New Genetics and Society, Vol. 25, No.

1, April 2006

‘Be ready against cancer, now’: direct-to-consumer

advertising for genetic testing
BRYN WILLIAMS-JONES
Groupe de recherche en bioéthique & Département de médecine sociale et préventive, Faculté de
médecine, Université de Montréal, Canada

ABSTRACT A recent addition to the debate about the benefits and harms of direct-to-consumer
(DTC) advertising of medicines and pharmaceuticals is a growing critique of DTC marketing and
sale of genetic tests. Academic and policy literatures exploring this issue have, however, tended to
focus on the sale of genetic tests, paying rather less attention to the particular implications of
advertising. The globalization of broadcast media and ever increasing access to the Internet mean
that public exposure to advertising for medical technologies is a reality that national regulatory
bodies will be hard pressed to constrain. Working through a case study detailing Myriad Genetics’
2002 pilot advertising campaign for their BRACAnalysis genetic susceptibility test for hereditary
breast and ovarian cancer, this paper highlights some of the diverse and often overlooked and
unregulated approaches to DTC advertising, and the associated social, ethical and policy implications.

Introduction
The appropriateness of direct-to-consumer (DTC) advertising of pharmaceuti-
cals and other health-related products is a hotly contested issue in Canada and
Europe (Consumer’s Association, 2001; Lexchin & Mintzes, 2002), and to a
lesser extent in the United States (Moynihan et al., 2000; Pinkus, 2002). A new-
comer to this debate is commercial genetic testing that is advertised and sold
through the mainstream media and the Internet. Consumers can now purchase
tests for paternity, identification, or immigration purposes (GeneWatch UK,
2003; Zitner, 2002), or obtain health-related tests for genetically linked
conditions (Gollust et al., 2003; Williams-Jones, 2003).
The social, ethical and policy implications of the commercialization of genetic
testing for health related conditions (the focus of this paper) are coming under
increasing scrutiny. Concerns include, for example, harms to individuals from
accessing complex genetic information without adequate counselling support,
the potential for discrimination and stigmatization of individuals or communities
and the social and economic costs of private purchase of genetic services for

Correspondence to: Bryn Williams-Jones, Programmes de bioéthique, Université de Montréal, C.P.

6128, Succursale Centre-ville, Montréal (Québec) Canada H3C 3J7. Tel: (514) 343 6111 x4881;
Fax: (514) 343 5738; Email: bryn.williams-jones@umontreal.ca

ISSN 1463-6778 print/ISSN 1469-9915 online/06/010089-19 # 2006 Taylor & Francis

DOI: 10.1080/14636770600603527
90 Bryn Williams-Jones

publicly funded health care systems (Burgess, 1999; Caulfield et al., 2001; Martin
& Frost, 2003). But with the exception of a few academic articles (Gollust et al.,
2002; Gray & Olopade, 2003; Hull & Prasad, 2001; Mykitiuk, 2004), and
government reports (Human Genetics Commission, 2003; Secretary’s Advisory
Committee on Genetic Testing, 2000), rather less attention has been directed
at those issues particular to the advertising as opposed to the sale of genetic tests.
Advertising appearing on television, in print, on the radio and over the Internet
is criticized for providing deterministic and simplistic explanations of genetics that
ties into pre-existing public concerns in order to exacerbate individual anxiety and
risk perception (Hutson, 2003; Tambor et al., 2002). Critics have argued that by
exploiting a climate of genetic determinism and public anxiety, DTC advertising
misleads consumers into believing they need and should purchase or demand
from their physicians expensive genetic tests that are unlikely to be clinically
useful. Given these serious concerns, one might reasonably assume that strict
government regulations would ensure the highest standards of information
content. However, the marketing of commercial genetic tests is a relatively new
phenomenon and few governments have yet developed specific regulatory
responses (Caulfield et al., 2001). Further, as approaches to controlling DTC
advertising vary substantially between countries, what may be restricted in one
is often permissible in another. When combined with the permeability of national
boundaries made possible by global broadcast media and the Internet, uncer-
tainty about what constitutes the best policy response will mean that exposure
to DTC advertising will be hard to constrain. The situation is further complicated
by the use of other more subtle methods of product promotion that rely on build-
ing public ‘awareness’. Internet websites, discussion lists and patient support
groups are being variously used by life science companies as part of comprehen-
sive marketing campaigns. As these methods of product promotion are not con-
sidered ‘advertising’ in the strict sense, they often fall outside existing ethical
critique and government oversight.
Given the dearth of literature examining DTC advertising for genetic tests, this
paper will draw upon the more substantial analyses of pharmaceutical industry
drug promotion (Mintzes, 1998, 2000)1 to investigate Myriad Genetics’ 2002
advertising campaign for the BRACAnalysis test for hereditary breast cancer,
one of the first and most dramatic instances (and unlikely to be the last) of a
coordinated media campaign for a commercial genetic test.

