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.¹ 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.² 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.³ 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.⁴ 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.⁵ 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.⁶

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.

There is a tricky balance here. In chapter 3, I praised the efforts of Philippe Pinel and Pierre Louis to monitor the outcomes of treatment in nineteenth century France. The response from French physicians at the time was to rail against attempts to standardize medical practice. At the start of the twentieth century in Massachusetts, the new diagnostic tests introduced by Richard Cabot and others led Alfred Worcester to complain that too great a focus on testing would lead to a neglect of the sacred doctor-patient relationship. Measurement and testing are not problems in their own right; in proper proportion they can be exceedingly helpful. The problems arise if they are captured by an interested party, such as the pharmaceutical industry, just as clinical trials have been.

There is no reason why clinical trials should necessarily lead to a rigid standardization. After all, people do not respond to drugs the way automobiles respond to oil or to the tuning of their running parts. As discussed in chapter 3, the data from clinical trials of drugs like the antidepressants, where four of five people apparently responding to drug treatment would have responded if put on placebo, support the exercise of clinical discretion in the use of these drugs rather than a rigid standardization.

Furthermore, rather than leading to standardization, clinical trials might have been expected to lead to a democratization of practice. Medicine is far more specialized than it was in the 1960s and as such it might have been expected that we would question our doctors even less now than we did then, but the proliferation of controlled trials that have been published have provided results open to the public and, with the advent of the Internet, more accessible than in the past. From the 1960s on, patients with complaints from breast cancer to depression could face doctors proposing radical mastectomy or electroconvulsive therapy (ECT) and could talk data to them. No longer could a doctor tell a patient, “Come back and ask me that question when you've had medical training and several years of clinical practice.” At least for a brief time, doctors were transformed from authorities into collaborators whose role was to review the evidence with their patients. The management of breast cancer and treatment with ECT gave rise in the 1960s and 1970s to the notion of informed consent,⁷ as the results from breast cancer operations and ECT studies in the 1960s came into the public domain.

But where public data like this has democratized authority within medicine, the fact that the data on drugs and the full range of their effects is hidden has also led to a diminution of medical authority, replacing it with something closer to a healthcare totalitarianism. We can question our doctors now about drugs and their effects, but neither we nor they can readily find out what is going on. And against this background the set of guidances drawn up by experts that should enhance clinical practice has become a set of guidelines that have constrained practice, and, paradoxically, led to calls for increased standardization of practice as clinical outcomes fail to improve in response to the efforts of the guideline makers.

But it is another set of measurements that have invaded clinical practice and are leading to a further standardization of care that concern us here. These numbers come from the instruments used in trials, whether from blood tests for cholesterol, peak flow rates, or rating scale changes tracking our moods or sexual functioning. These measurements have been central to the running of modern clinical trials and there seems to be little awareness that taking these measurements out of context and importing them into clinical practice might create a host of unforeseen problems. The measurements have in fact taken on a life of their own.

THE SEDUCTIVE POWER OF SCALES

The seductive power of numbers can be seen by looking at the first measurement technology to have an impact on healthcare—the weighing scale. The earliest weighing scales began to appear in the 1870s.⁸ Almost instantly people began weighing themselves and doctors began weighing patients. The new numbers persuaded doctors and the early insurance companies that a certain plumpness, which had formerly been seen as a sign of health, was actually a risk factor for future ill health. Physicians and insurers combined to extol the virtues of slimness. Within a remarkably brief period of time, European and American ideas of beauty also changed.⁹ Gone was the appeal of a Rubenesque woman. Voluptuousness became passé, replaced by the slim flappers of the roaring twenties.

By the 1920s, public weighing scales, commonly with plates fastened to their front giving norms for weight by height, were a regular feature in drug stores or other retailers. Then, in the 1960s, small portable weighing scales that could be placed discretely in the bathroom appeared on the market and soon became a household staple.

In parallel with the sales of weighing scales, a new set of diseases began to gain attention and grow in frequency—the eating disorders.¹⁰ Anorexia nervosa was first described in the 1870s. In the decades that followed, the new disorder seemed to become progressively more common and by the 1920s was occurring with noticeable frequency, though it is difficult to judge prevalence at the time with any certainty. The eating disorders exploded in the 1960s, spewing out variants such as bulimia nervosa, with estimates that up to a third of women might be affected. Curiously, these were Western diseases, not found in Asian or other populations. That eating disorders were apparently a Western phenomenon gave rise to questions about what it might be about the role of women in the West that would lead to problems like this. Was it wrong for women to work? Had they been abused in childhood? Were cultural expectations for women to be thin simply toxic?

There are biological, social, and psychological factors that contribute to eating disorders and that can help address such questions as why this syndrome primarily affects women rather than men. But the role measurement technology plays should also be considered. The weighing scale in this case offers possibilities to marry biological, social, and psychological inputs and expresses their result simply, concretely, and in a way that people can gauge from day to day, noting whether they are approaching or deviating from the goal they've set themselves. Without the weighing scale to organize these factors, it is hard to see how eating disorders could have mushroomed to affect 30 percent of Western populations.

It is tempting to relegate something as inert as the weighing scale to the margins of consideration. But its power as a behavioral reinforcer should not be underestimated. Stepping on the scales and finding the numbers are over a limit one thinks acceptable can be deeply unsettling. For anyone in training, falling outside a target on their stopwatch might be profoundly dispiriting to the point of abandoning the exercise, while shaving even single digits off a previous set of numbers can provide a huge incentive to keep going.

The example of eating disorders provides a dramatic metaphor for the problems of maintaining equilibrium once we position ourselves on a scale. In this case the numbers tantalize with seductive possibilities of control. Part of the problem is that numbers can trump non-numerical judgments, in the way a ringing telephone cuts across a live conversation we may be having. Unless we have great willpower, or wisdom, the only way to resist their lure may be to set up competing sets of numbers.

Similarly, as we have developed capacities to measure environmental radiation or chemicals, our difficulties with these hazards seem to increase rather than diminish. We need to be reminded that the rates of cancer from background radiation pose a lesser risk than being hit by a car crossing the street. Or that cabbages come with forty-seven natural pesticides in them, many of which would not get a license for use from regulators, but these are what give them their taste.

Or consider the lure of comparative measures in attempts to map and forecast economies. It is easy to produce figures from manufacturing industry and other areas of the economy and from this to construct indices of the Gross National Product (GNP), which people think is especially “good” if it appears to be growing from year to year. But presently scales like this one leave out such factors as the number of trees cut down, the amount of pollution generated, and changes in the quality of life of a nation's inhabitants—all areas that may critically affect our future well-being but can too easily be overlooked if attention is only paid to shifts in GNP numbers. Perversely as things are measured at present, an oil spill like that of the Exxon Valdez adds to measurable economic activity and increases GNP.

Our capacity to generate measures and scales in the health domain sets up formidable challenges that cannot readily be managed by just telling people to keep calm or be wise. Will we be helped or harmed by the increasing power of scanning technologies to pick up ever more subtle changes in breast tissue or thyroid gland configurations or prostate gland markers, for example? What will happen once we have technologies that can map out patterns of brain activation? We don't know. Will having wise heads at the medical helm be sufficient to stop us obsessing about the meaning of variations in our numbers?

