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Background
Medical research has established that direct to consumer advertising (DTCA) of prescription drugs is harmful to public health because it contributes to the increased consumption of drugs, often those which are yet of unproven harmlessness or effectiveness, or are more expensive.
Despite the apparent prohibition imposed by Canadian legislation on direct to consumer advertising of prescription drugs, a certain permissiveness in the application of said legislation has enabled daily exposure to advertising of prescription drugs on television or on billboards.
The government is under pressure to lift all restrictions on direct advertising of prescription drugs. In December 2005, CanWest Mediaworks, a conglomerate with interests in broadcasting, newspapers and the Internet, instituted legal proceedings against the federal government—alleging that the prohibition on DTCA constituted an unjustified violation of its freedom of expression as guaranteed under Section 2(b) of the Canadian Charter of Rights and Freedoms. In this regard, let it be noted that the pharmaceuticals industry invested 4.8 billion dollars U.S. in direct advertising to consumers in the United States last year1.
However, from the point of view of the public interest, there is no doubt that advertising, which aims first and foremost at selling a product, does not provide the full and impartial information we need to take informed decisions on health issues. Studies in the United States have shown that, in 1999, two-thirds of the increase in spending on prescription drugs were attributable to the more heavily advertised drugs2. A systematic review of the literature on direct advertising of drugs reveals that drugs advertising influences the demand behaviour of patients and the prescription practices of doctors3. After all, why would pharmaceutical companies spend billions on advertising if it were not indeed an effective way to boost sales and profits?
Thus, the DTCA contribution to rising health care costs is two-fold: first, advertising leads to greater consumption of medicines; and second, the costs of this consumption—all the higher as pharmaceuticals companies must cover their enormous advertising expenses—are in the end assumed by drug insurance plans.
Whereas a strict interpretation of the Food and Drug Act appears to prohibit all advertising on prescription drugs, regulations have authorized since 1978 “reminder advertising” in relation to prices:
C.01.044. Where a person advertises to the general public a Schedule F Drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug.
As it happens, pharmaceuticals companies use this authorization to promote products via highly emotionally charged advertising: i.e. ads that include much more than the name, price and quantity. It’s clear that such ads aim to increase the sales of certain specific products and not to abet price comparisons. In so doing, they thwart the intentions of lawmakers.
One may note that, since 1978, not a single fine has been imposed on a pharmaceuticals company for illicit advertising activities4. One further notes that, since that same date, this opportunity for consumers to compare prices has become totally irrelevant, as mandatory public or private drug insurance plans now cover such costs.
The Standing Committee on Health
In 2004, the Standing Committee on Health released a report5 in which it expressed its concern regarding the rising costs of health care in Canada. Furthermore, it observed that drug costs were a major factor in these rising costs.
“Canada will spend roughly $27 billion on pharmaceuticals in 2006. That represents over half what we will spend on hospitals ($45 billion) and 50 per cent more than we will spend on physicians ($19 billion) in 2006-and nearly three times what we spent on drugs in 1996 ($10 billion). While the majority of drug spending is for common, relatively cheap treatments for cholesterol, hypertension, heartburn & ulcers, and depression, several new, high-profile drugs are being priced at hundreds of thousands of dollars per patient, per year.” 6
The Committee expressed its firm conviction regarding the validity of the research data indicating that prescription drugs advertising, which directly targets the consumer, contributes to rising health care costs.
In the Committee’s judgement, advertising on prescription drugs (including reminder advertising) could endanger consumers, rather than empower them, as it is apt to foster the increased and improper consumption of drugs.
As the Committee noted, the rationale behind the 1978 authorization of reminder advertising is no longer as relevant to consumers given that most of them now paticipate in public or private drug insurance plans.
Finally, the Committee declared its deep dissatisfaction with Health Canada’s passive attitude regarding the enforcement of existing regulations on direct advertising to consumers, judging that the Ministry has abdicated its responsibilities re the enforcement of established rules. Consequently, the Committee demanded the adoption of strict measures to ensure rigorous adherence to the present prohibition on direct advertising to consumers.
Despite the unanimous support garnered by this report, despite the conclusions of the Commission on the Future of Health Care in Canada—which, in 20027, also concluded that the prohibition on direct advertising of prescription drugs to consumers in Canada should be maintained—direct advertising of drugs is increasing and Health Canada is still envisaging the lifting of restrictions on this practice.
Comments
Direct to consumers advertising of prescription drugs is prohibited in most industrialized countries; only two countries—New Zealand8 and the United States—do permit it.
However, the permissiveness shown by Canada is such that it enables pharmaceuticals companies to advertise in ways that even the U.S. prohibits9.
There is no longer has any rationale for the opening to direct advertising that Canada effected by authorizing “reminder advertisements.” They are neither justified in terms of usefulness (price comparisons) nor from the standpoint of public health. The provisions of the Food And Drug Act which were interpreted in such a fashion as to permit prescription drugs advertising should be abolished and the prohibition of all direct advertising should be reinstated.