DTC advertising and product promotion

The objectives of advertising and product promotion include building brand
recognition, raising awareness and understanding of diseases and products, and
targeting audiences in order to influence buying behaviour (Snow, 2002). In
2000, the pharmaceutical industry spent US$15.7 billion on drug promotion,
mostly aimed at health care professionals, with only 15% dedicated to DTC
advertising. Nonetheless, and directly related to a relaxation of restrictions on
TV advertising in the US, annual spending on DTC advertising tripled between
 ‘Be ready against cancer, now’ 91

1996 and 2000, reaching nearly US$2.5 billion (Findlay, 2001; Rosenthal et al.,
2002).
This advertising, unsurprisingly, tends to paint a rather rosy picture of the
safety and utility of new and existing drugs. Studies of pharmaceutical advertising
in Canadian and American newspapers, for example, found significant positive
bias with few reports of harmful side effects (Cassels et al., 2003; Moynihan
et al., 2000). In an environment characterized by tough regulations and effective
oversight mechanisms, it would not be in a company’s interest to make blatantly
false claims—national oversight bodies would penalize the company, while consu-
mer watchdogs would publicize any gross falsehoods, undermining the company’s
credibility and profitability. But without strong enforcement and publicity, there
will be powerful incentives for companies to use advertising to create consumer
‘need’ (Caulfield & Gold, 2000; Moynihan et al., 2002), to make optimistic
claims to attract investors (Melzer & Zimmerman, 2002) and to provide incom-
plete risk information to underplay potential harms and boost consumer confi-
dence (Davis, 2000).
One of the primary arguments in favour of DTC advertising for pharma-
ceuticals and other medical technologies is that information is empowering.
Patients, framed as autonomous consumers of health care, have a right to be
informed about breakthrough technologies and products so they can be active
participants in managing their health care (Rubin, 2001). Advertising, it is
argued, allows patients to better share their personal experiences and knowledge
of health or illness with their physicians, request particular tests or drugs, evalu-
ate the risks and benefits of treatment options, and become equal partners in
the patient-physician relationship (Calfee, 2002; Deshpande et al., 2004).
DTC advertising for pharmaceuticals also invariably encourages patients to
seek professional advice and talk with their doctors, and thus ‘if used appropri-
ately, direct-to-consumer advertising has the potential to increase patient aware-
ness about treatment options and enhance patient-physician communication’
(Council on Ethical and Judicial Affairs of the American Medical Association,
2000, abstract). As with the case of pharmaceuticals, DTC advertising
for genetic tests might improve relations between patients and their physicians
and even promote information seeking in the form of family discussions
about hereditary illnesses that could facilitate treatment and prevention of
disease.
This positive framing of the patient as empowered consumer and active partici-
pant in health care decision making is not uncontroversial. When patients are
encouraged to view medicines as consumer products, as something to be
demanded from physicians by name, the ability of physicians to make informed
decisions based on objective product information may be undermined (Findlay,
2001; Fisher, 2003). The concern is that advertising reduces the patient-physician
relationship to a mere service delivery arrangement, threatening the professional
responsibility of physicians and the safety of their patients (Lexchin & Mintzes,
2002; Pinkus, 2002). Moreover, advertising-induced patient demand for brand
name drugs and medicines may put significant pressure on managers of public
92 Bryn Williams-Jones

or private health care insurance plans to cover more expensive drugs when equally
effective lower cost generic drugs are available.
As health care systems begin to incorporate genetic technologies as an integral
part of their services (Department of Health (UK), 2003), it will be essential that
publics, academics, health professionals and policy makers be cognizant of the
implications of DTC advertising for commercial genetic tests.

