Corel ventura - untitled.chp
Signs of Inequality: Constructing Disability
in Antidepressant Drug Advertising
Patricia Peppin* & Elaine Carty**
Drug advertising constructs our understanding of disability. Drug ads use imageryto represent drugs, the disease conditions for which they are intended, the doctor-patient relationship, and the people with the condition. This imagery, understoodthrough semiotic analysis, draws upon existing values held by the viewers to createperceptions of the product being marketed for the condition. Through this process,drug advertising for psychiatric conditions replicates and constructs stereotypesabout mental disabilities.
In this article we examine advertising placed in medical journals to promoteantidepressants to assess the way disability is constructed through the ad process.
As background to this analysis, we will examine the legal framework and structuresthrough which advertising to professionals takes place. The way in which disabilityis constructed through advertising has effects that should be of concern. Becauseof its use of stereotypes, advertising has the potential to replicate and extendinequalities already present in the system of drug innovation and research.
Drug advertising reproduces stereotypes about socially disadvantaged groups
and promotes a medicalized and decontextualized view of disease. The primarypurpose of drug advertising is promotion and as a result, information conveyed inads is structured to achieve that goal. Ads for drugs used to treat mental illnessconstruct disability in particular ways and engage doctors in the process of perceiv-ing these limited views. Ads also create views of disease, cure, patients, doctorsand drugs consisting of an interventionist view of medical treatment, false certain-ties about cures, and a diminished role for doctors and patients in the healingprocess. Physicians and consumers who view drug ads need to be educated about
* Patricia Peppin, is an Associate Professor of Law at Queen’s University, Kingston, Ontario. ElaineCarty is a Professor in the Faculty of Nursing, University of British Columbia, Vancouver, B.C.
** This article is part of a project on drug advertising and hidden motivators of meaning. The authorswould like to express their appreciation for the financial support of the University of British Columbiathrough a UBC SSHRC grant and a Hampton Fund grant for this drug advertising research and toacknowledge with thanks the research assistance provided by Valerie Kan, Mark Mossey and AllaSotnikova. The authors appreciate the comments made at the University of Alberta, Health Law InstituteInnovation and Precedent conference and at the University of Toronto, Faculty of Law Health Law andPolicy Seminar.
Health Law Journal Special Edition, 2003
the means by which messages are transmitted so that they can guard against thesehidden motivators.
The focus of this article is drug advertising directed at psychiatrists to
promote anti-depressant drugs, and in particular, the best-selling selective serotoninreuptake inhibitors (SSRIs), Prozac, Zoloft and Paxil. These drugs are advertisedin professional journals as a primary means of communicating with prescribingprofessionals, who have the power to prescribe drugs for patients. Even as theUnited States has embraced and viewers in Canada have been exposed to direct-to-consumer advertising, the industry still spends a significant portion of its advertis-ing budget promoting its products to doctors. In 2001, the expenditure on journaladvertising alone in the U.S. was $425 million U.S.1 Overall, the rate of spendingon pharmaceutical products has accelerated so that, in the United States, it “is nowthe fastest growing component of the health care budget”, as reported by MeredithRosenthal and colleagues in the New England Journal of Medicine in February2002.2 They found that even though direct-to-consumer (DTC) advertising ofalmost $2.5 billion had grown disproportionately to other promotional efforts, itmade up only 15 per cent of drug promotion.
Arnold Relman and Marcia Angell, both former editors-in-chief of the New
England Journal of Medicine, have made a powerful argument for reform of thepharmaceutical industry, in a recent article in The New Republic.
3 They state:
Far from being a ‘research-based industry’, as it likes to call itself, thepharmaceutical industry now devotes most of its resources to function-ing as a vast marketing and advertising enterprise whose best productswere discovered and often partially developed elsewhere – usually atpublic expense. And this industry is hardly a model of free enterprise.
It may be free to decide which drugs to develop and to set its own prices,but its lifeblood is government-granted monopolies – in the form ofpatents and FDA-approved exclusive marketing rights…Moreover, itssales are not determined primarily by price or by consumer choice, butby the physicians who prescribe drugs.4
In support of their argument that the industry makes a relatively small contributionto research, Relman and Angell cite an unpublished National Institutes of Healthdocument that analysed the top five drugs in 1995 sales, a group that includedZantac and Prozac. Sixteen of the 17 key research papers leading to these drugdevelopments came from outside the industry and 85 per cent of all relevant
1 Allan Rubin, “Prescription Drugs and the Cost of Advertising Them”, online: www.therubins.com<http://www.therubins.com/geninfo/advertise.htm>.
2 Meredith B. Rosenthal et al.
, “Promotion of Prescription Drugs to Consumers” (2002) 346 New Eng. J.
Med. 498 at 498, n. 1.
3 Arnold S. Relman & Marcia Angell, “How the drug industry distorts medicine and politics: America’sOther Drug Problem” The New Republic
227:25 (16 December 2002) 27.
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n Signs of Inequality 163
published research came from labs supported by public funds or foreign labs and,even taking into account the greater incentive for academics to publish, theyconclude that publicly funded research rather than the pharmaceutical industry isthe major source of innovation.5
The antidepressant drugs known as selective serotonin reuptake inhibitors,
SSRIs, had their genesis in Scandinavian labs in the mid-1970s and the first paperon the subject of paroxetine (Paxil) was published in 1975.6 This class of drugsreplaced the tricyclic drugs, which had significant adverse effects, including thetics and uncontrollable movements of tardive dyskinesia. The new drugs promisedeffectiveness in a daily dose, which minimized the “compliance” problems ofpatients failing to take all the prescribed pills. When Astra’s SSRI zimelidinereached the market, five years before Prozac, it was found to be associated with aserious autoimmune disorder in some patients and had to be withdrawn from themarket.7 In early 1988, Eli Lilly Corp. introduced fluoxetine – Prozac – to themarket after year-end approval by the FDA, and at this point the new class ofantidepressants emerged into public consciousness. Prozac became a news story,“an emblematic product, a happiness pill that became a panacea for the world’sills”8, making the cover of Newsweek on March 26, 1990 as a “breakthrough drugfor depression”.9 Paroxetine was introduced soon after, as Paxil in North Americaand Seroxat in Europe.
Though there were early highly publicized reports of violent behaviour,
suicidal ideation and other serious side effects10 and litigation started based onparticular incidents of violence11, the sales of these new antidepressants soared.
Global sales figures compiled by the multinational health information company
at 30. They state that the internal document was obtained by Public Citizen through the Freedomof Information Act
6 Simon Garfield, “The chemistry of happiness (part two)” The Observer Magazine
(28 April 2002),online: The Observer <http://www.observer.co.uk/magazine/story/0,11913,706299,00.html>.
7 David Healy, The Antidepressant Era
(Cambridge, Mass.: Harvard University Press, 1997) at 138.
8 Garfield, supra
, note 6.
9 Geoffrey Cowley et al.,
“The Promise of Prozac” Newsweek
(26 March 1990) 42.
10 M.H. Teicher, C. Glod & J.O. Cole, “Emergence of Intense Suicidal Preoccupation During Fluoxetine[Prozac] Treatment” (1990) 147 Am. J. Psych. 207; and other articles discussed in Joseph Glenmullen,Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil and Other Antidepressants with Safe,Effective Alternatives
(New York: Simon & Schuster, 2000) at 135-36. The Teicher et al
article led toacademic controversy, including criticism. Andrew E. Falsetti, “Fluoxetine-Induced Suicidal Ideation:An Examination of the Medical Literature, Case Law, and the Legal Liability of Drug Manufacturers”(2002) 57 Food & Drug L.J. 273 at 275-78.
11 Joseph Wesbecker, who had been taking Prozac for his psychiatric problems, shot 20 people with anAK-47 semi-automatic assault rifle at the printing plant where he worked, killing 8 fellow workers, andcommitted suicide. The high profile trial in 1994 resulted in a jury verdict for manufacturer Eli LillyCorp., after family member plaintiffs entered into a secret deal with the defendant for payment of aseemingly large, although still unknown, sum of money, precluding introduction of evidence damagingto the company. Glenmullen, ibid.
at 22-3, 165-186. See Potter v. Eli Lilly
926 S.W. (2d) 449 (S.C.
Kentucky, 1996). Glenmullen outlined how the Wesbecker trial provided access to company documentsand testimony about problems and processes at the clinical trials stage. (ibid.
Health Law Journal Special Edition, 2003
IMS Health, in its World Review 2001, indicated that Prozac was 6th, Paxil 7th andZoloft 10th of all drugs in global sales of pharmaceuticals over 65 key internationalmarkets in the year 2000.12 Global sales of Prozac in that year were $US 2.9 billion,of Seroxat/Paxil were $2.4 billion and of Zoloft were $2.2 billion.13 By thefollowing year Paxil had increased by 19% to $2.8 billion, and Prozac and Zolofthad dropped off the top 10, while global sales of antidepressants as a class grew in2001 by 20 per cent to $15.9 billion.14 By the year 2000, only 12 years after the bigthree SSRIs began to be marketed, the global market for antidepressants totaled$13.4 billion,15 with much of this market concentrated in North America.
