Study 329: Big Risk

David Healy, MD
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Big Pharma

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?

Big Risk

The nineteenth century also gave rise to another profitable industry – the insurance 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 Marriage of Pharma and Risk

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?

big-insurance

The Shipwreck of the Singular

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 alone?

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 Robinson Crusoe.

Death Waits

BR1

“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.

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This article is adapted from DavidHealy.org

5 COMMENTS

  1. The biggest threat to our health is the corporate/capitalist system that puts profits before people. It’s the governments that seek to appease corporations (and their profit margins) instead of protecting the people.

    It’s not just “Big Risk” that’s the problem. It’s the entire system that’s the problem. It’s the status quo of power, profit, and control that’s the problem. It’s the psychopaths in power who are narcissistic and pathological liars who lack empathy, compassion, guilt, or remorse that’s the problem. The entire system (and the psychopaths who run it) are at fault, not any particular section of it. Fix the system, fix the problem. Attempting to fix one aspect of the broken system will be a band-aid solution at best.

      • I should have put my criticism in context. I’ve commented on a few of Healy’s articles and seen many others comment. But he never responds even when people have questions. I think if people are going to have their columns regularly appear on MIA, it would behoove them to actually engage in the discussion. One of the big goals of this site is dialogue among different people and groups. Maybe that’s why his articles seem to have been getting less comments recently, or at least as in this case, less directly relevant ones 🙂

  2. Hi David,

    “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…”

    When I first realized that, not only was my psychiatric treatment harmful (like most ‘patients’ I realized this from the first incarceration), but also likely to prove deadly, I sued – mainly to get the ‘treatment’ group to back off. What I found was that I was now at odds not just with psychiatry, but the medical union as a whole, right down through nurses and ambulance workers and, of course, members of the community for whom medical care was a motherhood issue.

    It was then that I assessed my actual dependence on the medical system. What had I actually gained from it in all these years? Taking out childbirth assistance (and it was very helpful, but not actually ever critical in my case – and it has never been lacking in society, medicine or not) NOTHING BUT – as you say – HARM.

    For me, there was a moment’s hesitation after this realization, then I thought, “I could risk it without these people.” Medicine at this point is a sell. It is not ‘saving us’ from death. We will die. Hopefully, it won’t be thanks to medicine either way.

    So…thanks for bringing that up so clearly.

    Write on…