Sense about Science: Follow the Patient

Editorial Note: This is the fourth of four posts about the links between Sense about Science and AllTrials. The first was Follow the Rhetoric. The Second was First Admit no Harm. The third was Follow the Lawsuit.

The simple act of defining doctors or patients concerned about adverse events as “critics” is a rhetorical stroke that marginalizes concerns – makes you a one percenter rather than one of the ninety-nine percent.

The ninety-nine percent

In addition to labeling “critics” as anti-vaccinationists or Andrew Wakefield clones, another criticism aired recently is that “critics” are anti-capitalism. In a recent Send in the Clowns Act, typical of the genre, Dave Nutt, Guy Goodwin and Dinesh Bhugra attempting to rally psychiatrists behind the pharmaceutical industry flung this jibe at Peter Gøtzsche who has done more for real data access than anyone else linked to AllTrials.

The irony is the pharmaceutical market is far from the free market as envisaged by Adam Smith or the Chicago School. This is the least free market on earth. Pharma’s control of information is even greater than was the control of information in totalitarian states like Stalin’s Russia. Corporations have traditionally seen the market as something to control rather than abide by. Pharma is Living Marxism’s dream – complete control. (Determining paternity can be difficult but Living Marxism appears to be one of the progenitors of Sense about Science).

Second like Athenian or early American democracy, this “democracy” has apparent citizen voters and non-voting slaves. In this “democracy”, doctors are the citizens (for now) and patients, usually called consumers although more accurately seen as helots, are the slaves with no say in their own condition and only able to access the goods through their owner (doctor).

Was the Soviet Union a good thing?

Bad Pharma was last year’s London Review of Book’s academic book sensation. This year it’s Thomas Piketty’s Capital in the Twenty-First Century – a major treatise on the difficulties linked to growing inequality.

Welcomed by many, including the Governor of the Bank of England, Piketty has drawn fire from David Graeber, one of the leading lights behind the Occupy Movement, because he [Piketty]

“denounces the lazy rhetoric of anti-capitalism. He has nothing against capitalism. He doesn’t seem to understand that it doesn’t matter how many books he sells or summits he holds with world leaders,… [or how many pharma companies sign on to AllTrials] if he only wants to save the capitalist system from itself this is the reason such reforms will never happen. The 1% are not about to expropriate themselves… If we want an alternative to stagnation, impoverishment and ecological devastation, we’re just going to have to figure out a way to unplug the machine and start again”.

Graeber’s argument is that capitalism is savage and we only had a relatively benign social democratic interlude between 1945 and 1989 because the Soviet Union forced capitalism to make some effort to compete for the hearts and minds of normal people. Now that this counterweight is gone we see capitalism in its true colors and it’s difficult to see what can get us back to the Halcion days of 1968.

The new Berlin Wall

The reason to mention Graeber or Piketty is not to endorse either view but to put the Access to Clinical Trial Data issue up there as a Building of the Berlin Wall moment of epochal importance.

Even though American healthcare is being brought to its knees by the forces involved, waiting for an American President to give a speech outside the gates of GSK or Pfizer and say “I am a Patient” is about as likely to be rewarded as would waiting for Krushchev to make a speech near the Brandenburg Gate saying “Ich bin ein Berliner” have been.

When or what might lead to the Fall of this new Corporate Totalitarianism?

Far from suggesting that everyone should read Piketty and Graeber to find out what we need to do next, a better bet would be to get  Piketty and Graeber to visit a doctor’s office. They could learn a lot about what might be needed to put the financial system and the environment right from witnessing the experience of the average doctor or average patient.

When a patient comes to a doctor, Piketty and Graeber will see the almost extinct embers of market forces being snuffed out by the counter-vailing forces of corporate control. They will see both doctor and patient become viscerally aware of this when treatment hits a bump in the road.

Medical democracy?

For a century beforehand, doctors had stood in implacable opposition to the rapacious and dangerous exploitation of patient by the patent pharmaceuticals industry. All of a sudden, ushered in by medical research and the second world war, the decades of the 1940s and 1950s threw up a cornucopia of new drugs from which industry could profit without having to be quite as egregious in its marketing as before. These drugs marketed themselves.

