Medicine, medicines and health
Keynote address at conference: THE ART AND THE CALLING
Williamstown, Massachusetts, USA, May 1998
I came to this conference two years ago and have recalled its spirit often. Since then, I have also been in regular contact with David Elpern who, more than anyone, makes these occasions happen. He is a rare bird: both as teacher and practitioner, a true messenger of medicine, with energy to match his commitment to health. I have been regularly reminded of this by flurries of E-mail from Williamstown which - in spite of the time difference between New and Old England - generally arrive before the morning call from Royal Snail Mail to my base in London.
Months back, David asked me to come and talk about the pharmaceutical industry and, in the moment, I agreed. It wasn't that I really wanted to talk about this, but I thought the topic negotiable and was determined not to miss the occasion. Many things make this an important event for me, and perhaps above all the active participation of so many prospective and established students of medicine. I value this both because it gives everyone the opportunity and incentive to propagate good ideas, also because I have been a professional student of pharmaceutical medicine, for over 20 years.
My work involves tracking and analysing small sectors of medicine, as part of a wider examination of corporate social accountability. I admit to being an irritating student, having no formal training in medicine and no clinical experience, no inclination whatever to stop writing, or graduate, being much inclined to ask pointed questions, and easily exasperated by evasive replies. Increasingly posted on the Internet, these questions tend to be sharp requests for information or explanation, mainly directed at the three main providers in medicine - professionals, pharmaceutical companies and government. (In Britain, government is responsible not only for drug policy and regulation, but for stewardship of the National Health Service as well).
I do not represent any patient or consumer constituency. My job is simply to raise issues that are of interest and relevant to medicine users - and fortunately, I can do this on an independent basis, free of obligation to vested interests. This is largely thanks to generous long-standing support from the Joseph Rowntree Charitable Trust - a Quaker charity, distinguished in the UK for its support for a wide range of groups which, like Social Audit, act as catalysts for social reform. In my field, the ability to operate independently counts as a real privilege, as increasing numbers of consumer and patient organisations become financially dependent on pharmaceutical company donations and professional resources.
I note that, in the United States, the month of May is the American Lung Association's Breathe Easy Month and the Asthma and Allergy Awareness Month as well. It is also National High Blood Pressure Month, National Stroke Awareness Month; and National Mental Health Month, including National Childhood Depression Awareness Day. I would imagine there is a fair amount of drug company money behind such initiatives. There usually is with asthma, hypertension and depression, and other conditions where long-term drug treatment is the norm.
Prozac for physician stress? It so happens that the main focus in my work over the last decade has been on psychiatric medicine, and specifically on drug treatments for anxiety, depression and mental distress. And that puts me in a difficult position at this conference, because physician stress is one of our main themes. What can I usefully say about this problem, when my main concern has been with the many physicians who habitually prescribe large quantities of drugs like Prozac and Valium, for stress in the community at large?
Suffice it to say that you might feel very disconcerted if I were to propose that such drugs might be the most appropriate treatments for physician stress. If so, you will appreciate why I feel very uneasy with the notion that the same such drugs will solve the problem of psychic distress in the community. The history of medicine has demonstrated the limitations of panacea-prescribing, over and over again. Bursts of epidemic prescribing of popular psychotropic drugs have always ended in tears. (Medawar, 1992)
Since the days of opium and heroin, all such panaceas have emerged as drugs of dependence, and their long-term effectiveness has proved pretty much an illusion. There is this concern too: the more people, individually, are helped by such drugs, the greater the danger that those drugs will sustain and promote the very conditions that led to their use in the first place. If they work, drugs like Valium or Prozac do so by raising tolerance to stress. To this extent they enable society to accommodate more stress. The effect, in the end, is simply to let more stress in.
There is no doubt that careful, short-term drug interventions do often help, though it much depends on the circumstances. You may recall how, in the late 1980's, the experts suddenly decided to recommend against the use of tranquillisers after bereavement. The rationale was that people positively needed to grieve and to try to adjust to loss and reconstruct their lives, desperately painful as that might be. Perhaps something of same would apply to many other kinds of distress, now routinely treated with drugs, for which there is an all too natural external cause.
But is there some clue to understanding physician stress in the tendency to prescribe large quantities of drugs intended to reduce community stress? I am not sure but - bearing in mind Balint's (1957) point, "that by far the most frequently used drug in general practice was the doctor himself", it is tempting to speculate that some sort of projection is going on. Could it be that some doctors are trying to cope with stress in their own work by prescribing Prozac or Valium for others, on a grand scale? I would certainly expect to encounter higher levels of professional stress in practices where such prescribing was the exception, rather than the rule - the reason being that physicians who look beyond simple solutions to extremely complex problems of course take much more on themselves.
