The UK Guardian reports on a special issue of PloS Medicine (an online peer-reviewed journal) on “disease mongering” – the practice of pharmaceutical companies’ deliberately increasing fear over – or in cases entirely inventing – diseases to increase public demand for drugs that, conveniently, can only be provided by the pharma companies that created that fear in the first place. Like “halitosis” – the imaginary “disease” of bad breath, invented by Listerine and now standard medical terminology – pharmas have created or exploited ambiguous medical terms like “mild cognitive impairment” (to expand the range of uses for medications for Alzheimer disease), “female sexual dysfunction” (to justify prescribing Viagra for women), “erectile dysfunction” (redefined from true organic impotence to any degree of dissatisfaction with erection, to expand the market for Viagra to include all men regardless of health status), and “restless leg syndrome” (vague feelings in the legs, which supposedly are symptomatic of a neurological condition). They have also actively worked to redefine or blur the definitions of recognized conditions so as to justify diagnosing them in more patients, thus increasing the potential market for their products, and have publicly advertised their products for conditions which affect small proportions of the population in order to create demand for medication for conditions – especially ones affecting children – that the public fears but does not understand, such as ADHD (by publicizing controversial treatments to parents and teachers) and bipolar disorder (through advertising literally intended to convince women that they are crazier than they or their psychiatrists believe).

More and more, “educational” advertising is intended to convince consumers they are sick, not to alert them to treatments if they are sick.

The extent of the practice is shocking. The Guardian gives an overview:

[A]ccording to reports published today . . . [h]ealthy people are being turned into patients by drug firms which publicise mental and sexual problems and promote little-known conditions only then to reveal the medicines they say will treat them. . . .

In 11 papers in the journal Public Library of Science Medicine, experts from Britain, the US and elsewhere argue that new diseases are being defined by specialists who are often funded by the drug industry.

According to the researchers, the campaigns boost drug sales by medicalising aspects of normal life such as sexuality, portray mild problems such as irritability in children as serious illnesses and suggest that rare health conditions, such as the urge to move ones’ legs, are common. . . .

In the journal’s editorial, guest editors Ray Moynihan and David Henry write: “Informal alliances of pharmaceutical corporations, public relations firms, doctors’ groups and patient advocates promote these ideas to the public and policy makers, often using mass media to push a certain view of a particular health problem.”

In one of the reports, Dr Joel Lexchin, a drug safety expert at York University in Toronto, alleges that Pfizer, the maker of Viagra, devised ways to “ensure that the drug was seen as a legitimate therapy for almost any man”, and “took steps to make sure Viagra was not relegated to a niche role of just treating men with [erectile dysfunction] due to organic causes, such as diabetes or prostate surgery”.

According to Leonore Tiefer, clinical professor of psychiatry at New York University, a textbook case of disease mongering is the creation and promotion of “female sexual dysfunction”. The campaign by a number of drug companies has been especially successful in the US, he notes, where there has been a heavily contested attempt to convince the public that 43% of women live with the condition.

In another paper, David Healy, director of the department of psychosocial medicine at the University of Wales, Bangor, describes how a TV advertisement from Lilly Pharmaceuticals encouraged people to find out about mood disorders via a website sponsored by the company. “This advert markets bipolar disorder,” he writes in the journal.

The specifics are quite damning, and the study authors have done a good job gathering the facts. (See the PLoS link above for full text.)

Bigger and Better: How Pfizer Redefined Erectile Dysfunction, by Joel Lexchin

The initial television ads in the US for Viagra used an aging Bob Dole (born 1923) as a spokesman, a 1996 Republican presidential candidate. Since then, Pfizer has refocused its advertising campaign to match the lifestyle message on its Web site. There is now advertising of Viagra at NASCAR races, and Pfizer hired 39-year-old Rafael Palmeiro, a former Texas Ranger baseball player as a spokesman. Pfizer teamed up with Sports Illustrated magazine to create the Sportsman of the Year Trivia Game (http://www.viagra.com/sports/index.asp). Between 1999 and 2001, Pfizer spent over US$303 million in direct-to-consumer advertising to get its message about Viagra to men. . . .

