Pharmageddon (29 page)

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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.