Selling Sickness : A Classic Paper: continued

The second and final part of the paper by Moynihan et al 

Mild symptoms as portents of serious disease: irritable bowel syndrome Irritable bowel syndrome has long been considered a common functional disorder, and a “diagnosis of exclusion” covering a range of symptom severity, yet it is currently experiencing something of a global ``makeover.” Without question many people with the condition are severely disabled by their symptoms, but the arrival of new drugs has seen manufacturers seek to change the way the world thinks about irritable bowel syndrome.

What for many people is a mild functional disorder—requiring little more than reassurance about

its benign natural course—is currently being reframed as a serious disease attracting a label and a drug, with all the associated harms and costs.

Confidential plan to “shape” medical opinion

A confidential draft document leaked from a medical communications company, In Vivo Communications, describes a three year “medical education programme” to create a new perception of irritable bowel syndrome as a “credible, common and concrete disease.” The proposed 2001­3 education programme is part of the marketing strategy for GlaxoSmithKline's drug Lotronex (alosetron hydrochloride).

In Vivo is one of a handful of companies specialising in corporate backed “medical education,” and the leaked plan provides a rare insight into the highly secretive world of drug promotion, with its new

emphasis on “shaping” medical and public opinion about the latest diseases.

According to the documents, the education programme's key aim is this: “IBS [irritable bowel syn­

drome] must be established in the minds of doctors as a significant and discrete disease state.” Patients also “need to be convinced that IBS is a common and recognised medical disorder.” The other main messages are about promoting the new “clinically proven therapy”—Lotronex.

The first step is to set up an “Advisory Board, com­prising one KOL [key opinion leader] from each state of Australia.” Its chief role would be to provide advice to the corporate sponsors on current opinion in gastroenterology and on “opportunities for shaping it.”

Further work would include developing “best practice guidelines” for diagnosing and managing irritable bowel syndrome and attending overseas meetings.Another strategy was to produce a newsletter in the pre­launch period to “establish the market” and  convince the “specialist market” that the condition is a “serious and credible disease.”

For general practitioners, In Vivo recommends a series of advertorials in leading medical magazines,

featuring interviews with members of the company's advisory board, because “The imprimatur of [board] members is invaluable in reassuring [general practitioners] . . . that the material they receive is clinically valid.”

Other groups to be targeted with promotional material include pharmacists, nurses, patients, and a

medical foundation described as already having a “close relationship” with In Vivo. A “patient support programme” is also planned for 2002­3, so that Glaxo­ SmithKline will “reap the loyalty dividend when the competitor drug kicks in.”

Medical education or marketing?

Although billed as a medical education plan, the document is clearly part of the Lotronex marketing

strategy. One clause explicitly stipulates that all publi­cations and manuscripts must be approved by the drug company's marketing, medical, and legal departments. The document also makes clear the media's role in changing public perceptions about irritable bowel syndrome, stating that “PR [public relations] and media activities are crucial to a well­ rounded campaign—particularly in the area of consumerawareness.''

Whatever the integrity or competence of the pro­fessionals or consumer advocates involved, and

without seeking to minimise the importance of thedisorder for some individuals, this plan shows that

staff and organisations sponsored by a drug company are helping to shape medical and public opinion

about the condition that company is targeting with this new product. Although GlaxoSmithKline has

argued that its sponsorship of education can improve doctors' prescribing habits (personal communication, 7 March 2002), the conflict of interest is obvious and potentially dangerous. Self evidently, the drug company's primary interest will be shaping opinion about irritable bowel syndrome in a way that will maximise sales of its medication.

In this case the proposed campaign was stopped because of the withdrawal of Lotronex from the

market, after reports to the US Food and Drug Admin­istration of serious and sometimes fatal adverse

reactions.8 In a recent letter to patients, the administra­tion suggested that indiscriminate use of the drug could result in more fatal adverse events and that many patients in whom the condition was non­serious could experience more harm than good.9

Conversations with industry insiders and other published material from the drug marketing industry

confirm that the strategies proposed for promoting irritable bowel syndrome by In Vivo were in no way exceptional. A “practical guide” published by Britain's Pharmaceutical Marketing magazine last year explicitly emphasised that key objectives of the pre­launch period were to “establish a need” for a new drug and “create the desire” among prescribers.10 The guide instructed drug marketers that they may need to “initi ate  review of the whole way in which a particular dis­ease is managed.”

