This is the Thirteenth in the Persecution Series, after The Persecution of Heretics, The Persecution of Vulnerable Adults, Harassment from the BBC to GMC, Harassment from Rolf Harris to James Coyne to Doctor Who, Persecution: Black Riders in the Shire, Persecution: Rumbles from Mordor, and seventh in the SUI Cide Series SUI Cide in Betsi, SUI Cide Trick or Treat, The SUI Cide Note, SUI Cide or Homicide, SUI Cide in the OK Corral, SUI Cide & Peace in our Time.
In a piece in the New York Times two weeks ago, Groopman and Hartzbrand claimed that insurance companies on the basis of a range of evidence and a variety of metrics were increasingly constraining the choices of doctors and patients and were jeopardizing patient safety in the process. This reprises the argument put forward in Pharmageddon, which was written in 2008.
This is not rapacious capitalism gone mad. If what Groopman and Hartman describe is new in the United States, it’s not new in the socialized medical systems of Europe and especially not new in the UK. In 2004, the Quality and Outcomes Framework – a system of payment for results that leads to primary care doctors reaching out to and giving patients problems they never knew they had – was introduced.
The latest twist in the UK came some weeks ago when both the Minister of Health and the Prime Minister announced a payment for all diagnoses of dementia. This shocked most doctors and much of the mainstream media. It felt like a step too far – given that there is nothing useful that can be done for dementia and making too early a diagnosis could have disastrous consequences for families. Speculation is rife as to whose interests are being served here – pharmaceutical or insurance companies.
The Shire and Mordor
Until recently, the rest of medicine has been more affected than psychiatry by the forces that have brought about situations like this. It’s been easier for real doctors to suck people into the new apparatus and make patients of them through their lipid levels, bone densities or peak flow rates than it has been to enslave people within the mental health system – we can’t measure brain serotonin after all.
This has meant that, as noted in Black Riders in the Shire, working in North West Wales mental health care until recently felt like living in an oasis like the Shire where you could be close to oblivious to the rumbles from Mordor. Sometimes living and working in such a place makes it easier to see what is happening elsewhere and this is where Pharmageddon came from.
But all this has now changed and devastation has been visited on the Shire. The instrument through which it has come has been Risk Management.
Two years ago Welsh Government brought a new Mental Health Act into being. The intentions of the politicians and others behind the original version was to empower patients – to make it mandatory that they had care-plans and give them access to what was being said and written about them. Some of us had been doing just this for 25 years – so it was clear that what was once inconceivable could be done and might bring benefits.
But tacked on to this Bill when it came into force was a recommendation that all patients should be risk assessed and risk managed. The recommendation came from the bureaucrats linked to Government who are typically there because they dislike seeing patients and may not have engaged with one for a decade or more.
Risk management is close to the quintessence of Pharmageddon. The statins and related drugs like those for osteoporosis, asthma and others out of which Pharma makes the most money are not treatments that save lives. They are treatments aimed at risks located in you and me. This is a world where the risks you and I supposedly carry around in our bodies are much more dangerous than the risks all around us from others, the environment or Acts of the Gods.
Companies can offer little more in terms of saving lives than they can forestall Acts of God. But in the case of what we carry around within us, they can create perceptions around risk management, and this is what Insurers and Governments want done.
In the new risk management metrics flooding into mental health, we see Pharmageddon in close to its purest form. Who needs a blood test when ticking a few boxes will do? Who cares that we already know that no matter how good the risk metrics, they are totally useless at actually reducing the risk of things going wrong? Giving antidepressants or antipsychotics for the most part increases your risk of premature death. All that counts is that once the boxes are ticked the organization whether hospital or insurer is immediately insulated from blame.
An adaptation of the immortal words of Werner von Braun as channeled by Tom Lehrer in the 1960s seems called for:
“Once the boxes are ticked who cares where they come down, that’s not my department” says Werner von Braun.
“You too can be a big hero once you’ve learnt to count backwards to zero. In German oder English I can count down and I’m learning Chinese”, says Werner von Braun.
The ring of power
The problem is intimately linked to clinical trials, perhaps the most seemingly innocent but at the same time the most dangerous innovation on the planet. RCTs, just like the Ring of Power, need to be handled with extraordinary care.
RCTs are always dangerous and should perhaps only be used in desperate situations when there is something to be gained in terms of damage mitigation that warrants risking the damage the trial will necessarily do.
They were first seen as a possible savior for those desperate situations when some amoral corporation intends to make money beyond the dreams of avarice out of the most vulnerable people on earth – when if the drug reaches the market they will likely extend their efforts to the youngest of children, even those in the womb. In such situations, one of the most wonderful, brave and altruistic things any of us can do is to take the risks of participating in a rigid mechanical exercise to test out the proposed remedy to see what happens.
Or it would be one of the most wonderful things we could do if companies and our governments were prepared to keep to the rules of the game and when the new treatment was shown not to work or was shown to come with an unacceptable risk, if they removed it from clinical use.
Playing by the rules offers a fair chance that if we take a risk that on balance we reduce the risks we might otherwise be exposed to.
