Time for New Zealand to ban direct-to-consumer advertising of prescription medicines
View Article PDF
The New Zealand government is this year developing a new Therapeutic Products Bill to replace the antiquated Medicines Act 1981. Among the many issues at stake is whether direct-to-consumer advertising (DTCA) of prescription medicines will continue to be permitted. Besides the United States (US), New Zealand is the only other high-income country that allows unrestricted DTCA, including both the name of the drug and its indications. Most other countries allow unbranded “disease-oriented” advertising, which falls outside the scope of pharmaceutical advertising regulations.
The nearly universal prohibition of DTCA is widely regarded as a health protection measure, especially for newly marketed drugs. In a survey of 300 new drugs approved in the US during 2002–2014, relatively small numbers of people (median 1,044) were exposed to the drugs pre-market,[[1]] too few to discover infrequent but significant adverse effects. More generally, drug-related harms are a common, often preventable cause of emergency department visits and hospitalisations,[[2]] underpinning the rationale to treat prescription medicines differently from over-the-counter and other consumer products.
Despite the New Zealand Labour Party historically opposing DTCA, the current Labour Cabinet has proposed that DTCA should continue based on four key arguments,[[3]] summarised here in relation to the research evidence:
Claim 1: the existing combination of government monitoring and industry self-regulation of DTCA is adequate.
This claim is manifestly false. The present arrangement is unable to ensure that ads contain accurate information on either benefits or harms of medicines, or on how advertised products compare to other available treatment options, including lifestyle modification.[[4]] Neither Medsafe, the New Zealand regulatory authority, nor the Commerce Commission proactively monitor DTCA; any monitoring occurs only after ads have appeared. On the industry side, the Advertising Standards Authority (ASA), an amalgam of media and communication agencies and advertisers, has developed the Therapeutic Products Advertising Code, while Medicines New Zealand, a lobby for research-based pharmaceutical companies, covers DTCA in its Code of Practice. The maximum penalty for Code violations is $80,000, unlikely to be a deterrent for multinational companies.
Claim 2: prescribing and drug expenditure triggered by DTCA may be beneficial
While stimulated prescribing may be appropriate and useful in some cases, a key question is the extent to which this is outweighed by the unnecessary or harmful prescribing that also follows DTCA. The best evidence bearing on this question comes from a controlled trial of brand-specific requests to prescribing doctors. Simulated patients were randomised to present scenarios of clinical depression or “adjustment disorder”—temporary distress for which pharmacotherapy is inappropriate. Requests from patients with adjustment disorder stimulated prescribing to a far greater extent than requests from patients with treatable depression.[[5]] Complementary evidence showing that DTCA-stimulated prescribing can be both inappropriate and harmful comes from a study of patients requesting advertised COX-2 inhibitors rofecoxib or celecoxib.[[6]] Combining survey data and health records, the authors found that patients responding to advertising were four times as likely as others to receive an inappropriate prescription. Rofecoxib (Vioxx) was heavily advertised for 5 years prior to its worldwide withdrawal in 2004. The VIGOR trial published in 2000 was the first to establish an increased risk of myocardial infarction with rofecoxib;[[7]] New Zealanders viewing Vioxx advertisements in the years that followed were not informed of this, with avoidable deaths a likely consequence.
Claim 3: people with lower educational status, poorer health or from an ethnic minority are more likely to seek care because of DTCA
While this is presented as a positive attribute, it is taken out of context from a New Zealand study that concludes DTCA may lead to “…the misuse or overuse of medications for diseases that may otherwise be improved by a healthier lifestyle”,[[8]] illustrating the importance of accessible and balanced health information for all sectors of the community. This survey found that those tending to rely on advertising reported less healthy lifestyle habits, suggesting that DTCA may have contributed to poorer life and treatment choices. Studies in the US found that exposure to statin DTCA was associated with inappropriate prescription to those at low risk of cardiac events,[[9,10]] suggesting DTCA can lead to both over-diagnosis and over-treatment.
