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 JOURNAL
CONTENTS
45 FROM YOUR AMWA PRESIDENT
Report from the Spring Board of Directors Meeting
Dominic De Bellis, PhD

FEATURES
47 Posting of Clinical Trial Results: Information for Medical Writers
MaryAnn Foote, PhD, and Philip David Noguchi, MD

50 Common Statistical Errors Even YOU Can Find!

Part 5: Errors in Reports of Diagnostic Tests
Tom Lang, MA

52 Oncology Basics
Part 1: What is Cancer?
MaryAnn Foote, PhD

59 How Writers Can Help Readers Understand Health

Screening Tests
Jessica Ancker, ELS, MPH

62 AMWA’s 65th Annual Conference

82 2005-2006 AMWA Slate of Officers

REGULAR FEATURES
71 Freelance Forum
74 Practical Matters
77 Reports from Other Meetings
84 Professional Development Resources
88 Student Center 2005
92 Chapter News
95 Dear Edie Volume 20
98 Melnick on Writing
99 Member Profile Number 2
100 Media Reviews
102 Calendar of Meetings
103 Instructions for Contributors

THE OFFICIAL JOURNAL OF THE AMERICAN MEDICAL WRITERS ASSOCIATION

 AMWA Journal
Mission Statement
Volume 20
Number 2
2005
The AMWA Journal expresses the interests, concerns, and
expertise of members. Its purpose is to inspire, motivate, Editor Lori Alexander, MTPW, ELS
inform, and educate them. The Journal furthers dialog Editor, in memoriam Ronald J. Sanchez
among all members and communicates the purpose,
Dear Edie Columnist
goals, advantages, and benefits of AMWA as a profession- Editorial Consultant Edie Schwager
al organization. Specifically, it functions to Chapter News Editor Julie Longlet
➲ Publish articles on issues, practices, research theo- Freelance Forum Panel Brian Bass
Sherri Bowen
ries, solutions to problems, ethics, and opportuni- Cathryn Evans
ties related to effective biomedical communication Donna Miceli
Phyllis Minick
➲ Enhance theoretical knowledge as well as applied Barbara Rinehart
skills of biomedical communicators in the health Media Reviews Editor Evelyn Kelly, PhD
sciences, government, and industry Melnick on Writing
Columnist Arnold Melnick, DO
➲ Address the membership’s professional develop-
Member Profiles Editor Bettijane Eisenpreis
ment needs by publishing the research results of
educators and trainers of communications skills Student Center Editor Heather Haley
and by disseminating information about relevant Peer Reviewers and
technologies and their applications Manuscript Editors S. Kim Berman, MS, ELS
James Cozzarin, ELS
Toniann Derion, PhD, ELS
➲ Inform members of important biomedical topics, MaryAnn Foote, PhD
ethical issues, emerging professional trends, and Thomas Gegeny, ELS
Norman Grossblatt, ELS(D)
career opportunities Julia Cay Jones, PhD
Karen Potvin Klein, MA, ELS
➲ Report news about AMWA activities and the Tom Lang, MA
professional accomplishments of its departments, Arkady Mak, MD
Denise Masoner
sections, chapters, and members Laszlo Novak
Mary Royer, MS, ELS
The AMWA Journal is published 4 times a year by Gayle Nicholas Scott, PharmD,
BCPS, ELS
the American Medical Writers Association (AMWA). Lynne Stockton
For details about submissions, see “Instructions for Elizabeth Smith
Contributors” on page 103. Bethany Thivierge, MPH, ELS
Michele Vivirito
Anne Marie Weber-Main, PhD
Subscription to the Journal is included with AMWA
membership. Nonmember subscriptions cost $75 per Proofreaders Anne Campbell
Mary Moore, BSc, MTPW
year. Individual archive copies can be purchased for $20 Melissa Stauffer, PhD
each, if available. For inquiries regarding subscriptions, Carol Williams
Administrator of
please contact AMWA headquarters. Publications Karen Potvin Klein, MA, ELS
Publications Committee Lois Baker
The opinions expressed by authors contributing to the S. Kim Berman, MS, ELS
Journal do not necessarily reflect the opinions of AMWA Dominic De Bellis, PhD
or the institutions with which the authors are affiliated. Toniann Derion, PhD, ELS
Douglas Haneline, PhD
The association accepts no responsibility for the opin- Anne Marie Weber-Main, PhD
ions expressed by contributors to the Journal. Flo Witte, MA, ELS
President, 2004-2005 Dominic De Bellis, PhD
The AMWA Journal is indexed in the MLA International
Executive Director Donna Munari, CAE
Bibliography and selectively indexed in the Cumulative
Index to Nursing and Allied Health Literature (CINAHL) Graphic Designer Amy Boches
print index, the CINAHL database, and the Cumulative
American Medical Writers Association
Index of Journals in Education (CIJE).
40 West Gude Drive, #101
Rockville, MD 20850-1192
Phone: (301) 294-5303; Fax: (301) 294-9006
The AMWA Journal is available as a PDF file [email protected]

in the Members Only area of Copyright 2005, American Medical Writers Association.
All rights reserved, worldwide. ISSN 1075-6361
www.amwa.org
 FROM YOUR AMWA PRESIDENT

