Editorial Note: This is the Fourth Crusoe Report.
“Death waits for these things like a cement floor waits for a dropping light bulb”
Study 329 seems to fit the classic picture. It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake.
Pharma began in the middle years of the nineteenth century when advances in the chemical and biological sciences underpinned the development of analgesics and antipyretics and later antibiotics. Within medicine, these were the first drugs that reliably worked. Within business, they led to developments in patenting and trade-marking, big profits and the emergence of an industrial-scientific complex.
The Second World War put a premium on pharmaceuticals. The development of Atabrine for malaria and Penicillin for everything else helped win the War – a lesson not lost on Governments. Pharma had become a strategic industry.
Government investment led to a cornucopia of new treatments in the 1950s and 1960s that transformed medicine. Lives were saved that would have otherwise been lost, research flourished, and the specter of premature death began to lift
Previously drugs had been developed in the pharmaceutical divisions of chemical companies. These divisions were now hived off as independent companies (Little Pharma) and these new companies rapidly became the most profitable on the planet.
In the late 1960s and early 1970s, Little Pharma called in management consultants in a bid to keep the goose laying the golden eggs. These outfits advocated outsourcing clinical trials to Clinical Research Organizations (CROs) and medical writing to Ghost Writing Agencies. They also advocated having businessmen and marketers as CEOs of the company rather than chemists or scientists or medics. They insisted on five year development plans that put a premium on the selling and reselling of popular diseases where even less effective products could be made into blockbusters rather than developing medicines for conditions that had no treatments. If the company was in the business of making profits, this switch in focus was a no brainer.
This advice created the very model of a modern major pharmaceutical – out of which came Big Pharma and Study 329.
But is this the whole story?
The nineteenth century also gave rise to another profitable industry – the linsurance industry which is now a broader risk management industry.
The collection of data by the first life insurance companies in the eighteenth century led in the nineteenth century to the creation of public health and the idea of preventive medicine. (This will come as an extraordinary claim to many, but the underpinnings of this can be seen in books like The Creation of Psychopharmacology).
The interests of the insurance industry to manage risks laid the basis for epidemiology and an interest in numbers in health. It led to calls to eradicate filth even before the germ theory had established what it might be about filth that caused problems. Today the preventive impulse in public health medicine leads to calls to eliminate poverty – which brings medicine into politics and politics into medicine.
The first public health physicians in the early nineteenth century were called Hygienists or Sanatarians. In addition to campaigning against filth, and the adulteration of food, and for temperance, the Hygienists in Germany and Britain advocated strongly for pensions as a public health measure which in turn furthered the growth of the insurance industry. And ultimately healthcare today worldwide is (or will be with the latest Trade Treaties) delivered through insurance schemes of one sort or the other.
In the second half of the nineteenth century, therefore, the growth of the economy and of the modern world got a huge boost from both the emerging biomedical and epidemiological sciences and their linked industries.
We celebrate the gains that medicine made in the 1950s that stemmed from the discovery and production of new drugs. We miss the transformation of medicine that data from yearly insurance check-ups produced in the 1960s. These data created the notion of risk factors such as hypertension, raised cholesterol levels and raised blood sugar. From a risk management point of view the data put a premium on treating risk factors – giving drugs to people the vast majority of whom had nothing wrong with them. This was not a Pharma plot – or not solely a Pharma plot. The story has been told in Jeremy Greene’s Prescribing by Numbers.
And just as the dynamics of modern corporations transformed pharmaceutical companies from companies at the forefront of an effort to discover drugs that treat the disorders that need treating for which we have no treatments into companies that focus on the production of drugs that make a profit, so also these dynamics changed the insurance industry. It changed from an industry that viewed the environment as risky and aimed to ensure our safety from these threats and to provide our families with a safety net in the event of our death, into an industry that located risks within us and wanted to protect itself from us. Big Risk will refuse to cover anyone who is in fact risky.