Claim 4: a more informed society enables better conversations and relationships between patients and prescribers
While a well-informed public is to be encouraged, this argument is undermined by evidence of the poor quality and misleading information typical of DTCA, irrespective of whether it comes from broadcast, print or online advertising.[[4]] For example, an analysis of 61 ads televised during prime time in the US in 2016 found few (16%) with educational content regarding risk factors, contrasting with almost universal (94%) emotional appeals linking the advertised medicine to recreation and other positive experiences.[[11]] Only 7% discussed lifestyle change as an adjunct to medicine use, none as an alternative. Another recent analysis of the 81 most heavily advertised drugs in the US found that only 20 (24.6%) were rated as having high therapeutic value.[[12]] Despite existing regulations, the content and style of televised DTCA undermine industry claims of educational and public health value. Proponents of DTCA also tend to disregard doctors’ reports of unwelcome pressure to prescribe advertised medicines[[13]] and the time it takes to resist inappropriate requests.
Conclusion
In conclusion, the government’s main arguments for allowing DTCA to continue in New Zealand are both unsustainable and bear remarkable similarity to those advanced by Medicines New Zealand, a body representing the pharmaceutical industry.[[14]] This coincidence may reflect the virtually unregulated access that lobbyists have to senior government officials in this country.[[15]] In any case, available evidence indicates that banning DTCA would help to promote population health by reducing over-diagnosis, over-treatment and iatrogenic harm.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1) Cherkaoui S, Pinnow E, Bulatao I, et al. The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes. Clin Pharmacol Ther. 2021;110(6):1512-25. doi: 10.1002/cpt.2320.
2) Pillans PI. Clinical perspectives in drug safety and adverse drug reactions. Expert Rev Clin Pharmacol. 2008;1(5):695-705. doi: 10.1586/17512433.1.5.695.
3) Manatū Hauora – Ministry of Health . Therapeutic products regulatory regime [Internet]. Wellington: New Zealand Government; 2023 [cited 2023 1 May]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime.
4) Lexchin J, Menkes DB. Can direct-to-consumer advertising of prescription drugs be effectively regulated? N Z Med J. 2019;132(1496):59-65.
5) Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patients' requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005;293(16):1995-2002. doi: 10.1001/jama.293.16.1995.
6) Spence MM, Teleki SS, Cheetham TC, Schweitzer SO, Millares M. Direct-to-consumer advertising of COX-2 inhibitors: effect on appropriateness of prescribing. Med Care Res Rev. 2005;62(5):544-59. doi: 10.1177/1077558705279314.
7) Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343(21):1520-8. doi: 10.1056/NEJM200011233432103.
8) Zadeh NK, Robertson K, Green JA. Lifestyle determinants of behavioural outcomes triggered by direct-to-consumer advertising of prescription medicines: a cross-sectional study. Aust N Z J Public Health. 2019 Apr;43(2):190-196. doi: 10.1111/1753-6405.12883.
9) Chang HY, Murimi I, Daubresse M, et al. Effect of Direct-to-Consumer Advertising on Statin Use in the United States. Med Care. 2017;55(8):759-64. doi: 10.1097/MLR.0000000000000752.
10) Niederdeppe J, Byrne S, Avery RJ, Cantor J. Direct-to-consumer television advertising exposure, diagnosis with high cholesterol, and statin use. J Gen Intern Med. 2013;28(7):886-93. doi: 10.1007/s11606-013-2379-3.
11) Applequist J, Ball JG. An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs. Ann Fam Med. 2018;16(3):211-6. doi: 10.1370/afm.2220.
12) Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA Network Open. 2023;6(1):e2250991-e. doi: 10.1001/jamanetworkopen.2022.50991.
13) Mintzes B, Barer ML, Kravitz RL, 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.
14) Medicines New Zealand. Submission on the Therapeutic Products Bill 2023 [Internet]. 2023 [cited 2023 1 May]. Available from: https://www.medicinesnz.co.nz/fileadmin/user_upload/Submissions/MNZTBP_Sub.pdf.
15) Espiner G. Lobbyists in New Zealand enjoy freedoms unlike most other nations in the developed world [Internet]. Wellington: Radio New Zealand; 25 March 2023 [cited 2023 1 May]. Available from: www.rnz.co.nz/news/lobbying/486670/lobbyists-in-new-zealand-enjoy-freedoms-unlike-most-other-nations-in-the-developed-world.