Depression, a disease that is more common in women than in men, is a major
cause of disability in North America.16 The lifetime risk of major depression hasbeen reported as 20 to 26 per cent in women and 8 to 12 per cent in men17 and thisdifference occurs throughout the life cycle from adolescence to old age. Prior tothe development of SSRIs and the potential for large pharmaceutical sales, womenwho experienced depression were either left to languish in their homes because oftheir inability to cope with life or, if they became suicidal or non-functional, wouldbe hospitalized in mental institutions. Because many of the symptoms of depressionsuch as insomnia, crying, and feelings of worthlessness overlapped with culturalexpectations of femininity in the past, there was little incentive to understand thesocial and cultural roots of this disability.18 Given this history, it is worth notingthe success of the pharmaceutical companies in turning depression into a common,socially accepted condition of both sexes so that their product has a huge market.
The market for each of the SSRIs has increased as it has been approved for
other forms of mental illness, some recognized by the Diagnostic and StatisticalManual IV and some not (yet) recognized. Since their initial launch as antidepres-sants, individual SSRIs have been approved for the treatment of the “diseases” ofpanic disorder, social phobia, post-traumatic stress disorder, generalized socialanxiety disorder, obsessive-compulsive disorder and other anxiety-based condi-tions. In addition, prescription of SSRIs among children and elderly patients hasvastly increased over the decade, adding significantly to these companies’ profitfigures.
12 IMS Health World Review 2001, “Global Leading Products by Sales”, online: IMS Health<http://ww0.ne.imshealth.com/public/structure/dispcontent/1,2779,1343-1343-136463,00.html>.
14 IMS, “IMS Reports 12 Percent Growth in 2001 Audited Global Pharmaceutical Sales to $364 Billion”,(April 26, 2002), Tables 2 & 3, online: IMS Health <http://ww0.ne.imshealth.com/public/structure/dispcontent/1,2779, 1341-1341-144056,00.html>15 IMS Health, “Antidepressants”, online: IMS Health <http://secure.imshealth.com/public/structure/navcontent/1%2C3272%2C1034-1034-0%2C00.html>.
16 Mark Larson, “Depression” in Cynda Johnson et al.
, eds., Women’s Health Care Handbook
(Philadel-phia: Hanley & Belfus, Inc., 2000) 381.
17 R.C. Kessler et al.
, “Lifetime and 12 month prevalence of DSM-II-R psychiatric disorders in the UnitedStates: results from the National Comorbidity Survey” (1994) 51:8 Archives of General Psychiatry 8.
18 Michelle Fine & Adrienne Asch, eds., Women with Disabilities: Essays in Psychology, Culture, andPolitics
. (Philadelphia: Temple University Press, 1988).
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n Signs of Inequality 165
In Prozac Backlash
, Dr. Joseph Glenmullen provided detailed analysis of
data indicating problems associated with SSRIs: severe withdrawal symptoms,suicidal behaviour and other violence-inducing tendencies, sexual dysfunction, andneurological side effects including tics.19 He concluded that “Drug advocates andadvertisements that portray serotonin boosters as having only trivial, transient sideeffects are terribly misleading. We need more systematic, long-term monitoring ofpatients who have developed these side effects and more thorough research on howthe drugs cause them. But while we are waiting for definitive answers that couldtake years, even decades, patients should know about these conditions sooner ratherthan later in order to make informed choices.”20
Litigation against the manufacturers of SSRIs has usually resulted in settle-
ments or summary judgments for the manufacturers.21 The Wyoming jury verdictin Tobin v. SmithKline Beecham Pharmaceuticals
was an exceptional finding ofcausation and liability that resulted in an order of $6.4 million damages against themanufacturers of Paxil for the murder of family members and suicide of DonaldSchell.22 The British Government announced creation of a government inquiry intothe side effects of the SSRIs in December, 2002, following media scrutiny of theissues of suicide and withdrawal difficulties and in response to pressure brought bypatients alleging serious withdrawal problems.23 The BBC’s Panorama
had broad-cast a program “Secrets of Seroxat” in October 2002 which led viewers to send in1,374 emails, and make 65,000 phone calls and 124,000 website hits, outlining theirnegative and positive experiences with the drug.24 These responses have beenanalysed by Charles Medawar, Andrew Herxheimer, Andrew Bell and ShelleyJofre in an article published in 2002. With respect to withdrawal symptoms, theyindicated that, “…reports of ‘electric head’, with linked ‘whooshing’ sensationswere the most common, distressing, disabling and distinctive feature of withdrawal.
Users identified this phenomenon as a main underlying cause of the dizziness thatis characteristic of paroxetine withdrawal.”25 The authors concluded that immersionin patients’ reports of their experiences with the drug gave them a different sensethan would have been obtained through reading continuing reports of adverse drugreactions, and recommended collecting these experiences to enhance drug safety
19 Glenmullen, supra
21 Anne Thompson, “Paxil Maker Held Liable in Murder/Suicide” Lawyers Weekly USA
(July 9, 2001),online: Baum, Hedlund, Aristei, Guilford & Schiavo <http://www.baumheldlundlaw.com/media/ssri/Paxil_murder.htm>; Falsetti, supra
note 10 at 283.
22 Tobin v. SmithKline Beecham Pharmaceuticals,
No. 00-CV-0025-Bea (D. Wyo. June 6, 2001), online:The Fitzgerald Law Firm <http://www.fitzgeraldlaw.com/paxil_verdict.htm>.
23 Sarah Boseley “Drugs inquiry thrown into doubt over members’ links with manufacturers. Drugsinquiry links to makers” The Guardian
(17 March 2003), online: The Guardian <http://www.guardian.co.uk/Print/0,3858,4626619,00.html>.
24 BBC Panorama, “The Secrets of Seroxat” (13 October 2002), online: BBC Panorama<http://news.bbc.co.uk/1/shared/spl/hi/programmes/panorama/transcripts/seroxat.txt>.
25 Charles Medawar et al.,
“Paroxetine, Panorama and user reporting of ADRs: Consumer intelligencematters in clinical practice and post-marketing drug surveillance” (2002) 15 International Journal of Risk& Safety in Medicine 161.
Health Law Journal Special Edition, 2003
and efficacy. The extraordinary response to the Panorama
investigative report ledto a follow-up program in May 2003 that analysed the reports of severe drugreactions, and unreported suicides of patients who had taken Seroxat.26 David Healyhas indicated that the program led a number of families to raise the issue at inquestsand to seek re-examination of earlier inquest verdicts of suicide.27 The manufacturerGlaxoSmithKline announced a change in the patient pamphlet removing the claimthat the drug was not addictive.28 These severe withdrawal symptoms have begunto be litigated in Canada and the U.S.29.
The UK government Medicines and Healthcare products Regulatory Agency
(MHRA) banned the use of Paxil in children and adolescents in June 2003, afteranalysis of data from clinical trials indicated that that the children taking this drug“may be more likely to self-harm or partake in suicidal behaviour”30. The reportfound that the drug was ineffective in treating depression in this group and thatthe risks outweighed the benefits. The MHRA also warned adults not to stop takingthe drug suddenly. On June 19, 2003, the U.S. FDA issued a recommendationagainst the use of Paxil for patients under the age of 18, stating that it was reviewing“reports of possible increased risk of suicidal thinking and suicide attempts inchildren and adolescents under the age of 18 treated with the drug Paxil for majordepressive disorder (MDD)” and although the review of the new study data hadnot been completed, “FDA is recommending that the drug not be used to treatMDD in these patients.”31 The FDA referred to the absence of evidence ofeffectiveness in children or adolescents with major depressive disorder and notedthat three “well-controlled trials” in this population failed to show that the drugwas more effective than placebo.32
26 BBC Panorama, “Seroxat: Emails from the edge” (11 May 2003), online: BBC Panorama<http://news.bbc.co.uk/1/hi/programmes/panorama/transcripts/emailsfromtheedge.txt> and<http://news.bbc.co.uk/1/hi/programmes/panorama/2982797.stm>.
27 David Healy, “No surprise from the e-mails”, online: BBC Panorama <http://news.bbc.co.uk/1/hi/programmes/panorama/3010853.stm>.
28 Sarah Boseley “Seroxat maker abandons ‘no addiction’ claim” The Guardian
(3 May 2003), online:The Guardian <http://www.guardian.co.uk/uk_news/story/0,3604,948620,00.html>.
