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Is Banning Direct to Consumer Advertising of Prescription Medicine Justified Paternalism?

Yvonne Lau
Genera/Surgeon, PhD Candidate in Bioethics

Abstract New Zealand is one of two OECD countries in the world where direct-to-consumer advertising of prescription medicine (DTCA-PM) is permitted. Increase in such activity in recent years has resulted in a disproportionate increase in dispensary volume of heavily advertised medicines. Concern for the potential harm to healthcare consumers and the public healthcare system has prompted the medical profession to call for a ban on DTCA-PM as the best way of protecting the public interest. Such blanket prohibition however also inte~eres with the public's right of access to information. This paper will examine if banning DTCA-PM would constitute a justified form of paternalism in the context of today's New Zealand.

Keywords Drug industry; advertising; public policy; ethics Introduction Direct-to-consumer advertising (DTCA) of medicines is permitted in New Zealand. The Medicines Act 1981 makes no distinction between prescription-only medicines (PM) and non-prescription medicines (NPM). The only other OECD country which permits DTCA-PM is the United States of America where there has been a signficant increase in this activity over the past decade.(1) In New Zealand, the state agency which purchases pharmaceutical products (PHARMAC) has reported a disproportionate increase in expenditure on newer, more expensive medicines. This trend has been attributed to DTCA-PM.(2) The New Zealand Ministry of Health has recommended that regulation of DTCA-PM be tightened.(3) However, it has not resulted in any substantial actions with much effect. In 2003, a group led by professors of general practice from all four New Zealand Schools of Medicine submitted to the Ministry of Health a report (hereafter referred to as the Toop Report) which called for DTCA-PM to be banned.(4) Banning DTCA-PM interferes with the freedom of the

public to receive information. Liberal societies do sometimes limit the freedoms and rights of citizens in order to protect their interests. This is referred to as paternalism. This paper asks whether a ban on DTCA-PM constitutes justified paternalism. In the first section of the paper, the regulation of DTCA-PM in New Zealand is reviewed. Part 2 of the paper explores the status of rights and freedoms that are protected in New Zealand. In Part 3, the alleged harms of DTCA-PM are discussed, and it is argued that banning DTCA-PM in New Z e a l a n d w o u l d not be j u s t i f i e d paternalism.
Part 1 : Regulation of DTCA-PM in New Zealand Direct-to-consumer advertising for prescription medicine (DTCA-PM) refers to 'promotional material transmitted via television, radio, magazines and the Internet, as well as to a range of'patient education promotional activities' (such as disease-oriented advertisements, toll-free telephone numbers, information materials distributed by companyfunded organisations, media reports generated by companys p o n s o r e d press conferences, and public meetings) generated for the purpose of marketing prescription drugs.(3) It has been said that DTCA-PM is permitted in

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New Zealand 'by default'(4) since the law regulating DTCA makes no distinction between prescription-only and nonprescription medicines. The latter distinction is made in most other 0ECD countries but no case has been made that it should be the standard for all regulation of DTCA. Sections 56 to 62 of the Medicines Act 1981 describe s t a t u t o r y r e g u l a t i o n s for m e d i c a l a d v e r t i s e m e n t s . Essentially, the law prohibits false and misleading claims, including unrealistic claims of efficacy. Additional rules dictate that certain types of information should be included and presented in a certain manner. Section 58 of the act also seeks to protect patients with specific conditions, including cancer, heart disease, diabetes, arthritis, obesity, sexual impotence and baldness. The Fair Trading Act 1986, the Consumer Guarantees Act 1994 and the Misuse of Drugs Act 1975 also restrict DTCA-PM. Monitoring DTCA-PM for compliance with the law is a matter of self-regulation. This is to a large extent the responsibility of the Advertising Standards Authority (ASA). Since the ASA's funding comes from advertisers, it has a glaring conflict of interest. In addition, its operating arm, the Advertising Standards Complaint Board (ASCB), has been accused of being insufficiently specialised to handle complaints about medical advertisements. On another front, the Association of New Zealand Advertisers (ANZA) introduced the Therapeutic Advertising Pre-Vetting System (TAPS) in 1999. The system is now mandatory for all medical advertisements destined for mainstream media, and it aims to remove problematic advertisements before they are broadcast.(5) The fact that pre-vetting is done by agents directly linked to pharmaceutical companies again raises the issue o f c o n f l i c t of i n t e r e s t and r e d u c e s the trustworthiness of TAPS, especially in the eyes of medical professionals. Implementing and enforcing law concerning DTCA has proved to be difficult, even in the United States where the FDA supervises DTCA-PM from a powerful and centralised position.(1) In New Zealand, a three-month survey of DTCAPM was conducted using adjudicators from the division of the New Zealand Ministry of Health which is responsible for overseeing the approval of medicines for general use (MEDSAFE). The survey found that up to 31 percent of DTCA-PM breached the law.(6) We can only guess how this result might have compared to adjudication by the ASCB. Furthermore, since the ASCB deals only with complaints, it is an open question as to how many of the

