t need trials.  Medical advice would be like telling people to wear a parachute when jumping out of a plane.

Slide 6

This old Deutschmark celebrates Carl Friedrich Gauss’ key scientific breakthrough. Around 1810 telescopes were unreliable and astronomers couldn’t be sure if they were looking at one or two stars. Gauss solved this with the confidence interval which you see beside him – if the measurements fell within the confidence interval they were from the same star and from different stars if one of them fell outside it.

Jerzy Neyman and Egon Pearson, who hated Fisher, said statistical significance was all wrong and experiments needed confidence intervals.

These guys also had nothing to do with science or medicine. They never did an RCT.  But in the 1970s, medical journals told us to drop statistical significance and start using confidence intervals instead.

Slide 7

This is the only complicated slide in this talk. You see Gauss’s confidence interval on top. Confidence intervals work for a measurement error problem like stars and telescopes. If you give a beta blocker to one person, their heart rate will slow but with some variation every time you check. We can call this measurement error and use Confidence intervals – the data will all be to the Left of the heavy line running through 1.0.

But if you give a beta blocker to ten people, it will slow the heart rate of 9 but the next person may have a heart rate increase. We should but we don’t view her as a different star. We just say beta-blockers slow heart rate.

Heart rate increases on beta blockers are rare but many psychotropic drugs sedate some while leaving others wide awake. Half of the measurements will fall to the Left of 1.0  and half to the Right, leaving companies able to claim their drug has no effect on sleep. This is not just wrong its psychotic.

On the lower Left we have another example. Both the Red and Yellow Drug here can kill you. If forced to take one of them, all your statistical training will tell you avoid the Red one because the confidence interval says it can kill you for sure.  The Yellow  confidence interval crosses 1.0 so supposedly we don’t know if it can kill you.

Well – the likely risk from the Yellow Drug is nearly 10 times greater than the Red one. If forced to choose, you should take the Red one.

The next example shows the suicidal events from FDA’s database of antidepressant trials – the Red Curve shows events in those 25 and under and Yellow Curve people who are 45-55. But FDA and others claim only those 25 and under are at risk from antidepressants.  There’s no problem if you are over that age.

The bottom line here is that neither statistical significance nor confidence intervals work in trials of a medicine.  We have tens of thousands of RCTs now but no-one can really work out what they mean.  Our use of statistics is based on convenience rather than reality. Confidence intervals can work if we know what we are doing in the first place but don’t if we don’t know what we are doing.  See The Antidepressant Tale: Figures Signifying Nothing.

Slide 8

The two tables you see here are identical in size and shape.  If you superimpose one on the other, they will match – confounding you. Randomizaton supposedly controls for unknown confounders. People talk about it in mystical terms. Put a drug through an RCT and even though a doctor has no idea what they are doing – the right answer will emerge.

The problem with this is neither Fisher nor Neyman ever thought an RCT could help someone who didn’t know what they were doing. You have to roughly know what you are doing before an RCT can be of any use.

Slide 10

The First Medical RCT was for streptomycin in tuberculosis in 1948. Tony Hill was the person who introduced randomization to a medical trial. Hill didn’t follow Fisher or Neyman. There was nothing mystical about randomization in his trial – it was just a method for fair allocation.

Two years previously clinicians at the Mayo Clinic had done an old-fashioned trial to evaluate streptomycin for tuberculosis – controlling for things like age and sex in both treatment and placebo groups. Both trials found streptomycin worked.  The Mayo trial found patients became resistant quickly and some went deaf. Hill’s RCT missed all this.

The Mayo studies were the only reason Hill’s trial was run – the answer to did streptomycin work was already known.  Hill didn’t discover it.

Slide 10

After Hill’s RCT, very few investigators could see much point in doing RCTs rather than the usual kind of clinical trial.  Something else happened to change that – as you will see.

Here’s Tony Hill in 1965 reflecting on RCTs. In an early part of this article, he says he is surprised at how popular RCTs have become. He is also surprised by the fact its mostly industry people pushing them – not doctors.

He says RCTs are just one way to evaluate Therapeutic Efficacy – that is evaluating one of the 100 or more effects all drugs have. This essentially means RCTs are not a good way to evaluate a drug – they have a place but do not offer a good view of a drug overall.

Slide 11

In the 1950s the most enthusiastic advocate for RCTs was Louis Lasagna. Lasagna had put the placebo and Clinical Pharmacology on the map.

Drug Regulation then was about Drug Safety. Lasagna thought RCTs offered FDA a way to establish if a drug worked. If they didn’t work, they couldn’t be safe. Nobody paid any heed.

Slide 12

Events changed everything. The horrific birth defects caused by Thalidomide triggered a political crisis – something had to be done.

The 1938 FDA Act which focused on safety kept Thalidomide off the US market. A new 1962 Act gave FDA a brief to establish that drugs were effective in addition to safe. Demonstrating effectiveness would be done using RCTs. The idea was 2 positive RCTs would be the criterion.  Everyone thought if there was one positive trial, all trials would be positive, and certainly with two positive trials – but we now know this is not the case. 50% of trials can be negative.

Adding effectiveness can only be a good thing – don’t you think? Well thalidomide later got licensed – under the 1962 Effectiveness Act.

Slide 13

Prior to the 1962 Act, only one drug had been shown to be both safe and effective in a placebo controlled RCT – Thalidomide and the person who did the trial was Louis Lasagna. Article Here. The mechanism we have put in place to stop Thalidomide happening again was one that it sailed through without a problem.

Everyone thought, and most still think, RCTs put a brake on pharmaceutical companies. Instead, RCTs have become the standard through which companies make Gold.

Slide 14

Twenty years later you see Lasagna responding to Rossi et al who say RCTs are the most sophisticated way to work out what a drug is doing.

He says this is only true if sophisticated means adulterated.  This is an older meaning of the English word sophisticated that most people today don’t realise.  Sophisticating wine means adding ethylene glycol to it.   Article Here.

He is saying essentially that clinical judgment is more accurate than RCTs at least for adverse events and more interesting to engage with.

Slide 15

Ten years later again you have him saying that his view of RCTs has changed completely since the 1950s. Interview Here.

And RCTs aren’t that useful – certainly not for the key question which is what am I going to do to help this person in our waiting room.

Slide 16

RCTs are supposed to control all confounders even the ones we don’t know about.  In fact, it is just the opposite. RCTs introduce confounders and make trial results essentially meaningless.

Slide 17

Imipramine was the first antidepressant.  It and other tricyclic antidepressants are stronger than SSRIs and SNRIs.  It beats them in RCTs.  It can treat melancholia – they can’t.  They are useless for severe depression.  Melancholia comes with a high risk of suicide.

Imipramine was launched in 1958. A year later at a meeting in England, Danish psychiatrists made it clear that while it was a wonderful treatment it made some people suicidal.  Nobody there argued.  This drug can cause suicide.

Let’s do a thought RCT of imipramine versus placebo in melancholia. Even though it can cause suicide, we would expect it to reduce the number of suicides in a trial like this because it treats the condition. This RCT would be great evidence antidepressants do not cause suicide.

Slide 18

Here is the data on the trials in mild depression that brought the SSRIs and SNRIs on the market – you see a doubling of suicidal events compared to placebo. Companies resorted to all sorts of illegal manoeuvres to hide this risk.

Slide 19

This is what the data for imipramine look like in the same mild depressions. Now it seems that it too causes suicides.  So RCTs tell us nothing about cause and effect – they can give us diametrically opposite answers. This is because these aren’t drug trials.  They are Treatment Trials and in any clinical Trial, the condition confounds the effects of the drugs – and these confounders hide drug effects.

People evaluating drugs in traditional trials, before RCTs, knew this.  People doing RCTs don’t. When a patient becomes suicidal in a trial you have to use your judgement to work out what is happened but in RCTs clinicians are not supposed to use their judgment.

Slide 20

This is not just the case for depression – it’s true in every clinical situation where drugs and conditions cause superficially similar effects – diabetes and glitazones both cause heart failure, osteoporosis and bisphosphonates both cause fractures

Slide 21

Here is what a drug trial looks like. Companies ran these studies in the 1980s and found that SSRIs make healthy volunteers suicidal, caused dependence and sexual dysfunction but we heard nothing about these problems when the drugs launched.  These Drug Trials enabled companies to engineer their Treatment Trials to hide these problems.  I will show you how this is done now in a moment but first look at this.

Slide 22

This slide shows some data straight from a 2006 GlaxoSmithKline paper. GSK’s SSRI paroxetine was in trouble – the RCTs data for Major Depressive Disorder seem to show paroxetine causes suicidal events. The real data I think are worse that GSK admit to here.

Slide 23

But never fear RCTs come to the rescue. GSK also did trials in people with Intermittent Brief Depressive Disorders – IBDD.  These are borderline personality disorder to most people – patients who have suicidal events much more often than anyone else.  But these patients can meet criteria for depression and could be entered into Depression RCTs.

Now Lilly had done a trial of Prozac in these patients – it didn’t work. GSK also did a trial of paroxetine which didn’t work and had a 3-fold higher suicidal act rate than placebo.  GSK then did another trial in a similar group of patients.  Why?

The answer is here. Here are IBDD data from the two GSK trials. I have seen other data for these two trials which make paroxetine look worse but let’s stick with GSK’s story. We could even add 16 more events to the paroxetine arm and still get the same magical outcome

Slide 24

When you add the IBDD data to the MDD data – all of a sudden paroxetine doesn’t cause suicidal events, it protects against them.

Something like this is going to happen in every treatment trial where the patients entered are heterogenous – back pain, breast cancer, diabetes, hypertension, osteoporosis, parkinson’s disease.  We can use an effect a drug causes to hide an effect a drug causes.

RCTs are not a good way to work out what is going on. Results of a back pain trial will insist you use analgesics rather than antibiotics – which is all wrong for the 5-10% of backpains caused by infections.

Slide 25

Now I mentioned in Healthy Volunteer Drug Trials, companies saw SSRIs give most people sexual problems. After only 2 weeks, you can be left unable to function ever again in your life – the condition is called Post SSRI Sexual Dysfunction (PSSD). It happens in young and old, female and male, all ethnic groups and in every country on earth.

But in company Treatment Trials, less than 5% of people seem affected in this way.

No laws need to be broken to achieve this. No skullduggery is needed. Just do an RCT. RCTs depend, as Tony Hill told you, on a primary endpoint.  Everybody assumes this is the commonest thing a drug does, and devoting attention to it makes sense.  All other effects will be less common or may only show up if you’ve been on treatment for months or years.

For SSRI RCTs, the primary endpoint is mood change. But mood change is not the most common effect. It is the effect of commercial interest.  What happens if you focus all attention on this –

Slide 26

This is what happens….  We are hypnotized and miss what is going on

Slide 27

The sexual effects of SSRIs happen in close to 100% of takers within 30 minutes of the first dose. They should be unmissable. But a focus on a primary endpoint makes them vanish.

Slide 28

Companies also knew from healthy volunteer trials that people become dependent on SSRIs but this problem vanished in RCTs.  The result is that 10-15% of the population of most Western countries are now on these drugs – primarily because they can’t get off.

The BMJ ran a lead article 2 years ago saying the British have stopped making love. They blamed depression but those of us in the mild states these drugs get given for often turn to love-making or eating to help.  The Benzodiazepines we used for these problems before the SSRIs didn’t cause any worse dependence and we were at least able to make love.

It’s the drugs 15% of us are on that make love-making impossible for maybe 20% of the population if you take our partners into account and perhaps 30% of people in areas where the use of these drugs is particularly high.

Slide 29

RCTs greenwash drugs.  They convert poisons out of which we can bring good, if we are not hypnotized, into sacraments. Sacraments are substances that can only benefit – that cannot harm.

Regulators tell us that drugs that kill us or wipe out our sex lives for ever have a positive benefit-risk balance. This claim is based on RCTs, which only look at one of a drug’s effects – that may not be the most common effect. The statement is totally incoherent – it was a drug company invented mantra that regulators have swallowed.

Slide 30

One of my key questions at the start of this talk was – What is Data?

In a trial of Pfizer’s antipsychotic, a man died from burns.  You can’t get any sense of what happened him from reading any of the 50 articles there are from every single drug trial. Few mention any hazards. The figures and statistical outputs in the papers from this trial give no hint.

His death triggered an internal company adverse event report. This shows he poured petrol on himself and set fire to it in an attempt to kill himself. He died 5 days later – and was coded as death by burns. If you didn’t have the adverse event report – which you can’t easily get – you’d have no way know what happened.

Slide 31

In GSK’s famous Study 329,which you will hear more about in the second lecture, a trial of paroxetine versus placebo in teenage depression, a 15-year-old boy was arrested by police because he was out on the street with a gun threatening to shoot people. The police took him to hospital.  He was taking paroxetine. This should have led to a serious event report but it didn’t because GSK had discovered if you say someone has an intercurrent illness – you don’t have to report on what happened.  Four children dropped out of this trial with intercurrent illness – all on paroxetine.

