Pharmageddon. David Healy

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СКАЧАТЬ will likely be transported there even if the showroom is in a different country, being wined and dined en route. Once in the showroom, a doctor won’t meet a salesman but instead, colleagues, or a local professor, or some medical eminence. The knowledge needed to construct a blockbuster brand is derived almost entirely from the physicians to whom the product is being sold. The careers of Lipitor, Nexium, Vioxx, Prozac, and Depakote make this clear. Doctors tell the company what they, the doctors, want to hear.

      In the course of a drug’s development, panels of medical academics— opinion leaders—are convened to see what the consumer wants. Pharmaceutical companies do nothing so crude as call these focus groups, but this is essentially what they are. The consumers being courted are jobbing doctors, and the process is aimed at guessing how these clinicians can be influenced. At the 1990 Paris pharmaceutical conference, Glaxo’s marketing chief told the audience “concepts sell drugs.”²⁰ The academic focus groups are where a company will find out just what concepts are current. After the demise of Vioxx, doctors needed something new for pain relief but rather than sell them Lyrica, a not very good analgesic, Pfizer married Lyrica to fibromyalgia and sold this combination. Fibromyalgia is a suitably vague condition characterized by nonspecific complaints of pain that had been knocking around medicine for a century.²¹

      The new role of medical academics is to broker this process. Where once these academics were the repositories and creators of medical culture, they are now a resource to be plumbed by companies to establish what prescribers can be induced to want rather than what’s best for the patient. The key thing is to establish what prescribers do want from a drug and ensure they appear to get what they want, whether or not there is much basis in the drug to think it might do what the prescriber wants. If pain has become an issue for doctors, the marketing of a new product will emphasize this quality even if there is nothing to recommend the new product for this purpose compared with older products. Companies trumpet the huge research and development budgets needed to bring a drug to market today. But it costs very little to make these medications. Research is undertaken on the new pill, but most of the studies are designed to secure therapeutic niches rather than to advance medical knowledge. The real “research” budget is devoted to establishing the mindset of clinicians at the time of launch. In 2003, it was estimated that thought-leader development in the United States accounted for a stunning 20 percent of marketing costs and was rising,²² compared with 14 percent put into direct-to-consumer ads.²³

      Take the bladder stabilizer Yentreve (duloxetine). Lilly had jettisoned duloxetine as a potential antidepressant in the 1990s because it triggered urinary retention among other effects, but then brought it onto the market in Europe as a bladder stabilizer. When Prozac went off patent in 2001 and its designated successor, Zalutria, appeared to produce cardiac problems, Lilly opted to bring duloxetine back to antidepressant life as Cymbalta. Cymbalta was marketed heavily as a pain reliever in addition to helping depression. Why? Because doctors had told market surveys they often have patients in pain of one sort or another and were uncertain how to treat them.

      Luckily for Lilly, just as Cymbalta was coming to market, the leading painkiller Vioxx was withdrawn from circulation because research showed it caused heart attacks. Anything that would help pain was catapulted forward in the promotions of all companies, and Cymbalta was certainly no exception.²⁴ As a result, a great number of patients attending pain relief clinics or visiting internists or primary care practitioners and complaining of pain were put on it, even though they showed no signs of depression. What doctors were hearing when they listened to the siren song from Cymbalta were their own needs. Duloxetine had nothing to recommend it for pain beyond what other antidepressants have, but Cymbalta relieved doctors’ worries about pain.²⁵ Such marketing might have been developed for Zalutria and simply switched to Cymbalta in just the way that the marketing for one brand of bottled water could be applied to any another. There is nothing in the water that gives substance to any of these perceptions.

      The patient given Cymbalta for pain relief is not to know that it is more likely to lead to agitation, sometimes severe enough to trigger thoughts of suicide—and that the FDA banned its use for urinary incontinence for this very reason. They are not likely to know that Cymbalta is more likely to cause urinary retention than it is to ease pain. But the patient is not the consumer, the doctor is, and his pain is eased by Cymbalta without any side effect to cloud the picture.

      Once the distinguishing feature of a marketing campaign has been identified, the appearances of scientific support are manufactured. A clinical consensus for a drug such as Lyrica (Pfizer’s drug ostensibly to treat fibromyalgia) or Cymbalta for pain, for instance, is built by means of scientific symposia, with articles apparently written by opinion leaders but usually ghostwritten, or by educational initiatives featuring well-known academics.

      Ultimately branding of this sort feeds off blue-skies research and medical education funded by governments in the United States and Europe. Without this there would be very little understanding of the effect a medication has on lipids or bones or blood pressure and as a result very little language available with which to describe the effects of the drugs for marketing purposes. From the point of view of marketing, the advantage of the medical sciences is not that they might lead to better drugs but rather that they provide concepts and languages for marketers to use.

      One of the best examples of this process has been the creation of the notion of chemical imbalance. Neurotransmitters were identified in the brain in the early 1960s. By 1965, this led some to hypothesize that the amounts of one or another of two common neurotransmitters, norepinephrine and serotonin, are lowered in depression and that antidepressants could top them up. By 1970, psychopharmacologists had abandoned these hypotheses because of clear inadequacy.²⁶ But twenty years later, the idea that serotonin was low in depression and restored to normal by treatment was resurrected within the marketing departments of SmithKline Beecham, Lilly, and Pfizer, as part of the sales pitch for Paxil, Prozac, and Zoloft. It was marketing copy par excellence, too tempting to spurn. In fact, mindless patter about restoring chemical balances did a great deal to make the SSRIs among the most profitable income streams for the pharmaceutical industry from 1990 onward. In similar fashion when selling drugs for osteoporosis, cholesterol reduction, asthma, and other conditions, marketers cherry- pick from the language of the appropriate science to dress up their products. As they put it themselves, they leverage the bits of the science base that suit them.

      In addition to using information from the basic sciences, one of the clearest strategies companies use is to market diseases in the expectation that sales of the pills promoted for them will follow. This has happened from the 1950s onward, when Merck educated physicians to recognize raised blood pressure (hypertension) and its consequences after their new diuretic agent, Diuril, turned out to have antihypertensive properties. They convened symposia and sponsored studies on the benefits of monitoring hypertension.²⁷ This approach speaks directly to clinicians in clinical language. It also puts an ethical onus on them to eliminate a disease by prescribing a pill—one that comes sanctioned by the experts in the field.

      Patients also have to be softened up so they are receptive to the idea of being prescribed a statin, or an antihypertensive, or a biphosphonate for their bones. In the United States direct-to-consumer advertisements school people on the importance of their “figures”—their lipid levels, blood pressure, and bone densities—or alert them to the possibility that what they regard as restless legs may be in fact be an illness,²⁸ or that feelings of urgency as regards micturition, low grade pain, or less than perfect sexual potency may be illnesses that can be treated. Ask your doctor if…

      Elsewhere in the world promotional stories appearing in the health pages of newspapers and magazines fulfill the same function. PR firms place stories in the media and help sponsor books such as Listening to Prozac,29 while marketers increasingly utilize Internet sites where patients can diagnose themselves and take the resulting information back to their doctors. If there is a buzz around some disorder the British, Australian, or French media are naturally going to be interested to feature it, even though direct-to-consumer ads are СКАЧАТЬ