Genetic testing for hereditary breast cancer

Current epidemiological evidence suggests that 5– 10% of all women who will
develop breast and ovarian cancer are likely to have inherited a particular
genetic mutation associated with increased risk of developing the disease
(Carter, 2001; Narod, 2002). The discovery and sequencing in the early 1990s
of two genes associated with hereditary breast and ovarian cancer (BRCA1 and
BRCA2) helped to make possible genetic susceptibility testing (referred to here
as ‘BRCA testing’, and involving the partial or full sequencing of the two
genes) for patients to determine their risk status. BRCA testing, which is
covered by public health care insurance plans in Canada and most European
countries and by most private health insurance plans in the United States, is
usually made available through medical genetics laboratories working in collabor-
ation with clinical oncology programmes. These programmes have guidelines
restricting test access to patients presenting with risk factors such as a strong
family history (multiple cases of breast or ovarian cancer), early age of onset
(pre-menopausal), or membership in a specific ethnic group (e.g., Ashkenazi
Jewish, French Canadian) (Carter, 2001).
The purpose of restricting access is to ensure that testing is made available only
to those people for whom it will be accurate, cost-effective and provide useful
information. Of the 5– 10% of women with hereditable breast cancer, testing
for known BRCA mutations will account for only 17 – 25% of those at risk for
the disease (Shih et al., 2002; Szabo & King, 1997; Frank et al., 2002); there
are likely other unknown genes and environmental factors involved. Nevertheless,
for those women with cancer ‘running in the family’, BRCA testing may still be a
useful test. If a mutation is identified in affected family members (i.e., a positive
result), then other members can be tested for the ‘family mutation’. This test can
thus be used to confirm (or disprove) a patient’s putative high risk status, encou-
rage physicians to more actively monitor their patients, and facilitate access to
other health care services that might reduce cancer risk (d’Agincourt-Canning,
2003). Those patients found not to have the identified family mutation are con-
sidered to be no longer at high risk (they will have the same risk as the general
population) and can thus avoid frequent, expensive and unpleasant monitoring.
However, where no family mutation is identified in affected individuals and/or
those with a strong family history of cancer, the test will be uninformative; the
genetic component of the hereditary cancer is unknown and thus individuals
remain at high risk based on their strong family histories.
 ‘Be ready against cancer, now’ 93

BRCA testing can provide tangible clinical results for some women, but it can
also have negative physical, social and psychological sequelae. Prophylactic
surgery involving the removal of breasts and/or ovaries (Hartmann et al., 2001;
Lynch et al., 2001) and drugs such as tamoxifen (King et al., 2001) can signifi-
cantly reduce the risk of developing cancer, but these treatments are not cures
and may be difficult to apply (Narod, 2002). Moreover, BRCA testing is not diag-
nostic or predictive in the sense that it will identify the onset of cancer; the test
provides only risk information. ‘Simply put, positive tests do not always mean
that an individual will develop cancer, and negative tests are not a guarantee
that they will remain cancer-free’ (Gray & Olopade, 2003, p. 3192). This risk
information, however, may be interpreted in a deterministic fashion such that it
leads patients to develop fatalistic attitudes about developing cancer, increases
fear and anxiety, or poses difficult choices about sharing results with family
members (Hallowell et al., 2003).
Given the complexity of genetic information and the challenge of understanding
the utility and limitations of a genetic test, not to mention the potentially profound
psychosocial implications, genetic counselling (provided by physicians, oncologists,
nurse educators, or genetic counsellors) is considered the medical ‘standard of
care’. Under public or private health insurance plans in the US, Canada or
Europe, testing is not provided to ‘patients off the street’ with little or no family
history of disease; instead, testing is offered only to those patients presenting
with a strong family history of the disease, as part of a comprehensive clinical pro-
gramme that includes pre- and post-test genetic counselling, a range of treatment
options and regular follow-up and monitoring (Peshkin et al., 2001). However,
this situation may be changing with the DTC advertising and sale of BRCA testing.

Myriad genetics and BRACAnalysis

Myriad Genetics (a Utah-based biopharmaceutical and genomics company) is
probably best known for its involvement with the international effort to discover,
sequence and patent the two genes (BRCA1 and BRCA2) associated with heredi-
tary breast and ovarian cancer and the deployment of a commercial genetic test,
BRACAnalysis. Myriad has vigorously and successfully enforced its patent rights
on the BRCA genes in the US—all hospitals and health insurance plans have been
required to purchase Myriad’s test—as a means of establishing complete control
of the US BRCA testing market (Borger, 1999; Murray, 1999). Myriad has also
been trying to build markets in Canada and Europe, albeit with much less
success; instead of acquiescence, Myriad has faced mounting public, professional
and government opposition, culminating in a widespread rejection of Myriad’s
patent rights to the BRCA genes (Williams-Jones, 2002).2

The advertising campaign

As part of Myriad’s attempt to control the market for BRCA testing, in September
2002 the company began piloting in two US cities (Denver and Atlanta) a public
94 Bryn Williams-Jones

advertising campaign for its BRACAnalysis test (Myriad Genetics, 2002).

Presented as a public service to educate women about the risks of and options
for dealing with hereditary breast cancer, the campaign was timed to coincide
with the US National Breast Cancer Awareness month. According to Myriad’s
media campaign website:

Hereditary breast and ovarian cancer is underdiagnosed. That’s why

Myriad Genetic Laboratories has launched an important pilot campaign
to help women and their physicians learn about this syndrome, and ways
to reduce cancer risk. . . . [An] effort to get the word out about the
importance of learning who’s at risk for hereditary breast and ovarian
cancer—so physicians and consumers can take action now to reduce
that risk. (Myriad Genetics, 2002b)