Personal or social problems as medical ones: social phobia

When Roche was promoting its antidepressant Aurorix (moclobemide) as a valuable treatment for

social phobia in 1997, its public relations company issued a press release, picked up by some of the media,announcing that more than one million Australians had an underdiagnosed psychiatric disorder called social phobia.11 The release described a “soul destroying condition” and quoted a clinical psychologist strongly endorsing the role of antidepressants in its treatment. At that time, government figures suggested the number of people with the disordermight be closer to 370 000.

In 1998, a newspaper article, “Too shy for words”—this time not orchestrated by Roche—suggested that two million Australians were affected by the condition.12 All the media stories seemed to be part of a wider push to change the common perception of shyness, from a personal difficulty to a psychiatric disorder.

An important aspect of Roche's marketing for moclobemide involved working with a patient group

called the Obsessive Compulsive and Anxiety Disorders Foundation of Victoria and funding a large

conference on social phobia. According to the foundation's chief at the time, “Roche is putting a lot

of money into promoting social phobia . . . Roche funded the conference to help get social phobia

known among [general practitioners] and other health professionals . . . It was a vehicle to raise aware ness with the media too.”11 Roch's promotion of its antidepressant drug also included working with ostensibly independent medical specialists, one of whom was later described by a public relations agent as“Moclobemide Man” (personal communication,

1998).

Pharmaceutical Marketing's practical guide singled out the promotion of social phobia as a positive example of drug marketers shaping medical and publicopinion about a disease.10 “You may even need to reinforce the actual existence of a disease and/or the value of treating it. A classic example of this was the need to create recognition in Europe of social phobia as a distinct clinical entity and the potential of antidepressant agents such as moclobemide to treat it,” said the industry guide. It went on: “Social phobia was recognised in the US and so transatlantic opinion leaders were mobilised to participate in advisory activities, meetings,publications etc. to help influence the overall belief in

Europe.” The medicalisation of human distress seems to have no limits.13

A senior Roche official recently conceded that company promotion exaggerated the prevalence of

social phobia in Australia. “A lot of disease estimates are blown out of all proportion . . . The marketing people always beat these things up” said local managing director Mr Fred Nadjarian (see news article).

Risks conceptualised as diseases:

osteoporosis

Like high blood pressure or raised cholesterol levels, the medicalisation of reduced bone mass—which  occurs as people age—is an example of a risk factor being conceptualised as a disease.

Unlike medicalising baldness, conceiving osteo­porosis as a disease is ethically complex. Slowing bone loss can reduce the risk of future fracture—just as low­ering blood pressure can reduce a person's chance of a future stroke or heart attack—but for most healthy people, the risks of serious fractures are low and/or distant, and in absolute terms, long term preventive drug treatment offers small reductions in risk. For example, in a placebo controlled trial in which alendronate was taken for four years by women who were free of fracture but had bone mineral density measurements 1.6 standard deviations below the mean for normal young adult white women, the incidence of radiographic vertebral fractures was 3.8% in the placebo group and 2.1% in the treatment group.14 This

equated to a 44% relative reduction in risk but an abso­lute risk reduction of only 1.7%.

Furthermore, the promotional focus on chemical solutions for the complex problem of preventing frac­tures takes attention away from a variety of modestly effective non­pharmacological strategies, such as dietary supplementation with calcium and vitamin D, smoking cessation, and weight bearing exercise.15

Despite the ethical complexities, osteoporosis remains a strong example of disease mongering

because the corporate role in changing the way populations think about bone loss has been so extensive.

Drug companies have sponsored meetings where the disease was being defined,16 funded studies of

therapies,17 and developed extensive financial ties with leading researchers. They have funded patient groups,disease foundations, and advertising campaigns (on both drugs and disease) targeted at doctors11 and have sponsored osteoporosis media awards offering lucrative prizes to journalists.

