by Dawn Garisch
What interests me is that some doctors with whom I broached the subject of bribery and corruption looked puzzled. They looked at me as though I were a bit weird in the head. They promptly changed the subject.
Back home, I discussed the matter with a colleague who I know is critical of the pharmaceutical industry's ploys. He pointed out that it used to be much worse, before the government passed legislation limiting the excesses. Back in the ‘good old days’, drug reps flew doctors and their spouses to game reserves in private jets, and bought new tyres for doctors' cars. As a drug rep told me, back in those days they would do almost anything to persuade a doctor to prescribe their product preferentially.
This is how crazy it gets: a company that manufactures medication for indigestion offered surgeons and their partners a trip down the Orange River, while a rival company offered surgical couples a weekend flight to Johannesburg to see a rugby final. After these outrageous bribes, which product would they prescribe one wonders? The competing products are essentially the same.
This is one of the reasons why health insurance is so expensive. The medical aids must know that this is happening, yet they don't protest. Deceit and deficiencies are embedded in the matrix of our society. It is so pervasive, it is passed off as normal.
19. Seeing and Believing
… humanity / In gloves / and chains.
Mxolisi Nyezwa76
Scientific method has led to evidence-based medicine (EBM). EBM is the practice of medicine using only those investigations and treatments that researchers have proved are valid. The intention is to provide reliable information from which clinicians and patients can decide on the best solutions for health problems. This is an excellent goal. No-one would want an out-dated treatment if there is a better option available.
EBM straddles several crucial questions:
• Does the treatment do any good?
• Does it do harm?
• Does it do significant good, and is the harm minor?
• Is it an advance over what is already available?
At first glance, this might appear a simple matter, but it is not. There is an art in research to answering these questions truthfully. There are many ways a study can founder. If it does, all the time, effort and money spent can come to nothing. Even worse, if no-one picks up the error, false results might be incorporated into policy or guidelines, which can affect the health and general welfare of millions of people. The responsibility to yield accurate findings is enormous.
In 1993, specialist groups convened to draw up guidelines to eliminate errors in drug trials. The Consolidated Standards of Reporting Trials (CONSORT) has a checklist of twenty-two items to assess the quality of randomised controlled trials, or RCT.
Bausell77 offers some simpler criteria that rule out the worst offenders:
• Subjects must be randomly assigned
• At least fifty subjects per group
• Less than twenty-five per cent dropout rate
• Publication in a high-quality prestigious, peer-reviewed journal
Ideally, those who engage in research do it because they are curious about how and whether something works and because they care about the betterment of humankind. But the temptation to fiddle results or ‘massage’ the data not only stems from those who stand to gain financially from a positive result. Researchers are under enormous pressure to publish. At stake are their chances for securing promotion as well as funds for future research. Some need to please their bosses, or to finish their degrees, or add a line to their CVs so as to market themselves.
For a doctor to keep up with the latest findings, and to sort out which are relevant and reliable, is a nightmare. Over two million articles relevant to medical practice are published every year. To keep abreast of discoveries in their field alone, doctors would have to read nineteen articles a day. This is impossible; instead, they read meta-analyses – overviews of all the recent studies looking at, for example, the treatment of osteoporosis.
The authors conducting the meta-analysis search for all articles on the subject published within a certain time frame. Editors are supposed to scrutinise articles before they publish to check whether the researchers used sound methods. Yet meta-analyses regularly report that they had to exclude studies with faulty design. When one considers the time, effort and expense involved in conducting studies, and how many are shown to be invalid, it is a shocking waste.
Even when studies are sound, this does not guarantee publication. The meta-analysis of trials looking at twelve antidepressants found that antidepressants were more effective than a placebo. On closer scrutiny, many studies showing that antidepressants had no advantage over a placebo had not been published, thus skewing the perception of doctors and the public.
The authors of this meta-analysis concluded: ‘We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients. ’78
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In a recent and damning case, a new non-steroidal anti-inflammatory drug (NSAID), rofecoxib, was marketed as a major advance over the older NSAIDs. The manufacturers claimed that the new medication was not only more effective, but that it caused fewer side effects. Encouraged by the hype, and anxious to avoid the side effects of gastro-intestinal haemorrhage in their patients, doctors prescribed the wonder drug in truck loads.
My colleagues and I were shocked when rofecoxib was withdrawn from the market due to convincing evidence that its use had caused cardiovascular disability and death in users at a significantly higher rate than that of the general population. Even more reprehensible is that the authors of the original study failed to represent accurately the adverse effects on the heart that had emerged during the trial.79
Evidence can be problematic for reasons other than corruption. An example: there is clear evidence to treat a patient who has a stroke caused by a clot to the brain. If he receives intravenous medication to dissolve the clot and restore blood circulation, he has a much greater chance of complete recovery than if he does not receive it. But we also know that he has a small but significantly increased chance of dying of a bleed into the brain caused by that same medication. Science cannot tell you on which side of the line you will fall.