A internal company email, which FDA never got to see, told the story of this boy. He brings out the meaning of data.

People are the data in clinical trials. You have to be able to interview them to find out if this boy’s case if he had an adverse event or did he really have another illness – did it clear when the drug was stopped?

Working out has a drug caused a problem is judicial – you do it by examination and cross-examination not by counting out the figures an algorithm spews out.  What Used to be Called Medicine was judicial – it was not algorithmic.

Slide 32

Imagine you break an arm and go to an Accident Department who say ‘Good news we are running an RCT of Plaster of Paris. We are going to put a POP randomly on one of your 4 limbs and compare this to no POP’.

Randomly putting a POP on some limb will do better than no POP but to start doing this on the basis of RCT results like this would be crazy.  This however is exactly what we are doing.

Slide 33

This however is what most doctors are doing. RCTs effectively remove our brains and replace them with something that can be programmed.

Slide 34

RCTs are pitched against clinical judgment.  Clinical expertise used to be at the heart of HealthCare – lived experience we could call it – but this is now a problem for health service companies.

Traditional doctors are like a gourmet Chef commenting about a Fast-Food meal and health has become a service industry like Fast Food – gourmet physicians aren’t wanted.

We are a problem for Guideline writers, regulators, and pharmaceutical companies, all of whom want to pitch objective knowledge in the form of RCTs against your and my expertise. The idea of bringing good out of the use of a poison doesn’t compute for insurers, managers or even the public who want religious sacraments.

What are these RCTs that are used to invalidate us?  The answer comes later.

The Politics of this are that in some sense we need health/medical co-operatives rather than Corporate Operations in which staff and patients are Cogs rather than central.

In a Galaxy too close to Home for Comfort

Long ago, in friendlier times, this blog ran a series of Modern Myths featuring Crusoe.  The plan was for a lot more but life got serious. Rummaging through files I came across some drafts. This one was dated 2010 but the original might have been written a year or more before. It was clearly the way things were going then. 

Beta Centauri was unquestionably a long way from Massachusetts.  Somewhat to her surprise Crusoe found breathing no problem, and the temperature seemed just about right.  The scenery as they’d come in was not unlike that of a temperate zone on earth.

Walking around, she had begun to wonder if there were clinics when she spotted the entrance to what was unquestionably a medical facility.  Going in, she found a procedure in progress.  It seemed sophisticated – no anaesthesia.  Wounds from battle or other encounters seemed to heal under the touch of a vibrating instrument passed slowly over them.  In other cases apparently normal limbs turned out to be quite artificial, and repairing them was entirely bloodless.  This was a new frontier.

But it was quite another building that drew her attention.  Where only those in obvious need of care for something like a severed limb went to what she would have called a clinic, everyone came to this other building at some point.  Here the staff administered a supply of some substance.  The same for everyone.  Crusoe took some.  She noticed no effect.

What was it?  She didn’t want to ask as who knew what would happen if the Centaurians realised she didn’t need what it seemed they did. It was only in one of the taverns in town, after a few drinks, that she was able to get someone to tell her what went on in the building without raising suspicions.

Some decades earlier, faced they were told with a major epidemic the entire population of the Economy was vaccinated.  This was done compulsorily.  The Corporation was the only body who held supplies of the right vaccine.  While treatment may have saved them from something, there was a side effect.  Not spotted at first – at least this was how the Centaurians viewed it.  The vaccine knocked out a gene and all children borne after that were short of a protein – alpha-nucleositol, without which life was impossible.

Fortunately very few children died, as when the problem declared itself in the first few children, the Corporation rushed out supplies of alpha-nucleositol and supplied it to everyone.  Provided they took it, everything was okay.  It came free of charge but with an requirement for annual screening.  If the screening revealed that the subject held aberrant views on the organisation of the Economy or the merits of the Corporation, the person’s supply was terminated.

Everyone including bioethicists and others with no links to the Economy or the Corporation justified this on the basis that the Economy couldn’t be expected to support the continued existence of those disagreed with its principles.

The rebellion began when Princess Leia escaped with a supply of the gene for alpha-nucleositol, and headed for a planet on the outer limits of galaxy, whose inhabitants it was now rumoured could live without being dependent on the Corporation.

This piece was previously built into:  The Data Access Wars

Crusoe features in many posts including Medystopia

The Tree Must Go

Watch where you Wave that Wand

 

 

Announcing a Birth

Samizdat is proud to announce the imminent birth of El Naufragio de lo Singular – a transformation into Spanish of Shipwreck of the Singular.  The birth is expected before the end of September.

The expectant parents welcome you to this post – the equivalent of a baby shower party.

Baby showers may be primarily or perhaps exclusively North American. This parent had certainly never heard of them before moving to Canada and doesn’t know if they are a tradition in Spanish speaking countries.

At baby showers, expectant parents provide treats for their visiting guests.  Killing a fatted calf as part of the celebration is not politically correct at the moment. It might be more a case of harvesting the prize heirloom tomatoes, the exotic mint or perhaps the habanero peppers and making them into something interesting to go over ice-cream.

As the party has to be virtual, we have instead uploaded the Spanish, Italian, French and English copies in PDF form of the Decapitation of Care, which can be accessed at this link.

Decapitation was published in the Spring of 2000 – it was a trailer for Shipwreck of the Singular.

You are welcome to download it and send to friends, family, or anyone you think might find it interesting.

La Decapitation del Ciudado
Una breve historia del auge y caída de la atención médica

Translated by Abel Novoa

La Sanità Decapitata

Breve storia dell’ascesa e del declino della cure mediche

Translated by Lara Merli

La Santé décapitée
Brève histoire de l’avènement et de la chute du système de soins

Translated by Ariane Denoyel and Bruno Harlé

The Decapitation of Care
A short history of the rise and fall of Healthcare

We will update you with links to El Naufragio when it pops out of the womb.  It has 4 parents waiting – Alex Oncina, Marc Casañas, Bill James and David Healy – not knowing quite what this birth has in store for them.

 

 

 

Escape from a Prescription Drug Maze

This post copies a letter sent to Michelle O’Neill and Jeffrey Donaldson, the leaders of the two largest parties in Northern Ireland.  It was sent with the letters to Eluned Morgan in Wales and Johnny Mercer in England featured here and on RxISK last week.  

The image is of Newgrange on the shortest day of the year – thought to be one of the most magical and hopeful symbols in Ireland.  Newgrange is right beside the Boyne River a symbol of Ireland’s deepest divisions. Some references have links not in the original letter.

Michelle O’Neill MLA                              Jeffrey Donaldson MP
Coalisland Sinn Fein Office                    The Old Town Hall
Coalisland                                                   Lisburn
Co Tyrone BT71 4LN                                Co Antrim BT27 4DH

August 15 2021

Dear Michelle O’Neill and Jeffrey Donaldson

Let me mention before proceeding that I briefly met Ms. O’Neill on Zoom a year ago, prior to a single meeting with members of Sinn Fein instigated by me hoping to alert them to health policy issues stemming from a 2019 inquest on Stephen O’Neill, an in-law of Ms. O’Neill’s.

I had been approached over a year prior to the inquest by Colleen Bell to offer expert input. I had no idea of Stephen’s background. Bell and O’Neill are surnames from both sides of the political divide. I would have agreed to help regardless of background in this case.

The inquest pointed to significant healthcare issues that affect all of the Western World, are getting worse, and may underpin some of the political divisions we now see linked to Covid.

My post-inquest meeting with Sinn Fein was aimed at drawing out the economic implications of issues such as the ghostwriting of the medical literature and lack of access to clinical trial data that are also leading to deaths like Stephen’s. Just so you and other readers are clear on what ghostwriting means – the academic names, even from the most distinguished institutions, on the authorship lines of medical articles about current drug treatments appearing in the most prestigious journals will not have written those articles or ever have seen the data underpinning them. The ghosts will not have seen the data either.

The NHS hinges on an assumption that effective treatments that save lives and get people back to work will pay for themselves. It cannot survive if flooded with treatments that cost lives and disable people – treatments typified by the sertraline that triggered Stephen’s problems.  (See Morgan vs Morgan: The Future of the NHS).

Your ability to bargain on the price of drugs hinges on pharma being able to claim the latest drug works fabulously and is free of risks.  Access to trial data levels this playing field.

Given that Sinn Fein had no prior involvement in setting up the features of the system now causing problems, they seemed less likely to be hamstrung by their past. It doesn’t, however, take much exposure to the system to become an insider.

Sinn Fein’s roots in the Irish Co-operative Movement offered a further reason to hope they might engage. The issues linked to Stephen’s death are neither Right nor Left issues.  They need politicians and activists to chart a path between Right and Left, as the co-operative movement once did, and AIDS activists did in the 1980s and 1990s.

Having made these points, my sense is that the DUP might have more libertarian leanings than Sinn Fein who perhaps are more authoritarian, and these leanings may play a greater part than anything else in how either of you receive this letter.

When my contact with Sinn Fein came to nothing, I reached out to Green parties also trying to chart a path between Right and Left, but whose health policies depend on technologies, which, no matter how innovative, seem at odds with their environmental policies.

This outreach led to a Politics of Care Forum, where my concerns are laid out. Two posts there – Can Politicians Save Us? and Can Politicians Save the World? – convey key points.

The Crack of Doom forum post has my correspondence with NICE, MHRA, the four Depts. of Health in the UK, the BMA, Brenda Hale and others, linked to Stephen’s inquest.  The only missing document is a May 2020 letter from Gillian Leng, the new CEO of NICE, to Ms. O’Neill. This letter confirms what I’ve been saying about NICE Guidelines being based on a ghost-written literature. Ms. Leng’s points about good practices are designed to distract.

Don’t let the silence surrounding the ghost writing of the medical literature and lack of access to trial data mislead you. Western Life Expectancies have been falling prior to Covid. A polypharmacy promoted by a ghostwritten literature that hypes the benefits and hides the harms, with no-one able to check the claims being made, plays a part in this.  We are also not meeting population replacement rates owing in part for the same reasons, and specifically to drugs like those Stephen was prescribed.

The silence means that problems about ghostwriting, building guidelines based on a ghostwritten literature, and the sequestration of trial data, are more embarrassing and awkward to those in a position to make a difference than the deteriorating global climate.

When it comes to climate change, nobody thinks swapping our car for a bicycle will make much difference. When it comes to the deteriorating climate in healthcare, many talk about reversing corporate influence but as with climate change no citizens can see a way to do this. My personal view is that it is doctors more than companies who are letting us down.

Healthcare, however, does offer a way for individuals to make a difference – standing our ground on treatment related adverse events.

Hold Your Own Inquest

The possibilities become clear if you consider inquests. Getting out the far side of one is more difficult than getting out of a Maze. Like cricket perhaps, the wider inquest system as it stands embodies an English idea of Fair-Play – eleven against one. Bereaved families would be better advised to hold their own inquests.

Statutory inquests mean:

  • Pitting decades worth of knowledge a family has of someone against a 10-minute slot a doctor has given him or her, and having your knowledge dismissed.
  • Pitting the possible bias of a family unwilling to think the worst of a child, or parent, against the undoubted bias of a doctor unwilling to contemplate their role in killing someone. The family ends up viewed as too biased to be believable.
  • Pitting an Evident transformation in someone seen by many people against Evidence consisting of a ghostwritten literature denying these transformations can happen – with no-one able to check this out, not you, nor any prescribers, nor MHRA. At inquest, the ‘Evidence’ counts for more than what is screamingly Evident.
  • Pitting a common-sense causality, that comes close to what the Federal Judicial Manuals in the US mandate as the way to establish causality in drug induced injury, an approach that doctors once took, and losing out to the view of a prescriber who today has no training in determining drug induced causality and is swamped by ‘Evidence’ telling him to avoid common sense.
  • Pitting what the company view in private might be against what they say in public about you and your family (see Healy to Morgan).

If you want to make the Statutory System work properly and advance public health:

  • You would have to enable coroners to finger a prescription drug as the obvious cause of a death, the way they can with a street drug.
  • You would have to work out a way to stop medical insurers blocking doctors like Dr Brannigan in the O’Neill inquest or Dr Adams in the Morgan inquest (Appendix 1), admitting a drug caused a problem.
  • You would have to provide guidance to inquest hearings that a ghostwritten literature with no access to trial data is not evidence that can be relied upon.
  • You would need to review the evidence admissible at inquests. In the O’Neill inquest, the coroner mistakenly refused to admit evidence from FDA reports of harms on the medicines Stephen was given. Regulators strip names off these reports making them hearsay, but the analysis presented to O’Neill inquest wasn’t hearsay.

You can overcome the coroner’s confusion in the O’Neill case by encouraging doctors and patients to submit reports to companies (rather than regulators) with both doctor and patient names attached so that these are no longer hearsay but more reliable evidence than the current company trial evidence. (See Can Doctors Save Us).   Ideally these reports is would also be lodged in a setting that can be accessed in the event of inquests and legal cases so that doctors and patients can be called as witnesses.  At present there is no point in doctors or patients reporting to MHRA.