For the PDF of this article,
contact nzmj@nzma.org.nz
Time for New Zealand to ban direct-to-consumer advertising of prescription medicines
View Article PDF
The New Zealand government is this year developing a new Therapeutic Products Bill to replace the antiquated Medicines Act 1981. Among the many issues at stake is whether direct-to-consumer advertising (DTCA) of prescription medicines will continue to be permitted. Besides the United States (US), New Zealand is the only other high-income country that allows unrestricted DTCA, including both the name of the drug and its indications. Most other countries allow unbranded “disease-oriented” advertising, which falls outside the scope of pharmaceutical advertising regulations.
The nearly universal prohibition of DTCA is widely regarded as a health protection measure, especially for newly marketed drugs. In a survey of 300 new drugs approved in the US during 2002–2014, relatively small numbers of people (median 1,044) were exposed to the drugs pre-market,[[1]] too few to discover infrequent but significant adverse effects. More generally, drug-related harms are a common, often preventable cause of emergency department visits and hospitalisations,[[2]] underpinning the rationale to treat prescription medicines differently from over-the-counter and other consumer products.
Despite the New Zealand Labour Party historically opposing DTCA, the current Labour Cabinet has proposed that DTCA should continue based on four key arguments,[[3]] summarised here in relation to the research evidence:
Claim 1: the existing combination of government monitoring and industry self-regulation of DTCA is adequate.
This claim is manifestly false. The present arrangement is unable to ensure that ads contain accurate information on either benefits or harms of medicines, or on how advertised products compare to other available treatment options, including lifestyle modification.[[4]] Neither Medsafe, the New Zealand regulatory authority, nor the Commerce Commission proactively monitor DTCA; any monitoring occurs only after ads have appeared. On the industry side, the Advertising Standards Authority (ASA), an amalgam of media and communication agencies and advertisers, has developed the Therapeutic Products Advertising Code, while Medicines New Zealand, a lobby for research-based pharmaceutical companies, covers DTCA in its Code of Practice. The maximum penalty for Code violations is $80,000, unlikely to be a deterrent for multinational companies.
Claim 2: prescribing and drug expenditure triggered by DTCA may be beneficial
While stimulated prescribing may be appropriate and useful in some cases, a key question is the extent to which this is outweighed by the unnecessary or harmful prescribing that also follows DTCA. The best evidence bearing on this question comes from a controlled trial of brand-specific requests to prescribing doctors. Simulated patients were randomised to present scenarios of clinical depression or “adjustment disorder”—temporary distress for which pharmacotherapy is inappropriate. Requests from patients with adjustment disorder stimulated prescribing to a far greater extent than requests from patients with treatable depression.[[5]] Complementary evidence showing that DTCA-stimulated prescribing can be both inappropriate and harmful comes from a study of patients requesting advertised COX-2 inhibitors rofecoxib or celecoxib.[[6]] Combining survey data and health records, the authors found that patients responding to advertising were four times as likely as others to receive an inappropriate prescription. Rofecoxib (Vioxx) was heavily advertised for 5 years prior to its worldwide withdrawal in 2004. The VIGOR trial published in 2000 was the first to establish an increased risk of myocardial infarction with rofecoxib;[[7]] New Zealanders viewing Vioxx advertisements in the years that followed were not informed of this, with avoidable deaths a likely consequence.
Claim 3: people with lower educational status, poorer health or from an ethnic minority are more likely to seek care because of DTCA
While this is presented as a positive attribute, it is taken out of context from a New Zealand study that concludes DTCA may lead to “…the misuse or overuse of medications for diseases that may otherwise be improved by a healthier lifestyle”,[[8]] illustrating the importance of accessible and balanced health information for all sectors of the community. This survey found that those tending to rely on advertising reported less healthy lifestyle habits, suggesting that DTCA may have contributed to poorer life and treatment choices. Studies in the US found that exposure to statin DTCA was associated with inappropriate prescription to those at low risk of cardiac events,[[9,10]] suggesting DTCA can lead to both over-diagnosis and over-treatment.
