





































 V38 N4 / 2023 

©2023 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     17

Q1:  How do continuing medical education/continuing 
education (CME/CE) medical writers balance the need 
for accurate scientific representation with the pressure to 
create content that aligns with pharmaceutical industry 
interests?

You’d think there was no need to even ask this question. 
But you’d be wrong. I once worked on a CME/CE project 
in which a supporter complained that faculty didn’t give 
sufficient attention to the supporter’s therapy in a live pre-
conference education session. Subsequently, the educa-
tion provider asked me to include additional material about 
the supporters’ product in the downloadable slide deck “to 
keep the supporter happy.” This behavior flouts a fair and 
balanced approach to content, threatens content integrity, 
and damages the regulatory firewall. 
 Accredited CME/CE content must be independent of 
any third-party influence or commercial interest. Standards 
and mechanisms have evolved in the United States to reg-
ulate the planning and delivery of CME/CE content and 
establish a firewall between commercial interests and edu-
cation content. These standards and mechanisms are dif-
ferent in other parts of the world. In the United States, the 
Accreditation Council for Continuing Medical Education’s 
(ACCME) 2020 Standards for Integrity and Independence 
in Accredited Continuing Medical Education specify the 
types of organization that can provide education, the types 
of content that they can create, and the criteria for creation. 
At a minimum, accredited CME/CE content must be evi-
dence-based and adopt a fair and balanced approach to 
describing and evaluating relevant therapeutic interven-
tions within a recognized standard of care for a given condi-
tion or disease. To this end, ACCME requires that education 
sponsors (often, but not exclusively, pharmaceutical man-
ufacturers) have no role in determining content, editing, or 
providing materials to support the content. 
 Medical writers are instrumental in developing content 
for the purpose of educating health professionals on how 
to provide care for and treat patients. As such, we are de 
facto bricks in the regulatory firewall. It’s our job to ensure 
that content meets the requirements of accreditation, so we 

need to be meticulous in the sources we review and use to 
create that content. We also need to be aware of the mecha-
nisms in place to protect content integrity and prevent com-
mercial influence. These mechanisms include financial and 
conflict of interest disclosures as well as independent and 
thorough content review processes. For the most part, these 
mechanisms are sufficient to maintain the firewall. 
 However, writers need to be aware that when phar-
maceutical manufacturers issue requests for proposals to 
design and deliver education programs or activities, they 
have internal objectives that they expect such education 
to meet. The business and sales managers within educa-
tion provider organizations know this. Their role in secur-
ing funding via the grant development process involves a 
delicate dance to ensure that content remains firmly within 
the 2020 ACCME Standards framework, yet also implic-
itly appeals to supporter interests. At times, they might 
zealously communicate these interests to writers. This is a 
form of tacit pressure. Similarly, when needs assessments 
are narrowly focused on a specific therapy compared with 
objectively identifying clinical and professional practice 
gaps, content is already skewed toward sponsor interests. 
Writing extensively about clinical trial data for one particu-
lar therapy is a common way that content gets skewed.
 As writers, we are bricks in the firewall between industry 
and education, charged with maintaining content indepen-
dence and integrity. We can do this by raising our awareness 
of areas in which tacit pressure can creep into the content 
development process and by pushing back on any potential 
to breach the firewall. 

—Alex Howson

It is not unusual for a pharma/biotech client to try to “spin 
the data” in a Continuing Medical Education (CME) or other 
educational article so that a favorable light shines on their 
own drugs or therapeutic agents. The Accreditation Council 
for Continuing Medical Education (ACCME) has published 
guidelines/rules for CME material to qualify for accredita-
tion and, presumably, most CME providers do try to adhere 
to these guidelines. You can access these guidelines easily 

FREELANCE FOCUS

Alex HowsonBrian Bass Cathryn D. Evans

http://www.amwajournal.org
https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf
https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf


