This is part 3 of a set of lectures organized by André Marx, a family doctor from Stockholm. Its alternate title is Girl who Eats Salt. This follows Girl with a Clinical Trial Tattoo, and Girl who Tackles Ghosts.
Our lady is still in the waiting room. She will come in before the end of the lecture.
This is the Menai Bridge, the oldest suspension bridge in the world. Seen from the side it is probably Wales’ most famous view. You are looking from the UK mainland side over at Ynys Mon, the Isle of Anglesey. I used to live just over here. Walking to and from work I crossed this bridge thousands of times.
It opened a century before we had cars. But it was engineered well and two centuries later the bridge can be full of heavy trucks and coaches of tourists and can take these no problem.
The message of randomized trials – RCTs – and evdence based medicine – EBM – is we now have engineered medicine so that just as Menai Bridge is a long way from the rope bridges we used to have, so also health services are a long way from What We Used to Call Medicine.
But Medicine is and always has to be a matter of rope bridges. It cannot be engineered the way some fantasize.
Since EBM, health services have become increasingly dangerous. We have let the slats on the rope bridge rot and some fall out without being replaced. Missing slats, unreported negative trials are bad enough, but negative trials reported as postive – rotten slats – are even more dangerous.
Even before Covid life expectancy was falling. We know increased drug consumption shortens lives, increases hospitalizations and reduces quality of life. We know that reducing medication burden can improve all of these but we don’t do it.
Another way to put it is this. EBM and RCTs give us a top-down approach to medicine – a shower approach. Adverse events require a bottom-up medicine – a bidet approach. We need both – but when we are at our most vulnerable, as infants or old and frail or injured, if you have to choose one only bidets or bottom up washing is more important. See Life is a Bidet Old Chum.
Earlier I said there are two questions – What is Data and What are RCTs. The answer to the first is that People are the Data in medicine. If you don’t have access to the people, you are not doing science. At the moment the only science we have is in Case Reports.
The answer to the second question is RCTs are a gadget. They aren’t knowledge. They are algorithmic – they try to exclude you and your patients’ judgments as to what is happening. They figure the truth will emerge from bytes.
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These gadgets are used to hypnotize us. The three elements of any hypnosis involve stimulus binding:
This is not a pharmaceutical company plot. Left wing parties have done even more to build the trap we are now in than the Right Wing – they are even more technocratic.
In 1998 the British Labour Party introduced NICE guidelines and then in 2002 a plan for the NHS which involved screening everyone’s blood sugars, lipids, blood pressure, peak flow rates and bone densities. The idea was to give everyone the same Quality treatment.
For every set of figures that are slightly out of joint, a drug becomes the irresistible answer – particularly if doctors get a bonus for prescribing.
As mentioned, we can have a free Health System if we primarily do things that save lives and get people back to work, but prescriptions are now mostly given to healthy people. This can only increase disability and take people away from work.
The idea of treating risks rather than diseases emerged in medicine in the 1980s before anyone had heard about Ulrich Beck and Risk Societies. Beck pointed to the risks in the technologies we were surrounding ourselves with and Germany took this on board and pushed back against nuclear power – environmentalism became a much stronger force
In health, perceptions of risk have not led to a pushback against technologies. Instead, we have embraced technologies and the risks of these technologies have vanished almost entirely.
Pharmaceutical companies have cleverly exploited this. Selling the idea that treating the risks of heart disease is cost effective in the way saving a life after a heart attack is. The system will save money.
Faced with complaints about high-cost drugs, companies say the drug bill remains a constant 10% of overall health spend. But if drugs work, health spend should fall and drugs should be a greater proportion of it. Our problem now is we don’t only pay a high cost for drugs, we increasingly pay for a sales force for drugs.
We pay for screeners to do bone scanning which leads to bisphosphonate prescribing, which leads to more fractures. So we pay the hospital costs of these fractures and other adverse events. There are now more admissions for bisphosphonates than osteoporosis and it is same for admissions with diabetes drugs and mental health drugs. In addition, we employ auditors to track what is happening – why are there more admissions when there should be less. And managers to make sure everyone is keeping to guidelines – because of course its doctors not keeping to the guidelines who are the problem.
This lets pharma claim their drugs remain 10% of the budget. The drugs are actually costing us more and more for which we get less and less. This is a game that is win-win for pharma – the more drugs given to healthy people, the more admissions to hospital which mean the drugs budget will always be 10% of overall health spend no matter how costly the drugs.
Pharma are not particularly skilful game-players. Should we blame pharma for playing the game or doctors and politicians for being so pathetic?
If we give drugs to people who are ill and save their lives and get them back to work we can have Free Universal Healthcare. Instead we are moving rapidly toward industry’s vision of Universal Health Coverage – everyone on drugs or vaccines – which will bankrupt us.
The Labour plan for the NHS in 2002 envisioned doctors being replaced by nurses. In 2004 the front page of this US magazine sees the same future in store for doctors. For you.
We are moving into a supermarket type health service. Nurses and pharmacists will be at the key points doing the scopes and issuing prescriptions.
