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Compliance of Disease Awareness Campaigns in Printed Dutch Media with National and International Regulatory Guidelines

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Background: The European legislation prohibits prescription-only medicines' advertising but allows pharmaceutical companies to provide information to the public on health and diseases, provided there is no direct or indirect reference to a pharmaceutical product. Various forms of promotion have become increasingly common in Europe including "disease-oriented" campaigns. Objectives: To explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by assessing their compliance with the World Health Organization (WHO) Ethical Criteria for medicinal drug promotion and the Dutch guidelines for provision of information by pharmaceutical companies. Methods: Materials referring to health/disease and treatments published in the most widely circulated newspapers and magazines were collected from March to May 2012. An evaluation tool was developed based on relevant underlying principles from the WHO ethical criteria and Dutch self-regulation guidelines. Collected disease awareness advertisements were used to pilot the evaluation tool and to explore the consistency of information provided with the WHO and Dutch criteria. Findings: Eighty materials met our inclusion criteria; 71 were published in newspapers and 9 in magazines. The large majority were news items but 21 were disease awareness advertisements, of which 5 were duplicates. Fifteen out of the 16 disease awareness campaigns were non-compliant with current guidelines mainly due to lack of balance (n = 12), absence of listed author and/or sponsor (n = 8), use of misleading or incomplete information (n = 5) and use of promotional information (n = 5). None mentioned a pharmaceutical product directly. Conclusion: Disease Awareness Campaigns are present in Dutch printed media. Although no brand names were mentioned, the lack of compliance of disease awareness campaigns with the current regulations is alarming. There were information deficiencies and evidence of information bias. A key concern is that the context in which the information is provided, mostly through indirect referral, is likely to support treatment with the sponsor's product.
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Compliance of Disease Awareness Campaigns in Printed
Dutch Media with National and International Regulatory
Guidelines
Teresa Leonardo Alves
1
, Auramarina F. Martins de Freitas
1
, Martine E. C. van Eijk
2
, Aukje K. Mantel-
Teeuwisse
1
*
1World Health Organization Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University,
Utrecht, The Netherlands, 2Independent Consultant, Utrecht, The Netherlands
Abstract
Background:
The European legislation prohibits prescription-only medicines’ advertising but allows pharmaceutical
companies to provide information to the public on health and diseases, provided there is no direct or indirect reference to a
pharmaceutical product. Various forms of promotion have become increasingly common in Europe including ‘‘disease-
oriented’’ campaigns.
Objectives:
To explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by
assessing their compliance with the World Health Organization (WHO) Ethical Criteria for medicinal drug promotion and the
Dutch guidelines for provision of information by pharmaceutical companies.
Methods:
Materials referring to health/disease and treatments published in the most widely circulated newspapers and
magazines were collected from March to May 2012. An evaluation tool was developed based on relevant underlying
principles from the WHO ethical criteria and Dutch self-regulation guidelines. Collected disease awareness advertisements
were used to pilot the evaluation tool and to explore the consistency of information provided with the WHO and Dutch
criteria.
Findings:
Eighty materials met our inclusion criteria; 71 were published in newspapers and 9 in magazines. The large
majority were news items but 21 were disease awareness advertisements, of which 5 were duplicates. Fifteen out of the 16
disease awareness campaigns were non-compliant with current guidelines mainly due to lack of balance (n= 12), absence of
listed author and/or sponsor (n =8), use of misleading or incomplete information (n = 5) and use of promotional information
(n = 5). None mentioned a pharmaceutical product directly.
Conclusion:
Disease Awareness Campaigns are present in Dutch printed media. Although no brand names were mentioned,
the lack of compliance of disease awareness campaigns with the current regulations is alarming. There were information
deficiencies and evidence of information bias. A key concern is that the context in which the information is provided, mostly
through indirect referral, is likely to support treatment with the sponsor’s product.
Citation: Leonardo Alves T, de Freitas AFM, van Eijk MEC, Mantel-Teeuwisse AK (2014) Compliance of Disease Awareness Campaigns in Printed Dutch Media with
National and International Regulatory Guidelines. PLoS ONE 9(9): e106599. doi:10.1371/journal.pone.0106599
Editor: Elisabeth Hildt, University of Mainz, Germany
Received February 4, 2014; Accepted July 31, 2014; Published September 8, 2014
Copyright: ß2014 Leonardo Alves et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: The authors have no support or funding to report.
Competing Interests: The authors have declared that no competing interests exist.
* Email: A.K.Mantel@uu.nl
Introduction
In 1988, the World Health Organization established the Ethical
Criteria for Medicinal Drug Promotion, defining promotion as ‘‘all
informational and persuasive activities of manufacturers and
distributors that affect the prescription, supply, purchase and/or
use of medicinal drugs’’ [1]. While not legally binding, these
criteria include a set of guiding principles that can be adapted to
national circumstances.
Advertising of prescription drugs to the public – also known as
direct-to-consumer advertising (DTCA) – is controversial and only
allowed in the United States and New Zealand. European
legislation prohibits advertising of products that have prescrip-
tion-only status, aiming to protect public health. Despite this
prohibition, however, manufacturers are using an increasing array
of techniques to advertise these medicines to the public both
directly and indirectly [2].
Media and communication channels are key influencers of
consumer decisions, helping to shape consumers’ information and
options, also on health and treatment [3]. Media can also exert a
powerful influence over human behaviours and public policy [4].
Health topics are often covered in printed media and they can
include factual information on diseases and conditions but also
treatment information of promotional nature [5,6].
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In Europe, pharmaceutical companies are explicitly allowed to
provide general information to the public on human health and
diseases, as long as there is no reference, even indirectly, to a
specific medicinal product [7]. This provision enables companies
to run unbranded ‘disease-awareness’ or ‘help-seeking’ advertise-
ments [8]. These materials draw viewers’ attention to certain
health conditions by focusing on symptoms and suggesting the
public to ‘ask their doctors’ for newly available treatment
information [9]. Such campaigns are not subject to any specific
regulations governing pharmaceutical promotion, nor pre-clear-
ance. They represent a grey area in regulation since regulators are
reluctant to consider them to be product-specific promotion unless
they include explicit links to branded information [10].
Disease awareness campaigns (DACs) can educate the public
about disease, make consumers aware of untreated health
problems and lead them to seek effective care at earlier stage,
thus leading to better health [11]. Advocates consider disease
awareness campaigns to be particularly important for under-
diagnosed diseases [12]. However, concerns have been raised
about the quality and nature of the information being provided to
the public in disease awareness campaigns [13]. Proponents of
direct to consumer advertising claim that it empowers consumers
by stimulating discussions with physicians, enabling patients to
obtain needed treatment at an earlier stage and improving
adherence. Evidence shows, nevertheless, that exposure to
advertisements increases prescribing volume and patient demand
and that it shifts prescribing into less cost-effective choices. In
addition, there is no evidence of improved adherence, nor
treatment quality or early provision of needed care [14]. In a
similar trend, albeit scarce, there is evidence that disease
awareness campaigns can lead to increases in consultation rates
and prescriptions for the advertisers’ product [15]. If campaigns
support use of newer, more expensive products with least well
understood benefit-harm profiles, over cheaper, well-known, older
medicines, they can lead to increases in consultations, inappro-
priate prescribing and more adverse drug reactions and drug-
induced harm, as well as increases in hospitalisations, thus
affecting both quality and costs of care [9]. While much research
has been done in other areas of traditional drug promotion, far less
is known about how these campaigns influence both physicians
and the public, or on their compliance with the current regulatory
framework [16].
