7th June 2019, Volume 132 Number 1496

Joel Lexchin, David B Menkes

New Zealand and the US are the only two developed countries where direct-to-consumer advertising (DTCA) of prescription drugs is legal. In New Zealand, DTCA developed because the Medicines Act 1981…

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Summary

The New Zealand government is currently considering a draft Therapeutic Products Bill and is posing the question about whether direct-to-consumer advertising (DTCA) of prescription drugs should be regulated or banned. Recent studies demonstrate that DTC ads in the US continue to be misleading and contain minimal if any educational value, despite governmental regulatory efforts. Self-regulation by industry is even more ineffective. Vulnerable population groups, eg, those with poorer self-reported health status, older, less educated, lower income and ethnic minorities and those with unhealthy lifestyles are most likely to be affected by DTCA. Since evidence has demon-strated that regulation has consistently failed to prevent the inappropriate promotion of prescrip-tion medicines, the conclusion is that DTCA should be banned.

Abstract

The government of New Zealand is currently considering a new Therapeutic Products Regulatory Scheme that includes how direct-to-consumer advertising (DTCA) of prescription drugs should be regulated. This article reviews three different types of possible regulation of DTCA: government regulation, industry self-regulation and a mixture of the two. Recent studies demonstrate that DTC ads in the US continue to be misleading and contain minimal if any educational value, despite governmental regulatory efforts by the Food and Drug Administration. Other regulatory models are equally unsuccessful at controlling DTCA. Available evidence suggests that DTC ads are commonly misinterpreted as trusted public health messages and are more likely to affect vulnerable subgroups of New Zealanders. Taken together with the international evidence that regulation has consistently failed to prevent the inappropriate promotion of prescription medicines, these findings suggest that DTCA is more likely to cause harm than benefit and should be banned.

Author Information

Joel Lexchin, Professor Emeritus, School of Health Policy and Management, York University, Toronto, Ontario, Canada; Emergency Physician, University Health Network, Toronto, Ontario, Canada; Associate Professor, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada;
David B Menkes, Associate Professor, University of Auckland, Waikato Clinical Campus, Hamilton.

Correspondence

Joel Lexchin, School of Health Policy and Management, York University, 4700 Keele St, Toronto, ON M3J 1P3, Canada.

Correspondence Email

jlexchin@yorku.ca

Competing Interests

In 2015–2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organisation), a panel at the American Diabetes Association, for a talk at the Toronto Reference Library and for writing a brief for a law firm. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. David Menkes serves on two New Zealand Government committees relevant to pharmacotherapy, and has been active in the International Society of Drug Bulletins (ISDB).

