Create a disease to market a new drug

An excerpt from White Coat, Black Hat.

by Carl Elliott

Many of us have a relatively simple, commonsense view of the way that drug development and marketing work.

People get diseases; scientists develop drugs to treat those diseases; and marketers sell the drugs by showing that the drugs work better than their competitors. Sometimes, however, this pattern works in reverse. Drug company scientists develop a drug with a range of physiological effects, none of which are terribly helpful, so the marketers must identify and promote a disease for the drug to treat. This might mean co-opting a rare disease whose borders can be expanded to encompass more patients, or redefining an unpleasant aspect of ordinary life as a medical pathology. Once a disease has achieved a critical degree of cultural legitimacy, there is no need to convince anyone that a drug is necessary. It will come to him as his own idea.

A classic drug industry example is the strategy developed by Merck in the 1960s to promote amitriptyline, its new antidepressant. At the time, clinical depression was regarded as a rare condition—so rare, in fact, that there appeared to be little profit in marketing an antidepressant. The solution was to increase the frequency of the diagnosis. To that end, Merck bought fifty thousand copies of a book by Frank Ayd called Recognizing the Depressed Patient and sent them out free of charge to general practitioners all over the country. Prescriptions for amitriptyline took off dramatically, despite the fact that a similar antidepressant, imipramine, had been available since the mid-1950s. The key to selling antidepressants, it became clear, was to sell clinical depression.

Fifty years ago this kind of marketing was aimed mainly at doctors. Today it is also directed at patients. The marketing buzzword is disease branding. To brand a disease is to shape its public perception in order to make it more palatable to potential patients. This is usually done by telling people that the disease is taken seriously by doctors, that it is far more common than they ever realized, and that having it is nothing to be ashamed of. As Vince Parry, the president of Y Brand, puts it, disease branding is a “win-win marketing strategy that illuminates, educates and promotes at the same time.”

Disease branding works especially well for two sorts of conditions. The first is the condition that, like clinical depression in the early 1960s, can be plausibly portrayed as common yet underdiagnosed. This sort of branding campaign legitimates the pain or discomfort that people experience, not just by giving it a clinical name but by assuring potential patients they are part of a large community of sufferers. Take, for instance, restless legs syndrome. Until recently, restless legs syndrome was seen by clinicians as an unusual, somewhat mysterious condition. It was characterized by a crawling or aching sensation in the legs, often more severe at night, which could be relieved by movement such as walking. It was not a common affliction. In 2005, however, GlaxoSmithKline got approval from the FDA to market Requip, a drug used to treat Parkinson’s disease, as a treatment for restless legs syndrome. GlaxoSmithKline soon issued a press release titled “New Survey Reveals Common Yet Under-Recognized Disorder—Restless Legs Syndrome—Is Keeping Americans Awake at Night.” The Requip public relations campaign went on to suggest that problems such as insomnia and depression might actually be symptoms of restless legs syndrome, which tormented as many as one in ten Americans.

The second disease-branding candidate is the shameful condition that can be destigmatized. When Pharmacia launched Detrol in late 1990s, for instance, the condition it treated was known to doctors as urge incontinence. Patients called it “accidentally peeing in my pants,” and they were reluctant to mention it to their physicians. Pharmacia responded by rebranding urge incontinence as overactive bladder. This helped in two ways. First, whereas urge incontinence implied a kind of constitutional weakness and was associated mainly with elderly people, overactive bladder suggested that patients were afflicted by some sort of supercharged organ frantically working overtime. This shift from weakness to strength made the condition seem less embarrassing. Second, in contrast to incontinence, which meant actual loss of bladder control, overactive bladder was defined to include people who very often simply had a strong urge to go to the bathroom. The vice president of Pharmacia, Neil Wolf, explained his strategy in a 2002 presentation called “Positioning Detrol: Creating a Disease.” By creating the disease of overactive bladder, Wolf said, Pharmacia expanded the treatable population nearly threefold, to a total of twenty-one million potential patients—the difference between a “niche product” and a “mass-market opportunity.” By 2003, Detrol and its long-acting version, Detrol LA, accounted for $757 million in annual sales.

Because it is difficult to create a disease without the help of physicians, companies typically recruit physician thought leaders to write and speak about any new concepts they are trying to introduce. “It is always presented as a scientific and clinical opportunity to help patients,” says Peter Whitehouse, a neurologist at Case Western Reserve University. Physicians must be convinced that a new disease category actually describes a patient population whose symptoms warrant a drug. It also helps if the physicians believe the condition is dangerous. When AstraZeneca introduced Prilosec (and later Nexium) for heartburn, for example, it famously repositioned heartburn as gastroesophageal reflux disease, or GERD. But it also commissioned research to demonstrate the devastating consequences of failing to treat it. Once physicians are on board, a company can get a concept like overactive bladder or reflux disease into widespread circulation simply by funding CME events, journal supplements, and disease-awareness campaigns. “That’s easy,” says Whitehouse. “You just have to have enough money.”

If a marketing campaign is really successful, it goes beyond hype to insinuate itself into the language and thought of the population as a whole, essentially remaking the way people think of themselves. Concepts such as reflux disease, erectile dysfunction, and irritable bowel syndrome have had considerable success, but the most remarkable changes have come in the language of psychiatry with the emergence of neurobiological concepts such as social anxiety disorder, attention deficit hyperactivity disorder, and bipolar disorder. What is striking about this neurobiological language is the extent to which ordinary people have come to incorporate it into their identities. You may have erectile dysfunction or irritable bowel syndrome, but you are bipolar or ADHD. Your diagnosis is part of who you are.

Carl Elliott is a writer for The New Yorker and The Atlantic Monthly and author of White Coat, Black Hat.

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