Healthy Skepticism International News

September 2004

Direct-to-consumer advertising: Healthy education or corporate spin?

Abstract:

Direct-to consumer advertising (DTCA) of prescribed drugs in mass media has recently emerged as a contentious issue internationally. Among industrialised countries, it is currently allowed only in New Zealand and the United States, where industry journals trumpet its effectiveness. Many of the drugs advertised are ‘lifestyle drugs’ and/or expensive new drugs touted as superior replacements for established drugs. DTCA advocates claim that it provides valuable consumer education about medical conditions and treatments. However, there are many objections, including overstatement of benefits and understatement of risks, escalating drug costs, and undermining of doctor-patient relationships. Although DTCA is not legal in Australia, de facto DTCA does occur in the form of advertisements about specific diseases and conditions and news stories about new drugs. Five case studies are presented to illustrate aspects of DTCA. It is concluded that there is a glaring gap between industry rhetoric and DTCA reality.
Department of Public Health, Flinders University
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Introduction

The pharmaceutical industry spends huge amounts of money on marketing, including advertising, primarily targeting doctors. Doctors are trained in diagnosis, pharmacology, and therapeutics, but patients generally have negligible knowledge in these areas. The doctor is therefore a ‘learned intermediary’ (Drazen 2002). However, in recent years, pharmaceutical companies have spent huge amounts of money on direct-to-consumer advertising (DTCA) of prescribed drugs in the mass media, raising people’s awareness of diseases and relevant drugs.

DTCA is controversial, and is banned in most industrialised countries, including Australia. However, the pharmaceutical industry is exerting a great deal of pressure on governments to legalise it. The industry is also increasingly engaging in de facto DTCA, including advertisements in which in high-profile drugs are not mentioned by name.

This paper begins by introducing DTCA and briefly discussing its history and its legal status in several countries. Then the arguments and evidence for and against it are reviewed and analysed. De facto DTCA is then considered, followed by case studies of key drugs.

Direct-to-consumer advertising

The pharmaceutical industry spends significantly more on prescribed drug marketing (including advertising) than on research and development (Ballance 1996, p. 97; Angell 2000; Nader 2001). US expenditure on marketing was approximately $15.7 billion in 2000 (Frank et al. 2002, p. 6). Nearly $3 billion of that was for advertising.

Traditionally, most marketing has been directed at doctors, via medical journal advertisements and promotional materials and samples provided by drug representatives (‘detailers’), because they are the gatekeepers to patients’ access to drugs. According to Davis (1997, p. 93) advertising has historically been a key issue in the status of drugs:

In contrast to the patent medicine sector promoting remedies to the public at large, pharmaceutical companies were concentrating on selling higher quality medicines to doctors. Such medicines were known as ‘ethicals’. This originally meant that they were honest – in their therapeutic claims – but came to mean that they were advertised only to the medical profession and not directly to the public. In other words, the distinctive features of ‘ethical’ drugs were the dual ones of scientifically demonstrated claims to efficacy and supervised administration by a trained professional.

Doctors are still the primary focus of advertising (Frank et al. 2002, p. 2), but DTCA has become big business, and an increasingly important marketing strategy, particularly in the United States and New Zealand. Advertisements in mainstream media (newspapers – both print and web editions – radio, and particularly television) are used to raise public awareness of particular diseases and conditions and relevant drugs. They also encourage people to consult their doctors. According to Frank et al. (p. 1), ‘Surveys have shown that over 90 percent of the public reports seeing prescription drugs advertisements’.

Which drugs?

DTCA focuses on a relatively small number of drugs (Frank et al. 2002, p. 2). Commonly advertised drugs include Viagra, weight-loss drugs, baldness drugs, antidepressants and anxiolytics (anxiety-reducing drugs), arthritis drugs, and heartburn/ulcer drugs.

