When it comes to assessing the benefits of drugs randomised controlled trials (RCTs) are over-rated, rarely if ever objective, and easily gamed. If you don’t know what you are doing to begin with, RCTs won’t find an answer and in practice will make the situation worse. The operationalism of RCTs helped tee up a Neo-Medicalism. Neo-liberalism is another word for this.
This is the state of affairs for the supposed strong point of RCTs – rating a treatment’s benefits. When it comes to assessing the adverse effects of treatment, things are much much worse. The exclusive focus of RCTs on a primary outcome (the benefit) means that the 99 other effects every drug has – some of which may be commoner than the primary outcome – are neglected and vanish.
The sexual side effects of SSRI antidepressants demonstrate this. Within 30 minutes of taking an SSRI, there is some degree of genital change in close to 100% of people but when the drugs came on the market, their labels reported sexual dysfunction as happening in 5% of people taking an SSRI.
The disappearance of something as obvious as sex can happen innocently in part; investigators spend so much ticking the boxes linked to benefits, they may only have minutes to ask about problems and are unlikely to register as an adverse event something they have been primed to think of as a feature of the illness – depression affects sex.
But something that would be disastrous for marketing purposes, severe sexual dysfunction had been seen in over 50% of healthy volunteers in preclinical trials. One of things about testing a drug in healthy volunteers first is that a company has years to work out how to “manage” the issue. It can be as blunt as telling investigators in later patient trials not to ask about sex.
But then to compound the problem, the academic glove puppets on company trials in “their” articles apply statistical significance tests and/or confidence intervals to these adverse effects and claim there is nothing significant here – so the problem isn’t happening or isn’t happening with any degree of frequency. This isn’t just garbage in and garbage out of statistical tests, this is garbage, lies and fraud in and garbage, lies and fraud out.
Once a drug is on the market, there is inevitably then a mismatch between what the trials published in the NEJFM or other Fake News outlets show and our experience taking or prescribing these drugs. In response to this mismatch, we are told there are indeed rare side effects of treatment that RCTs don’t pick up and for this we need post-marketing surveillance.
Rare side effects are not the problem. The pressing problem is that because of RCTs we are now missing the most common effects of drugs, ones like dependence on and withdrawal from SSRI drugs that now affect roughly 5 million people in the UK, 30 million in the US, and 50 million across Europe. This is a public health problem on a grand scale – and the problem was obvious from healthy volunteer studies done even before the drugs came on the market.
Sixty years ago, the problems new drugs caused were picked up within a year or two of coming into use. The problem now is that common effects of drugs are denied 20 or 30 years after the launch of drugs like the SSRIs, leukotriene antagonists, dopamine agonists, or fluoroquinolone antibiotics.
This is no accident. Companies have worked out how to disconnect us and our doctors from the harms their drugs can cause. Central to these efforts is the RCT. If it hasn’t been shown to happen in an RCT then it either isn’t happening or we don’t know that it is happening. This is a procedural, a bureaucratic, rather than a medical answer.
Every week of the year, I get emails from people making a good case that their relative or friend was injured or killed by treatment but running into a response from the health service they were treated in that the doctors concerned kept to the Guidelines. This is bureaucracy. This is not medicine.
Things have got so bad that doctors with a patient right in front of them who has turned blue and grown feathers, after being given a drug and whose problem improves after the drug is removed, will still not say the drug has caused the problem but will defer to a bureaucrat in FDA or EMA or MHRA who is there because they don’t like meeting people, who may have briefly practiced medicine, orthopaedics perhaps when the problem is being produced by an oral contraceptive. The bureaucrat turns to the RCTs and doesn’t find the problem there – although it might there coded in a way that fools most people, or the report he reads says there is nothing statistically significant there. The bureaucrat says there is no evidence this drug causes this problem and doctors tell patients the problem is in their mind.
This turns medicine upside down. Its supposed to be doctors telling bureaucrats the problems a drug causes.
And doctors do appear to report to bureaucrats, using MedWatch in the US or Yellow Cards in Britain and other reporting systems elsewhere. But crucially the patients name, Walter Raleigh, doesn’t appear on the form.