The BRACAnalysis Integrated Awareness Campaign ran for five months and
included TV, print and radio advertisements, coordinated with a toll-free
telephone number and two websites (www.bracnow.com and www.myriadtests.com,
accessed 14 December 2004). A one-minute commercial was shown during prime
time on the major TV networks (NBC, CBS, ABC, Fox, WB), supported by
print ads in Atlanta and Denver newspapers and magazines and ads on local
radio stations. Advertisements also appeared in popular magazines such as
People, Better Homes and Gardens, Ladies’ Home Journal, and Women’s Health
Monitor.
In Myriad’s TV advertisement and the corresponding print ads, a series of
smiling women from diverse ethnic backgrounds, apparently between 30 and
45 years of age (Mykitiuk, 2004), talk about having family members with breast
cancer and the need to learn about personal risk status in order to gain control
over the disease. BRACAnalysis, ‘a blood test that’s helped thousands of
women find their risk for hereditary breast and ovarian cancer,’ is portrayed as
a tool for enhancing autonomy and empowering women. The genetic test provides
only risk information and not a treatment for breast cancer, viewers are told, but is
still effective at reducing uncertainty and counteracting the inevitability that
people may feel about developing breast cancer. ‘After BRACAnalysis, I realized
I could choose to do something now,’ says one woman in the ad; this advertise-
ment suggests that with the BRACAnalysis test, an individual can learn about
their risk status and then explore appropriate prevention and treatment options
with their physician. The women in the ads are cheerful and optimistic because,
it is implied, they are gaining control: ‘if breast and ovarian cancer runs in your
family, BRACAnalysis can help you see the big picture so you can take steps to
reduce your risk.’ The advert aims to convince the viewer with a family history
of breast cancer (i.e., one family member with the disease) that the test is an
important means of reducing risk. By emphasising the tests status as critical
medical intervention, the advertising successfully ‘creates a chain between manu-
facturer, advertisement and doctor, with the ultimate profit going to . . . genetics
testing companies’ (Mykitiuk, 2004, p. 28).
 ‘Be ready against cancer, now’ 95

Myriad’s advertising acknowledges that only 5– 10% of breast cancers will be

hereditary, but what is not mentioned is that the BRCA test will, as discussed
above, detect positive mutations in only 17– 25% of patients with a strong
family history (i.e., early age of onset, multiple affected family members, multiple
cancers, etc.).3 Despite being an accurate test, it will still not provide any useful
information for 75 –83% of women with strong family histories—the heritable
component of their cancer risk remains unknown and they continue to be at
high risk (Carter, 2001). Further, given Myriad’s less stringent access criteria—
one affected relative, which does not constitute a strong family history (Carter,
2001; Smith, 1997)—most people purchasing testing will be found not to carry
a mutation, which would have been predicted by the person’s lack of a significant
family history.4
Myriad’s pilot ad campaign is one of only a few instances of concerted DTC
advertising for commercial genetic tests; other examples include University Diag-
nostics Ltd’s cystic fibrosis test in the UK (Harper, 1995), and more recently
advertising by Sciona and Great Smokies Diagnostic Laboratory for a variety of
nutritional and health related genetic tests (Zitner, 2002).5 These DTC advertise-
ments have met with strong opposition. Myriad’s ad campaign, for example, led to
numerous critical editorials and news stories (Agovino, 2002; Krasner, 2003), and
the US Centers for Disease Control (CDC) even conducted a study of consumers
and health care providers to evaluate the impact of Myriad’s DTC advertising.
The CDC study found that as compared with participants in two cities not
involved in Myriad’s advertising campaign, consumers in Atlanta and Denver
where much more aware of BRCA testing; health care providers in these two
cities reported more questions about testing, more BRCA tests requested, and
more tests ordered, but also reported lacking the necessary knowledge to advise
their patients about hereditary breast cancer or the appropriateness of testing
(Centers for Disease Control and Prevention (CDC), 2004). The advertising
campaign was clearly effective at raising public awareness of BRACAnalysis.
But in contrast to the image portrayed—that of an empowered, autonomous
consumer engaging with her physician in a collaborative decision making
process about suitable testing and treatment options—the reality is one of
increased awareness (and anxiety?) but without a corresponding understanding
on the part of consumers (or their clinicians!) of the utility or applicability of
the test. The paucity of relevant information in the advertisements challenges
the extent to which people can effectively decide on the suitability or necessity
of BRCA testing, and it seems implausible to expect consumers to ‘make an accu-
rate assessment of their risk when the advertisements build a strong case for
testing based on fear’ (Gray & Olopade, 2003, p. 3192). By advertising BRACA-
nalysis to the general public, Myriad is deploying a technology that is speculative
at best, exploiting a climate of genetic determinism and the public’s misunder-
standings of and anxieties about susceptibility, probability and risk.
While not in the same league as the pharmaceutical industry in terms of scale of
funding or consumer impact, biotechnology companies such as Myriad are none-
theless learning lessons from the pharmaceutical industry and deploying
96 Bryn Williams-Jones

comprehensive and coordinated media campaigns. The growing diversification of

media technologies, especially public access to international programming
through cable and satellite TV and the Internet, means that advertising can
now more easily reach an international audience. While companies will still use
country specific advertising through local media outlets, they are also deploying
global branding strategies (Betts, 2002; Burton & Rowell, 2003).