advertisements identified as problematic by MEDSAFE would actually have reached the stage of adjudication. Because the activity of TAPS does not depend on complaints being lodged, it would theoretically be an improvement over ASCB adjudication process. But the issue of its conflict of interest remains.
Part 2: Freedoms and Rights in New Zealand - when might limitations be placed? Every society has a unique history, culture and law. The extent to which human rights are respected and protected, and the manner in which they are respected and protected, varies from country to country.

A. The New Zealand Bill of Rights Act 1990
The New Zealand Bill of Rights Act 1990 lays down the fundamental rights and freedoms protected under New Zealand s t a t u t o r y law. To say that s o m e o n e has a fundamental right to do something in a given society implies that it would be wrong for the government to interfere with this right, or at least that there must be special reasons to justify the interference.(?: 188) Freedom of expression is protected under section 14 of the Act which states that '(E)veryone has the right to freedom of expression, including the freedom to seek, receive and impart information and opinions of any kind in any form'. While the presumption is in favour of protecting rights, the New Zealand g o v e r n m e n t m a y sometimes find reasonable justifications to restrict them. Under the law, freedom to receive information is protected as much as the freedom to impart or to seek information. In other words, a ban on DTCA-PM would be considered interference with the freedom of expression under New Zealand law.

B. The Code of Rights
The Code of Health and Disability Services Consumers' Rights, d e v e l o p e d u n d e r the Health and Disability Commissioner Act 1994, affirms the respect and rights due to every healthcare consumer. All healthcare services providers are obliged to c o m p l y with it. The Code presupposes that every healthcare consumer is sufficiently competent to make their own healthcare decisions, which should be respected as far as possible even if they might not be in full accord with preferences of the healthcare provider.

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Justified Paternalism?

C. Protecting rights and protecting the public interest: striking a balance
The case of Moonen v Film and Literature Board of Review(9) illustrates the circumstances under which it would be reasonable, under New Zealand law, to place limitations on the rights and freedoms protected under the New Zealand Bill of Rights Act 1990. The case concerns the classification of two publications as 'objectionable' on the ground that they tended to promote or exploit sexual activity with y o u n g boys under the Films, Videos, and Publications Classification Act 1993. The Court of Appeal declared that to classify M o o n e n ' s publications as 'objectionable', stringent criteria compatible with the Bill of Rights Act 1990 must be complied with, and the Board of Review had failed to do so. Tipping J recommended in his ruling that, where competing interests are present, the objective of a legislature must be to pose 'as little interference as possible with the right or freedom affected' and that 'the way in which the objective is statutorily achieved must be in reasonable proportion to the importance of the objective' with 'the limitation (imposed being) justifiable in the light of the objective:(8) Part 3: Is banning DTCA-PM Unjustified Paternalism? While there is always a moral reason to interfere with a party who causes harm to others, the law will only have a place to intervene when the harms are wrongful. Volenti non f i t injuria ('To one who has consented no wrong is done') is fundamental to the understanding of wrongful harms. A person cannot be held responsible for harm brought on another if the latter has voluntarily assumed the risk of harm himself through his free and informed consent.(9: 116) Risks are not uncommonly taken by individuals in their pursuit of interests, and harms might befall them with their full k n o w l e d g e . These are not w r o n g f u l harms. A government that intervenes to protect its citizens from every harm will result in an over-restrictive society where its citizens' every move will be controlled and regulated. This clearly exceeds the function expected of and the power permitted for any system of government based on liberal principles. However, occasions do arise when the state might find it necessary to interfere with their citizens' freedoms for their own good, be it to promote benefits or simply to prevent harms. Such government interventions will be regarded as paternalistic.(lO)

