What Counts? A Tale of Good and Evil

This title plays on words. Counting suggests numbers but also hints at values. This talk hinges on a clash between a worldview centred on numbers and one centred on values.

The slides and text are below.  A video record of the talk is here – What Counts?

Slide 2:            One of these two is on an antidepressant and unable to make love. Like drug induced Homicide, this drug induced problem impacts significantly on someone not on a drug.

Or one of them was on an antidepressant and years later is still not able to make love. We have known about Post SSRI Sexual Dysfunction (PSSD) for 40 years.

Just about 100% of us who go on an SSRI within 30 minutes of a first pill find our genitals turn numb or irritable.  Orgasms stop being pleasurable and we lose interest in love-making.  We may have been told this will clear once we stop treatment but for many things get worse when we stop. Genitals and maybe even groins get more numb and love-making stops completely.  We don’t know how this happens and we have no cures.  It affects women and men, young and old, and all ethnic groups.  Some recover years later, some still have PSSD decades later.

There are three issues here.

1. How come we have known about this for decades, but no-one put on these pills – and one in 7 are now on them – gets told about this hazard?
2. If we take this problem to a doctor why do we get laughed at and risk detention in a mental hospital for crazy ideas?
3. Why are doctors not looking at or listening to us in front of them? What are they looking at and listening to?  Do they have to seek someone’s permission to confirm what we know and, if so, whose permission?

Slide 3:            The antidepressant link to sex goes back to 1960. Early antidepressants were more powerful than the SSRIs. They cure melancholia – a severe mood disorder – SSRIs don’t.  People with melancholia lose interest in everything, including sex. But doctors 60 years ago could distinguish melancholic and drug induced sexual problems.

We get put on SSRIs if mildly depressed. We have no loss of libido and may be keen to make love to boost our mood. When that stops on the pills, we get told by doctors our new problem is caused by our depression not our pills.

By 1970, we knew one tenth of the dose of one of an older antidepressant could cause genital numbness within 30 minutes which could be used to treat premature ejaculation.

By 1980, we knew that stopping treatment could cause enduring sexual problems like Persistent Genital Arousal Disorder (PGAD).

In company healthy volunteer trials of SSRIs, many complained bitterly of sexual dysfunction. In later clinical trials, doctors like me were told not to ask about sex. This left companies able to claim sexual dysfunction affected less than 5% of trial participants.

By 1990, companies had a steady stream of reports of PSSD following treatment but told us nothing.  Regulators had too but did nothing.

In addition to reducing our interest in making love, SSRIs also cause birth defects, autistic spectrum disorders, miscarriages and lead to abortions.  Reproductive replacement rates have fallen in populations where these drugs are used extensively.

Slide 4:            Today, if you have a side effect on a drug, rather than it being stopped the dose is likely to be doubled or you will be treated for all sorts of diseases you don’t have.

You, or any doctor who figures you are right about what is wrong, will face a Tiananmen Square moment. You will be on your own against a ghostwritten academic literature, against regulators who have not seen the clinical trial data and who, even when they know a negative trial of your drug is published saying the drug worked well and is safe, say nothing. Half of antidepressant articles claim a trial was positive when the reality is it was negative.

These articles are built into guidelines that dictate what your doctor does.  The articles and guidelines give the impression that if antidepressants don’t work it’s because they are not strong enough and the answer is to double the dose or add more drugs.

There is no point reporting side effects to regulators, they never do anything about them and don’t know how to establish if the drug has caused the effect.

Slide 5:            Native American tribes once welcomed white men coming with useful technologies, hoping for peaceful co-existence. The two spiral wampum you see here is  a symbol of travelling in separate vessels but peacefully together. We face white coats who put no store on our native wisdom. Initially, they told us that the art behind their medicine involved bringing good out of the use of a poison, but they have forgotten this. They view our tobacco as poisonous not seeing it can be just as good as their pills.

Slide 6:            If a white coat figures we are right in our claims, he is accused of blasphemy. Their drugs have become sacraments – something that can only do good. Their idea of wisdom is to know more and more about less and less. They call this science but is it?

Slide 7:            The usual story about where their science began points to 1660, when Charles II founded The Royal Society.  The ground rule for science was it dealt with questions that could be settled with data.