Many of the drugs advertised are so-called ‘lifestyle drugs’ (Lexchin 2001; Gilbert, Walley, & New 2000), rather than drugs with demonstrated public health benefits. Another major category is expensive new drugs touted as superior replacements for established drugs, for example new nonsteroidal anti-inflammatories (NSAIDs), which are claimed to have fewer side-effects than older, cheaper NSAIDs and simple analgesics (Sasich 1999). Another common category is analogues or ‘me-toos’ – drugs that are minor variants of profitable existing drugs, rather than innovative drugs (Jewesson 2002).

High expenditure is most likely to be directed towards relatively new drugs with no generic competitors, and drugs for chronic conditions such as allergy, high cholesterol, and stomach ulcers (Frank et al. 2002, p. 3).

Content of DTC advertisements

The content of DTC advertisements incorporates many tried and true persuasion techniques, including many of the same strategies as used in advertisements in medical journals, as well as some distinctive strategies. The target behaviour is not the direct purchase of drug products, but the persuasion of doctors to prescribe them. This is more challenging than advertising directly to doctors. However, drug companies are able to tap into powerful emotional factors:

· the value of health (one’s own or that of loved ones)

· the fear of death

· the fear of disability

· the responsibility for taking care of one’s health and that of loved ones

· self-consciousness and vanity

· shame

· the vulnerability of people who are ageing, ailing, etc.

Statistics are sometimes quoted. They generally focus on the prevalence of disease, and the prevalence of untreated disease, but rarely on the effectiveness of drugs (as is the case with medical journal advertisements (Loke, Koh, & Ward 2002).

Many advertisements encourage people to consult their doctors. Sometimes materials (e.g. symptom quizzes) are provided for people to take to their doctor to discuss.

DTCA advertisements have some similarities to health promotion advertisements, in terms of promoting disease awareness. However, alternative nonpharmaceutical treatment and prevention strategies such as exercise and diet modification are rarely mentioned in DTCA (Kravitz 2000; Moynihan, Heath, & Henry 2002, p. 889).

Advertisements in medical journals often depict patients as passive, needy, even annoying people, in need of doctors’ expert help. DTC advertisements, however, portray consumers more positively. They may be in need of treatment, but they are often active decision-makers taking responsibility for their own health in partnership with their doctor.

History and legal status

The only industrialised countries in which DTCA is allowed are New Zealand and the United States (Toop et al. 2003, p. iii). However there is strenuous lobbying in many countries to change this situation. Also, in many countries, including Australia, de facto DTCA (discussed later in this paper) is increasingly common.

The legality of DTCA in New Zealand and the United States has significant implications for other countries. In particular, trade agreements increase the possibility of DTCA being legalised elsewhere.

United States

In the United States, the first DTC advertisements emerged in the early 1980s. However, in 1983 the Food and Drug Administration (FDA) declared a voluntary moratorium on it. Since the moratorium was lifted in 1985, and particularly since the FDA issued draft guidance allowing broadcast and electronic advertising in 1997 (Pharmaceutical Research and Manufacturers of America 2002), DTCA has burgeoned into a multi-billion dollar per annum industry. DTCA spending has dramatically increased in recent years: a nine-fold increase in DTCA between 1994 and 2000 (Frank et al. 2002, p. 1). Pharmaceutical industry journals trumpet the effectiveness of DTCA and celebrate its ‘nonstop acceleration’ (Morais 1998) and the ‘legendary successes’ produced by nearly US$7 billion expenditure in the five years to 2001 (Lieberman & Dunnan 2001, p. 22). DTCA is regulated by the FDA, but violations of the regulations are common and monitoring is under-resourced (Toop et al. 2003, pp. 33-34).

According to Drazen (2002, p. 523), ‘It is now practically impossible to read a major newspaper or a nationally circulated magazine, to watch television, or to listen to the radio without coming across an advertisement for a medical product or procedure’. In 2000, television advertising accounted for 60 per cent of US DTCA (Frank et al. 2002, p. 1). Many US websites also carry DTCA. Some state vacuously that they are ‘intended for US consumers only’.