The pharmaceutical and insurance industries were initially not perfect bedfellows. The insurance industry was hostile to individual doctors doing whatever they liked such as using the latest drug. But most doctors believed that medicine cannot be practiced by numbers – that the duty of the doctor is to the patient in front of her rather than to the population.
But still the early interplay between science and business within the health domain and between preventive medicine and biomedicine worked to the advantage of all. New drugs liberated us from the specters of disease. Insurance highlighted things we could do to safeguard ourselves, our families and communities.
But the situation became more ambiguous as the twentieth century went on. With the virtual elimination of mortality linked to bacterial infections some of the greatest hazards to health came from pollution linked to other new industries such as the lead and tobacco industries. Tackling the health problems that stem from industries that are important to the economy and jobs cannot expect to mobilize the same degree of community or political support, as fighting Tuberculosis or Ebola can.
In addition, the links industry developed with science in the nineteenth century left it well placed, and financially more able than academia, to mount epidemiological studies in the twentieth century. This awareness of the benefits of research along with greater resources to sponsor studies was deployed to great effect for instance in the defense of tobacco smoking and lead where industry demonstrated it had learnt to exploit the radical doubt that drives science.
There is also the tricky balance of working out where politics ends and medicine begins. There were vicious disputes in the nineteenth century between biomedicine and public health over filth. Mainstream medicine didn’t see it as its job to clear up filth. Public health insisted it was. Mainstream medicine discovered germs and embraced the elimination of germs as a legitimate medical contribution. Many in public health held out against the germ theory.
Is eliminating poverty (the modern equivalent of filth) a medical task? Or should medicine make its contribution by recognizing that many poor (a.k.a. non-white) children live in slums that still have lead in their paint and that lead poisoning knocks several points off a child’s IQ and is associated with criminality and that the medical contribution is to flag this up and find ways to eliminate lead poisoning in the face of determined efforts by a powerful industry to block them – leaving poverty to politicians?
Whatever balance you opt for in the above disputes, today, as has ever been the case, when you take a problem to a doctor for help, both you and she expect to be able to draw on the best evidence to solve your problems.
In 1990 at the start of the Big Pharma era, you and your doctor lived in a world where medical issues were found in journals, textbooks and a small number of popular books. Today there is likely to be a health story on the front page of the newspaper, with an entire section inside devoted to health. The amount of health related material on the Web is second only to pornography and even pornography is grist to the medical grind.
The political has become personal in an extraordinary fashion.
Unlike any time in medicine hitherto, when you go to a doctor today you will have to take your place in a queue of people, many of whom have been summoned to a consultation by a clinic screening for a wide range of things none of which bother the people who have been summoned. They will come to the clinic unaware of any problem but will leave with diagnoses and on medication. The doctors call them in not out of concern for them but because the doctors have targets to meet in order to get reimbursed – targets set by Big Risk.
Big Pharma play on this pitch but it’s Big Risk that draws the lines and sets up the goalposts.
When you do get in to see the doctor, you’ll find someone who adheres to Guidelines. She will do so in good faith, figuring this the way to bring the best evidence to bear on your case. She will not recognize she is being guided to see problems in certain ways and to deliver on patent treatments. She will not be treating you according to the Guideline for Treating You. If there were such a Guideline, the first point would be pay little if any heed to Guidelines for treating diabetes, or hypertension or depression or the menopause. (See The Macbeth Test).
If the problem is a mental health one, both you and your doctor are likely to be aware of conversations denigrating biological reductionism claiming that it risks dehumanizing clinical encounters. In practice however biology contributes almost nothing to clinical encounters about nervous problems.
These encounters are being dehumanized but the problem lies with an informational reductionism linked to the use of rating scales and operational criteria.
Within the mental health domain, a great deal of public discourse claims the medical model is inappropriate, diagnosis unhelpful, and the word “patient” to be abjured along with an increasingly long string of politically correct replacements. But in practice patients seek diagnoses, and the appeal of the language of chemical imbalances lay in the fact it was destigmatizing. The allure of biomedicine lies in its promise of treatments that work.
But for the first time in a century, today’s first line treatments are likely to be less effective than yesterdays.