One reason we can suspect wise heads at the helm will not be sufficient is that managing the numbers found in scales is not just a matter of advising people to put them in context. Like the brooms brought to unpredictable life in the Sorcerer's cave when in Disney's Fantasia the apprentice waves a magic wand, vivified by market forces the numbers can come to life. Scales set up markets. The numbers from weighing scales helped set up all sorts of markets in diets, health farms, and exercise equipment. Our performances as timed on stopwatches feed markets for sneakers, running gear, and lifestyle coaches. Our growing capacities to map individual variation from the genome to brain scanning will set up further markets for people wanting to minimize future risks for themselves or their children. Having identified a vulnerability in ourselves, we will all be in the market for a remedy.

RABBITS FROM HATS

The power that prompting concern in us about some measure of our apparent health can have in the development of new drug markets comes through dramatically in the cholesterol story. For fifty years it has been known that very high cholesterol levels and especially familial hypercholesterolemia, an uncommon genetic disorder that leads to high cholesterol levels, can be a risk factor for heart attacks. These are the people whose cholesterol levels really do count but these could often be picked up without a blood test by the old style clinical gaze alone—in people with this illness there are cholesterol deposits around the eyes.

In the early 1950s, the Framingham study, which followed 5,209 men and women from Framingham, Massachusetts, in an attempt to pinpoint the risk factors for heart attacks and strokes, identified the key risks as obesity, a history of heart attacks or other cardiovascular events, smoking, and a sedentary lifestyle.¹¹ Raised cholesterol was also a risk factor, but of much less importance; moreover, it was only a risk factor when one or more of these more serious risks were also present. The most important things, then, for people who have not already had a heart attack and even for those who have had a heart attack, are to reduce weight, get fit, and stop smoking rather than to measure their cholesterol levels. In fact most Western countries saw a 30 percent drop in cardiovascular mortality between the 1970s because of increased attention to smoking, diet, and fitness and the 1990s when the statin group of drugs became widely used to lower cholesterol levels. And aside from the selective use of statins after cardiovascular events, study data suggest that, if anything, there is an increase in mortality in people using statins who are not otherwise at risk of a cardiovascular event.¹²

While, therefore, there are some people, primarily in hospital care, who have already had a heart attack or stroke, who may be helped by cholesterol screening, widespread and indiscriminate cholesterol testing in society in general with the consequent treatment with statins that slightly elevated cholesterol readings almost inevitably lead to, may in fact lead to as much harm as good.

Since the development of the statins in the 1990s, pharmaceutical companies have put a premium on getting doctors to test for cholesterol and on prompting patients to find out about their cholesterol levels. Today, almost all adults in the United States, and increasingly people elsewhere, know their cholesterol levels. This campaign was facilitated by the fact that most routine blood tests that have been run since the 1980s have included those for cholesterol levels. As guidelines on cholesterol management began to recommend ever lower cholesterol levels, results that would not have been seen as problematic only a few years previously, began to trigger panic in doctors. In this way company marketing has effectively achieved the first case of mass screening for which informed consent was not sought.

While the cholesterol-lowering statins grew to become a $30 billion a year market in the late 1990s, it was also becoming clear that simply lowering cholesterol did not provide a person much benefit. Indeed, the drugs could be risky in their own right, and cholesterol itself, scientists were finding, was not without benefits. This however did not put a break on statin sales—the numbers were “refined.” Popular articles and medical reports began to distinguish between high and low density cholesterol and their ratio to each other, as well as triglycerides and fatty acids (which are further lipids found in blood). Where we all might have had an average overall cholesterol level before, it was becoming increasingly unlikely that any of us would be absolutely “normal” on all these measures and could walk out of a doctor's office without being proffered a drug to match our numbers, even though the attention that cholesterol and other lipids now receive in medical encounters is out of all proportion to their clinical usefulness.¹³

Extrapolation from studies that demonstrated a benefit in men already ill to the rest of us has led to claims that “balancing” our lipids will reduce our future risk.¹⁴ This is a completely mythical balancing, rather like remedying a supposed imbalance of neurotransmitters with antidepressants. Several studies have suggested there may be as much if not more benefit to be gained from adopting a Mediterranean diet, which is more likely to increase than reduce cholesterol levels.¹⁵ For women in particular, the data suggests that attempting to reduce cholesterol levels may increase mortality.¹⁶ Alarmingly women without coronary artery disease now constitute almost a quarter of those taking statins with almost 10 percent of women over the age of seventy being on statins.¹⁷ More generally 40 percent of people taking a statin have no history of coronary artery disease.¹⁸

These developments have been driven by a series of studies designed to map out norms for cholesterol and lipid levels, the achievement of which would supposedly lead to minimal or no risk of cardiovascular events.¹⁹ There is a set of cholesterol levels that is linked to almost no cardiovascular events—levels found in teenagers or people in their twenties. But these levels are linked to no cardiovascular events because cardiovascular events almost never happen at this age. There is thus no particular reason to believe that cholesterol levels in this range protect against strokes. Nevertheless, it is just these values that have been set up as the normal range for adults of every age. According to norms like these, 94 percent of New Zealand's population has elevations of their lipid levels that carry some risk.²⁰

It is a clear contradiction to set up as a normative standard a level according to which 94 percent of a population is abnormal. These may be optimal cholesterol levels but they are not normal levels. This is akin to what happened with the advent of drugs like Viagra, when impotence was reconfigured as erectile dysfunction. Impotence had been a disorder of men who were completely or close to completely unable to function. But the marketers have progressively redefined the target so that now even twenty-year-olds, who from time to time have an erection that falls in any way short of full rigidity, are invited to think of themselves as having a condition that could benefit from treatment and are encouraged to see a pill as a way out of anxiety.

In the case of cholesterol, the context in which any discussion of cholesterol levels made sense—where patients had a history of heart attacks in their family, smoked, were obese, and were also hypertensive—was progressively stripped away, so that the clinical gaze now focuses on the numbers themselves and their deviation from norms, partly because here is an area where a drug can be prescribed and a doctor can document that something has been done.

Just being constantly reminded of our own numbers on a scale of cholesterol norms can seduce. Even someone like me who knows better, who knows that cholesterol levels are for the most part meaningless in terms of overall health, when faced with his own lipid numbers, if these are thought to be even marginally too high, is likely to be unnerved or perhaps challenged. “I know there's no real need to get this marginally elevated level down, but hey, let's see what I can do.” Faced with an apparent deviation of our numbers from the norm, some of us can “feel” our arteries clog up on the spot and would find it almost impossible to do nothing.

Just as Sanjeebit Jachuk found his patients began suffering after a diagnosis of hypertension where they had been fine before (see chapter 3), so also many readers of this book would likely start to suffer from the effects they imagine excessive cholesterol brings if faced with their lipid levels. Once we only visited a doctor when we were suffering and we hoped to leave in a happier frame of mind about relief in the offing, often later grateful for an encouragement that we did not know at the time defied the numbers. Now we are much more likely to start suffering when some nonessential blood test, health program, or ad prompts us to visit a doctor, who is unlikely to counsel us to leave well enough alone.

