Direct ‐ to ‐ Consumer Advertising and Empowerment: an experiment ICH meeting Michel Schneider Lugano, Università della Svizzera italiana 20.10.09
DTCA Direct ‐ to ‐ Consumer Advertising for prescription drugs What is it? Advertising, allowed only in the US and in New Zealand, in different forms (Print, TV, Internet), to promote prescription drugs to the public
A controversial topic Stakeholders: ‐ consumers ‐ government ‐ health experts (physicians, pharmacists…) ‐ drug companies At stake: ‐ Health ‐ Money (a lot)
Total U.S. pharmaceutical industry spending on DTCA 1996 ‐ 2005 (taken from Donohue (2006))
(REAL ADS, ~1950)
Arguments pro and contra DTCA for prescription drugs Confuses patients by Inform public/patients presenting /consumers about promotional messages (new) treatment and as educational diseases Lead to preference Encourage people to toward branded, Make patients look for medical advertised ask for more attention for untreated prescription over expensive conditions more affordable, medications effective treatments Push people to Present unbalanced seek more information about information from risks and benefits other sources Medicalize normal Influence patient ‐ human experience physician relationship Empower patients PRO CONTRA
Important questions To what extent can DTCA be considered as educational, while it has to be promotional and persuasive? What kind of information do patients need, in order to take well ‐ informed decision regarding their health?
Educational potential of DTCA Content analysis emotional appeals are far more prevalent than rational appeals in the promotional portion of print DTCA (Main, Argo and Huhman, 2004) information about risk factors for or prevalence of the disease, and about the population at risk is rarely provided (8 ‐ 25% of the ads) (TV ads, Frosch et al., 2007) FDA speaks of an imbalance between risks and benefits, created by an overwhelming focus on the benefit side
Educational potential of DTCA Consumers misconceptions about DTCA (Bell et al., 1999) 50% of the respondents thought that DTC ads had to be submitted to the government for prior approval 43% thought that only completely safe drugs could be advertised 21% that only extremely effective drug could be marketed to the public 22% that ads of prescription drugs with serious side effects had already been banned attitude toward DTCA positively correlated with the beliefs that those misconceptions were true
Educational potential of DTCA Physician’s point of view mixed results DTC ad could have a positive effect (lead to better discussion with patients, increase patients awareness of treatment) DTC ad could have a negative effect (need to correct misconceptions, request of unnecessary drugs)
What kind of information? Consumers' preferences compulsory policies instead of voluntary or no disclosure ones (for information such as causes of the disease, other available treatment) numerical reporting of incidence level of side ‐ effects (over non ‐ numerical), side effects ordered from highest to lowest in probability, number of patients who discontinued the treatment Consumers' need ???
Patient empowerment and literacy Building on Schulz and Nakamoto model of health empowerment both concepts are useful to explain patients health behaviours and outcomes in the case of DTCA for prescription drugs, it is very important to assess if empowerment and health literacy moderate the effect of DTCA for instance, people having high level of health literacy may respond differently to advertising than people with low level of health literacy or people scoring high in empowerment may be more likely to seek a treatment than people having lower scores, after exposure to DTCA
My project – 3 facets effect of exposure to DTCA for antidepressant drugs on people’s definition of depressive disorders, perceived treatment options for depressive disorders, and perceived role of the physician when deciding to take a drug or not DTCA for antidepressants vs. “Balanced and complete information” effects Exploration of the role of people’s empowerment and health literacy in the case of exposure to DTCA and/or other sources of information
The experiment Expose participants to either DTCA for antidepressant, a more complete and balanced source of information, or both (or nothing, control group) ask them to read and evaluate a vignette case of a person experiencing unclear depressive symptoms (i.e. according to the standards of the APA, it will not be clear if the person present a “clinical” depressive disorder, and if she needs some kind of treatment or not 2 weeks later, measurement of empowerment and health literacy, and questions about personal history regarding depression
Design 2 (presence/absence of DTCA for antidepressant drug) x 2 (presence/absence of a more complete and balanced source of information about depressive disorders), between subject Control group: Group 1: Group 2: Group 3: No information DTCA for More balanced DTCA and more about depressive antidepressant source of balanced source of disorders drug information information Outcomes people’s definition of depressive disorders, perceived treatment options for depressive disorders, and perceived role of the physician regarding the decision to take a prescription antidepressant or not
Outcomes variables Task: evaluate a vignette ‐ case of a person suffering from unclear depressive symptoms Naming of the problem (open ‐ ended question) Giving advice to the person in the vignette about what she should do (open ‐ ended) Choosing the best ‐ suited category for the problem (multiple choice question) Choosing the best suited ‐ advice in a list (close ‐ ended) Measurement of the perceived need of a physician in order to decide if it would be a good thing for the vignette case person to take an antidepressant
Hypotheses H1: exposure to DTCA for antidepressant, and to the more balanced source of information, will make participants more likely to categorize the ambiguous case as “depressed” (instead of using other categories like stressed, tired, sad…), than participants without any source of information about depression H2: participants exposed to the more balanced source of information are less likely to choose the category “clinical depression” in a multiple choice question for the case, than participants exposed to DTCA only H3: participants exposed to DTCA only are more likely to choose antidepressants as the preferred treatment for the case, than participants of all other groups H4: participants exposed to DTCA are more likely to say that they may ask a doctor about a prescription antidepressant in the future, than participants not exposed to DTCA (however, here strong influence of the personal history regarding depressive symptoms)
Next steps Creation of the material advertisement for antidepressant drug, pretest fake brochure about health ambiguous case, pretest for ambiguity Preparation of scales empowerment (ex. Empowerment among users of mental health services, Rogers et al., 19997) health literacy for depressive disorders (construction with experts) personal history regarding depression …
Thank you for your attention
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