Whether you were Xtian, Hindu, Jew, Muslim, or Atheist, you had to explain what you saw happening in the apparatus in front of you without appealing to a Book or Authority. You could run the experiment again, adapt the apparatus, check it out for tricks – but you couldn’t refuse to come to a consensus about the best explanation on a balance of probabilities basis about what you were seeing. The verdict might not be right and you were encouraged to do more experiments to check out both the observation and the explanation.

This is exactly what should happen in a clinical encounter between a doctor and one of us taking a drug.

Slide 8:            This account of our history overlooks an important earlier event, when Walter Raleigh had his head chopped off – for liaison with some Europeans.  Raleigh was convicted on the basis of things said about him by people who did not come into court to be cross-examined – this is now called Hearsay.

The British legal system recognized an injustice and introduced Rules of Evidence. Hearsay was banned. The only evidence that counts has to be put in front of jurors who can see witnesses and material being examined and cross-examined. Twelve jurors are obliged to come to a consensus about what is in front of them.

This is the essence of science.  Let’s say I give Gloria an SSRI and she becomes suicidal on it. I can examine and cross-examine her, run lab tests and scans, raise the dose, stop the drug, add an antidote, check with colleagues if anyone has seen anything like this or can explain it without blaming the drug. Gloria may help if she has been depressed and suicidal before and can tell me this is different to what her depression causes.

If she and I conclude the drug has caused the problem and report this to FDA, EMA or MHRA, the first thing the regulator does is to remove her name. No-one can now examine or cross-examine her and come to a scientific view about cause and effect. Her Evidence has been transformed into Hearsay. Misinformation.

If Gloria says look there are 1000s of reports of suicides on SSRIs on adverse event reporting systems, she will be told this is Hearsay and she cannot bring it into court.

The assays companies do to get their drug on the market are all Hearsay. No-one can be brought into Court to give evidence – the patients don’t always exist and not even the apparent authors wrote the papers.  Names count. People are the data – not figures. Accessing the data means accessing someone like Gloria.

If Gloria and I report her case in a medical journal, with our names on it, we can be brought into Court and examined in front of jurors. This is both clinical science and good evidence.

Slide 9:            The French playwright Moliere loved poking fun at doctors but here he is in Le Bourgeois Gentilhomme, poking fun at Monsieur Jourdain, a pompous upstart, who is excited to find he can speak prose.

Doctors have done a reverse Jourdain. They were doing science recognizing and reporting the hazards of drugs but somehow they now think that an interview with you or me is just a bedside manner thing and the science lies in keeping to some guidelines.

If you asked them to write a scientific report on Gloria’s case – they universally say they don’t have the expertise to do it.  If they don’t have the expertise to do it, they shouldn’t be practicing medicine.

How did this reverse Jourdain come about – where did Le Sauvage Medecin come from?

Slide 10:          Curiously there is an 1886 book about a doctor transforming from a civilized gentleman scientist, someone decent, into an uncouth person – its Jekyll and Hyde. Jekyll is transformed by a drug.

Slide 11:       It wasn’t a drug that caused the problem in this case but a method of evaluating a drug. The first randomized controlled trial (RCT) in medicine was a trial of streptomycin for tuberculosis. Tony Hill used randomization as a method of fair allocation – he was not managing mystical confounders.

Hill’s RCT found out less about streptomycin than a prior non-randomized trial in the Mayo Clinic, which showed it can cause deafness and tolerance develops rapidly.

Slide 12:          Here in the Oval Office in 1962, John Kennedy has just signed a new Food and Drugs Act – standing up he hands the pen to Frances Kelsey the woman who blocked the approval of thalidomide in the US.

The post War years were a miraculous decade for new drug discovery – psychotropic drugs, antihypertensives, antibiotics, hypoglycemics, steroids, and others – all developed without an RCT in sight. Drugs that cured problems getting in the way of us living the lives we wanted to live – unlike the drugs we have now.