The Internet
The Internet offers a way for advertisers to quickly and cheaply provide potential
consumers with a wealth of information that would not, given cost and time con-
straints, be possible with mainstream media. Myriad’s BRACAnalysis media cam-
paign was coordinated with a dedicated website entitled, ‘BRACAnalysis—Be
Ready Against Cancer’ (Myriad Genetics, 2002c), which had been listed in the
print and TV advertisements. This site presents the viewer with the question:
‘Does breast or ovarian cancer run in your family?’ If concerned, ‘[y]ou can
reduce your risk. We can help’, because
Even if breast or ovarian cancer runs in your family, cancer doesn’t have
to be inevitable. BRACAnalysisw is a blood test that can provide answers
about your risk of hereditary breast and ovarian cancer by analyzing the
BRCA1 and BRCA2 genes. After BRACAnalysisw, you and your doctor
can discuss effective options and steps you can take to reduce your cancer
risk. Your results are kept confidential, and most health insurance
plans provide coverage for testing.
If you answer ‘yes’ to either of the following questions, you may benefit
from BRACAnalysisw.
† Have you had breast cancer before age 50 and ovarian cancer at any
age?
† Has anyone in your family (mother’s or father’s side) had breast cancer
before age 50, ovarian cancer at any age or male breast cancer at any age?
(ibid., original italics)
As with its TV and print advertising, Myriad’s bracnow.com website describes
breast cancer as if it is a uniform entity, the risk of which can be eliminated by
using their test. No mention is made of the complexity or diversity of types of
breast cancer, or the fact that the vast majority of cancers will be sporadic, even
for those people who answer ‘yes’ to having one family member with the
disease! The BRACAnalysis test is presented as a powerful diagnostic tool, and
not as is the case, a technology that will only provide risk information to a sub-
set of those people with a hereditary form of the disease.
The relative ease with which sophisticated and detailed websites can be created
and targeted to particular consumer groups, along with the growing numbers of
people with Internet access, makes the Internet an increasingly important site
for advertising (Lerer, 2002). There is, for example, some evidence that the
level of consumer trust in online pharmaceutical advertising is similar to trust
 ‘Be ready against cancer, now’ 97

in drug information from traditional media sources, and trust in online sources
stimulates further information searching and exposure to drug advertising
(Menon et al., 2002). Of concern, however, is that as with DTC advertising in
the mainstream press (Cassels et al., 2003), prescription drug websites tend to
underplay the risks while highlighting the benefits of their products, e.g., by
having risk information in a smaller font or located on a different webpage
(Huh & Cude, 2004). Yet consumers may be quite critical of the quality and vera-
city of information they find online. In one US study of 157 adults attending two
genetics clinics, 47% of patients had searched online for genetics related infor-
mation prior to their clinic visits but many (41%) found the information confus-
ing; interestingly, 92% of all respondents stated that they would be likely to visit a
genetics information website recommended by a geneticist (Taylor et al., 2001).6
Nonetheless, the convergence and internationalization of advertising media
raise serious concerns about how to protect the public from misleading or exploi-
tive advertising. In the case of Myriad, the company provides accurate and acces-
sible information about the risks of developing breast cancer along with
recommendations for risk reduction strategies and links to patient support
groups. But in the overwhelmingly positive descriptions of the utility and effective-
ness of BRACAnalysis, Myriad’s websites only briefly mention the possibility that
the test may provide ambiguous or uninformative results (e.g., mutation of
unknown status), or that even when no mutation is found a person may still be
at risk of developing cancer due to other gene mutations or social and environ-
mental factors.

Patient groups and public awareness

Supported by Internet websites and email discussion lists, non-governmental
organizations—known variously as patient-, advocacy-, disease awareness- or
public action groups—are becoming influential in shaping what services and
which medicines are made available to patients through public and private
health insurance plans. These groups develop for a diverse set of reasons: they
may translate disease-specific medical information and disseminate it to their
members and health care professionals, offer counselling and support services,
work to ensure that patients’ voices are heard, or engage in charitable fund
raising and advocacy for medical research (Mills, 2000). But these groups are
often run by volunteers and poorly funded, making them vulnerable to corporate
capture. More worrying is the insidious role of product manufacturers in the cre-
ation of such groups where none previously existed.
The growing status and influence of patient groups, along with their ability to
directly access specific populations, makes them attractive to companies inter-
ested in building ‘partnerships’ to support comprehensive product promotion
(Hayes, 1999). Patient groups are often already involved in raising awareness of
a particular condition or illness, along with the virtues of new drugs or diagnostics.
These groups also have enviable levels of public credibility, so information they
present will not be discounted as biased as might be the case for industry
98 Bryn Williams-Jones