At the epicenter of this are the companies who have cholesterollowering drugs to market. This is a market worth $35 billion per annum, with the best seller, Pfizer's Lipitor, making over $12 billion worth of sales in 2008. At the heart of the marketing of Lipitor have been a series of ads that have pulled no punches. One shows the soles of the feet of a corpse in the morgue, with a name tag on its left big toe, and a strap line on the side—Which would you rather have, a cholesterol test or a final exam? Another shows an open heart with its traceries of blood vessels and a strap line—Lipitor reduces risk of heart attacks by 36 percent. Behind claims like this, there is typically a study in which 3 percent of older men with a history of heart problems and other risk factors have a heart attack on placebo compared with 2 percent taking Lipitor or whichever drug—this is a 50 percent reduction in what is called relative risk in contrast to absolute risk. But even for consumers alert to this piece of trickery, there is nothing in the ad to let women or men with no history of heart problems know that these figures for risk reduction do not apply to them.

Pressure like this makes the idea of taking something that might lower lipids very seductive. So much so that even though using pills to lower cholesterol appears to increase mortality, the pill becomes a solution to the problem that attention to cholesterol levels has created. This follows the standard recipe for pulling a rabbit out of a hat—first put rabbit in hat.

A UNIVERSE TURNED RISKY

A remarkably similar dynamic has been playing out around another set of measurements. When I trained in the 1970s, osteoporosis was a rare disorder that involved an excessive thinning or weakening of bones, leading to an increased rate of fractures, which was diagnosed occasionally in older women who had unexpected fractures in response to minor traumas. It was also known that there was some loss of calcium in the bones of women after the menopause, but this was not seen as a particular problem.

In the 1970s with the marketing of hormone replacement therapy (HRT) for menopausal women the idea emerged that one of the benefits of treatment might be to keep women's bones young.²¹ When in the 1980s, pharmaceutical sales of HRT fell following suggestions that it might lead to breast cancer, Wyeth, one of the primary makers of HRT, helped sponsor a more aggressive marketing of osteoporosis, and it began to be portrayed as a much more ominous disorder. This promotional campaign featuring a benefit of HRT to counter attention to possible risks turned around the sales of HRT.²²

But osteoporosis only properly came into vogue after 1988 and the development of DXA (dual energy X-ray absorptiometry) scans. Using minimal radiation these low-cost machines measure bone density, something that had not been done before. In one sense the findings came as no surprise—there was variation around different sites in the body and in older women there was some thinning compared to women in their twenties. Across the lifespan, though, while women in their twenties have denser bones, they are perhaps the most abnormal: if we take both children, who have the thinnest bones, and older women into account, then bone densities as found in women in their twenties are far from being the norm for females.

DXA scans offered a golden opportunity to redefine osteoporosis, just as weighing scales did with refashioning standards of beauty. Women now were said to have the disease if their scans showed that bones in some part of their body had densities that were a standard amount less than the densities found in women in their twenties. All of a sudden one-third of postmenopausal women found themselves diseased.²³ A further large group of women—and their doctors—were faced with another problem. These were the women who fell in between the supposed optimal bone state of women in their twenties and the new diseased state. For women whose bones fell between these states a completely new condition was invented, osteopenia (literally, “less bone”). Women with osteopenia are at no increased risk of a fracture compared to their “normal” peers.

Two factors combined to ensure that the transformation in our perceptions to make room for this disorder would be particularly rapid.

One was that two companies, Merck and Procter and Gamble, were competing to be the market leader with products from a new drug group—the biphosphonates. Merck's Fosamax was up against Procter and Gamble's Actonel in a billion dollar battle. Both companies saw DXA scans as the way forward to increased sales and they competed to provide scanners for free to doctors—who of course could charge a fee for scanning.²⁴

The biphosphonate drugs conveniently provided an answer to the image of bone thinning—offering, at least in popular understanding, to remineralize bones. Given to women with severe reductions in bone densities, the biphosphonates can reduce what are called fragility fractures—hairline fractures primarily of the vertebrae that are picked up on X-ray without the person ever being aware they have had anything wrong. However, there is no difference between those on the drug and those not in the number of women who present to their doctors with an obvious fracture. Somewhere between 80 and 90 percent of women to whom biphosphonates are now given are unlikely to get even the X-ray changes in the rate of hairline fractures, and in some of those with minimal reductions in bone densities the biphosphonates have been linked to increased rates of fractures of long bones such as the femur.²⁵ Aside from increased risks of fractures, up to one-third of women given biphosphonates will have significant gastric distress, a small number (1 in 10,000) will get osteonecrosis (bone death) of the jaw or other bones, and an unknown number will develop generalized pain syndromes, or eye problems including blindness, or cardiac problems that may increase the risk of a stroke.²⁶ The difficulty in knowing how many will suffer from these complications is that the company trial data is almost unbelievable—in the company trials that have been released the rates of gastric problems are the same on the active drug as for the placebo.

These risks might be worth running for those rare women who have a clinically established form of osteoporosis if there were good evidence that medication could help or help as much as getting fit. There is good evidence that factors such as levels of a person's physical fitness are better predictors of fractures than are bone densities, and good evidence that encouraging women to improve their fitness will reduce their fracture rates.²⁷ But fitness clinics don't distribute articles with the results of controlled trials demonstrating such benefits of good exercise, whereas doctors are bombarded with articles in which an artful use of statistics appears to confirm a benefit to drug treatment, and women are subjected to ubiquitous advertisements on the benefits of the drug. And just as with the statins, for both doctor and patient prescribing a pill can seem easier than changing a lifestyle.

From the 1990s onward magazines for teenage girls began to feature discussions of osteoporosis. While none of these adolescents will have been the direct target of marketing by Merck and Procter and Gamble, still the change in culture these companies have created feeds through to all women, reinforcing the message in ads that are directly aimed at older women. Messages such as those in a Merck ad showing a very attractive woman apparently emerging from the bath, with a towel discreetly held to her upper chest but displaying enough of her body for the ad to be confident you will give a positive answer to its first question, “See how beautiful sixty can look?” This is followed by a further question, “See how invisible osteoporosis can be?” The sidebar then tells us that one in two women sixty and over have osteoporosis, and that while it may be invisible it leads on to broken bones and a dowager's hump. This Merck ad is not for Fosamax by name; instead it asks women to ask their doctor if a bone density test might be right for them.

The numbers that come from bone density scans and blood tests for cholesterol set up a new normality. If our numbers are abnormal, we almost immediately begin to feel at risk—dis-eased. And here we come to a key point. Whereas for centuries medicine had almost exclusively been about the treatment of diseases in the sense of biological disorders that posed an immediate threat to our lives, and still is in much of the world, Western medical practice now is increasingly about the management of risks—and this increasingly creates dis-ease.

When it came to treating diseases, epidemics aside, usually only a relatively small number of people had them. In the West much greater numbers are at risk as now defined. There are thousands of women with technical osteoporosis now for every one with clinical osteoporosis in the past, thousands with checklist depression now for every one with melancholia in the past, and entire populations with lipid abnormalities where hypercholesterolemia had been a rare disorder in the past.

In early twentieth century, we were rescued from the problems of a previous generation of celebrity drugs by the laboratory work of scientists and doctors from Robert Koch to Richard Cabot and others. Many physicians today remain confident that mapping of the human genome and other scientific developments will save us from the ravages of disease tomorrow. But there is a critical difference: the bacteriology of Koch alerted us to an external threat such as cholera, anthrax, or tuberculosis that we could mobilize against, whereas the mapping of the human genome promises to extend the riskiness of our universe. There are likely to be a much greater number of genetic markers for small degrees of risk than there will be genes for diseases. How do we mobilize against the uncertainties of the human body itself?