Pfizer denies that it is targeting younger men or that it is positioning Viagra as a lifestyle drug. Mariann Caprino, a spokeswoman for the company, is quoted in the New York Times as saying, “Have we gone out and given our advertising agency instructions to speak to this young population? No, we haven’t” [7]. But the message from the pictures on the Web site, in magazine ads, and from people like Rafael Palmiero is that everyone, whatever their age, at one time or another, can use a little enhancement; and any deviation from perfect erectile function means a diagnosis of ED and treatment with Viagra. Increasingly, the age profile of men using Viagra reflects the younger audience that Pfizer denies it is targeting. Between 1998 and 2002 the group showing the largest increase in Viagra use was men between the ages of 18 and 45, and only one-third of these men had a possible etiologic reason for needing Viagra.

Medicine Goes to School: Teachers as Sickness Brokers for ADHD, by Christine B. Phillips

The role of the teacher as the sickness and treatment broker for ADHD has been elaborated more clearly for ADHD than for any other childhood disorder. The DSM-IV diagnostic criteria accord teachers a formal role in diagnosis through specialised assessment instruments such as the Conners Teacher’s Rating Scale [8]. Teachers often agree to administer psychostimulant medication during the school day, although there is in Australia, the UK, and the US no legal compulsion to do so. A subtle incentive for teachers to administer medication in the middle of the day may be the assurance of a tractable child in the afternoon.

An informal role also exists for teachers as “disease-spotters.” There appears to be considerable difference internationally in the alacrity with which teachers engage in disease-spotting. In a study of 491 physicians in Washington, D. C., almost half of the diagnoses of ADHD in their patients had been suggested first by teachers. . . .

Both Shire (manufacturer of Adderell) [11] and Novartis (manufacturer of Ritalin) [12] have established educational websites separate from their own industry sites, each of which contains specific resources for teachers. On a page entitled “If parents ask…,” Novartis suggests responses teachers might make to concerned parents:

“Make it clear to them that it is important for them—and their child—to understand and follow the doctor’s medical advice about medication and other therapies for ADHD. ADHD is a serious condition that may require the child to be on medication and undergo counselling for a long duration [12].”

Each site incorporates links to the manufacturer responsible for the site [13] or directly to the psychostimulant produced by the manufacturer [14], discussion of the diagnostic process, and references to the legislation governing the rights of access for disabled people to treatment, such as the Individuals with Disabilities Education Act in the US. An activity such as Shire’s funding of an annual toll-free “ask the experts” ADHD hotline, 1-888-ASK-ADHD, [15] is another example of the provision of advertorial information to teachers in the guise of objective education. Experts provided for this free hotline, now in its seventh year, include teachers, as well as school nurses, doctors, and advocates; suggested topics include the management of ADHD within the school.

Other school personnel are also targeted. In 1997, Novartis collaborated with the National Association of School Nurses in the US to run a nationwide campaign, in which 11,000 school nurses were provided with a resource kit containing information on ADHD, its treatment, and various support organisations. . . .

In the US, the pre-eminent advocacy group for people with ADHD is CHADD (Children and Adults with Attention Deficit/Hyperactivity Disorder). In the 2004–2005 financial year (year ended 30 June 2005), 22% of CHADD’s total revenue came from the pharmaceutical industry [16]. CHADD undertakes educational programs for teachers [18], including acting as the lead editorial consultant of a special issue on ADHD in Health in Action, a quarterly publication of the American School Health Association. . . .

Female Sexual Dysfunction: A Case Study of Disease Mongering and Activist Resistance, by Leonore Tiefer

Pfizer, the world’s largest pharmaceutical company, was the main promoter of FSD from 1997 to 2004, when its quest to have Viagra approved to treat “female sexual arousal disorder” ended because of consistently poor clinical-trial results. In its public statement, Pfizer said that that several large-scale, placebo-controlled studies including about 3,000 women with female sexual arousal disorder showed inconclusive results on the efficacy of the drug. Commenting on these trial results on Viagra, John Bancroft, director of the Kinsey Institute, told the BMJ: “The recent history of the study of female sexual dysfunction is a classic example of starting with some preconceived, and non-evidence based diagnostic categorisation for women’s sexual dysfunctions, based on the male model, and then requiring further research to be based on that structure. Increasingly it is becoming evident that women’s sexual problems are not usefully conceptualised in that way”]. Nevertheless, Viagra (and the idea that it must work for women) has been so successfully branded that it continues to be prescribed off-label for women.

