Pharmageddon. David Healy

UNFOLDING

      Since the 1970s, a profound change has been occurring both in the nature of the drugs marketed and in the practice of medicine. New drugs, like the statins, have continued to appear as have new diagnostic tests to measure, for instance, our cholesterol levels, apparently in the tradition of testing that led to so many medical advances in the early twentieth century. But where previous drugs and tests were geared toward the diagnosis and cure of diseases that posed an imminent risk to life, now medical practice is increasingly geared to chronic disease management with drugs that modify risk and lifestyle factors rather than save lives. This is a post-Worcester and post-Cabot world, in which pharmaceutical companies sell diseases rather than cures.

      On the surface medical practice appears the same but underneath it's not. For instance, a small number of people have a genetic disorder that leads to excessively high cholesterol levels and for them drugs like the statins can save lives, almost in the way that antibiotics or insulin saved lives half a century ago. The statins can also save lives among people who have had strokes or heart attacks and who also smoke or are overweight, but in this case hundreds of people have to be persuaded to take them for the rest of their lives in order for a handful among them to be saved. For the most part, however, the statins are instead given to healthy people who have mild elevations of their cholesterol levels. Similarly, treatments for asthma or osteoporosis are now given to many people who would never have been diagnosed and treated before. Treatment happens now in response to results on a series of tests that have emerged in recent years—but these new tests don't help make a diagnosis that will lift a threat to our lives. Instead they effectively make a diagnosis of some drug deficiency disorder, and they often enter medical practice as part of the marketing strategy for a new drug.

      These new diseases and their treatments have gained a purchase on us because they are presumed to represent the latest advances in a story of progress that runs through insulin and the antibiotics and will hopefully lead someday to cures for cancer. These are the drugs that, had they been available, some presume might have saved many of my father's generation. But far from saving either their lives or ours, clinical trials show that the indiscriminate use of drugs to lower lipids or blood sugars, to relieve respiratory wheeze, or to block stress hormones may even increase the risk of loss of life,⁷ and appear to be doing so in the United States, the country that makes the greatest use of the latest pharmaceuticals, where since the mid-1970s life expectancy has been falling progressively further behind other developed countries.⁸

      If you looked around a restaurant, cinema, or office thirty or forty years ago that had a hundred or more people in it, you could predict that 5 to 10 percent of them might have a medical condition—sometimes unbeknownst to themselves—and a trained doctor would have been able to spot many of them just by looking. If you look around the same restaurant or office now at the apparently healthy people, those a doctor can't readily spot as ill, chances are that 80 to 90 percent of them could be diagnosed with one of these new “disorders.” Almost all will have cholesterol, blood sugar, blood pressure, bone density, or asthma numbers or one of an ever growing number of “mental health disorders” for which a pill will be suggested. Unlike being diagnosed with a traditional medical illness, these people won't be diagnosed because they are suffering and take themselves to a doctor. They will be diagnosed because an apparatus will come to them, perhaps coincidentally when they are at their doctor's for something else, or perhaps soon to a supermarket near them, an apparatus that will show them that their “numbers” are not quite right. It is only then that they will begin to suffer, either because of their discomfort and fear following a diagnosis or by virtue of the very real side effects triggered by the new pill they have been put on, a pill which has been marketed as an answer for any of us whose numbers aren't quite right.

      Recent books have attempted to diagnose what lies at the heart of our growing disquiet at what is happening to medical care.⁹ These critical studies almost universally blame the pharmaceutical companies, who are now among the most profitable corporations on the planet and who, due to grossly inflated estimates of drug development costs and the emergence of blockbusters—drugs that gross at least a billion dollars per year—are supposedly making too much money. This money lets them buy lobbyists and influence, do a variety of things to turn the heads of doctors, as well as sponsor patient groups to lobby against attempts to limit in any way access to the latest high-cost treatments.

      While making many excellent points and calling for action to tackle the problems the pharmaceutical industry poses, these concerned critics, largely from the medical profession, typically portray medicine itself as fundamentally healthy. The serenity of these physicians stems from their perception that, in contrast to an earlier time, medicine is now secure behind the ramparts of science. This science is not the laboratory science that emerged at the turn of the century with doctors like Richard Cabot but rather a science of randomized controlled trials (RCTs) that stems from the 1950s. In these trials new drugs are pitted against dummy pills, or placebos, and it is only if the new drug “wins” that it is allowed into use.

      These trials have laid the basis for what has come to be called “evidence-based medicine.” The results of RCT trials are also incorporated into evidence-based guidelines for the treatment of different diseases, and these guidelines, when embraced by particular agencies, constrain the prescriptions doctors can write. Many professionals involved in healthcare see such guidelines as keeping doctors within a straight and narrow path of therapeutic virtue, whatever the blandishments of pharmaceutical or medical equipment companies. Few suspect, as I will argue in chapters 5 and 6, that these guidelines in fact hand medicine over to the drug industry. Insofar as evidence-based medicine means that doctors stick to treatments that “work” and eliminate those that don't, many professionals involved in healthcare see it as offering the only possible basis for a universal healthcare system, if such a system were wanted. But as currently practiced, evidence-based medicine tolls a death-knell for the possibility of universal healthcare in the United States or its continued existence elsewhere.

      Aware that something is wrong, we cast around for a villain and often settle on the insurance companies or other third party payers for our current woes. While many grievances against insurance companies are legitimate, they too have a diminishing grip on the healthcare agenda. Because only the drugs and the style of care that goes with 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?