Then a thalidomide crisis struck.  Kelsey saved the US from disaster using the 1938 Act, which like other regulation for food, automobiles, or stock markets, focused on safety. Something had to be seen to be done about thalidomide.  A few years before, Louis Lasagna, a leading expert on the new drugs, had suggested that along with proving their drugs were safe, companies should show their drugs worked – too many drugs didn’t work and if a drug doesn’t work it can’t be safe.

Lasagna was a convert to the new RCT technique, which he believed companies could use to demonstrate a drug worked. What does it mean for a drug to ‘work’. Most people would say that it should save lives and reduce disability If a drug did either of these it would contribute to safety.

The new 1962 Act required companies to prove their drugs were Effective and Safe. Frances Kelsey was the only woman in the room when this Act was signed.  The Act replaced her professional judgement, that a sleeping pill, even if effective, should not cause a peripheral neuropathy, with an algorithm that biased development toward efficacy. Designed to contain pharmaceutical companies, the New Act handed control over to companies.

Slide 13:          Two years earlier, Lasagna ran a placebo-controlled RCT, showing thalidomide was an effective sleeping pil. His RCT missed the SSRI like agitation, suicidality and sexual dysfunction it causes. The hurdle to stop thalidomide happening again was one it sailed over.

Rather than giving us effective drugs, RCTs are a way to weaker drugs on the market – they just have to beat placebo.  But worse again, if demonstrating effectiveness by saving lives or reducing disability is your target a trial like this could take a decade. This is not going to work for pharmaceutical companies.  There was a default instead into showing an effect – a change in blood cholesterol, or sugar levels, bone densities or on rating scales.   And a drug that is said to work because it lowers your cholesterol levels can kill more people than it saves or a drug that thickens your bones can cause more fractures than it prevents.

The Act required companies to produce drugs for diseases rather than just drugs. Well if that was the case companies were going to be able to make the most money by making us all diseased and ideally with several diseases at the same time. Our high cholesterol levels became diseases just as dangerous as heart attacks or strokes.  And our mood scores became risks for suicide and in need or treatment whereas even if left untreated mild depressions clear up after a few weeks.

The biggest problem was replacing clinical judgement with an algorithmic mindlessness.

Slide 14:          Three years after 1962, here is Tony Hill taking stock of RCTs in a lecture. He says pharmaceutical companies have quickly become the main promoters of the RCTs put in place to contain them.

Hill didn’t think trials had to be randomized. He thought double-blinds could get in the way of doctors evaluating a drug. He was a believer in Evident Based rather than Evidence Based Medicine.

He said we had needed RCTs in 1950 to work out if anything worked.  By 1960 he figured we had lots of things that worked – none of which had been brought on the market through an RCT – and he thought the need was to find out which drug worked best.  This is not something RCTs can do – there is no such thing as a best drug.  RCTs have instead become a way for companies to get weaker drugs on the market.

He said RCTs produce average effects which don’t tell a doctor how to treat the patient in front of them.

All drugs do a thousand things – one of which might be useful for treatment purposes.  In focusing on one element, by default, Hill is saying RCTs are not a good way to evaluate a drug.  All RCTs generate ignorance. But we can bring good out of this harm if we remain on top of what we are doing.  Hill never saw RCTs replacing clinical judgement.

Slide 15:          By 1983 a view was emerging that RCTs offered the scientific and sophisticated way to establish if a drug had adverse effects as this quote by Rossi et al indicates:

Spontaneous reporting is “the least sophisticated and scientifically rigorous . . . method of detecting new adverse drug reactions.

Lasagna, the man who more than anyone introduced RCTs, responded:

This may be true in the dictionary sense of sophisticated meaning ‘adulterated. . . but I submit spontaneous reporting is more ‘worldly-wise, knowing, subtle and intellectually appealing’ than grandiose, expensive RCTs.

Slide 16:          And here a decade later, Lasagna is saying:

In contrast to my role in the 1950s which was trying to convince people to do controlled trials, now I find myself telling people that it’s not the only way to truth.

Evidence Based Medicine has become synonymous with RCTs even though such trials invariably fail to tell the physician what he or she wants to know which is, which drug is best for Mr Jones or Ms Smith – not what happens to a non-existent average person.

