Pharmageddon. David Healy

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Pharmageddon - David  Healy

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them have been proven to work, insurance companies are trapped into reimbursing for these treatments and in the case of hospital stays often only for periods of time that permit little more than the institution of a drug treatment regimen. In doing this they are just following the guidelines drawn up on the basis of the best evidence by medical academics with no links to industry, guidelines that typically endorse the latest high-cost treatments over more effective, cheaper, and more humane forms of care.

      The medical establishment, aware of problems in their interface with the pharmaceutical industry but not sure of the source of those problems, increasingly concedes there are senior figures and other opinion leaders in the field who have overly close links with the pharmaceutical industry or other conflicts of interest. But these academics are seen simply as the rotten apples that can be found in any barrel and the assumption is that their behavior will soon be put right by new rules on disclosure of links to pharmaceutical companies.

      There is also an acknowledgment that pretty well all the trials that a new drug has to go through for approval are designed, and implemented, by pharmaceutical companies, and a growing awareness that rather than being written up in journals by the academics whose names appear on their authorship line, these papers have commonly been “ghostwritten.” But for most commentators these are simply more reasons to rein in the pharmaceutical industry, rather than reasons to consider the need for more far-reaching changes such as the nature of our current patents on drugs or the prescription-only status of many drugs, or for a close look at how these ghostwriting and other practices, as laid out in chapters 4 and 5, compromise clinical care itself.

      Criticizing success is not a winning formula. In a market economy what company is going to try to be less successful? The door is left wide open for pharmaceutical companies to argue that the reason there are so many medical care problems is that the rest of the healthcare economy has not fully embraced the market.10 The argument is so seductive that even left-leaning commentators, whether in the United States or Europe, concede some validity to proposals that the way forward in health must involve some embrace of the market.11

      For the pharmaceutical industry, attacks from the medical community have turned into a version of rope-a-dope. Muhammad Ali-like, they let the medical George Foremans punch themselves out on issues like conflict of interest, the sponsoring of patient groups, and ghostwriting. Industry is happy to settle back on the ropes and take the punishment.

      I will argue that the problems that give rise to attacks from the medical community and other commentators stem from three sources not acknowledged elsewhere. First, at the start of the modern era of medical practice, in the 1950s, the basis on which drugs are patented was changed, allowing companies to have monopolies on drugs in a way they hadn't had before. This permitted the development of blockbuster drugs, laying the basis for the marketing of drugs we now see. Second, also in the 1950s these drugs were made available on a prescription-only basis, putting a relatively small group of people with no training in or awareness of marketing techniques—doctors—in the gun sights of the most sophisticated marketing machinery on the planet. Third, having been under siege by industry for a century, in the 1960s we in medicine woke up to find a horse outside the gates of Troy in the shape of controlled trials and hauled it inside, not realizing that industry-designed trials provide wonderful evidence about the benefits of drugs but very little evidence of what might be best for patients.

      Against this background, discussions of conflict of interest and ghostwriting, while important, only scratch the surface. We need to ask whether faith in controlled trials when we are not allowed to see the data from those trials can protect us against the biases introduced by commerce. Whether making drugs available on prescription-only status is appropriate in an age of blockbuster drugs. Whether the basis on which we now permit drugs to be patented is delivering the benefits to society that patents were originally designed to provide. As I will argue, every assault on industry paradoxically has instead reinforced the apparent need for controlled trials, prescription-only privileges, product patents, and further regulatory arrangements, and together these have bound the medical profession and government ever tighter to the pharmaceutical industry. These are the changes that among them laid the basis for companies to create blockbusters, and as long as these changes remain unquestioned industry is happy to settle back on the ropes and take a pounding.

      At times of change, there is a temptation to extol the virtues of some former golden age. But while the dogs may bark, the caravan invariably moves on. Generations of us have put our faith and the lives of those we love in the hands of doctors offering the latest in medical developments. Progress may be slow in many areas, but when it comes to life, death, and disability most of us—like my father—will opt for those who offer us hope however slender the odds may be. Up till now, we have been correct to do so. Is there a reason to think an author raising the prospect of Pharmageddon should detain us any more than concerned critics from Alfred Worcester to Ivan Illich have done in the past? Can the best critique do anything other than ask us to give up hope?

      Worcester, Illich, and others talked about losing our humanity and our ability to care. In part these critiques failed, even though no one wants to lose their humanity or ability to care, because there were no specifics about what it means to care nor how to recognize the moment at which our humanity is threatened. In part they failed because until recently, whatever the drawbacks to developments, there was little doubt that life expectancies were increasing. All this is now changing. We are in a world where increasingly we need protection from the latest miracle cure to ensure we do not die prematurely.

      It would never be good care to withhold a cure. But traditional medical wisdom as practiced by Worcester to my father's doctor, Dr. Lapin, stressed the quintessential importance of being able to recognize when a treatment might make things worse rather than better. This philosophy was best expressed two hundred years ago by Philippe Pinel, a doctor looking after the mentally ill in Paris in the midst of the French Revolution: “It is an art of no little importance to administer medicines properly,” he said, “but it is an art of much greater and more difficult acquisition to know when to suspend or altogether to omit them.”12

      Cures almost by definition should lead to a fall in drug consumption, and good medical care as defined by Pinel should too. But instead we have seen an astonishing and relentless increase in the sale of supposed panaceas that do little or nothing to save lives or significantly improve their quality. The consumption of blockbuster drugs has grown from 6 percent of the pharmaceutical market in 1991 to 45 percent in 2006,13 with the top ten drugs accounting for $60 billion in annual sales.14 Where once the pharmaceutical industry made its money from drugs that cured, the big money now lies in marketing chronic diseases for which the current best-selling drugs in medicine offer little benefit. We are quite literally taking pills to save the lives of companies who have a greater interest in the vitality of the diseases they market drugs for than in our well-being. The only historical parallel we have here is the flourishing of patent or proprietary medicines in the late nineteenth and early twentieth centuries.

      In 2010 the global market for pharmaceuticals was worth over $900 billion, more than the government bailout of the US economy following the 2008 financial crisis. Half of this came from sales within the United States and almost all came from treatments for chronic disease management rather than for life-saving treatments. Aside from treatments for cancer, in the global market for pharmaceuticals that year the best sellers were the antidepressants, mood stabilizers, and other central nervous system drugs ($50 billion), followed by the cholesterol-lowering statins ($34 billion), which along with other drugs for cardiovascular disorders were part of a $105 billion market, proton-pump inhibitors for acid reflux ($26 billion), the blood-sugar-lowering hypoglycemics ($24 billion), treatments for asthma like Advair (alone worth close to $8 billion), treatments for osteoporosis, and drugs like Viagra for sexual functioning.15

      These celebrity or blockbuster drugs have been showing

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