Claim 4: a more informed society enables better conversations and relationships between patients and prescribers
While a well-informed public is to be encouraged, this argument is undermined by evidence of the poor quality and misleading information typical of DTCA, irrespective of whether it comes from broadcast, print or online advertising.[[4]] For example, an analysis of 61 ads televised during prime time in the US in 2016 found few (16%) with educational content regarding risk factors, contrasting with almost universal (94%) emotional appeals linking the advertised medicine to recreation and other positive experiences.[[11]] Only 7% discussed lifestyle change as an adjunct to medicine use, none as an alternative. Another recent analysis of the 81 most heavily advertised drugs in the US found that only 20 (24.6%) were rated as having high therapeutic value.[[12]] Despite existing regulations, the content and style of televised DTCA undermine industry claims of educational and public health value. Proponents of DTCA also tend to disregard doctors’ reports of unwelcome pressure to prescribe advertised medicines[[13]] and the time it takes to resist inappropriate requests.
Conclusion
In conclusion, the government’s main arguments for allowing DTCA to continue in New Zealand are both unsustainable and bear remarkable similarity to those advanced by Medicines New Zealand, a body representing the pharmaceutical industry.[[14]] This coincidence may reflect the virtually unregulated access that lobbyists have to senior government officials in this country.[[15]] In any case, available evidence indicates that banning DTCA would help to promote population health by reducing over-diagnosis, over-treatment and iatrogenic harm.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1) Cherkaoui S, Pinnow E, Bulatao I, et al. The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes. Clin Pharmacol Ther. 2021;110(6):1512-25. doi: 10.1002/cpt.2320.
2) Pillans PI. Clinical perspectives in drug safety and adverse drug reactions. Expert Rev Clin Pharmacol. 2008;1(5):695-705. doi: 10.1586/17512433.1.5.695.
3) Manatū Hauora – Ministry of Health . Therapeutic products regulatory regime [Internet]. Wellington: New Zealand Government; 2023 [cited 2023 1 May]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime.
4) Lexchin J, Menkes DB. Can direct-to-consumer advertising of prescription drugs be effectively regulated? N Z Med J. 2019;132(1496):59-65.
5) Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patients' requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005;293(16):1995-2002. doi: 10.1001/jama.293.16.1995.
6) Spence MM, Teleki SS, Cheetham TC, Schweitzer SO, Millares M. Direct-to-consumer advertising of COX-2 inhibitors: effect on appropriateness of prescribing. Med Care Res Rev. 2005;62(5):544-59. doi: 10.1177/1077558705279314.
7) Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343(21):1520-8. doi: 10.1056/NEJM200011233432103.
8) Zadeh NK, Robertson K, Green JA. Lifestyle determinants of behavioural outcomes triggered by direct-to-consumer advertising of prescription medicines: a cross-sectional study. Aust N Z J Public Health. 2019 Apr;43(2):190-196. doi: 10.1111/1753-6405.12883.
9) Chang HY, Murimi I, Daubresse M, et al. Effect of Direct-to-Consumer Advertising on Statin Use in the United States. Med Care. 2017;55(8):759-64. doi: 10.1097/MLR.0000000000000752.
10) Niederdeppe J, Byrne S, Avery RJ, Cantor J. Direct-to-consumer television advertising exposure, diagnosis with high cholesterol, and statin use. J Gen Intern Med. 2013;28(7):886-93. doi: 10.1007/s11606-013-2379-3.
11) Applequist J, Ball JG. An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs. Ann Fam Med. 2018;16(3):211-6. doi: 10.1370/afm.2220.
12) Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA Network Open. 2023;6(1):e2250991-e. doi: 10.1001/jamanetworkopen.2022.50991.
13) Mintzes B, Barer ML, Kravitz RL, 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.
14) Medicines New Zealand. Submission on the Therapeutic Products Bill 2023 [Internet]. 2023 [cited 2023 1 May]. Available from: https://www.medicinesnz.co.nz/fileadmin/user_upload/Submissions/MNZTBP_Sub.pdf.
15) Espiner G. Lobbyists in New Zealand enjoy freedoms unlike most other nations in the developed world [Internet]. Wellington: Radio New Zealand; 25 March 2023 [cited 2023 1 May]. Available from: www.rnz.co.nz/news/lobbying/486670/lobbyists-in-new-zealand-enjoy-freedoms-unlike-most-other-nations-in-the-developed-world.
For the PDF of this article,
contact nzmj@nzma.org.nz
Time for New Zealand to ban direct-to-consumer advertising of prescription medicines
View Article PDF
The New Zealand government is this year developing a new Therapeutic Products Bill to replace the antiquated Medicines Act 1981. Among the many issues at stake is whether direct-to-consumer advertising (DTCA) of prescription medicines will continue to be permitted. Besides the United States (US), New Zealand is the only other high-income country that allows unrestricted DTCA, including both the name of the drug and its indications. Most other countries allow unbranded “disease-oriented” advertising, which falls outside the scope of pharmaceutical advertising regulations.