In all of medicine, one of the greatest sources of morbidity and mortality – perhaps the greatest – now stems from the treatments patients have been put on, the multiplication of hazards by polypharmacy and the denial of the possibility of risks by corporations whose own health depends on the continuing consumption of the greatest possible number of medications by the greatest possible number of patients from the earliest possible age.
In most of the medical and lay media, Big Pharma is the only whipping boy for these evils. But is it?
Epidemiological methods are used to deny these treatment related risks. RCTs come from Big Risk not Big Pharma. When they were introduced first they were a way to contain the pharmaceutical industry. Pharma lobbied vigorously against them. They began as a Risk Management Tool but have become the gold-standard way to hide risks – as Study 329 shows so dramatically.
Economically you might have thought it was in Big Risk’s interests to map out the epidemiology of treatment induced morbidity – the problems treatments cause. But it doesn’t do this. Big Risk’s traditional methods of prevention – Guidelines and RCTs – don’t work for treatment induced problems. And why solve a problem that generates more turnover?
Meanwhile so uncertain has Big Risk made access to care – so shredded has the safety net become – that any suggestions that consuming fewer drugs might be healthier are drowned out for most people by concerns about access to medicines. The ACLU for instance will not take up the issue of whether treatment induced violence might have led to inappropriate incarceration for fear it might complicate their efforts to ensure that prisoners have access to healthcare.
Just as a balance in drug development has tipped so that it no longer serves medical treatment, so also a balance within prevention has been perverted.
Big Risk should make it impossible for Big Pharma to take separate patents on drugs as similar as two drops of water by refusing to reimburse the second drop of water. It should make it impossible to ghost write over 90% of the literature for on-patent drugs and to sequester the data from clinical trials, in contravention of the fundamental norm of empirical science – but it doesn’t do any of these things.
Big Risk underpins a comprehensive failure to diagnose and treat in the face of morbidity and mortality on an epidemic scale. Before blaming Capitalism, the problem is the market isn’t working. It’s Big Risk that should make the market work and they aren’t. What we are looking at is the behavior of Corporations. This behavior is shaped by Rules and at the moment the Rules are not working for us.
Medicine is no longer what it was. Your doctor needs to relearn the skills of listening to, seeing and touching you. She will have to engage with a biology that recognizes the brain as a social organ rather than with the biobabble that stems from Pharma marketing. She will have to ignore an epidemiology that figures you can design authoritative RCTs without understanding the biology being investigated (most RCTs).
Both Big Pharma and Big Risk justify the status quo by saying they don’t want to impinge on the sanctity of the doctor patient relationship. So she will have to be able to take the dynamics of industrial power into account and Industry will have to figure she is made of the Right Stuff – unless we can find a way to rescue her from the pot in which she is now stewing.
Until such treatment becomes possible, we are all shipwrecked. We are all Crusoe.
“This generation thinks that nothing faithful, vulnerable, fragile can be durable or have any true power. Death waits for these things as a cement floor waits for a dropping light bulb. The brittle shell of glass loses its tiny vacuum. This is how we teach metaphysics on each other”.
The quote is from Saul Bellow’s Herzog. In Bellow’s imagery, the vacuum in the dropping light bulb contains our hopes, our aspirations, our fears. Big Pharma and Big Risk were once our allies in keeping our hopes alive – in keeping our children alive and well. They are now a threat. And of the two – Big Risk is the bigger threat.Share this:
Copyright © Data Based Medicine Americas Ltd.
I think my “Article for Independence Day” (2014) may be of relevance:
The argument again is that political failure (and worse) is at the heart problem – focusses on vaccines towards the end but equally relevant to the wider issue.
Beautiful quote from Bellow.
