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Twelve Years’ Experience with Direct-to-ConsumerAdvertising of Prescription Drugs in Canada: ACautionary Tale Barbara Mintzes1*, Steve Morgan2, James M. Wright3 1 Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, Canada, 2 School of Population and Public Health and Centre for Health Services and Policy Research, University of British Columbia, Vancouver, Canada, 3 Departments of Anesthesiology, Pharmacology and Therapeutics and Medicine, University of British Columbia, Vancouver, Canada Background: Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protectionmeasure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow ‘reminder’advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. ‘Reminder’advertising is prohibited in the US for drugs that have ‘black box’ warnings of serious risks. This study examines spending onDTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares tothat in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public inreminder advertising.
Methodology/Principal Findings: Prescription drug advertising spending data were extracted from a data set on healthsector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflationand compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 millionper year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% ofspending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which hasa US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadiantelevision in 2005 and 2006. Of 8 brands with .$500,000 spending, which together accounted for 59% of branded DTCA inall media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings.
Conclusions/Significance: Branded ‘reminder’ advertising has grown rapidly in Canada since 2000, mainly due to a growthin television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidenceof safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. Forgovernments searching for compromise solutions to industry pressure for expanded advertising, Canada’s experiencestands as a stark warning.
Citation: Mintzes B, Morgan S, Wright JM (2009) Twelve Years’ Experience with Direct-to-Consumer Advertising of Prescription Drugs in Canada: A CautionaryTale. PLoS ONE 4(5): e5699. doi:10.1371/journal.pone.0005699 Editor: An-Wen Chan, Mayo Clinic, United States of America Received January 8, 2009; Accepted April 30, 2009; Published May 27, 2009 Copyright: ß 2009 Mintzes et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permitsunrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: No specific funding - general University of British Columbia. The funders had no role in study design, data collection and analysis, decision to publish,or preparation of the manuscript.
Competing Interests: Dr. Mintzes has acted as a consultant for the Canadian government in a legal case on direct-to-consumer advertising (DTCA) in which amedia company, CanWest, is challenging the federal prohibition of DTCA.
* E-mail: Barbara Mintzes bmintzes@chspr.ubc.ca The Canadian government has hosted several national Similarly to all industrialized countries except the United States consultations on DTCA and introduced two major shifts in (US) and New Zealand, Canada prohibits direct-to-consumer administrative policy. First, a 1996 Health Canada advertising advertising (DTCA) of prescription drugs. However, Canada policy statement [3] redefined the boundary between ‘information differs from most other countries that prohibit DTCA in that there dissemination’ and ‘advertising.’ The redefinition appears to have is considerable population exposure to this advertising in US provided tacit government approval for unbranded ‘disease- media. Around 30% of English-speaking Canadians’ television oriented’ advertisements [4]. These advertisements mention a viewing is of US satellite and cable TV, which carries DTCA that condition and suggest viewers or readers ‘ask your doctor’ about available treatments but do not mention any brands [5].
Canada has experienced pressure for legislative change to Second, in November 2000, Health Canada published an introduce DTCA since the mid 1990’s. For example, Merck Frosst administrative policy paper that allowed branded ‘reminder argued in a 1996 submission to Health Canada that the industry advertisements’ targeting the general public [6]. A reminder ad had a legal right to advertise under freedom of expression is a form of DTCA that states a brand name but does not mention the product’s indication or make health claims. The November 2000 policy paper cited a 1975 regulatory amendment [7] (Food & excluded from our analysis. We also excluded brands that are Drugs Act, C.01.044) that was introduced to allow advertising of available as both over-the-counter and prescription-only formula- drug prices and, as described by Health Canada in 1984, thereby ‘‘to facilitate comparative shopping’’ [8].
Advertisements were classified as ‘unbranded prescription drug Branded reminder ads rarely if ever state a product’s price.
advertising’ if the advertiser was a pharmaceutical company that However, Health Canada judged reminder ads to be legal under sells prescription-only drugs in Canada and no brand name was the price advertising provision because advertising to the public of mentioned. This includes both corporate image advertising and ‘name, price and quantity’ is allowed. This regulatory approach is condition-related entries. An example of the latter type of entry is unique: Canada is the only country that prohibits DTCA yet ‘acid reflux information’ with Astra Zeneca listed as the advertiser.
makes an exception for branded reminder advertising. Reminder Annual spending for 1995 to 2005 was adjusted for inflation and advertisements are prohibited in all other developed countries that converted into year 2006 Canadian dollars using the within ban DTCA. Moreover, although in general the US allows country Consumer Price Index (all items). US figures were prescription drug advertising to the public, the US FDA imposes converted to Canadian dollars, using year-2006 Purchasing Power restrictions on reminder advertising. These restrictions apply both to ads targeting the public and professionals: no reminder ads are We obtained a list of US drugs with black box warnings from a allowed for drugs with a ‘black box’ warning — the strongest US dedicated website, http://formularyproductions.com/blackbox/, regulatory warning of serious harmful effects [5]. The US email: , and checked the labels of all identified products on the US restrictions apply both to products within a class with a boxed FDA website’s search engine, drugs@fda, url: . Health Canada’s warning extending to all members of the class (e.g. non-steroidal safety advisories were obtained from an e-mail subscription service anti-inflammatory drugs and the risk of gastro-intestinal bleeding), (MedEffect e-Notice) and confirmed on Health Canada’s website: and to product-specific warnings. The rationale for this prohibi- http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index- tion is public safety, as reminder advertising fails to provide information on product risks. Canada does not impose analogouslimitations on reminder advertising, and also does not have a system of ‘black box’ warnings. However, Health Canada sendsout safety advisories to the public and health professionals when Figure 1 presents an overview of inflation-adjusted spending on new evidence of product risks emerges post-approval.
branded advertising in outdoor, print and broadcast media. Totalinflation-adjusted spending on branded DTCA in Canada grew from under $2 million per year prior to 1999 to over $22 million in2006. The major growth in spending in branded advertising has There is no published research, beyond anecdotal reports, on been in broadcast media, reaching 83% ($18.4 million) of the experience with DTCA in Canada since the administrative policy changes in 1996 and 2000. We therefore aimed to describe Most of the spending on broadcast advertising has been on annual spending on branded and unbranded advertising by television ads ($15.5 million in 2006, or 84% of broadcast prescription drug manufacturers in Canada from 1995 to 2006, spending). There was no television DTCA from 1995 to 1997, and and to compare spending over this period to US DTCA spending.
television represented only 5% of branded advertising spending in This 12-year period was chosen to span Health Canada’s policy 1998 and 19% in 1999. However, branded television advertising changes and, in particular, to provide a time period before and became prominent from 2000 onwards, ranging from 34% to 70% after the year 2000 policy shift regarding branded advertising.
of total branded advertising spending.
In addition to looking at overall levels and trends in spending on From 1995 to 2006, the pharmaceutical industry spent $98.75 Canadian DTCA, we focused on heavily advertised products in million on unbranded pharmaceutical advertising in Canada — terms of conditions treated and whether or not these products had see Table 1. From 1995 to 2000, spending on unbranded ads in been subject to regulatory warnings of serious risks, including US Canada was three or more times the spending on brand-specific ‘black box’ warnings or Health Canada safety advisories.
ads. From 2002 onwards, annual spending on branded reminderads in Canada was consistently higher than on unbranded ads.
A total of CAD$191.23 million was spent on branded and We obtained data from a market research company, TNS unbranded DTCA in Canada between 1995 and 2006. Over the Media Inc., which tracks advertising spending in the US and same period, CAD$36.19 billion was spent on DTCA in the US.
internationally. Data were obtained covering all health sector Even on a per capita basis, DTCA spending in Canada was much spending in Canada on television, radio, magazines, newspapers lower than in the US during the entire time period. However, in and outdoor billboards for a 12-year period, from 1995 to 2006 relative terms DTCA spending in Canada has grown more rapidly (n = 12,372 entries) Data were also obtained from TNS Media on since 2001 than DTCA spending in the US. Spending in 2006 was US DTCA spending, with all media combined, from 1997 to over double the amount spent in 2001; whereas US spending 2005. We used published US data on DTCA spending for 1995 increased by 66% over the same time period.
[9] and 1996 [10] and IMS Health data for 2006 [11]. These three DTCA spending in Canada is highly concentrated on relatively sources all report on data obtained from TNS Media or few products, particularly early in the period being analyzed. Only Competitive Media Reporting (a company that was bought by one product per year was advertised in 1995 and 1996; this grew TNS Media in 2000). The US data cover all types of DTCA: full to 7 products in 1999, 13 in 2003 and 20 in 2006. In total, 48 product advertising (with both brand names and health claims), brands were advertised to the public over the 12-year period.
reminder advertising, and unbranded ‘help-seeking’ ads.
Spending on prescription drug advertising was extracted manually by product and manufacturer name. All brand names were checked against Health Canada’s Drug Product Database so Table 2 lists the top 15 products by advertising spending from that vaccines, over-the-counter drugs and medical devices could be 2001 to 2006, representing 99% of spending within this time Figure 1. Inflation-adjusted spending on branded direct-to-consumer advertising, 1995 to 2006 (year-2006, CAD$ millions).
doi:10.1371/journal.pone.0005699.g001 Table 1. Inflation-adjusted spending on DTCA in the U.S. and Canada, all media, 1995 to 2006 (CAD$ millions)*.
CAD# DTCA CAD spending CAD spending CAD = Canada; USA = United States.
*inflation-adjusted spending expressed in equivalent of year-2006 dollars.
{includes both unbranded disease-oriented advertising and corporate image advertisements.
**US data converted to CAD$, using year-2006 Purchasing Power Parity (general GDP PPP).
References, US data: 1995: Rosenthal et al. 2002 [8], calculated from Figure 1; 1996: Donohue et al. 2007 [9]; 2006: IMS Health. Total US promotional spend by type, 2007.
www.imshealth.com/deployedfiles/imshealth/Global/Content/StaticFile/Top_Line_Data/PromotionalSpendChartWebsite.pdf.
All other Canadian and US data from TNS Media Inc.
doi:10.1371/journal.pone.0005699.t001 period, and 95% of spending from 1995 to 2006. Viagra estradiol), which is not approved in the US, has been subject to (sildenafil) tops the list and is responsible for 26% of spending two safety advisories in Canada [13,14]. It is indicated in Canada as a second line treatment for severe acne in women.
These advertised products are also concentrated within relatively few indications: 9 of the 15 are contraceptives, impotence or acne treatments. Pfizer is responsible for 44% ofspending, on three products, from 2001 to 2006. In 2006, Although Canada’s Food & Drugs Act clearly states that Celebrex (celecoxib) was the most heavily advertised medicine advertising of prescription-only drugs to the public is prohibited, the pharmaceutical industry has spent over CAD $90 million onbranded advertising in Canada from 1995 to 2006. Almost all(88%) of this spending on branded advertising occurred after Health Canada stated in 2000 that branded reminder advertising Table 3 lists all of the medicines advertised on television during was consistent with a regulatory amendment created to encourage 2005 and 2006. Advertising was concentrated on eight brands for price competition in the 1970s. This interpretation in effect which advertising spending exceeded CAD$500,000 during either created a regulatory loophole allowing reminder advertising to 2005, 2006, or both of these years. In contrast, spending on each of the remaining 11 ‘minimally advertised’ brands was less than The growth in advertising spending since the year 2000 strongly suggests that policy decisions regarding Canada’s regulatory Seven of the eight brands heavily advertised on television in provisions matter. Advertisers may not have been as willing to Canada during 2005 or 2006 are approved for sale in both spend the large sums required to produce broadcast (particularly countries, and four (57%) have US black box warnings. Together television) ads if Health Canada’s policy statements had not these eight brands represent 99.7% of television advertising and provided some assurance that government would allow branded 59.2% of total branded DTCA spending over these two years. In three cases, the warnings are for risks shared by the entire drug The safety profile of the products that have been heavily class: cardiovascular risks associated with use of estrogen- advertised raises a further note of caution. Many of the drugs containing contraceptives in women who smoke and are over 35.
featured in reminder advertising have been subject to Canadiansafety advisories and to US ‘black box’ warnings.
The most heavily advertised product in Canada during 2006 In total, five of the eight heavily advertised products in 2005 and was Celebrex (celecoxib). Celecoxib is a cox-2 selective inhibitor.
2006 were subject to Health Canada safety advisories, excluding a Similarly to rofecoxib, celecoxib is associated with increased warning about counterfeiting of atorvastatin (Lipitor). In addition cardiovascular risks in a dose-related manner [15]. Health Canada to celecoxib and the contraceptive patch, Health Canada also sent issued its first safety advisory on celecoxib in 2002 [16], warning out a joint warning of visual adverse effects for three erectile physicians of similar risks of gastrointestinal bleeding to other non- dysfunction drugs in the same class: sildenafil, vardenafil and steroidal anti-inflammatory drugs. A 2004 advisory focused on tadalifil [12]. Another product, Diane-35 (cyproterone and cardiovascular risks [17], and in 2005, Health Canada warned Table 2. Top 15 brands by advertising spending, all media, 2001–2006.
LNG = levonorgestrel; EE = ethinylestradiol.
*Bayer acquired Berlex in 2007.
doi:10.1371/journal.pone.0005699.t002 Table 3. Safety advisories and black box warnings: products advertised on television, 2005 and 2006.
Tri Cyclen Lo / Tri Cyclen (norgestimate/EE) Minimally advertised (annual spending ,$30,000) Packaging problem, mixed with another -product (2005) physicians not to prescribe this drug to patients with heart disease failed to prevent advertising of products with a serious potential and recommended restricting prescriptions to : ‘‘… the lowest possible dose, and for the shortest, necessary period of time’’ [18].
The US industry association, PhRMA, announced self-regula- The heaviest advertising spending in Canada on celecoxib was in tory guidelines in July 2005, prohibiting television reminder 2006, after this advisory. Celecoxib was also advertised to the US advertising [22]. Coming six months after rofecoxib’s withdrawal, these guidelines have been interpreted as a response to the safety In 2005, Janssen-Ortho spent CAD $2.1 million advertising the concerns raised about the effects of DTCA following rofecoxib’s contraceptive patch Evra (norelgestromin/ethinyl estradiol) to the withdrawal [23]. There are no published evaluations of the impact Canadian public. Evra’s US black box warning is a class warning of these guidelines in the US. In Canada, spending on televised for all estrogen-containing contraceptives, but the patch has also reminder ads increased in 2006. All of the manufacturers with been found to have a higher dose of estrogen than expected, spending over $500,000 are Canadian subsidiaries of PhRMA leading to increased risks of venous thromboembolism. The FDA members or, in one case, the Canadian subsidiary of a European has sent out an advisory and required a labeling change as a result company with a US subsidiary that is a PhRMA member.
[19]. Excess risks of venous thromboembolism also spurred Health Despite the rise in spending in Canada during recent years, the Canada to send out two safety advisories warning physicians not to volume of advertising pales in comparison with the US. US prescribe Diane-35 (cyproterone/ethinyl estradiol) for contracep- advertisers spent on average 24 times the amount spent per capita tion or mild acne [13,14]. Although this product is only approved in Canada: a total of CAD $36.187 billion from 1995 to 2006.
as a second-line treatment for severe acne, it has been widely Additionally, although per capita spending is increasing in prescribed for unapproved uses: 45.5% of women in British Canada, annual growth is much lower in absolute terms than in Columbia who obtained initial prescriptions from1998 to 2003 the US: on average CAD $0.12 per year from 2001 to 2006, versus had no evidence of acne diagnosis or treatment within the previous CAD $1.53 in the US. Thus if current trends in both countries year [20]. Health Canada judged advertisements for Diane-35 to continue unchanged, exposure levels would be expected to remain be illegal, but found it difficult to prevent repeat violations [8].
These examples highlight the disconnect between marketing In the US, full product ads are the most common form of decisions to run DTCA campaigns aiming to stimulate sales and televised DTCA [24,25]. Because of their extra length, they are regulatory warnings attempting to limit use. Topol faulted the more expensive than reminder ads. If companies choose this form US FDA for allowing intensive DTCA for Vioxx (rofecoxib) of advertising for brands that can be legally advertised through despite mounting evidence of cardiovascular toxicity [21]. Our reminder ads, it is likely because of a stronger observed effect on analysis indicates, similarly, that regulators in Canada have Donohue and colleagues reviewed the experience with US in response to differences in provincial formulary listings for some DTCA from 1996 to 2005 [10]. In addition to the higher spending advertised drugs. Additionally, as all publicly reported US data on levels, a much broader range of products has been advertised to DTCA spending derive from TNS Media, we could not check the public in the US than in Canada over this period. The drug accuracy against another source. It was not always possible to classes with over 30% of promotional spending dedicated to distinguish corporate image advertisements from unbranded DTCA included statins, proton pump inhibitors and erythropoi- ‘disease-oriented’ ads; spending on unbranded DTCA is therefore etin products. The latter are used to avoid the need for likely to be an overestimate. Additionally, although the US transfusions in cancer patients undergoing chemotherapy. A US restricts reminder advertising of drugs with black box warnings on Congressional hearing critiqued unsubstantiated claims of reduced public health grounds, there has been no evaluation of the health fatigue and improved quality of life in DTCA promoting these agents for chemotherapy patients [26]. The US FDA issued ablack box warning for the class in 2007 of increased mortality, serious cardiovascular and thromboembolic risks, and tumour This review of 12 years of advertising spending in Canada is a progression or recurrence, particularly when used in patients with sobering reality check: many of the most heavily advertised haemoglobin levels over 12 g/dL [27]. The experience with products have been subject to regulatory warnings of serious risks.
erythropoietin illustrates a key concern about the effects of DTCA If public health is to be taken seriously, Canada’s government on public safety. Many prescription medicines are potentially needs to take action to stop reminder advertising. It makes no hazardous and must be used judiciously in order to ensure that for sense to send out safety advisories telling physicians to prescribe a a specific patient, the potential for benefit outweighs the drug cautiously because of serious risks and then, using a probability of harm. This need for limited use is at odds with regulatory loophole created to foster price competition, to turn a advertisers’ imperative to stimulate expanded sales.
blind eye to persuasive advertisements that make the same drug Despite the legal requirement for risk information in US full look like an effortless key to happiness and good health. The product advertising, provision is often inadequate. Minimization suggestion to ‘ask your doctor’ is no guarantee that the viewer is or omission of risks is the most frequent US regulatory violation, protected, as doctors often prescribe medicines that patients repeat violations are common, and as DTCA volume hasincreased over time, the proportion of ads the FDA is able to request although they might not have otherwise chosen to do so There is also evidence of poor communication of harmful effects In 2003 and early 2004, Canada’s parliamentary health in advertising that meets regulatory requirements. Adults with low committee held hearings across the country on pharmaceutical literacy who were tested for comprehension of information in policy, including DTCA. The committee highlighted the problem television ads scored much lower on risks than benefits [29]. In a of reminder advertising, stating that: ‘‘any direct-to-consumer systematic sample of magazine ads for HIV/AIDS drugs, 55% of advertising, including reminder ads, could contribute to increased or drugs with black box warnings or life-threatening harmful effects inappropriate drug consumption’’ [34]. Since this committee’s investi- provided incomplete information on these risks, and 48% failed to gation, spending on DTCA in Canada has more than doubled.
highlight them graphically [30]. Content analyses of systematic The US experience of widespread harm associated with the use of samples of DTCA have found that most ads fail to provide the the heavily advertised arthritis drug Vioxx (rofecoxib) [35] has also information needed for shared informed treatment choice [31], led to proposals for restrictions on DTCA as public safety benefits are described in vague, emotive terms [32] and emotional measures, such as the Institute of Medicine’s recommendation for appeals such as happiness, control over one’s life and social a 2-year moratorium on advertising of new drugs [36].
The experience in Canada provides a cautionary tale for In sum, the US experience illustrates why allowing full product governments in the European Union and elsewhere who are advertising is not a solution to Canada’s problem of reminder attempting to juggle industry demands for greater ability to advertising for drugs with serious risks. Neither the inadequate ‘inform’ the public about their medicines with public, professional communication of risks nor the negative consequences of and parliamentary reluctance to introduce ‘US-style’ prescription stimulating use of products with a serious potential for harm would be resolved. From a public health perspective, a betterapproach would be to address the problem directly, by closing the regulatory loophole that has allowed this advertising to flourish.
This study has several limitations. Our results are purely We would like to thank Stephen Adams and Jennifer Evans for theirassistance with data extraction.
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