Doctors will be like the supervisors marching up and down ready to answer queries should one arise – but with they will be in closely defined roles.
Your pet will likely get more person centred care from a Vet than you will these days from a doctor.
The managers are off site writing flowcharts for how the algorithms fit together. Medicine used to be about minimizing risks for your patients. Your health service job now is about adhering to processes aimed at minimizing risks doctors and their patients pose to the organization.
If something doesn’t fit into the process like a patient dying from an adverse event, a root cause analysis of the event will take place and say the system ticked all the boxes.
For the system to do anything else, there would have to be a box in the flowchart that recognises that adverse events can happen because the medical literature is fake. That would require a second box explaining how a fake literature would be managed – and not even Stefan Lofren the prime minister of Sweden, or Jacinda Ardern in Neew Zealand, has the authority, or cojones, to put a box like that in place.
Medicine, as it used to be called, aimed at bringing good out of the use of a poison. This does not compute for managers, or insurers, or regulators, or politicians.
For doctors to practice medicine rather than be health service supervisors of nurses – they would have to retain their saltiness. When salt loses its saltiness it’s no good for anything.
We are now training low-salt Doctors to be supervisors, passionate about appraisal, assessment, following processes and ticking boxes rather than physicians engaging with twentieth century things like adverse events.
In psychiatry, we were great at telling people to take responsibility for their own lives – while not being very good at living our own lives.
To save medicine we need to take responsibility. Our literature could not be ghostwritten if we were taking responsibility. Companies could not hide the data from us if we were taking responsibility. It’s our job to police the medical literature.
We need to take responsibility at inquests and pay no heed to medical insurers who tell us to never agree the drug caused a death. Insurers are supposed to be supporting medical practice but in fact they support pharmaceutical companies.
We need to follow the example of Lysistrata who persuaded Greek women they could stop a war by refusing to let their men make love to them until the war stopped.
Pharma needs us more than we need them. If we refuse to prescribe their drugs without the data, they will have no option but to hand it over – and drugs will become cheaper when everyone gets to see the hazards.
Why is it do you think that we report so few adverse events on drugs? 1 in 100 it seems. And why do regulators pay no heed to our reports. Pilots also have adverse event reporting systems. If no one pays heed to the hazards they report, pilots would stop flying – so the system pays heed.
In plane flights, getting to NYC 15 minutes quicker is not viewed as important as getting there alive. Safety is more important than effectiveness. Pharma has persuaded us we want to get places 15 minutes earlier – and in some cases provided fraudulent data that their pill will do it for us.
Regulators pay no heed to our reports. It’s not their job to heed them. They file them away. No regulator ever tries to work out if a drug has caused a problem. The Swedish or EMA regulator never decides if a drug is causing a problem.
Regulators are bureaucrats. They are not trained to make clinical judgments. The few who were clinically trained are now bureaucrats because they don’t like meeting the kind of person in the waiting room. Or they may have been an orthopedic doctor who is now being asked to give a view about contraceptives. They have no access to the data or way to check what really happened. And they are acting in an agency which is obliged to partner industry.
There is one thing regulators do which is very important. Important for pharmaceutical companies. They remove your name from any report.
The execution of Walter Raleigh in 1618 shows you what needs to be done to change this. Raleigh was executed on the basis of hearsay – people saying things about him who were not prepared to come into court and be cross examined. You have to be able to cross examine someone in order to know what weight to put on their testimony. After his execution, legal systems worldwide introduced a hearsay rule – evidence from people without names is not taken into account.
There are thousands of reports of PSSD with EMA or FDA. If you get PSSD and take an action against a doctor or company, and tell the court there are thousands of reports of this, their lawyer will jump up and say ‘Your Honor, this is all hearsay’. The Court will then block any mention of these reports.
To change this both you and your patient need to report and insist your names are left on the reports. Better again send named reports to the pharmaceutical company who market the drug. Companies are legally obliged to follow you up and work out if their drug caused the problem. Regulators are not.
We probably will have to have another repository of these reports. Perhaps something like RxISK.org
But this will take courage, and a heart and brains. You have to understand you are committing to taking on the scary Wizard of Oz. You are committed to going to Court, committed to having a pharmaceutical company come and interview you. Committed to going against the advice of your medical insurer who will say you should not blame the drug.
But don’t worry. You won’t end up in Court. Once you make this commitment, the curtain will drop and everyone will be able to see the fraud behind it.
Donald Trump weaponized the phrase Fake literature for me. He gave me another good idea also. After a school shooting in the US, he said we need a good guy with a gun outside all these schools. People were horrified at the idea. But had no easy answer for the follow up – well if a good guy with a gun isn’t a good idea why do we have them outside the White House?
Drugs are like guns – they can be very helpful in certain situations. But we know that letting them multiply up and leak into every situation is a recipe for problems.
Drugs and Guns are techniques – gadgets. All gadgets create an arms race. Whether the use of these gadgets enhance or diminish us is down to us – but if we stop thinking about what we are doing when we use them we are highly likely to be diminished.