New Zealand

New Zealand is the only industrialised country with both DTCA and a comprehensive publicly funded drug subsidy scheme (Toop et al. 2003, p. 1). It has permissive legislation and relies on self-regulation through the Therapeutic Advertising Pre-vetting System (p. 28), for which there is no regular prospective monitoring.

DTCA was never prohibited in New Zealand, but pharmaceutical companies did not take advantage of its legal status until recent years. However, it is increasing rapidly. In 2001, NZ$4,917,436 million was spent on DTCA for four prescription-only medications (Toop et al., p. 3).

DTCA was reviewed in 2000 by the Ministry of Health (2000), which recommended tightening of the regulations. However, this has not happened (Toop et al., p. v). Toop et al.‘s report is highly critical of DTCA and has generated significant controversy. Lynne Clifton, Executive director of the Communication Agencies Association of New Zealand reportedly stated:

We believe that this latest research from the Christchurch School of Medicine is a highly emotive attempt to stir unfounded concerns. (Ralston 2003)

The New Zealand pharmaceutical market is very small, but it is significant to the international pharmaceutical industry because of the legality of DTCA. It provides opportunities to test DTCA marketing strategies and to conduct research that purportedly demonstrates the value and acceptability of DTCA. Furthermore, as noted by Calfee (2002, p. 7, note 6), ‘The New Zealand experience is of obvious interest not just because DTC ads are permitted but also because they are regulated by the Advertising Standards Authority, a self-regulatory body’.

Australia

Prescribed drugs in Australia are regulated by the Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA), part of the Commonwealth Department of Health and Ageing. DTCA is prohibited in Australia by the Therapeutic Goods Act. This was reviewed in 2000/2001 as part of the review of all State and Territory drugs, poisons and controlled substances legislation against the Principles of National Competition Policy, commissioned by the Council of Australian Governments in 1999. The report recommended that:

the prohibition on advertising prescription medicines is retained, except that publication of the Consumer Medicine Information should be permitted as should advertisements which only provide information about the price of medicines or general information about disease states, in accordance with a code of practice underpinned by legislation to promote the informational nature of these advertisements (Galbally 2000/2001, p. xiii)

DTCA is also prohibited by the Medicines Australia (previously Australian Pharmaceutical Manufacturers Association) Code of Conduct (Medicines Australia 2002a), which sets out a formal process for dealing with breaches. However, internet ‘education’ is permitted:

The Code also recognizes the information need of members of the general public regarding prescription medicines and the requirement for the industry to meet those needs in a responsible and appropriate manner. Section 3.9 is designed to set a framework in which this information can be provided to members of the general public on the internet in a nonpromotional and educational manner. (Medicines Australia 2002b, p. 24)

European Union

In 2002, there was intense lobbying of the European Parliament about a proposal to allow DTCA of prescription medicines in the European Union. However, the proposed amendment was rejected (by a 12 to 1 majority) (Toop et al. 2003, p. vi).

Key players in the DTCA debate

The main advocates of DTCA are the pharmaceutical industry and associated industries, particularly the advertising industry. The pharmaceutical industry and its allies produce a considerable volume of papers, report, and submissions in support of DTCA. Three notable US organisations are the Pharmaceutical Research and Manufacturers of America (PhRMA) (e.g. PhRMA 2002), the IPI Center for Technology Freedom (e.g. Matthews 2001), and The American Enterprise Institute (e.g. Calfee 2002).

The main groups objecting to DTCA are health academics and lobby groups primarily comprised of health professionals. Many doctors object to DTCA (Kravitz 2000; Anonymous 1998), as do some US health insurance organisations (West 1998), and many consumer health advocates (Mintzes 1998; Sasich 1999). Consumer groups also participate in the debate, but some argue for and others against DTCA. Many consumers reportedly view DTCA positively (Anonymous 1998; Kravitz 2000). However, it depends on what they are asked and in what context. Mintzes et al. (2001, p. 35) found that only a minority of patients regarded media advertisements as accurate. Governments express conflicting views, and respond in contradictory ways. Not surprisingly, considerable debate occurs in mainstream media.