Another reason why a well-conducted trial might not yield trustworthy recommendations is that there are strict rules about excluding participants. Researchers set up trials to investigate whether one specific treatment will yield one measurable result. They frequently exclude children, the elderly, and anyone who has any disease other than the one under study.
In the real world we need answers that apply to everyone. Real people can have more than one condition, and this might impact on the drug's efficacy or toxicity. An oral vaccine like polio drops might be poorly absorbed by a child with a gastrointestinal disease. Or someone on treatment for heart failure might respond differently to someone who is not, when exposed to a new drug. Research settings do not mirror the real world.
In the UK, the National Institute for Health and Clinical Excellence (NICE) helps medical practitioners through this minefield. The chairperson, Professor Rawlins, is of the opinion that: ‘Randomised controlled trials (RCTs), long regarded as the “gold standard” of evidence, have been put on an undeserved pedestal.' He says that their appearance at the top of ‘hierarchies’ of evidence is inappropriate; and ‘hierarchies, themselves, are illusory tools for assessing evidence [and] should be replaced by a diversity of approaches that involve analysing the totality of the evidence-base. ’80
Jeffrey Bland, medical doctor and faculty member of the Institute of Functional Medicine, suggests a different model for evaluating a therapy's safety and effectiveness, derived from systems biology. Rather than attempting to control for all differences between two po
pulations being studied, so as to assess the role of one intervention, this model allows for study participants to engage in real world activities of daily living. Through the computing power of the twenty-first century, the captured complex data sets can be assessed using pattern recognition and cluster analysis.81
In brief, he is describing a dynamic way where the idiosyncrasies of an individual on any treatment can be evaluated as to whether he is benefiting. In the future the cumbersome, expensive, drawn-out and restrictive approach of traditional EBM must give way to another more inclusive and useful method of finding out whether care is effective or not.
Bland recommends that doctors listen to the patient's story in order to develop a response to it: ‘The approach to complex systems might be much more profound than just trying to pound a round peg into a square hole and get a singular diagnosis. ’
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Scientists change their recommendations as new evidence comes to light. For years we told patients that egg yolks contain too much cholesterol, and that it was unhealthy to eat more than an egg or two a week, particularly if you have a disorder of fat metabolism. We have since discovered that the cholesterol in egg is a kind that is not well absorbed by the human intestine. We are back to eating eggs every day if we want to, and the scientists have egg on their faces.
When scientists ‘change their minds’, it is easy for people reading the newspaper to discount medical advice as arbitrary. The problem with these criticisms, essential as they are, is that they lead some people to an undifferentiated distrust of things scientific. The baby is out, along with the bathwater.
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20. Sickness and Health
If this desire to sacrifice my own wants was so strong, I was faced with the paradox that perhaps what I wanted most to do was not to do what I most wanted to do. I knew many people of whom this seemed true, as soon as they had a moment to themselves free from obligations, they would rush off to find another obligation, someone else or something else to sacrifice their lives to … I noticed that these same people very often had periods of recurrent illness when they were forced to attend to themselves.
Marion Milner82
Penicillin, the first manufactured antibiotic, was formally discovered a mere seventy years ago by Alexander Fleming. Antibiotics are substances that kill or inhibit the growth of bacteria. This discovery was a major advance, in that people who developed severe infections such as pneumonia, septicaemia, mastoiditis, pyelonephritis, diverticulitis, peritonitis, cellulitis, meningitis, and sexually transmitted diseases, which in many cases would result in death or severe disability, could now be helped to recover fully.
Even in those days Fleming recognised that antibiotic resistance was a potential problem, and he cautioned against indiscriminate use. Despite this, both doctors and patients have come to regard antibiotics as a quick fix, even using them when it is obvious that an infection is viral (I know it is going to go to my chest, doctor; it always does if I don't get an antibiotic).
At a recent conference, a chest physician lectured us on the increasing problem of antibiotic resistance. This will present a serious challenge in the time of our children and grandchildren. One of his recommendations is that doctors should only script antibiotics after ten days of symptoms in sinusitis, throat and ear infections, unless the patient is deteriorating.
What this physician is prescribing is the age-old remedy called the tincture of time. He is reminding us that not all bacterial infections require antibiotics. He is suggesting that the GP dispense reassurance. But many patients come to their doctor expecting to receive something more tangible than that. The doctor is the keeper of the goodies, and they want some.
Many of my patients lose patience after only two or three days of illness. Ten days away from work, sport and the busy routine of life feels too out of control. They tell me they ‘can't afford’ to be off work. There is nobody to take their place when they are off sick, so the work-load just mounts up, and is still there on their return. They are at breaking point, which is a major reason why they are ill in the first place, yet they see illness as further complicating their busy schedule.