For many reasons, it is hard to imagine any pill, now or ever, as a significant remedy for physician stress. What pill is indicated for the problem of working under intense pressure to do more and to get it right - or at least never get it wrong? What tablet would protect against infinite yet growing demands for treatment, not only for serious infirmities and complex problems, but also for quick fixes and endless enhancements to health? For the conscientious practitioner, it must sometimes feel like trying to survive on an island of sanity in an ocean of madness.
Nor would pills seem much good for resolution of the many conflicts at the heart of much physician stress. How does one cope, for example, with the completely paradoxical part of the human condition that makes us both infinitely puny and wonderfully complicated beings, at the same time? Where does one strike the balance between the impossible extremes of selflessness and self? And how can one ever be mindful of one's limitations, yet always try to exploit human potential to the full?
Part of being a physician will always be an impossible mission and, because of what the quest for health has become, I fear it will get worse. We seem to be losing sight of "health" as an integral part of our being; increasingly it is perceived as something to be acquired, rather than organically grown:
"Look to your health; and if you have it, praise God, and value it next to a good conscience; for health is the second blessing that we mortals are capable of; a blessing that money cannot buy" (Izaak Walton, 1593-1683)
Medicine, medicines and health I was asked to talk about pharmaceutical companies but, when the time came to write an abstract for the conference programme, I went for: Medicine, medicines and health. I think I can best explain why I chose this title in terms of the aversion I have to the word "healthcare". It seems to me to try to join these three ideas - medicine, medicines and health - in a somewhat brutish embrace. The word healthcare seems to imply some irresistible linkage between the three - as if medicine and medicines were the true source of health, and health the product of the other two.
The main thing I want to do in this talk is to try to tease apart these three - to ask you to consider medicine, medicines and health as three quite separate elements, albeit with some close links between them. To do this, I need to ask this question: to what extent do medicine and medicines not actually promote health as we would want?
The starting point is the recognition that, if medicine and medicines do make a net contribution to health, they have only just begun to do so. It is worth recalling that, for over two millennia, doctors have enjoyed a respected and privileged status in the community, in spite of the limitations of the invasive treatments used in the (not too distant) past:
"Somewhere between 1910 and 1912 in this country ... a random patient, with a random disease, consulting a doctor chosen at random had for the first time in history a better than 50-50 chance of profiting from the encounter (Henderson, 1935)
That was the picture until a few decades ago, and of course it makes one wonder how the practice of medicine today will be perceived, a few decades from now. We tend to believe that medicine now works dramatically better than in the recent past, but still there is cause for concern, and reason to believe that we greatly overestimate the health benefits that modern medicine and medicines bring:
"Without denying the value of the personal health services, or of the specific therapy which has been a notable achievement of the past forty years, it seems right to conclude that the main influences responsible for the decline of mortality - our best index of improved health - since deaths were first registered in 1838 have been, in order of importance, a rising standard of living, improved hygiene, and specific preventive and therapeutic measures" (McKeown & Lowe, 1974).
We should be concerned too about levels of iatrogenic disease - all the more so because we have pretty much failed even to measure its impact and extent. However, a recently published US survey suggests that adverse reactions to drugs count as one of the leading causes of death in US hospitals. They account for something of the order of two million serious events and 100,000 fatalities each year (Lazarou et al, 1998).
Incredible as it may seem, some fifty years after the founding of the NHS, there are still no definitive estimates available in the UK. I have asked the UK authorities about this on many occasions, but have yet to receive any credible answer. The evidence there is suggests that, as in the USA, 3-5% of hospital admissions are caused by reactions to drugs taken with therapeutic intent - over and above the problems which hospitalisation brings. Thus, in the UK, each year, prescribed drugs probably cause a few tens of thousands of deaths and a few hundreds of thousands of hospital admissions - plus a few million sometimes quite troublesome unwanted effects, those which affect ambulant rather than hospital patients.
For this reason alone, it must be worth bearing in mind the essential proposition of Ivan Illich (1976), that "the medical establishment has become a major threat to health". The point may seem bald and exaggerated, and begs angry denial, but it points to questions we ignore at our peril. To what extent do medicine and medicines not actually promote health? What benefits do they bring, and who enjoys them, and how do they relate to the risks we run? Such questions are especially relevant in the third world.