References

  1. Ministry of Health. Direct-to-consumer advertising of prescription medicines in New Zealand: a discussion paper. Wellington, 2000.
  2. Berndt E. The United States’ experience with direct-to-consumer advertising of prescription drugs: what have we learned? In: Sloan F, Hsieh C-R, (eds) Pharmaceutical innovation: incentives, competition, and cost-benefit analysis in international perspective. New York: Cambridge University Press, 2007; 174–96.
  3. Ministry of Health. Direct-to-consumer advertising of prescription medicines in New Zealand: summary of submissions. Wellington: Department of Health, cited March 11 2019]. Available from: http://www.health.govt.nz/system/files/documents/publications/dtca-summary-submissions.pdf
  4. Therapeutic products and medicines bill tabled. Wellington: Beehive.govt.nz, cited March 11 2019]. Available from: http://www.beehive.govt.nz/release/therapeutic-products-and-medicines-bill-tabled
  5. Ministry of Health. Therapeutic products regulatory scheme: consultation document. Wellington, 2018. Available from: http://www.health.govt.nz/publication/therapeutic-products-regulatory-scheme-consultation.
  6. Schwartz L, Woloshin S. Medical marketing in the United States, 1997–2016. JAMA. 2019; 321:80–96.
  7. Faerber A, Kreling D. Content analysis of false and misleading claims in television advertising for prescription and nonprescription drugs. Journal of General Internal Medicine. 2013; 29:110–8.
  8. Frosch D, Krueger P, Hornik R, Cronholm P, Barg F. Creating demand for prescription drugs: a content analysis of television direct-to-consumer advertising. Annals of Family Medicine. 2007; 5:6–13.
  9. Lexchin J. Health Canada’s use of expedited review pathways and therapeutic innovation, 1995–2016: cross-sectional analysis. BMJ Open. 2018; 8:e023605.
  10. Klara K, Kim J, Ross J. Direct-to-consumer broadcast advertisements for pharmaceuticals: off-label promotion and adherence to FDA guidelines. Journal of General Internal Medicine. 2018; 33:651–8.
  11. Applequist J, Ball J. An updated analysis of direct-to-consumer television advertisements for prescription drugs. Annals of Family Medicine. 2018; 16.
  12. Woloshin S, Schwartz L, Tremmel J, Welch H. Direct-to-consumer advertisements for prescription drugs: what are Americans being sold? Lancet. 2001; 358:1141–6.
  13. Abel G, Neufeld E, Sorel M, Weeks J. Direct-to-consumer advertising for bleeding disorders: a content analysis and expert evaluation of advertising claims. Journal of Thrombosis and Haemostasis. 2008; 6:1680–4.
  14. Huh J, Cude B. Is the information “fair and balanced” in direct-to-consumer prescription drug websites? Journal of Health Communication. 2004; 9:529–40.
  15. Read J, Cain A. A literature review and meta-analysis of drug company-funded mental health websites. Acta Psychiatrica Scandinavica. 2013; 128:422–33.
  16. Thaul S. Direct-to-consumer advertsiing of prescription drugs. Congressional Research Service, R40590, 2009.
  17. Food and Drug Regulations, C.R.C., c. 870. Canada, 2014.
  18. Lexchin J, Mintzes B. A compromise too far: a review of Canadian cases of direct-to-consumer advertising regulation. International Journal of Risk and Safety in Medicine. 2014; 26:213–25.
  19. Jochem H. Direct-to-consumer advertising for prescription drugs in New Zealand: time for a radical change? Wellington, 2015, cited March 11, 2019]. Available from: http://researcharchive.vuw.ac.nz/xmlui/bitstream/handle/10063/5110/paper.pdf?sequence=1.
  20. Medicines New Zealand. Code of Practice. Edition 16: Medicines New Zealand, cited March 11 2019].Available from: http://www.medicinesnz.co.nz/fileadmin/user_upload/Ed-16-Final-Updated-22-Sept-2015.pdf
  21. Coney S. Direct-to-consumer advertisiing of prescription pharmaceuticals: a consumer perspective from New Zealand. Journal of Public Policy & Marketing. 2002; 21:213–23.
  22. ANZA. TAPS prevetting system. Takapuna: Association of New Zealand Advertisers, cited March 11 2019]. Available from: http://www.anza.co.nz/Category?Action=View&Category_id=369
  23. Toop L, Richards D, Dowell T, Tilyard M, Fraser T, Arroll B. Direct to consumer advertising of prescription drugs in New Zealand: for health or for profit? Report to the Minister of Health supporting the case for a ban on DTCA. Dunedin, 2003. Available from: http://citeseerx.ist.psu.edu/viewdoc/download;jsessionid=79768CCE1251A9761B1313227848A041?doi=10.1.1.127.420&rep=rep1&type=pdf
  24. Advertising Standards Authority. Rules of the Advertising Standards Authority: ASA, cited March 11 2019]. Available from: http://www.asa.co.nz/wp-content/uploads/2015/05/ASA-Rules-July-2016.pdf
  25. Ma A, Parkin L. Randomised controlled trials cited in pharmaceutical advertisements targeting New Zealand health professionals: do they support the advertising claims and what is the risk of bias? New Zealand Medical Journal. 2015; 128:22–9.
  26. Zetterqvist A, Mulinari S. Misleading advertising for antidepressants in Sweden: a failure of pharmaceutical industry self-regulation. PLoS One. 2013; 8:e62609.
  27. Zetterqvist A, Merlo J, Mulinari S. Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004–2012: a quantitative and qualitative study of pharmaceutical industry self-regulation. PLoS Medicine. 2015; 12:e1001785.
  28. Gleeson D, Menkes D. Trade agreements and direct-to-consumer advertising of pharmaceuticals. International Journal of Health Policy and Management. 2018; 7:98–100.
  29. Peters J, Nel D, Adam S. Reaching and influencing consumers in the prescription medicine market. Marketing Intelligence & Planning. 2009; 27:909–25.
  30. Graham D, Campen D, Rita H, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet. 2005; 365:475–81.
  31. Every-Palmer S, Duggal R, Menkes D. Direct-to-consumer advertising of prescription medication in New Zealand. New Zealand Medical Journal. 2014; 127:102–10.
  32. Zadeh N, Robertson K, Green J. ‘At-risk’ individuals’ responses to direct to consumer advertising of prescription drugs: a nationally representative cross-sectional study. BMJ Open. 2017; 7:017865.
  33. Zadeh N, Robertson K, Green J. Lifestyle determinants of behavioural outcomes triggered by direct-to-consumer advertising of prescription medicines: a cross-section study. Australian and New Zealand Journal of Public Health. 2019; Online. doi: 10.1111/1753-6405.12883.

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