Report from the Spring Board of Directors Meeting

By Dominic De Bellis, PhD, President

E
ach year, AMWA’s Board of Directors (BOD) meets in Association Executives (ASAE) and AMWA’s Long-Range
the early spring to discuss the progress of the year’s Planning Committee. AMWA’s election process is defined
initiatives set out during the BOD meeting at the in the Constitution and Bylaws (available in the Members
annual conference the preceding fall. As the winter chill Only section of the Web site) and is summarized in the
begins to fade away, the coming of the spring meeting is article announcing the slate of officers (page 82).
always an energizing time, as the group is well underway The BOD discussed the results of the 2005 AMWA
with its work and is looking toward the upcoming annual membership survey questions that pertained to the AMWA
conference. This year’s spring meeting was held in election process. The responses indicated that most survey
Alexandria, VA, on April 1–2, not far from the Headquarters participants found the process “very important” to “some-
office in Rockville, MD. what important” and “very satisfactory” to “somewhat satis-
The BOD consists of representatives from each chapter, factory.” The BOD agreed that the process is important and
referred to as Delegates to the Board, along with the satisfactory; therefore, no changes to the process were sug-
Executive Committee (EC) members, which includes the gested at this time. Importantly, the BOD offered excellent
officers. This year, 16 of the 19 chapters sent delegates to suggestions for methods to improve members’ awareness
the meeting, and in the future, we hope that all chapters of the elections process, such as publicizing the “pathways”
will be represented at these meetings. Donna Munari, articles in the December 2004 issue of the AMWA Journal.
AMWA’s Executive Director; Dane Russo, AMWA’s Education
Coordinator; Ronnie Streff, AMWA’s Member Services Web and Internet Technology
Coordinator; and Lori Alexander, the AMWA Journal Editor The Web and Internet Technology (WIT) committee has
were also present at the meeting. been researching potential enhancements to the AMWA
The BOD meeting is important because it provides an Web site. The BOD unanimously selected the addition of
opportunity for the chapter delegates to discuss matters licensed reference sources as its first choice for an enhance-
relating to their chapters, it enables them to become more ment and an electronic index of the AMWA Journal as its
acquainted with what the other chapters are doing, and it second choice. Further, in conjunction with Joan Nilson,
serves to familiarize the delegates with the various initia- the WIT committee will work to identify a list of books for
tives the EC and Headquarters staff are working on. medical communicators that can be added to the Web site.
Following are highlights from the spring BOD meeting. These books will be linked to Amazon.com so that when
members use these links to purchase books or any other
Budget and Finance products from Amazon.com, AMWA will receive a small
Cindy Hamilton, AMWA Treasurer, reported that AMWA’s referral fee.
new Endowment Fund now totals more than $10,000, with
many of the contributions coming from chapters. The Chapters and Membership
2005–2006 budget, prepared by Donna Munari, president- Melanie Fridl Ross, Administrator of Chapters and Member-
elect Susan Siefert, and Cindy Hamilton, was reviewed ship, reported on a variety of items under her purview and
and approved by the Board. Key items in the new budget presided over the chapter delegates’ meeting that was held
include increased revenues due to a growing membership as a separate session. Melanie reported that a newly created
base, increased expenses for improvements to the AMWA Chapter Revitalization Task Force, led by Christine Theisen,
Journal and Web site, new expenses for 2 self-study work- will formulate a plan to assist chapters that are trying to
shops, and new expenses for laptop computers to be used regroup or strengthen. A second newly formed task force,
at the annual conference to lower audiovisual costs. A sig- the Membership Recruitment Task Force, led by Anna Perez,
nificant savings was also realized by converting the mem- will work with the membership committee to continue to
bership directory to an online item. bolster recruitment.
The importance of membership benefits was discussed
AMWA Elections Task Force and the membership committee will continue to explore
The Elections Task Force was formed to assess the need, if possible new benefits, including research into the feasibility
any, to change AMWA’s elections process. The Task Force of endorsing health insurance options, among others.
evaluated recommendations from the American Society of Various “How-To” toolkits for chapters are being devel-