Furthermore, whereas the treatment of disease stops once the disease clears up, when it comes to managing risk, treatment potentially goes on forever. There is no natural endpoint except death itself. Where medicine once aimed at eliminating disease, now, for a pharmaceutical company, the trick is to persuade as many people as possible that they are at risk of a multitude of “diseases” and to convince doctors that these are all conditions that should be tested for and treated.

Insofar as being alive is risky, a health products market devoted to risk management has the potential to swallow up huge domains of our experience. Hitherto, sensibly or not so sensibly, we have often seen the risks in being alive in spiritual terms. But where before it was ascetics who attempted to control their bodies by fasting and punishment, now almost all ages and both sexes go to the same extremes in the name of health. Where once people in the West were said to have been born with an original stain, now we feel as though we have been born with a warranty—and if anything goes wrong we want to know who is to blame. Where once the focus was on living well in order to die well, now it is more likely to be on living well in order not to die, or at least to put off its eventuality as long as possible. There is a potential here not just for a health market, but for an ersatz religious universe. And if you're a drug company executive, there's opportunity here to sell not just pills but something closer to a sacrament.

In previous times we passed on a culture to our children embodied in fairy tales, folklore about health, national myths, and religious precepts, in which the life's risks were put in a larger context of meaning. Now an increasing part of what is transmitted centers on personal health for its own sake: figures for sugar and lipid levels, as increasing numbers of our children have diabetes or other dangerous metabolic states, or figures for peak respiratory flows as increasing numbers of young people have asthma, or statistics on some chemical imbalance as increasing numbers are being treated for ADHD, depression, or anxiety. Not only is such a culture two-dimensional, it changes the very nature of human experience.

MEASURING DIS-EASE

The new focus on blood sugars, blood lipids, bone density, and the like has transformed the encounters between doctors and patients. But the change has not come simply from blood tests and other obvious measurements. It has also come from the use made of scales developed to measure aspects of behavior. These rating scales were needed in trials of antidepressants, tranquilizers, analgesics, hypnotics, drugs for sexual dysfunction, and other drugs used to modify behavior, for the same reasons as cholesterol levels are needed in statin trials and DXA scans in biphosphonate trials. In lieu of evidence that patients get up from their beds and walk, feel better again, and return to work, these rating scales produce numbers that go in the right direction on treatment and can be held up as evidence that the treatments are working.

Rating scales consist of a series of items that physicians enquire about and then score the responses. In the case of depression, these typically included sleep, appetite, energy and interest levels, suicidality, feelings of guilt, and agitation. One of the very first of these scales was the Hamilton Depression Rating Scale (HDRS), published in 1960.²⁸ Although notionally credited to Max Hamilton, the scale was put together by Geigy to use in clinical trials of imipramine, their new antidepressant.

Many clinicians were initially skeptical of the merits of what appeared to be a basic checklist, not unlike the checklists in magazines, that the office receptionist could be easily trained to administer. Far from arguing against this clinical gripe, Hamilton apparently believed the main merit of the scale was that it facilitated the conduct of drug trials. Using the scale appeared to show imipramine and similar drugs, which increased appetite and sleep, worked compared to placebo. Clinicians could see there was a benefit with their own eyes, but rather than leave the matter to clinical judgment, the scale offered an apparently objective measure of effectiveness. But Hamilton was also aware that the wider use of such checklists might induce a substantial change in culture: “It may be that we are witnessing a change as revolutionary as was the introduction of standardization and mass production in manufacture. Both have their positive and negative sides.”²⁹

Forty years later, there are few clinicians who can remember that even Hamilton thought that checklists such as these were an abstraction from the richness of clinical reality. The rating scales that were initially validated by clinical judgment are now being increasingly imported into clinical practice to invalidate clinical judgment, apparently in the belief that reducing variability in the clinical encounter will make that encounter more “scientific.” Whatever the merits of using a scale in a trial, it would not have made sense to Hamilton to approach every depressed patient the same way. Clinical encounters that use a rating scale will resemble each other much more than encounters with physicians where no rating scale is used. This might sound momentarily appealing—but clinical encounters based on a rating scale will also be difficult to distinguish from encounters with a receptionist trained to administer the scale, and this is not what we want from a doctor. We want the experience and discretion that goes with a clinical training rather than an encounter that ultimately could be delivered by computer.

Primary care physicians prescribe the greatest amount of psychotropic drugs these days and they are increasingly encouraged to administer depression or other behavioral rating scales when seeing patients. Many of the guidelines for prenatal care now advocate using anxiety and depression rating scales for all pregnant women. While this might pick up some women in need of treatment who would otherwise be missed, it will pick up a lot of women who aren't in fact depressed, but who because of temporary changes in sleep patterns or irritability may score in a zone of concern on rating scales one week but not the next. When the diagnosis is based on clinical judgment the estimate is that 3–4 percent of women may have a nervous disorder prenatally compared with estimates of 15–25 percent of women when the diagnosis is based simply on rating scale scores. These rating scale scores all too often translate into treatment, without further thought. As a result, the antidepressants have moved in less than ten years from being rarely used prenatally to being among the commonest drugs given in pregnancy—despite convincing evidence that they double the rate of birth defects and of miscarriages.³⁰

Aware of this ambiguity in the value of rating scales—and the drug prescriptions that are likely to follow from their use—pharmaceutical companies now run symposia at major professional meetings aimed solely at introducing clinicians to rating scales. In the 1990s companies engaged in disease mongering by selling diseases such as social anxiety disorder or panic disorder in order to sell their drugs.³¹ In the decade 2000–2010 what we might call measurement mongering has succeeded disease mongering as the key promotional instrument. Thus Pfizer at the 2007 American Psychiatric Association meeting, for example, supported a symposium entitled “From Clinical Skills to Clinical Scales: Practical Tools in the Management of Patients with Schizophrenia.” The practical tools in question were rating scales whose items draw attention to ways in which the company's drug was superior to some others in the field. This is an ad in the form of a rating scale. It is just the same in its effects as makers of asthma drugs providing peak flow meters to doctors and Merck and Procter and Gamble providing DXA scanners, all the way back to the makers of antibiotics in the 1960s who provided thermometers to doctors.

Rating scales are not used just to sell diseases to doctors. Increasingly, companies disseminate rating scales directly to patient groups. Among the most strikingly successful maneuvers in this area has been to encourage patients with nervous problems to keep mood diaries. Getting patients to chart fluctuating emotional states has been a potent way to persuade both patients and their doctors that the patient has a bipolar disorder. In very short order, these methods have led to a boom in the diagnosis of bipolar disorder, with patients formerly seen as being depressed or anxious relabeled as bipolar and their treatment changed from one of the off-patent antidepressants to an on-patent mood stabilizer.

What has been lost since Hamilton's day is any sense that these rating scales are simply checklists. Far from being information rich, they are information poor. They may come with pompous, scientific-sounding names, but they have little more content than the checklists seen in periodicals like Vogue or Esquire that offer to map out aspects of our personal styles as lovers, socialites, or foodies. The main advantage likely to accrue from the use of these lists is to ensure that a number of questions that steer a doctor toward a particular prescription are checked off as asked. The allure to companies of these readymade questions in timelimited clinical exchanges is just this—these questions redefine clinical realities by pushing out what could be more probing and important questions that might lead away from drug treatments and toward efforts to modify lifestyles or change social situations. Increasingly, practice will be standardized—to the lowest common denominator.