In the Netherlands, a self-regulatory approach is used to oversee
medicines’ advertising [17]. In April 2011, the Foundation for the
Medicinal Products’ Advertising Code (CGR) published a set of
guidelines on the provision of disease and treatment information
about prescription-only medicines by pharmaceutical companies
to the public, thus aiming to define the boundary between
information and advertising [18].
Nevertheless, there is no instrument available to assess the
compliance of disease awareness campaigns with the provisions
included in the WHO Ethical Criteria for Medicinal Drug
Promotion or in the Dutch self-regulation guidelines.
Evaluating the quality and nature of the information provided
in disease awareness campaigns is very relevant to policy
discussions at European level. The proposal for a European
directive on information to the general public on medicinal
products subject to medical prescription, presented by the
European Commission in December 2008, foresaw changes to
the regulations on advertising. It contemplated an expanded role
for the pharmaceutical industry in the provision of information on
prescription medicines directly to the public [19]. This study aims
to inform future European policies regulating the dissemination of
disease and treatment information to the public by the pharma-
ceutical industry. This article assesses the frequency of occurrence
of disease awareness campaigns in printed media in the Nether-
lands and measures their compliance with current guidelines.
Objectives
The aim of our research was threefold:
1. To assess the frequency of occurrence of medicines’
promotion and disease awareness campaigns in printed media in
the Netherlands.
2. To develop a user-friendly instrument to assess the
compliance of disease information campaigns.
3. To use this instrument to measure compliance of disease
information campaigns, including those disseminated by pharma-
ceutical companies, in Dutch printed media.
Methods
1. Assessing disease-awareness campaign frequency in
major print media
We examined high-circulation print media, which included
three paid daily newspapers, three free daily newspapers and eight
paid monthly magazines [20]. Data collection took place over
three months (March to May 2012 inclusive). The three free
newspapers were collected at train stations whereas the 14 paid
publications were accessed in public libraries. Two authors (AMF
and TLA) independently selected materials based on the inclusion
criteria outlined below. If there were disagreements, these were to
be resolved by consensus. Consensus was reached in all cases.
Our inclusion criteria were based on an interpretation of
legal provisions, which prohibit direct and/or indirect reference to
a pharmaceutical product. Firstly, we included all materials which
addressed health and treatment issues. Materials on nutraceuticals,
homeopathic products, over-the-counter medicines and vaccines
were excluded, as they are governed by different legislation.
Secondly, we selected all materials which covered one or more of
the following four sets of linked information: (1) symptoms/health
issues (for prevention purposes)/diseases/conditions AND a
specific prescription-only medicine or a therapeutic drug class;
(2) symptoms/health issues (for prevention purposes)/diseases/
conditions AND a doctor or website referral/a description of a
drug’s mechanism of action or a suggestion to seek further
treatment; (3) name or the logo of a pharmaceutical company
AND mention of a symptom/problem/condition or referred to a
website; and (4) reference to disease management programmes and
discussion of adding another medical product to the ongoing
treatment regimen. Finally, materials were then separated into two
groups: disease awareness campaigns (Group I) – which included
no author and were to be assessed using the instrument – and news
items (Group II) – editorial content which included an author or
was attributable to the news desk.
Additional descriptive data which were also recorded included:
type of publication where materials were found (Paid or Free);
printed media frequency; topic; reference to non-pharmaceutical
interventions; reference to changes in the quality of life (either
positive or negative); referral to visit a physician; reference to a
clinical expert; referral to a website; reference to a patient
organization or support group; reference to a brand-name, use of
company’s name or logo, and reference to the availability of a new
medicine or treatment option.
2. Instrument development
The instrument (originally developed in Dutch and then
translated into English) is based on seven relevant criteria from
Compliance of Disease Awareness Campaigns with Regulatory Guidelines
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Table 1. Overlap between relevant provisions within the WHO Ethical Criteria for Medicinal Drug Promotion and the CGR
Guidelines for provision of information on prescription medicines.
WHO Ethical Criteria CGR Guidelines Relevant criteria identified
Article 6. Definition of promotion: ‘‘all informational
and persuasive activities by manufacturers and
distributors, the effect of which is to induce the
prescription, supply, purchase and/or use of
medicinal drugs.’’
Introduction. Definition of promotion: ‘‘all informational and
persuasive activities by manufacturers and distributors, the
effect of which is to induce the prescription, supply, purchase
and/or use of medicinal drugs.’’
Promotional information
Article 7. ‘‘Promotional material should not be
designed so as to disguise its real nature.’’
Introduction. ‘‘Instances whereby prescription medication or
pills are being mentioned without indicating the drug’s brand
name or company name’’ are considered indirect reference, for
example when naming the active ingredients or the drug’s
mechanism of action.
Article 9. ‘‘Scientific and educational activities should
not be deliberately used for promotional purposes.’’
Article 5. ‘‘Information may not encourage irrational use of
prescription medicines nor the search for unnecessary treatment.’’
Article 14b. ‘‘Advertisements to the public should not
generally be permitted for prescription drugs or to
promote drugs for certain serious conditions that
can be treated only by qualified health practitioners.’’
Article 6. ‘‘Information may not directly or indirectly lead to the
choice of a particular medicine from different available treatments.’’
Article 7. ‘‘Advertisements may claim that a drug
can cure, prevent, or relieve an ailment only if this
can be substantiated. … All promotion-making claims
concerning medicinal drugs should be reliable, accurate,
truthful, informative, balanced, up-to-date, capable of
substantiation and in good taste. They should not
contain misleading or unverifiable statements or
omissions likely to induce medically unjustifiable
drug use or to give rise to undue risks.’’
Article 3. ‘‘Information may not be misleading. The information
provided must comply with the most recent evidence and
practice standards. The information must be factually correct and
may not contain any misleading elements.’’
Misleading or incomplete
information
Article 17. ‘‘No comparison is allowed between relevant
treatments and medicines that suggests that the effects of a
treatment with a prescription drug are better or equal than
those of another relevant treatment or drug.’’
21.2 b) ‘‘No single option for treatment is to be highlighted,
for instance by using words, colours or images, different font
types, markings or any other elements. ’’
Article 21.2 d) ‘‘Treatments should be cathegorised based on
acceptable formats. For instance using therapeutic classes or
categories, or through therapeutic guidelines. Using expressions
such as ‘‘most recent, or new is better, most commonly used,
is not allowed.’’
