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.
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 neglect, 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.
It would be an easy matter to remedy this—by ensuring that the consent forms for a trial tell us whether the company will sequester our data. Without this any participation in such studies is more likely to jeopardize the health and well-being of our friends, children, and communities than to widen the compass of freedom from disease because companies will parade clinical trials where injurious side effects are hidden, artfully coded, or simply eliminated as evidence that their drug could not have caused the injury, and if doctors or the courts believe them, any effort on our part to seek redress will fail at the first hurdle.
Evidence-based medicine as first conceived was a highly moral enterprise. It takes courage to subject all our preconceptions to testing, and then to treat the people who come to us for care on the basis of the data. But what passes for evidence-based medicine has now been subverted by companies into an exercise that skirts conflicting values by appealing to preselected “data” that are supposedly value neutral. We need to recover the perspective that science, far from being value free, values data and does so with a passion. “Controlled trials” that involve restricted access to data are not science, and following selected “data” can only diminish both the carers and the cared-for.
If all the data on the benefits and hazards of treatment were available, the exuberance that companies can engender by marketing agents of supposedly extraordinary efficacy and almost no risks would to some extent be curbed, and if curbed the vast profits that support the most sophisticated marketing on the planet, that conjures diseases out of vicissitudes and can reconfigure our very selves to suit its purposes, would in some measure be limited. If this happened clinical practice would have a better chance of returning to something closer to what it once was, when one person consulted another.
We might require companies to post all records from clinical trials, with suitable safeguards to protect individual patient identities, to an Internet site, before any analysis of the evidence was published. This would simply replicate for medicine the common scientific practice of journals like Nature or Science that require the relevant genetic sequence to be posted to the Internet before any claims are published.
But the simple idea of posting the data reveals a profound ambiguity in the notion of evidence-based medicine. While most people assume medicine has been data-based for the last twenty years or so, there are vanishingly few articles in journals or presentations at meetings—other than, ironically, some good case reports—that offer data. In the course of clinical trials things happen to patients, but these things are assembled and analyzed using models that come with assumptions including that if a finding is not statistically significant it essentially does not exist. It is the “results” of these analyses that are published—rather than any account of what in fact happened to patients. When it comes to results, he who controls the program giving rise to the results can control everything.3
When we have Pierre Touery drinking ten times the lethal dose of strychnine in front of our eyes and surviving because he had previously taken activated charcoal or when a child with bacterial endocarditis gets up off her deathbed and walks after being given penicillin, we have data-based medicine. When you are put on a statin, a biphosphonate, or a psychotropic drug because in some trial that has recruited hundreds or even thousands of subjects so that a finding on a blood test or rating scale that suits some company has become statistically significant, you are being subjected to results-based medicine rather than cared for with data-based medicine.
When it comes to the hazards of drugs as reported by their makers we are invariably dealing with results rather than data. Consider the following excerpt from the deposition of Ian Hudson, then head of Global Safety at GSK:
Q: Okay. So, your view is: It's simply impossible for SmithKline Beecham to decide whether Paxil did or did not contribute to the homicidal or suicidal behavior of any one given individual; is that your testimony?
A: We would certainly gather all the information, but on an individual case basis it would be impossible to decide whether paroxetine caused an event or not…. It is impossible, on an individual case basis, from individual reports, to assign causality especially in a very complicated area such as this. That's why, when we have issues, we review all the available data and make a determination, on the basis of all the available data, whether there is an issue or not.
Q: Okay. Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?
A: I have seen no evidence to suggest that at all.4
Hudson is demonstrating the standard company approach to determining whether there is any link between an adverse effect and the company's drug. In brief, the company position is that unless an adverse event has been statistically significantly associated with the company's drug in a controlled trial, that event cannot be said to have been caused by the drug. And companies can ensure their drug never causes anything by making sure that trials are organized so that important adverse events cannot become statistically significant.
Taking this approach, even when faced with assessments by doctors or their own personnel that the company's drug has caused some problem, based perhaps on a temporal link between a Vioxx or a Paxil, say, and a side effect that emerges on treatment, clears when the treatment is stopped, and reappears when the treatment is restarted, the company will still not concede a link.
What, then, about the long list of side effects reported in ads for the drug or in the Physicians' Desk Reference (PDR)? The company view is that these have been reported but this is not the same thing as being caused. These reports are merely anecdotal unless or until they have occurred enough times in clinical trials to have their link to the drug come out as statistically significant. Drug company personnel will of course warn doctors about all proven hazards their treatment causes (conveniently, none as no trials are done to establish a linkage)—it would be inhuman to do otherwise in such a sensitive domain as medicine. But they will not, as they put it, spread rumors about their drug—that would be good neither for the company nor for the patient. In adhering to this kind of “science” company personnel—and doctors—have found a way to live with themselves that has echoes of a totalitarian regime where people have learned to live with themselves on the basis that they are obeying orders or keeping to the rule of law.
What these doctors miss is that companies are working from assumptions or results rather than from data. There may have been thousands of reports of a problem to the company as clinically significant as Pierre Touery's use of activated charcoal, but these never stand a chance of becoming statistically significant.
When John Snow, investigating the outbreak of cholera in London in 1856, found a cluster of deaths from the disease on Broad Street, he was not inhibited by considerations of statistical significance because this concept hadn't been invented. He was free to recognize a cluster. Clinical prudence dictated a course of action—remove the handle of the pump. Science mandates efforts to go behind the data in an attempt to establish what has given rise to the cluster. But if companies had controlled the pump and took an Ian Hudson approach, they would not countenance the removal of the handle or any investigation of what the mechanisms giving rise to the cluster might be—unless the findings were statistically significant, which in all likelihood at Broad Street they weren't.
