Pharmageddon (25 page)

When faced with evidence that guideline-mandated treatment with statins, antidepressants, or drugs for osteoporosis fails to make a difference, guideline makers sometimes attribute this failure to a delay in instituting treatment. In July 2008 the American Association of Pediatricians issued a new guideline on the health of children. It recommended screening children as young as eight years old for raised cholesterol levels, and then possibly instituting treatment with a statin.
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The promise is held out that catching people ever earlier will make a difference. Similarly, advocates of mood stabilizers commonly attribute the failure of their drugs to make a difference to the delay in starting the drugs, and they suggest catching and treating ever and ever younger children. Once the disease takes hold it is supposedly more resistant to treatment.

It seems strikingly difficult for clinicians and others to ask whether robust independent assessment of drugs can be undertaken in a world where data is privately held. The reviewers for the NICE guidelines on pediatric depression teetered on the brink of making this point but backed down. The point was finally made in January 2011 by the Cochrane Center reviewers of Tamiflu, who made it clear that in the current circumstances we have little option but to recognize that independent assessment of drugs is not possible.
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There has so far been a deafening silence from Western governments, all of whom have handed over billions of dollars to stockpile a remedy little better than one of the proprietary nostrums from the nineteenth century.

Some years ago, there was consternation in the Lake District of Britain, an area known for its narrow country roads and stone walls, as a growing number of juggernaut haulage trucks came roaring off the motorways and down the narrow roads, knocking over walls, getting stuck in the middle of towns and sometimes damaging property. The drivers were on autopilot. Alerted by their satellite navigation systems to delays ahead and advised of alternate routes, they followed the guidance. Putting patients on every drug indicated by a guideline—guidelines drawn up for diseases rather than for people—demonstrates a comparable blindness. The consequent polypharmacy constitutes a disorder in its own right if not an illness. Getting people off their medications has been demonstrated to reduce hospitalizations, reduce costs, and save lives.
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But doctors adopting this approach are getting and will get the sack, unless they can appeal to a guideline for treating people rather than diseases.

Some of us put on a guideline-mandated treatment will know when the new treatment is causing us problems; at that point surprisingly few of us have the fortitude to insist that the treatment be changed or stopped. Children have an even more difficult problem. Their complaints have to be filtered through a parent, who may be no more likely to think a doctor would do anything that might harm their child than once they might have thought a cleric capable of abuse. Children are even more likely to be hostages than was Bill when he was put on an ACE inhibitor after his stroke or Sheila when put on a statin after her cardiac event, or as the case of Aliah Gleason, forcibly removed from her family and treated according to the latest guidelines, demonstrate.

Sheila, Bill, Aliah, and the rest of us are increasingly faced with doctors who are treating diseases rather than treating us. There are no guidelines for treating us. There are only guidelines for the treatment of cholesterol levels or diabetes or depression. These doctors are caught in the pincers of an apparatus which is now being used to give us diseases and indeed often several different diseases at the same time. This apparatus has twin pincers—one pincer lies in the guidelines, the other is formed by a series of measurement technologies that now are being used to make us ill in ways we weren't before. It is to these measurement technologies and how they are used that we now turn.

6

The Mismeasurement of Medicine

When Jane, a woman forty-five years old, became increasingly wheezy she went to see her primary care doctor. He got her to blow into a peak flow meter, which measures the amount of air one can breathe out. She had asthma, he said, and prescribed a beta-agonist inhaler, called a reliever, that commonly has a dramatic effect on wheeziness. Even people who do not have asthma can feel they are breathing more freely after a puff of one of these inhalers. Treatments for asthma are among the current medical blockbusters, with a market value over $10 billion. Jane was also given a steroid, called a preventer, aimed at damping down the inflammatory responses that lead to asthma.

The reliever provided instant aid when she wheezed, but over the course of some months her problems get worse. Her peak flow dropped from the normal 500 liters per minute to close to 200, and sometimes she turned blue. On referral to a respiratory clinic, the specialist and nursing staff told her that it was impossible that the reliever could be making her problem worse. She was prescribed one of the latest asthma blockbusters, Advair, an inhaler that combines both a reliever and a steroid.

At subsequent clinic visits a further blockbuster, Singulair, a leukotriene antagonist, was added. In Jane's case, this produced only side effects.
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Older agents were added to the mix, but these only made her sick. Her physician started talking about experimental techniques not in common use.

Jane had had no problems before moving to the area, and her profile of blood tests suggested an allergic component to her problem. Accordingly she eliminated certain foods from her diet and took a variety of supplements which appeared to help marginally. But the clinic seemed uninterested, she felt.

She tried a new doctor, who took her off the combined inhalers and Singulair. The mainstay of her treatment became a different steroid given alone. She improved dramatically, but her new doctor didn't seem interested either in tracking down the circumstances that made her problem worse.