AMWAJournal.org     18Freelance Focus

via Google search. Nonetheless, some companies and/or 
their agencies will try to slither in a little bias toward a com-
pany product—this is not very difficult if the writer/author 
is clever. 
 Whether you are involved in accredited CME, Continuing 
Education (CE) for pharmacists, nurses, or nonaccredited 
educational material sponsored by a pharma/biotech com-
pany, the ethics remain the same, even if specific “rules” have 
not been published. Members of AMWA, as professional 
medical writers, are ethically obligated to pay attention to 
guidelines about content, sources, references, authorship, 
contributions, and acknowledgements.
 How to balance the needs vis à vis pressure from clients? 
First, we must speak freely and openly with clients to let 
them know when the ethical lines are starting to be crossed. 
Second, if we are going to be asked to spin toward the pos-
itive—or even hide data, perish the thought—it is essential 
that we address this in fair balance with other similar and 
likely competitive therapies by including appropriate infor-
mation about the other products as well. 
 If you do not have the moral integrity, or the profes-
sional confidence, to speak openly with your client about 
such things, probably you should not be a medical writer 
in pharma/biotech. These messages can be delivered quite 
diplomatically, no need for friction or hard feelings. We 
simply explain the rules, regulations, and guidelines around 
ethics in medical communication. Please note: if your client 
refuses to adhere to ethical standards and insists on the 
spin, I suggest you tacitly drop that client. (But, just in case 
of a future lawsuit,always make sure your recommendations 
are in writing, either in an email or within a manuscript—
without in any way accusing the client, of course.) I have 
had to do this numerous times; it is not easy, but I do it. So 
should you.

—Cathryn D. Evans

* * *
Q2:  When working on manuscripts involving multiple 
authors, how can medical writers help manage authorship 
disputes and ensure fair credit allocation following ethical 
guidelines?

It is not within the purview of a freelance medical writer to 
determine authorship or mediate their disputes—at least it 
should not be. If clients are passing this responsibility on to 
you, they are essentially asking you to be more than a med-
ical writer; they want you to be the Project Manager, a func-
tion that pays more than medical writing, so be sure to raise 
your rate if a client asks this of you. 
 Yes, I have had to take this role at different times. 
Generally, I am crystal clear in my communication with 

coauthors (and clients) about guidelines and regulations; 
likewise, I am usually well aware of the politics within compa-
nies and academia, so I address the issue directly. The politics 
are out of our hands—this is up to the client and/or the chief 
author, investigator, or scientist. We cannot take responsibil-
ity for the politics.

—Cathryn D. Evans

* * *
Q3:  How can medical communicators navigate cultural 
and linguistic differences in a global health care context, 
ensuring their work is accurate and culturally sensitive?

Medical communicators must always consider their audi-
ences when developing content, but there’s more to it than 
simply writing in one style for regulators, in another style for 
health care professionals, and in another style for lay audi-
ences. There are differences in the way people learn and 
in the way people understand that go beyond reading and 
education levels. For example, although it may have been 
thought at one time that visuals are the best way to commu-
nicate to people with low reading skills, infographics have 
become a popular way to communicate the results of clini-
cal trials to health care professionals.
 The ability to access and utilize information is influenced 
by so many factors: race, ethnicity, age, culture, religion, sex, 
gender identity, sexual orientation, socioeconomic status, 
geography, physical ability, and neurobiology among them. 
With so many possibilities, is it surprising we’re all different? 
That may be the biggest thing we have in common!
 Although medical communicators should have always 
thought about at least some of this, diversity, equity, and 
inclusion (DEI) finally being at the forefront makes it a lot 
easier. Now our companies and clients are thinking about it, 
too. I think they’re also more receptive to our doing some-
thing about it. It was wonderful when the American Medical 
Association (AMA) Manual of Style, 11th Edition, gave us 
permission to use “they” as a singular pronoun. The cir-
cles we used to have to write around a sentence in order to 
de-gender it!
 One of the best ways I can think of for medical commu-
nicators to navigate cultural and linguistic differences in the 
global health care universe is to think about DEI constantly 
and allow it to drive questions up front about how a partic-
ular communication piece will be delivered, to whom it is 
intended, and what considerations can and should be made 
to optimize its value to this audience. This should be an 
actual topic of conversation at the beginning of any project—
an agenda item! Establishing these guardrails from the begin-
ning will help us develop content that is best suited to achieve 
its communication objective. I also think it is important for us 

http://www.amwajournal.org


AMWAJournal.org     19Freelance Focus

to consider the characteristics we give to patients when writ-
ing hypothetical case studies and patient journeys. 