This account of what happens when our deaths or injuries on treatment are hidden or disguised may also help explain why doctors neglect what is happening to the person in front of them—in a manner that seems close to the antithesis of what good care should be. Anything that happens to the patient in front of a doctor has been degraded to an anecdote rather than an event that the doctor needs to pay heed to. If the doctor, using standard methods to decide if treatment has caused a particular problem, attempts to report it to a journal, the report will be turned down on the basis that journals no longer take case reports. If the doctor tried to report it to either the company or the FDA, it disappears into a statistical black hole that can swallow thousands of such events without the slightest indigestion. In the case of Vioxx it is estimated that there were at least 30,000 heart attacks linked to this drug from the time clinical trials first showed an increase in risk to the point where it was conceded there might be a problem and Merck drew back from its marketing blitzkrieg.5
The result is that, astonishingly, in the midst of this emphasis on evidence, medicine is collecting even less evidence on those harmed by treatments than it has done in the past. Although we now have the ability to register all patients with particular diagnoses or patients receiving any drug and could track all outcomes and assemble the data on what actually happens when treatments are given, there is in fact a yawning hole—through which Cora and others in the prime of life are abducted by Hades. Those who love them, who are left behind, have a right to complain to Zeus that there has been a fundamental breach here in the contract between heaven and hell.
But in addition to frustrating the giving of decent and reliable medical care, the neglect of data on the problems treatment may cause is cutting off our ability to develop new drugs. The single most fruitful source for the discovery of new drugs continues to be observations that a drug given for one purpose in some cases is doing something else. It is perhaps no coincidence that as the possibility of reporting “adverse” events has dried up, with journals unwilling to take reports on unexpected outcomes in individual cases and companies hiding effects that do not fit with the business plan for a drug, so also drug discovery has dried to a trickle.
In response to questions as to whether major medical journals should insist on access to the raw data from controlled trials, the editorial staff of the New England Journal of Medicine (NEJM) said in April 2009 they do not see this happening in the near future—“that would be a large step outside our role”—while at the same time maintaining that the NEJM offers transparency.6 As things stand we might all be safer if clinical trials were published in the New York Times rather than the NEJM, as the Times makes some effort to check the integrity of the primary sources for its stories, whereas the NEJM does nothing. When a Times story turns out to have been invented, as in the case some years ago of a series of articles written by Jayson Blair, it is national news, and the editor's job is on the line; not so when a drug trial such as Study 329 turns out to have been bogus.
Study 329 was the 1997 trial, discussed initially in chapter 4, in which Paxil was found to be no more effective yet more dangerous than placebo but from which GlaxoSmithKline (GSK) decided to select and publish the good bits, concealing the fact that six times more children became suicidal on Paxil than on placebo. The ghostwritten article was published in the most influential journal in child psychiatry, the Journal of the American Association of Child and Adolescent Psychiatry, whose editor at the time was Mina Dulcan. Dulcan had this to say in 2004 when interviewed by Shelley Jofre of the BBC after the history of the paper had become clear, and at a time when the paper was the basis of a fraud case taken by New York State against GSK:
SJ: The interesting thing is that GlaxoSmithKline actually acknowledged internally three years before you even published Study 329 that it had failed to show that Paxil was better than placebo. They took a marketing decision to effectively pick out the best bits of the study and see if they could get it published.
MD: That may be. That's not something that journals have any access to, that information.
SJ: Do you have no regrets about publishing the study?
MD: I don't have any regrets about publishing at all. It generated all sorts of useful discussion, which is the purpose of a scholarly journal. The purpose of a scholarly journal is not to tell people what to do. The purpose of a scholarly journal is to put out the data….
SJ: I can tell you that GlaxoSmithKline thought [publication] was fantastic and their sales reps were using your journal's name and influence to then say to doctors, here look, there's a published study, it works.
MD: Well, I think we all see salesmen of a whole variety of kinds, whether they are drug company salesmen or insurance salesmen and we certainly have no control over how they use something.
SJ: But, given what you know now about this drug and what it can do to children, don't you have any regrets that that published article was able to use your journal's good name to basically, as a cloak of respectability to say look, I have been in this journal. It must be true, look at the authors.
MD: I can't control the authors. No, I don't have regrets…. If someone misuses our journal we really have very little control over that….
SJ: Are you aware that 329 was ghost written?
MD: I have no way of knowing that. It doesn't surprise me to know it happens, but we have no way of259 having that information.
SJ: Does it worry you, do you think it matters?
MD: Well, certainly if I were an author I would not put my name on anything that I didn't feel was accurate. I can't speak to what those authors, to the extent, how much they saw the data. Someone can write something and you may or may not agree with it. The fact that someone puts the words together may be a good thing or a bad thing depending on what the words are….7
In contrast to what one imagines the position of the editor of the New York Times might be had they published Study 329, Mina Dulcan seems completely unfazed by her role in the publication of one of the most notorious studies of all time. At some point it is going to take a gutsy academic editor to risk being shut down by industry or the rest of us to consider whether we would be safer if publication of clinical trials happened in the New York Times and academic journals were reclassified as periodicals and academic meetings as trade fairs.
The response of many to these issues may be that we need a beefedup FDA to police what is going on. We don't. It would do no harm to beef up, or exit, those in the FDA who are weak and bureaucratic. But the FDA's primary brief is to regulate the wording of advertisements rather than to care about patients. When these drugs were made available by prescription only it was because legislators thought to put them in the hands of an institution that looked a lot more powerful than the FDA and a lot more concerned about the welfare of patients—medical doctors. If medicine and its academics have been neutered, any other beefed-up agency or set of regulations can be too. Any regulations should follow from our values rather than substitute for them—and the values in this case are that if the data aren't available it's not science.
