George approached me for a chapter on pharmaceutical industry input to the period. I wrote The Pharmaceutical Industry and the Standardisation of Psychiatric Practice. This chapter pulled no punches. I was pleased when George and Nick left it intact and indeed seemed to think it was quite good.
On October 5, my mother’s birthday, and the day of Frances Haugen’s testimony to Congress about Facebook, a meeting was held in the Royal Society of Medicine (RSM), featuring a day of talks from contributors to the book. The talks were recorded. Afterwards, I made several requests to the RSM for a copy of my talk in a form I could upload, without a reply – at this stage unaware of the closing comments.
I Zoomed in for the early afternoon session in which I was participating and missed the closing comments from Tom Burns, author of Our Necessary Shadow, The Nature and Meaning of Psychiatry – very much an establishment take on psychiatry.
Getting nowhere with the RSM, with the help of Bill James, I home recorded the talk on Zoom, in the same room, wearing the same clothes – see October 16 Presentation.. No two presentations however can be identical and neither map straight onto the text below.
TB’s advice to any doctor tuning in to the lecture is to check your blood pressure before and during as you, like he, despite the occasional useful point, are likely to fume.
Maybe Tom’s been fuming for 8 years. I reviewed Our Necessary Shadow when it came out – See The Nature and Meaning of Psychiatry.
Psychiatry has often been viewed as a backwater not the leading edge of medicine. This is odd in that psychiatry was the first medical speciality, the first to have its own hospitals, the first to have its own journals, and later the first to turn to community care.
More recently it has been the first to developments in the realm of industrialization and standardization – up to 1990 no one would have predicted its lead in these areas.
Around 1960 British psychiatry was flourishing in part because German psychiatry emerged disastrously from WW II and American psychiatry took a detour into Freud and psychobabble, leaving British psychiatrists as magisterial figures on the world stage.
1954 saw the arrival of chlorpromazine in Britain. The first RCTs of psychotropic drugs were done in Britain. Michael Shepherd whom you see here was the leading advocate of RCTs but later ended up with doubts about them. Laing was the face of antipsychiatry, which had a prominent home in the UK.
The tensions between new techniques like drugs and RCTs – were they enhancing or diminishing us – burst out onto the streets in1968. This is Paris – the students marched among other places to Jean Delay’s office – the discoverer of chlorpromazine and ransacked it. Where psychiatrists saw liberation from the shackles of illness, many saw a shackling by drugs.
These 1968 scenes look like something replaying again 50 years later.
Here you see Tony Hill who ran the first RCT – of streptomycin in TB. This found out less about streptomycin than a standard clinical trial two years earlier. No-one did RCTs for nearly 20 years after Hill’s – until an event – the birth defects caused by thalidomide – led to their incorporation into the 1962 US Food and Drugs Act.
Hill mentions in a 1965 lecture from which this quote comes that to his surprise the people who were most enthusiastically drawing doctors attention to RCTs were pharmaceutical company people.
This quote makes another point clear – RCTs have a place in evaluation but they are not a good way to evaluate a drug. They focus on one thing a drug does when many drugs have several thousand effects.
RCTs do, however, replace clinical judgements with operations. Their incorporation into the 1962 Food and Drugs Act was a key act in the standardization of medicine.
When Tony Hill ran RCTs on antibiotics the endpoint was saving lives or getting people back to work – and you can run a health service for free if you most of what you do meets these goals.
But in psychiatry as in many areas of medicines, RCTs often have more dead bodies in the active treatment arm than on placebo. Working in trials means an effect on a surrogate outcome which in the mental health arena means rating scales – the most famous of which is the HAMD.
Here you see Max Hamilton picking out a key consequence of the use of checklists. His view was they were prompts to help an interview – not a replacement for an interview.
But checklists risk standardizing the interactions between people, and rather than us helping people to live the lives they want to live, we end up helping them live the lives Pfizer would have them live.
As slide 6, which you see here, brings home.
Through to 1980, the pharmaceutical industry was seen as a good thing. In 1968 people were afraid of Big Medicine not Big Pharma.