The nearly universal prohibition of DTCA is widely regarded as a health protection measure, especially for newly marketed drugs. In a survey of 300 new drugs approved in the US during 2002–2014, relatively small numbers of people (median 1,044) were exposed to the drugs pre-market,[[1]] too few to discover infrequent but significant adverse effects. More generally, drug-related harms are a common, often preventable cause of emergency department visits and hospitalisations,[[2]] underpinning the rationale to treat prescription medicines differently from over-the-counter and other consumer products.
Despite the New Zealand Labour Party historically opposing DTCA, the current Labour Cabinet has proposed that DTCA should continue based on four key arguments,[[3]] summarised here in relation to the research evidence:
Claim 1: the existing combination of government monitoring and industry self-regulation of DTCA is adequate.
This claim is manifestly false. The present arrangement is unable to ensure that ads contain accurate information on either benefits or harms of medicines, or on how advertised products compare to other available treatment options, including lifestyle modification.[[4]] Neither Medsafe, the New Zealand regulatory authority, nor the Commerce Commission proactively monitor DTCA; any monitoring occurs only after ads have appeared. On the industry side, the Advertising Standards Authority (ASA), an amalgam of media and communication agencies and advertisers, has developed the Therapeutic Products Advertising Code, while Medicines New Zealand, a lobby for research-based pharmaceutical companies, covers DTCA in its Code of Practice. The maximum penalty for Code violations is $80,000, unlikely to be a deterrent for multinational companies.
Claim 2: prescribing and drug expenditure triggered by DTCA may be beneficial
While stimulated prescribing may be appropriate and useful in some cases, a key question is the extent to which this is outweighed by the unnecessary or harmful prescribing that also follows DTCA. The best evidence bearing on this question comes from a controlled trial of brand-specific requests to prescribing doctors. Simulated patients were randomised to present scenarios of clinical depression or “adjustment disorder”—temporary distress for which pharmacotherapy is inappropriate. Requests from patients with adjustment disorder stimulated prescribing to a far greater extent than requests from patients with treatable depression.[[5]] Complementary evidence showing that DTCA-stimulated prescribing can be both inappropriate and harmful comes from a study of patients requesting advertised COX-2 inhibitors rofecoxib or celecoxib.[[6]] Combining survey data and health records, the authors found that patients responding to advertising were four times as likely as others to receive an inappropriate prescription. Rofecoxib (Vioxx) was heavily advertised for 5 years prior to its worldwide withdrawal in 2004. The VIGOR trial published in 2000 was the first to establish an increased risk of myocardial infarction with rofecoxib;[[7]] New Zealanders viewing Vioxx advertisements in the years that followed were not informed of this, with avoidable deaths a likely consequence.
Claim 3: people with lower educational status, poorer health or from an ethnic minority are more likely to seek care because of DTCA
While this is presented as a positive attribute, it is taken out of context from a New Zealand study that concludes DTCA may lead to “…the misuse or overuse of medications for diseases that may otherwise be improved by a healthier lifestyle”,[[8]] illustrating the importance of accessible and balanced health information for all sectors of the community. This survey found that those tending to rely on advertising reported less healthy lifestyle habits, suggesting that DTCA may have contributed to poorer life and treatment choices. Studies in the US found that exposure to statin DTCA was associated with inappropriate prescription to those at low risk of cardiac events,[[9,10]] suggesting DTCA can lead to both over-diagnosis and over-treatment.
Claim 4: a more informed society enables better conversations and relationships between patients and prescribers
While a well-informed public is to be encouraged, this argument is undermined by evidence of the poor quality and misleading information typical of DTCA, irrespective of whether it comes from broadcast, print or online advertising.[[4]] For example, an analysis of 61 ads televised during prime time in the US in 2016 found few (16%) with educational content regarding risk factors, contrasting with almost universal (94%) emotional appeals linking the advertised medicine to recreation and other positive experiences.[[11]] Only 7% discussed lifestyle change as an adjunct to medicine use, none as an alternative. Another recent analysis of the 81 most heavily advertised drugs in the US found that only 20 (24.6%) were rated as having high therapeutic value.[[12]] Despite existing regulations, the content and style of televised DTCA undermine industry claims of educational and public health value. Proponents of DTCA also tend to disregard doctors’ reports of unwelcome pressure to prescribe advertised medicines[[13]] and the time it takes to resist inappropriate requests.