When it comes to the risks of treatment, the company trials that now dictate clinical practice are like the subprime mortgage market, in which risk was so cut up that all parties could act as though the hazards of lending had somehow vanished. By running small studies, the pharmaceutical industry has similarly cut up the appearance of risk to patients, using statistical significance to make these risks vanish. It then has come as a huge shock when large and independent studies show the risks to be alive and flourishing for Vioxx, Avandia, Advair, and other drugs. These shocks have been handled by denial.
Faced with these scenarios both doctors and patients cast around for a wizard for help but it has been as difficult to spot any influence for the good from the FDA as it was to spot any good from the financial regulators in the recent financial turmoil. In this case, doctors are the scarecrows, tin men, and lions who need to be told that they have the brains, hearts, and courage for the job. In the case of the FDA, we need a Dorothy to pull back the curtain and reveal the wizard as a simple auditor. But we have instead—to the benefit of no one except industry—drifted slowly into the position where professional bodies within medicine have turned to the FDA for a lead on the safety and efficacy of drugs where in the Kefauver hearings of 1962 it was envisaged that medicine would offer the FDA a lead. Given the failure of medicine to step up to the plate and the fact that the current regulations governing drugs have been in place for an extraordinary length of time—over fifty years, it is perhaps time to revisit what might be done.
PRESCRIPTION-ONLY STATUS
The problem within medicine, unlike the financial crisis, is not that we have abandoned regulations, but rather that the current regulations aren't working or are being manipulated to our disadvantage, in particular prescription-only regulations. Prescription-only status makes doctors, not patients, the primary consumers of our blockbuster drugs but this is a consumer group that in the 1950s effectively disbanded one of its only consumer bodies when the AMA stopped running its independent program of drug assessments. Medicine ever since has been like a frigate or tanker adrift on the high seas whose rudder is not functioning, a clear target for pirates.
Because doctors have always written prescriptions, and because today's doctors have only practiced in a prescription-only world, they think key medicines have always been available by prescription only. But prescription-only status is very recent, and just as with the French Revolution it may still be too early to judge all the consequences.
The initial prescription-only arrangements introduced in 1914 were a police function aimed at controlling the use of substances like heroin and cocaine. This seemed incompatible with the practice of medicine to many. We have since lost any perspective we once had that giving a doctor exclusive control over access to something as important as life-saving remedies might corrupt the doctor. The subsequent impetus to prescription-only status ironically first arose in the United States, the home of the free market, rather than in Europe or elsewhere. This restriction on the availability of drugs assumed that the doctors who prescribed medicines would be like Philippe Pinel in Paris two hundred years ago, Alfred Worcester a century ago in Massachusetts, or Nancy Olivieri in Toronto today (who lost her job after speaking out about the hazards of deferiprone as a treatment for thalassemia), doctors who were skeptical that all treatments were as beneficial as companies claimed and who were not afraid to speak out in defense of their patients.8 If these hopes had been realized, we might not have the degradation of medical care we now have.
But these hopes have not been realized. Rather than a bulwark against industry, prescription-only privileges have become a bulwark for physicians against competitors in the health domain, like homeopaths, psychologists, nurses, and others—a “precious” just like the Ring of Power in Lord of the Rings to be guarded jealously. A ring that puts physicians directly in the gun sights of the most sophisticated marketing on the planet. All the while, doctors seem be shrinking as did Gollum, the figure in J. R. R. Tolkien's novel who, under the influence of the Ring, became a twisted shadow of what he should have been. Given this, it is unbelievable that there does not appear to be a single medical course anywhere that offers physicians any education on marketing. The only doctors who seem to know something about marketing are those who have worked in the pharmaceutical industry. In the Lord of the Rings, in true market style, it was ultimately the self-interest of Gollum that saved everyone else. But that was only a fable—and while saving us, Gollum's self-interest destroyed him.
If we are to continue with prescription-only status as we have it now, our safety depends critically on doctors stepping up to the plate. They need to report on hazards and need to find a way to ensure their reports aren't airbrushed out of existence. They need to insist on companies undertaking adequate studies of drugs. Moreover, if companies are to be allowed to market their drugs under the banner of science, doctors need to ensure that companies adhere to the norms of science and make the data from these studies available, or else they need to undertake the appropriate studies themselves. They do, after all, report on the hazards of over-the-counter medicines and, funded by federal monies, doctors have undertaken research on drugs like tobacco, aimed at nailing down its hazards. Prescription-only arrangements once seemed like a mechanism to enhance the ability of medicine to interrogate the companies producing these “ethical” drugs. If it has become instead a mechanism that neuters medicine, it is time for medicine to take stock and then take action.
There are alternate arrangements to the current ones. We could make new medicines available by prescription only for a limited period before a decision was made as to whether they could be sold over the counter, during which time doctors would work hard to establish all the hazards of the new drugs. Alternatively, rather than have all new drugs available by prescription only, we could opt to make just highly toxic drugs available indefinitely by prescription only. We might distinguish between drugs used for traditional medical purposes and drugs for something closer to lifestyle enhancement, with the first group being available by prescription only and the second not.
The SSRIs offer an instructive example of what happens when essentially the same drugs are available by prescription only and over the counter. The SSRIs are antihistamines that inhibit serotonin reuptake. Available by prescription only, one set of selective serotonin reuptake inhibitors lead to agitation and suicidality, while very similar SSRIs available over the counter for allergies have occasionally been linked to irritability but appear in general to cause fewer problems than their prescription-only cousins. In part the differences likely stem from the difficulties described in chapter 7 in the case of Victor Motus: it is not easy to stop a treatment that doesn't suit a particular patient when a doctor has told that patient they need to remain on the treatment for several weeks before it “works.”