  • You would need to educate coroners on the futility of sending regulation 28 reports to MHRA. Unless the regulator changes their spots, they have no role to play in public health other than their current role which is to regulate the wording of adverts. They don’t even regulate the claims made in the adverts parading as medical articles, which are ghostwritten and optimized to sell drugs rather than promote safety.
  • You would need to make clear that MHRA responses telling coroners and politicians, that in addition to warnings they depend on the clinical judgment of doctors, avails of the notion of a doctor as a Learned Intermediary. This notion made sense until 1990. Since then, medical learning about drugs and devices comes from a ghostwritten literature with no chance to check the claims against the data. It is no longer clear that doctor’s judgments are worth any more than salt that has lost its saltiness.
  • You would need to ensure doctors, and increasingly nurses and others who prescribe, have training in how to establish whether a treatment is causing a problem – none have any training in this basic skill at present.

As things stand every family who has a member whose death is linked to treatment in healthcare would be better off holding their own inquest rather than trying to escape a Maze, where everybody you might refer them to – NICE, MHRA, BMA, Legal Authorities – will whisper their agreement there is a problem but will say it’s not theirs to remedy.

As a woman who lost her 15-year-old daughter to a prescription drug said to June Raine of MHRA:

It would have been better if she had been murdered – that way I could face the perpetrator in court.

Beyond Inquests

The problems come to a dramatic head at an inquest. The same problems hold true for all adverse events on a drug. At least at inquests, if they are damming the dead with the deceased’s family present, doctors express sympathy. Raise an adverse event in their office where no-one can see them and you will often face frank hostility or ridicule.

Still there are possibilities for significant change, which you may sense from Tracey, whose story was recently posted on RxISK.org – What’s a Life Worth?

Tracey’s MP is Johnny Mercer whose resignation as a matter of honour a year ago had an effect in Northern Ireland. I’ve challenged him to pick up these issues – see Appendix 2.  As a matter of honour, tolerating deceit, indeed proven fraud, on the scale we now have without calling it out is surely not an option.

The Conservatives, like the Republicans in the US, seem to have turned to populism. This is not a bad thing. The treatment induced problems affecting Mr Mercer’s constituents offer a basis for populism 101, pitting forgotten men and women like Stephen and Tracey against an unthinking bureaucratic system.

I have also written to Eluned Morgan, the Welsh Labour Minister for Health, in response to the inadequate way the system, she has responsibility for, has operated in the wake of the death of Samuel Morgan, killed by an SSRI drug like Stephen (Appendix 1).

Labour in Britain and the Democrats in the US may be the biggest obstacle to the changes needed. They are still campaigning for access to drugs, not realising this is a primrose path to polypharmacy. They, and you, should be campaigning for the information that transforms chemicals into medicines, the absence of which is rapidly making prescription chemicals more dangerous that street chemicals.

With street chemicals our natural caution comes into play, no-one is going to tell us the drug didn’t harm us when we are injured, and coroners can register a street drug as a cause of death but cannot do the same for a prescription drug.

There is a wrinkle though in my hopes for action from Mr. Mercer. Women most often get put on and harmed by these drugs, but Army recruits and veterans are another badly affected group. The British Establishment has denied the risks to its troops from medical treatments, as vehemently as Mr. Mercer stone-walled Tracey. How far will his sense of duty to veterans take him?

The denial of risks starts with doxycycline, which may have initiated Stephen’s problems, followed by mefloquine (Lariam). These are used when troops are deployed to areas where malaria is common. Both commonly cause suicide – as in the horrific death of 19-year-old Amanda Cutland that featured on the front pages of most British newspapers 2 years ago. The coroner was shocked, but MHRA took the opportunity to hone their skills at denying the undeniable. (I can send you details).

Then there is sertraline, which made Stephen’s problems worse. This is dished out to Army veterans for PTSD. Neither the veterans getting it, nor the doctors dishing it out, will know that prior to its licensing for PTSD all four of the trials done were negative for men. There was a flicker of benefit for women in two of these trials – women who did not have the kind of condition soldiers have.

A previously senior FDA figure, Paul Leber, was drafted in by Pfizer to help get sertraline approved by FDA for PTSD, despite it not meeting criteria for approval.  Its licensing for PTSD gave rise to a prize exhibit in my argument that the clinical trial literature is now ghost written and there is no access to trial data.

In the slide below from 1999, TBD means To Be Determined.  The articles had already been written by ghosts. The Pfizer marketing department at this point needed to decide whose names, featured as authors, would sell the most sertraline (Zoloft).

Politicians

In raising these issues, one or both of you could do more to reduce deaths among British Army personnel than were ever linked to the Troubles and reduce the number of homicides of innocent civilians, of which at present there are likely a greater number triggered by SSRIs every year or so among Army personnel or veterans than might have happened at the hands of the Army in Northern Ireland.

It is the best and worst of times to raise these issues. No-one wants to shake confidence in the vaccine program.

The system, however, that enables Pfizer bring a pretty ineffective drug like sertraline on the market without scrutiny of the underlying data, and can let them ghost write out of existence hazards like sertraline induced suicides and homicides, triggered both by starting it and stopping it, is the system through which we now bring vaccines to market. Nothing has changed. If anything, we have a Maze that is more difficult to escape.

Many people are clearly conflicted. Their difficulties are characterized as stemming from ignorance rather than a sense that something is amiss, even though surveys that have nothing to do with vaccines show a waning of public trust in drug regulators and the bodies representing medical professionals.

There is a lot that is amiss. The greatest concentration of fake literature on earth centres on the medicines doctors give you and your family and friends.

Two decades ago, when I became aware of the problems outlined here, I contacted MHRA suggesting I should not be saying things as serious as this if they are wrong. I offered to meet them and stop saying what I was saying if persuaded of the error of my ways. We met. They didn’t contest a single point. Soon after, a crisis blew up about these drugs that led to Black Box Warnings, and billion-dollar fines, but not the changes the crisis called for.

At a House of Commons Select Committee in mid-crisis, I repeated the points on the record, while figures like Iain Chalmers of the Cochrane Collaboration and Richard Horton, editor of the Lancet, downplayed concerns without attempting to rebut them. Neither Cochrane nor the Lancet look particularly good now.

I repeat my MHRA offer. I am happy to engage with anyone you suggest might point out the mistakes in what I am saying. If no-one is willing to engage in public on these issues, and over twenty years no-one has, I think the onus is on one of you to take a lead within the United Kingdom and the European Community not on chemicals that have to cross borders but on information critical to the safety of your constituents that should be universal.

While not without risks, this is a time when a politician who can seize the moment could exert significant leverage. Whatever about Reconciliation, a Truth Commission is called for. If either of you rises to the moment, I would be happy to help regardless of political background.

Yours sincerely

David Healy MD FRCPsych

See Can Politicians Save Us and Can Politicians Save the World

Morgan vs Morgan: The Future of the NHS?

This post features in a series of posts on the Politics of Care Forum.  It sits alongside Can Politicians Save Us, Can Politicians Save the World as well as What’s a Life Worth, Once We Were Warriors and Do Not Forsake Me Oh My Doctor.  There will be a follow-up post next week.  

The letter below (without the images) was sent to Eluned Morgan, Minister for Mental Health in Wales a week ago.  It followed her response to a letter to her from Tania and Ian Morgan following an inquest on the death of their son Samuel in December 2020. 

August 9th 2021

Eluned Morgan AS/MS
Minister for Mental Health
Welsh Assembly Government
eluned.morgan@wales.gov.

Dear Ms. Morgan

I am writing after seeing your correspondence with Ian and Tania Morgan. Over 200 drugs can trigger suicide. If a family member of yours kills themselves (or others) as a result of one of these, what happened to the family of Samuel Morgan recently will happen you also.

There will be an inquest.

The doctor who prescribed for your son, daughter or parent may be asked to be present or to prepare a report.  S/he will check with their medical insurer beforehand. The insurer will advise against conceding the drug caused the problem. At the inquest or in their report, the doctor will say s/he can’t rule out the mental disorder being treated or the one that must have been there if the suicide happens after taking an antibiotic like doxycycline or isotretinoin given for acne.

Medical insurers in this case de facto shield the pharmaceutical industry rather than support a doctor to act in the best interest of the patient’s family at a moment that calls for humanity and courage. The barrister for Dr Adams, Samuel’s prescribing doctor, pushed for an outright suicide verdict rather than an open or narrative verdict.

Dr Adams seems to be a decent man. Samuel’s case was open and shut – citalopram caused his suicide.  There is no other reasonable explanation for what happened.

Dr Adams knows comparatively little about these drugs and almost nothing about Samuel, having met him perhaps only once for maybe 15 minutes. Samuel had a family and close girlfriend who knew him far better than Dr Adams could possibly ever have hoped to.

At his inquest, Samuel had input from an expert who probably knows more about these drugs than anyone else in Britain and vastly more than Dr Adams and the barrister speaking for him.

Coroners are unable to say the drug caused the suicide for two reasons.  First, there is no box on their forms for this that they can tick. Second, they are semi-obliged to go by what the doctor says – s/he after all is a medical professional and coroners aren’t.

The coroner may believe however that suicide is the wrong verdict and strictly speaking if a drug triggered the death, the death cannot be suicide.  In this case a coroner may return an Open Verdict, or Death by Misadventure, or a Narrative Verdict.  This often feels important to a family who welcome an escape from the stigma of suicide.

If it seems obvious to the coroner that a drug caused the death of someone like Samuel Morgan  or Alana Cutland whose inquest was held a year ago, who had been taking doxycycline (Appendix 1), s/he may report to the medicines’ regulator (the MHRA), as Mr. Philips did in this case and Mr. Osborne in the Cutland case.

A referral to a regulator sounds good to most people, and likely to you, but regulators are bureaucrats who never go out on a limb and say a drug has caused a problem.

  • The regulator will invariably tell the coroner in the case of antidepressants for instance they have done all they can to keep people safe. This is how MHRA responded in the Morgan case and right back to the first Welsh SSRI inquest report I did in 1999.
  • In the case of drugs like doxycycline, the regulator will say the evidence about harms is not conclusive enough to support warnings or that they don’t want to deter people from seeking treatment, as MHRA responded in the Cutland case – when every sane person looking at the case saw a horrific drug induced suicide in a 19-year-old woman.

MHRA

Even when informed close to explicitly by a coroner of a death that looks triggered by a drug, as in Cutland case, the regulator will not agree a drug has caused or can cause a problem.

MHRA are de facto incapable of deciding if a drug has caused a problem. They are also tangled up in a web that pharmaceutical companies have spun for them.

When doctors report a problem to regulators, the regulator removes the patient’s name (usually pleading a concern about confidentiality). Once this happens no-one can establish whether a drug has caused a problem.  Establishing whether a drug can cause a problem cannot be done without investigating in detail the case of the person who has been harmed. If the harm is death this means interviewing relatives.  MHRA have not investigated Samuel Morgan’s death.

The doctor’s view at an inquest that a drug did not cause the problem, or failure to say it did cause the problem, is a get-out-of-jail-free card for companies and regulators.  For most people, the view of a doctor who killed your family member trumps everything else.

Unlike regulators, when problems are reported on their drug pharmaceutical companies are legally obliged to investigate them. This usually means contacting the doctor who prescribed the drug and asking for the person’s medical records.

You may be surprised to know that even if the doctor has explicitly said a drug did not cause a problem, companies who work through a person’s medical records may decide their drug did cause it. This happens often in clinical trials but these conclusions are never reported in the up to 50 almost entirely ghostwritten articles that may appear in the clinical trial literature reporting the results of a single trial – articles on which NICE base their Guidelines.

How do companies come to conclusions like this?  They use common sense – the problem wasn’t there before the drug was given, emerges after the drug is started or when the dose is raised, and clears if there has been a chance to stop the drug.

But in public, at court cases or inquests, the company will continue to deny a link to their drug and say that unless a randomized clinical trial (RCT) shows the problem being caused by the drug there is no proper evidence that it has been.  No trials are ever done to look at a hazard and the data from the trials that are done remain inaccessible.

This speaks to the web that companies have trapped regulators in.  Companies have persuaded regulators that RCTs offer gold standard evidence on what drugs do but also that a positive finding on an RCT means that the benefit-risk ratio for a drug is favourable and that warning about risks might deter people from getting that benefit.

Regulators appear incapable or unwilling to see the flaws in this argument, perhaps because it offers them a box to tick – an alibi in the event of a scandal.

RCTs can only properly investigate one of the more than 100 effects a drug has.  The effect chosen is called the primary endpoint. Most people assume this is the commonest effect of the drug and other events are rare or happen if you have been the drug for a long time. This view underpins the risk-benefit argument above.