Next in line with a potential drug for FSD has been Procter & Gamble (P&G), the multibillion-dollar soap, shampoo, and snack company that makes only five prescription drugs. . . . P&G had begun investing heavily in a testosterone patch (brand name Intrinsa) to treat “hypoactive sexual desire disorder.” The unnoticed shift in 2004 in FSD identity and promotion from female sexual arousal disorder to hypoactive sexual desire disorder is another hallmark moment in the FSD story . . . . Unfortunately for the drug company, an FDA advisory panel voted unanimously not to approve Intrinsa, saying that P&G had not provided sufficient long-term safety data and questioning the clinical significance of the Intrinsa trials. However, testosterone researcher Jan Shifren estimates that one-fifth of all the prescriptions of testosterone products approved for men are actually written (off-label) for women.

By 2006, FSD has become a medical and media reality, despite the obvious ongoing difficulties in defining the condition and in getting a drug approved. Disease mongering has led to the successful “branding” of FSD.

Cholinesterase Inhibitors: Drugs Looking for a Disease?, by Marina Maggini, Nicola Vanacore, Roberto Raschetti

Drug companies have invested heavily in developing treatments for Alzheimer disease, and then were actively involved in expanding the market to other forms of dementia. In the last decade, donepezil, galantamine, and rivastigmine have been tested not only in patients with Alzheimer disease but also in patients with vascular dementia, dementia with Lewy bodies, dementia associated with Parkinson disease, and mild cognitive impairment (MCI). Even when the evidence on the efficacy of these drugs is lacking, or inconclusive, the results are often presented in such a way as to create a false perception of efficacy. For example, about 23 different scales or instruments (on average six per trial) were used, in the trials considered here, as primary or secondary outcome measures. Most of them were not validated for the disease for which the drugs were tested and are not currently used in clinical practice, undermining the translation of these research findings into clinical practice. Moreover, the treatment effect in the trials is usually expressed through the average change from baseline in test scores, without discussing the clinical importance of the usually small effect size observed. . . .

Whether MCI can be considered a clinical entity is still a matter of debate (for example, Gauthier and Touchon have argued that “there is epidemiological evidence that many subjects labeled as having MCI do not worsen over time and may revert to normal cognitive abilities” [27]). Nevertheless, specific drug treatment for MCI has been proposed. . . .

A recent review on clinical trials in MCI concluded that none of the reviewed studies met their primary objectives; that is, none of the trials showed a benefit of cholinesterase inhibitors in delaying the conversion to dementia or in slowing symptom progression [30].

Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick, by Steven Woloshin, Lisa M. Schwartz

Discussions about disease mongering usually focus on the role of pharmaceutical companies—how they promote disease and their products through “disease awareness” campaigns and direct-to-consumer drug advertising, and by funding disease advocacy groups. But diseases also get promoted in another way: through the news media. News reports are a major source of health information for people. Unless journalists approach stories about new diseases skeptically and look out for disease mongering by the pharmaceutical industry, pharmaceutical consultants, and advocacy groups, journalists, too, may end up selling sickness. . . .

To get a sense of how the media works in the context of a major disease promotion effort, we examined news coverage of “restless legs”. In 2003, GlaxoSmithKline launched a campaign to promote awareness about restless legs syndrome, beginning with press releases about presentations at the American Academy of Neurology meeting describing the early trial results of using ropinirole (a drug previously approved for Parkinson disease) for the treatment of restless legs. Two months later, GlaxoSmithKline issued a new press release entitled “New survey reveals common yet under recognized disorder—restless legs syndrome—is keeping Americans awake at night” about an internally funded and, at the time, unpublished study [8]. In 2005, the US Food and Drug Administration (FDA) approved ropinirole for the treatment of restless legs syndrome (the first drug approved specifically for this indication). Since then, the restless legs campaign has developed into a multimillion dollar international effort to “push restless legs syndrome into the consciousness of doctors and consumers alike”. . . .

the news articles often included elements exaggerating disease prevalence. Only one article questioned the disease definition at all (and portrayed the act of questioning the definition as insensitive: “[the patient] knows it can sound trivial. That’s one of the problems with restless legs. Radio show host Rush Limbaugh, for example, has mocked it as a pseudoillness”).