A controversial definition

Contrary to much of the corporate promotion, thedefinition of osteoporosis is still controversial. Diagnos­tic criteria set by theWorld Health Organization, which set the bone density of young white women as “normal” and judge the bones of older women against this standard, are contentious.16 A key meeting of the WHO study group involved in defining the diagnosisof osteoporosis was funded in part by three pharmaceutical companies.16 

The link between bone density and fracture risk is also the subject of scientific controversy, with reviewers pointing out that while bone mineral density is associated with fracture, it is not a sufficiently accurate predictor of an individual's risk of fracture to be used as a guide to therapy.18 A recent evaluation by the Univer­sity of British Columbia concluded that “Research evi­dence does not support either whole population or selective . . . bone mineral density testing of well women

at or near menopause as a means to predict future fractures.”16

Good quality studies have shown that several drugs including oestrogens, selective oestrogen receptor

modulating agents, and bisphosphonates, reduce the risk of fractures.15 However, although public promotion of those drugs often relies on presentations of relative reductions in fracture risk, the absolute reductions for healthy women are small when weighed against poten­tial harms and costs.19

The marketing of fear

Osteoporosis Australia, a medical foundation, which has received funding from pharmaceutical companies, issued a press release recently urging people to take a one minute test for their risk of osteoporosis.20 According to the foundation, “we call this disease a silent thief:if you're not vigilant, it can sneak up on you and snatch your quality of life and your long­term health.” An accompanying 10 point checklist suggests that merely being a menopausal woman was enough to justify a

trip to the doctor to be tested for this disease. The con­struction of the widely used WHO diagnostic criteria is such that large numbers of healthy women at menopause will automatically be diagnosed as having this “disease” because their bones are being compared with those of much younger women.

Against a background of controversy over disease definition, poor predictive value of bone density

measurement, and heavily advertised expensive therapies offering marginal benefits to menopausal women,corporate backed promotional activities are attempt­ing to persuade millions of healthy women worldwide that they are sick.

Disease prevalence estimates framed to

maximise the size of a medical problem:

erectile dysfunction

Double page advertisements told Australians recently that 39% of men who visit general practitioners have erection problems.21 The advertisement featured an unhappy couple, who looked to be in their 30s or 40s, on opposite sides of a double bed, with the accompanying text: “Erection problems: hard to talk about, easy to treat.” As with much disease mongering,the key strategy here was to make the condition seem as widespread as possible.

The 39% claim in the advertisement was referenced to an abstract of a survey finding. The full

version of the published survey22 revealed that the 39% figure was obtained by tallying all categories of difficuties, including men who reported having problems only “occasionally,” and the average age of those reporting complete erectile dysfunction was 71 years.

Another recent Australian study, not cited in the adver­tisement, estimated that erection problems affectedonly 3% of men in their 40s, and 64% of men in their 70s.23

The advertisement's fine print cited a host organisation, Impotence Australia, and two other groups but did not mention that the advertisement was funded by the manufacturer of sildenafil (Viagra), Pfizer. Impo­tence Australia had at that time only recently been set up with a grant of $A200 000 (£74 000; $105 200; &119 400) from Pfizer. Its executive officer told the press, “I could understand that people may have a feel­ ing that this is a front for Pfizer.”24 Defending the public promotion of erection problems, a Pfizer spokesperson said, “The best consumer is an educated consumer . . . Who better than the manu­facturer to help this process?” (personal communica­tion, 5 March, 2002).

Discussion

These observations of disease mongering are selective and preliminary. They are not the result of systematic study, but rather a series of anecdotal case studies designed to provoke debate. We know little of the true extent of these industry funded zones of influence, and even less of their impact. But we believe more information and analysis of the nature and functioning of these “unholy alliances”2 is warranted. The key con­cern with the examples here is the invisible and unregulated attempts to change public perceptions about health and illness to widen markets for new drugs.

Although mainstream media already play an important role investigating and reporting on contem­

porary promotional activities, more could be done to expose and reduce misleading “wonder drug” stories, which help to facilitate so much disease mongering.

As a practical step, we suggest that health professionals, policy makers, journalists, and consum­

ers move away from reliance on corporate sponsored material about the nature or prevalence of disease.

Genuinely independent sources of information about health problems could replace those skewed towards making the maximum numbers of healthy people feel sick.

