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Should Canada allow direct-to-consumer advertising of prescription drugs?

YES

Correspondence: Dr Wong-Rieger, President and CEO, Institute for Optimizing Health Outcomes, 151 Bloor St W, Suite 600, Toronto, ON M5S 1S4; telephone 416 969-7435; e-maildurhane{at}gmail.com

It is time to end the debate in Canada. The greater risk to Canadian patients is not the drug advertisements from American-sourced media, but rather the lack of access to prescription drug information. As a patient advocate, a mother of 2 children with health conditions, and a wife of someone with multiple chronic conditions, I know the frustration of trying to get information about new therapies. In Europe, where similar barriers exist, a survey of 268 nonprofit patient organizations found that one-fifth of respondents reported they could "never" access high-quality prescription drug information, three-fifths said they "sometimes" could, while only 13% said they "always" could.¹

In Canada, the discussion of direct patient access to drug information has been derailed by the debate over US-style advertising. Critics often extend concerns with direct-to-consumer advertising (DTCA) to direct-to-consumer information, despite the lack of evidence.²

Supporting points

This paper discusses 4 points that support patient direct access to information about prescription drugs:

Drug or disease ads contribute to public health by increasing appropriate consultation for undiagnosed or untreated health conditions
Most studies agree that "disease awareness" or "drug awareness" ads lead to increases in consultations for targeted conditions.³ Critics complain that healthy patients seeking physician advice are a waste of health care resources⁴; however, there is scant evidence that these consultations are inappropriate.⁵

In a survey by the US Food and Drug Administration, physicians reported that the majority (88%) of patients asking about specific drugs after seeing advertisements did indeed have the conditions for which the drugs were intended.⁶ About one-fourth of patients whose visits were prompted by ads received new diagnoses, some for preventable conditions such as hypertension, diabetes, high cholesterol, and depression.⁷ And nearly three-fourths of physician respondents reported that the campaigns improved the quality of their discussions with patients. Overall, advertising can help redress the "health deficit" whereby serious conditions are underdiagnosed and undertreated.

Ads do not lead to patients getting inappropriate medications
Prescription drugs are among the few substances requiring approval of a learned intermediary, which tends to limit rather than promote access. While physicians report being asked by patients about advertised drugs, more than half of the physicians surveyed by the Boston Consulting Group said formularies had a major effect on their prescribing practices and one-third said they would not discuss treatments not covered by insurers.⁸

A longitudinal study comparing English-speaking Canadians exposed to (illicit) American ads about 3 drugs with French-speaking Canadians not exposed to such ads concluded that the ads did not affect prescribing rates for 2 of the drugs and led to only a short-term increase in the prescribing rates of the third.⁹

Similarly, the US Government Auditing Office concluded that only 27% of those who saw drug ads actually requested and received prescriptions for those drugs.¹⁰ Three-fourths of patients who sought physician advice after seeing a drug advertised reported that the doctors discussed health and lifestyle changes; more than half were prescribed a generic alternative, while 51% received suggestions about nonprescription treatments.

Direct-to-consumer information about pharmaceutical products serves an unmet patient need
Not only do most Canadians (68%) support direct-to-consumer prescription drug information, but most believe that DTCA is allowed.¹¹

Similarly, the European Commission has been pressed by the public to allow pharmaceutical companies to provide information (not advertising) directly to consumers through public media, including broadcasting, print media, and the Internet.¹² Most European cancer patient groups surveyed said they could not rely on their specialists to provide sufficient information and many felt doctors’ prescribing practices were governed by restrictive health authority budgets.¹³ In another survey, patient groups felt they should have the right to directly approach pharmaceutical companies for product information.¹⁴

Direct-to-consumer drug information must be balanced, screened, and monitored
In April 2008, the European Commission, while retaining the ban on advertising, proposed a framework supporting direct information on prescription drugs through public media and audiovisual and written material, subject to prescreening and monitoring by an independent body.¹⁵ Information could not be "misleading by omission" and required "balanced representation" of both benefits and risks so consumers could make informed decisions.

Health Canada’s guide for advertising nonprescription drugs recognizes that consumers should be provided with fair and balanced information about the benefits and risks associated with medications in order to make informed decisions. It acknowledges that the public is ignorant about package inserts or product monographs but does pay attention to product advertising. Therefore, balanced information to patients through advertising can promote appropriate use of drugs, with concomitant benefits to the health care system.¹⁶

I propose extending the same rationale and guidelines to prescription medicines. Information must be evidence-based and not exceed what has been approved for the product monographs. All substantive benefits and risks must be included and all communications pre-screened and approved. Inaccurate communications must be corrected or removed, and misleading information should lead to penalties.

Last words

It is illogical and irresponsible to allow a free-flow of DTCA across the border while restricting the more appropriate information created in Canada, which would be vetted and monitored by Canadian authorities. A patient-centred approach can be found to meet the need for balanced, high-quality, comprehensive information about prescription drugs that neither misleads patients nor promotes inappropriate medication use.