Bellow later in life became an unrestrained neo-liberal free marketeer but this was earlier and is a beautiful quote
I have only recently become aware of the issues you discuss above. Having been drugged for 40 years on nitrazepam and anti-depressants, it was hard enough to struggle through each day trying to work for a living. I have been bedridden for 2 years after withdrawing from nitrazepam. However, I am finally free from depression after four decades. My eyes are now wide open, my brain is now almost fully alert. Sadly my body is unwilling to function. I feel betrayed by the doctors who treated me. I hope that the truth about modern medicine will become widely known. Far too many people have no idea that they cannot trust their doctors. They assume that doctors know about the drugs they prescribe. I now feel I have been a pawn in a game of chess.
Oh Fiona, you are a woman after my own heart. I too, have been psychiatrically drugged for over 35 years, and have barely survived their withdrawals. But I live for the day when I hear other woman saying they no longer suffer the drug-induced crippling depressions as I did, that our eyes are now wide open to see – the truth, that our brains are more alert – although slightly or not so slightly permanently damaged. Look at the decades of our own lives that we gave up in order for psychiatry to fix our fictitious ‘chemically imbalanced’ brains, because we trusted them. What a mistake that was. It brings me such joy to hear that your doing so much better. And I so love Dr. David Healy for doing the work that he does. I finally feel that I have someone on my side when psychiatry threw me away years ago.
Thank you for your petition, Fiona French, and, for a remarkable story.
After all that you are on your way oot of it and sending you Scottish Hopes for Your Health from a West Coaster to an East Coaster..
Very moving and told like a true Scot, eloquent and indomitable…somebody has got to start listening and act on this…well done for everything. You have friends here.
Signed Up straight away.
Ms French, you have.
David, once again your postings come to my aol emails, and as always teach me something I do not know about.
We are beginning to finalize our plans for An International Benzodiazepine Symposium here in Bend, Oregon in September of 2017. I am still hoping you will be one of an illustrious group of your peers, and possible critics, during this gathering of people who have been involved in the benzo conundrum that has virtually ruined millions of people’s lives on their specific path of destruction.
If this email reply message is seen by someone who can send to David..in that I am eyeball deep in putting the final touches on The Benzo Blunder/ a memoir, I would appreciate it.
If not, continue your good works..
Marjorie Carmen, Bend, Oregon
Guess it’s not surprising that we hear so much lately about the glorious promise of getting our medical care from smartphone apps. You may have heard that Thomas Insel, the head of the National Institutes of Mental Health, has quit to take a job with Google developing apps to monitor and track your mental state:
Often this is openly advertised as a solution to the high cost of employing actual people to care for other people. But even more perversely, it’s sold as genuine Personalized Medicine that puts you the patient in control. In reality, you’re more powerless than ever (and not only because a flock of data-brokers are gobbling up bogus information about your emotions, sleep, attention span, etc. to sell to god knows who).
Unlike a human doctor, the App will only ask the questions it’s programmed to ask – and you cannot tell it what it has not been programmed to “want” to know. Someday it may give you an hour-by-hour readout of your blood sugar levels, but the app won’t tell you such “tight control” has actually been linked to higher mortality. Mostly it will ask you questions for which a pill or other product is the answer.
And of course it will replace one more messy human-to-human interaction with a nice, clean, predictable bit of screentime. Just what we all need to restore our health and sanity … NOT.
The Samaritans came up with a whizzy notion earlier this year – Twitter users should screen each other’s tweets for ‘danger’ words like ‘sad’ ‘lonely’ ‘fed up’. Then the Depression/Suicide Stormtroopers (it was never clear exactly who they were going to be) could be alerted to save people from themselves….the good thing was that there was a spirited backlash against such intrusion and the Samaritans dropped the idea….
But – the idea of being tracked by the internet for medication compliance (a.k.a personalised medicine) is truly horrific – I wonder how much health info is already reaching Big Pharma and Big Risk via the Google fitness apps? Or Fitbit etc..Likely, Big R is much more efficient at mining the data – Big P seems to be a tad useless at new technology but no doubt it’ll catch up.
I just read The Circle by Dave Eggars: (didn’t tell me anything I didn’t know but has put me off ever filling in another online survey). A dystopian novel about just how far a thinly disguised Google might go in terms of controlling behaviour..not brilliantly written but scary and interesting.
