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[e-drug] BMJ on WHO Ethical Drug Promotion

E-DRUG: BMJ on WHO Ethical Drug Promotion
-------------------------------------------------------------

[Are new guidelines on ethical marketing of pharmaceuticals needed in 
order to reach a wider audience or do the old principles still cover the 
new tactics of industry? Copied as Fair Use. Please refer to original 
article for references and figures/tables. DB]

Ethical drug marketing criteria for the 21st century

BMJ 2018; 361
doi: https://doi.org/10.1136/bmj.k1809 (Published 30 April 2018) Cite 
this as: BMJ 2018;361:k1809
https://www.bmj.com/content/361/bmj.k1809.full

 Lisa Parker, researcher, Jane Williams, researcher, Lisa Bero, professor

The World Health Organization has a long history of promoting the 
rational use of drugs with the aim of improving health. One element of 
its multipronged approach is to use its authority1 to establish 
normative guidance on promotion. An early guidance document, drafted in 
1968, focused on advertising of drugs. In 1988, it was updated in a new 
document, “Ethical criteria for medicinal drug promotion,” which was 
endorsed through a resolution adopted by the World Health Assembly.2 
Recommendations endorsed by the WHA are among the strongest guidances 
produced by WHO.

The 1988 ethical criteria (box 1) were intended as guidance for 
countries to use when developing their regulations and practices around 
medicinal drug promotion.34 The document is still used by regulators, 
governments, and academics as a yardstick for measuring the 
acceptability of promotional activities.5678 The criteria have also been 
incorporated into curriculums for educating health professionals about 
drug marketing tactics.9 WHO guidance documents are particularly 
important in countries where local regulation is absent or insufficient. 
These countries are likely to receive increasing promotional attention 
from drug companies as the potential for market growth in high income 
countries shrinks.10

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Box 1: Summary of WHO ethical criteria for medicinal drug promotion, 1988

Aim
- Improving health through the rational use of drugs, using the 
ethical foundation of truthfulness and righteousness.

Definitions
- Promotion: All activities by manufacturers and distributers that 
induce prescription, supply, purchase and/or use of drugs
- Drugs: All products that are promoted as a medicine, including 
prescription drugs, non-prescription (over-the-counter) drugs, and 
traditional medicines

Intended audience
- Industry, prescribers, dispensers, governments, teachers, 
professional and consumer associations, media

Sections
-� Advertising: Guidance on content, types of drug for which 
advertising to the public is acceptable
-� Medical representatives: Guidance on staff training, personal 
qualities, activities, sales commissions
-� Medication samples: �guidance on free samples for prescribers and the public
-� Promotional symposiums: Guidance on focus (science/marketing), sponsorship 
transparency and limits
- Industry funded research: �Guidance on data sharing, reporting of hazards, 
research-as-promotion
- Packaging, labelling and other sources of patient information: "Guidance on 
content, authorship, location of information (eg, package inserts, leaflets), 
style; relevant to drugs produced for both domestic and export use; drug 
information template provided
-----

The drug industry uses a variety of marketing strategies, implemented 
through a range of actors and tools and aimed at several targets (fig 
1).11 

It is important that health professionals and the public are 
educated about the promotional nature of industry activities, 
particularly those dressed up as research, education, or covert 
marketing through surrogates such as patient associations and key 
opinion leaders. The 1988 document covers a wide range of marketing 
activities, but many new marketing strategies have since been 
introduced, including through social media. The WHO document therefore 
needs updating.412

Fig 1 Model of drug promotion activities.11 A company’s strategy directs 
its choice of actors and tactics

Why drug promotion is an urgent problem

Drug promotion is reducing, not improving, health by contributing to 
mistreatment, overtreatment, and undertreatment (box 2).

-----
Box 2: How drug promotion drives mistreatment, overtreatment, and 
undertreatment

-� Mistreatment: Promotes increased use of new drugs with dubious efficacy or 
similar efficacy but worse side effect profile compared with existing products, 
or non-drug treatments such as behavioural therapies.13 14 15 16

-� Overtreatment: Promotes use of drugs when no treatment is needed, such as 
opioids for mild pain, antibiotics for viral infections,17 and drugs for 
conditions associated with overdiagnosis (medicalisation of normal experiences, 
unnecessary widening of disease definitions).18 

Overtreatment may harm health by, for example, facilitating antibiotic 
resistance, delivering unnecessary toxicity, and diversion of resources from 
those who really need them.
-
 Undertreatment: Drives industry attention towards diseases and populations 
likely to bring high profits over areas of unmet therapeutic need.19 For 
example, most newly developed drugs are minor variations on existing drugs 
rather than important advances in treatment.2021 

Contemporary company marketing is integrated with research and development 
agendas such that innovation is pushed towards profitable me-too drugs instead 
of drugs for uncommon diseases or infectious disease associated with poverty.22
-----

There is also good evidence that marketing causes problems beyond the immediate 
effects on health. Drug promotion reduces cost efficiency by, for example, 
increasing use of expensive drugs instead of cheaper, equally safe and 
effective alternatives (such as branded instead of generic).23 24 25 26 This 
creates financial burdens for individuals and opportunity costs to society, and 
threatens the sustainability of the 
healthcare system. Direct-to-consumer advertising, which is more persuasive 
than informative,27 may undermine patient autonomy, especially for vulnerable 
people with health concerns or lower health literacy.28 29

Marketing also exacerbates inequality in several ways. It can increase 
medication costs through increased prescribing of branded drugs,2324 and 
promotional free drug samples tend to be distributed to those who are 
less needy.30 Marketing also consumes huge company resources, driving up 
drug prices and making drugs less accessible for countries and 
individuals with limited means.