AMWA JOURNAL . VOL. 20, NO. 2, 2005 45

oped or expanded by willing delegates, including topics American Medical Colleges to support an annual confer-
such as Mentoring and Retaining Chapter Officers, Forming ence panel discussion. Furthermore, Cubist Pharmaceuti-
Chapter Satellites, How to Put on a Chapter Conference, cals, Inc., has become a new sponsor for this year’s 2
and Obtaining 501(c)3 Status. student scholarships. And, a grant to Abbott Laboratories
Chapters were encouraged to submit entries from their has been submitted for core curriculum support.
newsletters or Web sites for the Chapter Article Award, to
use the chapter e-mail list, and to circulate the Willingness- Education
to-Serve form at their meetings. They were also reminded Sue Hudson, Administrator of Education, reported the
that the online membership directory can be downloaded launch of the Professional Development Certificate (page
from the AMWA Web site as a PDF file. 84). As noted earlier, the education committee reviewed and
approved 4 new core and 3 new advanced curriculum work-
Publications shops that will be taught at the 2005 Annual Conference.
Karen Klein, Administrator of Publications, reported that In conjunction with Tom Gegeny, Sue and her committee
plans are underway to redesign the cover of the Journal. assisted in AMWA’s transition to electronic distribution of
Also, earlier this year, the online indexing service EBSCO precourse assignments, which has been pilot tested at 2
offered to list the AMWA Journal in its database, for which chapter conferences this spring and will be expanded for
AMWA would earn a small quarterly royalty fee based on the Pittsburgh Annual Conference. To help ensure the
usage. AMWA headquarters is working on a few remaining quality and consistency of AMWA’s curriculum courses, the
details and will provide an update at the July EC meeting. education committee has been assisting Dane Russo in
In conjunction with the education committee, an article obtaining current outlines for all curriculum courses. And,
was written about the new Professional Development the committee has begun work on the development of a
Certificate (page 84 ). Karen has also been working with science track of workshops in the core and advanced
members of the grant writing task force, led by Kevin Flynn, curricula. In addition, the Golden Apple award recipient
Administrator of Development, to prepare an application was selected from a group of qualified candidates.
to the Association of American Medical Colleges for support
of an educational panel discussion at the 2006 Annual Awards
Conference. One of the highlights of each spring BOD meeting is the
discussion and voting on the various award recipients.
Annual Conference and Workshops This year’s pool of well qualified individuals served to make
The annual conference committee, led by Tom Gegeny, has the tasks of each awards committee challenging, yet fulfill-
assembled almost 100 various lectures, open sessions, ing. Three AMWA Fellowships were awarded, as were 2
roundtables, posters, and other programs for AMWA’s 65th Honorary Fellowships. The BOD approved the Swanberg
Annual Conference in Pittsburgh; these are in addition to Award recipient and accepted the education committee’s
the workshops! Also, a new conference offering, the Coffee selection of the Golden Apple award recipient as well. You
and Dessert Klatches (Klatch means “an informal discus- can read more about some of these notable recipients on
sion”), will debut this year. Although similar in some ways page 70 and in subsequent issues of the AMWA Journal.
to the breakfast roundtables, this program will be more AMWA is truly proud of the achievements of these talented
discussion-oriented and cover a variety of topics such as and devoted medical communicators.
hobbies/pastimes, professional interests, etc. A variety of The BOD also approved the slate of elected officers
exciting tours are also being planned, so keep a look-out for brought forward by the nominating committee, led by pres-
the AMWA mini-mailings and the conference registration ident-elect Susan Siefert. Biographic details about the new
brochure for additional details. An overview of conference slate of officers begins on page 82.
happenings begins on page 62.
According to Michele Vivirito, this year’s annual confer- The meeting highlights discussed here cannot fully describe
ence workshop coordinator, 85 3-hour workshops will be the level of commitment and the amount of work that goes
offered in Pittsburgh. This year, 4 new core curriculum into keeping AMWA vibrant and competitive in our indus-
workshops will be offered, along with 3 new advanced try. The chapter delegates bring fresh perspectives and new
workshops (page 62). A variety of new noncredit courses are ideas to each meeting, and their year-round work imple-
being offered as well across topics such as basic immunolo- menting these ideas is a testament to what makes our
gy, Web design, and Office of the Inspector General (OIG) association strong.
compliance program guidance, among others. This year’s spring meeting was collegial, energetic, and
above all, indicative of everyone’s desire to see AMWA con-
Development tinue to grow as the many initiatives are brought to fruition.
Generating nondues revenue for AMWA is a continual chal- I wish to express my sincere thanks to all the delegates,
lenge that Kevin Flynn has taken an aggressive position on administrators, officers, and staff members who devote
this year. As mentioned, Kevin and his grant writing task countless hours to AMWA and made this meeting a success.
force have drafted an application to the Association of