sources. Companies thus have a strong interest in enrolling patient groups as

advocates for products, particularly in environments where DTC advertising is
restricted or prohibited (Herxheimer, 2003).
In the case of Myriad, while the company does have links on their websites to a
range of breast and ovarian cancer support organizations, there is no evidence that
the company directly funds or partners with these groups. Nevertheless, Myriad is
clearly aware of the utility of coordinating with community initiatives. By timing
the launch of their pilot DTC advertising campaign to coincide with the US
Breast Cancer Awareness month, Myriad effectively tied BRACAnalysis to an
already increased public awareness. As mentioned above, in Myriad’s ads risk
of breast cancer is portrayed as a unitary phenomenon, something that can be
resolved by genetic testing and appropriate medical treatments. There is a
subtle determinism at play in this message. The inevitability of the disease—‘I
wondered if it would be inevitable . . . it didn’t have to be’—is challenged by the
certainty of a test that accurately links genetics with risk. Concern is raised and
then resolved by the technology. This type of marketing may be attractive to
patient groups whose mandate includes lobbying for research and access to medi-
cines and diagnostics. Thus while biotechnology companies such as Myriad may
not (yet) be actively supporting patient groups, even limited enrolment will build
powerful allies for extending a company’s market.

A failure of oversight
In the United States and New Zealand, the political consensus seems to be that
the benefits of DTC advertising outweigh the costs; while there is still some oppo-
sition from public and professional groups (Coney, 2002; Kmietowicz, 2003),
both countries allow DTC advertising for prescription pharmaceuticals and
medical products (Hoek & Gendall, 2002). Until 1997, the US Food and Drug
Administration (FDA) had taken a position that made it very difficult for compa-
nies to advertise medical products and services direct-to-consumer. Following
intense lobbying from industry and a range of interest groups, the FDA
changed its position to allow brand name and disease indications to appear in
the same advertisement, greatly facilitating DTC advertising of prescription phar-
maceuticals (US Department of Health and Human Services et al., 1999). Over-
sight of advertising practices that affect commerce fall under the aegis of the
Federal Trade Commission (FTC), and the FDA is responsible for reviewing
medical and pharmaceutical safety and advertising, i.e., ‘labelling’. The FDA
restricts what claims can be made about a pharmaceutical and requires certain
disclosures (e.g., of common side effects) through the device of labelling,
including that there should be a ‘fair balance’ of information about product
risks and benefits.
The actual practice of oversight, however, is less encouraging. Numerous
pharmaceutical companies have been charged by the FDA (sometimes repeat-
edly) with violating advertising regulations by oversimplifying drug risks and over-
stating benefits. Studies of TV and Internet drug advertising have found repeated
 ‘Be ready against cancer, now’ 99

failure in the ‘fair balance’ requirement, undermining the claim that DTC adver-
tising is unproblematic and a positive means of conveying health information and
empowering consumers (Huh & Cude, 2004; Kaphingst et al., 2004). As Wolfe
notes, ‘the FDA is grossly understaffed for this important oversight function:
the entire Division of Drug Marketing, Advertising, and Communications has
had only 28 to 30 employees since 1997 . . . [and are further handicapped by
lacking] the legal authority to impose civil monetary penalties on companies,
even when they repeatedly violate the law’ (Wolfe, 2002, p. 526).
By contrast, Canada, the United Kingdom and most other European countries
continue to restrict DTC advertising of prescription pharmaceuticals and other
medical products. Some even have regulations to constrain industry use of
patient groups for product promotion (Jackson, 2003). While it might thus be
tempting to think that DTC advertising is only a concern for the US and New
Zealand, this is not the case. In Canada and Europe, for example, there has
been pressure to lift restrictions on DTC advertising (Jaderberg, 2002), and
reduced government funding of medical technology assessment has meant that
oversight bodies are finding it increasingly difficult to control even relatively
well-known types of DTC advertising (Brill-Edwards, 2000). This situation
may be even more problematic in the case of genetic testing.
Currently, most countries have little or no oversight of DTC advertising for
genetic testing. There tends to be no pre-market review of commercial genetic
tests or their advertisements, even though it would be within the purview of
many regulators (Holtzman, 1999). In the US, neither the FTC nor the FDA
appear to have the resources or the inclination to take up this task, while in
Canada there are similar difficulties (Caulfield et al., 2001). Pharmaceuticals
and medical devices are governed by the Canadian Medical Devices Bureau,
but there is nothing in the supporting legislation (the Food and Drugs Act and
the Broadcasting Act) or regulations ‘that would prohibit or regulate DTC adver-
tisements of genetic testing similar to Myriad’s campaign in the USA’ (Mykitiuk,
2004, p. 29). In the UK, the Advertising Standards Authority (an industry body)
regulates voluntary Codes of Advertising and Sales Promotion for non-broadcast
advertising, and the Office of Fair Trading has the power to seek court orders to
stop misleading advertisements. Both mechanisms could be applied to DTC
advertising for genetic testing, but as in the US and Canada, more willingness
and resources are required if the broad range of advertising media (e.g., TV, Inter-
net, patient groups) are to be adequately regulated.
In Europe, these regulatory challenges are to some extent offset by the presence
of universal health care insurance plans. Though there are no exact figures docu-
menting uptake of commercial testing, but where genetic tests such as BRCA
testing are available free of charge, e.g., from the UK National Health Service
(NHS), it will be difficult for commercial markets to develop. Indeed, while
Myriad licensed the Scottish company Rosgen to market BRACAnalysis in the
UK (Myriad Genetics, 2000), competition with the NHS meant that Rosgen
was unable to bring in sufficient funds to stay solvent and folded in 2001. By con-
trast, in Canada, the ad hoc nature of decision making and inconsistency of service
100 Bryn Williams-Jones