Finally, drug promotion activities transgress important ethical 
boundaries around honesty, transparency, and integrity. For example, 
clinical seeding trials and company driven ghost writing threaten the 
integrity of scientific research.313233 There is inadequate disclosure 
of industry sponsorship of key opinion leaders, including journal 
editors,34 and of patient group lobbyists.3536 It also reduces 
solidarity between health practitioners and the public through loss of 
trust in a profession perceived to be corrupted by industry funding.37

New tactics for drug promotion

Analyses of internal drug company documents,31 testimonies from whistle 
blowers,38 and transparency databases39 have revealed new marketing 
strategies that are not sufficiently covered by the 1988 WHO ethical 
criteria. Drug companies are using health professionals in new ways, 
including honorary authorships of scientific papers, excessive financial 
remuneration for speaking at so called educational events, and generous 
stipends for advisory positions or other nominal services.31 There are 
also new targets for promotional activities, including patient groups, 
which have become important power bases in health advocacy.40 Television 
based direct-to-consumer advertising in the United States has 
substantially increased in recent years, at least partly because new 
regulations require advertisements to contain only a link to information 
about harms.41 Social media enable advertising to consumers even in 
countries where it is illegal.42

Awareness has also increased of the marketing nature of certain 
activities conducted in the name of research. For example, there is 
increased recognition of seeding trials, such as the ADVANTAGE32 and 
STEPS31 studies. 

Seeding trials are promotional activities whose main aim is to increase 
prescriber familiarity with the drug rather than contribute to scientific 
evidence.33 
A Cochrane review shows that industry funded clinical research is more likely 
to deliver publications that are in favour of the funder's product.43 
The literature is skewed towards favourable results in several ways, including 
deliberate suppression of unfavourable results.31 43 44
Why and how should we judge medicinal drug promotion?

The 1988 document is functionally a code of conduct. It provides 
granular detail and judgment of drug promotion activities but does not 
underpin this with a cohesive ethical framework.

WHO recognises that drug promotion is a public health concern.45 As such, we 
advocate incorporating public health ethical principles46 into an updated WHO 
document. This will provide justification for the guidance contained within the 
document and improve accountability by enabling scrutiny of underlying values. 
It can also stimulate new approaches' ethical principles can provide a new 
model for thinking about drug promotion outside the traditional activities 
listed in the 1988 document. This can trigger different kinds of question and 
enhance awareness of research gaps (table 1). New ideas can then be cross 
checked against existing 
advice to inform and strengthen guidance for strategies and tactics.

Table 1: Public health ethics for drug promotion

Review of scientific evidence is an important part of answering 
questions triggered by ethical inquiry; conversely, questions raised by 
relevant ethical values can guide future research agendas.

What needs to happen next?

The existing WHO document on ethical criteria for drug promotion needs 
to be strengthened. The section on ethics should be expanded to include 
a broader range of ethical values than truthfulness and righteousness. 
Each listed value should be annotated with notes on how to interpret and 
act on the abstract concepts (table 1). The concrete guidance about 
specific promotional strategies and tools should also be extended to 
reflect new evidence and ideas - for example, restricting interactions 
between industry and prescribers or surrogate marketers, including 
prohibiting industry gifts to individuals or groups as well as meals, 
travel costs, and political donations47; banning free samples of 
prescription medicines; reducing or banning industry sponsorship of 
specific educational events or scientific studies48; restricting 
industry links with journal editors34; and encouraging the creation of 
independent detailing, education, and research.

The document should have sections providing guidance about important new 
aspects of drug promotion - for example, banning promotion of 
antimicrobials; mandating transparent reporting of all industry 
promotional costs; and prohibiting industry funded individuals from 
participating in policy.

The revision requires broad and intensive consultation with independent 
experts from the health professions and academia as well as 
representatives of consumer groups. The members of the group writing the 
guidance in the revised document should have no financial conflicts of 
interest. It may be helpful to include experts in public health ethics 
to facilitate conversations about relevant principles and their 
application in the context of drug promotion.49 Members of the drug 
industry and other interested parties could participate in open 
consultations on the document. It will be important to get industry 
support for the document, and industry groups could be encouraged, along 
with WHO member states, to adapt the revised document to their own 
situation.

Promotion of drugs is harming public health, and drug companies will 
continue to come up with new marketing strategies. To support countries 
to respond, we advocate for the revision of WHO's ethical criteria for 
drug promotion to incorporate a public health ethics justification that 
can be extended to other situations. We also urge communities and 
governments around the world to enact stricter policies that enforce change.

Key messages
- Medicinal drug promotion affects public health by facilitating 
overdiagnosis, inappropriate treatment, inequality of drug access, and 
increasing healthcare costs
-� Many new methods contravene standards of honesty and transparency, 
compromising professional integrity, and undermining the scientific 
evidence base
- Existing WHO guidance on promotion needs revising to take into 
account new marketing methods
- The document should also be strengthened by including ethical 
justifications for the standards

Acknowledgments: We thank Suzanne Hill and Barbara Mintzes for comments 
on the manuscript.

Acknowledgments: Provenance and peer review: Not commissioned; 
externally peer reviewed.

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