In addition, the Canadian government must take all necessary measures to vigorously defend before the courts the provisions that prohibit direct prescription drugs advertising.
What the numbers tell us
In the United States, the industry’s spending on advertising to consumers went from approximately 100 million to 2.5 billion dollars U.S. between 1990 and 200010. This explosive growth, which has continued—reaching about 3.7 billion dollars and 4.1 billion dollars in 2003 and 200411, respectively—is outstripping growth in spending on research and development. In effect, between 1997 and 2001, while advertising expenditures rose by 145%, spending on RD rose by 59%12. Drugs marketed directly to consumers account for a disproportionate fraction of the 21 billion dollar increase in annual expenditures on retail drugs between 1999 and 200013.
Prescription drugs advertising only leads to increased sales, patients asking their doctors for the drugs advertised and the latter prescribing them. Studies show that direct advertising of prescription drugs does achieve these goals. A comprehensive review of the research on direct to consumers advertising has led the authors of this study to conclude that this practice influences both the demand behaviour of patients and the prescription practices of doctors14.
In one study, over half of the patients who did not need antidepressants obtained a prescription when they requested an advertised brand15. Another study found that doctors proved nine times more apt to make a prescription if the patient asked for an advertised drug. An FDA survey revealed that the great majority of doctors, i.e. 26 out of 27, felt somewhat or strongly pressured to respect a patient’s wishes should the latter request a particular brand; just 4% affirmed that they felt no such pressure16.
What are the advantages to direct advertising of prescription drugs?
The findings of the survey17 do not suffice to substantiate the argument that direct advertising of prescription drugs enhances respect of the posology or that it leads to more timely seeking of necessary treatment.
As for benefits of the information provided to consumers:
“More than 80 per cent of a national random sample of 643 US physicians did not believe that direct-toconsumer advertising of prescription drugs provides balanced information.75 This is
consistent with a Colorado survey of 523 physicians in which fewer than 10 per cent of respondents saw DTCA as a positive trend in health care”18
Does direct advertising empower consumers?
“To be empowered and have more autonomy in decision-making, people need accurate, balanced information, including an understanding of the context in which communication takes place and a realistic appraisal of the potential for benefit and harm.”19
An FDA survey revealed that a quarter of respondents believed that only the safest drugs were advertised on American television20.
“A survey of 329 randomly selected Sacramento residents similarly found that 43 per cent believed that only completely safe prescription drugs could be advertised to the public, and 21 per cent believed that only extremely effective drugs could be advertised. Those with misplaced faith in regulation were more likely to say that they would pressure their doctor or go to another doctor if theirs refused a request for an advertised drug.”21
The handful of above findings clearly show that the alleged advantages cited by pharmaceuticals companies, or by those wishing to profit from the economic spinoffs flowing from their investments in advertising, are easily refuted by objective studies.
As for the prohibition of direct advertising in Canada...
Is the prohibition on direct advertising of prescription drugs in Canada effective? Does the restricting of authorized advertising to “reminder advertising” only provide sufficient protection to Canadians? Are we better protected from the advertising stratagems of the pharmaceuticals industry than our neighbours, who do permit direct advertising of prescription drugs?
- Reminder advertisements for prescription drugs subject to safety advisories or warnings in bold type, due to the serious risks they constitute, are banned in the United States. In Canada, they are allowed.
- Medical specializations may not be mentioned in reminder advertisements in the U.S., but this practice is allowed in Canada.
- Reminder advertising is banned on television in the United States, but not in Canada.
- Reminder advertising campaigns may not be launched immediately after the release of a new medication in the United States, but this is allowed in Canada.
- Visual and audio cues on the utilization of a product are not permitted in reminder advertisements in the United States, but in Canada they are. 22
In summary
Drugs are not just another consumer product. They shouldn’t be advertised like other types of consumer goods. We must oppose direct advertising of prescription drugs for the following reasons:
• Advertising doesn’t provide the full and impartial information we need to make informed decisions on health issues. The main goal of advertising is to increase sales.
• It’s almost always new prescription drugs that are widely advertised. And yet, the very fact that they are new implies that they are the products about which the health risks are least well-known. Moreover, although new prescription drugs are not necessarily more effective or safer, they are generally more expensive.
• No proof exists that consumer advertising of prescription drugs helps us to make better choices regarding their utilization or that such advertising has a positive impact on public health.
• The aim of advertising is to increase sales. In the U.S., between 1991 and 1999, spending on direct advertising of prescription drugs went from 55 million dollars U.S. to 1.8 billion dollars U.S., a staggering increase.
• In 1999, two-thirds of the increase in spending on prescription drugs in the United States were attributable to the 25 most intensively advertised drugs.
• In the United States, over a 12-month period in 1997-1998, 33 drugs were advertised on television. Of these 33 products, 17–i.e. over 50%–contravened the regulations of the Food and Drug Administration. Most of them minimized the risks and exaggerated the benefits of the drugs in question. Some even suggested that the product advertised could be used for purposes other than the ones for which it had been approved.