Conclusion
In conclusion, the government’s main arguments for allowing DTCA to continue in New Zealand are both unsustainable and bear remarkable similarity to those advanced by Medicines New Zealand, a body representing the pharmaceutical industry.[[14]] This coincidence may reflect the virtually unregulated access that lobbyists have to senior government officials in this country.[[15]] In any case, available evidence indicates that banning DTCA would help to promote population health by reducing over-diagnosis, over-treatment and iatrogenic harm.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1) Cherkaoui S, Pinnow E, Bulatao I, et al. The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes. Clin Pharmacol Ther. 2021;110(6):1512-25. doi: 10.1002/cpt.2320.
2) Pillans PI. Clinical perspectives in drug safety and adverse drug reactions. Expert Rev Clin Pharmacol. 2008;1(5):695-705. doi: 10.1586/17512433.1.5.695.
3) Manatū Hauora – Ministry of Health . Therapeutic products regulatory regime [Internet]. Wellington: New Zealand Government; 2023 [cited 2023 1 May]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime.
4) Lexchin J, Menkes DB. Can direct-to-consumer advertising of prescription drugs be effectively regulated? N Z Med J. 2019;132(1496):59-65.
5) Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patients' requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005;293(16):1995-2002. doi: 10.1001/jama.293.16.1995.
6) Spence MM, Teleki SS, Cheetham TC, Schweitzer SO, Millares M. Direct-to-consumer advertising of COX-2 inhibitors: effect on appropriateness of prescribing. Med Care Res Rev. 2005;62(5):544-59. doi: 10.1177/1077558705279314.
7) Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343(21):1520-8. doi: 10.1056/NEJM200011233432103.
8) Zadeh NK, Robertson K, Green JA. Lifestyle determinants of behavioural outcomes triggered by direct-to-consumer advertising of prescription medicines: a cross-sectional study. Aust N Z J Public Health. 2019 Apr;43(2):190-196. doi: 10.1111/1753-6405.12883.
9) Chang HY, Murimi I, Daubresse M, et al. Effect of Direct-to-Consumer Advertising on Statin Use in the United States. Med Care. 2017;55(8):759-64. doi: 10.1097/MLR.0000000000000752.
10) Niederdeppe J, Byrne S, Avery RJ, Cantor J. Direct-to-consumer television advertising exposure, diagnosis with high cholesterol, and statin use. J Gen Intern Med. 2013;28(7):886-93. doi: 10.1007/s11606-013-2379-3.
11) Applequist J, Ball JG. An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs. Ann Fam Med. 2018;16(3):211-6. doi: 10.1370/afm.2220.
12) Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA Network Open. 2023;6(1):e2250991-e. doi: 10.1001/jamanetworkopen.2022.50991.
13) Mintzes B, Barer ML, Kravitz RL, 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.
14) Medicines New Zealand. Submission on the Therapeutic Products Bill 2023 [Internet]. 2023 [cited 2023 1 May]. Available from: https://www.medicinesnz.co.nz/fileadmin/user_upload/Submissions/MNZTBP_Sub.pdf.
15) Espiner G. Lobbyists in New Zealand enjoy freedoms unlike most other nations in the developed world [Internet]. Wellington: Radio New Zealand; 25 March 2023 [cited 2023 1 May]. Available from: www.rnz.co.nz/news/lobbying/486670/lobbyists-in-new-zealand-enjoy-freedoms-unlike-most-other-nations-in-the-developed-world.
Contact diana@nzma.org.nz
for the PDF of this article
Time for New Zealand to ban direct-to-consumer advertising of prescription medicines
View Article PDF
The New Zealand government is this year developing a new Therapeutic Products Bill to replace the antiquated Medicines Act 1981. Among the many issues at stake is whether direct-to-consumer advertising (DTCA) of prescription medicines will continue to be permitted. Besides the United States (US), New Zealand is the only other high-income country that allows unrestricted DTCA, including both the name of the drug and its indications. Most other countries allow unbranded “disease-oriented” advertising, which falls outside the scope of pharmaceutical advertising regulations.