Almost two-thirds of articles provided an estimate of disease prevalence (most commonly, statements such as “at least 12 million Americans suffer from the syndrome” [11] or “[it] affects 1 in 10 adults in the United States” [12]). No article questioned the validity of the prevalence estimates. In fact, there are reasons to believe the estimates overstate the prevalence of clinically meaningful disease. . . .

Nearly three-quarters of newspaper articles highlighted the potentially serious physical, social, and emotional consequences of restless legs: “…the condition sounds like a joke, but its consequences can be devastating. Driven to despair by years of sleepless nights, patients have become suicidal”). While over 40% of the articles provided anecdotes about people with severe disease, no article provided anecdotes about people who did not find their symptoms especially bothersome. . . .

The articles also reinforced the need for more diagnosis. About half reported that the syndrome is underdiagnosed by physicians (“…relatively few doctors know about restless legs. This is the most common disorder your doctor has never heard of” [17]) and underrecognized by patients (“…many people can suffer in silence for years before it is recognized” [18]). One-quarter of articles encouraged patient self-diagnosis and suggested people ask their doctor whether restless legs might explain various problems (including insomnia, daytime fatigue, attention deficit disorder in children, and depression). One-fifth of articles referred readers to the “nonprofit” Restless Legs Foundation for further information; none reported that the foundation is heavily subsidized by GlaxoSmithKline. No article acknowledged the possibility of overdiagnosis (the idea that some people will be diagnosed unnecessarily and take medication they do not really need). . . .

About half the news stories mentioned the drug ropinirole by name. Only one story quantified the drug’s benefit. By contrast, about half the stories mentioning ropinirole included anecdotes about patients who took the drug (and in most cases noted substantial improvement). One-third of articles used “miracle language” to describe patient response to medication (e.g., “it has been a miracle drug for me” [19]). The actual benefit of the drug is modest.

One article quotes author Lyn Payer’s list of disease-mongering tactics. It makes a good touchstone on the issue:

The Major Disease-Mongering Tactics Identified by Lynn Payer

1. “Taking a normal function and implying that there’s something wrong with it and it should be treated”
2. “Imputing suffering that isn’t necessarily there”
3. “Defining as large a proportion of the population as possible as suffering from the ‘disease’”
4. “Defining a [condition] as a deficiency disease or disease of hormonal imbalance”
5. “Getting the right spin doctors”
6. “Framing the issues in a particular way”
7. “Selective use of statistics to exaggerate the benefits of treatment”
8. “Using the wrong end point”
9. “Promoting technology as risk-free magic”
10. “Taking a common symptom that could mean anything and making it sound as if it is a sign of a serious disease”

Payer L (1992) Disease-mongers: How doctors, drug companies, and insurers are making you feel sick. New York: Wiley & Sons. 292 pp

Though some are vague, it’s clear enough how these tactics are prevalent in the case studies given in PLoS. And we see them every day, in TV, magazine, and bus and subway ads, on the radio, and even in doctors’ offices. Indeed, doctors are part of the problem.

Perhaps to some degree the public is part of the problem, too – assuming every uncomfortable condition is accompanied by an convenient treatment, and, in some ways, medicalizing its own life with more and more cosmetic medicine and “cosmeceuticals”. If Botox makes sense, why doesn’t “pink Viagra”?

It’s not the expansionist conception of medicine that I care about, however. It’s the deception and manipulation engaged in by pharmas, to subject people to medications they themselves don’t want, or need, or even think they need. People wanting medications to achieve some personal notion of the good life doesn’t bother me. Corporations deliberately frightening and manipulating them into thinking they need possibly dangerous medications for conditions the don’t have and don’t even think they have is a scandalous offense. More and more, the companies that make our medications are a direct threat to our health.