Pharmageddon (3 page)

The Obama administration and others have suggested that the only rational way forward is to embrace evidence-based medicine. But just as the insurance companies have found, anyone turning to this source will be faced by controlled trials which demonstrate that the most recent drug treatments work and supposedly save money. They will encounter guidelines drawn up by the most distinguished and independent figures in the field, advocating the use of the latest drugs. They will be told the biggest problem lies in doctors failing to adhere to evidence-based guidelines. A new generation of web-based companies is even offering to build devices into electronic medical records to ensure adherence to the latest guidelines in a way that would make it impossible for doctors to exercise discretion.

In a world where corporations can market bottled water to us, it appears to have occurred to virtually no one to ask how such marketing power might be applied to drug therapies. If the goal of medical marketing is to find out what doctors want in order to get the doctors to sell the product to themselves—and it is—and if doctors say they are influenced by the evidence above all else—and they do—it should not come as a surprise that industry might set about ensuring the evidence points in the right direction. The availability of drugs on a prescription-only basis in these circumstances makes the job of company marketers a great deal easier than it might otherwise be by enabling them to zero in on a small number of consumers who, when it comes to marketing, are often more naïve than the average adolescent.

We have an extraordinary paradox that attracts absolutely no comment. On the one hand the medical establishment portrays evidence-based medicine as our best means of reining in the pharmaceutical industry, while on the other hand pharmaceutical companies are now among the most vigorous advocates of evidence-based medicine. And it is just this kind of evidence that administrations in both the United States and Europe seem to think will help control health costs. If catch 22 hadn't existed we would now have to invent it.

AVOIDING PHARMAGEDDON

While ghostwriting by pharmaceutical companies has begun to make the news, there is little awareness of the extent to which medicine's major journals have been complicit in the practice and how, faced with articles on treatment hazards, our journals self-censor for fear of legal actions. There is no analysis to explain how treatment guidelines drawn up by academic bodies that are independent of the pharmaceutical industry invariably endorse the latest company products.

All the while doctors and patients complain about the profound changes in their clinical encounters. Where once we consulted our doctors because we had a problem and met a doctor who could spot differences in us from one visit to the next, someone who might have spotted a treatment-induced problem, we are now likely to meet a different face each time we go to the clinic. The main task of many doctors has changed from monitoring us for evidence of life-threatening diseases or the adverse effects of treatment to monitoring the results on computer screens from the latest tests of our risk factors, and managing those numbers on the basis of guidelines. Not unreasonably, the managers who increasingly run health systems from the United States to Europe assume that if the job involves looking at numbers on a computer screen and then following guidelines for what to do next, doctors should be interchangeable.

The engagement of a doctor with the person in front of him or her now means increasingly that on the basis of targets linked to guidelines the role of the doctor is to “educate,” to cajole or coerce us into treatment for conditions we never knew we had, with treatments that in some instances are more likely to injure or kill us than improve our well-being. This is what caring has become.

Doctors complain about all this, but without an analysis of the forces pushing them to one side and unless they can offer an alternate model of care, such complaints are idle. Blaming the pharmaceutical industry without pinpointing anything they do other than make more profits than some might like is just scapegoating. Are the scapegoaters, we might ask, doing anything other than complaining? By the end of
chapter 2
it will be clear that current patent law and prescription-only arrangements for drugs may in fact give rise to many of our more superficial difficulties—but are there any doctors or others seeking to change these arrangements? By the end of
chapter 4
, it will be clear that blockages to our access of the data from clinical trials constitute a serious breach of scientific norms, but it will be far less clear that there are any doctors taking a stand against this breach.

All of these issues come to a focus in
chapter 7
in a description of a patient injured by treatment. Here we see at its clearest the divide between what medicine at its best once was and what it risks becoming. On the basis of the “evidence”—the published reports of controlled trials—our doctor may appear to have little rational option but to deny that the prescribed treatment could have caused us any problems. There is no evidence-based approach to determining whether treatments have injured a patient or what to do when it happens. Why ever not?

Avoiding Pharmageddon is not primarily a matter of containing the escalating costs of healthcare—although this is important. It is a matter of restoring the conditions in which doctors can diagnose what is afflicting us and can offer the appropriate care. This kind of care is not something intangible nor something that looks like current efforts to get health professionals to smile more and encourage their patients to have a nice day or other efforts to deliver a “good service.” When it comes to treatment-induced injuries it will increasingly require those whom we entrust with our care to have the “right stuff.”