But this is not what happens. Instead, companies get multiple attempts to pass through the eye of this needle. They can now outsource the trials to India or elsewhere where the patients might not in fact exist. They can hide the data so no-one sees the drug didn’t work and write up the results with claims the treatment was safe and effective.
As a result if we volunteer to take the risks involved in testing out a new treatment, our actions are perverted so that those we love on whose behalf we take these risks are even more likely to be injured and to have no legal redress in the case of an injury.
A degraded culture
The culture we have has now been so corrupted that very few readers are likely to be still with me at this point, and I will probably lose more with what is to come.
Quantification can be a wonderful thing. My career has been based on quantifying things, in some cases things that no-one else has thought it appropriate to quantify. So what follows cannot be dismissed as the rantings of someone who just doesn’t get numbers, or when it might be appropriate to reduce life to metrics. And in books like Pharmageddon, I have paeans of praise to controlled trials.
But the risks in RCTs stem from the way we quantify. We focus attention on the one effect of a drug that a company wants to make money out of – and bring a lot of metrics to bear on that. To do this we necessarily have to neglect the 99 other effects every drug has. This is a process akin to hypnosis. The doctors, patients and other observers miss the suicides, homicides and other effects happening out of the spotlight. And, in exactly the same fashion as the drunk at the lamp-post looking for his car-keys, companies, academics, journals, regulators and others line up to insist that the only things that are significant in this or any other trial are the things illuminated by the spotlight.
Far from generating knowledge, every trial generates ignorance. This is the risk we take. The culture in which trials happen moreover generate ignorance about our ignorance. And in this respect, companies don’t need marketing departments – the Cochrane collaboration and anyone who advocates RCTs as a way to contain industry do the marketing for them.
The risk within
The ultimate outcome is to locate risks in us that some drug will supposedly eliminate without causing any of the other 99 things that all drugs inevitably cause, and often cause more frequently than the possible benefit we seek.
We got away with this for a while in the 1960s when drugs like the antibiotics were given for short periods of time because poisoning someone for such a short time, given the resilience of the human body, is something we can survive. We aren’t getting away with it now.
Quite aside from the many injuries long term treatments inevitably cause, the greatest injury perhaps is cultural – both we ourselves and those from whom we might seek help are now conditioned into the assumption that the risks to us lie within us rather than in the bullying being done to us, the poverty of our circumstances, or the withholding of data on the risks of the chemicals we swallow in ever greater amounts. In so doing we lay the bodies of our children, parents and friends on the line to keep corporations healthy and tighten the grip that the Apparatus has on us.
Resistance is futile
So when risk management came to the mental health services in the Shire – some of us protested. Some of us drew the attention of management to lives that were blighted by or lost because of tick boxes filled up by well-meaning staff who had little idea of the havoc they were wreaking on patients they thought they were helping.
Some of us pointed to the increasing lunacy of situations where a Minister of Health visiting an over-stretched ER department and faced with queues out the door or patients being kept in ambulances to avoid them spending longer than some allotted period of time in the ER department. muttering they wished it was all over might find staff holding on to them because of possible suicidality that needed to be assessed. The problem then for the Minister is that even with an army of flunkies to guarantee his safety, risk management policies would dictate a wait of several hours for an ambulance to transport him the few hundred yards to the mental health unit for assessment. The very act of bundling him into an ambulance by locating the risk in him would injure him permanently in the eyes of others.
What happens when objections like this are raised? Well when the next government inspection of the Hergest Unit turns up, they are fed a story about an event that didn’t happen that casts David Healy in a bad light and they swallow it hook line and sinker. They are also fed a line from management that everything is fine and all staff think management are wonderful and marvelous except for one or two diehards like David Healy when the reality is just the opposite. Do the visitors attempt to check this out?
They report back to base and the Government calls the CEO of Betsi and demands the Hergest Unit be shut forthwith. That was last December. Only an extraordinary event a few days later prevented this from happening – or at the least troublemakers like Healy and a few others being moved out. Despite this, I still had no inkling anything was going on.
The Government inspection team came back a few months later when one of the visitors overheard a friendly bit of chatter between Healy and two other staff against the backdrop of a patient who had been secluded for three times longer than any patient had ever been secluded in North West Wales history. Rather than be concerned about the extraordinary and unwarranted seclusion, the functionary who remains nameless, despite my efforts to get a name, claimed terrible things were happening in Hergest – Healy was being let talk to staff.
The functionary was either psychotic or something else was going on.
The documents tracking what happened are jaw-dropping.
Equally jaw dropping was that all this took place against a backdrop of sustained illegality that the inspectors missed completely or decided to ignore.
The words above about the Cochrane Collaboration are savage. This is unfortunate in that some of my collaborators and friends are linked to Cochrane.
One problem is that any new religion tends to make enthusiasts out of its converts. It’s difficult to live without a religion and more difficult again to live without enthusiasm.
Another problem is that some within Cochrane agree with what is being said here about trials, but figure that ideas like this cannot be aired if we are to keep homeopaths and others out of the medical temple. In their own interests people have to be lied to.