The nearly universal prohibition of DTCA is widely regarded as a health protection measure, especially for newly marketed drugs. In a survey of 300 new drugs approved in the US during 2002–2014, relatively small numbers of people (median 1,044) were exposed to the drugs pre-market,[[1]] too few to discover infrequent but significant adverse effects. More generally, drug-related harms are a common, often preventable cause of emergency department visits and hospitalisations,[[2]] underpinning the rationale to treat prescription medicines differently from over-the-counter and other consumer products.
Despite the New Zealand Labour Party historically opposing DTCA, the current Labour Cabinet has proposed that DTCA should continue based on four key arguments,[[3]] summarised here in relation to the research evidence:
Claim 1: the existing combination of government monitoring and industry self-regulation of DTCA is adequate.
This claim is manifestly false. The present arrangement is unable to ensure that ads contain accurate information on either benefits or harms of medicines, or on how advertised products compare to other available treatment options, including lifestyle modification.[[4]] Neither Medsafe, the New Zealand regulatory authority, nor the Commerce Commission proactively monitor DTCA; any monitoring occurs only after ads have appeared. On the industry side, the Advertising Standards Authority (ASA), an amalgam of media and communication agencies and advertisers, has developed the Therapeutic Products Advertising Code, while Medicines New Zealand, a lobby for research-based pharmaceutical companies, covers DTCA in its Code of Practice. The maximum penalty for Code violations is $80,000, unlikely to be a deterrent for multinational companies.
Claim 2: prescribing and drug expenditure triggered by DTCA may be beneficial
While stimulated prescribing may be appropriate and useful in some cases, a key question is the extent to which this is outweighed by the unnecessary or harmful prescribing that also follows DTCA. The best evidence bearing on this question comes from a controlled trial of brand-specific requests to prescribing doctors. Simulated patients were randomised to present scenarios of clinical depression or “adjustment disorder”—temporary distress for which pharmacotherapy is inappropriate. Requests from patients with adjustment disorder stimulated prescribing to a far greater extent than requests from patients with treatable depression.[[5]] Complementary evidence showing that DTCA-stimulated prescribing can be both inappropriate and harmful comes from a study of patients requesting advertised COX-2 inhibitors rofecoxib or celecoxib.[[6]] Combining survey data and health records, the authors found that patients responding to advertising were four times as likely as others to receive an inappropriate prescription. Rofecoxib (Vioxx) was heavily advertised for 5 years prior to its worldwide withdrawal in 2004. The VIGOR trial published in 2000 was the first to establish an increased risk of myocardial infarction with rofecoxib;[[7]] New Zealanders viewing Vioxx advertisements in the years that followed were not informed of this, with avoidable deaths a likely consequence.
Claim 3: people with lower educational status, poorer health or from an ethnic minority are more likely to seek care because of DTCA
While this is presented as a positive attribute, it is taken out of context from a New Zealand study that concludes DTCA may lead to “…the misuse or overuse of medications for diseases that may otherwise be improved by a healthier lifestyle”,[[8]] illustrating the importance of accessible and balanced health information for all sectors of the community. This survey found that those tending to rely on advertising reported less healthy lifestyle habits, suggesting that DTCA may have contributed to poorer life and treatment choices. Studies in the US found that exposure to statin DTCA was associated with inappropriate prescription to those at low risk of cardiac events,[[9,10]] suggesting DTCA can lead to both over-diagnosis and over-treatment.
Claim 4: a more informed society enables better conversations and relationships between patients and prescribers
While a well-informed public is to be encouraged, this argument is undermined by evidence of the poor quality and misleading information typical of DTCA, irrespective of whether it comes from broadcast, print or online advertising.[[4]] For example, an analysis of 61 ads televised during prime time in the US in 2016 found few (16%) with educational content regarding risk factors, contrasting with almost universal (94%) emotional appeals linking the advertised medicine to recreation and other positive experiences.[[11]] Only 7% discussed lifestyle change as an adjunct to medicine use, none as an alternative. Another recent analysis of the 81 most heavily advertised drugs in the US found that only 20 (24.6%) were rated as having high therapeutic value.[[12]] Despite existing regulations, the content and style of televised DTCA undermine industry claims of educational and public health value. Proponents of DTCA also tend to disregard doctors’ reports of unwelcome pressure to prescribe advertised medicines[[13]] and the time it takes to resist inappropriate requests.