coverage across various provincial health care insurance plans means that many
potentially beneficial genetic services are not covered, raising concerns about
equity of access and leading to a potential market for commercial genetic services
(Caulfield et al., 2001; Williams-Jones & Burgess, 2004).7 DTC advertising
thus has the potential to be more effective in Canada and the US, although it
still poses challenges for the UK and the rest of Europe particularly in an age of
global advertising.

Conclusion and suggestions for improving oversight

The case of Myriad Genetics’ BRACAnalysis pilot advertising campaign, when
situated in the larger context of an increasingly international media environment,
highlights the difficulties that will be faced by countries attempting to restrict
DTC advertising. Regardless of local legislation, the permeability of national
boundaries that has resulted from the growth of the Internet will mean that
people can access information that would otherwise be restricted. While
Myriad’s TV commercial was only aired in two US cities for a period of 5
months in the Fall of 2002, an electronic version was easily accessible on
Myriad’s website and thus available to anyone until the middle of 2003 (Myriad
Genetics, 2002b, www.myriad.com/media/tv_brac.mpg, accessed 3 July 2003, on
file with author). Even where countries have in place regulations to control
DTC advertising, such legislation tends to ignore the more subtle or indirect
forms of product promotion. Be it the co-opting of patient groups and public
awareness campaigns, or highly publicized websites, indirect advertising will con-
tinue to be an effective and important means of product promotion (Burton &
Rowell, 2003).
Notwithstanding these problems, I believe there is still room for some opti-
mism about developing mechanisms to control DTC advertising. A growing
body of academic literature is seriously questioning the appropriateness of
DTC advertising and sale of genetic tests (Caulfield et al., 2001; Gollust
et al., 2002; Martin & Frost, 2003), and influential advisory groups in the US,
Canada, and the UK have highlighted the need for better oversight and
control (Human Genetics Commission, 2003; Ontario Ministry of Health and
Long Term Care, 2002; Secretary’s Advisory Committee on Genetic Testing,
2000).
Lessons can and should be learned from analyses of the negative consequences
of unrestricted DTC advertising for pharmaceuticals. Recent evidence clearly
demonstrates a dose-response effect such that in environments with less accessi-
bility to drug ads, there are fewer patient requests to physicians for those drugs
(Mintzes et al., 2002). In Canada and Europe, and to a lesser extent in the US,
the growing cost of pharmaceuticals as a portion of overall health care expendi-
tures is being taken sufficiently seriously that governments are increasing
support to the generic drug sector and even considering restructuring their
patent systems to weaken the monopoly powers of the pharmaceutical industry.
 ‘Be ready against cancer, now’ 101

In light of such moves, it would be incoherent to not also strengthen oversight of