In company trials, the primary endpoint is an effect of commercial interest rather than the most common effect.  In the case of SSRIs, the commonest effect is on sexual functioning. Sexual effects happen in pretty well everyone who takes these drugs, within 30 minutes of a first dose, whereas a convincing mood effect can take months to appear and is less common.  Because trials are designed to focus on primary endpoints, these sexual effects of SSRIs are missed – even though companies knew they were happening from healthy volunteer trials.

In terms of risk-benefit, when companies and regulators talk about a benefit against which risks can be set, in the case of SSRIs they mean a change on depression rating scale scores. There is a minimal difference between SSRI and placebo rating scale changes that perhaps means these drugs offer a ‘X’ in the case of one person in ten who takes them.

What does offer an ‘X’ mean.  No-one knows. X is a rating scale score. It does not mean get back to work or general functioning.  It does not mean lives saved; more lives are lost on SSRIs than on placebo.

These drugs are now taken by roughly one in six people in Wales – not because X is a benefit but because they cause dependence and people can’t get off them. Some may think the drugs are saving their lives because they feel so bad when they miss a dose and feel so much better if they get their pills again.

In the case of women, any X there might be is likely to be wiped out by the fact they cannot function sexually, and their libido vanishes. Up to a quarter of couples in some Welsh towns are likely not making love the way they might wish.

There has been a good deal of talk about miscarriages in the UK media lately. If a woman gets pregnant, while on an SSRI, her risk of a miscarriage is doubled. If she gives birth, the risk of a birth defect is doubled, as is the risk of her child will have behavioural problems. This is all likely contributing to Welsh birth rates falling below the replacement rate.

The idea that these drugs have a positive risk-benefit balance that warrants not warning properly about their hazards is ludicrous regulatory humbug.

Warnings

Your letter to the Morgan family notes the increased risk of suicide in mental illness.  Samuel Morgan was not at an increased risk of suicide from any condition he had, if he had any at all. Minor nervous conditions may even protect against suicide (Appendix 2). The suicide rate in the most severe mental illness was close to zero before the introduction of psychotropic medicines in 1955 (Appendix 3).

As you should know because of studies conducted in Wales, healthy volunteers can become suicidal, engage in suicidal acts, or commit suicide linked to their intake of these drugs. I’ve invited Vaughan Gething and Frank Atherton to look into this, but it looks like neither has or, perhaps just not passed the information on to whoever wrote the letter in your name.

Another factor in Samuel’s case is that in the United States these drugs come with a Black Box Warning.  Why a warning, you might ask, when regulators and companies do not want to deter people from seeking treatment?

This is not a matter of Black Box Warnings being a thing we don’t do in Britain. The FDA took the step they did because there was no benefit to the drugs for those 25 years old and under – as Samuel was. The lack of benefit in this age group came to light after GlaxoSmithKline was charged with fraud for claiming paroxetine was effective and safe in minors, and later fined $3 billion. (Many of the paroxetine healthy volunteer studies prior to its launch were done in Wales).

Samuel was on citalopram which is equally ineffective in his age group. The first citalopram trial done in minors had one of the highest suicidal act rates. Forrest Laboratories marketing it in the US were fined nearly $400 million.

But not even Black Box Warnings make it clear that these drugs can cause suicide in healthy volunteers. There is nothing in the UK or US labels of these drugs to tell doctors what to do if a drug is causing a problem. Instead of stopping treatment, they routinely double the dose, as Dr Adams would likely have done had an agitated Samuel come back to him.

I routinely tell people that MHRA don’t see study data. MHRA say they do. We can agree they see figures – from a selected set of company trials. In addition, in the case of Eluned Morgan’s file let’s say, MHRA will see figures from an EM file but are unaware there may be up to four alternate EM files differing in length by several hundred pages in some cases (See Children of the Cure).

If someone dies in a trial or has to go to hospital because of an adverse event, companies must fill out a serious adverse event form. Or once had to. They have discovered that if investigators decide a person dropped out of the drug or vaccine study because s/he had an intercurrent illness, no report is needed.

In one paroxetine study (Study 329), four teenagers dropped out with intercurrent illness, all taking paroxetine. One of these, a 15-year-old boy, was arrested by police for brandishing a gun in a public place threatening to shoot people. He was taken to hospital. This was likely a serious paroxetine adverse event, but GSK gave him an intercurrent illness and didn’t fill any paperwork. MHRA have no idea what happened here or to the others with intercurrent illness. Access to the data really means being able to investigate what happened – that is have access to the people in a trial. MHRA have access to NONE of the data from any study they review.

There is a link between this 15-year-old boy and Samuel. There have been 45 antidepressant RCTs in supposedly depressed minors – all 45 negative, but many written up as positive. This is the greatest concentration of negative trials ever. Yet antidepressants now appear to be the second most commonly taken drugs by teenage girls and their use is fast growing.

This isn’t just a matter of doctors inappropriately pushing these drugs. Greta Thunberg’s generation have transformed our awareness of the chemicals being pumped into the environment, but they are pumping more chemicals into themselves than any previous generation. Samuel was a case in point. He pressed Dr Adams to prescribe, as do an increasing number of young people you know.  Laying on therapy is not the answer because therapists routinely pressure people to get on meds.

Politics

While deferring to MHRA or NICE might look appealing, most people in Wales reading this will spot the irrelevance of MHRA, NICE, BMA or BMJ.  They:

  • Will be able to understand the issues and see the need for political input.
  • Will be horrified that MHRA, medical insurers, and the coronial system de facto prioritize the health of the pharmaceutical industry over the health of our families and friends.
  • Will be aghast at the idea that where drugs are concerned NICE guidelines are based primarily on a ghostwritten literature.
  • Will be amazed that coroners can’t tick a box to indicate a drug may have played a part in a death and there is no register of drugs people were on at the time of their death.
  • Will be puzzled that David Healy can continue saying these things with all the above bodies quietly agreeing with what he says, but no-one doing anything about it.

The National Health System (NHS) came from Wales. It hinged on the idea that effective treatments could be delivered for free paid for from the money saved by reducing premature mortality and disability. It cannot survive delivering ineffective and dangerous treatments.

The first mental health RCTs were done in Wales. Evidence Based Medicine was born in Cardiff. How would Linford Rees, Michael Shepherd and Archie Cochrane view the situation you now preside over?

Healthcare was once the badge of honour for progressive politicians. But the Labour party now plays into pharmaceutical company hands. It champions universal health coverage rather than universal healthcare and nowhere does this show more than with the SSRI group of drugs and what happens as a consequence to people like Samuel Morgan. Labour’s healthcare policies went out of date around 1990 when the SSRI drugs came on stream.

A year ago, the Conservative MP, Johnny Mercer, resigned from the Cabinet on a point of principle. You and I may not agree with the principle, but we can respect his view that it was a matter of honour for him. I mention Mr Mercer, as, triggered by one of his constituents, I have presented him with the same gauntlet I now present you.  See What’s a Life Worth?

It’s difficult to believe there isn’t a matter of honour here for you. Can you really tolerate a total lack of access to study data and an almost complete ghostwriting of the medical literature in respect of on-patent drugs with NICE, MHRA, BMA, BMJ all saying it’s not their problem?

I will post my letters to Mr. Mercer and to you online next week. I enclose a series of links to posts that include the prior correspondence to NICE, Welsh Government and others and you are welcome to show this letter to anyone you wish to show it to.

Yours Sincerely

David Healy MD FRCPsych

Can Politicians Save Us

Can Politicians Save the World

Crack of Doom

Revolution from Below: politics of care

 

There is an important post on RxISK – What’s a Life Worth?

Its author, Tracey G, like Violetta in La Traviata would not describe herself as having led a perfect life.

La Traviata is one of the all-time great operas and in Zeffirelli’s movie, with Teresa Statas, is beyond compelling – especially when Alfredo’s father steps in to castigate him for his dishonourable treatment of Violetta.   See Here.

“A man who offends a woman is worthy of contempt even if at the time he is prey to a blind fury” 

Honour still counted for something in 1852 when Alexandre Dumas wrote  La Dame aux Camélias from which La Traviata comes.  

In the light of the two posts Can Politicians Save Us and Can Politicians Save the World, Tracey’s post is eerily timely.  It has triggered three letter to politicians – one of which you’ll be able to spot in her post and two more.

The posts to come throw down a gauntlet to thee political parties.  Tune in here and on RxISK next week if you want to see whether honour still counts for politicians today.

Virtual Book Signings and Book Clubs? 

The Covid pandemic has been an extraordinary medical event on two levels.  On one level there is the disease with the host of issues linked to it from genetic susceptibility to controversial therapeutics.

There is a second political level also. The readers of posts here or on RxISK are likely keenly aware of this. Our hunch is that you are neither extreme vaccine mandators or anti-vaxx but if neither of these you likely are bewildered at the difficulty in finding a middle ground that should exist for discussing such an extraordinary event.

See Shifting Vaccine Confidence and Neo-Culturalism.

Covid and Samizdat were born at almost exactly the same time. The need that called Samizdat into being was a need to find a middle ground where health discussions could be had.  A middle ground that seemed to be vanishing in front of our eyes – before Covid.  A middle ground that likely most people with any interest in the complexities that medicines throw up would feel is essential to working out how to move forward.  A middle ground that gets lost in crises – or whose loss leads to crises.

Anyone reading this who writes likely attempts to reach this middle ground.  You may be finding it increasingly difficult to get published or heard. If you are, Samizdat may be a home for you. We have now published 6 books:

Jim Gottstein’s The Zyprexa Papers. In true Samizdat spirit this marries the consequences of company choices to individual lives and challenges readers to recognize the value of lives squashed, unnoticed, under passing company or political caravans.

Paul John Scott’s Malcharist gives an unparalleled account of what actually happens at medical conferences and what can start to happen to anyone who notices. There are likely many readers of these newsletters and posts who could write something comparable about where the corpses are.

Patrick Hahn’s Prescription for Sorrow focuses on antidepressants, the most confusing group of drugs we have.  Greta Thunberg’s generation are out on the streets protesting the dumping of chemicals into the environment, while swallowing more chemicals than any previous generation – especially antidepressants. What is going on.

David Healy’s Shipwreck of the Singular and with Joanna Le Noury and Julie Wood Children of the Cure offer an overview of a dysfunctional healthcare universe.  The Politics of Care Forum on this blog attempts to build on this and can do with your input.

Gottstein, Scott, Hahn and Healy can Zoom into book club or other meetings that pick up any of these books.

We can also send up virtual signings – signing whichever book you buy through the Samizdat platform or from us directly and posting it on to you.  You can contact us all through david.healy@rxisk.org.  In terms of book club or similar meetings we can come to arrangements for bulk buys.

Gottstein, Scott, Hahn and Healy also would love to welcome you to the Samizdat Writers Co-operative.  The more of us promoting each others work, the better the chance of creating a middle ground and becoming a force to be reckoned with.

 

 

 

 

Can Politicians Save the World?

This is part two of Can Politicians Save US.  Both are part of the Politics of Care forum. It would be great if you could print off these two posts and send to your local politician, asking what they figure on doing about some of these points.

Nine

Point Six in Can Politicians Save Us, mentions an Arms race and compared Drugs and Guns.  But there are important differences between Drugs and Guns. With Guns, successive weapon systems trumped older ones because they were demonstrably more effective than what had gone before.  This is not true of Drugs.

In the case of Drugs, it is the appearances of efficacy that trumps what has gone before. Unlike Guns, the latest Drug need not be better than the last Drug.  Drugs are almost unique among modern technologies – Guns, Autos, Phones, Computers – in often being less effective and less safe than what has gone before.

A Drug is a Chemical plus Information that tells us how to use this chemical effectively and safely.  The Chemicals were always dangerous and are not getting any safer.

Before the Fall of the Berlin Wall, the Information was largely accurate but now the greatest concentration of Fake Literature centres on the drugs our doctors give us.

In 1962, Pharmaceutical Companies were gifted a gadget that transforms poisons into sacraments and junk into life-saving remedies – the gadget is called a Randomized Controlled Trial (RCT).

RCTs are spun as offering Gold Standard Knowledge about Drugs but they are not knowledge.  They are an algorithm put in place to help evaluate one, and one only, of the several thousand effects every drug has. To evaluate an effect in which some company has a commercial interest.

This money-tree effect may not be the commonest effect of a drug.  In the case of SSRI antidepressants, numb genitals is the commonest effect.  A mood benefit is pretty rare in comparison.  But because RCTs hypnotize investigators to look at mood effects only, in SSRI trials they completely missed the numb genitals.

See The Fault Lies in Our Stars, Fawlty Stars and Does My Bias look Big in This.

Now, as outlined in Can Politicians Save Us, point 6,  we have falling Replacement Rates in most Western countries.

RCTs transform Poisons into Sacraments.  Sacraments offer Efficacy without Safety issues – although even the Vatican now supports Gluten-free Eucharists.

RCTs Greenwash Chemicals.

