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Author's response
Submit responseWe share Dr. Vitry's concerns about direct-to-consumer (DTC) prescription drug advertising: it generates exaggerated beliefs about drug efficacy and encourages overtreatment of everyday sensations traditionally outside the scope of medicine. The drug box directly addresses these concerns by providing balanced data about drug efficacy and harms. The effectiveness of the drug box approach - despite ad images - is demonstrated by our findings. Enthusiasm for Amcid was dramatically lower in the drug box group than the controls: 16% vs. 46% rated Amcid as "extremely" or "very" effective.(1)
To increase awareness of non-drug approaches to problems, the drug box includes a section called "Other things to consider doing". The Amcid box suggests dietary changes like eating smaller meals or avoiding alcohol before bedtime. We have not tested whether this information changes enthusiasm for heartburn drugs. We do not agree that the drug facts box approach legitimizes DTC advertising. Instead it would ensure that ads have some genuine educational value. This is especially important since a DTC ban is quite unlikely. If boxes were written independently by FDA reviewers using a transparent, reproducible process, consumers and physicians would have ready access to balanced, understandable information about prescription drug performance.
We would also like to emphasize that while we studied the effect of drug facts boxes as a replacement for the current "brief summary" in DTC ads, the boxes have an important role outside of ads. Boxes serve as a kind of executive summary of FDA's review documents and so highlight what FDA knew at the time of drug approval. Boxes could be posted on the FDA, the Center for Medicaid and Medicare Services, and National Library of Medicine websites, and of course in medical journals.
Finally, Dr. Vitry's last points are about the role of patient values in medical decision making. The whole point of the drug facts box is to promote consumers' engagement in decision making by making key information accessible. We certainly recognize that people need more than facts – they need to put the facts in context and they need some clarity about their values. Doctors of course can and should help here. For example, they could point out that clopidogrel's minimal effect on a composite outcome is not nearly as important as the statin's reduction in cardiovascular mortality. We hope that the drug facts boxes will enhance meaningful patient-physician discussion and promote truly shared decision making.
References
1. Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med. 2009;150(8):516-27.
Conflict of Interest:
None declared
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Drug facts box does not counteract negative impacts of DTCA
Submit responseI read with a lot of interest the results of the US study showing that including drug facts boxes in direct-to-consumer prescription drug advertising (DTCA) improved consumers’ knowledge of drug benefits and harms (1). Although this seems a laudable approach, I have several concerns. Firstly, it may give more legitimacy to DTCA but it is unlikely to counteract its negative impacts in terms of medicalisation of everyday life and neglect of lifestyle issues. The drug facts box approach does not address the issue of pictures and slogans used in advertisements that may convey a misleading message. For example the picture in the Amcid advertisement used in the study strongly suggests that medicines eliminate the need to change potentially harmful eating habits. DTCA also encourages unrealistic beliefs in the therapeutic value of new drugs. Thus health professionals will still be under pressure to prescribe advertised medicines although alternative treatments and/or lifestyle changes may be more appropriate for many patients.
Secondly, the simplicity of drug fact boxes may be misleading as the reality is often more complex. For example, contrary to the information in the drug fact box for clopidogrel, in many countries aspirin is still considered first-line treatment in the population targeted by the US advertisement for several reasons: limited extra benefit provided by clopidogrel, benefit mainly seen in people with existing peripheral artery disease, and inferior cost-effectiveness compared to aspirin. Although DTCA is prohibited in all western countries except the US and New Zealand, there is significant spillage into other countries, particularly Canada.
Thirdly, as the drug box groups were found to be somewhat less enthusiastic than the control groups about using medicines advertised, the authors suggested that “consumers may be insufficiently calibrated in judging what constitutes an important effect size”. Although the authors recognized that consumers may have different values it must be stated that consumers’ values are at least as legitimate as health professionals’. Medicine agencies have been criticized for approving the marketing of new drugs with minimal benefits and important or uncertain adverse effects (2). There is a growing recognition by health technology assessment bodies of the need to increase consumers’ engagement in decision making processes about new medicines (3). The evaluation of different presentations of medicine effects on patient choice needs to be evaluated to determine which presentations best help people make choices that are consistent with their own values (4).
References
1. Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med. 2009;150(8):516-27.
2. Garattini S, Chalmers I. Patients and the public deserve big changes in evaluation of drugs. BMJ. 2009;338:b1025.
3. Hailey D, Nordwall M. Survey on the involvement of consumers in health technology assessment programs. Int J Technol Assess Health Care. 2006;22(4):497-9.
4. Carling C, Kristoffersen DT, Herrin J, et al. How should the impact of different presentations of treatment effects on patient choice be evaluated? A pilot randomized trial. PLoS ONE. 2008;3(11):e3693.
Conflict of Interest:
None declared
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Problematic Survey
Submit responseA response rate of less than 50% raises doubt that was not lessened the by authors' claim that little bias is engendered by non-response. The authors' question is fine. But the limitations of this survey require a more extended discussion--perhaps just like the ads do.
Conflict of Interest:
None declared