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Both the health industry and the New Age movement recommend that we strive for health, wholeness, wellness, centredness and living a well-balanced life. This book too might stop at that. It may seem like a good idea, but on closer examination, this approach excludes suffering and death. Having wellness as a focus can feed our denial. We forget that one day our flesh will decay back into the earth. We forget that our bodies are groaning under the strain of the contemporary mode of living.
If we are interested in the truth about life, we need to question whether it is symptom-free. I am grateful that we have remedies to help people who carry more physical and mental anguish than they should have to bear, yet I question the modern idea that life should flow smoothly that problems should be vanquished as soon as possible, and that everything can be fixed with a pill. Slowing down, going to bed, withdrawing a while from the bustle of society, paying attention to the inner rather than the outer – these could have benefits not immediately apparent.
Illness and disability, like most other crises, stop us in our tracks. They force us to pay attention to our bodies and our inner reality. In bed, or hobbling round, we are taken out of the collective and forced into the margins of life. We are no longer productive or useful, and so we become failures in our own or in society's eyes. We are left with a cup of tea while others rush back to their obligations. We are left alone.
Artists, other than those in theatre or dance, have to be alone. There are artists whose aloneness has been accentuated by chronic illness, and who have harnessed their suffering in service to their art. Frida Kahlo, for example, had polio at six and later a tram accident left her leg and spine injured, resulting in thirty operations. Her self-portraits gave her a means to express these experiences, and to develop the images of her wounded and courageous life.
Jung suggests that being alone is the primary doorway into one's own being. ‘I know from experience that all coercion – be it suggestion, insinuation, or any other method of persuasion -ultimately proves to be nothing but an obstacle to the highest and most decisive experience of all, which is to be alone … The patient must be alone if he is to find out what it is that supports him when he can no longer support himself. Only this experience can give him an indestructible foundation. ’83
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If finding out who you are and what it is you need to do while on this earth is a worthy quest, it is one that is very likely to lead you astray from the norm. As children, we take so many things for granted. Our brains and outlook are shaped largely by the beliefs, attitudes and environment we were brought up in. If the human spirit were simple, we would all fall into line and live happily ever after. But, even within a relatively homogenous group that has the same outlook and goals, there always emerges some impetus to tip the status quo. It seems that humans are inherently curious and challenging beings. Whether it is stamped into our genetic code or propelled by spirit, we look for information outside the known. Often that brings us into conflict with the established ways of doing things.
Programmes and interventions based on achieving peace have never worked for long. Peace is a temporary state which might be achieved briefly when a conflict is resolved, before the next challenge arises. For peace to be a steady state, it implies that those who disagree with the dominant ideology or situation must find a way to be compliant and not rock the boat, which will at the very least set up conflict within themselves.
People are interested in conflict. We know this because the basis for a good story is: ‘there is a person who has a problem’.
Joseph Campbell's book, The Hero With a Thousand Faces84 looks at myths and stories across time and culture, and identifies common aspects of the journey that the central character, or hero, takes to reach his or her goal. Heroes sometimes do not reach their goals, or reach a different goal than t
he one they set out towards. Heroes can unwittingly set out on a course of action, or have a crisis thrust upon them. Often the protagonist first has to overcome something in herself before she is able to overcome the external difficulty.
Stories are the earliest way that humans tried to make sense of the world, who we are, why we are here, and what we are supposed to do about it. Handed down the generations, stories impart information about life and how to live it. We read because we want to find out how other people have messed up their lives, and what happened next. Any story that does not deal with human imperfection will not have a large print run, if it gets printed at all.
Illness and accident are disruptions of peace or the norm. They are motive forces, even as they confine you to bed. They are part of what inspires the hero's journey.
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We might declare that we want to ‘be normal’. But ‘normality’ is merely one of many ways of being and behaving; it means middle of the road, average, or median.
There is a place and a time for choosing normality, but if you are to fulfil your unique potential, you are going to follow some private impulse and end up out on a limb, out on your very own branch, far from centre and the collective, and overhanging the terrifying abyss.
Mindell claims that chronic illness is one of the means through which the motif of your life is revealed.85 Illness, by interrupting your own or your culture's preconceived ideas about which direction to pursue, can lead you away from what's ‘normal’, and into your own version of a life well lived.
The psychoanalyst Lyn Cowan86 suggests that striving for wholeness (implying health and harmony) and balance is a kind of madness. She says the idea that it is possible for humans to attain a state as symmetrical as a mandala is a self-deception. She points out that unique expression is eccentric – it is not an idealised sphere. It is a wholeness that is asymmetrical. ‘He is a real character’, we say of someone who sticks out in the crowd -not because of fame or status or riches, but merely because he is not afraid to be entirely himself. So it should be. We should all be real characters in the stories of our lives.