29 In re Paxil Litigation
, No. CV 01-07937 MRP, 212 F.R.D. 539 (2003, C.D.Cal,), 2002 WL 31375497(C.D.Cal.), 2002 WL 1940708 (C.D.Cal.), For updates of the class certification proceedings, see Baum,Hedlund, Aristei, Guilford & Schiavo <http://www.baumhedlundlaw.com/Paxil/paxilupdate.htm>. InCanada, class certification proceedings have commenced in Ontario (North v. GlaxoSmithKline PLC andGlaxoSmithKline Inc.
), Quebec (Goyette c. GlaxoSmithKline Inc.
) and B.C. (Beer v. GlaxoSmithKlineInc.
30 BBC News, “Children ‘should not take Seroxat’ ” (10 June 2003)<http://news.bbc.co.uk/1/hi/health/2976498.stm>; Alliance for Human Research Protection, “UKHealth Department/British Prime Minister/Issue Warning Statement No Paxil for Children”, online:Alliance for Human Research Protection <http://www.researchprotection.org/infomail/0603/10.html>.
31 “FDA Public Health Advisory” (19 June 2003), online: Food and Drug Administration<http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01230.html>.
32 The effectiveness of the SSRIs has been brought into question recently by analyses of clinical trials datacomparing the drugs to placebo. Hypericum Depression Trial Study Group, “Effect of Hypericumperforatum (St. John’s Wort) in Major Depressive Disorder” (2002) 287 J. Am. Med. A. 1807; see inresponse, Klaus Linde et al.,
(Letter) “St John’s Wort and Depression” 288 J Am. Med. A. 447. See alsoIrving Kirsch & Guy Sapirstein, “Listening to Prozac but hearing placebo: A meta analysis of antidepres-
Peppin & Carty
n Signs of Inequality 167
Drug promotion in Canada takes place within the parameters established by
the Food and Drugs Act
33 and the regulations34 under it. This legislation prohibitsthe making of false, misleading or deceptive claims or any likely to create anerroneous impression about the product’s composition, merit or safety (s. 9(1)).
Canadian law prohibits transmission of certain types of information except throughcertain media to certain targets.35 Advertising directed to doctors is the acceptablemeans of advertising.36 No person is permitted to advertise drugs to the generalpublic as a treatment, preventative or cure for a Schedule A disease – those requiringphysician involvement, including such diseases as heart disease and cancer (s.
3(1)). No representations other than the drug’s names, price and quantity may beadvertised directly to consumers. Ads in professional journals appear in two parts:the visual image and supporting text appearing in the body of the journal, and theproduct monograph, which contains detailed information about product composi-tion, indications, contraindications and drug interactions, appearing at the back ofthe medical journal. The federal government has been reviewing its healthprotection statutes, including the Food and Drugs Act
, in order to create proposednew health protection legislation that deals with legislative authority over thereview process for new drugs and other products and mechanisms to deal withadvertising of health products, including the possibility of direct-to-consumeradvertising.37
The Food and Drugs Act
is federal legislation in the form of a criminal statute
with a regulatory scheme set out under it. While occasional prosecutions have takenplace, the primary vehicle of enforcement in this hybrid structure is voluntarycompliance. In the drug approval process, government has authority to permitmarketing of the drug after it has met safety and efficacy standards. The Competi-tion Act
38 applies to marketing practices and prohibits misleading or deceptiverepresentations in advertising. As well, the interpretive guidelines for this legisla-tion require that claims of efficacy or performance be made on the basis of adequate
sant medication” (1998) 1 Prevention & Treatment, online: Prevention & Treatment
<http://journals.apa.org/prevention/volume1/pre0010002a.html> and the response by Donald F. Klein,“Listening to meta-analysis but hearing bias” (1998) 1 Prevention & Treatment, online: Prevention &Treatment <http://journals.apa.org/prevention/volume1/pre0010006c.html>. Such analyses raise im-portant questions about the effectiveness of this class of drugs, particularly if evaluated in relation to theexpectations raised by promotional activities.
33 R.S.C. 1985, c. F-27.
34 Food and Drug Regulations
, C.R.C. c. 870.
35 See the discussion of this issue in Barbara Mintzes et al., An Assessment of the Health System Impactsof Direct-To-Consumer Advertising of Prescription Medicines (DTCA)
(Vancouver: University ofBritish Columbia Centre for Health Services and Policy Research, 2002).
36 A significant report to the New Zealand Minister of Health has recommended banning direct-to-con-sumer advertising in New Zealand. Les Toop et al., “Report to the Minister of Health supporting the casefor a ban on DTCA, Direct to Consumer Advertising of Prescription Drugs in New Zealand: For Healthor For Profit?”, online: <http://www.haiweb.org/campaign/DTCA/DTCAinNZcaseforaban2003.pdf>.
37 Health Canada, “Health Protection Legislative Renewal”, online: Health Canada <http://www2.itssti.hc-sc.gc.ca/HPCB/Policy/LegislativeRenewal.nsf/WebHome/575087A7>. SeeSection B10.3 for the advertising proposals.
38 R.S.C. 1985, c. C-34.
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and proper testing that has been completed, with significant and meaningful resultsand reliable data.
Ads in Canada are vetted by the Pharmaceutical Advertising Advisory Board
(PAAB), which is a non-government organization made up of representatives ofthe industry trade organizations (both the patent-holding companies, known asRx&D, and the generics), doctors, pharmacists, advertisers, medical publishers,consumers. While Health Canada is not a member, it sends an ex officio
ob-server/advisor. PAAB also deals with inter-company disputes through this proc-ess.39 The respective roles of the federal government and PAAB were set out in a1996 policy statement, currently available on their website.40 The PAAB system ofvoluntary preclearance of ads and promotional materials is described as “analternative to government authorization of advertising prior to use.”41 Further, thePAAB Code is described as conforming to the Act, Regulations and applicableguidelines and policies. The government role is described as being “to set minimumstandards to be met in drug advertising by developing appropriate regulations,guidelines and policies and by bringing these standards to the attention of the PAABso that they may be incorporated in its Code.”42 The government will reviewadvertising directed to health professionals that contravenes the Act and Regula-tions when it “may present an imminent and/or significant health hazard” or whenadvertising that contravenes the Act or Regulations “arises from failure of theself-regulatory mechanism through willful nonparticipation with the self-regula-tory system, or willful noncompliance with the PAAB Code.”43 Advertising Stand-ards Canada is another independent advertising preclearance agency givenresponsibility for preclearing consumer-directed broadcast and mass media printadvertising for non-prescription drugs and other roles.44
Since preclearance of drug advertising directed to doctors is carried out by a
non-governmental organization, the federal government’s authority to require
39 The pharmaceutical industry, through its organization Rx&D for the patent-holding companies, hasadopted a Code of Marketing, has agreed under it to abide by the decisions of the PAAB, and has draftedthem to reflect the global pharmaceutical manufacturers code, the International Code of the Pharmaceu-tical Manufacturers Association. The PAAB acts to monitor inter-company disputes, for instance aboutcomparison ads. The PAAB checks ads for conformity with federal requirements and the Rx&D statesthat the federal government can ask for precleared materials to be held back if they pose a threat to healthand the Rx&D will follow certain steps in response.
40 Health Canada, “PAAB and Drugs [now Therapeutic Products] Directorate Roles and ConsultationRelated to Advertising Review” (11 January 1996), online: TPD – Web <http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/paab-adv_e.html>.
44 Health Canada, Therapeutic Products Directorate, “Advertising Standards Canada and the TherapeuticProducts Programme’s Roles and Consultation Related to Advertising Review and Complaint Adjudica-tion” (22 January 2001), online: TPD – Web <http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/advcaf_e.html>; Health Canada, Therapeutic Products Di-rectorate, “Therapeutic Comparative Advertising Directive and Guidance Document” (6 April 2001),online: TPD – Web <http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ther_comp_adv_mar-2001_e.html>.
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n Signs of Inequality 169
change is held up as a standard rather than being directly invoked except where asignificant health hazard exists or the process is not being respected.45 Assessmentof ads prior to distribution to health professionals is an important means of ensuringthat high standards of health promotion that form part of Health Canada’s jurisdic-tion are protected through the drug marketing process. Intervention before an adreaches the audience is critical. Otherwise the time lag creates the opportunity formisleading and harmful claims to reach and affect the target population. As theUnited States General Accounting Office reported in October 2002, the recentlyimposed requirements leading to an increase in time for legal enforcement ofviolations by direct-to-consumer ads found to be inaccurate, misleading or incom-plete means that the regulator may not have issued a notice of violation until afterthe ad has finished airing.46
Canada has ratified several resolutions that call on governments to implement
the 1988 World Health Organization’s Ethical Criteria for Medicinal Drug Promo-tion.47 Drug policy researcher Barbara Mintzes has argued that Canada needs to domuch more to implement these standards.48
Several bases are available to claimants wanting to assert that they have been
harmed through a manufacturer’s inadequate disclosure. The failure to discloseaction49 has been the primary basis for legal actions in Canada including those
45 In the U.S. system, the issue of authority to hold advertisers to a standard in advance of distribution wasraised in relation to the FDA in an article by David A. Kessler et al.,
“Therapeutic Class Wars – DrugPromotion in A Competitive Marketplace” (1994) 331 New Eng. J. Med. 1350.