So if I David Healy am having sexual difficulties after an SSRI and try to take a lawsuit against a company or doctor or take my case to the media, and say I know the regulators have thousands of these cases on file, the company response, or their lawyers response in Court, is “Ah but, this is hearsay”. These are anonymous reports. Nobody can be brought into Court to be cross-examined and so because of Walter Raleigh, the regulator might have a million pieces of paper on file, but this is all they are – pieces of paper.
This is at least semi-deliberate on the part of the system.
When reports go to companies, they are legally obliged to track down the patient and their medical record and cross-examine them. They do this in an attempt to find the ingrown toenail at the age of 2 they can point everything on. Despite their best efforts company reviewers often end up unable to explain the problem away and have to conclude their drug has caused it and list the problem in the label.
The problem then appears in a section of the label called Other Reports or Post-marketing Experience, which is small print and comes a long way after the section of the label that lists the adverse events noted in RCTs and most laughably lists their frequency. It’s the RCT section doctors read as offering the best evidence. They assume anything listed in Other Reports are things that have been reported to companies from flat-earthers and other whackos and this wonderfully transparent company is listing these events for the sake of completeness.
Regulators in contrast never follow you up or make an effort to determine if the drug has caused the problem. You will not be surprised to hear that companies are doing their damnedest to get doctors to report to regulators rather than to them. To many observers this looks like a step in the direction of transparency. It’s just the opposite.
But the biggest problem of all is that both we and our doctors have lost confidence in our own judgement – and this is the key condition for the emergence of cults.
The issues of deciding whether a treatment is worth it or not, or whether it is causing problems or not and then deciding whether to trade possible benefits against inevitable hazards are as delicate as the challenge to teenagers grappling with how to shape an identity in our very messed up world. RCTs trample across these issues and rather than support nuance and give time for reflection create a scenario for doctors and the rest of us in which we have to Choose – to be part of the damned or the saved, the rational or the woolly, male or female – and we have to choose right now.
These are the conditions that lead to the creation of cults. From the psychoanalytic cult from 1920 to 1960, to the Nazis in the 1940s, the Children of God and a plethora of religious cults in the 1960s, and now medical cults from EBM and Vaccine cults to an emerging cult affecting adolescent girls who are being bounced into gender transitioning. In all these cases, the cult-masters seek to abolish individual judgement.
Those who don’t sign up to the message are branded unbelievers, irrational, or phobics. Their resistance to joining becomes evidence that the cult’s members are on the right track. Any internal doubts a member of the cult has are branded neurosis, or internal transphobia, or blamed on scaremongerers. If you want to spot a cult look for the people calling others phobic or irrational or neurotic – as those riding shotgun on the vaccine stagecoach do.
One of the features of cults until recently is that they were a minority interest. Christianity is not a cult but the Christian and other religious cults of the 1960s circling around it were. Psychodynamic psychology is not a cult, but psychoanalysis became one. The Nazis came close to changing the game. While only a minority of Germans were members of the party close to all became de facto members. Vaccines are not a cult, but the current mandatory vaccine scheme come very close to making us all Germans now.
A growing body of the “truths” that both the highest echelons of medicine and medical rank and file now endorse are Fake. Even more important is that hemmed in by Guidelines, and a risk of referral to regulatory bodies, it is understood that physicians will not now exercise their own judgement or support a patient in doing so.
This is why Drug Wrecks are so important. One of the key differences between justice and bureaucracy lies in establishing Facts. Bureaucrats don’t do this. Justice has to. If those of us working in health don’t take a stand on the facts, we are working in a health system and collecting our pay rather than delivering Healthcare.
In the case of Drug Wrecks, the details that need assembling into facts are right in front of our noses. Our conversations with family and friends are a first step in doing this. The conversation with a doctor or another person in the health system is a potential next step – can we get them to Care. Can we get the jury – us and them – to reach a common verdict, a diagnosis, that moves things forward?
We need to replace Credo Ergo Sum and Cogito Ergo Sum with Decernimus Ergo Summus – it’s in working together to establish facts, that we are.
When we have a doctor blow us off by telling us an enduring sexual dysfunction after treatment is all in our minds, both we and s/he come out of the encounter reduced.