Health for all? I first started to work in this field in the late 1970s; heady days they were. At the World Food Conference in 1974, Henry Kissinger had promised that "within a decade no child will go to bed hungry" and, not long after, the World Health Organisation embarked on its campaign of "Health for all by the year 2000". Meanwhile, the holocaust grinds on - child deaths from hunger alone are equivalent to three Hiroshimas each week, or more.
Perhaps it was naive to believe in progress then, yet it was clear that the opportunities were there - and in Britain we had good evidence of the transformations that, with commitment, could be achieved. Less than a decade before I was born, half the population in Britain was officially classified as malnourished; Britain was a developing country by the standards used today. That changed even before the setting up of the National Health Service, 50 years ago.
Things changed in, and because of, the Second World War, with the introduction of national food policies including vitamin supplementation. It was called "food rationing" (which is how it was perceived by those who received less) but the redistribution did mean that most people were fed well enough. The upshot was that by the end of the War there were believed to be more cases of hypervitaminosis than of vitamin deficiency. Thus one might optimistically have concluded that "Health for All" was just possible - even if, in Britain, it took a war to make it happen.
Twenty years have now passed since WHO's benchmark conference at Alma Ata and the launch of the Essential Drugs programme. With it came the determination to attack irrational prescribing and drug use, and the great waste of resources and lives resulting from it. At that time, over half the world's population had no access to modern medicine, though well over half of all medicines were either positively undesirable or superfluous to need.In general, the situation is not much different today - but one exception is worth mentioning as an indicator of what can be achieved, at a manageable cost. Life expectancy in Cuba and the USA are identical, though the US Gross National Product is 250-higher than the GNP of Cuba (Footnote). Why? Crude as such comparisons may be, the question seems to me to raise fundamental issues about the nature and value of health - also about the location of the point of diminishing (and even deteriorating) returns.
Next tough question: are the health deprivations that are more typical of third world countries in any sense the consequence of health and other policies in richer parts of the world? In other words, is our meat their poison, and are the meat-eaters in some way to blame? The example of Cuba suggests that the answer is not necessarily so. On the other hand, it is hard to see how some Western policies would not have a marked effect on health in poorer countries - for example, excessive promotion and over-investment in medicines, rather than infrastructure; high drug prices; or the pretty single-minded focus in research and development on treatments for the diseases of affluence, so called.
And perhaps some glimpse of an answer may be found by comparing the WHO today with the organisation it was around 20 years ago. There is much evidence that things have gone downhill. The major changes I would identify include conspicuously diminished drive in major health development programmes, and staff demoralisation; acute sensitivity on all 'controversial' issues; increased dominance by the US and other major drug-producing nations (over half the WHO budget is provided by the top four countries); and a huge increase in commercial sponsorship and involvement.
For example, half the WHO mental health programme is now funded by "extra-budgetary contributions", much of it from companies with a direct stake in policy making and outcomes. Major donors to this programme include Eli Lilly (Prozac) and Hoffman La Roche (Valium etc).
With the appointment this month of a new Director-General, Mrs. Gro Brundtland, we have reason to hope that things may improve. Nevertheless, WHO is now subject to much pressure and dependent on the commercial sector for many of its programmes. A good starting point for the new administration would be to clarify how much is received in donations (in cash or kind) from each of the major sectors, and to explain what safeguards exist to avoid the conflicts of interest that surely may arise.
This needs to be known, because the output of some programmes may have a substantial, direct effect on drug sales. Some, for example, involve drug evaluation and selection, others involve the scheduling of drugs under the UN Narcotics Convention, and WHO's activities increasingly include drawing up diagnostic criteria and treatment guidelines. These are as good as blueprints for drug indications and market position.
Medicine & democracy It is central in this analysis that medicine tends to deliver health best when run on democratic lines. The need for real and equal participation was nicely made in a WHO Expert Committee report, some years ago, before the big decline:
"...science and technology can contribute to the improvement of health standards only if the people themselves become full partners of the health-care providers in safeguarding and promoting health ... people have not only the right to participate individually and collectively in the planning and implementation of health care programmes, but also a duty to do so." (WHO, 1983)
Medicine and democracy should be natural allies, even kindred spirits. They were, after all, born in the same cradle, in ancient Greece, over 2,000 years ago, and they are both concerned with the basics of community. Both medicine and democracy are intimately linked to human development and meeting basic needs, with rights to self-determination, and with the relationship between individual, communal and public interest. By linking these two, I want to emphasise that the guiding principles of medicine, defined over 2000 years ago, are not obsolete. They are as relevant today as the ancient tenets of democracy themselves.