Combining RCTs in the Guidelines of Evidence Based Medicine (EBM) locks everyone in healthcare into a cage the way GDP locks politicians into an economic cage.  GDP reflects activity of a certain kind rather than activity we necessarily value.  The activity includes cleaning up after the Exxon Valdez oil spill but doesn’t include pristine, plastic or oil free oceans.

In the same way the Drug Wrecks that come from administering Poisons with gay abandon, thinking they are Sacraments, has made treating the consequences of our treatments the leading form of health service activity.

If you are desperate for a metric – create one that flags up the proportion of health service activity that stems from treatment induced injury and death. This may now be as much as 50% of all activity, stemming especially from treatments supposed to be ‘preventive’ that companies market as reducing health costs.

Ten

Point Six in Can Politicians Save Us, and Nine above, mention an Arms race and compare Drugs and Guns.  With Guns, successive weapon systems trumped older ones because they were demonstrably more effective than what had gone before.  This is not true of Drugs.

In the case of drugs its the Propaganda Techniques not the Pharmaceutical Technologies that persuade people to buy.  There is no access to the data on drugs that shows how efficacious they actually are or how safe. The claims about what they do and don’t do are written up by ghostwriters.

Biden has just been blaming Facebook and Social Media platforms for vaccine misinformation.  While the New England Journal of Medicine and JAMA and other leading journals are stuffed full of ghostwritten articles about on-patent medicines, articles that in some cases have been proven outright fraudulent and perhaps are all to some extent fraudulent, with the journals saying its not their job to guarantee the integrity of the data, without Joe mentioning this, its difficult to know what to call him – naïve or hypocritical or what – part of the Deep State perhaps?

The greatest concentration of Fake News on earth centres on the drugs our doctors give us.

TBD in the slide above means To Be Determined.  The document from which this slide comes was prepared in 1999. The articles on Zoloft studies for NEJM and JAMA had already been written by the ghostwriters – along with dozens of others.  Zoloft was being sold for PTSD for which it was ineffective and unsafe, likely leading to the suicide of many US Veterans.

After the articles are written, pharmaceutical company marketing departments let the ghosts know which academic and clinical names are best suited to go on the authorship line. Best suited means who will be the best advocates for the drug.

Pfizer in this case had been advised by Paul Leber, ex-head of the CNS division of FDA, on how to get Zoloft which was ineffective, approved by FDA for PTSD, a condition Leber didn’t think was a real condition.

In response to a HealthCare rapidly deteriorating into health services, when things go wrong we are told that this is a problem of doctors not keeping to Guidelines.  Its just the opposite. Doctors and increasingly nurses keep to the Guidelines more than ever before – because prescribers now get sacked if they stray from them.

Keeping to Guidelines cannot give us better Care if these are based on junk designed to sell the latest product with no regard as to whether the product is more effective or safer or better value for money.  The Guidelines for PTSD endorsed the use of SSRIs like Zoloft.

Eleven

Require universities to tackle their academics who let their names be put on ghostwritten medical articles without having access to and without being able to share the full study data with other doctors and academics and ideally the wider public.

At present Guideline Makers, Regulators, Journals, Politicians, Medical Associations all say it is not their business to police the medical literature.  Facebook operates to a much higher publishing standard than Medical Journals.

Anyone who wants to know more should read Paul John Scott’s all too real account of exactly what goes on.  Whichever country you are in you can substitute in the names of many of the most prominent medical academics such as Siegfried Kasper, Professor of Psychiatry in Vienna.  We are told we can trust these academics because they have over 1000 articles to their names.

Twelve

Behind this Fake Literature, there is an even deeper problem.  There is no access to the data from clinical trials.  No-one gets to see this.  Remember drugs are not chemicals – they are chemicals that come with information about their use.  Significant amounts of the information we get are fraudulent but in the absence of access to the data, this cannot be exposed.

  • Regulators don’t see the data,
  • Guideline Makers don’t see the data,
  • The ‘Authors’ of papers reporting study results don’t see the data,
  • The Ghosts who really write the papers don’t the data,
  • The Doctor who might be treating you or your family hasn’t seen the data,
  • If you are injured by a drug and want to find out more, you could not see the data even if you were Prime Minister, Chancellor or President.

The correspondence with regulators, Guideline Makers, Politicians, Medical Societies and others, supporting these claims is laid out in From Stephen O’Neill to the Crack of Doom.

When raising this problem with all these bodies I made it clear that it is not their job to police the medical literature.  They now all parrot this response.

See Access to Clinical Trial Data, property rights, privacy rights and phoney rights 

In honour of and Harvard/Boston where ghostwriting has been endemic and there is an understanding that no data will be asked for, a policy supported by successive Deans of Medicine like Jeff Flier, who presided over an orgy of shoddy links between a university and industry – see tweet in a series about ghostwriting and Harvard since deleted –

And the New England Journal of Medicine, who in 2009, made it clear they didn’t feel it was the journal’s responsibility to have check on the integrity of clinical trial data – see Philip Fine’s article HERE

Perhaps, its time for a Revolution or at least a Tea Party with the catchphrase:

No Prescription without Representation. 

Thirteen

Change the consent forms for clinical trials.

Consent Forms began life in 1962 informing you that you were participating in research – you were often participating without knowing it before that.

Companies have since inserted phrasing telling us they will show our data to no-one. Reassured, we sign.

Companies now use these forms to block access to our data. There is no ethical, legal and in particular no scientific basis to refuse access – see Good Science or Good Business.

Our Signatures now put our families, friends and communities in a state of Legal Jeopardy – See Clinical Trials and Legal Jeopardy.

The data, which does not belong to companies, is being hidden for commercial reasons not out of any concern for the privacy of anyone who enters a trial.

There can be no argument about getting access to the data from premarketing healthy volunteer trials of drugs.  These are run before drugs come on the market and in the case of the antidepressants revealed the suicidality, homicidality and permanent sexual dysfunction these drugs can cause.  After marketing companies denied completely that these hazards exist and it took 15 years to get warnings about suicidality and we still don’t have the appropriate warnings about sexual function.

There are no issues of clinical confidentiality here.  These are the trials that show what drugs are really causing – that allows pharmaceutical companies to game their later clinical trials in patients, where everything can be blamed on the illness being treated.

This is what an original consent form looked like.

Fourteen

It may take political support for Doctors to screw up the courage to ask companies for clinical trial data on a drug they are proposing to give you or your family.  See Can Doctors Save Their Jobs and the World.

It may take political support for Doctors to screw up the courage to refuse to use guidelines – like the NICE Guidelines – that are not based on data – See The Nice Before Christmas.

If they are unwilling to do this, then doctors are like salt that have lost their saltiness – useless.

Like the Greek Women in Aristophanes drama Lysistrata, who stopped a war and the killing of Greeks by Greeks by refusing to make love to their men, so also pharmaceutical companies need doctors more than doctors need them.

Make it possible for doctors to refuse to tango with Pharma while they continue to kill and maim so many of your voters because they lack a backbone.  Get them to do their job and your job will be done.

Remember No Prescription without Representation – or perhaps that should be We will not be Dicktated To.

Fifteen

Mobilise us, your voters, at risk of being killed or maimed when we visit our doctors, to ask if our doctor has access to the data on the drug they are proposing to prescribe to us. Empower us to declare a preference for being given medicines whose data is accessible -there will always be older, better and less expensive drugs that can be used.

See If you are going to Treat Patients, Man Up  and Scaremongers of the World Unite.

Sixteen

Require doctors to report adverse events their patients suffer on treatment to pharmaceutical companies leaving the doctor’s name on these events and indicating a willingness to be cross-examined about the event. At present doctors only report 1 in 100 serious adverse events, primarily to regulators, and do not expect to be interrogated about these. This will call for medical courage.

Reporting to companies is important because companies are under a legal obligation to investigate the event and decide if their drug caused it.  Companies are busy trying to get doctors and others to report to regulators who have no legal obligation to investigate and never link a drug to a problem.

Regulators never investigate because they strip away the names of doctors and patients and this immediately makes the reports worthless to us but gold-dust to industry.

Consider closing down the regulatory reporting systems run by FDA, EMA, MHRA and others – they are a waste of time. Some countries have pharmacovigilance systems that are independent of regulators and companies – strengthen these.

Companies are availing of an opportunity that opened up 420 years ago with the execution of Walter Raleigh.  Raleigh was executed on the basis of testimony circulating about him outside of his trial.  His detractors were not brought into court to be cross-examined.  The injustice of this was recognized after his death and Hearsay was no longer accepted as evidence.

When regulators strip our names away – claiming confidentiality concerns – they transform our evidence into Hearsay or Anecdotes.  But if our names remain on the reports and we and/or our doctors indicate a willingness to be cross-examined about what happened we may be able to help someone who is injured in the way we were or killed in the way one of our family was.

Encourage us, as the takers of a medicine, to report adverse events to companies and leave our names on the event. Remove our names and they are worthless to everyone except industry for whom this information is gold-dust – helping them to manage any debate about treatment hazards.

Without out names, we become Invisible and worse again add to the dangerous myth that RCTs give the best view of what drugs do – when even companies acknowledge that cross-examination does.

With our names present, we fracture a consensus that company propaganda aims at building about what drugs do and don’t do.  Even Emperors can be put in their place by just one of us – even a young girl – speaking up.

Seventeen

Reform the coronial system, so coroners record in an accessible archive the drugs people are on at the time of death. This doesn’t happen now. After Age, when people die from Covid, vaccines or anything, the number of medicines they are is the greatest predictor of death but no one collects the details of the drugs they were on.  Some are likely more dangerous with age or in medical emergencies than others.

Enable coroners to indicate that a prescription drug may have contributed materially to a death. They can’t at present. See Spotlight on the Suicides, The Coroner.

Advised by Medical Insurers, Doctors routinely betray us at Inquests.  You will have to stop insurers advising doctors against stating that in their opinion a drug, prescribed in good faith, has killed their patient.

At inquests, at present, medical insurers de facto act in the interest of pharmaceutical companies rather than patients who have been killed by treatment.

You may have to limit the liability of doctors in order to embolden them to take a step that as a matter of honour they owe us but at present shirk. See Can Doctors Save Us.

Eighteen

The Access to Medicines campaign that secured access to Triple Therapy for HIV infections was one of our greatest ever moral and political triumphs within the health domain.

But current Access to Medicines campaigns increase polypharmacy and benefit industry rather than us. While reform of the patent system may help with this, it may not be the best option.  An alternate approach would refuse to buy any new drug without access to the full trial data.

Universal HealthCare used to be a goal of progressive politics but it is rapidly coming to mean Universal Health Coverage, which for Pharma means that everyone has access to technical answers to health problems – as in the map above – and demand this as a right no matter what the cost.  If Access to Medicine campaigns didn’t exist, Pharma would have had to invent them.

There is no meaningful Access to a Medicine without access to the data – a medicine is a chemical plus the information that informs its use. Having accessed the data on harms the public could be asked how much is this drug worth?

Industry pitch drug prices at what the market is prepared to pay for Sacraments – and we can be persuaded to build Cathedrals for Sacraments, while all around starve.

This would change if we are asked to weigh up How Much This Poison is Worth.  Politicians are less likely to be viewed as rationing objects of desire to which we feel entitled if we are weighing up how much a Poison is worth.

Nineteen

In 1918,  just after a Communist Revolution had been put down in Germany with Rosa Luxembourg shot, attempting to marry the Left and Right, Max Weber gave a lecture On Politics.

In it he said that government consists of political leaders and bureaucrats.  The thing that distinguishes a Leader from a bureaucrat is that Leaders know there are times they have to act like Doctors and persuade their people to take their medicine.  In Weber’s day this meant swallow a poison from which both the Leader and the People hope Good can be brought.  He had no illusions that Leaders offer Sacraments.

For Weber a real Leader has a sophisticated mind in the sense that Scott Fitzgerald later defined this – a mind that has the ability to entertain two contradictory thoughts at the same time and still function.  This is what doctors could once do – but not any longer. Entertaining two contradictory thoughts at the same time is likely to be something that focus groups can’t manage with quite the same reliability as they assess soundbites

Twenty

Where’s Greta?

Greta Thunberg’s generation stands as possibly the greatest symbol of the extent to which politicians, the media and many of us don’t get what is going wrong in healthcare. And if we don’t understand this, can we understand what is going wrong in the world?

Greta mobilized hundreds of thousands of her generation to come out and protest about the environment.  A modern Joan of Arc.

But Greta’s generation is swallowing and demanding vastly more psychotropic and other drugs than any previous generation in history.  Not for them any worry about becoming Stepford Wives or having their Revolutionary Consciousness dulled by Drugs.

They go to the Gym, eat their Veggie Burgers perhaps delivered by Uber, and see each other as empowered when they swallow Zoloft and Ritalin.

These drugs are now the second most commonly taken drugs by teenage girls after contraceptives.  In the case of antidepressants like Zoloft, we have the greatest concentration of negative studies in human history – 45 out of 45 trials are negative – yet the consumption goes up and up.