When rating scales are imported into healthcare the clinical gaze risks being captured by those whose interests are served by the measurement technology. The rating scales add to company abilities to hypnotize clinicians and enfold them in a world defined by the marketing departments of pharmaceutical companies.

But it is not only the clinical gaze that is captured. The very nature of human experience can be redefined. Thus the creation of female sexual dysfunction (FSD) hinged on producing treatment changes on rating scales that include items such as clitoral numbness—because this is the kind of thing that can be tallied on a rating scale. Focusing on whether one's clitoris is numb or not, while making love, risks changing the entire experience of making love. It also creates a discontent, and perhaps focuses other discontents on this area, with a drug becoming the apparent answer to these discontents.³²

The rating scale maps out the contours of this new condition. The measurement and disease mongering of FSD has led in recent years to women in their twenties with three young children who have lost interest in sex being encouraged to think they should have their testosterone levels checked rather than considering that their problems may stem from the circumstances in which they find themselves.³³ But aside from the women who may opt for low-dose testosterone as a result, the wider culture surrounding these issues has changed in ways that affect how all women perceive what is going on in them, in a manner analogous to the way the marketing of HRT up until recently persuaded a lot of women that being postmenopausal was to be diseased.

While rating scales, along with blood tests for cholesterol levels or bone scans for bone densities, do generate data, exclusive reliance on such data, an increasing temptation among harried doctors, leads to what I call informational reductionism. Critics have complained for decades about the biomedical reductionism that supposedly dehumanizes clinical exchanges. Reducing humans to their bodies—whether hormones or neurotransmitters or the mechanical actions of their heart— for these critics is not a fit way to treat people. But where an old-style medical encounter might lead to a focus on some important aspect of a patient's physical state, the upside of such reductionism has always been that the doctor might thereby pinpoint something that would help lift us out of some real disability or even save our life. In contrast, there is not a single benefit likely to accrue from this new informational reductionism whether embodied in lipid levels, bone density measurements, or rating scale scores—although the measurements are sold as empowering us.

In one sense measurements from mood scales to lipid levels involve new ways of looking at ourselves, and as such they can claim the mantle of scientific progress. But if they lead to overlooking context or other dimensions of an individual's functioning—dimensions that may not be open to measurement or that are simply not being measured—rather than being modestly scientific by measuring what we can and attending also to what we cannot measure, we risk being pseudoscientific. Scientific measurement and quantification succeed when they force us to look ever more closely at things while allowing us to see them in their wider contexts. By stripping away context, mindless measurement does exactly the opposite. This mindlessness is doing to medical practice something similar to what an exclusive focus on manufacturing goods driven by the target of increasing GNP is doing to the environment and the quality of life.

An older generation of clinicians would have readily made a case that even in the treatment of eating disorders weighing scales should rarely if ever be introduced. But where in the 1970s measurement technologies were considered by many an interference with clinical practice, today measurement management style is rapidly becoming the norm. Across medicine, clinicians are increasingly likely to feel uncomfortable at the prospect of encountering a patient without a battery of such technologies at the ready.

The diagnostic tests that have come into medicine since Richard Cabot's time are invaluable in some circumstances and no one would want to go back. Even the tests for bone densities or cholesterol levels and scales for aspects of behavior such as sexual functioning can be helpful. But doctors should also be able to encounter their patients as Alfred Worcester once did—person to person. The problem is that few doctors can now do this, raising the question as to whether the attempt to import into clinical care the measurement technologies needed for clinical trials, which are widely described as offering the gold standard of medical knowledge, is transforming medicine from a cottage practice into a scientific medicine or producing a golden sterility of the sort that once destroyed Midas.

The sterility of dumbed-down medicine comes through quite clearly in the case of the “operational criteria” that dominate mental healthcare. Against a background of competing views as to what constituted psychiatric disorders, in 1980 the American Psychiatric Association introduced operational criteria for its disorders into the new, third edition of its Diagnostic and Statistical Manual (DSM-III).³⁴ From this point on, people would be said to have depression or schizophrenia or obsessive compulsive disorder if they had, say, five out of nine clinical features, or two features from column A and two from column B. The exercise was aimed at overcoming entrenched clinical biases that on the one hand saw psychiatric disorders as simply biological or on the other hand saw them as simply psychodynamic. But it was still assumed that the application of any checklist like this would require some exercise of clinical judgment so conditions such as pregnancy or influenza would be taken into account. But times have changed and a body representing both the American College of Obstetricians and American Psychiatric Association have recently suggested that 15 to 25 percent of expectant mothers may be depressed—on the basis of surveys in which women tick boxes on checklists of “depressive” symptoms.³⁵ These checked boxes have made antidepressants among the most commonly prescribed drugs in pregnancy.

In the wake of DSM-III's publication, awareness of the criteria proposed for various disorders grew worldwide. The development of the Internet, which allowed criteria to be posted online, fostered a dramatic increase in measurement mongering to people wondering whether they met criteria for ADHD, Asperger's syndrome, PTSD, or a host of other disorders. In the extreme I have had people with successful careers in the public domain come to me after finding on the Internet that they seemed to meet criteria for Asperger's syndrome or other serious behavioral disturbances, when by virtue of their successful careers they could not have such a serious condition. Worse again, having taken the matter to mental health professionals, they found the professionals quite accepting that if they met criteria for ADHD and Asperger's syndrome they therefore had these disorders.

What is happening in the case of operational criteria is comparable to what clinicians now do faced with evidence from blood lipid levels or DXA scans—they agree the patients meet criteria for conditions for which treatments could be given. Where once doctors might have told someone not to worry about a finding or used the test results to talk to a patient about diet and lifestyle, now they will more likely default to prescribing Lipitor or Fosamax, Paxil or Zyprexa.

Making DSM's operational criteria available on the Internet at the click of a mouse creates consumers in just the way giving DXA scanners to doctors did. This dynamic, amplified by the advertisements of the pharmaceutical industry, underpins the mushrooming of a range of disorders from FSD to PTSD but in particular the huge surge in diagnoses of behavioral disorders in children from bipolar disorder to ADHD, autism, Asperger's disorder, or depression—disorders that seem to clamor for a pharmacological fix.

There is a difference between meeting criteria for a disorder and having the disorder, but it takes an act of judgment informed by a culture to make the right distinctions. Severe reductions in bone density are linked to fractures, severe depression to suicide, marital breakdown, and loss of employment, and markedly raised lipids against a background of other risk factors are linked to cardiovascular events, but the availability of operational criteria for behavioral disorders, scanners for bone density, and blood tests for cholesterol have led to a far greater rate of diagnosis of a range of conditions that are, in effect, Lipitor, Fosamax or Prozac deficiency disorders rather than traditional medical disorders that come with real risks that would make treatment appropriate. We have moved from what was medicine to a new variant of horoscopy.

Meeting criteria has set up a market where both patients and doctors can feel they are doing something and doing it well. The medical response might be quite different if these drugs were not available by prescription only. But increasingly the position of the doctor has come to resemble that of the car salesman who might point out the green credentials of a hybrid car if there is one in his range, but for whom there is no incentive to advise the customer against driving as much.