Doctors like Dr. Trostler, whom Victor Motus went to for help, have no training in the many things they do, aside from issuing a prescription for medication, that may enable or disable the people for whom they are trying to care from contributing to that care. They appear to have no feel for the fact that prescription-only arrangements put them in the position of a Roman emperor, with their patients in the role of tasters.
At a time when pregnant women have learned to shun over-thecounter drugs, even down to coffee, doctors have for over a decade dramatically increased their patients' prenatal consumption of SSRIs in the face of growing evidence these drugs double the rate of major birth defects and miscarriages. Drug companies like GlaxoSmithKline are aware that farmers have known for centuries to keep their herds out of fields in which the serotonin-reuptake-inhibiting St. John's wort grows as it leads to miscarriages, but these same drug companies have still manipulated doctors very successfully into herding women into the pastures in which their serotonin reuptake inhibitors grow.9
There are other benefits that might flow from lifting the prescriptiononly status of many drugs. The current arrangements constrain new drugs within a disease framework. If this were changed, a range of diseases from social phobia to osteopenia would vanish overnight. In the case of the antidepressants, for example, some that enhance appetite and sleep might be marketed as tonics rather than for depression. The SSRIs are more like St. John's wort and might be marketed similarly—for stress or burnout. At present, to get Prozac a person has to be labeled as suffering from depression or social phobia or obsessivecompulsive disorder first. If the drugs were marketed instead for stress or burnout there would be much less stigma in using them. In the case of the statins for cholesterol or biphosphonates for osteoporosis, the marketing would likely be aimed more for keeping arteries or bones young and not for supposed diseases. There might have been no fewer drugs sold but we would have fewer diseases. There would be a greater dividing line between medicine and daily life than there is now.
If many more drugs were available over the counter, company marketing would doubtless throw up a different set of abuses. It is doubtful, though, if the abuses could be any worse than the marketing of the proprietary panaceas that dominated the drug market in the late nineteenth and early twentieth centuries. But a century ago, when faced with these panaceas, there was a group of skeptics we could turn to— doctors. There are no skeptics now, and there need to be.
Where in the 1960s there was a gulf between the pharmaceutical and tobacco industries, partly owing to prescription-only arrangements, now it is increasingly difficult to distinguish between the two, except insofar as medicine supports one and not the other. If our current blockbusters were available over the counter, there is little doubt that the pharmaceutical industry would have marketed them as vigorously as the tobacco industry marketed cigarettes and likely caused as much damage with them as tobacco has. Would we be safer if our current blockbusters came with warnings that have the clarity of those found on tobacco products?
Abolishing prescription-only arrangements is a thought experiment. We have a tendency however to solve problems by opting for more rather than less regulation, and it is unlikely that this thought experiment is ever likely to be adopted. What we perhaps need to appreciate however is that these regulations are part of a growing apparatus within healthcare that Sam Sessions has referred to as a “Shadow Government.”10 Doctors are no longer free to follow the market for drugs on the basis of price or quality—they have to adhere to a variety of diktats in the form of guidelines and other instruments that have been fostered by companies. It is this range of instruments that pivot on the existence of prescription-only arrangements that effectively govern healthcare today. Whether in the United States or Europe, voices are increasingly raised against the involvement of government in healthcare—but when we look to Washington or other capitals for the culprits we are looking to the wrong place.
Another thought experiment might bring out what else could be done to make a prescription-only market work more efficiently than it does now.
RXISK.COM
In August 1973, a bank robbery at the Kreditbanken in Stockholm triggered a five-day siege with bank employees held hostage. After the siege ended, to the surprise of everyone many of the hostages, as if hypnotized, spoke well of their captors. “Stockholm syndrome” was born. Now recognized as common, the conditions that trigger this change in behavior seem to be isolation, a fear that your life is at risk, and kindness on the part of the hostage-takers.
Disease isolates us as profoundly as incarceration or anything else might. Our lives are at risk, and our doctors who control the exit to freedom are almost certain to be kind. But not a single doctor is trained to manage Stockholm syndrome, to suspect that our apparent insouciance or congenial conversation might conceal deep unhappiness with a proposed course of treatment or, even worse, alarm at new problems that have emerged on treatment.
From about the time of the 1973 Kreditbanken siege, doctors have become increasingly likely to suffer their own variant of Stockholm syndrome. If something goes wrong with a treatment a doctor gives, even though the label may concede that the drug can cause the problem, the makers of the drug and the doctor's colleagues will deny that it is likely to have done so in any particular case. Speaking up about a problem, once the material of medical advance, is now a recipe for professional suicide. A doctor attempting to rescue a patient is likely to be accused of being a persecutor who victimizes the patient by withholding effective treatment.
Offers to describe problems at professional meetings are turned down. Journals are ever less likely to accept publications outlining a new problem. Invitations to apply for better jobs, to attend conferences, or simply to go with colleagues to local eateries funded by drug companies are ever less likely to happen for doctors linked to adverse events. Those holding doctors hostage have been very kind indeed—there are ever fewer medical departments or medical conferences not awash with company support, when it comes to paying for meals with colleagues most doctors have forgotten what a credit card looks like, and of course in supplying drugs they supply the objects that make doctors desirable.
As a result bit by bit over the last forty years any of us seeking treatment have been disappearing in front of the eyes of our doctors, who in turn are increasingly inaudible and invisible to companies, academics, and regulators. A key component of the fog that envelopes both us and our doctors lies in the published trials that have hypnotized everyone. Individual observations, the logic goes, are unreliable, while trials supposedly offer reliable estimates about the consequences of treatment. When a doctor does report an adverse event to regulators, the report is invariably marked and filed as uncertain and unreliable information.