DTC advertising for pharmaceuticals.
In a similar vein, governments should be more aggressive at enforcing DTC
advertising regulations for genetics-related products and services. This might
necessitate devoting substantial resources to better support already over-stretched
regulatory agencies. But I would go further and argue that new regulatory and
oversight bodies are needed to specifically address the challenges raised by new
genetic technologies (Hoedemaekers, 2000; Human Genetics Commission,
2003). The Internet, global communications channels and the variability of inter-
national regulation will make it difficult if not impossible to control all forms of
DTC advertising. Nonetheless, a government that is sufficiently concerned
about promoting the health of its citizens and controlling the health care cost
effects of DTC advertising is not without options. For example, following the
UK Human Genetics Commission’s recommendations, governments can take a
proactive stance by supporting credible groups to develop websites and
public resources that provide complete and balanced information and evidence
about commonly promoted genetic tests (Human Genetics Commission,
2003). This type of ‘official’ source, particularly if it actively targets physicians
to whom patients are still turning to for advice, could be very influential in
shaping patient demand and supporting physicians in prescribing appropriate
services.
Moreover, as appears to be the case in the UK and some European countries,
serious consideration must be given to the comprehensive evaluation and pro-
vision of suitable genetic testing services as part of national health insurance
plans. Such public access would be an important countervailing force and
means of constraining the costs of DTC advertising. Health insurers—be they
European governments, provincial health authorities in Canada, or private US
insurance plans—can control appropriate provision of genetic tests by making
them only available to those people likely to show a clinical benefit. The hetero-
geneity of US insurance coverage, however, makes it much more difficult to
control access to genetic services than would be the case in health care systems
with universal insurance coverage.
Myriad Genetics is only one of many companies exploiting a climate of genetic
determinism and public anxiety to sell speculative technologies (Williams-Jones,
2003). There are significant social, ethical and political implications of such
behaviour, and I suggest that these can to some extent be mitigated by regu-
lations that address the diverse means by which companies promote their pro-
ducts. As Mintzes (1998) argues, ‘all promotion by definition is information
whose aim is to market a product and as such has an inherent bias towards
showing the product in the best possible light’. However, given ‘the current
level of scientific uncertainty, gaps in consumer protection and low levels of
consumer education’, the situation is sufficiently worrying to support the
strong proposal of the UK Consumer’s Association that ‘for the foreseeable
future . . . adverts for direct genetic testing services should be banned’ (Consu-
mer’s Association, 2002, p. 6).
102 Bryn Williams-Jones

Acknowledgements
The author would like to thank Chris MacDonald, Oonagh Corrigan, Martin
Richards and Janice Graham and for their helpful commentaries on various
drafts of the paper. This work was supported by fellowships from the Social
Sciences and Humanities Research Council of Canada and Homerton College,
Cambridge.

Notes
1. The intent is not, however, to directly analogise DTC advertising of pharmaceuticals with that
of genetic testing. Clearly, the therapeutic benefit and potential harm of drugs, alongside their
more prevalent use (and cost) as part of health care service provision will mean that the
associated social, ethical, and policy concerns are likely to differ substantially from those
associated with commercial genetic tests. Instead, the purpose of exploring DTC
advertising of pharmaceuticals is to clarify the various means by which a company can
create public awareness and consumer demand for its products.
2. In the US, with its largely decentralized employment-based health insurance system, Myriad
had only to challenge local hospitals and insurers with the threat of patent infringement suits
to convince those institutions to desist in their local provision and agree to purchase testing
from Myriad (Merz, 1999). By contrast, in Canada and Europe, BRCA testing is
commonly part of universal health insurance plans, thus it was governments that were
ultimately responsible and these were willing to use their greater financial and political
powers to reject Myriad’s patent claims. In Canada, this opposition took the form of
provincial governments simply ignoring Myriad’s demands and waiting for Myriad to sue
(which has yet to occur), while in France a consortium of laboratories and European
countries successfully challenged and overturned Myriad’s EU BRCA1 and BRCA2
patents in 2004, further weakening Myriad’s control of the BRCA testing market (Mayor,
2004; Pollack, 2004).
3. A 2002 study by Myriad researchers detected BRCA mutations in 17.2% of 10,000
individuals tested (Frank et al., 2002), information only available (and somewhat buried)
on the company’s breast cancer information webpage for Health Professionals (Myriad
Genetics, 2002d, www.myriadtests.com/provider/mutprevo.htm, accessed 14 December 2004).
4. A UK study by Pharoah et al. (2000), based on 2809 cases, estimated that in the general
population 6.8% of women under the age of 50 would have at least one first degree relative
with breast cancer; only 2% of women under 50 would have a family history conferring
significantly increased risk (at least 2.5 times). The authors conclude that a family history
of breast cancer is common in the general population, but that preventive interventions for
women at high risk (based on family history) will have limited impact on breast cancer
morbidity as a whole (Pharoah et al., 2000).
5. There are many companies selling a variety of genetic tests direct to consumers, but their
advertising tends to be limited, often restricted to company websites. An exception to this
would be paternity tests, which are heavily advertised in the mainstream press and on the
Internet (Gollust et al., 2003; Williams-Jones, 2003).
6. Concerns about accuracy of information have led some online health information companies
to publicly subscribe to codes of ethics (such as the HON Code) that include principles
related to protection of privacy, quality, authority and accuracy of information, and
transparency of interests (Cho, 2000; Williams-Jones, 2003).
7. For example, in contrast to the position taken by provincial governments across Canada, the
British Columbian government acquiesced to Myriad’s patent claims and for a period of two
years (2001 – 2003), in effect prohibited the provision of BRCA testing through the
provincial public health care system; agencies providing testing would have to purchase
 ‘Be ready against cancer, now’ 103

the service directly from Myriad at triple the cost, exceeding their limited budgets. This
situation led to two categories of patients, those who could and those who could not
afford the test—patients were treated differently depending on the province where they
lived.

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