Just as car salesmen compartmentalize the selling of cars from issues of climate change, so healthcare professionals increasingly segment risks according to their specialty. Doctors prescribing statins to lower cholesterol are typically happy if the drugs they prescribe do this, even though clinical trials show an increase in overall mortality if the patients who get these drugs have no other significant risks for heart attacks. In just the same way clinical trials suggest that Dianette or Ro-accutane for acne, beta-blockers for hypertension, beta-agonists (reliever inhalers) for asthma, blood-sugar-lowering agents for diabetes, rimonabant for weight loss, and varenicline or buproprion for smoking cessation can all trigger death, suicidality, or psychosis, but if the problem falls outside the usual purview of the treating doctor it is likely to remain invisible.³⁶ Even though the labels of these drugs come with warnings about mortality or suicide or psychosis, it can prove very difficult to get doctors to recognize the dangers and difficult to rescue patients from their doctor in these cases. Overall, drug treatments given by doctors in hospital settings are now the fourth leading cause of death in hospital settings.³⁷

Given that the vast majority of medication is now given outside of hospital settings where treatment is less supervised so that problems are less likely to be detected before it is too late, one wonders what contribution drugs might be making to deaths in community settings. Where monitored by organizations such as the Institute for Safe Medication Practices, there is a 5 to 10 percent rise per year in the overall numbers of deaths or serious adverse events reported to the FDA, a large proportion of which come from blockbuster medications such as the asthma drug Singulair that Jane, described at the start of the chapter, was put on, or the diabetes drug Avandia, the mood stabilizer Seroquel, or Champix used for smoking cessation.³⁸

THE LURE OF QUALITY

The mechanization and automation of production that came with the development of industry in the nineteenth century required a standardization of both goods and labor. At a basic level, if a machine was to be broken down into its components, new parts had to fit together just as well. For mass-produced goods ultimately to be consumed in as large quantities as possible, they had to have maximum compatibility— televisions, computers, and other electrical goods have to come with standard outlets or wireless components so that they can communicate together. And following from that, work on assembly lines that arose to facilitate manufacture of components was itself broken down into discrete segments and standardized.

From the 1970s onward, what appeared to work for industry became a model for those charged with running a health service. Against this background professional discretion seemed to perpetuate a cottage industry model and medical exchanges to involve the type of production that prevailed before mass production. What had spared medicine in previous decades was the relatively small scale of its enterprise, with inherently unpredictable demand and uncertain outcomes. Leaving it to doctors didn't cost much.

But things had begun to change. It was widely assumed in the 1950s that the rising availability of new and effective treatments to eliminate infectious and other diseases would lead to falling health costs—as ill-health was eliminated. Countries such as Britain decided it made economic sense to provide free health care: sick and diseased people drag the economy down and returning them to productive status would surely aid the economy.

Reading the literature that began to emerge in the 1970s on health costs and the efficiency of health services, whether in private healthcare systems or in socialized medical systems, however, is to encounter an astonishment among analysts at the time that, far from falling, healthcare costs had begun to escalate rapidly during the 1960s, leading by the end of the decade to the first calls for cost containment and for a focus on eliminating the inefficiencies that it was assumed lay behind the rising costs. It was this set of concerns that underpinned in part the initial call for evidence-based medicine that, described in chapter 3, emerged in the 1970s. In its first manifestation advocates stressed that claims of efficacy and cost effectiveness for many medical procedures, from screening tests to high-cost coronary care units, might not be supported by the evidence. Sticking to what had been proven to work would, it was claimed, make for efficiencies and lower costs. When treatments work this is indeed what happens. But if the bills for US healthcare costs have grown from little more than 1 percent in the early post-World War II years to 17 percent of Gross Domestic Product and are continuing to grow, something else is clearly going on.

We will pick up the political question below of whether these are issues best left to the market or whether this is a point at which the government should intervene, but stepping back from this larger framework, evidence-based medicine has offered a technical response that to some held out the hope of avoiding political choices. What could be wrong with attempting to bring clinical practice up to a common standard? What could be wrong with making it more effective? Or, in management language, what could be wrong with having a quality service?

In the 1960s, to talk about quality in medicine would have conjured up visions of medical encounters to which doctors not only brought great medical skills but also were able to subordinate the clinical gaze to a concern for the situation of the person. Encounters, in other words, in which doctors were seen to have descended from the pedestal from which they had previously operated and begun to collaborate with their patients, using the new forms of evidence as a resource to determine what medical treatment best suited their patient or where their patient might be best served by looking at aspects of their lifestyle.

But this is not what has happened. Instead of our increased abilities to treat and cure in conjunction with increased funds for healthcare leading to a more humane system, the word “quality” as applied to healthcare has come to have more of an industrial meaning. Elsewhere in industry, goods or services meet quality standards if they are predictably the same each time. From this point of view, McDonald's offers a quality hamburger—even if for hamburger connoisseurs it might rank among the worst possible hamburgers.

One way to get the appearance of quality outcomes of this sort is to become increasingly a risk management service rather than a service aimed at curing diseases or caring for those who have them. It is a great deal easier to get quality outcomes in the reduction of blood pressure or blood sugar or blood cholesterol levels than it is in the treatment of strokes or heart attacks. Sugar and lipid levels invariably drop with treatment. Because of this, for managers within health care, against a background of escalating health costs, it is all but impossible not to McDonaldize their services. But focusing on this kind of outcome is rather like focusing on the valeting of a car rather than on repairing any real problems it has.

A quarter of a century ago, basing his case on the growing clamor to contain costs and the increasing premium on standardization, Thomas Bittker, a forensic psychiatrist from Reno, predicted that these essentially industrial processes would be applied to healthcare organizations, even to psychiatry, which at the time must have looked as far removed from a “quality” organization in the industrial sense as it was possible to be.³⁹ He outlined a world in which clinical care would be restructured just as pharmaceutical companies had been restructured in the 1960s and 1970s and the rest of industry had been restructured half a century earlier. The clinical encounter would be disassembled into its component parts and reassembled in a way that would enable managers, who clearly cannot alter the course of disease, to get as close to industry-standard quality outcomes as they could while managing their physician resource.

Bittker's predictions have all come true. Doctors, from those offering primary care to those offering respirology and mental health care, particularly in the United States, now are expected to practice according to strictly defined, brief medication management sessions with patients. So much is this the case that it is not uncommon to find American lawyers in malpractice cases referring to doctors as pharmacologists rather than doctors. Combining brief visits, which offer little chance to find out much about the person attending, with a set of disorders with which many physicians fundamentally disagree and sets of algorithms that dictate treatments with drugs that many think may well be inferior to the treatments they would wish to give, is producing an ever more dispiriting situation for many doctors.⁴⁰

The case of Dr. N, the primary care physician discussed in the introduction, who spent his entire clinical contact time filling out forms so that he failed to recognize his patient's double amputation, while extreme, typifies where much of clinical practice is heading. In 1984, the US Public Health Service set up the Preventive Task Force, a body established to recommend what screening tests and other procedures might be put in place in primary care to improve the health of the population.⁴¹ If primary care doctors were to implement all the screening recommendations suggested by this task force, they would have no clinical time left for the complaints that brought patients to them seeking help.⁴² This is a new medicine in which good medical care is increasingly at odds with the smooth distribution of health products, a situation in which doctors practicing good medicine risk dismissal.