But we know that over 80 percent of the reports on the adverse consequences of treatment, dismissed as anecdotes, have turned out to be correct.11 We also now know that close to 30 percent of the clinical trials that have been undertaken remain unreported, and that of the 50 percent that are reported almost all will be ghostwritten12 and roughly 25 percent of the published trials altered to the extent that a negative result for a drug will have been transformed into evidence the drug works well and is safe.13 In 100 percent of cases, the data from trials remain inaccessible to scrutiny. Given these facts it is not reasonable to suggest that the observations of doctors or patients are any less reliable than clinical trial evidence.
Reporting the adverse effects of treatments has always been a delicate thing for doctors, because it involves recognition that they may have harmed a patient they intended to help and also because drugs once seen as poisons are now seen as fertilizers necessary to our growth and wellbeing rather than risky. There is also no feedback to doctors after they make report that would incentivize them to report further—nothing that recognizes that what they have done could be beneficial.
As a result doctors now report fewer than 5 percent of serious adverse events on treatment. Faced with this lack of reporting, American and European regulators have allowed patients to report on the adverse effects of drugs. But the new systems put in place for online reporting by patients are not user friendly. Minimal information is sought rather than the greatest amount of and richest possible details. Other than for altruistic reasons, or out of anger, there is very little incentive for a patient to report.
Consider what could be done. Roughly 25 percent of serious events have not been reported before, but whether reporting on a new problem or a problem already featured on a drug's label or elsewhere in the world literature, there is still a matter of deciding when I turn blue on a drug known to cause some people to turn blue, if in fact my blue hue is linked to treatment. There are standard ways to check out the likelihood of a linkage by noting the time of onset of the problem, what happens if the drug is stopped or the dose reduced, what happens if the drug is reintroduced or the dose increased, whether I have ever had reactions like this before on another drug, and whether anything else makes a difference. This approach can also help us decide if a drug might be linked to a problem never before reported.
Imagine if on making a report you were taken through these questions and then issued with a letter from an expert website to take to your doctor outlining the suspected reaction and the factors that in your case might help you and your doctor decide if there is a link to treatment. Imagine that this letter also lays out a case to your doctor that in-person, professional observations as to whether your treatment was likely to be linked to the problem are at the moment much more credible than the clinical trial data, and then invites your doctor to supplement or take issue with your report.
A few days later on the basis of the best possible input from both your doctor and you, when the reaction is coded and the database to which you've reported can assess how many other reactions like this there have been, imagine both you and your doctor get letters letting you know that a thousand other people have reported a similar problem and a hundred other doctors have endorsed a link between treatment and the effect. If 80 percent of medical reporting is likely to be correct, there comes a point where, even if the clinical trial data says otherwise, it is just not reasonable to say the problem can't be happening in at least some people. This compilation of individual reports offers your doctor and you a variation on an age old strategy—if you're going to owe the bank money, it is best to owe so much the bank has a problem—in this case it will be regulators and companies who have the problem. Far from being inaudible you and your doctor have been handed a megaphone.
Now take one more step. Hundreds of billions of dollars have been pumped into genomic research but very few genes have been found for major illnesses based on studies that have recruited tens of thousands of patients. Researchers have found small genetic risks contributing to common diseases like diabetes, hypertension, or mood disorders but little else. However in the case of clearly described adverse reactions to drugs, studies may only need to recruit fifty to a hundred people to find a gene coding for the treatment-induced problem. This makes sense as treatment effects have to be mediated biologically and a striking reaction to a drug is much more likely to be mediated through a single protein than is a complex condition like diabetes.
Getting us and our doctors to report on effects and work together to clarify the nature of the problem—whether turning blue on treatment involves two different conditions with one being turning blue from the waist up and the other blue from the waist down—will set up exactly the kind of conditions that make it possible to detect genetic inputs to such treatment effects. An effect tied to a gene is very difficult to dismiss as an anecdote. Health providers, insurers, and investors won't dismiss them. These are genes, moreover, that will reduce rather than increase our health insurance premiums—they point to risks we can avoid rather than risks waiting to happen.
Genes are just a tip of an iceberg. They code for proteins that are part of a biological mechanism. Even without knowing the gene, clear descriptions of problems will in many cases enable physiologists, pharmacologists, and others to pinpoint the larger mechanism producing an outcome, making it possible to state that X causes Y—the cholera bacillus causes cholera or SSRIs can causally trigger a suicide.14 It is in the laboratory rather than in a clinical trial we ultimately establish causes—in Koch's laboratory rather than Snow's epidemiology. But where Snow saw his epidemiology as paving the way for a hunt for causes, the exclusive turn to clinical trials in medicine today stops doctors and others from any effort to hunt for the mechanisms that make sense of the trial data.
There are new forces, like the Internet, emerging that will either swing us back toward Koch or entrench a mindless turn to trials and guidelines. Seeking answers to health issues is now the second commonest reason to access the web. Many companies are gearing up to create electronic medical records, into which many of these Internet sites feed—sites offering to tell us for instance whether problems have been reported on our treatment. But all of the sites we might visit are at present linked to evidence-based medicine and current guidelines. The promise of companies providing these new technologies to healthcare organizations is that they will alert managers and doctors when prescribing if an electronic record strays from guidelines. This is sold as offering the organization a chance to ensure doctors give the best in medical care but in fact, unless medicine is driven by patients rather than guidelines, such electronic Big Brothers risk obliterating our individuality comprehensively.
This top-down approach aims at replacing individual judgments with the wisdom of experts supposedly relying only on the best available evidence. In contrast, the reporting model outlined above offers a bottom-up approach. It supplements the wisdom of experts with the wisdom of individual patients and doctors. This approach fits well with the ability of Google or social media like Facebook to track events.