Alan Broadhurst on the left here working in Geigy did a huge amount to get depression recognised and antidepressants used – he probably compiled the HAMD checklist.
George Beaumont, also from Geigy, played a similar role for OCD and clomipramine.
What they did would be called disease mongering now but was viewed as educational then.
Clinicians, meanwhile, recognised the adverse effects of treatment in a way they are unable to do now. Even though we largely viewed the antipsychotics as an extraordinary boon, like Covid vaccines now, doctors were able to recognise problems like Tardive Dyskinesia – even in patients on backwards who were unable to advocate for themselves.
Now we have equivalent syndromes, like PSSD or protracted withdrawal syndromes, affecting thousands of people with great media contacts but these conditions remain invisible now because we – doctors – get in the way.
Our apparent core business at this point was schizophrenia. Schizophrenia has been vanishing – there are much fewer cases than before. We show no interest in this disappearance – just as classic postpartum psychosis has all but vanished with mother and baby units closed all around the country without anyone wondering why.
Maybe our core business is not what we thought it was.
Around 1980, all changed. DSM III emerged. In the UK, before 1990 we paid little heed to DSM except to note a strange new illness we’d never heard of before – Panic Disorder. Was it real – or were the Americans just catching up with something we called by a different name?
Was it really Upjohn disorder – coined to market Xanax?
Some of us began to hear about operationalism for the first time. It had a basis in the philosophy of science – names like Carl Hempel were bandied around. DSM brought an explicit operationalism to the fore. A check-listing. A standardization.
Meanwhile pharma which had been small began to get Big and intrude into our lives. When a crisis blew up about the benzodiazepines, Pharma were in the frame.
This crisis had a superficial continuity with antipsychiatry but Pillars of the Establishment sided with patients who were ordinary people rather than people marching to change the world order.
The Benzodiazepine crisis brought the media into health. The benzodiazepines could never have become the crisis they were, were it not for That’s Life, which you see here.
Before 1980 health rarely featured in the news, aside from standout events like Heart Transplants but now we got health pages, and health on the front page – sometimes occupying more than one slot on front pages. All of Health, not just Mental Health was en route to taking the place religion and politics had previously had.
The work Risk had featured in the Titles of Abstracts of less than 200 papers up to 1970 – by 1990 it had featured 20,000 times. Medicine – or rather pharmaceutical companies discovered risk before Ulrick Beck mentioned Risk Societies.
And where an increased awareness of man-made risks led to a Green movement and a push-back against chemicals and nuclear power – in health it led to just the opposite – an increased consumption of chemicals.
In just the same way as medicine discovered risk before the wider culture did, so also medicine discovered the operationalism and hypnosis by metrics that we now call neo-liberalism. Thatcher and Reagan followed the 1976 introduction of operationalism into what became DSM III.
The idea of the money-supply then and the inflation target appeared – something politicians could focus on to treat the economy or the country and be praised for doing even if the country fell apart as a result.
This followed behind medicines turn to treating Blood Pressure, Blood Sugar, Peak Flow Rates or Rating Scales numbers – all of which call for the use of a pill which we can be praised for prescribing, indeed will be penalized for not prescribing even when it’s a disaster for the patient for us to do so.
We can see the dead hand of measurement and targets in these two images – management are certain that checking lists has to be more objective and scientific than being present with someone. Two thousand years ago, the Greeks could see how foolish this might be.
Behind the scenes, Pharma was stirring.
They played a significant part in bringing down the benzodiazepines – which were off patent and worthless – in favour of non-dependence producing antidepressants. Britain was about to switch from being anxious or tense and having nervous breakdowns, to being depressed – a low serotonin people as this Guardian article suggested.
In the late-1980s, the NHS began to outsource services like cleaning staff in response to the suggestions of management consultants.
The years before that, in the mid-1970s, in response to the suggestions of management consultants, the pharmaceutical industry had outsourced the running of clinical trials to Contract Research Organizations, now a $40 billion business and the writing up of clinical trials to medical writing companies – ghost-writers.
CROs are the ones who code and collate the figures collected in trials passing them on to the ghostwriters. No one gets to see the data – not FDA, MHRA, NICE or anyone.