Present day healthcare systems employ doctors, of course, but it cannot be certain that future systems will need to do so to the same extent. The kind of quality that can be achieved screening for and managing risk factors brings these medical services into the domain of commodities in a way that could not have been done with traditional medical care. In the current jargon, these interventions can increasingly be commoditized and, rather than delivered in clinics, they might be delivered in retail outlets such as supermarkets. Something similar can be done with many basic legal services, leading to a perception that the tide is going out on professionalism.⁴³

In the case of many of these medical practices, furthermore, if the drugs work well and the basic need is to have them delivered according to guidelines and algorithms, the job is likely to be done not just less expensively but possibly with greater fidelity by nurses or others if given the legal authority to dispense medicines, as both nurses and psychologists have been doing in many settings in the United States and Europe.

That the work of physicians has seemed increasingly to have become something of a factory or office job, or that doctors may have to worry about job security for the first time, will not cut much mustard with anyone who has always had to work in a factory or office. But the problem for all of us now is that there are times when we do need to be treated for diseases and cared for rather than simply risk-managed.

BEYOND MEASUREMENT

Many observers of current practices of medical care, especially those who attempt to tackle the question of medicine's interface with the market, get dewy-eyed about the vocational aspects of healthcare. While the more hard-headed analysts point out that since antiquity doctors have charged for their services, that for long periods up to the nineteenth century physicians were often indistinguishable from charlatans and quacks, and that medical organizations have often operated more as quite ruthless trade associations than as scientific bodies concerned about the welfare of patients, caring has nevertheless been held to be a great part of the medical art. Although doctors make a living out of treating sickness, they are not ordinarily thought to exploit people who are ill and vulnerable.

This is beautifully caught in the following quote by James Spence, in his day one of Europe's leading pediatricians, from a book published posthumously in 1960: “The real work of a doctor is not an affair of health centers, or laboratories, or hospital beds. Techniques have their place in Medicine, but they are not Medicine. The essential unit of medical practice is the occasion when, in the intimacy of the consulting room or sick room, a person who is ill, or believes himself to be ill, seeks the advice of a doctor whom he trusts. This is a consultation, and all else in Medicine derives from it.”⁴⁴

There is a difference between medicine of this kind, which still persists to some extent when we are very ill and in isolated pockets of practice, and the healthcare which offers us almost no time or opportunity to consult but which will screen, recall, educate, and sometimes coerce us into treatments, sometimes simply so that our “carers” can hit their targets. On one side is a healthcare in which patients unknowingly are helping doctors rather than being helped; on the other side is a form of practice that is beyond measurement.

The problem does not lie in our new technologies of curing. Penicillin and insulin allow much more effective caring than was possible before. But these drugs arose as part of a kind of medicine different from the statins for cholesterol lowering, biphosphonates for osteoporosis, or antidepressants. When doctors gave penicillin to patients they were in almost all cases helping their patients. When patients take a statin or a biphosphonate, they are in many cases, perhaps a majority of cases, helping their doctors, a drug company, or a government agency rather than themselves. Giving statins and biphosphonates routinely appears to be part of traditional medicine, but in fact these treatments are more closely linked to an approach now most commonly termed chronic disease management or preventive medicine. This approach emerged in the 1980s and led, for instance, to the establishment of the Preventive Task Force noted above. The initial impetus to this approach came from prior successes in the 1950s and 1960s screening for and eliminating infections through vaccination and other programs. A growing awareness of the role of raised blood pressure and diabetes in leading to deaths from heart attacks or strokes, as a result of reviews such as the Framingham study, appeared to provide comparable targets for screening.

There are solid economic arguments for a preventive approach to medicine. In the eighteenth century, France and Britain, wary about each other and about Germany, mapped out their citizenry and in so doing learned about links between environments and diseases, and how national productivity or defense might hinge as much on proper sanitation and the quality of food supplies as on industrial innovation. As James Lind remarked in the mid-eighteenth century, the British navy was losing more men to scurvy than to any hostile engagements with her enemies.⁴⁵ Florence Nightingale produced figures to show that more soldiers were dying in hospitals than on the battlefield in the Crimean War and went on to create modern nursing in response.⁴⁶ And Rudolf Virchow, a key person in the creation of both modern laboratory medicine and of the notion that citizens have a democratic right to health, went so far as to suggest that “medicine as social science and politics is nothing more than medicine on a grand scale.”⁴⁷ Since then historical investigations have made it clear that poxes and pestilences have done more to bring down empires and economies than wars or failures in the marketplace.⁴⁸

So what could be wrong with mass screening for cholesterol levels, mapping bone densities, and administering rating scales for undetected mood disorders? The first problem is that almost as soon as it appeared pharmaceutical companies realized that preventive medicine or chronic disease management offered the perfect cover for their marketing. Far better for companies to market a treatment doled out over decades than a brief course of antibiotics that saves a life. In the 1960s, when challenged by Senator Kefauver at the congressional hearings on the pharmaceutical industry about the high cost of their drugs, Francis Brown, the president of Schering Plough, responded “Senator, we can't put two sick people in every bed where there is only one person sick.”⁴⁹ In the 1980s chronic disease management opened for industry a route to putting multiple diseases within the one patient, effectively having several different people being treated in the one body.

The second problem is that company marketing distributes the instruments that screen for what they want screened for while efforts by doctors or others to screen for more important risk factors are marginalized. In this way companies invert the hierarchy of risk. Where the advice should be “stop smoking and lose weight,” it becomes “take a statin.” There is little or no research on what it might be about our diets or lifestyles or environments that is leading to a surge in asthma diagnoses—the pressure is not there to research a disease that is not ordinarily fatal and for which the drugs available are so lucrative—Advair alone, the inhaler that Jane (described at the start of the chapter) was put on, is worth $8 billion per year to GlaxoSmithKline, while the Singulair she also took is worth $5 billion to Merck despite the fact that the published studies show a minimal benefit for this treatment.

A third problem is that while there may have been a cost in terms of injuries from the vaccines and other treatments necessary to eliminate polio and other medical scourges, the benefits overwhelmingly outweighed the costs, but this is not often the case for the statins, biphosphonates, hypoglycemic agents for diabetes, beta-agonists or combined beta-agonists and steroids for asthma, or antidepressants, especially when all these drugs are given in primary care as they have to be to become blockbusters.

When it comes to managing risk factors or chronic treatment, medical discretion is called for, but such discretion is regarded as suspect by those who frame guidelines for diseases. To managers, permitting discretion appears to be a recipe to return medical practice to the cottage industry era. It is, moreover, difficult to exercise discretion when healthcare systems have been redesigned so that a doctor rarely sees the same patient on consecutive occasions or knows much about their family or circumstances.

Right through to the 1960s medicine remained a rather pure market catering to our needs to have cures to life-threatening diseases. But just as satisfying our basic needs for industrial goods half a century earlier led modern companies to focus then on marketing and the creation of ever-larger consumer demand, our liberation from servitude to many diseases laid the basis for a creation in both doctors and patients of medical wants that has underpinned the marketing of conditions such as osteoporosis, raised cholesterol levels, and a range of behavioral disorders from female sexual dysfunction to ADHD.

It also laid the basis for the emergence of the medical consumer, who would shop not just for drugs but also for services, especially services whose specification includes not only an adherence to guidelines but friendliness and the appearances of concern for the consumer. For advocates of free markets it was just this kind of consumer who would drive healthcare costs down.