Arguments for DTCA

Advocates of DTCA tend to argue that it is a win-win situation in terms of both health and economic outcomes (e.g. Calfee 2002). They claim that it provides valuable consumer education about medical conditions and treatments (Moser 2002). DTCA encourages people to consult doctors (West 1998), so advocates often cite research about people’s (particularly men’s) reluctance to consult doctors. For example, Dow (2003) alluded to the Australian Institute of Health and Welfare’s recent report (Bayram, Britt, Kelly, & Valenti 2003) documenting men’s under-utilisation of GP services. Advocates also argue that DTCA can improve doctor-patient relationships by increasing communication (Matthews 2001, Executive summary).

Opponents of DTCA are often characterised as paternalistic (e.g. Matthews 2001, p. 15). Civil libertarian arguments are also used. Ralston (2003) quoted a communications industry spokesperson: ‘Quite simply, it comes down to a patient’s rights to choose and to have access to information’.

Advocates (and advertisements) sometimes often cite statistics about the prevalence of diseases, and the number or percentage of untreated cases. However, these statistics are often questionable, exaggerating the severity and/or frequency of conditions to expand markets (Moynihan et al. 2002, p. 886). In addition, the sources of statistics are often obscure. For example, according to Moser (2002):

Ads for one drug may lead patients to receive treatment for other illnesses. Since drug advertisements for erectile dysfunction have appeared, millions of men have visited their doctors for a prescription and have learned they had other serious health issues needing treatment. For every million who asked for the medicine, it was discovered that 30,000 had untreated diabetes, 140,000 had untreated high blood pressure, and 50,000 had untreated heart disease (PhRMA, 7/24/01)

The internet link provided for the PhRMA reference is obsolete (as is the link for Moser’s ‘fact sheet’), making it difficult to assess the validity of the claim. This is common in pro-pharmaceutical industry publications.

Implicit in such statements are concerns about not only the public health significance of untreated illnesses, but also the economic costs. Advocates also use other economic arguments, particularly that DTCA reduces drug prices. This statement, ‘The average price of brand-name prescription drugs with DTC ads is $78.19, while unadvertised drugs average $90.65 (Pfizer 2002)’, used by Moser (2002), warrants several comments. Firstly, average prices are often highly unrepresentative (hence the use of median prices in real estate reporting). Secondly, it is not just the unit cost that matters in economic terms, but also the volume. Many DTCA drugs are for chronic conditions. Thirdly, the source cited was a ‘Pfizer, Inc. Conference Presentation’ – there is presumably no written public record, so it is not possible to check the data sources and methodology.

Not surprisingly, a key argument is that DTCA increases competition and therefore, following purist economic logic, improves efficiency. According to Matthews (2001, Executive summary):

As long as patients are insulated from the cost of medical care and doctors stand between patients and their prescriptions, the health care marketplace cannot work exactly like a normal market. But it still can be competitive. Advertising will play a major role in expanding that competition. We have no reason to fear advertising; what we should fear is the people who want to control it.

Arguments against DTCA

Objections to DTCA fall into two main categories: the potential negative impacts on health, and the economic impacts. There is also concern about the effect on doctor-patient relationships. A joint statement by the Health Action International Europe and European Public Health Alliance (2002) argued that:

advertising of prescription medicines is a grave threat to public health and puts the profits of the pharmaceutical industry ahead of public health…. it clearly places undue stress on public health budgets, increases the amount of misleading and unhelpful health information and increases the inappropriate and unnecessary use of medicines.

Negative health impacts include direct harms from unnecessary use of drugs (all drugs have potentially harmful side-effects), and reliance on drugs rather than safer and more effective alternatives such as exercise and sensible diet, which often play a role in the prevention and control of multiple diseases, not just the one targeted by a particular drug.

There are significant problems with the quality of information in advertisements and promotional materials targeting doctors (Loke et al. 2002; Stryer & Bero 1996; Wilkes, Doblin, & Shapiro 1992). In particular, benefits of drugs are overstated, and risks understated. Despite their medical education, doctors need training in ‘separating the wheat from the chaff’ (Shaughnessy & Slawson 1994). It therefore seems unrealistic to expect consumers to be able to make genuinely informed choices.