46 United States, General Accounting Office, “Prescription Drugs: FDA Oversight of Direct-to-Con-sumer Advertising Has Limitations” (October 2002), GAO-03-177, online: General Accounting Office<http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=184.108.40.206&filename=d03177.pdf&directory=/diskb/wais/data/gao>.
47 World Health Organization, Ethical Criteria for Medicinal Drug Promotion
(Geneva: WHO, 1988),online: World Health Organization <www.who.int/medicines/library/dap/ethical-criteria/ethicalen.htm>48 Barbara Mintzes, “Blurring the Boundaries: New Trends in Drug Promotion”, online: Health ActionInternational – Europe <http://www.haiweb.org/pubs/blurring/blurring.intro.html>.
49 The pharmaceutical industry has a duty to disclose risks that are known or ought to be known and theserisks are to be made known to the doctor, the “learned intermediary” between the manufacturer and thepatient. The hierarchical nature of this relationship was acknowledged by the Supreme Court of Canadain Hollis v. Dow Corning Corp
.,  4 S.C.R. 634, as it had been by the Ontario Court of Appeal inBuchan v. Ortho Pharmaceutical (Canada) Ltd.
(1986), 54 O.R. (2d) 92 (C.A.) [Buchan
] where the courtanalyzed the “enormous informational advantage” held by the manufacturer over the consumer and“indeed” over the doctors. The tort action for failure to warn provides a second parameter around theadvertising activities of the industry. The issue in Buchan
was the manufacturer’s inadequate disclosureof the risk of stroke that caused Pauline Buchan’s stroke. Justice Robins, for the unanimous five-membercourt, commented that the promotional activities should not undermine the risk disclosure. This commentindicates that disclosure should be assessed in the context of the overall promotional efforts directed atphysicians – and now consumers. The Buchan
court did this, examining the various means used bymanufacturers to reach doctors and assessing the Canadian efforts in relation to the explicit warningsprovided by the parent company in the U.S. The negligence action has been the primary vehicle forfailures related to disclosure. Fraud and misrepresentation actions would also be available to focus onintentional masking of information and the inducement of reliance.
Health Law Journal Special Edition, 2003
related to birth control pills and breast implants. Justice Robins for the five-memberCourt of Appeal in Buchan
stated that the promotional efforts of the company mustnot undermine disclosure: the warning “should be in terms commensurate with thegravity of the potential hazard, and it should not be neutralized or negated bycollateral efforts on the part of the manufacturer.”50 Fraud and misrepresentationprovide further bases for litigation where the facts warrant it.
Research indicates that the prescribing practices of doctors are influenced by
exposure to advertising.51 Many doctors resist this notion, and clearly some doctorsdo not read ads. However, drug companies believe that an expenditure of $425million U.S. on advertising in medical journals is justifiable.52 Ads are supportedby the promotional efforts of detailers, the pharmaceutical sales representativeswho visit doctors, distribute samples and conduct direct sales campaigns. Promo-tional efforts take place in many other ways including sponsorship of continuingmedical education events, in locations such as Whistler, and medical conferenceswhich sometimes include freebies such as tickets to musicals for the doctor andfamily members. Advertising in medical journals has a particular role to playthough, since the claims acquire a patina of legitimacy through their associationwith published peer-reviewed research and highly regarded editorial boards ofestablished journals.
A question about a possible judicial role in review of ad content in the United
States was raised in the California case, In re Paxil Litigation
. U.S. District CourtJudge Mariana Pfaelzer issued an order on August 16, 2002, enjoining GlaxoS-mithKline “from airing TV commercials advertising Paxil treatment that state,orally or in writing, that ‘Paxil is non-habit forming.’ ”53 The Justice Departmentasked for reconsideration, partly on jurisdictional grounds. The Justice Departmentstated that her decision was in conflict with federal law giving the FDA the solejurisdiction over drug ads, that her order was inconsistent with “FDA’s scientificand carefully considered view of appropriate risk communication”, and that thecase would lead to a multiplicity of labelling decisions on a state by state basis fornationally marketed products.54. Judge Pfaelzer stayed her order, asked FDA formore information about their review of the Paxil ads prior to airing, and sub-
50 Buchan, ibid.
51 M.S. Wilkes, B.H. Doblin & M.F. Shapiro, “Pharmaceutical Advertisements in Leading medicalJournals: Experts’ Assessments” (1992) 1166 Annals of Internal Medicine 912; Joel Lexchin, “Enforce-ment of Codes Governing Pharmaceutical Promotion: What Happens When Companies Breach Adver-tising Guidelines?” (1997) 156 Can. Med. A.J. 351; J. Avorn, M. Chen & R. Hartley, “Scientific VersusCommercial Sources of Influence of the Prescribing Behavior of Physicians” (1982) 73 Am. J. Med. 4;Mintzes et al.
52 Rubin, supra
53 In re Paxil Litigation
54 Associated Press “Fda Faults Ruling on Paxil Ads” (22 August 2002), online: InteliHealth<http://www.intelihealth.com/IH/ihtIH/WSIHW000/333/8014/354086.html>; “Judge Bars PaxilMaker from Claiming Drug Is Not Habit-Forming” (2002) 18:5 Pharmaceutical Litigation Reporter,online: <http://www.andrewspub.com/rptr_desc.asp?pub=PHA>; Ira Teinowitz “Feds Ask Judge toReconsider Paxil Ad Ruling”, online: AdAge.com <http://www.adage.com/news.cms?newsId=35800>.
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sequently reversed the order.55 In the meantime though, GlaxoSmithKline hadagreed to stop making the claim that they had studied Paxil in short and long-termuse and that it was not associated with dependence or addiction, since they had notdone such a study, and also agreed to stop claiming that Paxil “may cause mild,usually temporary, side effects in some individuals”.56 This motion to requirechanges to advertising brings into the open the question of any government’s abilityto monitor advertising before it affects its target audience. The General AccountingOffice reported that only 5 FDA staff (with 2 vacant review slots) had responsibilityfor reviewing all the direct-to-consumer advertising.57 The GAO Report also notesthat, “Although FDA generally does not have the authority to preapprove adver-tisements before they are disseminated, companies may voluntarily submit theirmaterials to FDA for advisory comments before launching an advertisement.”58Canadian staffing at Health Canada, significantly reduced in the cost cutting of the1990s, would have little capacity to respond to complaints about advertising claimsand most preclearance activity takes place indirectly through the PAAB.
The Ad Process
Semiotic theory provides an analysis of the process by which advertising
works, and allows us to move beyond the explicit claims to the implicit meaningscalled upon through the ad process itself. Drug ads convey conceptions of the drugand its effects on patients. Stereotypes and myths about social groups are used inthe ads, which replicate inequalities in the social context.
Semiotic theory defines a sign as a material object – a person or a character
– plus its value or meaning.59 Another essential concept in the theory of signs issignification, the process of attributing meaning to an object. Once the meaning ofthe object is created, this value is transferred from the sign to the product to beconsumed. In Decoding Advertisements
, Judith Williamson illustrated this transferof meaning in a Chanel No. 5 ad that showed the sign, Catherine Deneuve’s face,with a bottle of Chanel No. 5 superimposed in the bottom right-hand corner.60 Theviewer generates the meaning of the sign – beauty and elegance – and transfers thissignifier to the Chanel No. 5. And finally to the consumer: we will be femmes fatales
55 “Judge Stays Her Paxil Ad Ruling At FDA Request” (10 September 2002), online: Adlaw by Request<http://www.adlawbyrequest.com/inthecourts/Paxil091002.shtml>. For a discussion of earlier litigationsee Melinda Katz, “Prozac: Another Drug Wrongfully Attacked – What Can be done to Stop the LegalSystem from Driving Good Drugs Off the Market, While Protecting State and Federal Interests” (1992)25 Akron L. Rev. 635.
56 “Judge reconsiders Paxil Makers’ request to keep ads on air claiming the drug is non habit-forming”,online: Baum, Hedlund, Aristei, Guilford and Schiavo <http://www.baumhedlundlaw.com/media/ssri/paxil/Injunction/troyfda.htm>.
57 United States, General Accounting Office, supra
note 46 at 17.
59 Roland Barthes, The Semiotic Challenge
(New York: Hill and Wang, 1988); Ferdinand de Saussure,Course in General Linguistics
. trans. by Roy Harris (London: Duckworth, 1983).
60 Judith Williamson, Decoding Advertisements: Ideology and Meaning in Advertising
(London: MarionBoyars, 1978).