Article 23. ‘‘Information should be displayed objectively and
neutrally and must not contain information which relates
directly to a specific treatment. When reference is made to
specific treatment guidelines, the source must be listed…
References to scientific literature should also be published…’’
Article 14: ‘‘While they [advertisements] should take
account of people’s legitimate desire for information
regarding their health, they should not take undue
advantage of people’s concern for their health.’’
Article 9.‘‘Information should not aim nor encourage the
public to seek unnecessary treatment, advice or further
examination; nor on the other hand refrain the public from
seeking treatment, advice or further examination.’’
Use of Fear
Article 5. ‘‘Information may not encourage irrational use of
prescription medicines nor the search for unnecessary treatment.’’
Article 15. ‘‘Language which brings about fear or
distress should not be used.’’
Article 4. ‘‘Information should not boost or amplify feelings of
fear and superstition and should be displayed realistically.’’
Article 20. ‘‘The information may not be unjustified, unnecessarily
alarming or misleading images of changes to the human body
resulting from illness or disease.’’
Article 29. ‘‘The wording …if prepared specifically for
patients, should be in lay language on condition that
the medical and scientific content is properly reflected.’’
Article 7. ‘‘Information should be tailored to the average
consumer and have understandable language. Medical and
scientific terms should be avoided as much as possible, to
avoid confusion.’’
Inadequate Language
Article 7. ‘‘All promotion-making claims concerning
medicinal drugs should be reliable, accurate, truthful,
informative, balanced, up-to-date, capable of
substantiation and in good taste. They should not
contain misleading or unverifiable statements or
omissions likely to induce medically unjustifiable
drug use or to give rise to undue risks… Comparison
of products should be factual, fair and capable of
substantiation’’.
Article 9.‘‘Information should not aim nor encourage the public
to seek unnecessary treatment, advice or further examination;
nor on the other hand refrain the public from seeking treatment,
advice or further examination.’’
Lack of Balance
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the WHO Ethical Criteria for Medicinal Drug promotion [1] and
the KOAG/CGR guidelines [17]. These were identified by
overlapping the relevant provisions within the two sets of
regulatory guidelines that can be used to judge the content and
quality of disease-oriented information (Table 1). These are
promotional information, misleading or incomplete information,
use of fear, inadequate language, lack of balance, use of
testimonials and absence of listed author and/or sponsor. These
criteria were translated into evaluation statements to judge
whether or not a principle is being adequately applied (compliant,
non-compliant and not applicable). An option to insert additional
comments was also included. A reference to a company’s name or
logo in a disease awareness campaign was not considered sufficient
for a material to be deemed non-compliant.
Three external reviewers (pharmaceutical policy researchers)
tested the instrument using three examples of disease awareness
campaigns by the pharmaceutical industry, previously published in
European printed media. As a result, five statements were altered.
Changes included merging, division or rewording of statements.
The final instrument is included as Table S1.
3. Assessing compliance of disease awareness campaigns
with guidelines
As the instrument is based on legal guidelines, the existence of a
single non-compliant statement is sufficient to consider the
material to be non-compliant. Two authors (TLA and AMF)
independently assessed each of the seven criteria for all disease
awareness campaigns and differences in scoring were discussed
Table 1. Cont.
WHO Ethical Criteria CGR Guidelines Relevant criteria identified
Article 17. ‘‘No comparison is allowed between relevant
treatments and medicines that suggests that the effects of
a treatment with a prescription drug are better or equal than
those of another relevant treatment or drug.’’
Article 21. ‘‘Information should be as balanced and complete
as possible. It should reflect the state-of-the-art. When providing
information, all relevant factors should be taken into account.
All information should be equally displayed both in content
and layout, with the same amount of detail.’’
Article 21.2 c) ‘‘The positive and negative effects of a treatment
are not to be emphasized in such a way that the pros or the
cons of a given treatment are highlighted’’.
Article 21.2 d) Information about different therapeutic
interventions can be provided. In that case, all relevant treatments
should be named, including pharmacotherapy and other
interventions, such as adjustments to lifestyle, nutrition and
habits. Relevant treatments are the standard of care provided,
as per treatment guidelines. Completeness ensures that no
information is deliberately omitted. When enumerating all the
pharmacotherapeutic options for treatment, all the relevant
prescription drugs for the specific treatment are to
be mentioned.’’
Article 7. ‘‘Promotional material should not be
designed so as to disguise its real nature.’’
Article 18. ‘‘Testimonials should portray the opinion or
experience of the user truthfully (not that of a professional or
any other public figure). They should not include any
comparison of the user’s situation before and after drug
treatment…Before/after testimonials are not allowed because
they can lead the public into false expectations regarding
the speed of the treatment’s effects’’.
Testimonials
Article 9. ‘‘Scientific and educational activities should
not be deliberately used for promotional purposes.’’
Article 7. ‘‘Advertisements may claim that a drug can
cure, prevent, or relieve an ailment only if this can be
substantiated. … All promotion-making claims con
cerning medicinal drugs should be reliable, accurate,
truthful, informative, balanced, up-to-date, capable
of substantiation and in good taste. They should not
contain misleading or unverifiable statements or
omissions likely to induce medically unjustifiable
drug use or to give rise to undue risks.’’
Article 22. ‘‘Each message is to contain the name of the
person responsible for the information’’.
Absence of Source/Author
Article 23. ‘‘Information may refer to scientific studies
and results…The source must always be included. The
studies and the results that are mentioned must always come
from other sources than the medicine’s producer and should
be verifiable…’’ ‘‘Information should be displayed objectively
and neutrally and must not contain information which relates
directly to a specific treatment. When reference is made to
specific treatment guidelines, the source must be listed…
References to scientific literature should also be published…’’
doi:10.1371/journal.pone.0106599.t001
Compliance of Disease Awareness Campaigns with Regulatory Guidelines
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and resolved by consensus. Any remaining disagreements were
then adjudicated to a third author (AMT). The frequencies of the
information provided in both groups were measured using the risk
ratio (RR). When information was absent, a cell in Table 2
obtained a zero and no RR could be calculated. This was dealt by
adding 0.5 to every cell in Table 2 to be able to calculate an
estimate of the RR [21]. Whenever possible, data analysis was
conducted using SPSS version 20.0 (SPSS Inc. Chicago, Illinois,
USA).
Results
1. Assessing disease-awareness campaign frequency
On average six materials covering disease and treatment
information were published per week. A total of 80 materials
were collected, 59 of which were news items (73,8%), whereas 21
were disease awareness campaigns (26.3%) (Table 2). Five of these
disease awareness campaigns were duplicates - published in
different printed media - leaving 75 materials for further
description and 16 materials for the compliance analysis.