Although paternalism arises from a sense of altruism, it is morally undesirable. The opportunity to rightfully decide for oneself, to exercise one's autonomy is fundamental to the recognition of this person as a full and competent member of society. Removal of this opportunity robs the person of the rightful respect he or she deserves. In a society whose government follows such liberal principles, any paternalistic policies will require serious justifications. Feinberg's ' w e a k p a t e r n a l i s m ' allows the state to interfere in order to protect individuals from their nonvoluntary choices. A person's consent is considered voluntary 'when he is a competent and unimpaired adult who has not been threatened, misled, or lied to about relevant facts, nor m a n i p u l a t e d by subtle forms of conditioning:D: 116) Where the decision is non-voluntary, it could provide a justification for external interference. In this manner, state interference will only be permissible if it is the sort to which the agent would consent to as if he were making a fully voluntary choice.(ll) Voluntariness will be assessed with direct relevance to the individual's circumstances and the seriousness of the decisions that he faces. The 'Principle of hypothetical individualised consent' aims to 'nudge (the agent) back onto a path compatible with his own goals and values'.(10: 87) This type of autonomy respecting paternalism would probably a p p r o x i m a t e most to the paternalististic b e h a v i o u r compatible with New Zealand society. As we have seen, the freedom to receive information is a fundamental right and freedom ensured for every New Zealand citizen. To justify a ban on DTCA-PM, the state must show that the voluntariness of action based upon information from DTCA-PM is sufficiently compromised to warrant a paternalistic policy. The nature and the seriousness of the harms caused by DTCA-PM will be crucial to the verdict.

A. How substantial are the alleged harms of DTCA-PM?
The Toop Report(4) offers a comprehensive documentation of the harms of DTCA-PM. Much of the evidence comes from the USA which is battling steeply rising costs in the health care sector. New Zealand's health care system is different to that in the USA. Hence it is problematic to generalise the US experience of DTCA-PM to New Zealand. Any decision to ban DTCA-PM in New Zealand will need to consider such a ban within the local context.

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1) DTCA is harmful because the information it provides is biased, incomplete, misleading or deceptive The fact that advertisements are inherently biased or inadequate as sources of information is not sufficient reason to ban them. Advertisements are common in capitalist economies. Consumers generally understand their nature and do not trust all the claims that advertisements make.(12, 13) According to both the Colmar Brunton telephone survey quoted in the Toop Report (14) and the survey conducted by the UK Consumers' Association,(15) consumers are in general sufficiently aware that the information provided by drug advertisements may not be trustworthy. Given that sick people might be more vulnerable to e x p l o i t a t i o n , and given that i n a p p r o p r i a t e use of prescription medicines can lead to serious harm, New Zealand regulators have insisted that certain information be included in DTCA-PM so that sound choices can be made. Where there are serious omissions (e.g. failure to mention side effects or specific indications for use, or where benefits are exaggerated), it would be simple enough to require that advertisements be more specifically and tightly regulated under the existing provisions of the Medicines Act 1991. Health warnings similar to those that appear on tobacco advertisements could be mandated to advise consumers that a drug may have a higher risk of side effects. Closer monitoring of advertisements and heavier penalty for non-compliance are more direct ways of dealing with the problem of bias and incompleteness. It is concerning that up to 30O/oof all DTCA-PM in New Zealand may have breached the law.(6) The introduction of TAPS in 1999 shows that advertisers are not completely resistant to regulations, although concerns about conflict of interest make the system controversial. Representation of medical and health professionals in the adjudication process may bolster the efficacy of this system of regulation as well as public confidence in it. While the system is not completely effective yet, it is not convincing that a satisfactory level of protection might not be achievable using different means other than a ban. Indeed, a survey conducted in New Zealand showed that almost 700/0 of over 600 adult respondents opposed such a ban.(16) 2) DTCA is harmful because it leads to over-prescription of expensive new drugs and distorts expenditure on health In 2002, PHARMAC reported a 42% increase in dispensing volumes for the four most heavily advertised prescription