Health Law Journal Special Edition, 2003
too if we use this product. Saussure referred to the material form as the signifierand the mental concept conveyed as the signified.61 The meaning created in the adis based on the viewer’s pre-existing knowledge, and the ideological source of thismeaning is called the referent system, a system of meaning operating within thatcultural milieu.62 The culture provides the meaning that will be attributed to thesign and transferred to the product and the advertiser constructs the ad to draw uponthese cultural elements. Advertisers of consumer goods have made use of consumerawareness of these techniques by devising ads that are self-conscious and playful63and self-referential – like the cool bobsledding polar bears convincing us to drink(cool) Coke at the (cool/cold) Winter Olympics. They create ads specifically forthe aware viewer to deconstruct, such as the television ad that shows a middle-agedwoman, dressed in shorts and rubber boots, wading through the snow to turn on theair conditioner – an ad that seems to require some degree of awareness of hot flashesto assist the interpretive leap.
Advertisers use their expectations of what will work, drawn from their
understanding of the value structure or referent system within which it is to operate,to power the ad. The advertiser appropriates the system of meaning from a segmentof society for the purpose of targeting that group. The primary referent systems indrug advertising are social stereotypes and the medical political culture, reflectedin the assumptions doctors are thought to make about their practices, professionalself-images, patients, doctor-patient relationships, and the nature and expression ofdiseases. In the process of identifying and attributing meanings, alternative mean-ings are by-passed. Like the music in western or horror films that alerts the audienceto the presence of danger, ads create pathways to conclusions for viewers.
All of the ads selected for this study were published in the Canadian Journal
of Psychiatry, the official journal of the Canadian Psychiatric Association. Ads forSSRIs were analyzed from 1989, when the earliest Prozac ad appeared in theJournal, until 2002.
An ad for depression medication from the Canadian Medical Association
Journal in 1963 provides a background for analysis of current ads.64 In this ad thedoctor and the patient are depicted, both with their backs to the camera, slightlyturned toward one another. This is the pre-Reibl v. Hughes
doctor-patient relation-ship with the paternalistic doctor dispensing beneficence without patient efficacyor power. The doctor wears the symbol of authority – the white coat. She defers to
61 Signifier and signified are inseparable in Saussure’s view.
62 Robert Goldman, Reading Ads Socially
(New York: Routledge, 1992).
63 Doctors bring expertise to the interpretive task. They are experienced in reading the meanings ofmedical symptoms, the signs of disease.
64 This ad was drawn to our attention by medical historian Dr. Jackie Duffin, who has assembled acollection of early ads.
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him in her posture and in the set of her head.65 The indications of her middle classstatus are present in her conservative hat and coat. She can rely on him. She is afemale white patient with a male white doctor, reflecting the norm of the professionat that time and the typical patient for antidepressants.
The earliest ad for Prozac was published in the Canadian Journal of Psychia-
try in April 198966. This ad covered three pages. The first part of the ad, on the firstpage, showed a side view of a stylized blue brain in section, with yellow linesintending to suggest the effect of Prozac. The text, in large font, says, “In thetreatment of depression it’s time to follow a new course”. This first image, with itsaccompanying text, plants the idea that fluoxetine is acting bio-chemically on thecentral core of the brain to change chemical pathways. There is double meaning inthe text as it not only suggests the way the drug works but also tells the doctor thatit is time to use these drugs as a new way of treatment. The following page showsimages of patients: a woman potting plants (used in subsequent ads), an older manshowing a grandson how to putt, and a woman behind her desk working. This adshows seemingly normal people doing everyday things. It’s a compression of theimages of typical “before and after” ads since the people could be either or both.
The normalization of depression, which we discuss below, and the biomedicalmodel of depression are both portrayed in this first ad. On the third page of the adis a picture of a doctor’s hand, indicated by the white sleeve, with fingers softlyflexed, holding out a single yellow and green capsule. Soft drugs. It is an image ofthe doctor and the drug as rescuer. Take this and you’ll feel better is the messageof this part of the ad.
This Prozac ad from 199267 focuses on two figures, a woman with a young
girl, who is presumably her daughter, riding on her shoulders and being held by hermother’s hands. They are connected. Both look happy and carefree. The text on theopposite page asks in bold type: “What’s so extraordinary about this picture?” Thetext continues with the answer: “That it’s so wonderfully ordinary. A first goal ofantidepressant therapy is to help a patient regain interest in the ordinary pleasuresa healthy person takes for granted.” There is no doctor present in the ad itself. Thead explicitly raises the issue of normality since the woman, whom we presume hasa condition requiring medication, is portrayed as being just like anyone else andnot abnormal. The ad photo doesn’t distinguish between the woman before andafter taking the drug, so that her normality appears to be part of both times.
65 Dale Spender, Man Made Language,
2nd ed. (London & Boston: Routledge & Kegan Paul, 1985).
66 (1989) 34:3 Can. J. Psych. 187-89 (Eli Lilly Canada Inc.).
67 (1992) 37:2 Can. J. Psych. 75-76.(Eli Lilly Canada Inc.).
Health Law Journal Special Edition, 2003
This ad plays against
the stereotype that people with mental illness are
“other”.68 It signifies that depression is a common disorder that can be experiencedby anyone and suggests that depression is widespread and invisible. When treated,the person can enjoy ordinary pleasures such as family relationships again. The adexpands the target group for the medication and therefore the market. This strategyis consistent with efforts that have been made to increase the rate of diagnosis ofdepression by doctors.69 David Healy has said that depression, as it is understoodnow, is “an extremely recent phenomenon, largely confined to the west. Itsemergence coincides with the development of the selective serotonin reuptakeinhibitors (SSRIs).”70 In his opinion, “In many respects the discovery of antidepres-sants has been the invention of and marketing of depression…”71 Charles Medawar,of the British public interest organization Social Audit, has noted that the Diagnos-tic and Statistical Manual (DSM-IV) definition of depression:
…is now identifiable in 300 manifestations (including manic depres-sion), detectable through the expression of many commonplace symp-toms and characterised by often familiar behaviours…Inauthenticating more and more diagnoses, the DSM process has helpedto legitimise a dramatic increase in drug use (the dominant treatmentmode) for conditions that become wider and wider in scope.72
After evaluating the DSM-IV symptoms, he concluded that the broad
boundary of depression has coloured the question of whether antidepressantswork and undermined one significant instrument of regulatory control sincelicensing for marketing permits marketing only for defined indications. Sincemarketing is linked to the symptoms of depression, and those symptoms are soloosely defined in the DSM-IV, marketing for antidepressants has wide scopeand regulatory control is limited. Medawar illustrates this point through a 1993Eli Lilly Prozac ad that lists “all nine symptoms of depression”: “Depressedmood” “Loss of interest” “Fatigue” “Sleep disturbances” “Weight/appetite change”“Lack of concentration” “Slowness/ restlessness” “Guilt/feelings of worthlessness”“Thoughts of death”.73 Elaine Showalter used the phrase “culturally contagious”to describe the spread of biomedical constructs of disease through stories in thevarious popular media, including “talk shows, patients support groups, internet
68 Kelley Johnston, Deinstitutionalizing Women: An Ethnographic Study of Institutional Closure
(Cam-bridge: Cambridge University Press, 1998).
69 Healy, supra
note 7 at 103.
70 David Healy, “Good Science or Good Business?”(2000) 30:2 Hastings Center Report 19 at 20. Healyadded that Prozac has not been shown to be effective in classic depressive disorders, there is someevidence that antidepressants may actually increase the rates of suicide and disability associated withdepression, and even though children and teenagers are given the drugs, the weight of evidence is againstprescribing for this group.
71 Healy, supra
note 7 at 181.
72 Charles Medawar, “The Antidepressant Web”, online: Social Audit <http://www.socialaudit.org.uk/1.4.html> at 2.4 and 2.5, originally published as Charles Medawar,“Secrecy and Medicines” (1996) 9 International J. Risk & Safety in Med. 133.
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chat rooms, and more”.74 The marketing phenomenon associated with introductionof the SSRIs has played into the pill culture of North America and a lifestylededicated to self-improvement.
The ad also suggests that people with mental disabilities look like anyone
else in society. The ad signifies that underneath they are not normal and needtreatment. The ad signifies both normality and abnormality through its conjunctionof the “normal” mother with daughter, along with the text connection to depression.
Everyone can be disabled. We all need Prozac. You can appear “normal” and stillneed Prozac. Depression is more widespread than is apparent. Prozac makes youmore normal and you won’t have to admit to a mental illness or receive psychiatrictreatment. The suggestion to doctors is that the product can be used among patientswho have less severe forms of depression and not only for severe forms. It is, then,suggesting itself as a substitute for the minor tranquillizers, although its approvalwas based on data indicating that it was better than a placebo for moderatedepression. David Healy indicates that, “There is increasing evidence that patientswith milder depressions do not always benefit from antidepressants.”75
The next ad for Prozac, appearing later in 199276, is a rescue ad. It shows
three people, two women and one man, all white adults. Each one is neatly dressedand groomed. The woman wears a dark coloured dress with a scoop neck, widePeter Pan collar and polka dot bow that has all the sexuality of a maternity dress.