Overall (n = 80) the seven most commonly mentioned condi-
tions were: allergies and respiratory diseases (n = 22; 28%),
diabetes (n = 7; 9%), cardiovascular diseases (n = 5; 6%), cancer
(n = 5; 6%), contraception (n = 4; 5%), Attention Deficit Hyper-
activity Disorder (ADHD) (n = 4; 5%) and pain (n = 4; 5%). Within
disease awareness campaigns, allergies and respiratory diseases,
and contraception were common topics. Most notably, all the
disease awareness duplicates regarded allergies and respiratory
diseases. One disease awareness campaign was sponsored by a
patient organisation.
Disease awareness campaigns were significantly more frequent
in free publications (RR = 2.8, 95% CI 1.7; 4.5) and in
health-related supplements (RR = 3.4, 95% CI 1.9; 5.6). When
comparing news to disease awareness campaigns as to the
information provided, the latter were more likely to mention a
pharmaceutical company (RR = 2.8, 95% CI 1.1; 6.8), a website
(RR = 5.3, 95% CI 2.8; 10.1) or a visit to the general practitioner
(RR = 2.2, 95% CI 0.9; 5.16) but less likely to include a brand-
name (RR = 0.3, 95% CI 0.04; 2.2) (Table 2).
2. Assessing compliance of DACs with guidelines
The initial inter-rater agreement in the assessment of overall
compliance was of 88%; disparities between assessors were
arbitrated by the fourth author. Fifteen out of the sixteen materials
assessed were non-compliant with the guidelines. Non-compliance
was more frequent due to lack of balance, absence of listed author
and/or sponsor, use of promotional information or use of
misleading or incomplete information (Table 3, Figure 1). Inter-
estingly, most instances of non-compliance with the misleading or
incomplete information criterion involved a lack of references.
Most notably, five out of the sixteen materials included the logo
or name of a pharmaceutical company, referred to a particular
condition and mentioned a treatment indirectly. Other four
materials discussed a condition and indirectly a treatment, while
including a referral to a website sponsored by a pharmaceutical
company. Table 3 provides examples of non-compliance aggre-
gated per key criteria and disease awareness campaign topic.
Discussion
In this study we have shown that there is a focus on disease and
treatment information in printed media in the Netherlands, both
through news items and disease awareness campaigns. The
majority of disease awareness campaigns identified during our
Table 2. Material Characteristics.
Type of publication
Group 1 Disease awareness campaigns
(n = 21) (% within group)
Group 2 News items
(n = 59) (% within group)
Risk Ratio
(95% CI)
All publications
Paid 5 (24%) 43 (73%)
Free 16 (76%) 16 (27%) 2.8 (1.7; 4.5)
Publication frequency
Daily 5 (24%) 38 (64%)
Weekly 2 (9%) 3 (5%)
Monthly 0 (0%) 4 (7%)
Occasionally 14 (67%) 14 (24%)
Health Supplements
15 (71%) 13 (22%) 3.4 (1.9; 5.6)
Information included
Group 1 Disease awareness campaigns
(n = 21) (% within group)
Group 2 News items
(n = 59) (% within group)
Risk Ratio
(95% CI)
Non-pharmaceutical interventions in addition to
therapy
5 (31%) 19 (32.2%) 0.9 (0.4; 2.2)
Suggestion to visit the general practitioner 6 (37%) 10 (17%) 2.21 (0.9; 5.1)
Reference to a Clinical expert 3 (19%) 14 (24%) 0.8 (0,3; 2.4)
Website 13 (81%) 9 (15%) 5.3 (2.8; 10.1)
Patient or support group 6 (37%) 9 (15%) 2.45 (1.0; 5.9)
Pharmaceutical company 6 (37%) 8 (8%) 2.8 (1.1; 6.8)
Brand name 0 (0%) 10 (17%) 0.3* (0.0; 2.2)
New medicine or treatment option 2 (12%) 15 (25%) 0.5 (0.1; 1.9)
* RR calculated by adding 0.5 to all cells.
doi:10.1371/journal.pone.0106599.t002
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Table 3. Examples of non-compliance per key criteria from the disease awareness campaigns.
KEY criteria Problem identified Example
(CONDITION)
Promotional
information
Reference to pharmaceutical products to
treat a condition or disease in combination
with: the name, logo and website of a
pharmaceutical company; or a website for
a disease awareness campaign; or quick
response codes to dedicated websites.
‘‘We are an international company with expertise in lung diseases…we develop innovative
pharmaceutical solutions…’’ (Respiratory diseases)
A dedicated website is mentioned in big and bold typeface, as well as the name, logo and
website of a pharmaceutical company. (Contraception)
‘‘X strives respond to challenging medical conditions through innovative approaches. Pain
treatment is one of our priorities… physical and emotional challenges borne by pain
patients are key. Our R&D programme seeks alternative solutions to fight pain.’’ (Pain)
‘‘Our website helps you to choose the best treatment for your lifestyle. You will be able to
find information about all therapies…and also do a test to help you select a suitable
treatment.’’ (Kidney Failure)
‘‘Do you have, or someone close to you has, urinary incontinence? Have a look at our
different links: (company) website; your digital logbook for your mobile phone; your online
digital logbook to share with your doctor.’’ (Urinary incontinence)
Misleading or
incomplete
information
No reference is provided on the sources
of information provided about prevalence
of disease.
‘‘One out of every 8 adults in the Netherlands has high cholesterol’’. (Cardiovascular
diseases)
‘‘One out of each 10 Dutch has asthma …‘‘one out of every 5 Dutch has hay fever’’.
(Allergies)
‘‘More than 5000 people get post-traumatic dystrophy every year.’’ (Post-traumatic
dystrophy)
‘‘Approximately 40.000 Dutch suffer from renal disease. There are several treatments
available for this debilitating disease.’’ (Kidney Failure)
‘‘One third of those who suffer from migraine in the Netherlands do not get the
appropriate treatment…2.5 million Dutch suffer from migraine.’’ (Migraine)
Use of fear Reference to disability caused by the
disease, either through text or picture.
An image of a disabled hand is used. (Post-traumatic dystrophy)
‘‘Besides the pain…migraine also has implications for society…it costs the Netherlands 1.7
billion per year… I have seen people who cannot fulfil their dreams…. That is terrible…
(Migraine)
Inadequate language Uses medical terminology ‘‘Perinasal inflammation…abscesses…metabolic diseases…’’ (Alarm signals)
Lack of balance More emphasis on the benefits of
pharmaceutical treatment than risks.
Symptoms are accentuated by layout
and/or enumeration. Risk factors are
portrayed as diseases. Treatment is
accentuated.
‘‘This disease can have a great impact on the individual and its environment. It disturbs
your daily life. It is important to diagnose it at an earlier stage, so that treatment can begin
quickly. Therapy includes anti-inflammatory drugs and painkillers.’’ (Post-traumatic
dystrophy)
‘‘These symptoms can seem mild, but they can have a great impact on your daily life, at
school or at work, and even disturb your sleep patterns’’.