While on the surface physicians and others in healthcare are now encouraged to become our partners, in fact the impulse to nurture us when we are afflicted so that we can realize our potential to its fullest extent is being thwarted by processes that render treatment-induced problems invisible. As a result, a vast reservoir of idealism and goodwill that those working in healthcare bring to their work daily is being squandered. And insofar as the essential wealth of a nation is people functioning at their best, rather than oil or other resources in the ground, our countries and economies are being correspondingly impoverished.

There is a climate change taking place in modern medicine that is quite different than the loss of perspective bemoaned by Worcester and generations of doctors since. Coming to grips with the factors driving this shift in climate may involve changes to things like patent law, prescription-only status for drugs, and access to the data from clinical trials, but it also needs doctors and patients as individuals to take action. In the face of global warming, actions on an individual scale can seem futile, but in medicine as in climate change, adding one to another can make a difference.
Pharmageddon
is part of that effort. It is written in the belief that almost every doctor in practice and every person who visits them will, once the issues are examined, be alerted to the growing chill in clinical care and that between us we can make a difference.

1

They Used to Call It Medicine

The careers of Alfred Worcester (1855–1951) and Richard Cabot (1868–1939) in Boston spanned the formative years of modern medicine. Worcester's medical training in the late nineteenth century included repeated visits to the homes of the sick and dying as a doctor's apprentice, whereas students of Cabot in the early twentieth century were trained in the new sciences basic to medicine, like bacteriology, and rarely got to meet the same patient more than once. Second-year medical students of 1912 knew more about diseases than the doctors of his generation ever did, Worcester conceded, but he argued that at the end of the day an exquisite knowledge of disease mechanisms was more likely to tell a doctor what his patients had died from rather than how to help them live or die. Older doctors, while not ignoring what they understood of disease processes, knew vastly more than their younger colleagues about human helplessness and were comfortable managing it. “It is when dealing with the mysteries of life that science fails the modern doctor,” Worcester said.
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Bemoaning a recent shift in Harvard that saw pharmacology now taught by someone who had never engaged in medical practice, Worcester noted that “in the modern medical schools science is enthroned. Carried away by the brilliance of etiological discoveries, the whole strength of the school is devoted to the study of disease. The art of medical practice is not taught; even its existence is hardly recognized.”
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“Little wonder is it,” he went on, that people “turn to the Christian

Scientists, or other charlatans who, either in their absurd denial of the existence of disease or for mercenary reasons, at least leave some hope in the sick room.”

Worcester's words have an uncomfortable ring of truth. But while we undoubtedly hope our doctor will be “old school,” few if any of us are prepared to give up the benefits science has brought to medicine over the past century. Aware of the hazards of a narrowly “medical” approach, many medical schools, Harvard in particular, attempt to ensure that students realize an illness is but an episode in their patient's lives.
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But despite these efforts, clinical practice still seems to be degenerating.

Patients treated by Worcester might have seen him with an apprentice in tow or when they went to see Cabot at Massachusetts General they could well have encountered medical students sitting in on the visit. But now the pharmaceutical industry has been able to persuade doctors to allow trainee drug reps to sit in on clinics—recently illustrated in the movie
Love and Other Drugs.
For example, as part of her training as a sales representative, Jeanette got to sit in with Dr. N on a “medication management clinic.” Dr. N is the fictional name for a real doctor— a high-volume prescriber of drugs—who is the subject of a research project looking at modern clinical practice.
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Jeanette was struck by the amount of paperwork he had to fill out on each patient—charts tracking both the doctor's and patient's perceptions of whether a drug was working and whether any side effects were apparent. He was so busy filling out the forms that he barely looked up during his 10-to 15-minute sessions with patients.

One day, a middle-aged man came in, and while Dr. N completed the paperwork for the previous patient, Jeanette engaged him. He seemed to be in a good mood considering he was in a wheelchair and recently had had both legs amputated because of vascular problems. Dr. N began to ask the usual questions, ticking boxes as he went.