In the case of these drugs, we also have the greatest known divide between what the academic literature says – the drugs work well and are safe – and what the data shows when accessed – the drugs don’t work and aren’t safe.

Any Leader who wants to save the World needs to do something about this. But this is not a moment for being seen to do things without understanding what is being done.

You have to avoid repeating JFK’s move on October 10 1962, which in response to the Thalidomide Crisis, effectively prioritized Efficacy over Safety, Technique over Judgment.  Kennedy was a White Heat of Technology dude.  Frances Kelsey kept Thalidomide – a drug proven to be Effective – off the US market on the basis of Safety.  The judgment calls of people like Kelsey were undone that day in October.

Can Politicians Save Us?

This is a post in the Politics of Care Forum. It lies in the sequence of posts about What You Can Do to Save the World, and What Doctors can Do to Save the World.  It will be followed by Can Politicians Save the World – it turned out there were just too many things to draw to politicians’ attention for one post.

One

We need to reign in Technique.  That means voting for politicians who understand why.

Technologies and techniques have brought us extraordinary benefits in health and wealth domains, but they are now also driving dangerous changes in the healthcare and global climates.

The dangers techniques pose cut across traditional divides between parties of the Left and Right. See The Deep NeoLiberal State. Our problems are not now with capitalism or socialism but with techniques.

We cannot Care for Health or the Environment, unless We the People regain control of our technologies and techniques.

This is not impossible. Greta Thunberg has helped mobilize a generation to tackle climate change.

In the 1970s and 1980s, Germans forced a pause in the development of nuclear energy.

There is now a growing awareness of Surveillance Capitalism and talk about the need to tackle the Internet Giants – see Why Silicon Valley can’t fix Itself.

The talk is mostly about the profits they make.  It shouldn’t be.  It should be more about the techniques they use and whether these – like SSRI antidepressants – have the potential to cause more harm than good.

As An Ugly Truth, a recent book on Facebook quotes:

So we connect more people. That can be bad if they make it negative. Maybe it costs someone a life by exposing someone to bullies. Maybe someone dies in a terrorist attack coordinated on our tools. And still we connect people. The ugly truth is that we believe in connecting people so deeply that anything that allows us to connect more people more often is de facto good.

This skips the money made out of connecting people. But even more important is that behind Facebook and related companies are a set of operant techniques that have the power to control vast swathes of our behaviour to a greater extent than anyone has ever been able to achieve before.  Even if those who increasingly control us are doing so for benign or even purposes they view as neutral, there is a problem here.

We have of course had Edward Snowden for some years and now we have Pegasus.

In all these areas we have made progress in grappling with the dangers of techniques but not in Health.  The Guardian and New York Times for instance who have helped break many of these stories have a blind spot when it comes to health – they are pro technique and technology.  There is no questioning of Progressive Health care policies, no feel for our collective Health blind spot.  Life expectancy was falling before Covid, and is falling even more so now. Population Replacement Rates are also falling. No-one is asking why.

If we have fewer people isn’t that good for the environment?

If video consults reduce petrol consumption isn’t that a good thing?

Two

A Physical Environment policy platform that does not recognize the parallel degradation within the Health Environment cannot succeed. There are many ways in which properly recognising what is going wrong in Health will add teeth to Environmental policies. Its time for Politicians concerned about Sustainability, concerned about our Future, to discover this.

There is a chance to create a message of hope and value rather than be painted as Luddite, Rationing or Anti-Progress but it needs an understanding of Health that few people – either those who complain about NeoLiberalism or those worried about Deep States – have.  See the Deep NeoLiberal State.

At present Green or Sustainable HealthCare policies are aggravating the problems we have in Health.  Green politicians appear to think the primary contribution they can make to Health is to clean up the environment and after that encourage innovative and evidence-based Health policies.  Innovation and Evidence Based are hazard markers – See The Controlled Healthcare Opposition  and The MedicoChemical and PetroChemical Twins.

Three

Ulrich Bech’s book Risk Society helped create the modern environmental movement and cement in people’s minds the hazards of the modern world.

Neither science, nor the politics in power, nor the mass media, nor business, nor the law, nor even the military are in a position to define or control risks rationally…. We are living in a world that is beyond controllability.

Shortly before Beck appeared on the scene though, the pharmaceutical industry had discovered our risky world and the marketing of risk has enabled them to increase the amount of drugs we take by over 2000 per cent and grow from a $20 billion industry to over $1.2 trillion and rising fast.

In 1980 few of us were on 1 drug per say.  Now over 40% of over 45s are on 3 drugs every day of the year and over 40% of over 65s are on 5 or more drugs every day of the year.

Within healthcare – poisons (medicines) are seen as the way to manage risks. This is sold to politicians as preventive medicine.

The Zeitgeist, or something, has helped turn what were viewed as poisons into sacraments (something that can only benefit) and an increasing number of us figure we need to take Daily Meds to handle Risks in the way we once sought out Daily Communion (Eucharist), or said prayers to Mecca.

Pharmaceuticalization and financialization are now the way we manage risks – and at the moment progressive and sustainable health policies are digging this hole deeper.

Four

Adverts like this are directed to politicians and managers.  The message – medicines like anti-hypertensives, bone thickening drugs, blood sugar reducing drugs, airway opening drugs, and drugs to reduce risky behaviours will reduce hospital admissions, making for lower costs, while at the same time being better for patients.

We now have more hospital admissions and disability caused by these drugs than we have from leaving untreated the notional risks they claim to manage.

The line in the advert here about drug prices only being 10 per cent of healthcare budgets fools policy-makers, insurers, the public and their politicians.  Ten per cent of a $4 trillion budget in the United States is $400 billion.  If these drugs worked, their cost would be a greater percentage of a falling budget.

We are now paying not just for the drugs, but also for the screeners whose job it is to detect risk, and the auditors and managers you need to put in place because something is going wrong with hospital admissions and escalating costs and you don’t know what. Governments and insurance premiums are paying for the salesforce for the drug – pharma don’t need to send drug reps around any more.  Or even take docs out for meals.

An increasing chunk of the $3.6 trillion in the US is going on healthcare staff who are selling the drugs.

Another chunk goes on the increased admissions the drugs that are supposed to be reducing costs cause and the difficulties in effectively remedying spiral fractures of the femur caused by bone-thickcning drugs, dementia caused by hypoglycemics, rhabdomylosis caused by statins, or the mental instabilities caused by psychotropics.

Five

The amount of medicines in us is rising faster than CO2 levels are rising in the atmosphere or the amount of guns circulating in the United States.

Doctors are dishing these risk management meds out with a liberality the National Rifles Association can only envy – and they are causing more death and disability than guns are.  Doctors are following a line from Donald Trump – the answer to risks is to have a good guy with a gun outside every school.  They go one step further and are arming every school-child with a set of drugs.

Ask any doctor you know and medical authorities why there are no Guidelines for People, the first element of which would be a recognition that medication burdens should be contained?  See What Doctors Can Do To Save the World.

If they agree Guidelines for People should take precedence over Guidelines for Diseases, which push doctors to prescribe more drugs, ask what plans there are to make this happen – or is it a matter of keeping the beaches open for the tourist season?

Six

A little over a decade ago, Deprescribing came on the radar. A paper by Garfinkel and Mangin indicated that reducing medication burden from 10 or more drugs especially in older patients to 5 or less can reduce hospitalizations, improve quality of life, and extend life expectancy.

More important than saving money and helping people feel better, Deprescribing has the potential to bring home the role of technique.

Deprescribing exposes the Nuclear Bomb problem at the heart of all techniques.

As with armaments, drugs produce an arms race.  The side with the most effective weapons wins so there is no option but to compete.  And weapons get more and more effective until we get to the Nuclear Bomb which is too effective to use.

Efficacy has its limits.  And just as we can have bombs too effective to use, so we cannot now use all our drugs.  Effectiveness starts falling off once we go above 3 drugs per day.

Getting the maximum bang for our buck means deprescribing.  This is not a matter of rationing, its a matter of sustainability.  And there is no place for an algorithm in sustaining what each of us might want sustaining.

This is not just a matter of overall efficacy.  Its also clear that having too many guns around and letting them leak into places they shouldn’t be in, even if we have a good guy with a gun outside every school, is not effective in the sense of achieving what we want from guns which for the most part is Safety.

Seven

Targets are a bad idea.  But if we can set a target for temperature rise, lets also Target:

  • Turning around current falls in Life Expectancy.
  • Stabilizing our Falling Replacement Rates

Re Life Expectancy, as this graph in the Wall Street Journal shows, with Covid we now have a dramatic fall in Life Expectancy.

Look not just at the red bar for 2020 but the ten years before that when life expectancy had been falling each year compared with ten years before that.  The only comparable time this happened was in the 1950s and 1960s when the falling life expectancy was also put down to drugs – in this case tobacco.

 

The single easiest way to turn this trend around will be to deprescribe.  There are now 3 studies looking at factors linked to Covid deaths and in all three the quantity of medication the person was on before they got ill has been a factor in their deaths – Dennis the Menace gets Covid.

Re Replacement Rates:

Across the Western World, roughly 15% of us take antidepressants.  These affect the way every single one of us who takes them makes love, in most cases abolishing our ability and/or desire to do so, which of course affects another 15% of the population.  This is increasingly a young person’s problems – not an old folks one.

(The BMJ article here blames depression but the kind of depression they are talking about increases sexual activity rather than reduces it and just as with the issue of Drugs and increased likelihood of death on Covid, journals are not happy to link any problems to the sacraments we are taking even when the problem is as obvious as genital numbing within the first 30 minutes after taking an antidepressant).

Given the uneven distribution of these drugs, it is quite likely there are areas of most countries where 20-30% of the population are not making love.  At the moment, this is more a matter for white folk than for any other ethnic group.

If a woman does conceive, while on treatment, the meds double the rate of miscarriages, increase rates of voluntary terminations, double the rate of birth defects and double the rate of children who will have behavioural problems like autistic spectrum disorders.  A recent estimate suggests a looming bill of over $5 trillion.

Eight

Drug regulation was based on Safety until 1962.  A 1938 Safety Act in the United States kept thalidomide off the market there.

The Thalidomide tragedy triggered a change.  Companies were required to prove the Efficacy of their drugs.  This was supposed to contribute to Safety but this focus has given us weaker and weaker drugs with their hazards concealed – drugs are much less Safe now than they were in 1962.

Restoring the Primacy of Safety must be something for the first 100 days of office of any incoming administration that aims at Sustainable Healthcare.

In 1962, medicine was the scene of one of the strangest twists in human history.  As of 1962, only one drug had ever been through a placebo and randomized controlled trial (RCT) before being brought on the market, in which it had been shown to be efficacious and safe – the test we now have in place to stop Thalidomide happening again.

That drug was Thalidomide.

 

 

The Deep NeoLiberal State

Care Homes placed a spotlight on private enterprise, greed, and short-termism in ‘Care’ Homes.  The data cited on deaths in Canadian Long-Term Care (LTC) facilities look better for public or voluntary provision than for private provision.

The apparent differences between the figures, however, might really mean that public and voluntary are grim with private provision even grimmer rather than one is inherently good and the other bad, particularly if both increasingly operate the same way even if it is for different reasons.

Both academic and lay accounts of what is going on in the care sector, particularly dealing with Covid linked care home deaths in facilities run by mega-companies, invariably mention neo-liberalism, asset stripping, outsourcing, and auditing as though these are all features of private enterprise.

Not so in between the lines, we are being told we need a rethink private enterprise.

For two centuries, however, risk averse governments putting money into things have been more insistent on auditing and evaluating the results they are getting than risk taking entrepreneurs who were more likely to just take a gamble. And the personal touch has generally been thought to be more likely in a private enterprise than a public one.

While the Left see the problem as neoliberalism, entrepreneurs and the Right see the problem as socialism, bureaucracy, or a Deep State getting in the way.

Blaming Neoliberalism and the Deep State are too easy when either no-one can nail down what either of these are, or everyone has their own idea.

This post is part of the Politics of Care Forum.  A version of this and the following two posts was posted last week on the website of the Institute of Art and Ideas News under the title How Modern Medicine Became Dangerous, where the Care theme is more obvious

Deep Neoliberal States

It is an absolute article of faith on the Left that Reagan and Thatcher ushered in neoliberalism – even though few on the Left can define it – other than to vaguely intimate the world is going badly wrong and this started in the 1980s and is an Anglo-American thing.  And of course Reagan and Thatcher endorsed Milton Friedman and Chicago School talk about Free Markets, and ultimately Friedrich Hayek and The Road to Sefdom.

This iconic image of Reagan and Thatcher featured right at the start of a Guardian article on Neoliberalism, the ideology at the root of all our problems by George Monbiot, one of Britain’s most prominent Green campaigners.  George has done a great deal of good on very many fronts. He was early drawing attention to the dangers of Sense about Science and the Science Media Centre.

The article was written in 2016.  By then, it had become almost impossible to suggest this view might not be entirely correct.