‘‘Symptoms such as shortness of breath, cough and wheeziness result in an asthma
attack…Red and itchy eyes, running nose, stuffy nose, sneezes and tiredness can have
serious implications.’’ Allergies)
Symptoms are referred to in headings in big and bold typeface. (Allergies) (Alarm signals)
(Urinary incontinence)
‘‘…when you have high cholesterol, you have a higher risk of developing cardiovascular
diseases… you can reduce that risk by…treating your high cholesterol levels. Have a look
at our new website about healthy living with lower cholesterol’’. (Cardiovascular diseases)
‘‘Now women are able to choose a pill that contains a natural hormone and a
progestogen. This natural hormone is easily absorbed by the body…this pill has a neutral
effect on acne, weight-gain and blood pressure…your periods will be shorter and
lighter…’’ (Contraception)
Contraception is mentioned on six occasions in big and bold typeface. (Contraception)
The sentence: ‘‘I (do not) want a pill’’ and the address of a dedicated website are included
in big and bold typefaces. (Contraception)
‘‘…suffering from migraine, days in a row, a pain impossible to bear…with nausea, and
sensitivity to light and noises…seek a good treatment…Medicines play an important
role…we advise patients to try two different triptans…’’ (Migraine)
Use of testimonials Specialist mentions treatment and
specific drug classes
‘‘The doctor can prescribe anti-histamines…or corticosteroids… immunotherapy can be
considered an option’’. (Allergies)
Compliance of Disease Awareness Campaigns with Regulatory Guidelines
PLOS ONE | www.plosone.org 6 September 2014 | Volume 9 | Issue 9 | e106599
study period did not comply with the WHO ethical criteria nor
with the current Dutch self-regulation guidelines.
Most collected materials on health and treatment were news
items (74%). On average there were at least five news items
published every week and seven disease-awareness campaigns
published every four weeks. Our results seem to indicate that
pharmaceutical companies often opt to reach a wider audience by
publishing their unbranded product advertisements in free media
outlets, most notably in dedicated health-supplements. The
frequency of occurrence of disease awareness campaigns observed
in our study is consistent with the results of an Australian study,
where a total of sixty campaigns were identified in popular
women’s magazines over eleven months [22]. From these, fifteen
contained a corporate brand or logo – a result also similar to ours.
The findings on low compliance are worrying, since serious
information deficiencies in disease awareness campaigns result in
information bias. A key concern is that the context in which the
information is provided will be biased towards supporting
treatment with the sponsor’s product. One third of the disease
awareness campaigns in our study referred readers to their
physicians. Disease awareness campaigns can stimulate patients’
intentions to make requests to doctors for prescription medicines
products, increase consultation rates as well as prescriptions for the
advertiser’s product [15,23]. A survey in Australia has shown that
26,9% of the 800 patients enquired had approached their GP to
discuss a treatment they had heard about in the media. Half of the
patients reported that their inquiry had resulted in a treatment;
more than forty-eight percent of those receiving treatment,
reported being prescribed a medicine [5]. This has serious
implications for general practitioners and regulators.
There is evidence that self-regulation of drug promotion is
ineffective. A recent Swedish study demonstrated an overall system
failure compounded by lax oversight, regulation lags, and low fines
for violations [24]. The authors concluded that the current
regulatory regimes have failed to deter industry from providing
unreliable information. Researchers have raised concerns in the
United States about the effects of indirect medical advertising,
claiming that medical decisions based on such influences, as
manipulated by advertisers, are likely to result in worse outcomes
for patients, and have called for indirect advertising to be curtailed
[25].
In contrast, researchers in Australia have concluded that the
value of disease awareness campaigns could be improved if
regulations and guidelines stipulated disease information require-
ments [23]. Our research suggests that in the Netherlands – where
such guidelines do exist – pharmaceutical companies are aware of
Table 3. Cont.
KEY criteria Problem identified Example
(CONDITION)
A comparison is made of the patient’s
experience before and after treatment
with a specific drug.
‘‘I had tummy and back aches with another pill. I visited my doctor and together we have
chosen a new pill with a different ingredient. That has helped’’. ‘‘ The first pill I took caused
weight-gain and emotional changes. My GP then prescribed a lighter pill and I am feeling
fine’’. (Contraception)
Absence of author
and/or sponsor
No author and/or sponsor identified. (Allergies), (Alarm signals), (Cardiovascular diseases), (Contraception), (Migraine)
doi:10.1371/journal.pone.0106599.t003
Figure 1. Non-compliance of disease awareness campaigns (n = 16) per key criteria. Fifteen out of the sixteen materials assessed were non-
compliant with the guidelines. Non-compliance was more frequent due to lack of balance, absence of listed author and/or sponsor, use of
promotional information and use of misleading or incomplete information.
doi:10.1371/journal.pone.0106599.g001
Compliance of Disease Awareness Campaigns with Regulatory Guidelines
PLOS ONE | www.plosone.org 7 September 2014 | Volume 9 | Issue 9 | e106599
the regulatory grey area that disease awareness campaigns
represent – and of their subsequent limited regulatory response
– thus circumventing the law and exploring new avenues in
unbranded product advertising.
The indirect reference to a treatment in association with the
name or the logo of a pharmaceutical company – observed in five
disease awareness campaigns – constitutes unbranded product
advertisement and seems to be in contravention of European law
[7,17]. Our results are consistent with those of a 2009 study in the
Netherlands which analysed 41 websites offering health informa-
tion in the Dutch language: 32 were either hosted or sponsored by
a pharmaceutical company, and 23 (72%) contravened national
regulations by referring directly or indirectly to a specific
prescription medicine [26].
The absence of an identifiable advertiser or sponsor was one of
the main factors of non-compliance in our sample. This might be
deliberate, as pharmaceutical companies face a real threat of
litigation from unsubstantiated marketing claims. Their goal is to
raise awareness about a condition and the availability of a
treatment, but to leave the responsibility for a decision to the
patient, who should ‘‘talk to the doctor the advantages and
disadvantages of this new therapy’’ [27]. There is evidence that the
rate of diagnoses of specific conditions increases during associated
advertising campaigns [14]. A randomized controlled trial using
standardized patients found that if patients requested an advertised
brand, they were as likely to receive a prescription whether they
had the condition that the product treated, depression, or milder
life problems not requiring a medicine (‘adjustment disorder’) [28].
More than half of the disease awareness campaigns in our study
(62%) referred to websites, some of which seemed independent at
first glance, but were sponsored and/or maintained by one or
more pharmaceutical companies. Bearing in mind the growing
interest in online health information and that consumers are more
likely to seek out more prescription drug information after
exposure to advertising, as well as to engage in more communi-
cation with doctors about prescription drugs, the evaluation of the
content and quality of disease awareness websites should also be
envisaged [29].
