Pharmageddon

by David Healy

  These events led a Senate committee to investigate GlaxoSmithKline and issue a damning report.70 Legal cases have been instituted. These reveal extensive ghostwriting of the medical literature as part of the marketing of Avandia, comparable to that found in the marketing of Hormone Replacement Therapy (HRT)71 or oral contraceptives such as Yaz. These cases reveal that the pattern of using evidence-based medicine to drive prescribing is now all but universal. Apparently rational prescribing in such circumstances is close to certain irrationality.

  Zeus responded to Demeter that he was helpless to do anything about her daughter. Once, if our daughters were threatened by Hades, doctors from Philippe Pinel two centuries ago, to Alfred Worcester and Richard Cabot a century ago, and Dr. Lapin who looked after my father a quarter of a century ago, might have intervened on our behalf, but for the moment all we have standing between us and Hades is a small group, comprised of mothers and wives like Mathy Downing and Mary Ellen Winter and a dwindling number of Lapins, Worcesters, and Pinels. It is these who do the job of alerting us to the hazards of treatment, a job that one might have thought lay at the heart of good medical care. How long they can hold on before the Heavens answer is not clear.

  8

  Pharmageddon

  Nothing more

  But the sense

  Of where we are

  That seeks to find, to rescue

  Love to the chill

  Upper world, and to speak

  A substantial language

  Of Dignity

  And of respect.

  —George Oppen, “Orpheus”

  Medicine as we have known it is at death's door. Real disease brings the specter of death with it, and every medical journey to some extent follows in the steps of Cora into the underworld, leaving Demeter to implore heaven to restore her to some measure of life.

  Over the last quarter of a century, what was medicine has increasingly turned into healthcare, part of a vast global market in healthrelated products. Pharmaceuticals are exemplars of the goods in this modern health products market, but entire services can be packaged and managed as commodities, just as drugs are.

  Only the market can guarantee efficient production, we're told, and we must surrender to it. The industrialization and marketization of healthcare has entailed a gamut of changes similar to those that have been seen in other industries. We see a standardization of care, with practices geared to treating patients in the same way as a service station handles a car that comes in for servicing—albeit with appropriate expressions of concern that wouldn't be necessary with a car. Meanwhile, the labor of taking risks in trials of new drugs has been outsourced to the Third World, Enron-scale scandals with drugs like Vioxx and Zyprexa have erupted, and to sell the products, healthcare advertisers now promise what automobile and shampoo advertisers have promised for years with purchase of their products—an enhanced life.

  The corporate world of today's health services industry is a long way from the clinics in which nurses, doctors, and others working with those who are suffering try, often against the odds, to produce health. Ads for healthcare products that portray patients as vigorous and embracing life, as if drugs were just another set of consumer goods at the mall, conflict with the reality of diseases that shorten and compromise lives. People with diabetes are taught to prick the side of their fingers to get blood samples because the disease brings a risk of blindness and they may need the pulp of their fingers to remain touch-sensitive—good care does not deny these possibilities or put them in the small print of an advertisement. Medicine aims at a myriad of adjustments, with as much assistance as possible from technology, in order to cope with the frailties of the human body and mind; it aims at producing as much health as possible out of mankind's most debilitating afflictions.1 This is quite a different project than the enhancements health products offer.

  At the heart of medicine is an act of care by doctors who talk, look, listen, and do something for patients who come to a clinic acutely ill with an abdominal problem, a heart attack, or a broken limb, or druginduced injury where every patient is different and care necessarily has to reflect this. While today's rhetoric is more and more about personalized medicine, the practice of dispensing health products has moved increasingly to standardized screenings for risk factors with treatments like the statins, or drugs for osteoporosis, nervous problems, or blood sugar control that clinical trials suggest in many cases are at least as likely to harm us as to help—a practice that is as far from caring as it is possible to get.

  Generations of revolutionaries have talked about the alienation market forces and industrialization produce, the loss of jobs and skills, of values and ways of life, but many of us in the economically developed world have seen our material circumstances improve and have shrugged. Why should we expect anything less than comparable improvements in medical care—especially as we seem to hear of ever more medical breakthroughs in the media?

  There are a few reasons why things are different now. One is that drugs and other services in the medical market physically act on the stuff of which we are made and may reconfigure us quite dramatically in ways we are not told about. Unlike short courses of antibiotics, which do not substantially change us, chronic courses of treatments aimed at managing risk factors do change us. Whether it be a cholesterollowering statin, an anti-inflammatory such as Celebrex, a treatment for osteoporosis such as Actonel, or a psychotropic cocktail, these drugs do not just have the action we are told about but often have much greater effects throughout the body than the one the company markets, potentially leading to an increased risk of dementia in the case of Vioxx and Celebrex, an enduring susceptibility to heart attacks in the case of Fosamax and Actonel, or changes in our ability to make love in the case of Paxil, Cymbalta, or Zoloft. Beyond these specific problems, the indiscriminate actions of many of these drugs on our physical constitution quite probably alter both our susceptibility to various diseases and our personalities too in subtle ways.

