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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  • http://astridvanwoerkom.wordpresss.comq/ Astrid

    It is of course not said that these diseases are not real. They are maybe rarer than currently diagnosed, but that doesn’t mean they’re in essence real diseases.

  • http://jayneduvall.com Jayne

    How are medical schools incorporating this into their training, that is keeping the minds of young physicians sharp to recognize the marketeering of big pharma?

  • knin

    Im a bit confused about amitriptyline because my girlfriend has been taken them for four years for her insomnia, and she is taking a modern day antidepressant, Citanopram, for her depression. Is amtitriptyline supposed to be an anti depressant or a sleeping tablet what is it? I thought these drugs go through vigourious testing. Don’t get me wrong I does what she expected it to do but is it the placebo effect or the chemical reaction of the drug?

  • http://www.lifesupportmedical.com/en/ Art NMD

    Not so kind advertising sales strategy has been around for a very long time and yet educators and governments have not successfully counter measure it.

  • Finn

    @knin, amitriptyline is a tricyclic antidepressant that causes drowsiness, so it was probably prescribed to your girlfriend for both depression and insomnia.

    There are 2 big problems with this kind of marketing strategy. First is, obviously, overprescribing & the resulting risk of polypharmacy. Second is the growing belief, even among some physicians, that these conditions are fictitious. There are people who need drug treatment for restless leg syndrome, GERD, IBS, ADHD, depression, incontinence, and bipolar disorder–just not as many as the drug companies would have us believe, and in most cases nondrug treatments should be tried first.

  • Natalie Sera

    I don’t think RLS is as rare as you make it out to be. I was born in 1948, and have suffered from RLS since I was a young child. In my family, it is hereditary; my mother had it, my brother has it and my son has it. But for many years, I would describe it to docs, and they would just shake their heads and say “I dunno.” And I’m sure it left their consciousness immediately. So for me, and I’m sure many people, it wasn’t that it didn’t exist, but that it was ignored.
    There are now diagnostic guidelines that did not exist when I was younger, and more docs have heard of it — that’s not a market expansion, but a long overdue response to a real but long-unrecognized condition.

  • http://myheartsisters.org Carolyn Thomas

    I recommend Dr. Ben Goldacre’s book, ‘Bad Science’, for those interested in this pervasive trend towards “marketing-based medicine”.

    He particularly laments this practice of “disease mongering”, which is what drug companies have had to do because all the good diseases are already taken. Goldacre explains:

    “Because they cannot find new treatments for the diseases we already have, the pill companies have instead had to invent new diseases for the treatments they already have. Recent favourites include social anxiety disorder (a new use for SSRI antidepressant drugs), female sexual dysfunction (a questionable diagnosis in women), the widening diagnostic boundaries of restless leg syndrome, and even night eating syndrome.”

    Here in Canada, we’ve been following a controversial scandal around a University of Manitoba grad student being granted a Ph.D. despite failing the required exams not once but twice, and then claiming he suffers a “disability” called extreme exam anxiety.

    More at The Medicalization of Everyday Life at THE ETHICAL NAG: MARKETING ETHICS FOR THE EASILY SWAYED at http://ethicalnag.org/2010/01/29/medicalization-everday/

    • Natalie Sera

      What exactly are the “widening diagnostic boundaries of restless leg (sic) syndrome?

  • http://myheartsisters.org Carolyn Thomas

    Hi Natalie – I’ve already responded at length to your comment on ‘The Ethical Nag’, but just to recap here in answer to this question about Dr. Goldacre’s “widening diagnostic boundaries”:

    In a large 2004 Johns Hopkins study reported in the Archives of Internal Medicine, “only 7% of subjects being treated for RLS reported all four RLS diagnostic criteria, and only 2.7% reported moderately or severely distressing symptoms two or more times per week (i.e., the group for whom medical treatment might be appropriate).”

    That’s likely why the journal Public Library of Science Medicine concluded in its April 2006 report, “Giving Legs to Restless Legs: A Case Study of How The Media Helps Make People Sick”:

    “The market for RLS treatment gets enlarged in two ways:
    - by narrowing the definition of health so normal experiences get labeled as pathologic
    - by expanding the definition of disease to include earlier, milder, and pre-symptomatic forms.”

    The interesting disease-mongering story of how drug giant GlaxoSmithKline – maker of the RLS drug ropinirole – got its marketing ball rolling in 2003 by sending out news releases based on its internally funded and unpublished “study” can be found at PLoS Medicine – http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0030170

  • MIS Prof

    I absolutely agree with the problems of direct-to-patient advertising (in whatever form) and with the dangers associated with polypharmacy.

    But I also agree with Finn and Natalie. I get annoyed at the notion that a condition which has previously been considered rare … really is rare after lots of reports of it pour in. Just because doctors can’t diagnose a disease or condition doesn’t mean that disease or condition doesn’t exist in a patient or a population. I’m very critical of the pharmaceutical industry, but I have to admit that sometimes they find things the medical community has missed or ignored.

    I think in the past after being told by a doctor that there was nothing wrong with them, people just ignored symptoms, toughed it out, and went on with their lives. People spent years feeling miserable and having their physical or mental health deteriorate.

    I know this happened to me in the 1960′s and 1970′s when I was dealing with endometriosis. I had a number of doctors in several states tell me nothing was wrong and to quit complaining. So I shut up and lived with the pain until there was a palpable pelvic mass that couldn’t be ignored. By then a devastating amount of damage had been done. Now this disease is recognized much more easily and the prevalence of diagnosis is much higher.

    As the medical community gets better diagnostic tools and the body of knowledge expands, more conditions can be recognized and more damage and suffering can be minimized or eliminated. From the patient’s point of view, sometimes it is reassuring to know that you are not alone in dealing with a condition and that you aren’t crazy … that the condition really exists and that there is help if it gets unbearable. If the pharmaceutical industry can help with that, then I’m all for it.

    I’d appreciate doctors having a little more humility and compassion when dealing with patients’ descriptions of symptoms which don’t fit neatly into a classic, convenient, and fast diagnosis. If someone had done that for me, I might have been able to have children. Docs, the next time you blow off a patient’s concerns or use the term ‘junk’ disease, I’m going to haunt you for 24 hours (to borrow a psychological trick from Admiral Grace Hopper).

    • Natalie Sera

      Right on, MIS Prof! I essentially did shut up after being blown off many times, but eventually found a doc who believed me and cooperated with me, and while the relief is not perfect, it is certainly better than untreated RLS was, and I am deeply grateful.
      The other issue is misdiagnosis. I was diagnosed in my early 30′s with hypertension. Well, yes, my BP was high, but no one ever tried to find out why. Lately, I have found out about Inappropriate Sinus Tachycardia, and I fit the symptoms to a T. Fortunately, I did get beta blockers, which turn out to be the treatment of choice for this condition, but I wish I had known exactly what it was for all these years.

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