Disease awareness campaigns have been identified as a form of
disease mongering or ‘‘widening the boundaries of treatable illness
in order to expand markets for those who sell and deliver
treatments.’’ [30,31] A recent commentary by Schwartz and
Woloshin provides a template for how disease awareness
campaigns work, using three basic strategies: lowering the bar
for diagnosis (turning ordinary life experiences into conditions that
require medical diagnoses), raising the stakes so that people want
to get tested, and spinning the evidence about drug benefits and
harms [16].
While seasonality might have influenced the conditions being
mentioned in the materials – namely allergies and respiratory
diseases - it is unlikely that it would have affected their quality.
Contraception was one of the key topics covered in disease
awareness campaigns. A new contraceptive pill was launched into
the EU market in May 2012 [32]. This might indicate a potential
marketing strategy of the marketing authorisation holder to draw
attention to their new product. Newspaper readers were also
amply exposed to information on diabetes. This might have been
related with the inclusion of linagliptine into the Dutch
reimbursement list [33].
One of the main limitations of our study has been the small
sample of unique advertisements, due to the monitoring and
inclusion process. A longer data collection window of a full
calendar year would have allowed better sampling and extended
statistical analysis.
The dynamics of disease awareness campaigns are intricate and
deserve closer scrutiny by physicians, consumers and regulators
[27,34]. While our proposed instrument has not been systemat-
ically evaluated, it represents an attempt to translate the relevant
provisions included in the WHO Ethical Criteria for Medicinal
Drug Promotion and the Dutch self-regulation guidelines into
measurable operational components [1,17,18]. Further validation
and testing are needed, to verify our tool’s consistency and
reliability.
Conclusions
We have demonstrated that disease awareness campaigns are
present in Dutch printed media. Their compliance with current
self-regulation guidelines is low, which warrants the need for
further research into the effects of these campaigns. The use of our
instrument could help identify disease awareness campaigns of
promotional nature and further encourage effective monitoring
and implementation of the regulation by competent authorities.
Supporting Information
Table S1 Instrument to assess the compliance of
disease and treatment information disseminated by
pharmaceutical companies to the public with the WHO
Ethical Criteria on Pharmaceutical Promotion and the
Dutch ‘KOAG/CGR guidelines for information on
prescription medicines.
(DOCX)
Acknowledgments
Barbara Mintzes for providing valuable guidance on the design and
methods of this study and for reviewing this article.
Author Contributions
Conceived and designed the experiments: TLA AMF MVE. Performed the
experiments: AMF TLA. Analyzed the data: TLA AMF AMT MVE.
Contributed reagents/materials/analysis tools: AMT. Wrote the paper:
AMT MVE AMF TLA.
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... All ED television advertisements are sexually themed and mention sexual side effects, including erections lasting longer than 4 hours. Exposure to sexual content in the media has been linked to higher rates of sexual activity among adolescents (Brown et al. 2006;Collins et al. 2004) and teen pregnancy and sexual transmitted infections (Abma and Sonenstein 2001;Alves et al. 2014;Chandra et al. 2008;Devlin et al. 2007). As a result, ED advertising has been criticized by the American Academy of Pediatricians (AAP), which found that "ads for ED drugs give children and teens inappropriate messages about sex and sexuality at a time when they are not being taught well in school sex education programs" (Strasburger 2006(Strasburger : 2565. 1 AAP recommends that ED ads be broadcast only after 10:00 p.m. (Fuld et al. 2013). ...
... Our analysis also benefits from utilizing data on all ED broadcast advertisements during the period of study. This study is limited by its focus on compliance with one self-regulatory principle, and one category of drugs, although our findings are consistent with findings of other studies of pharmaceutical industry self-regulation that firms routinely fail to meet selfregulatory guidelines (Alves et al. 2014;Arnold and Oakley 2013;Devlin et al. 2007;Zetterqvist and Mulinari 2013). Other drug classes found to violate self-regulatory standards include treatments for reactive airways disease, gastroesophageal reflux, dyslipidemia, and pain (nonsteroidal antiinflammatory drugs; Devlin et al. 2007) and psychiatric disorders (antipsychotics and antidepressants; Zetterqvist and Mulinari 2013). ...
... In Central Hudson the court found that commercial speech that "does not accurately inform the public" or is "more likely to deceive the public than to inform it" has no grounds for constitutional protection. Given the widespread deception in pharmaceutical marketing revealed by the Department of Justice and states' attorneys general (Arnold et al. 2016;Gagnon 2013) and identified in previous research (Alves et al. 2014;Arnold and Oakley 2013;Devlin et al. 2007;Zetterqvist and Mulinari 2013), restrictions in the public interest appear justified. In cases where deception is not present, the government may nonetheless regulate speech when there is a substantial public interest and when it is not more extensive than necessary to protect those interests. ...
Article
Context: Spending on direct-to-consumer advertising (DTCA) for prescription pharmaceuticals has risen to record levels, five times as much as in 1996 in inflation-adjusted dollars. Major health care provider organizations have called for additional regulation of DTCA. These organizations argue that the negative impact of such advertising outweighs the informational value claimed by the pharmaceutical industry. The industry maintains that further restrictions on DTCA are not warranted because it is successfully self-regulating via "guiding principles" for DTCA as certified by firm executives. Methods: The authors measured recent industry spending on DTCA and used regression models of Nielsen Monitor-Plus data to assess pharmaceutical firm self-regulation after the public disclosure of noncompliance with industry self-regulatory principles, specifically regarding the exposure of children and adolescents to broadcast advertisements for erectile dysfunction drugs. Findings: Public disclosure of noncompliance with self-regulatory DTCA standards did not bring advertising into compliance. Results demonstrate that firms failed to meet the industry standard during every quarter of the six-year period of this study. Conclusions: Results support previous research findings that pharmaceutical self-regulation is a deceptive blocking strategy rather than a means for the industry to police itself. Policy recommendations include broadcast restrictions on adult content and deincentivizing DTCA via tax reform.
... While the literature on disease awareness campaigns is relatively scarce and comes from industrialized countries, there is some evidence that such activities increase awareness of the advertised conditions, as well as rates of consultations and prescriptions of the sponsored product [17][18][19]. Research in Australia and the Netherlands also suggest that exposure to this type of campaigns is relatively common [20,21]. In a previous study, we developed an instrument to assess the compliance of printed disease awareness campaigns in the Netherlands with international and Dutch regulations [21]. ...
... Research in Australia and the Netherlands also suggest that exposure to this type of campaigns is relatively common [20,21]. In a previous study, we developed an instrument to assess the compliance of printed disease awareness campaigns in the Netherlands with international and Dutch regulations [21]. Although this was a small pilot study over a short study period, it identified an alarming lack of compliance of disease awareness campaigns in Dutch printed media with the WHO Ethical criteria for medicinal drug promotion [22] and with national pharmaceutical industry self-regulatory guidelines [23], as well as some evidence of likely contraventions of EU legislation. ...