If we are open to finding out what is really going on, we can get people not just to report events but to outline the impact of these events on their lives—the son who went off the rails on a stimulant and dropped out of college, the end of a marriage because of sexual dysfunction when taking an antihypertensive, the car crash because of temporary lack of coordination while on the heart drug amiodarone or many other drugs, the investigation for dementia because of cognitive difficulties on statins, the cost of a jail term following murder while on the smoking-cessation drug varenicline. We are aware these things can happen but have no idea how often they might be happening. We have no idea what the true costs of treatment might be, although we have hints that the cost of managing treatment-induced problems is more than the entire drugs budget.15
We are at a fateful moment. The Internet is awash with sites taking a top-down approach. None of these sites are ever likely to discover anything. Many of them are likely to aggravate our problems while promising to empower us. They coexist with and indeed all but entrench the greatest failure of the free market on the planet—no where else is there so much important data pertinent to economic well-being that remains uncollected and unused. A bottom-up approach in contrast would offer a market-based solution to a growing market failure and in so doing would wrest control away from the “shadow government”16 that runs health care and would restore it to patients and doctors.
PATENTS ON DRUGS
When Senator Estes Kefauver attempted to come to grips with the pharmaceutical industry in the early 1960s, his bill ended up mandating randomized controlled trials without being aware he had done so, as one of his aides slipped these into the 1962 act. Kefauver maintained support for the prescription-only status of new drugs, despite expressing compelling doubts about arrangements in which one person orders what another will have to consume. But he couldn't muster the votes for the one thing he actively sought to change, the system of patenting drugs. Changing this system, he thought, was crucial to bringing down the prices of drugs.
The American—and now worldwide—system enables companies to take out product patents on drugs. A patent of this type offers companies a monopoly on a new drug for twenty years, effectively on a worldwide basis. We grant this privilege to companies in return for novel and truly beneficial compounds. But the system was put in place at a time when patents were restricted to a national territory and when the idea of a blockbuster drug was inconceivable.
The current arrangements have failed us—although they work wonderfully well for companies. They have failed in that companies are not producing novel drugs of the type we desperately need. We do not have the breakthroughs for cancers, dementia disorders, or for the neurological and rheumatoid conditions that still cripple and kill us—often from quite a young age.17 In fact we now have a situation, brought about in part by product patents, where, in principle, it is not in the interest of companies to improve our therapies—certainly not to the extent that would eliminate disorders. Treatments that cure rather than maintain disorders risk leading to a fall in company revenues and, as the example of using antibiotics to cure ulcers shows, companies will make efforts to block the adoption of cures that appear on the horizon. Getting rid of the incentive to develop a blockbuster that product patents offer would reorient drug development back to what most people think both medicine and pharmaceutical companies are trying to do, which is to eliminate the scourge of disease.
Furthermore, the ability to have an exclusive patent on a drug creates conditions suitable to blockbuster marketing. As drugs have increased in celebrity status in the 1990s and 2000s, any independent assessments made of the therapeutic advantages offered by new drugs have consistently indicated that these have been minimal at best. Indeed, pharmaceutical companies now seem to be able to make blockbusters out of drugs that are virtual carbon copies of already available and cheaper drugs—Nexium out of Prilosec, Lexapro out of Celexa, Lyrica out of Neurontin. These are companies who are masters at generating and maintaining wants rather than companies who are any good at making drugs. Indian and Chinese pharmaceutical companies are today more innovative when it comes to producing novel and needed drugs than are the Western pharmaceutical manufacturers. As long as our companies can make their money from our wants there is no need for them to meet our needs.
It is far from clear that we need any patents on medicines. Asian companies have produced innovative compounds profitably without the protections of a product patent system. And as the makers of generic drugs show, a great deal of money can be made from drugs that are offpatent or sold over the counter. If patents are needed, one option is to reduce the length of protected time companies get for their patents—this was the option favored by Kefauver in 1962. Another option is to return to a system that offers patents on processes rather than products—a system that worked well in Germany for a century and led to the greatest rate of discovery of therapeutically useful drug treatments ever. If product patents are retained, at the very least we should insist on a return to the spirit of the law—namely that we, the community, will offer your company certain privileges in return for a genuine benefit.
Companies argue that the high cost of developing drugs, put at up to a billion dollars per drug, means they need the returns they get from the current system. But the greater part of these costs come from clinical trials that are in fact part of marketing and these costs escalate the weaker and less needed a drug is. The current patent system is central to both drug development costs and drug prices, and if we want to reduce drug prices the patent system has to change.
We have in fact engineered a lose-lose scenario. The current arrangements underpin the development of blockbusters that have become so important to the health of companies that they are prepared to conceal trials or adverse events that might pose problems for their marketing, ghostwrite such trials as are published, and aggressively counter attempts by doctors to describe problems that arise in the course of therapy. This is a situation that is as toxic to good medical care as it is possible to have.
THE FACTORIES OF POSTMODERNISM
In the 1990s a dispute blew up that has since been called the Science Wars.18 At its most extreme, scientists who viewed the products of science as real were faced with radical skeptics, postmodernists from the humanities, who appeared to deny the reality of anything. Everything, including scientific articles, the postmodernists claimed, were just texts whose truth value was uncertain.
Postmodernism is linked to modern science. Once we in the West had seen God's revelation as coming in two books, the Bible and the Book of Nature. The rise of science led on to a radical or modernist doubt about the events portrayed in the text of the Bible. For a period, science remained immune to the crisis of belief in the biblical text, or indeed became a substitute for the lost certainties produced by viewing the Bible as simply a text. But as scientific advances began to show that older scientific “truths” were far from true, science itself faced a new radical doubt, postmodernism, that contested its claims to possess any revelation.
