Drug Familiarization and Therapeutic Misconception Via Direct-to-Consumer Information

Abstract

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising (DTCA). However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information (DTCI) campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA.

Dear DTCA, Please Don’t Deceive Me, Don’t Play on My Fantasy

“…DTCC includes two large families of communications to patients: DTC advertising (DTCA) and DTC information (DTCI). For instance, in the most DTCC permissive countries (i.e., the US and New Zealand), consumers will be subjected to DTCA, such as TV commercials presenting the merits of a certain product [1]. But consumers in countries that do not allow DTCA may still be subject to DTCI campaigns sponsored by pharmaceutical companies.…”

“…But consumers in countries that do not allow DTCA may still be subject to DTCI campaigns sponsored by pharmaceutical companies. For example, campaigns in Canada, the United Kingdom or the Netherlands may be televised, in-print or on the web with the aim of "raising awareness" for a 1 Matthew Dear, "Her Fantasy", Label: Ghostly International -GI-156. Released June 4, 2012.…”

“…ISSN 1923-2799 2 / 4 particular disease [1,2]. With the advent of new media and social networks, DTCI and DTCA are now available far beyond the borders of permissive countries, reaching out to a larger audience than the local population [3].…”

Preparing for the arrival of “pink Viagra”: strengthening Canadian direct-to-consumer information regulations

“…These campaigns, such as the one by Eli Lilly, are aimed at ... creating general disease awareness (e.g., about symptoms and associated health risks) and encouraging patients to ask their doctor about whether they might have the medical condition. 3 Sprout Pharmaceuticals has cited evidence that between 7% and 33% of women have hypoactive sexual desire disorder, 4 so the potential market for this drug is huge. We can thus expect flibanserin to be the subject of a direct-toconsumer information campaign in Canada, most likely with messages similar to those offered for tadalafil: that it is imperative that women be sensitized to this public health problem, one that can have a substantial impact on their quality of life -and that of their partners.…”

“…3 In their campaign to achieve FDA approval of flibanserin, Sprout has argued that hypoactive sexual desire disorder affects as many as one in three women in the US. 4 This, too, is a very convincing marketing claim, but reliable and independent scientific data show that only about 1 in 10 women experience distress as…”