medicines: Flixotide (Fluticasone), Losec (Omeprazole), Lamisil (Terbinafine), and Oxis (Oxiconazole).(2) This may appear alarming, but it should be considered in context. The increase in dispensing volumes could reflect an increase in the need for the drugs rather than unreasonably raised expectations. In New Zealand, PHARMAC determines when and how government subsidies will be made available, and for which medicines. Its influence in the use of prescribed medicines is substantial. For prescription medicines that are not covered by PHARMAC, the entire cost is borne by the c o n s u m e r with no effect on the healthcare budget. PHARMAC effectively controls public expenditure on medicines. Its budget has increased at a consistent rate of 1.5O/o per annum over the past ten years in spite of the rise in DTCA-PM activity in the past six years.(17) Furthermore, information disclosed by PHARMAC in 2003 showed that the actual e x p e n d i t u r e on asthma inhalers, w h i c h represented one of the medicines heavily advertised and subsidised, had remained relatively stable over a three year period from 2000 to 2003.(18) Thus, it appears that more people might be benefiting without a concomitant increase in overall cost. So far, there is no data to support a distortion of the distribution of the healthcare budget. 3) DTCA is harmful because it puts pressure on doctors to prescribe new drugs whose side effects are not fully known Like other medicines available to the consumers, DTCAPM drugs have gone through Phase III clinical trials and relevant approval processes. The fact that they are relatively new might mean that not all possible side effects are known. New Zealand law recognises the potential harm that could result from indiscriminate use of these medicines. Medical knowledge and experience together with proper monitoring are required for their administration. They are classified as prescription-only medicines in order that they can only be legally sold, supplied and administered with a prescription from a medical practitioner or other designated personnel. Prescribers are the 'gate-keepers'. An ordinary consumer does not have direct access to these medicines. The only option for a consumer persuaded by the information received from DTCA-PM is to approach his or her doctor for f u r t h e r advice. A p a r t f r o m cost and m i n o r inconveniences, no substantial harm would result from such a visit. On the contrary, it is often a source of valuable medical information.