Slide 17:          The Usurpation of Science

Slide 18:           Fifty years ago, Britain joined the EU and ran into trouble. They were told that Cadbury’s chocolate, their favorite, could not be called chocolate. It didn’t have the right quota of cocoa solids. Consternation over chocolate ultimately led to Brexit.

The name of the US regulator – FDA – tells you it regulates Food and Drugs. Faced with butter or chocolate or drugs, regulators require companies to meet an assay standard – so much cocoa solids, animal fats, or points on a Depression rating scale in 2 trials.  Meet that and FDA let you use the words chocolate, butter, or antidepressant. It’s not FDA’s job to decide if this is good butter, or if chocolate is good for you, or to police the medical literature for articles that claim a drug works when the company has told FDA it doesn’t.

Slide 19:          What’s a slide about laxatives doing in a talk like this?  There are 4 different kinds of constipation and 4 different ways laxatives can work, only one of which is likely to help the constipation you have.  Get the wrong one and you may end up on 4 laxatives, 4 drugs doing very different things and with treatment resistant constipation.

Almost no drugs are Magic Bullets.  They offer Therapeutic Principles – and in the case of laxatives there are 4 of them. Doctors used to be good at working out which one you needed. But once companies get a license to use the word laxative they work hard to replace clinical skills with a reflex prescribing of a laxative – any laxative will do.

Exactly the same is true for antihypertensives, hypoglycemics, and almost all drugs we use.  Few doctors now have the clinical skills to work out which therapeutic principle is the one for you. FDA have made them all antihypertensives and you’ve raised blood pressure, so doctors just give them. And when there is no improvement on the first 3 but a benefit from the 4^th, the doctor leaves you on all 4 because all are antihypertensive.

This is bad for you, good for companies. By 2000, this combined with companies treating us for cholesterol and blood pressure rather than heart attacks, or strokes had created a new pandemic – polypharmacy.

Slide 20:          In the case of depression, the consequences are particularly grim. Until recently there was no such thing as treatment resistant depression. Now there is. It stems in great part from doctors just chucking pills at people. Psychotropic drugs can give healthy volunteers PSSD, a dysthymic mood, or makes them suicidal with disorders that have no treatment. Young people in these states are now being offered MAiD – medical assistance in dying.

Slide 21:          Seven years after Lasagna said that good clinical interviews were the way to recognize a drug was causing a problem, in this article 3 Boston clinicians claimed fluoxetine caused 6 people to become suicidal. Analyzing the cases closely using clinical science to link cause and effect, this article established that fluoxetine could make some people suicidal.

Lots of other groups reported similar findings – cases of people who were challenged, dechallenged and rechallenged with an SSRI. Children. There was no way to explain what happened them except that fluoxetine had caused it.  This was Evident Based Medicine.

Sllide 22:          In response, BMJ published an article in which Eli Lilly, the makers of Prozac, claimed their analysis of their RCTs showed no evidence Prozac made anyone suicidal.  The cases being reported, therefore, were sad but anecdotal – and the plural of anecdote is not data. Depression was the problem not fluoxetine. Clinical trials are the science of cause and effect. Doctors, the public, media, and politicians were being asked – are you going to believe the science or the anecdotes?

This was a knowledge creation moment that likely had input from all companies and perhaps FDA. This article created Evidence Based Medicine and just as with RCTs 30 years earlier, the people most commonly exhorting doctors to practice EBM today are Pharma companies.

In fact, the original phrase is the plural of anecdotes is data – otherwise Google wouldn’t work.

The idea the disease is responsible for suicide attempts and suicides in healthy volunteers is hard to believe but companies can wheel out experts to say just that.

But the key point is Evident Based Medicine is the science. In so far as it contains company trials, Evidence Based Medicine is an artefact. My challenge to you is which are you going to believe the Science or the Artefact?

The Science of Medicine lies in making hard judgement calls. The made by algorithm approach, combined with inappropriate statistics, creates artefacts not science.

Among other things, Lilly cooked the books. When you get their trial data, the Evident Based Medicine and Evidence Based Medicine approaches here can be reconciled – as you might expect with real science.