... From all the items covering health topics identified in the various media, we selected materials which mentioned conditions or symptoms or manufacturers and provided treatment suggestions (either directly or indirectly). The full inclusion criteria followed the methodology of a previous study [21] and were based on an interpretation of legal provisions [14], which prohibit direct and/or indirect reference to a pharmaceutical product. From all the items covering health topics identified in the various media, we selected materials which mentioned conditions or symptoms or manufacturers and provided treatment suggestions (either directly or indirectly). ...
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... Direct-to-consumer campaigns sponsored by the pharmaceutical industry, including direct-to-consumer advertising (DTCA) and direct-to-consumer information (DTCI) campaigns, have been a recent focus of prescription drug-use promotion in developed countries [1][2][3][4]. DTCA campaigns directly promote specific brand name medications, whereas DTCI campaigns are aimed at informing people about seeking healthcare services but should not directly promote specific drugs [4][5][6][7]. ...
... Spending for DTCA campaigns has increased from USD 1.2 billion in 1998 to USD 4.5 billion in 2009 in the US [1,4]. In many countries including Japan, where direct brand name drug promotion has been prohibited, DTCI campaigns (also known as disease awareness campaigns) have rapidly increased [5][6][7]. The current Japanese government regulations prohibit a DTCA campaign due to its direct promotion of a specific drug, but do not prohibit a DTCI campaign without such direct promotion of a specific drug. ...
... As a result, pharmaceutical industries are practically able to conduct DTCI campaigns in Japan. Although DTCI campaigns, including public awareness campaigns for specific diseases, are distinguished from the advertisement of specific drugs by law and permitted in many settings, some recent reports raised concerns about their potential advertising effects [6,7]. However, little is known about how DTCI campaigns affect the patterns of prescription of treatment drugs. ...
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Background: Direct-to-consumer information (DTCI) campaign is a new medium to inform and empower patients in their decision-making without directly promoting specific drugs. However, little is known about the impact of DTCI campaigns, expanding rapidly in developed countries, on changes in prescription patterns. We sought to determine whether a DTCI campaign on overactive bladder increases the prescription rate for overactive bladder treatment drugs. Methods: We performed a 3-year retrospective cohort study of 1332 participants who were diagnosed overactive bladder but not prescribed treatment drugs prior to the examined DTCI campaign (exposure), using the health insurance claims dataset of the Japan Medical Data Center (November 19, 2010 to November 18, 2013). The DTCI campaign for overactive bladder included television, Internet, and print advertising (November 19, 2011 to December 22, 2011). We divided the study period into Pre-Campaign Year (2010-2011), Year 1 (2011-2012), and Year 2 (2012-2013). Each year began on November 19 and included Period 1 (weeks 1-5) through Period 10 (weeks 46-50). The main outcome was first-time prescription of the treatment drug for each patient, measured by 5-week periods. Using Period 10 in the Pre-Campaign Year as the referent period, we applied the Cox proportional hazard model for each period. Additionally, we performed the interrupted time series analysis (ITSA) for the first-time prescription rate per 5-week period. Results: Following the DTCI campaign, patients were about seven times more likely to receive a first prescription of a treatment drug during Period 4 in Year 1 (hazard ratio 7.09; 95% CI, 2.11-23.8; p-value<.01) compared with the reference period. Similar increases were also observed for subsequent Periods 5 and 6 in Year 1. The ITSA confirmed the DTCI campaign impact on the level of prescription rate (one-time increase in the regression-intercept) that increased by 1128.1 [per standardized 100,000 persons] (p < .05) during Period 4 in Year 1. Conclusions: The examined DTCI campaign appeared to increase the prescription rate among patients with overactive bladder for 15 weeks with a 15-week delay. Clinical outcomes of the patients with targeted diseases need to be monitored after DTCI campaigns by a future study.
... In fact, in many countries-such as Australia, Canada, Italy, the Netherlands, the United Kingdom (UK) and Sweden-marketing activity is primarily governed by such voluntary codes administered by the pharmaceutical industry's own self-regulation systems (Lexchin 1999;Fox et al. 2006;Doran and Löfgren 2013;Zetterqvist and Mulinari 2013;Alves et al. 2014). A recent comparative study analyzing self-regulation in the UK and Sweden suggested that the regulatory regimes in those countries could best be defined as "delegated self-regulation as an integral part of a co-regulatory scheme involving industry and national medicines regulatory authorities" (Zetterqvist et al. 2015, p. 2). ...
... In practice however, critics say self-regulation often fails to live up to its theoretical promise (Lexchin 2003;Lexchin 2012;Doran and Löfgren 2013). Accordingly, studies have documented discrepancies between the ethical standard codified in Codes of Practice and the actual conduct of companies in some countries (House of Commons Health Committee 2005;Arnold and Oakley 2013;Zetterqvist and Mulinari 2013;Alves et al. 2014;Zetterqvist et al. 2015). For example, the 2005 House of Commons Health Select Committee's report on the inf luence of the pharmaceutical industry in the UK expressed concerns about lax oversight over medicines promotion, substantial lags in the self-regulatory system that allow firms to continue running misleading advertisements for extended periods of time, and insufficient sanctions that fail to deter companies from providing unreliable information. ...
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This essay reviews work in sociology and cognate fields regarding pharmaceutical marketing and its regulation. In particular, it considers how this literature contributes to a better understanding of the process of pharmaceuticalization, defined as “the translation or transformation of human conditions, capabilities, and capacities into opportunities for pharmaceutical intervention.” The review addresses two research areas that offer productive avenues of investigations of the marketing-regulatory nexus in the context of pharmaceuticalization. The first concerns the sociopolitical mechanisms underlying development and enforcement of marketing rules. The second considers the impact of rules and enforcement schemes on corporate marketing practices and, consequently, on the shaping of pharmaceutical markets and health.
... A study explored examples of such campaigns in printed media in the Netherlands by assessing their compliance with the WHO Ethical Criteria for medicinal drug promotion and the Dutch guidelines for provision of information by pharmaceutical companies. It concluded that although brand names were not mentioned in the campaigns, there was an overwhelming lack of compliance with the regulations mainly due to a lack of balance, absence of a listed sponsor, use of misleading or incomplete information and use of promotional information (Leonardo Alves et al. 2014). ...
Article
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Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutical companies with the aim of enhancing product sales. We look in greater detail at promotion techniques aimed at prescribers, such as sales representatives, pharmaceutical advertisements in medical journals and use of key opinion leaders, along with the quality of information provided and the effects thereof. We also discuss promotion to the public, through direct-to-consumer advertising, and its effects. Finally, we consider initiatives to regulate promotion that come from industry, government and nongovernmental organizations.
... Although direct-to-consumer advertising (DTCA) of prescription-only medicines is illegal in all industrialized countries except the United States and New Zealand, manufacturers may run disease-awareness campaigns without mentioning a brand name. [7] This is a regulatory grey area, largely unaffected by restrictions on advertising of prescription-only medicines. [4] Disease-awareness campaigns for testosterone also have unique advantages. ...