Conclusion
In conclusion, the government’s main arguments for allowing DTCA to continue in New Zealand are both unsustainable and bear remarkable similarity to those advanced by Medicines New Zealand, a body representing the pharmaceutical industry.[[14]] This coincidence may reflect the virtually unregulated access that lobbyists have to senior government officials in this country.[[15]] In any case, available evidence indicates that banning DTCA would help to promote population health by reducing over-diagnosis, over-treatment and iatrogenic harm.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1) Cherkaoui S, Pinnow E, Bulatao I, et al. The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes. Clin Pharmacol Ther. 2021;110(6):1512-25. doi: 10.1002/cpt.2320.
2) Pillans PI. Clinical perspectives in drug safety and adverse drug reactions. Expert Rev Clin Pharmacol. 2008;1(5):695-705. doi: 10.1586/17512433.1.5.695.
3) Manatū Hauora – Ministry of Health . Therapeutic products regulatory regime [Internet]. Wellington: New Zealand Government; 2023 [cited 2023 1 May]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime.
4) Lexchin J, Menkes DB. Can direct-to-consumer advertising of prescription drugs be effectively regulated? N Z Med J. 2019;132(1496):59-65.
5) Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patients' requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005;293(16):1995-2002. doi: 10.1001/jama.293.16.1995.
6) Spence MM, Teleki SS, Cheetham TC, Schweitzer SO, Millares M. Direct-to-consumer advertising of COX-2 inhibitors: effect on appropriateness of prescribing. Med Care Res Rev. 2005;62(5):544-59. doi: 10.1177/1077558705279314.
7) Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343(21):1520-8. doi: 10.1056/NEJM200011233432103.
8) Zadeh NK, Robertson K, Green JA. Lifestyle determinants of behavioural outcomes triggered by direct-to-consumer advertising of prescription medicines: a cross-sectional study. Aust N Z J Public Health. 2019 Apr;43(2):190-196. doi: 10.1111/1753-6405.12883.
9) Chang HY, Murimi I, Daubresse M, et al. Effect of Direct-to-Consumer Advertising on Statin Use in the United States. Med Care. 2017;55(8):759-64. doi: 10.1097/MLR.0000000000000752.
10) Niederdeppe J, Byrne S, Avery RJ, Cantor J. Direct-to-consumer television advertising exposure, diagnosis with high cholesterol, and statin use. J Gen Intern Med. 2013;28(7):886-93. doi: 10.1007/s11606-013-2379-3.
11) Applequist J, Ball JG. An Updated Analysis of Direct-to-Consumer Television Advertisements for Prescription Drugs. Ann Fam Med. 2018;16(3):211-6. doi: 10.1370/afm.2220.
12) Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA Network Open. 2023;6(1):e2250991-e. doi: 10.1001/jamanetworkopen.2022.50991.
13) Mintzes B, Barer ML, Kravitz RL, 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.
14) Medicines New Zealand. Submission on the Therapeutic Products Bill 2023 [Internet]. 2023 [cited 2023 1 May]. Available from: https://www.medicinesnz.co.nz/fileadmin/user_upload/Submissions/MNZTBP_Sub.pdf.
15) Espiner G. Lobbyists in New Zealand enjoy freedoms unlike most other nations in the developed world [Internet]. Wellington: Radio New Zealand; 25 March 2023 [cited 2023 1 May]. Available from: www.rnz.co.nz/news/lobbying/486670/lobbyists-in-new-zealand-enjoy-freedoms-unlike-most-other-nations-in-the-developed-world.
Contact diana@nzma.org.nz
for the PDF of this article
Time for New Zealand to ban direct-to-consumer advertising of prescription medicines
The New Zealand government is this year developing a new Therapeutic Products Bill to replace the antiquated Medicines Act 1981. Among the many issues at stake is whether direct-to-consumer advertising (DTCA) of prescription medicines will continue to be permitted.
Subscriber Content
The full contents of this pages only available to subscribers.
Login, subscribe or email nzmj@nzma.org.nz to purchase this article.