Modern medicine was born on Kos, a small island just a couple of hundred kilometres from Athens - the birthplace of democracy - across the Aegean Sea. Kos was where Hippocrates practised, and he gave medicine its soul. He was a physician and surgeon; head of the medical school and the author of many of its books and writings. You will get some inkling of his importance if you can imagine having this said about you, 2,500 years from now:
"The content of the(se) books, the wealth of original observation, the unerring sense of what is relevant, would set them among the great works of genius. What makes them unique is the spirit in which they are written. They establish for all time how medicine ought to be practised and what doctors should try to be." (Wingate, 1985)
Hippocrates defined medicine as an art and a calling. Exploitation and superstition were rejected and doctors were distinguished from priests and sorcerers - as human observers, counselors and servants of the sick. The need for openness and accountability was fundamental to the kind of medicine Hippocrates had in mind.
If medicine is now moving away from democratic ideals, it is partly because these ideals themselves are becoming redefined - as we move towards the kind of democracy in which money and ownership count more and more, and the divisions between winners and losers grow. I do not see this as a healthy development, even for the supposed winners - both because health is a journey, not a race, and because it cannot be enjoyed in isolation. If the spirit of society is sick, ill-health is inescapable - other than through indifference, insensitivity or gross displacement.
Science and medicines Good medicines emerge from honest science. Some of it is, and brilliantly so, but most is not. By most, I mean definitely over half, and measurably so. These are some of the main problems there seem to be: high quality increasingly buried by unmanageable volume; recycling and repetition; high degrees of sponsorship, with control over study protocols; use of end points and surrogate markers of no real clinical relevance; a profusion of me-too studies which blur the distinction between marketing and medicine; in-house company writing machines which churn out investigators' reports; abstracts, summaries and conclusions which do not reflect results; short cuts, games of hide-and-seek and relentless evidence of nagging bias; methodological inadequacies; improper statistical treatments; and secrecy and non-publication of negative results. All of these are compounded by the unwillingness of regulatory agencies to reject evidence that is not fair or sound.
I can recommend two good papers which put flesh on these bones, and an excellent book (Moore, 1995), if you want sober but vivid illustrations of the detail.
One of the papers is a recent report of a formal audit of 100 company-sponsored trials, conducted by the ethics committee of the RCGP (Wise & Drury, 1996). This audit identified substantial problems, but the paper is especially memorable for a key point made almost as an aside: if it isn't scientific, it isn't ethical.
The other is a short report about the scrutiny of papers submitted for publication to The Lancet. This explains that once papers have been short-listed as "candidates for publication", they are given an independent statistical review - and that half of these papers fall at this hurdle, even after revision. This tells us a lot. Given that only a tiny proportion of the remaining 20,000 biomedical journals would undertake anything like such scrutiny, one may safely conclude that a random doctor reading a random report in a random medical journal is at considerable risk of not profiting from the encounter (and probably not realising it either). (Gore et al, 1992)
There is one other picture of this scene that I always pack - another fine idea from Lewis Thomas (1979):
"We do have some science in the practice of medicine, but not anything like enough. And although we have achieved, through the application of science, a degree of mastery over many infectious diseases formerly responsible for great numbers of premature deaths, the introduction of science into medicine did not really begin with the management of infection. Long before that event, some time in the middle of the nineteenth century, medicine showed its first signs of scientific insight by undergoing quite a different sort of professional transformation. It stopped doing some things" (Emphasis added)
Good science demands a high degree of accountability - and who knows what medicines really do, without it? Accountability is the all-important common denominator between medicine and democracy, a key ingredient to making medicine responsive to human need. Without it, medicine will always tend to fail.
Pharmaceutical companies And so I come to the matter I was asked to address, the pharmaceutical industry, though I have already said most of what I want to say.
I can see why David Elpern wanted me to talk about the drug companies and what they get up to, and I share his many concerns. The pharmaceutical industry now has colossal power and influence over the conduct of medicine and the distribution of health. Quite simply, industry now rules medicine, albeit often through proxies: pharmaceutical companies have a legendary reputation for letting other people get its own way. Industry money gets everywhere. Companies have now gone beyond supporting and rewarding clinicians who promote their interests and recommend their drugs. Company money is now finding its way into formal determinations of the meanings of health and illness, and official guidelines for diagnosis and treatment - not to mention the expression of consumers' views.