Conclusion
The Minister of Health and all Members of Parliament must undertake to follow the recommendations of the Standing Committee on Health, as well as the expert advice of the Health Council of Canada, and ensure strict enforcement of the law. Nothing justifies, from a public health standpoint, a permissive interpretation of a clause authorizing advertising on prices such that it enables pharmaceutical companies to openly promote their products to the public.
In addition, the government must resolutely and effectively parry the attack against the prohibition of direct advertising of prescription drugs waged by CanWest, which invokes fundamental freedoms with the sole purpose of profiting from the colossal sums that the pharmaceuticals industry is disposed to invest in advertising to boost the consumption of its products.
At a time when New Zealand which, after a few years of experience with general consumer advertising for prescription drugs, has initiated a review process of its regulatory regime, based on a university report demonstrating all of the negative consequences of such advertising for the health professional-patient relationship and especially for the quality of health care23, it would be aberrant for Canada to consider turning a deaf ear to the considerations that have brought about a consensus, to which the United States alone refuses be a party, and envisage authorizing or tolerating direct advertising to consumers of prescription drugs, under any form whatsoever.
1 FLOOD, Colleen et Michelle Zimmerman. Direct-to-consumer advertising: CanWest's Charter Challenge. In: IHSPR Research Spotlight Pharmaceutical Research and Policy. August 2006. Available on Canadian Institutes of Health Research website, online: http://www.cihr-irsc.gc.ca/e/32055.html
2 UNION DES CONSOMMATEURS. Étude sur les médicaments sur ordonnance. Presentation before the Standing Committee on Health of The House of Commons . October 2003. 5 pages.
3 MINTZES, Barbara. Direct-to-Consumer Advertising of Prescription - What are the Public Health Implications? January 2006, p.2. Available on the Health Council of Canada website, at: http://healthcouncilcanada.ca/docs/papers/2006/hcc_dtc-advertising_200601_e_v6.pdf.
4 ibid, p.10.
5 OPENING THE MEDICINE CABINET: FIRST REPORT ON HEALTH ASPECTS OF PRESCRIPTION DRUGS. Report Of The Standing Committee On Health, April 2004. Available on Canadian Health Coalition website, at: http://www.healthcoalition.ca/healrp01-e.pdf.
6 Morgan, Dr. Steve. In: IHSPR Research Spotlight Pharmaceutical Research and Policy. August 2006. Available on Canadian Institutes of Health Research website, at: http://www.cihr-irsc.gc.ca/e/32055.html
7 Commission on the future of Health Care in Canada. Final Report. P. 223.
8 Since studies have demonstrated the negative consequences of that type of advertising, New Zeland is presently reexamining its position on the matter. See: Publicité grand public pour les médicaments de prescription : abus et confusion, in La revue Prescrire, 1 er novembre 2006, <en ligne> http://www.prescrire.org/aLaUne/dossierDTCA.php.
9 For example, see the case of Viagra advertising mentionned by Mintzes , op.cit. 3, p.18.
10 MERTENS, G. (1998). Direct to consumer advertising : Global drug promotion. Londres : Financial Times Healthcare. Voir aussi: ROSENTHAL, M.B., E.R. Berndt, J.M. Donohue, R.G. Frank, et A.M. Epstein (2002). Promotion of prescription drugs to consumers. N Engl J Med; 346: 498-505.
11 ARNOLD, M. (2005). Changing channels. Medical Marketing and Media; 40(4): 34-39.
12 US General Accounting Office. (octobre 2002). Report to Congressional Requesters: FDA Oversight of Direct-to-Consumer Advertising Has Limitations. Publication GAO-03-177. www.gao.gov/new.items/d03177.pdf.
13 MINTZES, op.cit 3, p.14.
14 GILBODY, S., P. Wilson et I Watt (2005). Benefits and harms of direct to consumer advertising: A systematic review. Quality and Safety in Health Care; 14: 246-250.
15 MINTZES B., chapter 5 : Patient/doctor survey in Sacramento and Vancouver. Direct-to-Consumer Advertising of Prescription Drugs: Effects on Prescribing and Policy Implications. Thèse de doctorat. Vancouver : Université de Colombie-Britannique, 2003.
16 AIKIN, K.J., J.L. Swasy et A.C. Braman (November 2004). Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs – Summary of FDA Survey Research Results. Food and Drug Administration. Center for Drug Evaluation and Research. www.FDA.gov/cder/ddmac/Final%20Report/FRFinalExSu1119042.pdf.
17 MINTZES, Op.cit. 3.
18 MINTZES, op.cit.3, p.31.
19 Ibid , p.33.
20 MINTZES, Op.cit. 15.
21 MINTZES, op.cit 3, re: Bell, R.A., M.S. Wilkes et R.L. Kravitz (1999). Advertisement-induced prescription drug requests; Patients’ anticipated reactions to a physician who refuses. J Fam Pract ; 48 (6): 446-552.
22 MINTZES, op.cit.3, p.17.
23 La revue Prescrire, op.cit. 8
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