The response of science has been that any attempt to restructure science along postmodernist lines would produce a cargo cult. In the course of World War II, US Air Force planes flew into islands in the Pacific, disgorging all sorts of goods. Some of the islanders were so impressed by the appearance of these flying cornucopias that long after the US military left they maintained the runways and control huts, beside which they continued to fly the American flag, in the apparent belief that the right appearances would lead to the right results. These were the cargo cults. For scientists reality is not a text that can be read one way today and another tomorrow. The ultimate defense of science has been that its planes fly, whereas having postmodernists in a laboratory would reproduce the airstrips and the US flag—and leave us waiting forever for results.
The new drugs developed from the 1940s to the 1970s, based on breakthroughs in biology, pharmacology, and other medical sciences, meant the pharmaceutical industry of the time was about as far removed from a cargo cult as it was possible to be. In the face of such advances there was very little place for radical doubt. The first darkening of the medical horizon came in the 1960s with concerns about the emergence of a technological society, concerns that were applied to medicine by Ivan Illich in the 1970s. Illich's critique of medicalization came at a time when many had sensed the first intimations that not all was well with medicine.19 The criticism at the time was directed at medicine itself, an apparently all-powerful institution, increasingly arrogating to itself the right to pronounce on life, death, and disability—not at industry.
Illich's critique crystallized battle lines already emerging between a medical sciences camp and a social sciences camp over “the medical gaze,” discussed in chapter 6. For one side this gaze was good, for the other it was dehumanizing. Some critics saw an overlap between scientists, physicians, and capitalism on the one side, and social scientists and socialism on the other. The degree of identification here is not important and it varied widely. But the key point is that there was an opposition, issues were contested, and the debate was open to a wider public. At its extreme it spawned an antipsychiatry that contested the legitimacy of any mental illnesses. Three decades on, debate has all but ceased.
The turn to quantification in medicine has transformed social scientists, medical anthropologists, and others into Stepford handmaidens of the establishment who embrace the New Biology. A medicopharmaceutical complex has triumphed; everyone seemingly accepts that it would be irrational to do anything but act in accordance with the “evidence.” Any sustained attempt to critique current trends is now likely to be dismissed as not evidence-based or as an advocacy of postmodernism that denies the reality of disease or scientific progress—in just the way that critics of psychoanalysis were once deemed ipso facto to have an unresolved neurosis.
But, while we now have in branches of medicine the appearances of science—controlled trials, a relentless quantification, and a sometimes stupefying recourse to statistics—the health care planes aren't flying any more, in the United States especially. In fact quite the opposite, over the past two decades the figures for life expectancy in developed countries show the United States falling progressively behind other developed countries, despite spending more money on healthcare than any other nation on earth—falling behind as well in terms of any ability to care, as the expectation that we will be rescued by magic has led us to neglect many of the caring skills we had.20
Meanwhile, the marketing departments of pharmaceutical companies are the postmodernists par excellence. They rewrite the text that is the human body from year to year with afflictions such as osteopenia, erectile dysfunction, and pediatric bipolar disorder that appear out of nowhere, creations of ghostwriters who practice to deceive.
Take Donna, for example. In marketing Zyprexa for bipolar disorder, in 2002, Lilly produced Donna, “a single mom, in her mid-30s appearing in your office in drab clothing and seeming somewhat ill at ease. Her chief complaint is ‘I feel so anxious and irritable lately.' Today she says she has been sleeping more than usual and has trouble concentrating at work and at home. However, several appointments earlier she was talkative, elated, and reported little need for sleep. You have treated her with various medications including antidepressants with little success…. You will be able to assure Donna that Zyprexa is safe and that it will help relieve the symptoms she is struggling with.”21
In the 1960s and 1970s Donna would have been seen as anxious, a poster case for treatment with Valium. In the 1990s, presenting with the same symptoms, she would have been seen as depressed, and in need of treatment with Prozac. Neither neuroscience nor any aspect of clinical science had moved forward by 2002 in a manner that might justify rediagnosing Donna as bipolar. But this doesn't stop companies who are quite happy to read the vast majority of our problems one way today and quite another tomorrow.
And when it comes to the hazards of Zyprexa Donna may suffer from, just as with the hazards of the Lipitor she may have to take because Zyprexa has raised her cholesterol levels, or the Celebrex she may be on because of arthritis linked to Zyprexa-induced weight gain, or the Avandia she needs because Zyprexa has caused diabetes, Donna and her doctor will find themselves up against a radical skepticism. When it comes to the hazards of a pharmaceutical company's drug, the rules of science do not apply and causality, it seems, can never be proven. A more succinct definition of the arch-skepticism of postmodernism cannot be found than the phrase “doubt is our product.”
Almost the only critique left in town is limited to attributing all our problems to conflict of interest—the reason things are going wrong is that companies can hire academics to proselytize on their behalf. Somewhat ironically the champion of this charge has been a Republican senator, Chuck Grassley, rather than anyone from academia or the “left.”22 While Grassley has been nothing if not magnificently persistent in pursuing academics with links to pharmaceutical companies, forcing a number of eminent figures23 to resign from their university posts, and in proposing a Sunshine Act,24 his activism risks creating the impression that our problems stem primarily from a few rotten apples in the academic barrel rather than from anything more deep-seated. This is postmodernism for the twenty-first century—the text gets written according to the interests of the piper who pays the tune.
This superficial conflict-of-interest critique helps industry by focusing attention away from their unwillingness to allow access to the data. It is ignorant of the history of science, forgetting that John Snow's case for removing the handle on the Broad Street Pump was only aired because it was in the interest of the owners of local abattoirs and other businesses who were being blamed for the cholera epidemic to provide a platform for these views that supported them.25 It appears to imply that the State rather than private companies will need to run clinical trials or fund the academics who will present the results of these trials but this forgets that the specter of conflict of interest in science was first raised by another Republican—Dwight Eisenhower—concerned that public funding of research might lead to a military-industrial complex: “In holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy itself could become the captive of a scientific and technological elite.”26 If there is no access to the data, it is immaterial if the funding for science comes from private or public sources.