Finally, the patient interrupted: “Look at me, Dr. Do you notice anything different about me?” He repeated this several times until Dr. N looked up and focused directly on the man, while pushing his glasses up with his thumb. He stared at the patient for several seconds and finally said, “No, I don't notice anything different, what's up?” The patient smiled and said excitedly, “I got my legs cut off since that last time you saw me!” Dr. N steered the conversation back to the patient's medication, and the session ended a few minutes later.

While this neglect may have been extreme even for the fictional Dr. N, many of us face something similar when we visit our doctors today; even the best seem to spend an increasing proportion of their time looking at computer screens rather than at us. While Cabot was more committed to the latest science than Worcester, there is little doubt that he would have been as appalled at this as Worcester might have been. There is moreover no reason to believe that an embrace of science should lead to such degradation of medical practice. The case of Dr. N, comically extreme as it is, puts in stark relief a type of medical practice encouraged by the dominant forces in healthcare today.

This book sets out to explain how we have come to a situation where a Dr. N can not just exist but may become something of the norm in the near future. As a first step we need to outline two histories, one a relatively traditional history of medicine's relation to drugs culminating with the emergence of a set of truly effective magic-bullet treatments in the middle years of the twentieth century and the other a history of marketing that starts in the late nineteenth century. These two histories initially have little in common but in recent years, as we shall show, medicine seems to have become the home of the most sophisticated marketing on earth. The transformation is undeniable but if we wish to change things it is not sufficient to simply assert there has been a transformation—we need to pinpoint the mechanisms driving the change.

FROM MEDICINE TO MARKETING

In a 1951 ad featuring American soldiers at war, the pharmaceutical company Eli Lilly outlined the contribution it and other companies were making to the United States:

A record of American Achievement. Thousands of Americans and of our allies too, are alive today because of the lifesaving gains made in World War II. The mortality rate of our own wounded dropped to the lowest level in the history of any army in the world. This was accomplished through better methods and techniques of medical care and especially through the use of new and improved pharmaceuticals. Tremendous quantities of penicillin, anesthetic agents, sulfonamides and processed blood were quickly supplied by such manufacturers as Eli Lilly and Company. The rewards of free enterprise had built an American industry large enough to do the job.
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Ironically, most of the treatments mentioned in this ad were produced not through free enterprise but through government funding or by the prewar German pharmaceutical industry cartel IG Farben. During the 1950s and 1960s, Czechoslovakia, then part of the Soviet bloc, produced more new drugs per capita than any other country. Nevertheless, capitalism and free markets at some level “work.” Everyone now recognizes this. And, given a choice between a system that produces the best hi-tech healthcare in the world and contributes to the development of breakthrough drugs but is run as a business or a system that isn't run as a business, puts a premium more on caring than on breakthrough drugs, and takes social factors into account in considering appropriate care, the average person will opt for breakthroughs every day of the week.

The problem with this free market view of the world, nowhere more so than in the pharmaceutical industry, is that the free markets that supposedly lead to better mousetraps were cannibalized in the twentieth century by what became a few large firms, one of them being Eli Lilly, that were then in a position to favor marketing over innovation as the ultimate key to their profits. Where the research and development budgets of large pharmaceutical companies like Lilly and Pfizer were once much greater than their marketing budgets, the reverse is now true. The pharmaceutical industry, for example, now spends $30 billion annually on marketing in the United States alone. In 2002, Pfizer devoted roughly $1.2 billion to marketing the statin Lipitor as a treatment for raised cholesterol levels, an amount equivalent to the US National Institutes of Health budget for research on Alzheimer's disease, arthritis, autism, epilepsy, influenza, multiple sclerosis, sickle cell disease, and spinal cord injury combined.
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Given that Lipitor was only one of six statins on the market at the time, anyone trying to get out a competing medical message—that statins have a very limited role in healthcare or that there are alternate ways to lower cholesterol through diet and other approaches—faces a daunting challenge. With money like this behind them, twenty-first-century corporate marketers are supremely confident they can sell anything. Bottled water, oxygen, and with the right packaging, even inferior mousetraps. And if they can do this, why not homeopathic or relatively worthless medicines?