This period through to the late 1960s offered a medical equivalent of the social democracy, semi-admired at least by both Piketty and Graeber. The relationship between doctors and patients then briefly combined an older medical professionalism with a cornucopia of new drugs and the surgical and other treatments that these drugs made possible. This was just before Ivan Illich fell asleep and had a nightmare he named Medical Nemesis. As Freud might have told him, the figures in our dreams are often stand-ins for other more threatening ones – in this case Evidence Based Medical Nemesis.

While prescription only arrangements worked well initially, making the miracles of 1950s pharmacological breakthroughs available through a system like prescription only medicine meant that the system carried within itself the seeds of decadence. No provision was made to maintain medical wisdom and professionalism in the face of a marketing that would be targeted on doctors – central to which was the notion that what we claim our RCTs have shown should trump the evidence of a doctor’s or patient’s own eyes.

Bow to the bureaucrat

When it comes to an adverse event now, in scenes worthy of Kundera or Solzhenitsyn the system now requires doctors and patients (even Nobel Prize-winning Patients) to defer to a bureaucrat who sits in EMA or FDA who, if they come from a medical background, is there because they don’t like meeting patients, has probably never used the drug being reported on and was not trained in the first instance in the area of medicine at issue.

If doctors pay heed to the bureaucrat, there is no possibility of feedback from the marketplace. If they don’t pay heed to the bureaucrat, the system will squash them. Meanwhile even the perception of possible risks is being ironed away by groups with names like Sense about Science who manage Risk but who do not have the lived experience of grappling with a treatment related hazard in their own lives or the lives or their children or partners or parents.

This divorce sets up conditions of extreme alienation. It is profoundly disempowering. Despite doctors being trained to be ever more civil, patients who have a Drug Traffic Accident become nearly invisible to their doctors. They are just healthcare kill.

The doctor who came in from the cold

It’s difficult to convey to those who have not been affected what is involved. To mark the death of Gerry Conlon this weekend, let’s try it like this.

In the mid-1980s, four innocent Irish people were jailed following a pub bombing in Guildford England.  Convinced there had been a miscarriage of justice, a lot English people worked hard to overturn the sentence. Giving a view on the growing evidence that the four were innocent, Lord Denning, the Master of the Rolls, said

“If their story is right, it is such an appalling vista it cannot be. Wrongfully convicted prisoners should stay in jail rather than be freed and risk a loss of public confidence in the law”.

Exactly the same thing happens patients suffering an adverse event. Confidence in a brand – a branded drug is not the same thing as a medicine – requires the patient’s experience to be invalidated.

As part of ensuring that it will be invalidated, extraordinary pressure is brought to bear on doctors. Few of them are consciously aware of the pressure – that their consultation room is really a Checkpoint Charlie.

(I gave a talk at the recent How The Light Gets In Festival in Hay on Wye – The Persecution of Heretics – that attempts to make explicit the usually implicit pressure. The talk was recorded and is supposed to be available to view in a few weeks time).

In essence, doctors have a choice. They are either the steamroller that rolls over their patient or the steamroller rolls over them.

The moment needs its John Le Carre to write The Doctor who came in from the Cold. Just as I write this, news is coming in that some senior doctors have had the temerity to go public with claims – that despite Ben Goldacre’s paper on statins – these drugs cause significant problems. Will they be shot as they attempt to get over the Wall?

Healthcare kill

Everything is aimed at stopping a doctor and patient working freely together. This is the moment that should create value for the economy, for science, for the doctor and for the patient. It is increasingly the moment when value is destroyed, and lives are impoverished as a consequence.

Key to what has happened is the climate changing effects of a fetish for RCTs and the operations of groups like Sense about Science. In the 1960s, drugs were poisons and the doctor and patient fully expected things to go wrong. The magic lay in bringing something good out of the use of a poison. Now that poisons have been put through the clinical trials blender and become fertilizers, no-one expects anything to go wrong. When something does go wrong, the patient becomes a loser and is ostracised. The herd moves on leaving the wounded animal to the hyenas.

