E-drug: DTCA and Canada 3
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3. Direct-to-consumer prescription drug advertising in Canada:
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David M. Gardner, Barbara Mintzes, and Aleck Ostry
CMAJ 2003;169 425-427
From the Department of Psychiatry and the College of Pharmacy,
Dalhousie University, Halifax, NS (Gardner); and the Departments of
Pharmacology and Therapeutics (Mintzes) and of Healthcare and
Epidemiology (Ostry) and the Centre for Health Services and Policy
Research (Mintzes, Ostry), University of British Columbia, Vancouver,
BC.
Correspondence to: Dr. David M. Gardner, QEII HSC, AJLB 3005, 5909
Jubilee Rd., Halifax NS B3H 2E2, fax 902 473-4596;
david.gardner@dal.ca
The advertising of prescription drugs aimed directly at the public is
prohibited in most countries, including Canada. However, a shift in
interpretation of the policy governing this marketing strategy, known
as direct-to-consumer advertising (DTCA), has occurred in Canada,
resulting in its partial introduction without public and
parliamentary debate.1 Consultations on the potential introduction of
DTCA have been held by Health Canada since 1996, but there has been
little interest in allowing DTCA from health professional and
consumer organizations or provincial governments.2 Despite this, some
forms of advertising of prescription drugs to consumers have become
widespread. It is important for clinicians to be aware of how DTCA
has developed in Canada, its current status and potential outcomes
for health care.
There are 3 types of prescription drug advertisements aimed at the
public: product claim advertisements, which include both the product
name and specific therapeutic claims; reminder advertisements, which
provide the name of a product without stating its use; and
help-seeking advertisements, which inform consumers of new but
unspecified treatment options for diseases or conditions. All 3 forms
of advertising are permitted in the United States. In Canada,
although all 3 forms appear to contravene the Food and Drugs Act,
reminder advertisements and help-seeking advertisements are now
everyday events in broadcast and print advertising, with little or no
regulatory response.
Canada's Food and Drugs Act prohibits DTCA in 2 ways. First, it
prohibits the advertising of any drug to the general public as a
treatment, preventive or cure for serious diseases (Schedule A
diseases). Second, it prohibits the advertising of prescription-only
medicines (regardless of indication).2,3 The only relevant amendment
to the Act occurred in 1978, in which a clause approving the
advertising of drug prices was added. The amended section reads
"Where a person advertises to the general public a Schedule F Drug [a
prescription 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."3 This amendment, which was added to
allow for competition between pharmacies, does not make allowances
for the inclusion of additional information, such as text, sound or
images. So, if the regulations have not changed to permit DTCA in
Canada, what has? The answer appears to be found in policy statements
published by Health Canada that imply that the Act and its
regulations have been reinterpreted.
In 1996, a policy statement that set out to define the boundary
between information dissemination and advertising suggested that
Health Canada was ready to relax its interpretation of the Act.4 It
stated that Health Canada "recognizes the importance to the
pharmaceutical industry and to the general public of being able to
disseminate and access nonpromotional information regarding drugs for
human use." The effect of this statement was tacit approval of
help-seeking advertisements for serious diseases. A policy paper
released in November 2000 suggested an even more liberalized
reinterpretation of the Act.5 It explicitly stated that help-seeking
and reminder advertisements, but not product claim advertisements,
were legal.
The responsibility for interpreting and enforcing drug-advertising
regulations lies with Health Canada. How this works in practice is
complex and, because of resource limitations, involves other bodies
with delegated mandates, including the Pharmaceutical Advertising
Advisory Board (PAAB) and Advertising Standards Canada (ASC). PAAB
regulates pharmaceutical advertising to health professionals and ASC
has primarily focused on over-the-counter drug advertising targeted
to consumers. Manufacturers submit advertisements to these bodies on
a voluntary basis for pre-clearance. These bodies also handle
complaints. There are important differences in the process for DTCA
(Mr. Ray Chepesiuk, Commissioner, PAAB: personal communication,
2003). First, to comply with Health Canada's 1996 policy and the
applicable laws the term advertisement cannot be used, because
advertising prescription drugs to Canadians is illegal.4 Second,
there is no option for pre-clearance. Instead, manufacturers can, on
a voluntary basis, provide "nonpromotional information" submissions
to PAAB or ASC requesting advice to determine whether or not they are
in compliance with Health Canada guidelines.4 And, third, complaints
are handled only by Health Canada.
The problems with this system are evident. Advertisements can be
released to the general public without being reviewed by government
regulators or their delegated bodies. Response to complaints tends to
be slow, probably reflecting Health Canada's undercapacity to
regulate DTCA, and, arguably, ineffectual.6 For example, a television
advertisement for Zyban (bupropion) was allowed to run for months,
although Health Canada judged it to contravene the law.7 An added
concern arises when Health Canada decisions on specific advertising
campaigns appear to directly contravene the Food and Drugs Act. For
example, reminder and help-seeking advertisements that appeared
concurrently for Alesse (ethinyl estradiol and levonorgestrel) were
each individually judged to be legal.8 In practice, this means that
regulation of the accuracy of DTCA in Canada is haphazard.
The rationale for prohibiting the advertising of prescription drugs
to consumers is public safety. Compared with over-the-counter drugs,
prescription-only products are generally more toxic and are used to
treat conditions that are not easily self-diagnosed and self-managed.