Direct negative economic impacts include costs to the consumer, potentially at the expense of adequate food, housing, and other factors that affect health, and costs to the government or insurance provider. With the escalating costs of drugs threatening the viability of public subsidy schemes such as the Pharmaceutical Benefits Scheme (PBS) (Goddard, Henry, & Birkett 2001), economic costs also potentially translate into health costs. A particular concern is ‘leakage’ – prescribing for patients without indications for which drugs have been listed on the PBS (Henry & Birkett 2001; Harvey 2002).

The medicalisation of everyday problems is also a key issue. Shyness is transformed into social phobia, to be treated with antidepressants. Baldness and erectile dysfunction are similarly turned into diseases to be medicated (Moynihan et al. 2002).

In relation to doctor-patient relationships, as mentioned above, DTCA encourages people to consult doctors. However, it also encourages them to ask for specific drugs (Kravitz 2000). According to Mintzes et al. (2002, p. 279):

Patients’ requests for medicines are a powerful driver of prescribing decisions. In most cases physicians prescribed requested medicines but were often ambivalent about the choice of treatment. If physicians prescribe requested drugs despite personal reservations, sales may increase but appropriateness of prescribing may suffer.

Patients sometimes change doctors if their requests are refused (Bell, Wilkes, & Kravitz 1999), which can lead to disruptions in ongoing medical care.

Doctors are trained as medical experts, but they are also trained to empathise with patients. When they encounter patients requesting a specific drug, either by name or by implication (e.g. ‘that new arthritis drug’), they can experience significant conflict, particularly if they have previously developed positive relationships with patients (and often their families). Patients who have previously made appropriate requests may now ask for drugs that their doctors do not think are warranted. In other cases, doctors may be pleased to see previously passive patients actively engaging in their own health care. Furthermore, doctors are under significant pressure to maximise their throughput of patients. A patient requesting a specific drug is likely to be satisfied very quickly by a prescription for that drug. Also doctors may believe in the power of the placebo: if a patient has already been convinced that a drug is effective, this belief may make it effective.

De facto DTCA

In many countries, including Australia, de facto DTCA increasingly occurs in the form of ‘unbranded’ advertisements about specific diseases and conditions (Yates 1998), in which in high-profile drugs such as Viagra and Xenical are not mentioned by name but are commonly recognised by the public. Unbranded advertisements often include web addresses, and the websites often include information such as how to raise potentially embarrassing issues with doctors.

Another common strategy is disease awareness campaigns. They often involve doctors and consumer groups:

Within many disease categories informal alliances have emerged, comprising drug company staff, doctors, and consumer groups. Ostensibly engaged in raising public awareness about underdiagnosed and undertreated problems, these alliances tend to promote a view of their particular condition as widespread, serious, and treatable. Because these “disease awareness” campaigns are commonly linked to companies’ marketing strategies, they operate to expand markets for new pharmaceutical products. (Moynihan et al. 2002, p. 886)

Celebrity endorsements are also used. For example, in May 2002, Camilla Parker Bowles spoke about osteoporosis at an international meeting in Portugal. She received no funding from pharmaceutical companies, but the meeting and a report she promoted were both partly sponsored by a company with a new osteoporosis drug (Moynihan 2002).

Mainstream media often publish or broadcast news and current affairs reports that are little more than free advertisements for new drugs. They are often based uncritically on skilfully prepared media releases from pharmaceutical companies. They often contain emotive language such as ‘New hope for [disease] sufferers’, and ‘Breakthrough in the fight against [disease]’. A common plot is:

Doctors are hailing a breakthrough in the treatment of [disease]. Until now, the only options have been drugs X and Y, both of which have troubling side-effects. A new drug Z, 10 years in development, is set to change all this. Doctors say it is safer, more effective….