But let’s says there had been a real incompatibility. This can happen. The first antidepressants could treat melancholia an illness that causes suicide. But doctors around 1960 were able to say yes but they can also cause suicide – just like they could distinguish melancholic sexual problems from antidepressant sexual problems.  So in an RCT of these older drugs in melancholia we would expect these older drugs that cause suicide to save more lives than they take – but in mild depression it would be the other way around. Resolving discrepancies is how we do science.

This points to deep problems with Lilly’s argument.  They are not in the business of being scientific – resolving discrepant observations. Recognizing a place for both Evident and Evidence Based Medicine. Lilly’s argument is a religious one – a dogmatic one – they forbid us to believe the evidence of our own senses.

This allows companies dictate what the risks, benefits and trade-offs of drugs are. Let’s them force us to live the lives they want us to live rather than engage with the business of helping us to live the lives we want to live. Following this Artefact transforms doctors from civilized to uncouth.

Slide 23:         Medicine’s Management Problem

Slide 24:          Weighing scales on which we edweigh ourselves were introduced in the 1860s. In the 1870s, we got descriptions of a new illness anorexia nervosa. In the 1920s, weighing scales in drug stores had norms for ideal weight attached and eating disorders mushroomed. In the 1960s, bathroom scales migrated into our homes and eating disorders became epidemic – in countries where people weighed themselves.

A stopwatch or weighing scale can be a wonderful motivator to achieve a dream – breaking the 4-minute mile barrier. It’s great if we can remain on top of the data from one fraction of our lives but measuring weight show how difficult this can be.  If the numbers aren’t perfect, companies know that their drug can look like an appealing answer to the problem they have given us.

Companies marketing bisphosphonates for osteoporosis took care to give clinics free bone scanners.  Show some bone thinning and sales will follow. This is true for any measure – peak flow rates, blood pressure or lipids, or sugar, behavioral rating scale scores – or even vaccine dashboards – especially as the trials have shown that the drugs ‘work’ to put numbers right even while they kill or disable us.  The measurements became the illness.

We made this problem worse with RCTs – which do not show lives saved but do show benefits on numbers.

Up until 1980, we brought our problems to healthcare – seeking help to live the lives we wanted to live.  After that health services began to give us problems with lipids and bone thinning and the amount of medicines we took rose dramatically. They began treating our numbers rather than us. The goal shifted from helping us to live the life we want to live – to getting us to live the life Pfizer want us to live.

Slide 25:          There is an extra element to the equation. In the 1950s the Service industries emerged. Through to 1980 or so, no-one viewed health as a service industry – doctors were professionals who exercised judgement the way a Judge might. But service industries have managers.  When health became a service industry and we got managers.

Before 1980, a doctor’s exercise of clinical discretion was a jewel in the crown of Care. The religious orders or charitable foundations or the administrators in Britain’s National Health Service keep the buildings and technologies ticking over but they didn’t they knew more than the medical and nursing staff how to do a healthcare job.

The arrival of Guidelines changed things.  Now managers could think they knew how to do the job just as well as a doctor. You give the latest drug – the studies show that even if it costs a hundred times more than the old drug it will save us money. Doctors’ contracts increasingly began stipulate that they should adhere to Guidelines that in the case of drugs are deeply problematic.

Before the transformation of healthcare into health services, a doctor’s job was to mobilize an organization’s resources to handle the problem you brought us. It became handling the risks you posed to the organization. There was a palpable change that everyone could feel.

Slide 26:          Managers manage what they can measure. The figures they generate have a sheen of scientific gold, which covers everything in health services these days and is killing Care. We have produced a modern version of the King Midas story.

Slide 27:          Doctors and pilots have adverse event reporting systems. When pilots report, safety systems pay heed – they know she won’t fly if they don’t. This is good for you she knows if you die, she dies.

Jane Frazer on the right is the CEO of Citibank. She moved into a senior position at the time of the financial crash. At the time of the crash, bankers and financiers were seen as being in a state of moral hazard. Their job was outsourcing risk in the knowledge that if things crashed, the bank would repossess your home. You would lose but they would still get bonuses. There was no incentive for them to be honest with you.

Doctors outsource risk as well – and this too is morally hazardous. Just as bankers should have known, they must at some level know the medical literature is deeply compromised and the outcomes of treatment are not what they are told.  Its bait and switch.