In terms of a larger politics, these conversations are a prototype for Citizens’ Assemblies, which have come to the fore recently as a means of tackling a series of seemingly intractable issues such as those linked to climate change or inequality or child abuse. These assemblies seem to have some potential to help us find ways of bridging rather than deepening divisions.
What is happening here is a replacing of a hierarchy with a democracy. With a hierarchy, the moral order was imposed from the top-down. This was lost with the execution of kings and we have been seeking ever since to find a way to restore a moral order. There has been a reluctance to entertain the idea of an order that arises from the bottom up.
Athens had citizens assemblies. But the citizens were all property holding men. This was androcracy rather than democracy, just as the hierarchy was de facto a patriarchy.
Unlike Germans in the 1940s, faced now with a falling life expectancies and Drug Wrecks rapidly becoming our leading cause of death and disability, we have no opportunities to emigrate. The new bureaucratic medicine is a global phenomenon. No armies are going to arrive from elsewhere to save us. The unfortunate among us will get on the train as we are told. Others will keep their heads down. Some will take advantage of the situation.
We need a new moral order arising from the bottom up. Incorporating women is critical to any idea about how such a moral order might arise. The desperate emails I get from people wondering how to get justice for a loved one who has been killed or injured come from women, not men. The people who take on doctors and the system for the sake of a loved one are women. Pharma already know this – it leads them to target women as a way to get drugs into men, children and older people.
One example of how a citizen’s assembly might work would be the creation of pregnancy registries where every woman getting pregnant would log every med taken, every health issue and perhaps many other things. To this would be added all outcomes in respect of the child, perhaps out to their teenage years.
When it comes to interpreting what the data mean, the key people at the table would be women – ordinary women. Sure, it would help to have some experts too and industry should also have a seat the table – we need people who will do their utmost to explain away possible links to a med or vaccine. At the end of the day though, the purpose of the exercise is to leave it to ordinary women in the light of genuine data to decide what to take or what to do when pregnant, figuring that they are best placed to decide what hazards are acceptable to risk and what aren’t.
It takes a community to sustain complexity. Healthcare used to be a community, albeit a rather top-down one. Now it has no citizens. When we control medical techniques, we can have healthcare. When they control us, we have health services – a bureaucracy. This is what we now have – a system that doesn’t trust its people.
Upholding facts is a precondition for sanity and citizenship as Tiananmen Square shows. Facts lead to justice. The good thing about the horror of Drug Wrecks is that it is still in our hands to establish the facts. No doctors are trained in how to establish these facts. No-one is. But the facts can be readily established and a failure to engage diminishes each and every one of us that is party to that failure.
Key to establishing facts are our names. Whether as doctors or patients we need to put our names to the events on a drug we are seeking to establish. We need to be willing to come into court to be cross-examined if need be – a pharmaceutical company might threaten this but would never want to carry it through.
Our names are key to restoring HealthCare. If a doctor and a person affected both put their names to a report indicating they have considered the issue in detail, this is the essential act of solidarity that can restore the moral order we have now lost. But it won’t be easy. RxISK was set up to build RxISK Maps of doctors and patients willing to do this but it has proven almost impossible to get it to happen – other than in the case of a small number of people with PSSD.
RxISK partly needs a revamp to make it clear we are anything but anti-medical but this doesn’t account for why so many have been so reluctant to approach doctors with a request to consider their adverse effect with them. It doesn’t account for doctors reluctance to co-operate with something that in my opinion is their single best chance for staying in business.
One more thing needs doing. We need to designate RCTs, at least when it comes to adverse events, as hearsay. Unless the people affected can be brought into the assembly to be cross-examined, the numbers purporting to represent their experience can make no contribution to establishing facts.
Who knows what Walter Raleigh would have made of all this. Below is his epitaph, penned the night before his execution. He lived in a time when it was impossible not to believe in the hierarchy. Who knows what he might have written now.
Even such is time that takes in trust
Our youth our joys our all we have
And pays us with but age and dust
Who in the dark and silent grave
When we have wandered all our ways
Shuts up the story of our days
But from this earth this grave this dust
My God shall raise me up I trust