This slide is from a document produced by a company co-ordinating the ghostwriting of articles on Zoloft for Pfizer – see Cattell for more. You see on the right – 2 PTSD articles have been written and the company knows where these will go – to the very best journals in the field. None of these journals are bothered about whether the patients actually exist or whether the claim that the drug works is valid or not. None ask to see the data.
On the left you see TBD – To Be Determined. The ultimate authors need not be people who ran the experiment. Neither these authors, nor the people who ran the study, nor the ghostwriters have access to the data in the trial. The authors will be the people who Pfizer marketing think will do the best job selling Zoloft.
Just like Tony Hill was surprised to find drug companies promoting RCTs – in the 1990s drug companies strongly supported a new kid on the block Evidence Based Medicine (EBM). Doctors meanwhile thought EBM was a way to control pharma, like they had once viewed RCTs.
Doctors don’t now have obvious pharma people in their office giving them free lunches, or if they do these reps will encourage doctors to be evidence based. Pharma now have totally independent groups writing guidelines to sell medicines for them – like the National Institute for Healthcare and Clinical Excellence (NICE). And medical job contracts increasingly mandate that we adhere to these guidelines.
Where drugs are concerned, these guidelines are based on a ghostwritten literature. The people who write them have no access to the data from any of the trials they cite as evidence in support of what you or I are supposed to do. Guidelines only talk about the Benefits of treatment – not the Hazards.
I have written to the Chair and CEO of the NICE guidelines in the UK, regulators in the UK and Europe, politicians and others and none of them deny these points. Their response is one that I have given them – that it’s not their job to police the medical literature. See Crack of Doom.
All of the correspondence is available on the Politics of Care Forum on davidhealy.org
There are some key dates in the transition away from What Used to be Called Medicine to the health service jobs most of us have now. One date was September 20, 1991 – almost exactly 30 years ago. All through the year before, there were convincing reports of people given Prozac, becoming suicidal, with the problem clearing when Prozac was stopped, and reappearing when it was restarted. See Let Them Eat Prozac.
FDA were forced to have a hearing on antidepressants and suicide. Eli Lilly pitched their RCTs in response stating:
On the day of the FDA meeting, the BMJ, the most pro EBM medical journal, published Lilly’s meta-analysis of its RCTs, which claimed to show no increased suicide risk.
The article shows an increased number of suicidal events on Prozac – but in the main paper this was not statistically significant which meant BMJ were happy with a statement that the problem didn’t exist. BMJ must not have read the small print in a footnote of the article they published which contained an admission about an ‘illegal’ coding of one event. Reverse this and the suicidal events were statistically significant.
FDA talked about heart-breaking cases reported to them but concluded the science didn’t support the drug causing the problem. FDA meanwhile were sitting on data for sertraline and paroxetine showing the same limited efficacy compared with older antidepressants, like imipramine, and increased suicidal event rates on all three SSRIs with Lilly, Pfizer and SmithKline breaching FDA regulations to hide the problems.
FDA opted not to warn because warning would put people off seeking the benefit – from a treatment that according to them had a favourable benefit-risk ratio even though more people were dying on the active treatment than on placebo.
From this point on the hazards of drugs began to vanish. Journals like the BMJ became scared to take case reports which previously had been the bedrock of medicine. Drugs and Therapeutics Bulletins vanished – replaced by Guidelines which only listed benefits.
Doctors have now lost a sense for drug induced toxicity which is often coloured by anxiety or depressive symptoms. There are no treatments licensed for toxicity and so faced with someone saying they feel anxious or depressed as you can do when you have the Flu, are pregnant, or have a toxic reaction to a drug, doctors increasingly give more of the drugs that are causing the problems in the case of psychotropic meds.
As a result, Patients have become Invisible. We don’t hear or see them in the way we used to.
If patients become invisible, we do too. Managers don’t see or hear us dealing with toxicities that need expert input. Managers see drugs that the evidence says work well and are free of problems and figure doctors can be replaced with cheaper prescribers.