Just as it is difficult to distinguish Neoliberalism from the Deep State, so also it is difficult to distinguish either or both from Technocracy.

In this sense, the first mention of a new problem came from Dwight Eisenhower on January 17 1961, when he referred to a military-industrial and scientific-technological complex. The key excerpts are here but the whole is worth reading.

A vital element in keeping the peace is our military establishment… Our military organization today bears little relation to that known by any of my predecessors in peacetime…

Until the latest of our world conflicts, the United States had no armaments industry. American makers of plowshares could, with time and as required, make swords as well. But now we can no longer risk emergency improvisation of national defense; we have been compelled to create a permanent armaments industry of vast proportions. Added to this, three and a half million men and women are directly engaged in the defense establishment. We annually spend on military security more than the net income of all United States corporations.

This conjunction of an immense military establishment and a large arms industry is new in the American experience. The total influence — economic, political, even spiritual — is felt in every city, every State house, every office of the Federal government. We recognize the imperative need for this development. Yet we must not fail to comprehend its grave implications…

In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military-industrial complex. The potential for the disastrous rise of misplaced power exists and will persist.

We must never let the weight of this combination endanger our liberties or democratic processes… Only an alert and knowledgeable citizenry can compel the proper meshing of the huge industrial and military machinery of defense with our peaceful methods and goals, so that security and liberty may prosper together.

Akin to, and largely responsible for the sweeping changes in our industrial-military posture, has been the technological revolution during recent decades.

In this revolution, research has become central; it also becomes more formalized, complex, and costly. A steadily increasing share is conducted for, by, or at the direction of, the Federal government.

… the free university, historically the fountainhead of free ideas and scientific discovery, has experienced a revolution in the conduct of research. Partly because of the huge costs involved, a government contract becomes virtually a substitute for intellectual curiosity. For every old blackboard there are now hundreds of new electronic computers.

The prospect of domination of the nation’s scholars by Federal employment, project allocations, and the power of money is ever present and is gravely to be regarded. Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientific-technological elite…

Equally compelling is a letter Eisenhower sent two years earlier to a dying Veteran, Robert Biggs, where he stresses that what is essential for a successful military operation cannot be the basis for a Free Society – Eisenhower to Biggs.

The Military

Eisenhower’s mention of a military being conjured up almost out of thin air just before World War II will surprise many.

As part of this conjuring act, we got military technology like never before culminating in the Atomic Bomb.

Less well known was the military turn to Cybernetics and the support of Cybernetics after the War.  Computers would be the future of industry, warfare and much else – with DARPA later laying the basis for the Internet.

Cybernetic thinking brought algorithms and operationalism into the frame, along with flowcharts.  Flowchart and provisioning rather than generalship or leadership were critical to mounting operations like D-Day.

They also laid the basis for a new Management Science, Systems Theory, that developed after the War. This management science laid the basis for MBA and related degrees which American Universities opened up to accommodate returning soldiers, particularly the officer class.

The new managers, allied to an increase in automation facilitated by computers, appear to have been supported by the military in automating a lot of US heavy industry – in part because the workers on the factory floor, particularly skilled workers, were viewed by the military as a possible fifth column, communists supposedly, who could handicap a military response in the case of a crisis.

This has been documented in detail by David Noble in Forces of Production – which was later developed into his more apocalyptic The Religion of Technology.

The Military and the Left

So, when Kennedy and the Democrats took hold of the reins of power a few days after Eisenhower’s speech, what happened?

This was the party of the Left, the representatives of skilled and unskilled workers.  Well Kennedy had campaigned on closing the missile gap with the Soviet Union, a gap that Eisenhower wasn’t bothered by.  He engaged in a Space Race – putting a man on the moon was a test of Democrat virility.  As was invading Vietnam, where a few years before Kennedy had been sympathetic to Ho Chi Minh and viewed Vietnamese wish for independence from France as similar to American wishes for independence from Britain.

Neoliberalism is widely viewed as an Anglo-American thing.  At the same time as Camelot was flourishing, in Britain Harold Wilson, the new leader of the Labour Party, was sloganizing about how the White Heat of Technology would make Britain great again.

A few years later, Labour Peers were talking about UK plc – years before Thatcher came to power. When Thatcher won, Labour briefly flirted with a return to its socialist roots but then turned to Tony Blair and the Third Way – a code for neoliberalism

Years before Reagan came to power, Jimmy Carter’s Democrats were openly technocratic.  They were talking and implementing deregulation long before Reagan.  See Democrats and NeoLiberalism.

The Democrats didn’t entertain the idea of returning to socialist roots of any sort. In the early 1980s, before anyone else had heard of neoliberalism, the Democratic National Committee, the body that later propelled Clinton to power with a mission to End Welfare as we know it, had agreed to adopt the tenets of what was later called neoliberalism as the platform for returning to power.

One of the few people on the broader Left who took a different view was J.K. Galbraith.  In his 1967 The New Industrial State, Galbraith identified a neo-corporatization.  Private companies were no longer run by entrepreneurs – they were run by bureaucrats (managers).  These people were trained in business schools, who had not asked what the consequences for business might be if we replaced entrepreneurs with bureaucrats – now one of the key features of Deep State complaints.

There was in effect no such thing as a Free Market anymore.  Corporations were at one with the government – at least in being process driven and averse to risk-taking. Grappling with them was increasingly Kafkaesque.

In contrast, another icon of the Left, Michel Foucault, was by the 1980s clearly making the transition to neoliberalism – again before anyone had heard the words.  Foucault branded Sartre, the previous leading figure on the French Left as a nineteenth century liberal – what came to be called an ordo- as opposed to neo-liberal. Sartre hadn’t realized according to Foucault that governance was now how we governed ourselves.

The Powell Memo

Many on the Left point to a moment in 1971, when the US Chamber of Commerce approached Lewis Powell, one of the Supreme Court Justices, to draft a plan to save US corporations from a growing democratic threat. After 1968, democracy did seem to be tottering – the people seemed more powerful than ever before.

Powell’s 1971 prescription fuelled the huge increase in corporate lobbying that is such a feature of politics today. This prescription is spun as the key remedy that restored corporations to good health.

Power and control were restored soon after this – and the people were put back in their place.  But it is not clear that anyone on the Right or Left of politics could have had much sense as to how order was about to be conjured out of chaos.  It had little to do with corporate lobbying.  If Galbraith is right, Powell’s memo was effectively promoting the Deep State.

Less than two decades later, whether we came from the Right or Left, the idea that if we apply the best techniques to problems we will get the best possible results, seemed utterly obvious.  Technocracy had arrived. But in 1971, this was not on many people’s radar and certainly not on Powell’s. Corporate lobbying increased but this usefully diverts our attention away from more important drivers of events.

As outlined in Shipwreck of the Singular, looking at what happened in medicine at the same time, faced as it was with an antipsychiatry and Ivan Illich castigating Big Medicine, an establishment being besieged by the people, it is clear that no-one had any idea about how control was about to be restored there either – but it was.  How?

Lobbying increased at both the macro and micro-level with every doctor individually lobbied by company reps.  Groups like No Free Lunch formed to undo the corrupting influence.  This usefully diverted attention away from more important drivers of events – the technocracy that Medicine turned to in an effort to save itself ironically from this pharmaceutical industry lobbying – Evidence Based Technocracy.

Neoliberalism and Deep States?

Pointing to all these discrepancies in the traditional narrative about the rise of Neoliberalism and Deep States doesn’t tell us what either of these are or indeed whether one of them is both the same.

There are two elements to both.  One is an operationalism, incorporated in a new management science, that led to a neo-corporatization, or a bureaucratization of corporations that had not been there before.

This led to the outsourcing or subcontracting, which along with auditing many see as Neoliberalism and others see as part of the Deep State.

But we don’t have the full Neoliberal or Deep State deal, the thing that locks the Iron Cage shut on us, without a turn to metrics, to figures, for which an algorithmic, if X then Y, is the answer.  If the temperature goes up, the air-con turns on or furnace turns off.

If an economic metric goes up or down, the politicians do whatever it takes to get the figure back to where it should be regardless of what happens the country or the climate.  There is, as Tina said, no alternative.

If physiological figures go up or down, a drug is the answer and it is becoming increasingly close to negligent not to prescribe, regardless of what happens the patient.

We are now heading toward mandating biopharmaceuticals.  This is not just the superficial rationality of correcting some figures with something that claims to be an answer but an increasing inability to think of any alternatives.

The patients are waiting for HARPA.

Again and again reviews of the failure of Social Care indicate that the number of complaints point to ‘problems with systems and policies’ rather than ‘one-off mistakes’.

Added to the constraints of rationality that lock our politicians and doctors into a prescribed course of action, the system failures bring a hopelessness that stems from a failure to imagine anything other than what we have and perhaps a lack of the courage to make a difference.

Our dilemmas were caught beautifully by Chuang Tzu in 323 B.C.:

For security against robbers who snatch purses, rifle luggage, and crack safes, one must fasten all property with ropes, lock it up with locks, bolt it with bolts. This is elementary good sense. But when a strong thief comes along, he picks up the whole lot, puts it on his back, and goes on his way with only one fear – that ropes, locks and bolts may give way.”

There Are Options – TAO.

Chuang Tzu was fishing with his bamboo pole in Piu river.
The Prince of Chu sent two vice-chancellors to say
“We hereby appoint you Prime Minister”.

Chuang Tzu said:
I am told there is a sacred tortoise offered and canonized 3000 years ago,
venerated by the prince, wrapped in silk
in a precious shrine, on an altar in the Temple.

What do you think, is it better to give up one’s life
and leave a sacred shell as a cult object in a cloud of incense for 3000 years,
Or to live as a plain turtle dragging its tail in the mud?

Go home. Leave me here to drag my tail in the mud.

Succeeding posts will cover the operational

and metric components

of Neoliberalism, Deep States and Technocracy, and the impact of these on Care.

 

Can Doctors Save their Jobs and the World

This post ideally should be titled – Savoury or Saviour? – as will become clear.  Its part of the Politics of Care forum. It follows What You Can do to Save the World in a sequence of posts about what a range of people from us to Politicians and Us can do to turn around the crisis posed by our growing inability to care for others when sick, when treatments go wrong, when they need social care or to care for our environment and climate. 

One

Until recently doctors were there for us and our families first. They were much more than people who were a conduit to drugs.  To get back to a position where we thought the Magic lay in them as we once did, rather than in the Medicines they now dish out in ever increasing amounts, they need to create Guidelines for People, the first element of which would recognize the need to contain medication burdens.

They need to get rid of Guidelines for Diseases primarily because these are harmful to us but also for the reasons laid out below – Guidelines for Diseases are largely based on a ghost-written literature with no access to the data from the studies claiming to support the treatments they prescribe – junk in other words.

The doctor's nightmare (from Fildes)

Two

Doctors need to create or support deprescribing programs, aimed at reducing medication burden from more than five drugs, especially in older patients, to less than five. This will enhance the efficacy of the drugs the patient remains on and can reduce hospitalizations, improve quality of life, and extend life expectancy.  See Introducing Taper MD and Five Minutes to Midnight.

There is a growing amount of deprescribing babble but less and less deprescribing in practice – partly because patient demand for more and more meds is growing – younger people in particular.

Deprescribing is not just a matter for older folk. Putting young people on antidepressants or other drugs they can’t get off will use up a medicine slot that may be needed in a later emergency.  Explaining to a young person that drugs aren’t all they’re cracked up to be will be a challenge – you’ll find yourself called an old-timer who knows nothing about the latest research.  Are you really up for the challenge?

Three

Life expectancy is stalled or falling and was before Covid. See Shipwreck of the Singular references for references on this.

If we are going to operate according to targets, why not target turning that around rather than the multiple targets for cholesterol, blood pressure, bone densities etc that we have at present that are making things worse rather than better.

Four

Insist on access to clinical trial data. There is none at present. No one gets to see the data – not the authors on papers reporting the results of studies, not regulators, not anyone.  See Correspondence with NICE, the BMA, Brenda Hale, then Chair of the Supreme Court, Government Departments of Health – in From Stephen O’Neill to the Crack of Doom, The NICE before Christmas,  The Death of Stephen O’Neill and The Perfect Killing Machine.

No-one gets to see the figures or the records.  Data really means named people, not figures in a spreadsheet, or statistical outputs. If a death in a trial is coded death by burns, you will only know if the person poured petrol on himself trying to commit suicide and then died five days later from his burns if you have access to his full medical records or can interview his wife.

Without access to the data, we are not dealing with science – science is not about believing what some High Priest tells us. Any doctor who, in the current circumstances, tells patients to trust them because they are being scientific, may mean well but is essentially as fraudulent as the Wizard of Oz.

Leunig depression cartoon

Five

Insist on full access to all healthy volunteer trials data with the ability to interview volunteers. These are the only drug trials.  Clinical trials are condition trials where the effects of drugs and illnesses make it too easy for companies and regulators to duck a link between a drug and a hazard.