Eisenhower caught a glimpse of a world in which both the market and science might become forces for alienation rather than liberation. We have arrived there. This is a failure of historic proportions—seen rarely before except in the former Soviet Union. In the face of this failure, some belated critiques of practices such as ghostwriting or concerns about conflict of interest are profoundly inadequate.
In the face of the industrial postmodernism we see today, we need to recapture the ability to say that an increase in mortality is an increase in mortality and blockbuster drugs cause adverse events. We need to be able to recognize that little that glistens with statistical significance is therapeutic gold, and refuse to allow companies, their experts, and regulators to stand common sense on its head. Speaking out would be a way for doctors and scientists to demonstrate the “right stuff.” In addition to helping remedy our current difficulties, doing so might engage a wider public in the task of making real progress possible, rather than have us lulled into quiescence by fantasies of progress.
We need our media studies and other university departments to deconstruct industry rhetoric. But we also need to recover a belief in real progress and a faith in the biological sciences that would explain what lies behind the correlations thrown up by controlled trials. At present, in part because it suits industry, doctors are being taught that the controlled trials of evidence-based medicine are the answer to medicine's problems rather than being taught that they are a first step on the road to an answer—just as John Snow's isolation of the Broad Street Pump as a source of the cholera epidemic in London in 1856 was the first step on the road to an answer rather than itself the answer. It was Robert Koch's discovery of bacteria rather than Snow's researches that explained the cluster of events in Broad Street. Koch's work opened the way to a raft of inputs from the laboratory sciences into medical care that flourished in the work of clinicians like Richard Cabot a few years later.
THE FUTURE OF MEDICAL CARE
The juxtaposition of markets and health produces shudders, jolts, and every so often quakes as the tectonic plates of production, efficiency, equity, and choice collide. Americans embrace markets because they want choice—they don't want to be dictated to. Europeans have steered away from markets in medicine, seeing both equity and strength in the musketeer's one for all and all for one.
James Lind opened his treatise on scurvy in 1753 with the statement that “armies have been supposed to lose more of their men by sickness, than by the sword.” Perhaps aware that empires and economies have been more likely to be destroyed by plagues and pestilences than by losses on the battlefield, Europeans have placed greater emphasis on ensuring the production of health by making it free and if necessary compulsory.27 But the development in our day of biological interventions, from cosmetic surgery to risk management medicines, that have the appearance of medical treatments but far from enhancing productivity and well-being almost certainly reduce it, parasitize universal health care to the point where it may not survive. No one would ever have thought to include the proprietary medicines of the nineteenth century in a universal health care system, but this is close to what is happening now. And as a consequence, universal healthcare is also today under threat in Europe, where healthcare costs are rapidly rising toward American levels.
Americans meanwhile have seen the market deliver extraordinary developments in technology. They have seen transformations in living standards happening globally, and they believe that to some extent these developments have hinged on responses to consumer demand. Even within the health domain, consumer demand, for better or worse, has led to rapid developments in, for instance, cosmetic surgery. Pharmaceutical company executives lead the queue to say that if the same forces were unleashed more widely within the rest of medicine, we would solve all our healthcare problems.28
If, as commonly believed, both markets and science deliver progress, it seems inconceivable to many that the domain in which markets and science interact to the greatest extent would be one characterized by decline rather than progress. But when it comes to pharmaceuticals, because of prescription-only arrangements, the current operation of patent laws, the sequestration of trial data, the ease with which medical experts can be seduced by junk epidemiology, and the extent to which bad data has driven out good data, this is not a market that can respond to patient pressure. It is a market where patient pressure is perverted by pharmaceutical marketing campaigns, where outcomes can get worse with no apparent consumer (medical) concern, a market in which the mental sets of consumers (doctors) have been captured so that it is difficult for them to conceive of alternatives to those being sold to them, a market in which there is almost no possibility of discrepant data emerging to trigger a thought that might be unwelcome to a pharmaceutical company, a rigged market that operates in terms of five-year plans. Indeed, it is a polity, rather than a market, that in its control of information is perhaps best described as totalitarian.
Hitherto one of the major selling points of the Western way of doing things has not been the availability of consumer products such as Levi jeans so much as progress in health—our children have been less likely to die in infancy or childhood, our men and women less likely to succumb to a crabbed age and more likely to live beyond the traditional three-score and ten years. But there is a growing disenchantment with the Western way of doing things. And there is a growing likelihood that we in the West will be regarded as the new barbarians as we feed antipsychotic drugs to infants and envisage children as young as eight years old being put on drugs like the statins. Even though we have an increasing number of hospitals that look more like hotels, complete with gourmet meals and the latest online entertainment, there will be many who view these as the products of a healthcare system that is losing sight of some of the most precious things about being human, a system in which values are becoming valueless, a system in which ticking boxes is more important than trust in people, a system that, as a result, is losing its abilities to heal.
After Cora descended into Hades, in the face of Demeter's insistence, Zeus buckled and she returned as Persephone, bringing life back to the planet with her. After a wondrous period of time in the middle of the twentieth century when we combined to force open the gates of Hades and rescue children who might otherwise have died, today's Demeters find themselves faced with pharmaceutical companies adept at using a mother's wish to get the best possible treatment for her family, including the child in her womb, to expand their markets. In a tale of almost mythic resonance in its own right, Estes Kefauver, using the example of children deformed by thalidomide, attempted to restore wonder and force Hades back but ended up being outflanked. If with Demeter we hold that care of the sort outlined in these pages is the heartbeat of our world, we need to take up Kefauver's cause and see it through. Whether that heart continues to beat is up to each of us.