CLOSING ARGUMENTS Drug or disease advertisements contribute to public health by increasing appropriate consultation for undiagnosed or untreated health conditions. As prescription medications require approval of a learned intermediary, advertisements do not lead to patients getting inappropriate medications. Patient surveys suggest that direct-to-consumer information about pharmaceutical products serves an unmet patient need. Direct-to-consumer drug information that is balanced, screened, and monitored can promote the appropriate use of drugs.

 

Footnotes

Cet article se trouve aussi en français à la page 134.

Competing interests

Unrestricted educational grant support from pharmaceutical companies was provided to the Institute for Optimizing Health Outcomes and the Canadian Organization for Rare Disorders (CORD). The Institute for Optimizing Health Outcomes is funded through service contracts and sponsorships from the Ontario Ministry of Health and Long-Term Care and the British Columbia Ministry of Health; service contracts with health care institutions, clinics, and health services; and by unrestricted educational grants from pharmaceutical companies. The Canadian Organization for Rare Disorders receives unrestricted educational grants from pharmaceutical companies and foundations, including Alberta Gaming and Liquor Commission. The author receives no remuneration for volunteer services with CORD.

References

1. Medicines and Healthcare Products Regulatory Agency (MHRA). MHRA public consultation with patient representatives: medicines information and advertising. Powys, UK: PatientView; 2005. Available from: www.patient-view.com/3.%20Main%20Report%20to%20MHRA%20Public%20Consultation%20with%20Patient%20Representatives,%20Sept%202005.pdf. Accessed 2008 Dec 18.
2. Moynihan R, Henry D. The fight against disease mongering: generating knowledge for action. PLOS Med 2006;3(4):e191. Epub 2006 Apr 11.[Medline]
3. Mintzes B, Barer ML, Kravitz RL, Bassett K, Lexchin J, Kazanjian A, et al. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ 2003;169(5):405–12.[Abstract/Free Full Text]
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5. DeLuca C. Direct to consumer advertising of prescription medicines: assessing the impact of consumer directed drug advertisement and the legality of current prohibitions. Toronto, ON: University of Toronto Health Law and Policy Group; 2005. Available from: www.law.utoronto.ca/HEALTHLAW/docs/student_DeLuca-DTCA.pdf. Accessed 2008 Dec 18.
6. Aikin KJ, Swasy JL, Braman AC. Patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs. Summary of FDA survey research results. Washington, DC: Food and Drug Administration, Center for Drug Evaluation and Research; 2004. Available from: www.fda.gov/cder/ddmac/Final%20Report/FRFinalExSu1119042.pdf. Accessed 2008 Dec 19.
7. Weissman JS, Blumenthal D, Silk AJ, Newman M, Zapert K, Leitman R, et al. Physicians report on patient encounters involving direct-to-consumer advertising. Health Aff (Millwood) 2004, Suppl Web Exclusives):W4-219–33. Available from: http://content.healthaffairs.org/cgi/reprint/hlthaff.w4.219v1. Accessed 2008 Dec 19.
8. Wynia MK, VanGeest JB, Cummins DS, Wilson IB. Do physicians not offer useful services because of coverage restrictions? Health Aff (Millwood) 2003;22(4):190–7.[Abstract/Free Full Text]
9. Law MR, Majumdar SR, Soumerai SB. Effect of illicit direct to consumer advertising on use of etanercept, mometasone, and tegaserod in Canada: controlled longitudinal study. BMJ 2008;337:a1055.[Abstract/Free Full Text]
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11. Alliance for the Access to Medical Information. How do Canadians feel about direct-to-consumer advertising of prescription medicines? A summary of the Ipsos-Reid survey results. Ottawa, ON: Canadian Association of Broadcasters; 2002. Available from: www.cab-acr.ca/english/research/02/ipsoreadsummary_jan3102.pdf. Accessed 2008 Dec 19.
12. European Commission Enterprise and Industry Directorate-General. Key ideas of a legal proposal on information to patients. Summary of the public consultation responses. Brussels, BE: European Commission; 2008. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/patients/docs/summary_publ_cons_220508.pdf. Accessed 2008 Dec 19.
13. Gooderham C, Nead C, Wyke A. Information on prescription medicines for cancer patients: an unmet need. Cancer Futures 2003;2:33–5. Available from: www.can-cerworld.org/CancerWorldAdmin/images/static_modules/images/1428/CF_1_Vol2_33.pdf. Accessed 2008 Dec 19.
14. PatientView. Prescription drug information for the public: a strategy document. London, UK: PatientView; 2002. Available from: www.patient-view.com/projects4.htm#4. Accessed 2008 Dec 19.
15. European Commission Enterprise and Industry Directorate-General. Public consultation. Legal proposal on information to patients. Brussels, BE: European Commission; 2008. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_02/info_to_patients_consult_200802.pdf. Accessed 2008 Dec 19.
16. Health Canada. Issue paper: Health Canada’s approach to the inclusion of risk/safety information communication (Section 2.21) in the revised consumer advertising guidelines for marketed health products (for nonprescription drugs including natural health products). Ottawa, ON: Health Canada, Health Products and Food Branch; 2006. Available from: www.hc-sc.gc.ca/dhp-mps/advert-publicit/report-rapport/hc-sc_issue_paper-document_reference_section_221-eng.php. Accessed 2008 Dec 19.

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