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The Toop Report suggested that doctors perceive pressure from healthcare consumers exposed to DTCA.(4: 6, 19) Studies conducted on family practitioners in New Zealand have not shown this to be a serious concern. For example, a majority of the general practitioners interviewed in one study reported that most patients accepted recommendations that were different from what they had asked about without serious disappointment. Only under a quarter of GPs perceived, in less than a quarter of their patients, serious disappointment to the extent that patients would consider changing doctors.(20: 23) Today's healthcare environment nurtures a partnership relationship between doctors and patients. As patients become more generally informed, they also become more forthcoming and assertive with their needs. Feeling some pressure in the clinical encounter is therefore not unusual. Prescribing a medicine requires not only knowledge and experience, but also good communication skills. With or without DTCA, patients frequently have preconceived ideas about a medical condition. Doctors need not perceive these as unreasonable demands from patients and therefore a source of pressure. The clinical encounter provides a precious opportunity for communication. Handling pressure does require skill. Training doctors in communication and pressure management will be useful. By establishing guidelines and recommendations in the use and monitoring of medicines, as well as by continually educating the public on good medical practices, the medical profession promotes positive exchange of information. Recent data revealed serious harmful effects of certain new drugs such as Vioxx (Rofecoxib), which have to be recalled by their manufacturers.(21) The magnitude of the harm was alarming. Given that these drugs were very heavily advertised directly to consumers, it was tempting to conclude that pressure induced by DTCA-PM was the primary reason for the problem. But instead, at a United States Senate Hearing on Finance, serious flaws were discovered on how the FDA, through its Center for Drug Evaluation, approved and monitored new drugs.(22) It would have been easy to blame DTCA for the harm of Vioxx (Rofecoxib). Paradoxically, this might have caused more harm as the real reason for the problem might have remained hidden.

source of information for underprivileged groups who enjoy limited access to other sources of information. If it were not for information obtained from DTCA, consumers may not become aware of new treatments (e.g. for male sexual impotence) and discuss treatment options with their doctors. In a recent survey about the role of media in women's healthcare decisions, half of the respondents indicated that DTCA had helped them better understand and better c o m m u n i c a t e with their doctors about p r e s c r i p t i o n medicines.(23) A n o t h e r s u r v e y found that AfricanAmerican doctors supported DTCA because it prompted their African-American patients to ask questions about their medical conditions thus increasing their awareness and participation in treatment.(24) Providing information that is vetted by qualified medical professionals is desirable. Limiting its provision to medical sources is however not a good idea. The medical profession has not always placed the interests of patients first, as the history of medical experimentation shows. A diversity of information sources could protect the public against the possibility of unethical medicine. Ensuring minimal interference with information exchange enables such diversity to exist. Granted that it does not guarantee the accuracy or the comprehensiveness of information, even partially true or incomplete information can have benefits. Diversity of information trains the mind to be inquisitive, sceptical and aware. In the context of the 'information revolution', the practicability of limiting sources of information is doubtful in any case. Banning DTCA-PM is unlikely to achieve the result of 'sanitising' health-related information that the public is exposed to.

B. The negative implications of banning
Advertisements reach audiences that span different social classes and education levels. They may be an important

Conclusion There are presently insufficient justifications for imposing a ban on DTCA-PM in New Zealand. A ban directly contravenes the public's right to freedom of expression. Blanket prohibition of advertisements on prescription medicines removes not only the problematic information but also useful and informative health messages. While there may still be many inadequacies in its regulation, there is insufficient data to support that the claim that DTCAPM is causing serious harms to New Zealanclers. Restrictive g o v e r n m e n t policies require clear and c o n v i n c i n g justifications that are lacking in this case. Admitting h o w e v e r that DTCA-PM can cause serious potential problems, the government has undeniable responsibility

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to explore alternative solutions. Policies should be specifically directed towards preventing the anticipated h a r m . T h e m e d i c a l p r o f e s s i o n also h a s a c r u c i a l role to play. P r a g m a t i c p r o g r a m m e s to e n h a n c e d o c t o r - p a t i e n t communication a n d to e d u c a t e t h e p u b l i c are u s e f u l . L i m i t i n g i n f o r m a t i o n d i s s e m i n a t i o n to s p e c i f i c s o u r c e s is unnecessary and impractical. Any intervention for the purpose of preventing harm must be balanced against restricting fundamental rights and freedoms. Paternalism is j u s t i f i e d w h e n t h e i n t e r e s t s to b e p r o t e c t e d r e p r e s e n t t h e likely projected interests of the particular individual, when t h e m e a n s o f d o i n g so w o u l d p o s e t h e l e a s t i n t e r f e r e n c e with his rightful freedoms, and when non-interference was n o t a n o p t i o n . T h e p r o p o s i t i o n to b a n D T C A - P M h a s n o t b e e n s h o w n to m e e t t h e s e criteria. B a n n i n g D T C A - P M is therefore not justified paternalism.