Her blonde hair is neatly held back, she is wearing pearls – the symbol of the middleclass patient – and she is seated in front of modern art. The older man wears glasses,has his hair groomed, is casually dressed in a turtleneck and is depicted outdoors(where men belong) against a lake. The younger woman is dressed in a pink printdress, her hair is wispy and she holds her head on her hand as she sits in front ofwhat appears to be the lake. The signs for the disease are the glazed expression andaverted gaze of each face. The text says, “For Patients Suffering From Depression”and a rope runs across the text.
They are in need of the line of the rescue illustrated by the life preserver and
rope depicted on the second page of the ad. The rope from the first page connectsto the life preserver, which has the word “PROZAC” on its side. The backgroundcolour is blue. Inside the life preserver floats a pill bottle labeled “Rx PROZAC 20mg. TAKE 1 CAPSULE DAILY”. The text above this sign states, “PROZAC Asyour first line of action.” It is typical of rescue ads in clearly depicting the drug
asthe rescuer. In its presentation of three patients the ad indicates that depressionaffects a variety of people, although these three patients do not cover a wide
74 Elaine Showalter, Hystories: Hysterical Epidemics and Modern Culture
(New York: Columbia Uni-versity Press, 1997).
75 Healy supra
note 7 at 97.
76 (1992) 37:10 Can. J. Psych. at A10-11 (before 671). (Eli Lilly Canada Inc.)
Health Law Journal Special Edition, 2003
spectrum of a socially diverse society. The ad drives home the message that Prozaccan help a range of depressed people who need to be rescued.77 The medical modelof disease78 is applied to mental illness so that the mind is seen as amenable tobiochemistry. Intervention per se
is viewed positively, and particularly interventionthrough drug therapy. The absence of doctors from these ads (except semiotically)is indicative of the takeover of the heroic role of medicine by the drug.
Paul Longmore’s analysis of television and movie imagery of people with
disabilities found79 the most common image was one of personal maladjustment.
Disability was seen as:
…a problem of emotional coping, of personal acceptance. It is not aproblem of social stigma and discrimination…Both fictional and non-fictional stories convey the message that success or failure in livingwith a disability results almost solely from the emotional choices,courage, and character of the individual.80
Similarly, Douglas Biklen analyzed the media treatment of the Baby Doe andElizabeth Bouvia cases, both cases of individuals with severe disabilities and theprospect of dying. Not surprisingly, Biklen found that the popular print media failedto inquire into the situation of people with severe disabilities: “The prevailingframework for covering disabilities, a combination of charity, pity, tragedy, and‘overcoming disability’ makes no place for this story.”81 In the movies, “actors who
77 At the bottom of the page, the ad specifies the benefits of Prozac: “Helps provide your patientswith…[in bullet points] Effective relief from depression. Fewer therapy limiting side effects whencompared to TCAs. Compliance through convenient once a day dosing. A wider margin of safety inoverdosing than TCAs. Effective relief from the symptoms of anxiety and insomnia associated withdepression. [all points footnoted]”78 Medicalization is defined by two Merck executives in this way:Medicalisation refers to the theory that people seek to categorise life’s normal vicissitudes as medicalproblems. The term is also used in medical sociology, to suggest that those with a pecuniary or territorialinterest in ill health – not least doctors and the pharmaceutical industry – try to foster exaggerated anxietyabout disease and potential disease, so as to encourage essentially healthy people to seek unnecessarymedical products and services. In this latter sense ‘medicalisation’ has become a theory of social controland has been used as an argument against direct to consumer communication by pharmaceutical compa-nies.
Silvia N. Bonaccorso and Jeffrey L. Sturchio, “Direct to consumer advertising is medicalisingnormal human experience: Against” 324:7342 British Medical Journal 910 at 910, nn. 1-2.
79 Paul K. Longmore, “Screening Stereotypes: Images of Disabled People in Television and MotionPictures” in Alan Gartner and Tom Joe, eds., Images of the Disabled, Disabling Images
(New York:Praeger, 1987) 65 at 67. He found three common prejudices: “…disability is a punishment for evil;disabled people are embittered by their ‘fate’; disabled people resent the nondisabled and would, if theycould, destroy them.” Longmore sees this as transference of fears and biases by the stigmatizer to thestigmatized. They are stigmatized as less than human and asexual or sexually menacing as in the Phantomof the Opera or Whose Life Is It, Anyway?80 Ibid.
81 Douglas Biklen, “Framed: Print Journalism’s Treatment of Disability Issues” in ibid.
79 at 87-88. Seealso Deborah Kent, “Disabled Women: Portraits in Fiction and Drama” in ibid.
47;Guy Cumberbatch & Ralph Negrine, Images of Disability on Television
(London: Routledge, 1992).
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n Signs of Inequality 177
play someone with a disability are heroic by proxy” commented reviewer LiamLacey in assessing the 2003 Academy Awards.82
These portrayals are devoid of the political dimension of disability by which
the disadvantage and prejudice shown in society comprise part of disability’smeaning. Deborah Kent described it this way in her study of more than thirty playsand novels portraying disabled women:
…As radically as these pieces differ in other respects, they are remark-ably alike in their presentations of disabled women. Whether she isblind or deaf, facially disfigured or paraplegic, the disabled woman istypically shown to be incomplete not only in body, but in the basicexpression of her womanhood. Frequently she is a victim…Most ofthese characters, at one point or another in their histories, expressbitterness, despair, and self-loathing. Their anguish is generally seenas the inevitable outgrowth of the disability itself. Social stigma, whichis in fact responsible for so much of the pain endured by disabledwomen in real life, is seldom explored or even acknowledged. The girlwith a clubfoot is miserable because she cannot dance; the blind girllongs for the sunsets she will never see. They do not rebel against theworld’s view that they are helpless, useless, pitiable, and undesirable.83
The purpose of having protection against disability discrimination isnot to give persons with disabilities a right to do things they cannot do.
Rather, the dual purpose is to take proper account of what cannot bedone owing to a disability as well as to give persons with disabilitiesthe right to do things that they are able to do, notwithstanding anyfunctional limitations, despite perceptions that they cannot do thesethings. Thus, protection against disability discrimination has every-thing to do with countering stereotypical perceptions of ability basedon an able-bodied frame of reference.84
In these drug ads it seems that people with mental disabilities are unable to beheroic. Only the drug is assigned that role.
82 Liam Lacey “The Broadcast” The Globe and Mail
(22 March 2003) R1.
83 Deborah Kent, “In Search of a Heroine: Images of Women with Disabilities in Fiction and Drama” insupra
note 16, 90 at 93.
84 Diane Pothier, “Connecting Grounds of Discrimination to Real People’s Real Experiences” (2001) 13C.J.W.L. 37 at 48.
Health Law Journal Special Edition, 2003
This 1992 ad85, the earliest ad for Zoloft in the Canadian Journal of Psychia-
try, uses the before-and-after convention. Before, a woman is huddled inside theglass or plastic petals of a closed flower with drooping petals that suggestsvulnerability and a response of hiding. Her face is weary and her eyes are rimmedwith exhaustion. Because the flower in which the woman is enclosed looks likeglass, has pointed petals, and appears to be swaying in the wind, the reader feelsuncomfortable, thinking that it must feel insecure to sit inside that flower about totopple over. The text at the top of this page says, “Antidepressant Therapy ThatCauses Insomnia Can Prevent A Patient From Flourishing During the Day” and itcontinues on a subsequent page, “Night closes in and the insomnia of depressioncan be exacerbated by an antidepressant that causes agitation…. Zoloft, a newselective serotonin reuptake inhibitor (SSRI) had neither a sedative nor a stimula-tive effect at therapeutic doses….”
On the second page, the text says blandly, “Introducing Once-A-Day Zoloft”,
perhaps because this page was used alone in the first issue in January 1992.
Post-drug, the woman is the pistil in the middle of the now-awake and openedflower. She has not only blossomed but she has also sprouted wings – she’s takingflight – is she Tinker Bell? She’s wearing an unfortunate prom dress stronglyreminiscent of the mid-1960s. Her eyes have awakened too and she has acquiredeyeliner. With her long dark hair there is a suggestion of a fairy princess dressedfor the ball. Since the pistil is the seed-bearing organ of the flower, there is anallusion to awakened reproductive capacity. Perhaps the flight imagery of the aftershot is meant to suggest the soft drug image and high to be obtained from SSRIs.