When you are faced with a patient who thinks they have become suicidal on treatment – the first scientific task is to work out what is happening. This is a judicial task. Key to this is the conversation with the patient who may say ‘Doc I’ve been depressed and suicidal before but this was different – I think it’s the drug – it cleared when I lowered the dose’.
This engagement is a scientific engagement with the data – the person. If you conclude the drug has made the person suicidal but the published academic adverts do not seem to support this, the next scientific task is to reconcile the mismatch.
In the case of SSRIs and suicide, you find:
When you get to the bottom of this you find what your patient has told you squares with the real science behind the apparent science. Case reports offer the only science in clinical psychopharmacology.
We in psychiatry used to be great at telling people to Take Responsibility for your Own Life
The challenge for us now is to Take Responsibility for our Prescribing
The quote is from Louis Lasagna the man responsible for incorporating RCTs into the 1962 Food and Drugs Act, who soon after came to doubt the wisdom of what he had done.
This is a clever use of the word sophistication – which I doubt if many non-native English speakers will immediately appreciate.
If you smile at the poor medical candidate here whose passions are not about saving patients from the effects of poisons, engaging with them in some of he most important conversations possible but are instead appraisal, assessment and ticking boxes – you shouldn’t.
You know the interviewers are equally constrained to ask exactly the same questions of each candidate and not be remotely intuitive. You go along with this and the College supports this totally – on the advice of management consultants.
The judgement calls of clinicians are now a problem. They are pitched against RCTs, which supposedly deliver valid knowledge. Even if done by angels RCTs don’t evaluate drugs.
Another problem for the generalist featured here is the increasing size and crazy nature of drug cocktails that partialists – like us – recommend.
As a family doctor recently said to me – if I refer a patient to a cardiologist the response will often be there is no cardiac issue. Ditto for gastroenterological or respiratory referrals. But a psychiatrist will never respond this patient is normal.
Life expectancy is now falling as a result – and was before Covid. Polypharmacy is almost certainly one cause – and it has become harder to establish if a drug is causing a problem, not because of lack of access to trial data or the ghostwriting of the clinical trial literature but because people are on so many drugs that picking out the causative factor has become harder. Medicine as we have known it for two centuries is over.
In 2002, a New Labour plan for the National Health Service foresaw nurses replacing doctors for many tasks that can be standardized from colonoscopy to prescribing.
This advert in a US magazine from 2004 envisages the same future.
We are now training Low Salt Doctors and have no room for old style clinicians who listened to and saw patients. The people on the coalface will be nursing staff and pharmacists, who will keep to guidelines. If doctors have a role it will be as managers enforcing processes – I should say bureaucrats enforcing processes – managing the risks clinicians and patients might pose to the organization.
There will be no option for many patients unable to get treatment for harms but to resort to being entrepreneurial.
We now work in health services not healthcare. Our work is managed on the basis of metrics and criteria – things that make psychiatrists look like doctors and manageable – things that empty out the concept of a professional.
Schizophrenia used to be our core business. It is vanishing.
This may not be a problem if we have all become American and the business of both the professions and pharmaceutical companies is growing business rather than eliminating it.
Psychiatry has been rather successful at growing business – perhaps even more so than other branches of medicine and even more so since its turn to the body and drugs that can be impossible to stop.
The main growth area now centres on antidepressants and minors.
All 15 pre 1990 RCTs of antidepressants and depressed minors were negative. All 30 post 1990 RCTs Negative. This includes the two Prozac for children trials that got it licensed – along of course with the 3 negative paroxetine trials that FDA agreed with GSK’s view that they were negative but were still willing to approve paroxetine for minors and not mention in the label that the trials were negative.
Psychiatry has the proud honor of hosting the greatest known divide in medicine between what the trial data shows when accessed and the claims in the peer reviewed academic literature.
Despite 45 out of 45 Antidepressant trials for depression in minors being negative, these are now the second most commonly taken meds by teenage girls.
Greta Thunberg’s generation are out protesting about the chemicals in the environment but swallowing more chemicals than any other generation ever did.
If you stand up to the management, regulatory, political and other tanks, these kids will trample you to death in an effort to get at the eucharist they see as their due.
Peter Selley sent the image below with a comment – RSM attendee had lucky break