I have long thought that the day Big Risk, the insurance companies, decide that the cost of medication-induced road accidents is too high – and refuse to cover people on any drug that affects judgement – will be a tipping point. People being offered antidepressants for exam stress, bereavement, divorce/domestic violence-induced anxiety, phobias, post childbirth exhaustion…may well think twice about accepting, if the price is that they must surrender their driving licence. We value the freedom to drive very highly and everyone who finds themselves landed with a bi-polar diagnosis suffers hugely when they are forbidden to drive, even for a few weeks. Similarly if you aren’t allowed to drive whilst taking opioid painkillers, statins, smoking cessation drugs – I wonder how far the prescription rate would fall.
That doesn’t mean GPs should do nothing – everyone in distress needs to be heard and helped. But it will mean taking time to talk, and work out when a calming drug or painkiller is more important to a patient than the freedom to drive.
Big Risk is massively influential – as a newly qualified lawyer dealing with many road traffic accident injuries, I spent 80% of my time dealing with insurance companies, not clients – or even applying all the legal knowledge I’d spent so long learning. The first lesson I learnt was – never, ever tangle with an insurance company. They make vast bucks from reducing their own risk of ever having to pay out on a claim to virtually nil- and anyone who has failed to declare the tiniest detail will find that their policy is invalid. Anyone with serious health problems: stroke, heart attack, serious mental illness will find it hard and extortionately expensive to get any insurance for travel – because they are simply too risky – the chance of the insurers having to pay out is too high!
And never trust a GP who says ‘If I say you’re OK to drive, you’re safe’ – because you ain’t. Rear end some-one and give them a whiplash neck? When the insurers find out (as they will) that you have a ripe old medical history of depression/bi-polar/psychosis – and that you still take medication – you will be in for a battle.
All boils down to money in the end – as usual.
May be of interest to some readers that the DVLA ( here in the UK) need to be informed of your medication levels for mental health conditions. They will revoke your licence if they feel that information given by you, your GP or psychiatrist warrants such. Your licence will then most likely be given back to you once you are deemed to be “a safe driver” once more, however, it will be a 12 month licence which means that you, your GP and/or psychiatrist will need to fill a form again within the 12 months. If you are unfortunate enough to be admitted into a psychiatric unit at any time, then, once discharged, driving is out of bounds until you show “3 months stability” – and you wait again for permission to drive. At the moment, the waiting time for DVLA to respond to your case once they have all the relevant information is 9 weeks ( getting the ‘relevant info’ having taken a good few months already of course!). They provide you with a letter, early on in this procedure, telling you that, while you wait for their reply, “if your GP states you are fit to drive then you may do so”. All of this, of course, in addition to the fact that if you use Diazepam or similar you must not drive anyway as the Police now have powers to drug test at the roadside.
Gets complicated doesn’t it?
Outstanding blog post! – opens up a new way of talking about these linked problems
There’s a different angle for you…………..”we don’t know if the trial might be asking the wrong question in the first place”
Picking apart the unpickable…
Does Murray Stewart really think that he can get off….that lightly
Full twitter feed with photo and ” and ” on Twitter @ GSK
GSK @GSK 6 hrs6 hours ago
We need to be fully transparent with how we work with healthcare professionals – Murray Stewart, our CMO, at #FTPharma
3 retweets 4 likes
• • GSK @GSK 6 hrs6 hours ago
Murray Stewart at #FTPharma on why patients need to be involved at the beginning of the clinical trial process
7 retweets 4 likes
• • GSK @GSK 6 hrs6 hours ago
We need to work with regulators to define relevant endpoints for patients – Murray Stewart @GSK at #FTPharma
2 retweets 8 likes
• • GSK @GSK 6 hrs6 hours ago
How do we get patients aware of how pharma can help them? We bring the patients in – Murray Stewart @GSK at #FTPharma
4 retweets 8 likes
• • GSK @GSK 6 hrs6 hours ago
We need to get doctors and patients to trust what we do – Murray Stewart @GSK at #FTPharma
I’m sticking this link here, because I’m not sure where else to put it – nothing to do with insurers – but a tiny gleam of evidence that maybe patients aren’t always a walk-over when it comes to selling them a drug.