Just as researchers from the Cochrane Collaboration are generating systematic evaluations of the best

evidence about therapies, a similar effort may be required in evaluating and/or producing unbiased

information about illness—starting with those condi­tions most prone to disease mongering. Independent lay involvement is crucial to produce accurate, comprehensive, and accessible materials.

The public is entitled to know about the controversy surrounding disease definitions and about

the self limiting and relatively benign natural course of many conditions.A publicly funded and independently run programme of “de­medicalisation,” based on respect for human dignity, rather than shareholder value or professional hubris, is overdue.

We dedicate this article to the late Lynn Payer, medical writer,

who died last year. We thank David Newby for his help in

conducting literature searches.

Competing interests: DH has received funding from Ameri­

can Home Products to conduct research into non­steroidal anti­

inflammatory drugs.As amember of the Australian Pharmaceu­

ticals Benefits Advisory Committee, he has has twice been the

subject of legal action by Pfizer.

References 

1 Illich I. Limits to medicine. London: Penguin, 1990.

2 Payer L. Disease­mongers. New York: John Wiley, 1992.

3 Crawford R. Healthism and the medicalization of everyday life. Int J

Health Services 1980;10:365­88.

4 Pilgrim D, Bentall R. The medicalisation of misery: A critical realist analy­

sis of the concept of depression. J Mental Health 1999;8:261­74.

5 Gilbert D,Walley T, New B. Lifestyle medicines. BMJ 2000;321:1341­4.

6 Williams S, Calnan M. The “Limits” of medicalization? Modern medicine

and the lay populace in “late” modernity. Soc Sci Med 1996;42:1609­20.

7 Hickman B. Men wise up to bald truth. Australian 1998 May 21:p4.

8 US Food and Drug Administration. Glaxo Wellcome decides to withdraw

Lotronex from the market. www.fda.gov/bbs/topics/ANSWERS/

ANS01058.html (accessed 18 March 2002).

9 Lotronex information. Dear IBS patient. www.fda.gov/cder/drug/

infopage/lotronex/dear_patient.htm (accessed 18 March 2002).

10 Cook J. Practical guide to medical education. Pharmaceutical Marketing

2001;6:14­22.

11 Moynihan R. Too much medicine? Sydney: ABC Books, 1998:137­68.

12 Heath S. Too shy for words. The Age 1998 Mar 30:16. (“Living” section.)

13 Heath I. There must be limits to the medicalisation of human distress.

BMJ 1999:318; 439­40.

14 Cummings SR, Black M, Thompson DE, Applegate WB. Effect of

alendronate on risk of fracture in women with low bone density but with­

out vertebral fractures: results from the fracture intervention trial. JAMA

1998;280:2077­82.

15 Wade JP. Rheumatology: 15. Osteoporosis. CMAJ 2001;165:45­50.

16 Green C, Bassett K, Foerster V, Kazanjian A. Bone mineral density testing:

does the evidence support its selective use in well women? Vancouver,

BC: British Columbia Office of Health Technology Assessment, 1997.

17 Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt

MC, et al. Randomised trial of effect of alendronate on risk of fracture in

women with existing vertebral fractures. Lancet 1996;348:1535­41.

18 Wilkin TJ. Changing perceptions in osteoporosis. BMJ 1999;318:862­4.

19 Moynihan R, Bero L, Ross­Degnan D, Henry D, Lee K, Watkins J, et al.

Coverage by the news media of the benefits and risks of medications.

N Engl J Med 2000;342:1645­50.

20 Osteoporosis—take the time to take the test. Osteoporosis Australia News

release, 6 Aug 2001.

21 Advertisement. SydneyMorning Herald 2000 21 Oct:76­7. (GoodWeekend

supplement.)

22 Chew K, Earle C, Stuckey B, Jamrozik K, Keogh E. Erectile dysfunction in

general medicine practice: prevalence and clinical correlates. Int J

Impotence Res 2000;12:41­5.

23 Pinnock C, Stapleton A, Marshall V. Erectile dysfunction in the commu­

nity: a prevalence study. Med J Aust 1999;171:353­7.

24 Moynihan R. Taking the soft option. Australian Financial Review 2000 Nov

13:29.