Pharmaceutical companies have perhaps done more to undermine traditional markets than any other industrial companies. Not coincidentally, from Lilly's 1951 ad to a 2005 book by Hank McKinnell,
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then CEO of Pfizer, they are also the corporations most active in spreading the message that there is no alternative to a free enterprise system. But while in fact many industrial corporations came to the conclusion a century ago that the capitalism of cutthroat competition and free markets didn't work as well as it might—at least not for them—no other branch of industry has been able to pursue this agenda in quite the way pharmaceutical companies have.

To begin to see how pharmaceutical companies have engineered what they have, we need to return to the mid-nineteenth century when the first science-based companies began producing goods made possible by the new physical and chemical sciences. These sciences formed the basis of electrical manufacturing as well as the chemical and metal industries, leading to a string of new goods from automobiles to plastics, explosives, dyes, rubber products, artificial fibers, and, later, pharmaceuticals. In all these cases, competition between companies should in theory drive prices down in an open market, especially when increasing automation reduced the cost of production. Faced with the risk of falling profits, the new manufacturing companies commonly banded together in cartels to keep prices artificially high. A cartel presents the world with apparent competition between companies when in fact the companies have agreed among themselves to coordinate prices and market arrangements, allowing them to enjoy the advantages of de facto monopolies.
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But government resistance to cartels mounted in the United States and Europe at the end of the nineteenth century.

Companies needed to find another way to maintain or increase their profits. It was this that led to a turn to marketing. For manufacturers the problem was that as the genuine need for automobiles, plastics, dyes, nuts and bolts as well as mousetraps were increasingly met with capacity to spare, ever more production could only drive prices down. If prices could not be rigged by cartels, could demand be maintained or increased by tapping into what people might be persuaded they wanted or needed?
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An appreciation of the opportunities that marketing opened up led to the emergence of marketing departments within companies and the first university courses on marketing in the 1920s.
¹⁰
In a supreme irony, much of the raw material for these courses came from a brilliant set of ad hoc developments that underpinned the marketing of proprietary, over-the-counter medicines in the nineteenth century. The early exponents of the new science of marketing realized that the true experts on understanding what people might be persuaded they needed were quacks pushing worthless medical remedies. It was these who more than anyone else created advertising and shaped modern marketing.
¹¹

One of the first lessons that proprietary medicines taught later marketers came in the 1830s, when a war broke out in the newspapers between Samuel Lee, Jr. of Connecticut who produced “Bilious Pills” and another Samuel Lee from Connecticut who also produced a Bilious Pills remedy. Far from leading to market collapse, this dispute spurred demand for Bilious Pills, and soon other proprietors across the country were joining in with their own preparations. In contrast to the producers of dyes and metal goods, these businessmen found competition among producers led to increase in sales for their commodities, without prices falling. In the drug domain this phenomenon has been demonstrated again and again from the marketing of Aspirin as a brand name product in the nineteenth century to that of Lipitor and Vioxx in this century.
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In 1804, there were some ninety over-the-counter proprietary medicines listed in New York. By 1857, this had swollen to more than fifteen hundred countrywide. The growth in business paralleled the growth of the press and literacy. Where there were two hundred newspapers in 1800, there were four thousand by 1860. The proprietors of these remedies took advantage of this explosive growth and were among the first to market nationally. They also marketed heavily: the proprietary medicines industry spent more than any other industry on advertising in the second half of the nineteenth century. By the end of that century up to $i million was being spent on telling the American people about the benefits of Scott's Emulsion, just one of an estimated fifty thousand compounds in a trade that had a retail value of several hundred million

dollars.
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The proprietary medicines industry was the first to market lifestyles rather than the compounds per se—this was marketing before the modern term had come into being. There was a simple reason for this: there was little if any value in these substances. The key ingredients were on the bottle rather than in it—the branding. It was no accident that one of the leading early lights in advertising, Claude Hopkins, would say that “the greatest advertising men of my day were schooled in the medicine field”
¹⁴
—schooled, that is, in how to persuade the public that Carter's Little Liver Pills, Lydia Pinkham's Vegetable Compound, Clark Stanley's Snake Oil Liniment, or Coca Cola or, later, 7-UP would restore health or beauty, resolve halitosis, conquer fatigue, or ward off calamity. The money thrown into the marketing campaigns came from huge markups in the selling price of these compounds, typically inflated to five times their cost of production.
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