They put pills in your mouth and if these kill or maim you, you lose but they sail on collecting their pay – unless they agree the treatment injured you – at which point things might turn nasty for them.  There is little incentive for them to do the right thing.

Slide 28:          We now have a target based culture in medicine that parallels the target based culture we had in financial services from 1980s through to 2007. Where there were inflation and money supply targets then that financiers could bet against, there are blood pressure and related targets in medicine that hedge funds can bet against now.

We now have a pharmaceuticalization crisis to rival the financial crisis of 15 years ago. Then money chased money as poverty rose, now drugs cause drugs as life expectancy falls.

Slide 29:          Here is a recent New York Times image of Life Expectancy in the US, which has been falling you’ll note well before COVID.  This began around 1980, when we began treating numbers and healthcare became health services.  The previous dip in the 1960s was also caused by drugs – then it was tobacco.  Now it is polypharmacy. The UK has similar falling Life Expectancy data – again pre-COVID.

Slide 30:         Is Recovery Possible

Slide 31:          Weapons and Drugs create an Arms Race. The country with the best weapons and medical techniques wins wars. Weapons and Drugs like all techniques are amoral. Whether they enhance or diminish us depends on us.

This shows clearly in the case of weapons and drugs – both can kill, or with care we can bring good out of their use. When anesthetics came into being around 1850, deaths from the anesthetic were common and the question of whether it was right to risk killing someone even though good might result was a clear one. This question is still there each time we use a medical treatment.

The Atomic Bomb has shown there is a limited to effectiveness. In medicine polypharmacy points to a similar limit.  In 1980, few of us were on more than one pill per day. By 2000, some of us by 50 were on 3 pills per day – over 1000 pills per year – and the word polypharmacy was coined. Now 50% of us are on 3 or more pills per day by 50, and 50% of us on 5 or more per day – thousands per year – by the age of 65.

Life expectancy as you’ve seen is falling and this can only get worse because polypharmacy now begins in the teenage years and while after thalidomide pregnant women avoided drugs in pregnancy, and now avoid soft cheeses, processed meat, alcohol, coffee and nicotine, they now take more meds in pregnancy than ever with antidepressants the second most commonly taken.

We know that reducing medication burdens can increase life expectancy, improve quality of life and reduce hospitalizations – diabetes meds hospitalize more people than diabetes, bisphosphonates hospitalize more of us than osteoporosis does, antihypertensives hospitalize more than hypertension, psychotropic drugs get the hospital door revolving faster than anything else does.

Slide 32:          The pressing medical need today is to reduce our medication burdens.  As this still from the Hurt Locker movie shows this is hazardous. Many of the bombs we are on explode on withdrawal. We need to be able to track prescribing cascades back to their source, work out which is the only antihypertensive someone needs to be on and crucially what you want from treatment.

You are the apparatus in which this experiment is happening. You hold vital clues to the best way forward. And it is only science if we reach a consensus.  Following the dictates of an expert or cleric is not science – its religious. Scientific medicine can only be evidence based if it is first of all relationship based.

Critically, no RCT, guideline or algorithm will ever help us reduce medication burdens. RCTs and guidelines get us on but not off drugs.  Reducing medication burdens is about individuality. The path a doctor and I track through the maze may never be repeated by anyone else.

Slide 33:          Let me tell you about a man I liked a lot who had OCD, which made his job very difficult. Keen to help, I gave him the usual treatments – an SSRI. He got worse. We upped the dose, added another drug. Each time he came back worse.

Some weeks later he came in looking better but embarrassed to tell me it was since he stopped the drugs I put him on and went back smoking. Before doing this he had researched trials on the benefits of nicotine for OCD, something that would never have occurred to me. These show nicotine related drugs work as well for OCD as SSRIs do.

He brings home two points. First if I said to you he was bringing good out of the use of a poison, because its nicotine you might agree with me. But SSRIs and other drugs are on prescription because we have every reason to think they are more dangerous than alcohol and nicotine. Just as with alcohol and nicotine, staying on several prescription drugs for the rest of your life is likely to lead to premature illness and death – but people hiss at me if I say a doctors job is to bring good out of the use of a poison.