The news reports generally show emotive images (sick child, disabled elderly person, impressive-looking medical equipment etc.). Often a relevant medical specialist is briefly interviewed to add professional credibility.

The fact that the new drug is often much more expensive than the older drug is rarely reported, nor the fact that it will not be possible to know for several years whether it has any serious long-term effects. Its short-term side-effects might be mentioned, but are likely to be glossed over. Overall, according to Moynihan et al. (2000, p. 1645):

News-media stories about medications may include inadequate or incomplete information about the benefits, risks, and costs of the drugs as well as the financial ties between study groups or experts and pharmaceutical manufacturers.

Case study 1: Viagra

One lifestyle drug that has been a very prominent focus of DTCA is Viagra. A 1999 advertisement in the New Zealand newspaper The Dominion displayed a photo of a middle-aged couple cuddling in bed, under the caption ‘Bring back the spark that made you both so happy’. The advertisement was clearly suggesting that they had just had successful coitus. According to Mansfield (2000), the advertisement overstated the magnitude of the problem of erectile dysfunction, overstated the efficacy of Viagra, and understated its risks.

There has been considerable de facto DTCA of Viagra in Australia. One two-page unbranded magazine advertisement in the Qantas magazine in November 2001 showed a couple closing their hotel room door, with the text: ‘Your doctor can treat your erection problems. The rest is up to you’. Pfizer, the makers of Viagra, also use celebrity endorsement in newspaper advertisements featuring the legendary soccer player Pelé advocating consulting a doctor about erection problems:

[large photo of man apparently in his 40s]

One in three men have Erection Problems. Until last week he was one of them.

Once he talked to his doctor, he discovered that Erection Problems are a common medical condition that can be successfully treated. If you have Erection Problems, see your doctor. Or, for a confidential discussion or a free video and booklet, phone 1800 800 614 or visit the website below.

“I would.” Pelé

“ATHLETE OF THE CENTURY”

Call 1800 800 614 or visit www.impotenceaustralia.com.au

[small photo of Pelé]

Pfizer

Better love life.

Better you.

(The Advertiser, Saturday 2 November 2002, p. 32)

The apparent age of the man in the larger photo is significant. According to Pinnock et al. (1999, p. 353), ‘Erections inadequate for intercourse affected 3% of 40-49-year-olds’, and only 7.3% reported ‘erections less than half the time when wanted’ – a far cry from one in three.

Viagra is not mentioned in the advertisement, nor on the main webpage of Impotence Australia, but it is mentioned in some of their newsletters, as is Cialis, a newer, longer-lasting drug which is now being vigorously promoted to consumers. Eli Lilly used its secondary sponsorship of Team New Zealand’s recent ill-fated defence of the America’s Cup to promote Cialis (Tunnah 2003).

Medical experts are also being used in disease awareness campaigns for these drugs. Dow (2003) reported on a recent tour by urologist Gerald Brock:

Brock, whose current Australian tour is sponsored by Eli Lilly and GlaxoSmithKline, says epidemiological studies estimating that two million Australian men have erectile dysfunction is probably a conservative estimate. Sociological studies have shown men who are unable to sustain an erection are more likely to suffer depression than men with fulfilling sex lives, and encounter more relationship difficulties with partners.

There is a strong implication that erectile dysfunction causes depression and relationship difficulties, yet the unnamed sociological studies probably report correlations, which cannot prove causation. There is no mention of the fact that sexual dysfunction may be caused by depression (Lue 2000, p. 1803) or by antidepressants (Rothschild 2000). Furthermore, advertisements and media reports about erectile dysfunction rarely mention common causes of erectile dysfunction such as excessive alcohol intake, smoking, obesity, lack of exercise, and prescribed drugs (Pinnock et al. 1999; Morgentaler 1999; Keene & Davies 1999).

Women are not being ignored in these marketing strategies. Moynihan (2003, p. 45) triggered debate in the medical literature and the media by criticising the ‘corporate sponsored creation… of female sexual dysfunction’. According to Moynihan (p. 45), ‘researchers with close ties to drug companies are working with colleagues in the pharmaceutical industry to develop and define a new category of human illness at meetings heavily sponsored by companies racing to develop new drugs’.

