Pharmageddon. David Healy

supposedly affects up to 50,000 people per million, and efforts are now underway to persuade primary care clinicians that a wide range of the minor nervous problems they see are indicative of underlying bipolar disorder rather than anxiety or depression, and that these patients should be treated with newer and more costly mood stabilizers, such as Zyprexa or Seroquel, rather than older and cheaper antidepressants or tranquilizers.³⁶

      Bipolar disorder became intensely fashionable with extraordinary rapidity, promoted by assiduous disease awareness campaigns through direct-to-consumer advertising on television in the United States, and patient educational material in Europe, encouraging patients to complete self-assessments and ask their doctor whether bipolar disorder might be the cause of their problems. It became fashionable to the point where clothes and accessories could be bought online celebrating the wearer's bipolarity.³⁷ Within a decade, one of the most serious of mental illnesses had gone from being a devastating disease to being a lifestyle option.

      Everybody, it seems, stood to gain—physicians, companies, and patients. Bipolar disorder could be portrayed as a genetic disorder—not a parent's fault. While no one likes to have a biological disease, this one was portrayed in pharmaceutical company sponsored booklets³⁸ and ads as a disease linked to creativity that supposedly had affected major artistic figures of the nineteenth and twentieth centuries from Vincent Van Gogh and Robert Schumann to Robert Lowell and Sylvia Plath. Public authorities meanwhile could support screening programs such as Teenscreen, introduced in many American schools beginning in 2005, to detect the condition and trigger treatment as early as possible in order to avoid any number of social and individual ills such as suicide, divorce, career failure, crime, and substance misuse that might stem from a failure to detect and treat.³⁹

      For the specialists new journals appeared—Bipolar Disorder, The Journal of Bipolar Disorders, Clinical Approaches in Bipolar Disorders, and others. made possible by unrestricted educational grants from pharmaceutical companies. From 1995 onward a slew of societies and global conferences appeared as well—The International Society for Bipolar Disorders, The International Review of Bipolar Disorders, The International Society for Affective Disorders, The Organization for Bipolar

      Affective Disorders, The European Bipolar Forum, The Australasian Society for Bipolar Disorders, and many others.

      In just the same way impotence vanished and was replaced by erectile dysfunction, frigidity by female sexual desire disorder, boisterousness in children by ADHD. The skill lies in understanding the market and positioning a drug accordingly. In 1980, for instance, the newly created panic disorder was viewed as a severe form of anxiety; the marketing goal for Upjohn was to get Xanax on the market for panic disorder in the expectation that creating the perception that Xanax was good for severe anxiety would lead to leakage into prescriptions for other forms of anxiety also.⁴⁰ As we shall see in later chapters, marketing like this can conjure diseases like osteopenia, restless leg syndrome, and fibromyalgia out of thin air. This is now called disease mongering. But even more alarming, an “opportunity cost” of marketing like this is that medical diseases with a pedigree going back two millennia, such as catatonia, can vanish if no company stands to make money out of helping medical or nursing staff to recognize its presence and as a result patients may die, when the means to treat them may be lying inches away.⁴¹

      Once the addition of a branded drug to a doctor's arsenal was a minor addition to medical culture, but now the insertion of a Viagra or a Vioxx into the medical marketplace will often replace existing medical culture in an area of treatment, as the examples of mood stabilizers and bipolar disorders illustrate. Disorders that were once defined by patients' needs for medical services and doctors' perceptions of their pathology are now increasingly defined by the goals of marketers. Furthermore this now happens on a global basis. Whereas once the brand names of drugs differed from country to country and huge differences existed between Japanese and American medicine, say, and between French and German medicine, from the mid-1990s drugs like Zyprexa, Lipitor, and Viagra have been launched globally with essentially the same marketing in every country. Partly as a result of these onslaughts, differences in medical cultures are flattening down to a common pharmaceutical denominator. Where almost no one had bipolar disorder, osteoporosis, or female sexual dysfunction two decades ago, these new conditions are now global epidemics.

      Claims like these are cheap. If it were so simple to capture the institution of medicine just by coming up with fancy names for drugs, drug classes, and diseases, the proprietary medicines industry of the nineteenth century would never have died out. But driven by a real desire to care for the most vulnerable in society and a commitment to science, medicine eliminated these imitations of medical remedies for a century, with the exception of some holdovers from the former era such as Listerine and Clearasil. Good medicines clearly pushed out bad ones, in large part because they were based on good science. And good science continues—we now have astonishing developments in genetics and in medical imaging, so the argument presented here needs to pull back the curtains on the tricks of the pharmaceutical trade and show not only how modern marketing has closed in on the holy grail of fooling all of the people all of the time, but also why there has been so little resistance among doctors.

      A great deal of the marketers' sleight-of-hand has involved a manipulation of the appearances of science. There is the early twentieth-century science that produced the sulfa drugs and other antibiotics such as penicillin that let the dying rise from their deathbeds. Science like this cuts across marketing. The results were so dramatic that the drugs in effect sold themselves. But the best-selling drugs today aren't like this. They come wrapped in numbers that appear to come from science but that have been fashioned by marketers to indicate abnormalities of lipids, blood pressure, blood sugar, mood, bone density, and respiratory flow, as well as penile stiffness and clitoral sensitivity that their company's drugs just happen to treat.

      But science on its own, however artfully presented, would not have produced the comprehensive shift toward lifestyle drugs we have seen in recent decades or permitted pharmaceutical companies to penetrate the inner sanctums of medicine and transform it from a profession deeply hostile to marketing into a marketer's dream. There has been more involved. We have dealt with one structural element—the change in patent laws. We will now move on to two others—the emergence of prescription-only status for new drugs and the turn to controlled trials in the evaluation of drugs.

       CLIMATE CHANGE

      In retrospect the twenty-five years stretching from 1937 when the sulfa drugs were first introduced to 1962 when the US Food and Drugs Act was revised to tighten up regulations governing pharmaceuticals seems like a golden age. There were more novel agents introduced during this period than at any time before or since—the first antibiotics, antihypertensives, antipsychotics, and antidepressants, and the first oral antidiabetic drug. The period had not started well, however. Soon after sulfanilamide was introduced in 1937, a pharmacist in Oklahoma, unaware of the risk of ethylene glycol, sold sulfanilamide made up in this solvent, leading to over a hundred deaths.⁴² In response, in 1938, American politicians stepped in to regulate commerce in medicines, through the Food, Drugs and Cosmetics Act. In 1962, American politicians stepped in again to regulate the industry with consequences that will follow us through to the end of the book.

      Up to the late 1950s, prior to the passage of the 1962 amendments, in a history all but forgotten, the American Medical Association (AMA) had laboratories where they conducted their own testing of new drugs. They vetted any advertisements run in their journal, the Journal of the American Medical Association (JAMA), for accuracy and only permitted those that earned their Seal of Approval. They regularly ran assessments of new treatments that were not beholden to the pharmaceutical industry. They were known for their support of generic formulations of drugs in preference to branded drugs. But in the 1950s these curbs on promotion stopped. The Seal of Approval scheme was watered down as the AMA sought further advertising revenue from pharmaceutical and other companies to fight Democratic plans to introduce a bill for Medicaid in Congress. With the new advertising, their revenues doubled.

      In the 1950s there emerged a new set of discontents with the practices of the pharmaceutical industry and the prices these companies were charging for their drugs. The discontents were brought to public focus by the Democratic senator from Tennessee,