  A second reason things are different now is that unlike other industrial processes, many of which have led to tangible benefits, the logic of healthcare marketing may block real benefits. Companies initially attempted to play down the evidence that ulcers were linked to a bacterium that could be eliminated, because this information wasn't good for business. They have similarly been extraordinarily successful at replacing older generations of antibiotics, psychotropic drugs, and anti-inflammatories with less effective and more hazardous agents such as Celebrex, Prozac, and Cipro. As a result some of us are now dying earlier than we should, and many more are suffering needlessly. By taking us away from productive work any premature deaths and incapacity come at a cost to the economy, and so it is in the interest of all of us to pay attention to the medical care each of us gets.

  A third and perhaps most important reason is that these drugs also serve as a screen for a set of processes that act on us just as potently as the drugs themselves do. Companies take our inner aspirations and fears and mold a strategy designed to readjust our identities and get us to consume drugs more faithfully than we would do if we were living in a totalitarian regime and required to consume.2 The changes in the way we live can be so mundane as to be almost invisible. Take the case of Josephine, a fit sixty-year-old who had been told she had osteopenia—a normal state for a woman of her age that comes with no risk of a fracture. But led to believe she has an illness, and put on Actonel or Fosamax, she is now afraid to mow the lawn for fear of falling and breaking a hip—though mowing the lawn instead of taking the drugs is a better way of reducing her risk of a fracture. Josephine's sixties are being shaped in ways she could not easily guess by the patents on a group of drugs. Our very ideas of ourselves are now subject to change at intervals coinciding with the fall of off-patent and rise of newly patented compounds.

  Macbeth's unmet desires for fame and power left him vulnerable to seduction by the witches. Many of us can live without fame and power, but we are almost all vulnerable to seductions
that offer us freedom from disease, with possible enhancements of our potency or beauty. Just as reaching for what was on offer produced disaster for Macbeth, so also our reaching seems to have left us with potentially reduced life expectancies, a growing discontent with who we are, and an atrophied ability to care for others.

  If we fall prey to the witches' seduction in the health domain, our abilities to resist the industrial processes now encroaching on teaching and farming and other domains are also likely to crumble. Ultimately even the rearing of children may be affected. The hour is already late; just as patients have been eliminated from medicine in favor of medical consumers, so teachers have been replaced by educators whose brief it is to make available a range of educational products to their clients rather than to try and foster the growth of a person. We may not be far from a time when, for the sake of ensuring quality upbringing, mothers (and fathers) will be encouraged to look after their young clients in standardized ways. If as a society we cannot care for patients, it is not clear that we can care for children or for the planet.

  It doesn't have to be like this. Ironically, indeed tragically, our new medical systems now produce as many perverse outcomes as they do in part because of some mechanisms we have put in place that stem from our recognition of how central health is to everything that counts for us. Given this centrality, it seemed important to Senator Estes Kefauver to control the pharmaceutical industry, and he, on our behalf, attempted to do so by making new drugs available by prescription only and then only letting them on the market once they had been through controlled trials. These safeguards, which were designed to bolster the role of doctors and contain industry, have in industry's hand been turned to do just the opposite. Increasingly alienated, doctors are not the force they once were and it is very difficult to view them as a body likely to rise up and demand change.

  If, however, there is a path down into Hades, there must also be a path up. And there is hope in the knowledge that life often teems even in the most inhospitable environments. The first step back is to decide what kind of society we want to live in, what kind of economy we want.

  At present we are trained from infancy to believe that the key things we produce are cars, computers, pharmaceuticals, and other goods. No one would accept that these are the things we care about the most, but we have slipped into a de facto acceptance that these things have a primacy largely because they can be readily commodified and quantified. The problems with the kind of system we have ended up with become very clear when we find that the cleanup of an oil spill like the Exxon Valdez, because it leads to a quantifiable increase in the consumption of commodities, adds to our economic wealth. As the service sector of the economy has grown, we produce units of service rather than old-style goods and this is what Western economies now depend on to an ever greater extent.

  When it comes to health and education, the dangers in this model become ever more apparent. Just as with the Exxon Valdez in measures of gross domestic product, so in health, the side effects of treatments are at present (a lawsuit or two aside) an unalloyed good for pharmaceutical companies. They tend to lead to treatment with ever more drugs to manage side-effect problems rather than to a reconsideration of the original treatment; for instance Avandia and Lipitor are given to manage the diabetes and raised cholesterol triggered by a guideline-mandated drug like Zyprexa rather than rejecting this newer drug and returning instead to older, off-patent, less expensive drugs that would be much less likely to cause these problems. Increasing rates of treatment-induced mortality so far have had little effect on these practices. Instead, we have increasing efforts to standardize treatment delivery through the development of guidelines, which happen to recommend the latest onpatent medications that in many cases clinical trials have suggested may increase rather than reduce mortality. In this way the side effects of our latest blockbuster drugs have become one of the primary drivers of health system growth.