RCT gadgets mean the drugs arms race is not about creating more effective chemicals – it’s about creating more effective propaganda. Almost by definition this diminishes us.
The guns arms race brings out an important message. Efficacy has its limits. We can make weapons more and more effective to the point that they can’t be used and as a result the Vietnamese and Aghans can beat the Americans.
The same holds true for drugs. If you are on more than 3 medicines, effectiveness diminishes. To get the most effectiveness you need to be on 3 or less.
Two years ago, 40% of over 45s are on 3 or more drugs every day of the week – this figure includes the people who never come to see doctors – so even more of those doctors see will be on this number of drugs. 40% of over 65s are on 5 or more drugs every day of the week.
And we know that life expectancy even before Covid was falling. We know that reducing medication burdens can increase life expectancy, reduce hospitalizations and improve quality of life.
Paring our rapidly escalating medication burdens back to 3 or less should mean taking the values of the patient into account – in terms of quality of life as well as length. But we are not doing it.
We introduced RCTs so that efficacy could be used to improve safety. Which hasn’t worked – it has produced just the opposite outcome. Now there is a real chance to improve safety by focussing on efficacy in a different way – by deprescribing in order to get efficacy.
Our lady has come into the room. What is it she wants? She is a tough woman, but still she is nervous that her doctor will be hostile. She is going to tell you she has a problem with a drug you gave her, and she knows you wll bristle.
She has seen at inquests for family members killed by drugs that you betray bereaved families when they need you most. You might express sympathy, but you never say the drug you gave her someone’s son killed him. You are advised by your medical insurer never to say the drug caused the problem – it is always the disease that kills as Eli Lilly said in 1991.
If you betray her at a public inquest, how much nastier are you likely to be in a quiet office where no-one can see or hear you?
One mother whose 15-year-old daughter with no mental health history recently committed suicide after taking Accutane for Acne said about inquests – that it would be better if her daughter had been murdered because at least that way she might be able to meet the perpetrator in Court.
Medicine is now full of crimes with no perpetrators.
She knows you are only being nasty because you too are scared. If you publicly admit a drug can cause a problem, you fear the regulators and guideline makers, and your colleagues and politicians and the media will be nasty to you. Even Greta Thunberg’s generation will mobilize against you. So, you’re passing the pressure on you on to the woman who has come with a problem.
Patients with PSSD often go on to commit suicide. It’s partly because of the horrific problem. It’s partly also because of the ridicule they get at from doctors. You tell them they will remain ill for ever if they research things on google. You ask how could a drug that has left their body years ago still be causing problems? You suggest they might need an antidepressant.
In this story, as in the Arthurian legend it is based on, once you listen to this woman and give her control of her own life, you bring out the best in her. She or he can become the most interesting and, in that sense, attractive people imaginable.
Rather than a problem for you, the people in the waiting room could be free research assistants making your job much more interesting if you just weren’t so commigtted to being the expert and bristling at any hint it might be otherwise…. I have a PhD in the serotonin system but have learnt more from patients googling things about the serotonin system than I ever knew.
Our lady wants your help to live the life she wants to live. There may be a disease that needs treating – but this is important in so far as it impacts on the way she wants to live her life. She doesn’t want you to tell her how to live a life – she may be doing better at that than you or I.
What’s at stake is that you can have 100 heartsink patients or 100 free researchers helping you discover things you never knew about. Your job could be fun.
I’ve talked about the courage needed to change things by putting your name to adverse events. I’ve talked about a smart way to do things by getting safety in through the back door by deprescribing. But there is another central element. Its something very strange and hard to put in words – you have to like people. There is possible virtuous cycle here if you like someone they become more interesting and you like them and others more, which leads them to like you too because you like them.
Someone who thinks they possess absolute truth does not like people.
I have outlined some problems in this talk. The full story of how we got here is in Shipwreck of the Singular. The references to this are online on Samizdat.org – they include not just details of the articles and books and interviews but many of these articles and books can be downloaded, as can over 100 interviews with key players in this history.
There is also a davidhealy.org blog which has a Politics of Care forum where this lecture will appear.
And RxISK.org where people harmed by drugs can report their problems on treatment.
If any of you want to chase these issues further, please feel free to contact me on firstname.lastname@example.org
Perhaps you can now see why I find this quote from Vaclav Havel so compelling – it was shortly before the Velvet Revolution.
One word has been changed. The Word Health on the first line. Havel said Europe.
A Spectre is haunting Health… the spectre of Dissent
You do not become a ‘dissident’
just because you decide one day to take up this most unusual career.
You are thrown into it by your personal sense of responsibility…
You are cast out of the existing structures and placed in a position of conflict with them.
It begins as an attempt to do your work well
and ends with being branded an enemy of society. …
The dissident is not seeking power.
He has no desire for office and does not gather votes.
He does not attempt to charm the public.
He offers nothing and promises nothing.
He can offer, if anything, only his own skin—
He offers it solely because he has no other way of affirming the truth he stands for.
His actions simply articulate his dignity as a citizen, regardless of the cost.
Vaclav Havel, The Power of the Powerless, 1978Share this: