COMMUNICATION OF RISKS AND SIDE EFFECTS IN PRESCRIPTION MEDICINE ADVERTISING
Janine Anthony, Janet Hoek and Judith Holdershaw
Track: Advertising / Marketing Communication Issues
Key Words: Direct to Consumer Advertising; Prescription Medicines; Marketing
At present, only New Zealand and the United States permit direct to consumer advertising (DTCA) of prescription medicines. This advertising remains highly controversial for many reasons (Lexchin and Mintzes 2002), including the alleged lack of balance between risk and benefit information. To address this problem, advertisers could either provide more information or make the information currently provided more accessible. Because earlier researchers suggested increases in the level of information could depress recall, this research explored the latter option: how varying the mode and presentation of drug information affected recall of a medicine’s risks and side effects. Four advertisements, including a control and three versions that re-formatted information, introduced a voice-over, and increased the length of time allocated to the end-screen were developed for an anti-allergy medication, Flonase®. These were embedded in a commercial pod and shown to independent samples of between 97 and 141 respondents recruited from local affinity groups.
Re-formatting the information and reducing the level of technical detail had little effect on recall of risk details. However, the introduction of a voice-over had a highly significant effect on recall of all four risks and side effects, although increasing the length of the end screen from 5 to 15 seconds had little effect once the voice-over had been included. This work has important public policy implications and, should DTCA continue, voice-over presentation of risk and side effect details should become a mandatory element of all television advertisements for prescription medicines.
Only New Zealand and the United States currently permit direct-to-consumer advertising (DTCA) of prescription medicines. However, in both countries DTCA evolved by chance rather than design, as statutes regulating the approval and promotion of medicines did not specifically prohibit it. Morris & Griffin (1992) suggested DTCA came about because pharmaceutical companies now find it increasingly difficult to reach and influence doctors, and thus seek to communicate directly with consumers. Sheffet and Kopp (1990) and Levitt (1995) also argued that
ANZMAC 2003 Conference Proceedings Adelaide 1-3 December 2003
financial imperatives have prompted the drug companies to undertake DTCA as a means of recouping their expensive research and development investments. By contrast, proponents of DTCA have argued that this advertising increases patients’ ability to play an active role in their health care management and improves their compliance with existing treatment programmes (RMI 2000; Calfee 2002). Whether the motives underpinning DTCA are altruistic, financial or some combination of both, this advertising has generated considerable controversy in both New Zealand and the United States. Several researchers have questioned the effects of DTCA on patient-doctor relationships, arguing that it undermines the trust that typically exists between doctors and their patients (Maguire 1999; Mansfield 1999; Reast & Carson 2001; Lexchin & Mintzes 2002; Coney 2002; Toop et al 2003). In particular, they suggest some patients might demand medicines that may not suit them or believe that drugs rather than lifestyle changes will best address their condition. Some have also argued that patients might become anxious about the suitability of their current medication (Morris, Brinberg, Klimberg, Rivera & Millstein 1986; Davis 2001; Coney 2002; Findlay 2002; Mintzes et al 2002). As well as alleging a lack of balance in DTCA promotions, opponents of this advertising have also claimed that lay consumers lack the knowledge necessary to understand and interpret DTCA (ACP & ASIM, 2001). Pointing out that only those with detailed technical training can appreciate the interaction between the promoted drug and any other medication patients may take, Mansfield (1999) noted that some patients might fail to appreciate the risks associated with advertised medicines (see also Wilkes et al, 2000). While some of the arguments advanced represent a philosophical opposition to DTCA, others cite the lack of information provided, particularly about risks and side effects, as misleading and ultimately detrimental to patients. More specifically, the emotional appeals used in some advertisements, together with a lack of detailed risk information, have fuelled concerns over DTCA’s ability to meet the high standards of social responsibility required by the self-regulatory code (Coney 2002). A recent US study that analysed 67 DTCA magazine advertisements found that 67% used emotional appeals and only 13% provided data (rather than vague qualitative descriptions) on the benefits of the medication (Woloshin, Schwartz, Tremmel & Welch 2001). The format used to present drug information has also attracted criticism. In New Zealand, advertisers must include information about the drug’s active ingredients, its indications, contra-indications, adverse effects and risk factors. In addition, they must specify its status, include standard precautionary information and outline further contact details (Hoek and Gendall 2002). This information has the potential to overwhelm television advertisements, which often screen for only 30 seconds. To ensure adequate time for the creative content of an advertisement, these technical details typically appear in an end-screen that features for five seconds. This leaves consumers little time in which to absorb and comprehend details of the promoted drug. Research examining consumers’ knowledge of drug attributes following exposure to an advertisement suggests many have an inadequate understanding of the characteristics that would determine the drug’s suitability for their condition (Morris et al 1986; Hoek, Gendall & Feetham 2001).
Advertising / Marketing Communications Issues Track
These conclusions suggest further research into how the communication effectiveness of DTC promotions can be improved is urgently required. The research outlined below examined how variations in the mode and presentation of drug information affected recall of the medicine’s risks and side effects. In particular, it tested the following hypotheses:
Simplification of the information presented will significantly improve viewers’
The introduction of dual modality will significantly improve consumers’ ability to
Extending the time for which the end screen features will significantly improve
consumers’ ability to recall product attributes.
An advertisement for an anti- allergy drug, Flonase®, was obtained from a US based advertising agency. This product was selected as it is not currently available in New Zealand, thus respondents would not have previously been exposed to the advertisement. In addition, the drug treated a common condition, likely to be experienced by a high proportion of respondents, and was particularly relevant given the timing of the fieldwork (spring). Four versions of the television advertisement were created, each featuring a different version of the end-screen. The first version was a control that featured a traditional end screen with detailed product information for 5 seconds. The second version removed technical details from the end screen, which now contained key details of risks and side effects, and further information sources, and was shown for 5 seconds. Version 3 added a limited voice-over to the visual material contained in version 2, while version 4 included an extended voice-over and featured the end-screen for 15 seconds. Each version was embedded in a commercial pod containing five other control commercials; the total length of the commercial pod was four minutes, which approximated a normal television commercial break. The commercial pods were each shown to independent samples of between 97 and 141 respondents, recruited via local affinity groups (schools and church groups). Respondents viewed the tape and answered some general questions about all six advertisements before answering specific questions about the content of the Flonase® advertisement. The questionnaire then explored respondents’ perceptions of DTCA and concluded with a short set of demographic questions. The questionnaire took between five to ten minutes to complete.
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We first examined recall of the five control advertisements to assess whether the sub- samples’ recall varied; there were no significant differences in recall across any of the control advertisements. We also examined the demographic composition of the sub- samples and noted that all demographic characteristics except age were evenly distributed across the sub-samples. To compensate for the age difference observed, the data were weighted to ensure the age distribution was matched across all samples and the analyses described below were performed on both weighted and un-weighted data. No differences in the relationships were apparent. Further preliminary analyses examined whether the salience of the product varied across the sub-samples, but a similar proportion of each group suffered from allergies or other conditions Flonase® could treat. We next examined whether recall of four types of information: product details; product benefits; product risks, and information sources, varied across the four versions of the Flonase® advertisement. Table 1 contains the results of these analyses. Table 1: Recall of Flonase® Attributes
(n=129) (n=103) (n=92) (n=135) ___________________________________________________
.07 Benefits Treats hay fever
.14 Information Sources Doctor Advertising / Marketing Communications Issues Track
.00 Risks and Side Effects Headache
.00 ________________________________________________________________________ Recall of the product form (a nasal spray) was predictably high, as was recall of the brand name, which featured several times during each commercial version. Although a significantly lower proportion of respondents exposed to version 2 of the Flonase® advertisement recalled the product name, this finding does not fit the overall pattern of results and seems likely to be little more than a random fluctuation in the data. Awareness of the manufacturer, whose logo only appeared during the end screen was correspondingly lower, and awareness of the active ingredient was virtually non-existent. Irrespective of the version they saw, around a quarter of respondents recalled each of the three treatments promoted in the Flonase® commercial. As the benefits were promoted throughout each version of the advertisement, the overall similarity in the responses was highly predictable. By contrast, recollection of the sources from which viewers could obtain additional information varied considerably. Following exposure to version 1, the control version, 20% of respondents correctly recalled that they could obtain additional information from a doctor. A reduction in the level of technical information provided to produce a clearer end screen (version 2) had little effect on recall levels. However, the introduction of a voice-over significantly increased recall (version 3) although extending the length of exposure (and thus voice-over) did not result in further improvements. The same pattern was evident in recall of the URL and 0800 numbers. Examination of the risks and side effects recall results reveals some striking differences, particularly between versions 2 and 3 where the voice-over increased the proportion recalling risk information by around a factor of ten. Recall of risks and benefits differed greatly between the versions without a voice-over (versions 1 and 2) and those that included a voice-over (versions 3 and 4). Average risk recall for the first two versions was 1.5% (compared to 27% benefit recall) whereas the two versions that included the voice-over had an average risk recall of 40% was (compared to 23% benefit recall). Further analyses using logistic regression examined the proportion of variance accounted for by the versions respondents saw and their demographic characteristics. In each equation, only the advertisement version was significant.
ANZMAC 2003 Conference Proceedings Adelaide 1-3 December 2003
Limitations to the research included the use of affinity samples, although each sub-sample represented a good demographic spread. The use of hall tests may have resulted in respondents paying more attention to the advertisements than they would normally pay. However, our interest lay in comparing the difference between the versions, rather than estimating the wider population’s recall of the variables tested.
Reducing the level of technical detail contained in the end screen had no effect on respondents’ retention of the risk information featured, contrary to hypothesis 1. However, the introduction of a voice-over significantly improved recall of risk and side effect information and supports hypothesis 2. Increasing the exposure time of the end screen from five to fifteen seconds resulted in no further improvements in recall, and leads us to reject hypothesis 3. These findings support the mandatory inclusion of voice-overs to re-iterate the risks and side effects of prescription medicines. As extending the time allocated to presentation of risk information had little effect on respondents’ overall recall, the current five-second time period appears adequate. However, replication research should examine whether this finding holds for medicines that treat less common conditions, as the salience of the product category may have reduced the time required to outline risk factors. Further research should test the effects of integrating a voice-over explaining risks throughout the advertisement, in the same way as benefits are currently communicated. Use of a voice-over to highlight the status of the drugs (prescription only), acknowledge the existence of other treatment options, and reinforce doctors’ role in making the treatment decision, could also address other concerns raised by critics of DTCA. In summary, this research has identified a simple yet critical communication strategy that will promote the development of more socially responsible prescription medicine advertising, promotions and that may address some of the many criticisms currently levelled at it. References American College of Physicians and