The Iron Curtain

Graeber outlines eloquently how being middle class in America in the 1960s had nothing to do with income but was better described as having a sense that the system worked for you – that a bailiff was not going to turn up outside your door and repossess you or that a health event would not bankrupt you.  They didn’t have a middle class behind the Iron Curtain. But now an increasing number of people in the West have lost this sense of security – they are in an increasingly squeezed middle.

It’s exactly the same for many doctors. A middle class doctor was one who could see the benefits and hazards of treatments. Now it is no longer possible for a doctor to see that treatments have hazards – how else can we explain doctors putting patients on 10 or more poisons at the same time.

A curtain was drawn through the middle of most doctors consulting room somewhere around 1989, and we now interview patients through this. It’s a curtain of Guidelines. Guidelines for treating Hypertension, Diabetes, or Depression. On my side of the curtain, just as in the movie The Lives of Others, there are an increasing number of people scrutinizing whether I adhere to the latest guideline or not.

I want to be able to Occupy My Office again. To be able to drag the curtain back so the patient and I can see each other. To be able to tell the watchers, that “In here we operate according to Guidelines for Treating People, and the first commandment is ignore all Guidelines for Diseases” (See The Macbeth Test).

At the end of every year doctors have to fill an end of year Continuing Professional Development prospectus outlining what we will do next year to keep abreast of the things we need to keep abreast of. For several years now I have put as one of my objectives – to avoid being sacked for offering Good Medical Care (GMC). The problem is I don’t know how to avoid this.

Ghost bodies

There used to be a communication between my consulting room and the chambers of Professional bodies for Physicians, Psychiatrists, Paediatricians, Geriatricians and Surgeons. But now the Presidents of these bodies swan around the world chairing meetings that would not exist but for Pharma largesse, and writing editorials denouncing doctors who might put their patients interests before those of pharmaceutical companies. These bodies and their Presidents now subvert rather than protect the exercise of medical judgement.

The alienation goes right to the top. In the 1960s the bosses of pharmaceutical companies would have been thrilled to have a meeting with the Presidents of major professional bodies. Now junior functionnaries in Pharma treat our representatives with visible contempt.

As doctors began to fail in their role as advocates for their patients, patients increasingly formed self-defense groups to look after their own interests. But this model was infiltrated by Pharma on a here today but gone tomorrow basis depending on the patent life of the latest blockbuster drug.

Now we face a situation where treatment induced death has become one of the commonest causes of death – perhaps even the leading cause. Now more than ever we need groups like Public Citizen. We need a medical equivalent of the Sierra Club or a group that in UK might be called The Royal Society for the Protection of Patients (& Doctors) – RSPPD.

How would Piketty and Graeber view AllTrials?

RxISK: We are the ninety-nine percent

RxISK’s motto could easily be We are the Ninety-Nine Percent. It’s for people who want their engagement with their doctor to count for more than his engagement with companies and their “Evidence”. It’s for doctors who want to occupy their own offices again.

It’s for doctors and patients who believe that the information that is extracted from us in the course of clinical trials should not be kept secret from us. That if we create the value, we should at the very least not be damaged by what we have helped create.

It goes beyond providing information in the way Public Citizen does. It aims to get patients and doctors engaged – to each other – good marriages are held by most to be the foundation of social order. We have a Dream.

Over 18 months ago, RxISK attempted to open up a debate on the ambiguities and conflicts at its heart.  Doing what it does, could it operate as a business in the marketplace or should it be a Foundation or an Occupy your Doctors’ Office movement?

It seems clear that pharmaceutical companies are legally obliged to access any adverse event data they are aware of. But even though they know we are collecting this information, they have not approached us. Companies seem unlikely to endorse RxISK in the way they have endorsed AllTrials.

They seem to be pushing us toward finding something more co-operative – perhaps something that is not out there yet – perhaps something that David Graeber or Thomas Piketty might have views on. Perhaps something you have views on.