9. 10. 11. 12. 13.

14.

15. 16. 17.

Bibliography
1. GAO. Prescription drugs: FDA oversight of direct-to-consumer advertising has limitations. In: Report to Congressional Requestors. United States General Accounting Office; 2002. 2. PHARMAC. Analysis of the increase in dispensing volumes in 2001/ 2002. In. Wellington: PHARMAC; 2002. 3. Ministry of Health. Direct-to-consumer advertising of prescription medicines in New Zealand. A discussion paper. In. Wellington: Ministry of Health, New Zealand; 2000. 4. 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? In: New Zealand Departments of General Practice, Christchurch, Dunedin, Wellington and Auckland Schools of Medicine; 2003. 5. Health Care Program. Direct-to-Consumer Advertising (DTCA) and Marketing of Pharmaceuticals (http://www.ncsl.org/programs/health/ rxads.htm), accessed 10 May 2005. 6. Pratt P. The results of a regulatory compliance survey of direct-toconsumer advertisements for medicines. In. Wellington: Medsafe; 2000. 7. Dworkin R. Taking Rights Seriously, 7th edn. Cambridge, Massachusetts: Harvard University Press; 1980. 8. Moonen v Film and Literature Board of Review. In: 2 NZLR. vol. 2: 18. 19.

20.

21. 22.

23. 24.

CA; 2000: 16. Feinberg J. Harm to Others, vol. 1. New York: Oxford University Press; 1984. VanDeVeer D. Paternalistic Intervention the moral bounds on benevolence. New Jersey: Princeton University Press; 1986. Feinberg J. Harm to Self, vol. 3. New York: Oxford University Press; 1986. Hodnett J. Targeting consumers. Medical Marketing ~t Media 1995; 30(11):91-95. Calfee J E. Public policy issues in direct-to-consumer advertising of prescription drugs. Journal of public policy and marketing 2002; 21(2):174. Colmar Brunton. Consumer opinion: Prescription medicines information. Prepared for Department of General Practice Christchurch School of Medicine and Health Sciences. In: Colmar Brunton Social Research Agency; 2003. Consumers' Association (UK). DTCA survey results. In. London: Consumers' Association (UK); 2002. Massey News. Massey Researchers Question Otago DTCA Survey Conclusions. In: Massey News, Massey University, 2003. Association of New Zealand Advertisers. Direct to consumer advertising of prescription medicine (DTCA) part of a well functioning democracy and economy. In: New Zealand Direct Marketing Association Inc., 2004. Saunders B. DTCA and the cost of asthma inhalers. The New Zealand Medical Journal 2003; 116(1185):672. Aiken K J. Direct-to-consumer advertising of prescription drugs: physician survey preliminary results. In. Rockville, Maryland: Division of Drug Marketing, Advertising and Communications, FDA; 2003. Eagle L, Chamberlain K: DTC. Dogma, doubts, diversity and divergence: Perspectives from the medical professions regarding the impact of the promotion of medications direct to consumers- Technical report 03.01. In. Auckland: Massey University; 2003; 1-64. The Vioxx Recall (http://www.abe.net.au/4eorners/eontent/2005/ s1341036.htm), accessed 10 May 2005 United States Senate Committee on Finance Hearings 'FDA,Merck and Vioxx. Putting patient safety first?' (http://finanee.senate.gov/ sitepages/hearing lll804.htm), accessed 10 May 2005. Kahn C. How the media influences women's perceptions of health care. Marketing Health Services 2001(Spring):13-17. Allision-Ottey S D, Ruffin K, Allision K B. To do no harm. In: Survey of the physicians of the National Medical Association regarding perceptions on DTC advertisements. Survey of the physicians of the National Medical Association regarding perceptions on DTC advertisements; 2002.

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