the American Society of Internal Medicine. (1998) Direct to consumer advertising for prescription drugs. Available at http://www.acponline.org/hpp/pospaper/dtcads.htm. Calfee, J. (2002) Public policy issues in direct-to-consumer advertising of prescription drugs. Journal of Public Policy and Marketing, 21 (2), pp.174-193. Coney, S. (2002) Direct-to-consumer advertising of prescription pharmaceuticals: A consumer perspective from New Zealand. Journal of Public Policy and Marketing, 21 (2), pp.213 – 223. Davis, J. (2001) Riskier than we think? The relationship between risk statement completeness and perceptions of direct to consumer advertised prescription drugs. Journal of Health Communication, 5, pp.349-369. Findlay, S. (2002) Do ads really drive pharmaceutical sales? Marketing Health Services, Spring, pp.21-25. Advertising / Marketing Communications Issues Track
Hoek, J. & Gendall, P. (2002) Direct-to-consumer advertising down under: An alternative perspective and regulatory framework. Journal of Public Policy and Marketing, 21 (2), pp.202 – 212. Hoek, J., Gendall, P. & Feetham, P. (2001) Could less be more? An analysis of direct to consumer advertising of prescription medicines. Marketing Bulletin, 12, pp.1-15. Levitt, G. (1995) Advertising prescription drugs directly to the consumer. Available at http://www.venable.com/tools/elecmarket/dirtocom.htm. Lexchin, J & Mintzes, B. (2002) Direct-to-consumer advertising of prescription drugs: The evidence says no. Journal of Public Policy and Marketing, 21 (2), pp.194-201. Maguire, P. (1999) How direct-to-consumer advertising is putting the squeeze on physicians. http://www.acponline.org/journals/news/mar99/squeeze.htm. Mansfield, P. (1999) Report on DTC pharmaceutical promotion for PHARMAC. Available at http://www.healthyskepticism.org/. Mintzes, B., Morris, L., Kravitz, R., Kazanjian, A., Bassett, K., Lexchin, J., Evans, R., Pan, R. &. Marion, S. (2002b) Influence of direct to consumer pharmaceutical advertising and patients’ requests on prescribing decisions: Two site cross sectional survey. British Medical Journal, 324 (2 February), pp.278-279. Morris, L. Brinberg, D. Klimberg, R, Rivera, C. & Millstein, L. (1986) Consumer attitudes about advertisements of medicinal drugs. Social Science Medicine, 22 (6), pp.629-638. Morris, L. & Griffin, J. (1992) The evolving role of FDA in prescription drug promotion. Journal of Drug Issues. 22 (2), pp.245-257. Reast, J. & Carson, A. (2000) UK Physicians’ attitudes towards direct to consumer advertising of prescription drugs: An exploratory analysis. International Journal of Advertising. 19, pp.397-415.
Researched Medicines Industry (2000) Direct to consumer advertising can enhance public health. Available at http://www.rminz.co.nz.
Sheffet, M. & Kopp S. (1990) Advertising prescription drugs to the public: Headache or relief? Journal of Public Policy and Marketing, 9, pp.42-61. Toop, L., Richards, D., Dowell, T., Tilyard, M., Fraser, T. & Arroll, B. (2003) Direct to Consumer Advertising of Prescription Drugs in New Zealand: For Health or for Profit? http://www.chmeds.ac.nz/report.pdf Wilkes, M., Bell, R and Kravitz, R. (2000) D-T-C prescription drug advertising: Trends, impact and implications. Health Affairs, 19 (2), pp.110-128. Woloshin, S., Schwartz, L.M., Tremmel, J. & Welch, H.G. (2001) Direct-to-consumer advertisements for prescription drugs: what are Americans being sold? Lancet, 358 (9288), pp.1141-1146.
ANZMAC 2003 Conference Proceedings Adelaide 1-3 December 2003
Original Research Weight Loss and Lipid Changes with Low-Energy Diets: Comparator Study of Milk-Based versus Soy-Based Liquid Meal Replacement Interventions James W. Anderson, MD and Lars H. Hoie, MD Department of Internal Medicine, University of Kentucky, Lexington, Kentucky (J.W.A.), NutriPharma, Oslo, Norway (L.H.H.) Key words: clinical trial, obesity, meal replacements, serum chole
MEDIA RELEASE EMBARGOED UNTIL WEDNESDAY, NOVEMBER 11, 2009 Youth on antipsychotics at increased risk of metabolic side effects such as obesity and Type 2 diabetes Provincial Mental Health Metabolic Clinic to assess and treat youth, provide education (Vancouver – November 11, 2009) – Youth taking certain types of anti-psychotic medications have three times the ris