This ad depicts a middle-aged woman as the patient with the disease. The
early literature on medical advertising, developed through twenty years of obser-vation of European, North American and Australian journals, found that most drugads over-represented men, in a 2:1 ratio. The exception to this rule, apart from theobvious obstetrical/gynaecological ads, was psychiatric drug advertising wherewomen were over-represented, even in relation to the higher level of diagnosis ofmental disorders among women. Women’s incidence ratio for psychiatric illnessis 2:1 in relation to men.86
Our examination of ads for SSRIs indicates that only white
people seem to be
affected by these psychiatric conditions. More diverse ads began to appear in themid-1990s, for instance using a framing technique with portrayals of people from avariety of social classes, age groups, and both genders (but not race) in an ad for thethe anti-depressant Effexor87. The preponderance of white middle class people in the
85 (1992) 37:2 Can. J. Psych. A27-32 (after 136) (Pfizer Canada Inc.).
86 Wanda Leppard, Shirley Matile Ogletree & Emily Wallen, “Gender Stereotyping in Medical Adver-tising: Much Ado About Something” (1993) 29 Sex Roles: A Journal of Research 829.
87 (1996) 41:1 Can. J. Psych. A12-13 (Wyeth-Ayerst Canada Inc.).
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n Signs of Inequality 179
antidepressant ads might reflect earlier views of the condition known as melancholysince Hippocrates. Sherwin Nuland writes that in 18th century England, melancholywas very common, and that “between those who had it, those who imagined it, andthose who aspired to it because it was thought to confer a certain aesthetic superiorityon its sufferers, the British began to think it was their disease.”88
IMS Health reported that the dominant market for SSRIs has been North
America, which had almost 75 per cent of the sales in 2002, when antidepressantssold $13.4 billion worldwide.89 The World Health Organization “estimates thatdepression is soon to become the second leading cause of disability – behindischaemic heart disease and ahead of road accidents…”90
Paxil (2002) Worry Ad
This current ad91 portrays a woman in classical dress supporting a huge
rock-like object with a crack in it. The woman is an Atlas figure, carrying the weightof the world on her shoulders. The rock is viewed through a cutout of the kind foundin children’s books, where the readers puts a finger into the hole and findssomething different and surprising. When the page is turned, the picture shows therock/nut object being held between the thumb and forefinger of a hand, illustratinghow manageable the lifting is. The cracks in the rock appear on the hand as well,and this crackling paint signifies its age. The text says: “Helping change the wayyour patients see the world.” Followed in smaller type by:
She presents with a host of physical complaints and other psychiatricdisorders. Yet the greatest burden is her excessive, uncontrollableworry that the worst will happen – the “what if” worry of GeneralizedAnxiety Disorder (GAD). How can you help change her view ofthings?With Paxil. The first and only SSRI indicated for GAD. The antide-pressant with more indications than any other SSRI or SNRI.92
The weight of the world is the worry perceived by the woman. The sign
includes the patient and the need for rescue from a great burden. The beneficenthand achieving the rescue is the signifier for the drug. Mental illness is a rock withcrack defined as worry; it creates something burdensome that isn’t really there. It
88 Sherwin B. Nuland, The Mysteries Within: A Surgeon Reflects on Medical Myths
(New York: Simon& Schuster, 2000) at 156.
89 IMS Health, “Antidepressants”, supra
90 Simon Garfield, supra
note 6. The NHS is dispensing 60% more SSRI compounds than 4 years ago. Hewondered whether they should be worried or grateful.
91 (2001) 46:10 Canadian J. Psych. 901-03 (GlaxoSmithKline)92 Generalized Social
Anxiety Disorder is defined in the ad as “(persistent fear; anxious anticipation oravoidance of multiple social situations and/or performance situations) – this diagnosis should not be madeunless symptoms interfere significantly with a person’s routine, job or social life or cause markeddistress”.
Health Law Journal Special Edition, 2003
is difficult to move without a helping hand. The hand is of classical vintage and is– (incidentally?) male. A vulnerable female victim needing a male rescuer is afamiliar myth. The rock and the hand both have cracks. Goldman and Montagnehave pointed out advertisers’ reliance on abstract visual metaphors of the mind andits relationship with medication. They say: “Note how these abstractions corre-spond to everyday metaphors for mental illness – ‘I’m cracking up’ or ‘I am so inthe dark’ ”.93
With the drug as rescuer, the condition of illness – the worry – is lessened so
that it appears in its real size. The classical motif runs through Paxil advertising ofthis period. Use of this mythology has several purposes. It is intended to distancethe viewer, so that the events appear to take place in a more objective way. Classicalimagery provides legitimacy as it goes to the roots of our culture and draws onmyths that remain vibrant. Using established myths to create new myths provideseven more power to the ad from a semiotic point of view.
This ad illustrates the transition from marketing the drug as an anti-depressant
to marketing it for other forms of mental illness. Manufacturers have soughtapproval for marketing for other purposes and have devoted ad copy to the otherindications. For example, one Paxil ad made use of classical statues to indicate eachof the new indications: “Look for the Paxil Spectrum in every patient.” And thestatues were labelled DEPRESSION, GSAD, PANIC DISORDER and OCD[obsessive-compulsive disorder].94
Effexor Xr (2001) Bees Ad
This October 200195 ad portrays mental disorder as a swarm of bees. Bees
produce anxiety and this drug is targeted at Generalized Anxiety Disorder – “WhenGeneralized Anxiety Disorder drives your patients to distraction, act fast.”, the adsays. It’s an exterminator image of drug action – drive away the anxiety with thedrug. Anxiety is the current marketing target, replacing depression as the focus ofSSRIs. The bees suggest something out of control but not catastrophic and thereforesomething amenable to solution. The speed of the drug is suggested in the referenceto acting fast and this is also a call to doctors to move quickly to prescribe the drug.
Punning, visual metaphors, and double meanings are all staples of semiotic con-struction. The image of a person standing still without visible hands while beingswarmed by bees is improbable. It suggests a comparison of the anxiety scenariowith reality in which no swarm of bees is actually present. In addition, like thepentimento ad, the bees ad suggests that mental disability is something external tothe individual that can be quickly driven away.96
93 Robert Goldman & Michael Montagne, “Marketing Mind Mechanics: Decoding Antidepressant DrugAdvertisements” (1986) 22 Social Science & Medicine 1047 at 1057.
94 (2001) 46:6 Canadian J. Psych 478 (GlaxoSmithKline).
95 (2001) 46:8 Canadian J. Psych. 582-83 (Wyeth-Ayerst Canada Inc.).
96 The swarm of bees ad shares certain characteristics with a 1996 ad for Zoloft, produced by PfizerCanada, that we call the pentimento ad which shows a painting of a Renaissance beauty resting on an easel
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n Signs of Inequality 181
Individualization and decontextualization are characteristic of drug ads. The
individual is the locus of the disease, ignoring the important aspects of one’s lifethat contribute to human health.
When other family members are present, they are there as victims of the
patient’s depression, needing her to return to the family, or happy beneficiaries ofthe drug’s effects in “after” scenes. Elizabeth Ettore and Elianne Riska analyzedpsychotropic drug advertising in Gendered Moods
. Noting that tranquilizers wereused for social control purposes and then began to be seen as a social problem,Ettore and Riska criticized the individual rather than socio-political approach:“Transgressing women and not the gender system are the focus of attention.”97
Ads such as these ignore and downplay the inequalities experienced in
people’s lives. These factors are recognized as social determinants of health by theWorld Health Organization and health researchers but they are absent from thedecontextualized view of disease.98 Each of the factors of race, aboriginal status,gender, age, disability has a separate history of discrimination, prejudice, inequalitythat needs to be factored into any thorough understanding of the phenomenon ofdisease. Locating the disease within the individual serves the interests of drugcompanies. In their study of psychotropic drugs, Kleinman and Cohen concludedthat ads for psychotropic drugs individualize responsibility by portraying Abnor-mality and the ability to adapt to the mainstream as attributes of individuals99. Thebiomedical view of psychiatric illness carries with it the further idea that thecondition is amenable to biomedical cure. The desirability of normality and theindividual locus of disease were both evident in the second Prozac ad, which asked,“What’s so extraordinary about this picture?” Under the individualized view,accountability is located in the individual, who is responsible to friends, family andworkplace for the illness and for taking the cure. Returning to social roles is depictedin a guilt-inducing way – without acknowledgment of the contribution of the rolesto the mental condition. This simplified portrayal underlies all the ads. For example,the swarmed worried woman should use the repellant to get rid of those bees.
as a work to be restored. The painting is covered by a dirty surface, signifying the mental illness.
Depression may be wiped clean by using the drug to restore the real patient who is underneath. The patientis shown in a passive way. The pentimento ad signifies that mental illness exists on the surface of anindividual. The drug will act as a restorer to remove the surface layer of depression and uncover the personunderneath. This ad was discussed in Patricia Peppin & Elaine Carty, “Innovation, Myths and Equality:Constructing Drug Knowledge in Research and Advertising” (2001) 23 Syd. L. Rev. 543 at 569.
97 Elizabeth Ettore & Elianne Riska, Gendered Moods: Psychotropics and Society
(London: Routledge,1995) at 2998 Arthur G. Nikelly, “Drug Advertisements and the Medicalization of Unipolar Depression in Women”(1995) 16 Health Care for Women International 229.