So why did I hesitate to take this topic on? One reason is that, like all things in life, medicines and manufacturers comprise a mix of good, bad and indifferent - and responsibility for the real damage done doesn't lie at any single door. The worst of it has more to do with a culture of medicine - itself part of a wider culture - which is undermining confidence in health. I was also reluctant to go deeper and deeper into a diagnosis without also suggesting something of a prescription - when pretty much convinced that the remedy, whatever it might be, is not to be found through self-regulation.
True, many honourable individuals work for drug companies, but I cannot see such organisations effectively policing themselves. By analogy, I think of trying to prevail upon a cat not to chase mice - the point being that it wouldn't be a cat if it willingly refrained. Just as the cat is programmed, so pharmaceutical companies are. They have a job to do; it is to sell drugs, and their self and survival depends on it. At the end of the day, companies are rigidly dedicated to this, and can be relied on to use every legitimate means to do so. This naturally includes working to change the law to accommodate their interests and needs.
It seems to me that solutions can only come as part of a wider recognition that, as a general rule, true health implies independence of medicine, and that moderation in the pursuit of health is most likely to succeed. There are of course many good and useful medicines but again, collectively, they have paradoxical effects. For the more medicines seem to work, the more they tend to reduce our confidence in our own bodies. When companies exaggerate the benefits of their products and our need for them, it undermines the public health, reinforcing the belief that health means taking something, several times a day:
"It is extraordinary that we have just now become convinced of our bad health, our constant jeopardy of disease and death, at the very time when the facts should be telling us the opposite ... The trouble is, we are being taken in by the propaganda, and it is bad not only for the spirit of society; it will make any health-care system, no matter how large and efficient, unworkable. If people are educated to believe that they are fundamentally fragile, always on the verge of mortal disease, perpetually in need of support by health-care professionals at every side, always dependent on an imagined discipline of 'preventive' medicine, there can be no limit to the numbers of doctors' offices, clinics, and hospitals required to meet the demand. In the end, we would all become doctors, spending our days screening each other for disease.
"We are, in real life, a reasonably healthy people. Far from being ineptly put together, we are amazingly tough, durable organisms, full of health, ready for most contingencies. The new danger to our well-being, if we continue to listen to all the talk, is in becoming a nation of healthy hypochondriacs, living gingerly, worrying ourselves half to death" (Thomas, 1979)
Medicine still has a lot to learn from that old adage about the fundamentals of development. Do not give your patients a fish; teach them how to, instead.
Conclusion This being the rather special kind of conference it is, I would like to close by reading a poem. It has no title. It is by Sheenagh Pugh:
|Sometimes things don't go, after all,|
|from bad to worse. Some years, muscadel|
|faces down frost; green thrives; the crops don't fail|
|sometimes a man aims high, and all goes well.|
|A people sometimes will step back from war;|
|elect an honest man; decide they care|
|enough, that they can't leave some stranger poor.|
|Some men become what they were born for.|
|Sometimes our best efforts do not go|
|amiss; sometimes we do as we meant to.|
|The sun will sometimes melt a field of sorrow|
|that seemed hard frozen: may it happen to you.|
M. Balint, The doctor, his patient and the illness (London: Pitman Medical, 1957)
S.M. Gore, G. Jones, S.G. Thompson, The Lancet's statistical review process: areas for improvement by authors, Lancet, 11 July 1992, 340, 100-102.
L. J. Henderson (circa 1935), attributed in H.L. Blumgart, Caring for the patient, N Eng J Med, 27 February 1964, 270, 9, 449-456.
I. Illich, Limits to Medicine - Medical nemesis: the expropriation of health (Harmondsworth, Middlesex: Penguin, 1976).
J. Lazarou, B.H. Pomeranz, P.N. Corey, Incidence of adverse drug reactions in hospitalised patients, JAMA, 15 April 1998, 279, 1200-1205.
T. McKeown, C.R.Lowe, An introduction to social medicine, 2nd ed., (Oxford, Blackwell Scientific Publications, 1974), 16.
C. Medawar, Power & Dependence - Social Audit on the Safety of Medicines (London: Social Audit, 1992).
T.J. Moore, Deadly Medicine, Why tens of thousands of heart patients died in America's worst drug disaster (New York: Simon & Schuster, 1995)
L. Thomas, The Medusa and the Snail: More notes of a biology watcher, (New York: Viking, 1979).
WHO Expert Committee: New Approaches to health education in primary health care; TRS No. 460 [Geneva: World Health Organisation, 1983].
Wingate P: Medical Encyclopaedia (Harmondsworth: Penguin, 1985), 220
P. Wise, M. Drury, Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners, Brit Med J, 16 November 1996, 313, 1245-1248.