Case study 2: Xenical

Another high-profile de facto DTCA drug in Australia is Xenical, advertisements for which do not mention the drug, but do include the Roche company name and pill-shaped logo, and encourage people to consult their doctor. Glossy trifold brochures about Xenical have been displayed in pharmacies for customers to pick up. The front panel shows:

Linda is 30kg lighter and a whole lot wiser

[photo of attractive young woman in swimming pool]

[solid green rectangle]

Lose weight.®

Gain life.

Inside is information about overweight and associated risks, and weight-loss options. There are questions for readers to answer about their weight, and the instruction to ‘Take this form to your doctor or show it to your pharmacist. This information will enable them to help you lose weight and gain life’. There is no mention of the unpleasant side-effects, including flatulence and diarrhoea.

There are further problems with explicit Xenical advertisements. According to Galbally (2000/2001, p. 54):

In New Zealand, where advertising has not been prohibited, examples are emerging of the subtly misleading way in which advertising can make truthful statements. Such statements are not permitted to be misleading under trade practices legislation, but it takes argument and regulatory effort, after the event, to prove they are misleading despite being truthful. For example, Xenical (weight reduction treatment) was said, in the advertisement, to be twice as effective as diet alone. This is misleading because diet alone, without exercise, is broadly ineffectual. Twice zero is still zero, but that is an oversimplified statement and the argument has to be explained in terms of the need to apply a better control, like other measures in combination with diet, compared with diet alone. The message of advantage is already in the public arena.

Case study 3: Prilosec and Nexium

Omeprazole, a ‘blockbuster’ drug for gastric reflux (heartburn), had been heavily promoted in the US through DTCA, firstly as Prilosec, then as Nexium (‘the new purple pill’) when the Prilosec patent approached expiry (Swidey 2002). In 2000, AstraZeneca, spent US$107.5 million on DTCA of Prilosec, for which sales in 2001 were US$5.68 billion in 2001 (Families USA 2002, p. 15). In 2000, General Motors (US) spent US$52 million on Prilosec for its employees and retirees, much more than it believed it should have spent (Noonan 2001, p. 46).

Stylish advertisements for Nexium have frequently appeared on the New York Times website, among others, offering free samples. In 2001, Nexium was also advertised on an Australian website, Public Debate (2001):

CLICK HERE TO GET YOUR PERSONAL FREE 7-DAY TRIAL CERTIFICATE.

AstraZeneca, makers of Prilosec® (omeprazole), would like to introduce you to NEXIUM (esomeprazole magnesium), the new purple pill. That’s why we’re offering a certificate good for a free 7-day trial of this new prescription medicine.

Case study 4: Celebrex

In the US in 2000, Searle spent US$78.3 million on DTCA of Celebrex, sales of which were US$2,015.5 million in 2000 (Families USA 2002, p. 15).

Celebrex was the subject of a major de facto DTCA campaign in Australia, with television advertisements showing middle-aged people running then hobbling along a beach. According to Harvey (2002):

In 2000, the PBAC recommended that…Celebrex should initially be priced at $1.00 a day, with the government negotiating a contract to halve the price once an agreed number of scripts had been issued. The Pharmaceutical Benefits Pricing Authority was apparently unable to get the manufacturer to accept the PBAC’s advice. Instead of supporting the PBAC, the then Health Minister, Dr. Michael Wooldridge, accepted the Pricing Authority’s recommendation to charge patients $1.20 a day with no cap on the numbers of scripts issued. Listing Celebrex on the PBS was estimated to cost about $50 million per year. However, following an extensive promotional campaign by the manufacturer, Celebrex cost the PBS $100 million in the first five months alone… and pharmacists commented that it was being prescribed for a variety of minor complaints including strains, sprains and sports injuries.

The use of Celebrex for minor complaints is a striking case of leakage, clearly driven by DTCA.