  Is there an alternative to these “diabolical” scenarios?

  One option is to put a fostering of persons at the center of the economic (oikos nomos) stage. Just as in a home (oikos), it makes more sense to view our family or our people, rather than any provisions, the furnishings, or money salted away, as the ultimate source of our wellbeing, including our economic well-being. The trick will lie in redesigning the rules (nomos) of our collective home to reflect this. This would not mean turning our back on the production of goods. The problems we face do not come from technical advances—few among us would not welcome more effective treatments for dementia or cancer, and technical advances now seem a crucial component to saving life on the planet—the home of our homes.

  The problems come from the social arrangements, the rules, through which at present all developments in health are filtered. It is these rules that give rise to our alienation and also increasingly block the emergence of the developments we need. Senator Kefauver adjusted the rules one way, perhaps the right way for his time, but in a manner that seems to be contributing to our problems now. Are there any adjustments that might steer medicine back toward what it could be and at the same time give us a glimpse of what a properly human economy (oikumene) might look like? There may be other steps to take, but following Kefauver we can look at company practices of sequestering clinical trial data that inhibit the ability of doctors to practice data-based medicine, the availability of medicines by prescription only, and the current patenting arrangements for drugs.

  Reforms in these areas will require wisdom—having good intentions is not sufficient. Social arrangements have a great capacity to deliver exactly the opposite outcomes to those their proponents intended, as perhaps Kefauver's 1962 Act demonstrates better than anything else. But our intentions are also important. There must be some attempt to answer just what it is we want or need in order to determine whether our arrangements are likely to facilitate this or not. In the following pages I will review changes in terms of whether they are likely to foster an ability to care or not.

  Our story will end on the wider shores of myth, where by myth I mean our more general orientation to the unknown. But it is in specific changes to the social arrangements that govern our way of life on the planet and vis-à-vis each other that the survival of medicine is likely to lie.

  DATA-BASED MEDICINE

  In the 1960s randomized controlled trials appeared to be an almost perfect way both to harness the benefits that industry could bring to the common good and to contain or even eliminate the evils of pharmaceutical marketing. In the 1990s, in response to growing commercial pressures on medicine, this medical turn to controlled trials evolved into a commitment to what came to be called evidence-based medicine. Far from resisting these moves that were meant to constrain it, industry embraced them, and from the 1990s has proselytized for evidence-based medicine. Few seem to have noticed the irony, and among those who do there is bewilderment as to how to manage this Hydra who grows new heads no matter what efforts are made to prune it back.

  Medicine today has to be based on evidence—but what is evidence? Industry has masterfully exploited ambiguities in the word and, especially, a gap that lies between data—what actually happens to a patient—and the later construction of “evidence” as to what a drug does. Where doctors are faced with the word “evidence” they for the most part believe they are dealing with data-based medicine, and as long as they think this way industry can vigorously promote their version of what happened when drugs are given under the banner of “evidence”- based medicine.

  There are several ways in which the data that should be at the heart of medical evidence are hidden by the pharmaceutical industry. First, there is a drug company's outright hiding of the data that is collected so that no one gets to see it. Second, the remaining data is disguised through certain kinds of statistical models and what comes out the far end is presented as “evidence,” while the injuries that happen to you and me are degraded to the status of an anecdote. And finally companies have created a culture of data negl
ect, in which doctors have become blind to what is happening to the person in front of their eyes.

  The issue of hiding data is not the scandal it should be in part because common perception is that drugs are made in company laboratories. This view misses something fundamental: companies make chemicals, but we are the laboratories in which modern drugs are made. Drugs are chemicals used for a social purpose—to treat conditions that we define as diseases. Drugs cannot come into being unless we as healthy volunteers and later as patients in clinical trials agree to take them to see what happens. Without our participation, there is no drug.

  Our willingness to participate in these studies was borne out of a sense of civic duty in the 1950s. We participated on the understanding that taking risks might injure us but would benefit a community that included our friends, relatives, and children. We did so for free— in perhaps the greatest ever example of how a system geared around people rather than products can make much more economic sense. The system worked and extended the compass of human freedom from the many epidemics and other scourges to which our forefathers had been subject for millennia.

  But the research in which we once participated has morphed from scientific studies whose data was in the public domain into company trials where the data has been sequestered. There are all sorts of protections now built into trials that weren't there in the 1950s—centering on informed consent about the possible benefits and side effects of treatment and suitable safeguards of anonymity. But we are never informed about and asked to consent to the sequestration of our data in company trials. We assume we are participating in science and that the data arising from the risks we take are available to scientists more generally, as they once were.