Moreover, heavily advertised drugs tend to be newer and, thus, there
is less information available regarding their relative benefits and
risks. As a result, DTCA stimulates early uptake of these drugs in
the marketplace9 and, in cases of unforeseen harms, magnifies the
dangers of their use. Examples of drugs marketed to the public that
were soon found to be harmful include benoxaprofen, cisapride,
alosetron and troglitazone.10,11,12,13 The finding that 20% of new
drugs eventually receive new black box warnings on the product
monograph after marketing or are withdrawn from the market because of
serious safety concerns supports the concern that DTCA may contribute
to public harm.14
Supporters claim that DTCA responds to the consumer's right to
information and need for information about prescription drugs and
about health care choices.15,16,17 Whereas providing consumers with
information about prescription drugs is a shared goal by those for
and against DTCA, there is no evidence that DTCA adequately achieves
this goal. In contrast, an evaluation of 320 magazine advertisements
of 101 brand-name pharmaceuticals found that few advertisements
reported illness-related precursors, illness prevalence or common
misconceptions about the condition or its treatments, that
alternative treatments were discussed in less than 30% of
advertisements and that less than 10% of advertisements stated the
treatment's success rate.18
Other stated benefits of DTCA include earlier diagnosis of serious
conditions, better treatment adherence and improved health
outcomes.15,16,17 However, evidence to support these claims is weak
or absent.19 The only empirical study to test the effect of DTCA on
disease diagnoses found that 11% of patients had new diagnoses of
"high-priority" conditions as a result of consultations prompted at
least in part by DTCA.20 This study, however, failed to include a
control group, making it impossible to estimate the effect of DTCA on
the rate of new diagnoses.21 A final argument for DTCA is increased
consumer awareness of new, improved drug therapies. There is ample
evidence that DTCA has increased consumer awareness of advertised
prescription products16,20,22,23 and that this has affected consumer
behaviour and physician prescribing practices,24 but very few new
drugs have demonstrated advantages over standard therapies.25,26
Several evaluations of newly patented medications have found that
only a small proportion provide important therapeutic gains: 16% in
the United States before 1992, 6% in Canada in 1996-2000 and 3.4% in
France in 1981-2000.27,28,29,30 Moreover, new products can be
inferior to comparable therapies, as was found with 2.6% of new
approvals in France.30 Another perspective is that DTCA helps
consumers to become aware of consistently more expensive new
treatment alternatives.9,19
The costs associated with DTCA have generated significant concerns.
In the United States, investment into DTCA grew from $791 million in
1996 to $2.5 billion in 2000, representing 32% of total spending on
the promotion of prescription drugs (exclusive of product sample
costs).9 This sharp increase in spending was a result of regulatory
changes that facilitated radio and television advertising of
prescription drugs.16 All expenses incurred by the pharmaceutical
industry are incorporated into a drug's price and recovered through
product sales. In other words, consumers pay for DTCA, either in the
price of the prescription or through insurance premiums or through
taxes. All those who pay insurance premiums or taxes feel the costs
of DTCA, whether or not they take advertised medicines. Because of
concerns that DTCA increases demand by consumers and drug
expenditures for third-party payers, Canadian provinces have stated
their preferences for a continued ban on DTCA in Canada.2 Despite
this, DTCA has moved forward in Canada.
In March 2002, federal Health Minister Anne McLellan questioned the
value of DTCA based on the US experience: "The doctor tells them
there is no increased or enhanced effectiveness by providing the drug
advertised, but the patient is very persistent once they see the
advertisement. One has to question whether you are getting better
medical outcomes."31 Not addressed by this statement are the public
health concerns and cost implications of Health Canada's recently
relaxed policies regarding DTCA that allow for help-seeking and
reminder advertisements. These policy changes are not in keeping with
the spirit or the wording of the Act, its 1978 amendment or the view
stated publicly by the health minister.
The aim of banning DTCA is not to limit consumer access to health
information. On the contrary, the goal is to provide consumers with
independently developed, balanced, comparative information on the
full range of available medical treatments. The Canadian Medical
Association, the Canadian Pharmacists Association and the Consumers'
Association of Canada have all taken strong policy positions against
the introduction of DTCA, calling instead for publicly financed
alternatives.
The current state of DTCA in Canada, with regulatory creep occurring
behind closed doors, is unacceptable. Legislation banning DTCA either
needs to be reinforced or put to public and parliamentary debate. If
loopholes exist in the Act, clarifying wording can be introduced
along with regulations to further limit entry of US DTCA. The issues
at stake - public health and the sustainability of health care
services - are too important to be quietly set aside.
� See related articles pages 405 and 421
Footnotes
This article has been peer reviewed.
Contributors: Each author contributed substantively to this paper.
Dr. Gardner completed the early research, drafted early versions of
the paper and integrated feedback from the other authors. Dr. Mintzes
significantly reformulated the paper and added key content and
perspective. Dr. Ostry drafted the initial version of the commentary,
which was taken from a larger body of work that all the authors had
developed.
Acknowledgements: Dr. Gardner is supported by a Department of
Psychiatry infrastructure grant from the Nova Scotia Health Research
Foundation. Dr. Ostry holds a New Investigator award from the
Canadian Institutes of Health Research and a Scholar Award from the
Michael Smith Foundation for Health Research. Dr. Mintzes holds a
postdoctoral fellowship from the Canadian Institutes of Health
Research.
Competing interests: None declared.
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