Second, I hope you can see that he is the person best placed to work out what is right for him – to make what is called a Benefit Risk Judgement. He knows the risks of nicotine but is able to judge its benefits compared to an SSRI.

Until recently this is not a remarkable statement. Now regulators tell us they license drugs on a Benefit – Risk basis. The mood benefits of SSRIs they see in RCTs and the lack of sexual side effects are the reason there are no warnings – so as not to deter you from seeking treatment.

This is FDA and EMA getting you to live the life Pfizer and Lilly want you to live. The mood benefit with SSRIs is barely discernible. SSRIs don’t fix anything wrong in the serotonin system and in RCTs more lives are lost on them than on placebo.

In contrast, SSRIs interfere with everyone’s ability to make love.  This was known before these drugs were approved but eliminated from clinical trials.

Regulators have no grounds and have no right to say the Benefit Risk ratio for these drugs is favorable. You have the grounds and it is your right to decide on this.

Slide 34:          Nor do regulators have the right to strip away our Names – who gave them the right to convert our Evidence into Hearsay? After forty years of reports of PSSD and related conditions, with regulators doing nothing, action is finally happening because people with PSSD have insisted on putting their names into the public domain, creating Evidence that is the media and a wider community cannot ignore.

Slide 35:          At the heart of this is a matter of individuality. RCTs and statistics typically focus on averages and wipe out individuality. The impression conveyed is that approaches like this are using objective Chance to control our Bias but the history of science points to the opposite – a use of our Subjective Bias to control Chance.

All good science, from genetics to astronomy, progresses from the average to the individual. Early telescopes gave orange glows, but James Webb gives us zillions of stars.  A scientific medicine will be keenly aware of individuality.  Anecdotes are data.

Slide 36:          This lady comes from an Arthurian Legend – Gawain and the Loathly Lady. Arthur has been defeated in combat by a Black Knight who spares his life if he can answer a riddle – What do Women Most Desire. He must come back within a year with the answer or die. Arthur and his court hunt the answer for months to no avail.  The day he is due to die, Arthur and his troop meet this woman by the edge of the road who tells him that she can give him the answer to the riddle but one of his knights must become her husband. Gawain jumps down and offers himself up.

Slide 37:          The Black Knight is furious when Arthur gives the right answer but lets him go and the next day in Court Gawain gets married. Everyone there is desperately unhappy for him.

Slide 38:          In the bedchamber Gawain can’t bear to look at her. She approaches him and he finds a most beautiful lady. She asks – do you want me to look like this in the bedchamber or during the day in court or the other way around. He has no idea what to say and says – whatever you want. Which turns out to be the right answer.

She like us wants to control her own life. Give us this and we can become the most interesting and, in that sense, attractive person imaginable. There may be a disease that needs treating – but she doesn’t want me to tell her how to live a life, or have negative emotions eliminated with a pill. She may be doing better at living life than I.

Keeping to Evidence Based Medicine and its Guidelines, I end up with 100 heart-sink patients – none of whom are doing as well as the Guidelines tell us they should be. Practising Relationship Based Medicine, I get a 100 free research assistants whose motivation is worth at least as much as any expertise I have.  My expertise, diminished by sticking to guidelines, is enhanced by listening to you.

Science depends on collaboration with others. Healthcare is a collaborative venture not a technical service. Good relationships are central to Care. they support people in the judgement calls they make about their own lives.

Slide 39:          The ethics of technology resemble the ethics of medicine – the challenge is to bring a good out of evil, where evil means an absence of good.  Poisons and technologies are morally neutral.  The latest technology is Artificial Intelligence. This has the potential to create a human husbandry or mediculture – to treat us the way we have treated animals and plants. Whether good results from its use depends on us.

This sets up a Secular Creation Myth. In the original, as you see here, one of the Creator’s Angels vanquishes the Created.  But will the outcome be the same this time?  Will the Created vanquish the Creator?

We are not doing all that well at bringing good out of evil, which raises the question – did the Creator win in the Original Account?  Did he bring Good out of Evil?

Slide 40:          At one point the Creator seems to have thought that Relationship Driven Living would be better than Guideline Driven Living and he figured he needed to engage with us to get this started. How has this worked out?