Dick's case was a bit different. He was eighty–one when referred by his generalist to a respiratory clinic with an atypical wheeze. A reliever inhaler made little difference to his peak flow rate, which was in fact better than that of most twenty year olds. Nevertheless, he ended up with not just a reliever inhaler but a series of other asthma medications. Dick did not have asthma, though. His breathlessness was caused by a disturbance in the movement of his diaphragm (a respiratory dyskinesia), probably caused by a previous treatment for nausea. The only treatment for a respiratory dyskinesia is time and avoiding any unnecessary treatments, such as treatments for asthma, which worsen the problem.

Until recently, asthma was relatively uncommon. It was found most often in children, who usually grew out of it. Later-onset asthma was a serious but rare condition. The first concerns that treatment might aggravate the condition and even lead to death were raised in the late 1970s, coming to a head in New Zealand in the early 1980s.
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These concerns might have been expected to slow the rate of diagnosis, but clinics now register cases as asthma, even ones as grossly atypical as Dick's, at a much greater rate than previously.

Many of us may suspect that synthetic chemicals, perhaps ones we're not being told about, could be causing conditions such as asthma.
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Although toxins may play some part in the current epidemic, there is another, altogether more visible culprit at work as well. Coincident with the rise of asthma over the last thirty years has been the emergence of peak flow meters, which have given rise to norms according to which many of us are diagnosed as asthmatic though a doctor forty years ago would never have diagnosed that disease in most cases. In the 1980s, the companies marketing treatments for asthma provided peak flow meters to doctors. As a result many of us are now only one bout of wheezing or coughing away from our GP discovering we have reduced peak flow rates and then putting us on inhalers, which might initially make us feel better, whether or not we have asthma. This response cements the diagnosis in place. We will also be sent home with promotional literature sponsored by some company advising us to keep a daily chart of our peak flow rates and to increase the amount of medication we take should the readings fall. Every time we take an inhaler, we will be able to see our own peak flow rates “improve,” trapping us into a medication cycle as Jane was.

It's hard to fathom the apparent lack of medical concern demonstrated in the continuing prescription of beta-agonist inhalers in the face of study data showing an excess of deaths on these inhalers compared to placebo.
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Such lack of concern likely stems in part from the very visible short-term benefits doctors find in their patients' peak flow figures. This seems to trump all else—even death. This chapter is about the lure of such measurements on the ability of doctors to care for us.

CARING AND MEASURING

Medical matters and health in general are now among the leading media items, whether in newspapers and magazines or on television or the Internet. These are surprisingly recent developments. Only a few decades ago, healthcare was at the margin of our social awareness. There were no health pages in newspapers, no magazines devoted to health, no television or radio programs about health issues, and relatively few books about health in bookshops. But now medical breakthroughs or concerns about diseases regularly dominate the headlines. The issues may be far removed from blockbuster drugs, focusing instead on healthcare reform, insurance coverage, rising costs, or the latest pandemic of swine flu or other disorder, but the marketing of pharmaceuticals has done more than anything else to make health in general the front page news it now is.

The influence of company marketing on this shift has been profound, although not necessarily because the treatments we hear about work. In fact the less effective the treatment, the greater the need for marketing support, including a marketing of the conditions that a drug might treat. For over three decades pharmaceutical companies have been more likely than any other players within the medical arena to retain public relations companies to ensure that we all get to hear the message of salvation through the use of one or another pharmaceutical or to hear experts counteract some story that a company thinks likely to undermine sales of their drug.

As health hits the front page of our lives and healthcare becomes an ever bigger business and an arena of increasing competition, healthcare managers, clinicians, and drug marketers are faced with problems of increasing complexity. This is an arena where differing values linked to ethnic, social, or religious backgrounds, or based on class and gender, clash. Trumpeted as providing gold standard evidence, randomized controlled trials, along with the apparently objective evidence that comes from measurement, seem to offer an alluring solution to some of these complexities. These measurements have brought a standardization to medicine that has transformed the meetings between doctors and patients as well as the nature of modern medical care.

Up to the 1960s in United States and even more recently in Europe, a patient walking in to see a doctor encountered a man in a white coat, perhaps even a suit, possibly with a stethoscope dangling around his neck. Patients might have been aware of themselves as the object of attention of what social scientists in the 1960s began to refer to as the clinical gaze. Social scientists and even many physicians had a number of problems with this clinical gaze. At its worst it saw a specimen rather than a person. It noticed pallor, odd breathing patterns or fetid breath, abnormalities of gait, a lump in the throat, a mole on the skin, the shake in a hand, but might be blind to the person's social circumstances, history of difficulties, and experience of disease. But at its best, the clinical gaze encompassed all of these things, in part because of a relationship between doctor and patient that meant the doctor was noticing differences from one visit to the next, had learned more about the person and the person's family over time, and knew a lot about the circumstances in which they were living.
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There was a clear link between this kind of doctor and doctors like Richard Cabot and Alfred Worcester from Massachusetts, over half a century earlier.