Purpose of review: To summarize the research evidence on promotion of testosterone for 'Low T', or age-related hypogonadism. Recent findings: Marketing of testosterone for 'Low T' has relied on strategies that are inadequately regulated to prevent off-label promotion, such as unbranded 'disease-awareness' advertising campaigns targeting the general public, sponsored continuing medical education (CME) and ghostwriting. A recent US analysis of television advertising exposure levels versus insurance claims found that both unbranded 'disease-awareness' advertising and branded ads were associated with increased rates of testosterone testing, treatment initiation, and treatment without prior testing. Exposés of sponsored CME and ghostwriting indicate misrepresentation of the research evidence on the sequelae of untreated low testosterone and on treatment efficacy. In the United States, advertising to the general public ceased in 2014 after the Food and Drug Administration changed product labeling to clarify that testosterone is only indicated for pathological hypogonadism. Unbranded 'disease-awareness' advertising to the general public and 'Low T' messages for health professionals have continued elsewhere. Summary: The review of the experience of promotion of testosterone for 'Low T' and research evidence on effects of advertising targeting the public highlights the need for improved regulation of unbranded 'disease awareness' advertising to ensure adequate protection of public.
... Interestingly, Canada is not the only jurisdiction that struggles with regulating DTCI-like activities; for instance, the Netherlands has similar dispositions allowing disease awareness campaigns that are framed by a self-regulated agency. A study from Leonardo Alves et al. (2014) demonstrated that there is low compliance with self-regulation guidelines in the Netherlands. Even if their study was focused on the print media, the authors raised questions about the growing interest for online drug information and the importance of evaluating "the content and quality of disease awareness websites" to determine the effect on consumer behaviour (Leonardo Alves et al. 2014: 8). ...
Article
Full-text available
Like most jurisdictions, Canada prohibits direct-to-consumer advertising (DTCA) of prescribed drugs. However, direct-to-consumer information (DTCI) is permitted, allowing companies to inform the public about medical conditions. An analysis of Eli Lilly's 40over40 promotion campaign for erectile dysfunction (ED), which included a quiz on ED, shows that DTCI, like DTCA, can be an effective means of drug familiarization. The pharmaceutical industry is "playing by the rules" currently in effect in Canada. Regulators should thus seriously consider whether existing rules permitting DTCI actually meet stated objectives of protecting the public from marketing campaigns (i.e., DTCA) that may deliver misleading information. Copyright © 2015 Longwoods Publishing.
Chapter
Die weitreichenden Entwicklungen der technischen, ökonomischen und rechtlichen Rahmenbedingungen erhöhen den Kosten- und Innovationsdruck auf das allgemeine Geschäftsmodell der Pharmaindustrie (Kap. 1). Diese richtet sich daher in den Bereichen der Forschung und Entwicklung, der Markteinführung und des Vertriebs neu aus (Kap. 1 und 6 ff.; Camacho 2014, S. 426).
Chapter
Selbstregulative Strukturen und Mechanismen, mit denen Wirtschaftsakteure in die aktive Sicherstellung einer rechtskonformen Unternehmenspraxis eingebunden sind, zeigen sich nicht nur innerhalb von Unternehmen (dazu Kap. 4), sondern auch auf einer kollektiven Ebene (allgemein dazu Abschn. 1 in Kap. 1). Hiervon ist bspw. dann auszugehen, wenn Vereinigungen und Verbände von Wirtschaftsakteuren (d. h. Unternehmen, ggf. aber Individualunternehmern) entsprechende normstützende Maßnahmen entwickeln. Nicht selten geht es dabei um Verhaltenskodizes, die für die jeweiligen Mitglieder gelten und die durch bestimmte Vorkehrungen abgesichert werden (bspw. durch verbandseigene Sanktionen).
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This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of unbranded advertising of prescription medicines, conducted by or on behalf of pharmaceutical companies, on consumers’ attitudes, knowledge, behaviour, health services use, health outcomes and costs.
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Over the last twenty years, the use of disease awareness campaigns has become predominant in our everyday lives. What started out as a technique to market lifestyle drugs for cosmetics and sexual enhancements in the 1980s and 1990s, has now increased in usage to include many other areas of medicine. Its not uncommon to see drug advertisements in consumer magazines and on television for everything from psychotropic drugs, to drugs that are intended to improve the quality of everyday life for more average Americans. Indeed, its hard to find a popular press magazine that doesnt have at least one such advertisement, while most magazine issues have many such advertisements.
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This report describes ways in which pharmaceutical companies provide the public with information about diseases and conditions. It provides an overview of the various methods used, and the impact that public information campaigns can have. The aim of this report is to demonstrate how companies use public information campaigns about diseases and conditions as tools to market their medicines. In the research, we have carried out three case studies to demonstrate how various methods are applied and the parties are involved.
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The alleged efficacy of pharmaceutical industry self-regulation has been used to repudiate increased government oversight over promotional activity. European politicians and industry have cited Sweden as an excellent example of self-regulation based on an ethical code. This paper considers antidepressant advertising in Sweden to uncover the strengths and weaknesses of self-regulation. We analyzed all antidepressant advertisements in the Swedish Medical Journal, 1994-2003. The regulation of these advertisements was analyzed using case reports from self-regulatory bodies. The authors independently reviewed this material to investigate: (1) extent of violative advertising; (2) pattern of code breaches; (3) rate at which the system reacted to violative advertising; (4) prevalence of and oversight over claims regarding antidepressant efficacy and disease causality, and (5) costs for manufactures associated with violative advertising. Self-regulatory bodies identified numerous code breaches. Nonetheless, they failed to protect doctors from unreliable information on antidepressants, since as many as 247 of 722 (34%) advertisements breached the industry code. Self-regulatory bodies repeatedly failed to challenge inflated claims of antidepressant efficacy, lending evidence of lax oversight. On average, 15 weeks elapsed between printing and censure of a wrongful claim, and in 25% of cases 47 weeks or more elapsed. Industry paid roughly €108000 in fines for violative advertising, adding an estimated additional average cost of 11% to each purchased violative advertisement, or amounting to as little as 0.009% of total antidepressant sales of around €1.2 billion. Lax oversight, combined with lags in the system and low fines for violations, may explain the Swedish system's failure to pressure companies into providing reliable antidepressants information. If these shortcomings prove to be consistent across self-regulatory settings, and if appropriate measures are not taken to amend shortcomings, many countries may want to reconsider the current balance between self-regulation, and legislative control with government oversight.
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Despite progress in raising the level of transparency about funding, conflicts of interest, and ghostwriting, drug companies remain free to pursue subtle and, therefore, effective means of marketing. Continuing medical education programs and "consensus" panels continue to be funded by companies selling products directly tied to the messages being conveyed by the resulting "educational" materials. And patient education materials continue to be created that, while factually accurate, subtly shift attitudes by including only selected facts and/or omitting ideas that would undermine the funder's preferred paradigm.