There are no confidentiality issues in healthy volunteer trials – other than commercial ones.  Most of these trials remain completely unpublished and those that are published ordinarily omit adverse effects totally.

The suicidal and persistent sexual side effects of antidepressants were evident in healthy volunteer trials before these drugs were ever licensed and provided an early warning to companies on how to construct their clinical trials to hide problems like these.

Whose Fault Is It?

Six

Support a change in the consent forms for clinical trials to mandate access to trial data. There is no ethical or legal basis to refuse this. The original clinical trial consent forms told participants they were taking an experimental drug – something they were not routinely told prior to that. Phrases telling people we will never show your data to anyone else, which sound good to trial participants, were inserted later by drug companies.

Seven

Encourage other doctors to ask companies for clinical trial data and to refuse to prescribe treatments that are not based on data. There is no science without access to the data. Companies need doctors more than doctors need them – if a group of you target certain drugs and refuse to prescribe without access to the data you can change everything.

This was an advert for Risperdal before it was launched – the drug that helped doctors give pre-teen boys breasts and a company who played a big role in the opioid epidemic.

Eight

Ignore guidelines for drug treatments that are not based on access to data – they are advertisements. (Currently all guidelines are based on a ghost-written literature without access to the data. Guideline makers know this.)  See The NICE before Christmas – and there is much more correspondence like the correspondence  with NICE mentioned there where I offered them a phrase – its not NICE’s job to police the medical literature that they and regulators and health departments have leapt on ever since.

TBD means To Be Determined.

Nine

Require universities to tackle medical academics who put their names to medical articles without having access to and being able to share the full study data.  This happens right across medicine but psychiatry as ever has led the way. A good symbol comes from Vienna, Freud’s old stomping ground, where the professor of psychiatry, Siegfried Kasper, is now a poster boy for just this kind of activity. The University of Vienna has refused to do anything about it. And the leading neuropsychopharmacology association, the CINP, recently made him their president.

In a similar move, the American Academy of Child and Adolescent Psychiatry made Karen Wagner their president, a woman who has testified under oath that most if not all of her articles reporting clinical trials have been ghost-written.

We are told we can trust people like these, and Charles Nemeroff below, because they have over 1000 articles to their name. See Tweeting while Medicine Burns, Tweeting While Psychiatry Burns and Burn Baby Burn.

If all of this is new to you and you know nothing about medical writing – you can get an astonishingly close to real life version of what its really like by reading Malcharist which is a thriller but like John Le Carre’s The Spy who Came in from the Cold is written with inside knowledge.

Ten

Learn about how to establish causality in the case of drug induced adverse events. This is not done by reading randomized controlled trial (RCT) results – RCTs are the gold standard way to hide adverse events.  This is much more important than the passions doctors are trained to have these days.

Even God got around to realising Guidelines aren’t the way to go, when things go wrong.  Mind you things didn’t work out so well when he did come down to take the training in person but you have no option.  If you haven’t read it – read David Lewis’ Can we have some Courage in Leadership Please – from which the cartoon below comes.

Eleven

Report any adverse event a patient suffers on treatment leaving his/her name and your name on these events and indicating a willingness to be cross-examined. Leaving your name on these events will call for medical courage.  It is not clear how many doctors have this kind of courage.  But to adapt St Augustine, a doctor supported by a doctor has the strength of a Walled City.

Give a copy of any adverse event report you send to the regulator on an adverse event to the patient affected and encourage her/him to file a report also leaving their name on it.

Anonymous reports only help pharmaceutical companies – they do not help doctors or patients.

Being cross-examined is nothing to worry about.  Regulators like FDA, EMA, MHRA remove patients’ names immediately and file your report away to grow mouldy. They are not about to get in touch with either you or your patient – the very last thing a regulator wants is any detail that might force them to connect a drug to a problem.

(Regulators are looking after the health of the pharmaceutical industry not patients.  You are supposed to be putting your patient’s health ahead of company health).

Patient and doctor names on these reports transform them from hearsay into evidence.  While regulators will do nothing, someone who is seriously injured by the treatment may be able to use a report with names on it in a way they cannot use the hundreds of thousands of other reports submitted to regulators, which get dismissed as hearsay.

Twelve

Report any adverse event on treatment to the pharmaceutical company that made the drug. If the patient was on a generic drug, report the event to both the original brand name company (who remain responsible for the drug label) and to the generic company.

Get your patient also to report to the relevant companies.

The report will ideally leave both your patent’s name and your name on it.  Unlike regulators, pharmaceutical companies are under a legal obligation to establish cause and effect between their drug and any problem. They would prefer you to report to regulators and not to them – see A Call to H*ARMSExtreme Reporting and Let’s do the AbbVie again. So do what they don’t want you to do.

The company should contact you and your patient. An approach from a company can be a fun and enlightening experience for both you and your patient.

See American Woman and American Woman 2.

Thirteen

If you ask your medical insurer whether telling a company that you think their drug has caused a problem is a good idea, they will likely advise you not to participate in this core element of medical care. Medical insurers would also likely advise you not to cross the road if you asked their advice on that.

If you make a mistake and consult your insurer and their response is a typical one, you/we will need to find a way to draw the attention of doctors more broadly to the fact that insurers are getting in the way of doctors being honest, advocating on behalf of our patients and saving medical business.  We need to stop our insurers de facto supporting pharmaceutical companies rather than us.

Your courage will be called on at an inquest if one of your patients has died as a result of a drug you gave them. Your insurer will advise against telling the coroner that the drug caused the death.  But this is the one place where you can make a difference.  If you endorse a hazard of these drugs, it will make it easier for the coroner to make it difficult for the regulator and others to ignore it, which otherwise they will do.

See Do Not Forsake Me, Oh My Doctor.

Sodom and Gomorrah were destroyed because Lot – seen fleeing the city below – couldn’t find 10 just men. Saving medicine will require ten doctors willing to go against the advice of their lawyer and do the right thing by patients like Stephen O’Neill or Samuel Morgan.  Lot’s wife ironically in this context is seen turned to salt-  see below for the irony.

See If I find you ten just doctors… , Model Doctors?Professional Suicide ,  Professional Suicide – The Clancy Case,  Listen doctor and you shall hearWe Need To Talk About Doctors ,   Dance of the Sugar Plum Fairies: How prescription-only keeps doctors healthy and wealthy but not wise

Fourteen

Push for reform of the coronial system, so coroners record in an accessible archive the drugs people are on at the time of death. They don’t at present. When people die from Covid or vaccines for Covid, no one collects details of the drugs they were also on.

See Spotlight on the Suicides: the Coroner and From Stephen O’Neill to the Crack of Doom.

Enable coroners to indicate that a prescription drug may have contributed materially to a death. They can’t at present. Your testimony at an inquest can facilitate this.

Coroners and you need to be able to follow a precedent just set by Pfizer.  If anyone, in this case a young person, commits a gruesome suicide or homicide on sertraline – Zoloft, Pfizer will wheel out the Tiananmen Square tanks to blast the anti-science crowd away.  But in clinical trials in 12-15 year olds of the BioNTech vaccine, some children became severely depressed on the vaccine, which Pfizer blamed on the SSRIs they were also on.

The medical – coronial system erases what actually happens patients when things go wrong as surely as details of what happened in and around Tiananmen Square in early June 1989 have been erased.

Fifteen

Consider submitting a RxISK Report on your adverse event and get your patient to file a complementary report.

Both you and your patient should consider notifying RxISK and giving us permission to let law firms acting for people suffering from the same or similar event that you have had contact you and/or your patient to discuss what happened.

There is a conflicting interest here.  You and all other doctors are going to go out of business unless the powers that run healthcare can be persuaded that drugs are poisons and that it takes great skill to bring good out of the use of a poison, which warrants a better level of pay that just dishing out stuff per guidelines.

If medicines are sacraments that can only do good and cannot harm, then nurses of pharmacists are much cheaper prescribers and better because they are less likely to interrupt the managerial or political High Priesthood in the way a decent doctor might.

In the near future nurses and pharmacists and you will be replaced by prescribing robots.  Robots may save more lives and reduce drug induced disability to a greater extent than you have been doing.  If they do this, it will be because they take the feedback from patients more seriously than you have, and will reduced medication burdens.

So we are not asking for you to be moral – we are asking you or someone to be self-interested.

Doctors are on borrowed time.  They make much too easy a living from the fact these drugs have been prescription only and we can only get them from doctors.

They ignore the fact that prescription-only is a police function and most of their patients get just as uncomfortable with them as doctors get with policemen.

The opioid epidemic has shown that medical common sense or values no longer exist.  Too many doctors now dish out too much stuff that many patients can see is not sensible.  If patients could get their meds over the counter, how much business would doctors still have?  If the answer is not much, doctors need to think about what it might take to make them attractive to people who could get their drugs elsewhere.

Sixteen

If you agree that drugs can cause adverse events, we have begun a set of RxISK Maps that locate doctors willing to agree that drugs can cause problems and willing to work with people to establish what is happening on treatment.

If this can be developed it may be good for medical business. If the ‘market’ works as it is supposed to do, a Map showing patients where to go to get savoury medical input, should slowly bring other doctors around to recognising the need for them to agree drugs are complex things that can cause problems.  Enabling them to remain in business too and support you in the process.

See RxISK Map: Professionals who just want to have Fun.

Seventeen

There is a good deal of emphasis these days on Choosing Wisely.   A lot of doctors sign on to the need to avoid unnecessary tests and procedures, although the services in which they work may not.

A wise choice is probably more likely if there isn’t a measuring instrument of any sort in sight.  See The Macbeth TestIf you have taken to rating scales or checklists or admit into the conversation a checklist a patient uses, the option to choose wisely will rapidly close.  Companies know that figures for which their drugs can be pitched as an answer are the best way to drive sales – its the first step in their act of hypnotising us.

Its being able to sit in a room with another person and really listen without turning to a technique that might save doctors jobs. It might also provide a template for saving the world. Saving the world is about getting back to embedding techniques in judgement calls we make rather than having techniques de facto make the judgement calls for us.

Eighteen

The image here is a symbol of the Cochrane Collaboration and is touting RCTs as the gold standard in evidence, something that offers doctors a shield to battle against every possible bias that might compromise their judgement.

Cochrane don’t let you know that they build their reviews of drugs on a ghostwritten literature and that when they had a chance to push for access to trial data, they flunked the challenge.

But even if Cochrane had a spine and trials were done by angels, there would still be a problem.  RCTs evaluate a primary endpoint – one of the 100 effects every drug has.  They are therefore by definition not a good way to evaluate a drug.

They are the gold standard way to make adverse effects vanish.  The people who most commonly exhort doctors to practice evidence based medicine are pharmaceutical companies.

For more on the limits of trials, see

In just the way we fetish guns and drugs figuring they kill or heal, when we do the killing and the healing, doctors and the system now fetish RCTs.  RCTs supposedly make the right judgement calls. If we don’t make the judgement calls, they aren’t going to be right.

We is a key word here.  Fetishes didn’t have much to do with sex before Venus in Furs, written 150 years ago. In this Leopold von Sacher-Masoch concludes that until women were as powerful, educated and wealthy as men, the relations between men and women wouldn’t be right – men would default into fetishes among other things.

Between access to the Internet and having skin in the game when things go wrong on treatment, many patients taking problems to doctors are better educated than they are.

Doctors increasingly have a choice between a job that involves 100 heartsink patients and twisted relationships, or having fun collaborating with 100 free researchers. If you are really relating to the person in the room with, you will find yourself able to put to one side any fetish with RCTs you may have been leaning toward.

Nineteen

The greatest scandal in medicine today is that there have been 30 RCTs done in children who are depressed – all of them negative, including those published as roaringly positive, yet doctors are dishing these drugs out like smarties.  The ghost-written academic literature has led to the greatest known divide in medicine between what the Bible says and what the facts on the ground say if they are accessed.

Despite this, antidepressants are now the second most commonly used drugs by teenage girls – many of whom won’t be able to get off them, who will be unable to make love while on them, who will miscarry if they do get pregnant and if they don’t are more likely to have a child born with physical or mental handicaps.

The full story of how this happened is told in Children of the Cure.

Doctors need to work out a way to get back to the kind of street wisdom Homer Simpson shows below.  This isn’t easy.  Don’t let talk of Shared Decision Making fool you, or think because you read articles about adherence rather than compliance that things will be okay. If you try this out, you will find yourself swimming against an increasingly strong cultural tide – particularly among young people.

You can go with the flow or you can you look after patients.  If you opt to look after patients, there is little option but to Man UP.

Finally

If salt loses its savour what good is it to anyone?  We don’t need our doctors to be saviours but we do need them to be savoury.

 

Posts to come will cover what Politicians can do, what the media and others can do. 

These ideally need to be drawn to the attention of politicians who whatever their background are the only ones that can get the kind of debate that is needed going.  Of course one way to draw it to the attention of politicians is for a doctor to refuse to prescribe without access to the data.