Regarding the ‘female viagra’ – not quite the avid appetite for it from women as Valeant had maybe forecast? I’m sure that a heap more cash will be thrown at promoting the drug and that it might just be a slow starter – nonetheless heartening to see maybe women aren’t sold a pup all that easily…
As to Risk, I’ve just moved to a new town and plan to start with the naturopath here to get the lay of the land. That, plus swimming and riding my bike, eating organic food, making friends and making art, are my plan for health.
RIAT have delivered the Golden Egg, and, yet……
Interesting that on MIA, The Big Risk, wants David Healy to respond to comments when they are flying all over every article with comments……..
ben goldacre @bengoldacre Nov 15
ben goldacre Retweeted Sense About Science
Still no elaboration or explanation from @adbeggs over why he thinks asking 4 access to trial results is a bad thing
Very interesting! I was completely unaware of any of this!
Come in No. 15..
GSK @GSK 6 hrs6 hours ago
Thanks @raconteur for honouring our CEO, Andrew Witty, as a Brit who’s changed the world. Read more at http://gsk.to/1l7fLDT
In manner, something of the grand seigneur still clung to him, so that he even ripped you up with an air, and I have been told that he was a RACONTEUR [storyteller] of repute.
The Adventures of Peter Pan by Barrie, James Matthew
This is a Rxisk Story all by itself
Fiona F…what a woman
Nevertrustadoctor….a truer sentiment has never thus been spake..lying murderous bloodhounds…yet, the cold turkey approach got her off it…just…this is the thing
Face death, deal with it, move on….just like all doctors
FF Story in Scotland on Sunday, Newspaper, but, of course, it should be International on Everyday
Irish Corporation tax 12.5%
Beefing up its roster..
Only this morning I had conversation with someone about high cholesterol. A lot of attitudes are ” ill be ok because you can get tablets for it “. I say why do that when you can just eat healthier and they look at me gone out.
It’s madness. Your body is telling you to look after it a bit more, but why bother if you can take a tablet.
Whilst waiting for David Healy IAI, Mark Salter said:
If language is inherently unstable, then how can we hope to diagnose illness accurately?
Doesn’t ssri, benzo, statin use have a Lazy Way about it.
If a Psychiatrist or Gp doesn’t know what to do, then the ‘choice’ language they choose is ultimately the way you will go.
Choosing your Pill, custom made for You, is one way of doing it and yet the Rules are constantly and consistently being flaunted.
With Statins, it will Run and Run; you pays your money; you takes your choice
Typically or not typically:
“I thought I might give you a statin”
“You thought wrong”
GSK @GSK 15 hrs15 hours ago
We’re changing the way we work with doctors for the better. Here’s what happening in Europe: http://gsk.to/1N9FZw0
GSK @GSK 20 hrs20 hours ago
Dr Waheed Jamal on why we’re changing how we work w/ doctors. Here’s what we’re doing in EU: http://gsk.to/1N9FZw0
[Cough] BMJ 1977
ben goldacre ✔ @bengoldacre
Fab new WHO statement on data sharing in emergencies. Note background paper is by [cough] me +colleagues! #alltrials http://www.who.int/medicines/ebola-treatment/blueprint_phe_data-share-results/en/ …
Retweeted by Sam Downie
Centre for Evidence
Nuffield Department of Primary Care Health Sciences,
University of Oxford
Centre for Evidence
The World Health Organization commissioned this r
eport. The views expressed are those of the
, and are not those of the World Health Organization
. The authors have received funding from
the Medical Research Council, the National Institute for Health Research (NIHR), NIHR Diagnostic
erative, NIHR School for Primary Care Research,
, Laura and John
West of England Academic Health Sciences Network,
and the World Health
Organization. The authors have not accepted funding from any manufacturers of diagnostic tests
or services related to this report
. This is a draft report which due to the
been subject to internal peer review
Who is in/out of control…Boom. Boom.