Making medicines safer for all of us

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 9^th 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

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.

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.

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.

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.

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.

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.

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.

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*ARMS,  Extreme 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 hear,  We 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 Test.  If 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

• Sex and Evidence Based Medicine
• Does my Bias Look Big in This
• The Fault Lies in Our Stars
• Fawlty Stars
• Clinical Trial Fraud

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.