The doctor's interest in a patient's physical state might lead to the use of instruments to directly observe things—a stethoscope to listen to breath and heart sounds, perhaps an otoscope to look in ears or ophthalmoscope to look in eyes as symptoms required. Otherwise it was hands on—a feel of the abdomen to rule out acute organ pathology, a check of the glands, a tapping of the chest. A hand on the forehead to check temperature was often used rather than a thermometer. Even in teaching hospitals, like Massachusetts General, that had made their reputations on the back of diagnostic tests introduced by Richard Cabot and his successors, measurements in general were still only taken when evidence for a specific disease was being sought. The first changes to this practice came with the use of blood pressure cuffs in the 1960s in yearly insurance check-ups—but these were marginal to normal medical care. Through to the 1960s the patient might leave a doctor's office without anything being measured.

Now, medical consultations will include assessments of blood pressure and weight, and blood tests for sugars and cholesterol. In the case of women it might involve a referral for a bone scan or mammogram, or in men a screen for prostate-specific antigens. There may be some listening to breath sounds, but the person will also be invited to blow into a meter to establish their peak flow rate. While waiting to see the doctor they may have been invited to complete a series of general health questionnaires or answer questions related to mood or other aspects of their mental health.

Although doctors of an earlier time could rightly be accused of missing critical aspects of their patients' lives, today they are much less likely to notice a difference in gait or pallor that the doctors of yesteryear would have spotted, if only because the patient is less likely to see the same doctor from one visit to the next. The clinical gaze is now more akin to being on autopilot. It doesn't really matter which doctor is present. Any medical person could consult the numbers from the previous visit, even a holiday stand-in just jetted in from New Zealand. The doctor's horizon is often now numerical rather than personal.

The key group we will follow in this chapter are people who walk into a doctor's office thinking they are normal but whose “numbers” are not quite right on that day. These numbers put us at much greater risk of becoming patients than ever before. Just how this can depersonalize us becomes clearer in the case of anyone who has a chronic disease such as diabetes, hypertension, or asthma. In these cases, the disease cannot be cured but some set of numbers can be put right or at least adjusted, and doctors increasingly focus on this rather than on the messier business of what it might mean for their patients to have to live with this condition. The patient may be worried about a lot of things stemming from his illness; but the doctor looks at the computer terminal for last week's blood results, perhaps consoling herself by thinking that while she may not be addressing what is really bothering the patient, she at least is reducing the risk of problems that might bother him in the future. The fact that some numbers are going in the right direction will do something to ease her concerns about possible side effects the patient may be suffering.

She can also take comfort in the likelihood that an increasing number of her colleagues would endorse her approach. She is meeting acceptable standards of care—standards that are intimately tied to the emergence of guidelines in the 1990s but in daily practice also driven by the measurements doctors now take in clinics—often in lieu of talking to us.

STANDARDIZED MEDICINE

The roots of standardization can be traced back to the establishment of alphabets, or to the units of measurement that enabled a trade in agricultural goods, or the units of time that replaced earlier ways to map the day. In all these cases a standard approach offers a structure that facilitates interactions between communities and allows agreed-upon comparisons between things that were formerly distinct, although it may override what seem like more natural and seasonal rhythms. Some aspect of a primal Eden may be lost, but a lot is gained.

From ancient China to the modern day, those in favor of establishing more standards or spreading the reach of existing ones have proclaimed that they are needed to stop rogues. Those against increasingly elaborated standards argue that they can just as easily facilitate greater roguery and that they have a deadening effect on human interactions. Those in favor of a greater stipulation of standard procedures in medicine argue that they lift it out of parochialism, while those against argue that standards will ultimately reduce medicine to a cookbook exercise, often at the patient's expense.
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Prior to the development of clinical trials, medicine was one of the preeminent professions. While still prestigious, based on the technical accomplishments of heart surgeons during the 1970s, for instance, and probably better paid now than before, there has been a profound change in the degree to which a doctor can exercise discretion—once the hallmark of a professional. When you met a doctor in the 1960s you did not question his judgment or if you did, the likely response was that he would be happy to have this discussion with you when you had been through ten years of medical training.

For a state wanting to ensure good medical care for all its citizens, or for a health delivery organization keeping an eye on the legal and financial sides of its business, or for many of today's informed consumers of healthcare, the idea that you might get a completely different treatment if you go to doctor A rather than doctor B is close to insupportable. Advocates of good medical care of this kind viewed traditional medicine with its great variability based on professional discretion as something closer to a cottage industry in which patients all too often had to endure both their illness and their doctor. They see a resistance to standardization as something less than noble—an attempt to hold on to private practice—and wonder if the art of medicine in question isn't a cover for laziness and old boy networks.