99 Daniel Lee Kleinman & Lawrence Jack Cohen, “The Decontextualization of Mental Illness: ThePortrayal of Work in Psychiatric Drug Advertisements” (1991) 32 Social Science & Medicine 867 at 867.
Health Law Journal Special Edition, 2003
100 Dancing ad
A woman in her bathrobe and slippers is evidently experiencing depression,
sitting in a chair while her partner sits apart from her, looking elsewhere. She looksinto the camera, without expression. “When you’re depressed, a minute can seemlike an hour, an hour like a week, and a week like a year”. “Foreshadow the futureof depression” the ad tells us, and a shadow on the wall shows us the woman dancingwith her partner. The drug will allow her to enjoy life and socialize, it suggests, andshe can return to being a partner. When she is ill, she is alone. In this ad depressionmakes her “other” and not simply a version of normal. Once treated, time will returnto normal.
Sexuality is largely absent from these ads depicting mental illness and while
this is consistent with the way that people with disabilities are desexualized,101sexuality is largely absent from other types of drug ads too. In both cases, sexualityis alluded to in “doing things together” scenes. Unlike consumer ads, which can bemore playful and make overt use of sexuality, drug ads usually strive for the moresober aura of legitimacy. In the portrayal of depression though there is also animplication of her failure to create desire. Featherstone has commented that inconsumer culture the body is portrayed as a way of achieving pleasure,102 and themore youthful, sensual and thin the body the greater its value.103 The depressedbody shown by this woman has failed to stimulate the interest of the man, whosegaze is averted. Sexual dysfunction is a side effect of SSRIs, and surprisingly, thiswas portrayed in an ad series first suggesting the problem and then indicating thata particular drug did not have this result. This ad was unusual in breaking out ofthe pack to suggest a general problem with this class of drugs – although the evidentreason for this was the alleged solution found by this manufacturer.104
Ads over this period have rarely depicted people with depression and the
Remeron ad is an exception to this trend. Mental illness is shown as a swarm of
100 (2001) 46:6 Can. J. Psych. 479-81 (Organon Canada Ltd.) Remeron (mirtazapine) was approved bythe FDA as an anti-depressant in 1996; “Remeron cleared by the FDA for the treatment of depression”(19 June 1996), online: DG News<http://main.pslgroup.com/news/content.nsf/MedicalNews/9000A0A9F704A6AB8525634F0058E35B?OpenDocument&id=>.
101 Kelley Johnson’s ethnography of deinstitutionalized women indicated that “…the evidence from my field work revealed that the perceived failure of the women to take up a position within discourses which frame our view of normality as applied to girls and women made it difficult for their families to identify who they were or their place within the family.” Supra
note 54 at
This led to confusion about who their daughters were and to removal of them from the family, makingthem “other” (ibid.
102 Mike Featherstone, “The Body in Consumer Culture” (1982) 1 Theory, Culture & Society 18 at 21-22.
103 Chris Shilling, The Body and Social Theory
(Sage: London, 1983) at 3.
104 This shows two people’s feet widely separated in bed followed in a subsequent ad showing the feetentwined. Another version showed a woman’s finger with hooker red lipstick on her long nail, held up toher lips in an “I’ve got a secret” gesture.
Peppin & Carty
n Signs of Inequality 183
bees or surface layer of dirt, the threat of the Minotaur or being lost in a labyrinth.
The classical statues and mythology used for Paxil, the normality and rescue adsfor Prozac are indicative of unwillingness to give bodily form to depression. It isconveyed, though, in the sleepy hard stare of the Remeron woman and the absentexpression of the Renaissance beauty in the painting. In contrast, an ad series thatdepicts how mental illness affects a person has appeared recently in the BritishJournal of Psychiatry portraying patients acting out some of schizophrenia’sdelusions. The first ad shows a young woman mutilating herself, cutting gashesinto her stomach. The second ad shows a man protecting himself from alieninvasion by covering all the surfaces of his apartment with tinfoil. These ads are instark contrast to the antidepressant ads. If depression is a loosely defined category,as Healy has argued, this reluctance to give bodily form to the disease is significant.
Paxil (1997) “this Is Panic”
“This is PANIC” appears in bold type.105 The ad tells us, “This is panic as
expressed by R.B., a 43 year old patient with the disorder.” Most of the page ispainted red, with the upper right portion providing a blue background against whichis painted a greenish brown flexed hand, outlined in white, with fingers spread outin a startled image. The captured instant has immediacy and force. The clash ofcolours and simplicity of the image carry emotional force. The disability literatureincludes references to the need to hear the voices of those with disabilities.106Developmentally disabled women and institutionalized people, for example, arerarely heard from. This ad presents us with a vivid illustration of panic attacks. Eventhough it appropriates the image for commercial purposes, it has a power that ismissing in other depictions. The text following the illustration page begins, “THISIS PAXIL” and continues by claiming that it is “highly effective at relieving theanxiety symptoms of panic disorder” and that “the most common adverse effectsare those generally seen with the SSRI class (including nausea, somnolence andasthenia [lack of strength]).” This ad illustrates the expansion of indications forSSRIs to include panic disorders.
Advertising draws on social stereotypes in several ways. Stereotypes provide
an ideological source for ads, which use commonly accepted characterizations tosignify qualities to be associated with the product. We have seen the constructionof disability in these ads: the normal patient who can be treated, the female Atlasimagining excessive worry, the sad trio waiting for a life-preserver, the huddledpatient enclosed in a glass rose waiting for the drug to allow her to blossom andfly, the swarmed woman.
105 (1997) 42:7 Can. J. Psych. 686-87 (SmithKline Beecham Pharma).
106 See, for example, Pothier, supra
Health Law Journal Special Edition, 2003
Ads create and replicate myths about the nature of any condition, the
population with a condition, and the appropriate treatment. When stereotypes areused in the creation of such perceptions, then a disease will be perceived in a certainway and associated with a particular group. For example, the “normal” woman inthe Prozac ad provides a pathway to the type of person who needs Prozac. Theomission and under-representation of groups in visual imagery create and reinforcethe image that certain diseases occur only or predominantly in certain groups. Theseinclude the possibility of overlooking the condition in one group, the risk ofpursuing it more zealously in the other group, and the potential to miss the diseasewhen it manifests differently in various social groups. Stimson suggested in anarticle almost thirty years ago that to the extent that doctors accept ad portrayals“they have lost control over their diagnoses.”107 A simplified version of diseasecombines with stereotypes and unrepresentative patient populations to create falsecertainties about patients, diseases and cures.
Advertising that portrays disease in an individualized fashion pushes a partial
conception of mental illness – one that calls for intervention through drugs. Whenthe disease itself is constructed in a broad and expansive way, the market for thedrug and number of patients exposed to the drug increase significantly. It dimin-ishes the role of doctors as healers, and patients as active participants, and insteadsubstitutes the curative power of drugs. It decontextualizes mental disability andsuggests that drugs can simply remove the layer of mental illness or swarms of beesover the real person. The people in these ads fit the vulnerability approach todisability, which is tailor-made for drug promotion as rescuer. The value farthestfrom these ads is rights. These ads sell control over disease as constructed by thecompany, in the process bypassing the human being, their rights, the socialdeterminants of health, and a healthy doctor-patient relationship.
These types of stereotyping show us how existing paradigms of social worth
can be used by the drug industry to create perceptions of their products, with theintention of promoting sales. Unless government takes a more active role inregulating advertising, courts play a role in setting standards of review based in thefundamental values of equality and autonomy and ensuring that advertising doesnot undermine the duty to warn of product risks, and journalists bring publicattention to ad portrayals, we are unlikely to see significant change. Doctors needto be aware of the processes used by the advertisers to create these perceptions andof their own contributions to the stereotypes and myths used to power these ads.
Patients need to be aware of the distorting perceptions conveyed and created in thead process. Only then will it be possible for doctors and patients to insulatethemselves from the distorting impact of the myths.
107 Gerry V. Stimson, “The Message of Psychotropic Drug Ads” (1975) Journal of Communication 153at 160. The diagnostic profile suggested by Stimson adds another layer to the medical symptoms thatcombine to provide a profile for diagnosis, and provides linkages that also may be partial or otherwiseflawed. The fact that such linkages are made without being perceived by the viewer means that the controlthat might be exercised by medical expertise is unlikely to operate.
VERSIÓN CONSOLIDADA DEL TRATADO DE FUNCIONAMIENTO DE LA UNIÓN EUROPEA ACTOS JURÍDICOS DE LA UNIÓN, PROCEDIMIENTOS DE ADOPCIÓN Y Artículo 288 (antiguo artículo 249 TCE) Para ejercer las competencias de la Unión, las instituciones adoptarán reglamentos, directivas, decisiones, recomendaciones y dictámenes. El reglamento tendrá un alcance general. Será obligatorio en todos sus e
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