Case study 5: Antidepressants

Antidepressant consumption increased nearly three-fold in Australia between 1990 and 1998 (McManus et al. 1999: 458). Most of the increase has been in the uptake of selective serotonin reuptake inhibitors (SSRIs), most notably Prozac. Like most new classes of drugs, SSRIs were significantly more expensive than their predecessors. Antidepressants are one of the most costly categories of drugs in many countries, and in Australia they impact significantly on the Pharmaceutical Benefits Scheme. Sertraline (Zoloft) was the eighth most costly drug to the government in 1998 (Commonwealth Department of Health and Aged Care, p. 20, Table D). 1,455,271 PBS and RPBS scripts were dispensed, costing the Government $45,174,008.

Not surprisingly, antidepressants are also prominent in terms of DTCA: Paxil (paroxetine), the eighth largest selling drug in the US in 2000 had the fourth highest expenditure (US$91.8 million) (National Institute for Health Care Management 2001, p. 7) and US$1808.0 million in sales (p. 8). Prozac and other antidepressants are advertised extensively in magazines (particularly women’s magazines) and on television, sometimes using celebrity endorsement:

United States professional football sensation Ricky Williams last week sparked a blaze of publicity when he revealed that he had social anxiety disorder and was benefiting from both therapy and Paxil (Seroxat/paroxetine), the drug that earned GlaxoSmithKline global sales last year of US$2.7bn (Moynihan 2002, p. 286)

A more extreme form of promotion occurred in 2002, with unsolicited samples of Prozac Weekly being mailed to people in Florida (Stagg-Elliot 2002). The mailout was jointly organised by Eli Lilly, a medical organisation, and a drugstore chain.

Media reports play an important role in the promotion of antidepressants. According to Moynihan et al. (2002, p. 888):

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. . . . At that time, government figures suggested the number of people with the disorder might be closer to 370 000.

In a surprisingly frank admission 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 (p. 888)

Other antidepressants are now being promoted for the treatment of social phobia and other anxiety disorders. A major reason is that many of the best-selling antidepressants have reached or are approaching the limits of their patent protection. It is not unusual for drugs at that stage be promoted via DTCA for new indications (Frank et al. 2002, p. 3). A prominent case is the reformulation of Prozac as Sarafem for premenstrual dysphoric disorder (PMDD). Sarafem is patent protected until 2007 (Rebensdorf 2001).

Antidepressant manufacturers have also benefited from some literary de facto DTCA. In 1993, Peter Kramer’s Listening to Prozac: A psychiatrist explores antidepressant drugs and the remaking of the self, argued that Prozac can make people ‘better than well’ (x). More recently, Andrew Solomon’s (2001) The Noonday Demon, defended antidepressants against: ‘an industry of Prozac detractors who misrepresent the drug as a grave peril that is being foisted on an innocent public’ (p. 81). Solomon’s father is chief executive of Forest Laboratories, US distributors of Celexa (citalopram), a high-profile SSRI (Oransky 2001; Forbes.com 2004).

Conclusion

DTCA is a potent marketing strategy that is skilfully utilised by the pharmaceutical industry. Although explicit DTCA is illegal in most industrialised countries, de facto DTCA is well established in many countries, including Australia.

DTCA advocates and critics both focus primarily on purported health and economic benefits and risks, but are in polar opposition on the net balance. The case studies presented here illustrate key aspects of DTCA and de facto DTCA, including the focus on lucrative ‘lifestyle drugs’, the use of celebrity endorsement, the use of free samples, and the use of the media to provide effectively free advertising.

Industry arguments that DTCA provides valuable health education to consumers are not supported by the content of DTCA. Information about potential causes of disorders such as erectile dysfunction is notably omitted, as is information about non-pharmaceutical treatments. Benefits of the advertised drugs are overstated and risks understated. Furthermore, the selection of drugs for DTCA is clearly linked much more strongly to commercial imperatives than to consumer health needs. Overall, there is a glaring gap between industry rhetoric and DTCA reality.