But while a market of consumers of this sort can readily be envisaged for enhancement technologies from designer vaginas to optimal cholesterol levels and is perhaps the only way to handle these healthcare products, real disease is not something we consume. Like death, albeit slower, it consumes us. It may transform our identities irreversibly, in a way that no subsequent purchases can undo. We make our accommodations with disease as best we can, and since the time of Philippe Pinel that accommodation has involved a medical realization that sometimes the greatest wisdom is to do nothing other than have the medical team and the patient endure together.

Companies, however, have been so successful at restructuring the market in terms of the wants of both doctors, the primary consumers of blockbuster drugs, and patients, who are corralled by direct-toconsumer ads to seek out these treatments, that few medical or patient consumers now understand no. And this new consumer-driven market has all but swept away traditional medicine.

Is there any alternative to the health products market that appears to have replaced what once was medicine? To see where medicine might go instead, let us look at another set of productive relationships: the caring a parent, often in tandem with a whole village, gives a child that helps to produce a person. Caring of this sort remains in touch with the child's zone of proximal development so that they get the right challenges, opportunities, protections, and discipline at the right time. The right caring by a teacher or school similarly helps children develop. Caring of this sort is not at odds with technologies—mothers and teachers will want their children to have computers at an appropriate stage of development and make use of other tools of culture. It is a people, rather than raw material or technology, that ultimately forms the bedrock of an economy, especially a knowledge-based economy. It involves discretion—although this discretion is rapidly being eroded by increasing regulations about schooling requirements. These are areas, furthermore, where most of us want to limit the intrusions of both the market and the state.

This is very close to the kind of caring once found in the best of medicine, as exemplified by James Spence or Alfred Worcester—often delivered now as much by a multidisciplinary team as by an individual and increasingly dependent on cooperation between doctor and patient. Medical care of this kind is productive of people, and of human dignity—or as much dignity as a disease will allow. This caring will readily embrace the appropriate technologies, from insulin to surgery, in order to get the best possible outcome for the person. The focus on real disease that comes with such caring relegates consumption to a secondary role. No pharmaceutical company is ever likely to provide a scanner, meter, or rating scale for medical care that focuses on the person rather than a disease.

What is at issue can be illustrated by considering a doctor's role as the gateway to sick leave and disability payments. One of the most striking lessons doctors learned in World War II was that soldiers due to go on leave would often fail to report serious illness, while others with no prospects of leave became strikingly ill. The doctor was the passport out of active service, if he could be fooled into thinking you were ill. These insights were brought back from war by a generation of physicians who were more sensitive, accordingly, to the ways in which we might all be trying to escape from the prison of our circumstances—an element present in many consultations that cannot readily be measured but which may lead all of us to play along with suggestions that we have disorders like osteoporosis or mild asthma in need of management with the latest drug.

But it was only some doctors who had learned these lessons—not health economists or health planners or even all doctors, which may explain what happened next. The discovery of penicillin and streptomycin in the 1940s eliminated tertiary syphilis and tuberculosis and with these diseases the costs linked to the occupancy of thousands of beds. These cures returned thousands of people to able-bodied and productive status, thereby increasing the wealth of the nation. Further breakthroughs in the 1950s with the first treatments for asthma, first oral antidiabetic agents, first antihypertensives, first antipsychotics and antidepressants, should, if used judiciously, have increased national productivity by many multiples of what the treatments might have cost, but instead sickness rates and disability payments began to skyrocket and the costs of healthcare grew faster in the United States than elsewhere, growing from $100 per person per annum in 1950 ($500 per annum in today's prices) to $7,681 per person per annum in 2008.⁵⁰

There was an increase in productivity but much less than in other countries. Where US medicine led the world in the 1960s, in 2000 the World Health Organization ranked the United States 72^nd on what it termed health system attainment and performance and 24^th from among 191 countries worldwide in terms of overall health, as measured by indices such as infant mortality and life expectancy,⁵¹ while in 2008 the Commonwealth Fund ranked the United States last among developed countries in terms of quality of healthcare.⁵²

One of the factors contributing to a comparative decline in American life expectancy rates is most visible among the elderly. Recent years have seen a startling rise in the extent of polypharmacy, where people are given several different drugs at the same time. It might not be so surprising to find that some people take both a treatment for asthma and for osteoporosis, but as Jane found when being treated for asthma alone few people end up with less than three different treatments. Similarly it is common in the mental health domain to find people on cocktails of four or more drugs rather than just an antidepressant. People with two conditions may be on seven to eight drugs. And ten drugs or more is fast becoming the norm for the elderly especially in the United States. But in this age group, in addition to the problems caused by each blockbuster drug, there are the problems caused by the increased likelihood of interactions between them. In the elderly the rate of hospitalization due to adverse drug reactions is six times higher than in the young and rises sharply in proportion to the number of drugs being taken.⁵³

It is almost impossible to get data linking polypharmacy to productivity, because doctors simply do not collect it and companies have no incentive to look at it. Pharmaceutical companies have detailed data on what every doctor prescribes and use the data to spur their sales force on just like an athlete uses a stopwatch, but doctors only record and report one in a hundred of the deaths or serious injuries that happen on drugs. None of our measurements track people. Whether you think we are dealing with poisons to be used judiciously or fertilizers to be given out indiscriminately, few people can ingest ten or more chemicals given together without toxic effects—but we don't track this.

A recent report from the Congressional Budget Office identified the growth of prescription-only medicines and other high-tech medical developments as the greatest contributor to escalating costs of medical care in the United States.⁵⁴ But aside from the raw costs of drugs, pharmaceuticals contribute in many other ways to our rising health costs. If the increasing costs of drugs led to people being more productive this could be justified, but as we have seen repeatedly many of our more recent treatments if used injudiciously, as the clinical trials we have reviewed have shown, will injure and kill more than they save. Despite this evidence, the media hype surrounding new treatments raises expectations and leads people to seek medical care when they don't really need it. When companies manufacture new diseases (disease mongering) they also pull people into medical care who don't need it. In all these cases, as Sanjeebit Jachuk found back in the 1980s, a significant proportion of people will be made less healthy and less productive.

Finally, the drugs bring in their wake a fetish with measurement. In the face of ever-escalating costs doctors can only afford to do things that come with an evidence base demonstrating they “work.” But here we run into a paradox. While the evidence from trials of many drugs, as discussed in chapter 3, shows that watchful waiting may help far more patients than intervening with an active drug, watchful waiting cannot be shown in its own right to “work.” It can't be measured against anything. As a result, there is no longer any basis for medical discretion, no basis for a consultation. This is a world in which doctors are forced to adhere to guidelines and provide unambiguous benefits that can be demonstrated for instance when the figures on a peak flow meter go the right way. A world in which it only makes sense for insurance companies to reimburse for visible disorders of the type demonstrable on DXA scans or through blood cholesterol markers and for treatments that look good on company-run trials and sold on the promise that despite their cost doing what works will ultimately bring healthcare costs down.

In a world where measurement has such powerful effects, it seems more than ironic that measurements such as the ones cited for healthcare costs and life expectancy have so little effect in galvanizing reform or seem only to demoralize us and perhaps inhibit our abilities to do anything. What is it that doctors and patients today are missing that might help them restore “care” to medicine, or what is it that they are up against that seems so difficult to grapple with?