—Brian Bass

Much medical writing already occurs in a global context, 
requiring cultural awareness to ensure content resonates 
across different health care settings. Writers must consider 
linguistic, cultural, and identity differences to create inclu-
sive materials that engage diverse audiences. We need to 
bring this same awareness to cultural and linguistic differ-
ences in a US health care context. If you’re a writer in CME/
CE, you are already likely doing so via the concept of cul-
tural competence. 
 Almost 20 years ago, the Commonwealth Fund defined 
cultural competence as “the ability of providers and organi-
zations to effectively deliver health care services that meet 
the social, cultural, and linguistic needs of patients.” To this 
end, accreditation bodies such as ACCME, the American 
Nurses Credentialing Center, and the Accreditation Council 
for Pharmacy Education expect CME/CE providers to inte-
grate cultural competence into education for the intended 
learner audience, be they physicians, pharmacists, or nurse 
practitioners. The California Medical Association, which 
accredits CME organizations in California, has also devel-
oped standards to ensure the inclusion of cultural and lin-
guistic competency statements in accredited CME, as well 
as content that addresses, implicitly or explicitly, topics like 
communication skills, health care disparities, biases/stereo-
typing, cross-cultural pharmacological issues, and sociocul-
tural factors that affect health beliefs and behaviors. ACCME 
is also working to ensure that DEI is incorporated into all 
aspects of accredited education. 
 A primary way to integrate cultural competence stan-
dards to CME/CE is by broadening representation within 
education content, such as in patient cases. We can diversify 
the social, cultural, and linguistic characteristics of patient 
cases by using diverse names, describing different marital 
statuses and relationships, and including images that rep-
resent people with disabilities, as well as Black, Indigenous, 
and additional people of color, and people in lesbian, gay, 
bisexual, transgender, queer, intersex, asexual, and many 
other identities (LGBTQIA+) communities. We can also 
educate ourselves on cultural norms related to communi-
cation, decision-making, family dynamics, spirituality, and 
other factors affecting health and health care. 
 Many tools and resources are available to help us nav-
igate cultural and linguistic differences in both the United 
States and the global health care context, and to integrate 
cultural competence standards into CME/CE.  

The Association of American Medical Colleges Diversity and 
Inclusion Toolkit is a terrific place to start, with resources on 
how to think about power and privilege, cross-cultural com-
munication, and the diversity of identities in health care 
contexts. The Disabled and Here collection, Photoability, 
Tonl, the Gender Spectrum collection, and many other 
archives provide access to inclusive images. Resources such 
as the Inclusive Language Playbook: Writing for LGBTQ+ 
Communities,the 11th edition of the AMA Manual of Style, 
and the Council of Science Editors' perspective on inclusive 
sex/gender language can help writers avoid discriminatory 
or stigmatizing language. 

—Alex Howson

Reference
1.   DeTora LM, Lane T, Sykes A, DiBiasi F, Toroser D, Citrome L. 

Good Publication Practice (GPP) guidelines for company-
sponsored biomedical research: 2022 update. Ann Intern Med. 
2023;176(3):eL220490. doi:10.7326/M22-1460

Online Resources for Freelance Writers
ACCME Standards for Integrity and Independence in 
Accredited Continuing Medical Education: https://
accme.org/publications/standards-for-integrity-and-
independence-accredited-continuing-education-pdf

ACCME Accreditation Criteria: https://www.accme.org/
accreditation-rules/accreditation-criteria

International Committee of Medical Journal Editors: 
Defining the Roles of Authors and Contributors: https://
www.icmje.org/recommendations/browse/roles-and-
responsibilities/defining-the-role-of-authors-and-
contributors.html

Association of American Medical Colleges: Diversity and 
Inclusion Toolkit: https://www.aamc.org/professional-
development/affinity-groups/cfas/diversity-inclusion-
toolkit/resources

Inclusive Language Playbook: Writing for LGBTQ+ 
Communities: https://communicatehealth.com/
wp-content/uploads/ch-lgbtq-playbook.pdf

Council of Science Editors: Inclusive Language 
Communication: https://www.councilscienceeditors.org/
inclusive-language-communication

Inclusive Imagery:
https://www.awesomefoundation.org/en/projects/114332-
disabled-and-here
https://tonl.co/
http://photoability.net/
https://genderspectrum.vice.com/

http://www.amwajournal.org
https://www.commonwealthfund.org/sites/default/files/documents/___media_files_publications_fund_report_2002_oct_cultural_competence_in_health_care__emerging_frameworks_and_practical_approaches_betancourt_culturalcompetence_576_pdf.pdf
https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources
https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources
https://www.awesomefoundation.org/en/projects/114332-disabled-and-here
http://photoability.net/
https://tonl.co/
https://genderspectrum.vice.com/
https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf
https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf
file:https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf
file:https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf
file:https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf
https://www.accme.org/accreditation-rules/accreditation-criteria
https://www.accme.org/accreditation-rules/accreditation-criteria
https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources
https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources
https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources
https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf
https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf
https://www.councilscienceeditors.org/inclusive-language-communication
https://www.councilscienceeditors.org/inclusive-language-communication
https://www.awesomefoundation.org/en/projects/114332-disabled-and-here
https://www.awesomefoundation.org/en/projects/114332-disabled-and-here
https://tonl.co/
http://photoability.net/
https://genderspectrum.vice.com/