46 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 POSTING OF CLINICAL TRIALS AND CLINICAL TRIAL RESULTS:
INFORMATION FOR MEDICAL WRITERS
By MaryAnn Foote, PhD, and Philip David Noguchi, MD
Amgen Inc, Thousand Oaks, CA, and Washington, DC

D
uring the past year, pharma- than among patients receiving naprox- product has been approved. Draft
8
ceutical companies have been en and was not a comparison of rofe- guidance, EudraCT, was issued about
under great scrutiny on the coxib and placebo. The controversy the kinds of data that would be consid-
related subjects of how clinical trials about the drug itself and about when ered useful for inclusion in the data-
are conducted and how the data from the sponsor knew of safety issues con- base.
these clinical trials are presented. In tinues to be discussed in the courts In October 2004, the Fair Access to
summer 2004, GlaxoSmithKline (GSK) and in the press. Clinical Trials Act (FACT Act) was intro-
was named in a lawsuit filed by the These 2 situations are only the duced in the US Senate, and a similar
state of New York.1 The suit alleged that most recent in years of controversy bill was introduced in the US House of
GSK had withheld the publication of about the dissemination of clinical trial Representatives.9 Although neither bill
crucial clinical data about the effects results.6,7 Because of the perceived was voted on in 2004, another bill,
on children of one of its drugs, Paxil problems in reporting data from clini- FACT Act 2005, was introduced in
(paroxetine). Paxil has not received US cal trials to the general public, patients February 2005.10 Section 113 of the
marketing approval for treating chil- and patient advocacy groups world- Food and Drug Administration (FDA)
dren, but US physicians can legally wide began to call for stricter rules to Modernization Act of 1997 (FDAMA
prescribe the drug for children, a prac- ensure transparency in the conduct of 113) requires the Secretary of Health
tice called “off-label use.” The lawsuit clinical trials and the dissemination of and Human Services (HHS) “to estab-
alleged that, as early as 1998, GSK’s their results. Governing bodies began lish, maintain and operate a data bank
clinical trials had yielded results sug- to mandate that drug sponsors release of information on clinical trials for
gesting that children and adolescents information about how patients could drugs for serious or life-threatening
with depression should not be treated enroll in clinical trials of new drugs for diseases and conditions.” The National
with this drug. GSK settled the lawsuit severe and life-threatening conditions Institutes of Health’s (NIH) National
by paying $2.5 million and agreeing to and that drug sponsors also publish Library of Medicine operates this reg-
establish a public, online database the results in a timely fashion, eg, with- istry (Registry). FDAMA 113 provides
containing summaries of results of all in a year after receiving marketing for an exemption from inclusion of a
of its clinical trials.2 approval for the product. Medical sponsor’s clinical trial information in
In September 2004, Merck & Co., writers who work for drug sponsors, the Registry if such disclosure would
Inc., voluntarily stopped the writing clinical trial reports or papers substantially interfere with the spon-
Adenomatous Polyp Prevention On based on clinical trial results, must be sor’s timely enrollment of subjects in
VIOXX (APPROVe) clinical trial for the aware of the new rules. the study. In those cases, a sponsor
treatment of adenomatous polyps and must certify to HHS (through the
removed its cyclo-oxygenase (COX)-2 ACTIONS TAKEN BY REGULATORY FDA) that the respective study meets
inhibitor, VIOXX® (rofecoxib), from the AGENCIES the criteria for this exemption. HHS
market because of possible links to an Legislation in Europe mandated the reserves the right to reject such certifi-
increased incidence of heart attacks establishment of a database, cation and to require inclusion of the
and strokes among patients taking the EuroPharm, that provides a range of clinical trial information in the
3
drug. A meta-analysis of the results of publicly available information on Registry.
the VIOXX Gastrointestinal Outcomes medicinal products with marketing
Research (VIGOR) trial,4 released in authorization in the European JOURNAL EDITORS AND INDUSTRY
2000, noted that VIOXX was associated Community (EC). The EC has also ASSOCIATIONS WEIGH IN ON
with a higher risk of cardiovascular discussed the issue of transparency THE TOPIC
5
events than was naproxen. Merck in reporting clinical trial data. The Regulatory agencies are not the only
argued that the meta-analysis of the EuroPharm database is accessible to groups involved in clinical trial posting
rofecoxib data suggested that the risk European regulatory authorities when and dissemination of results. Even
of cardiovascular events was higher a trial is initiated, and some data will before the controversies surrounding
among patients receiving that drug be made publicly accessible once a Paxil and VIOXX, in September 2001, 12

AMWA JOURNAL . VOL. 20, NO. 2, 2005 47

journals simultaneously published a have voiced support for clinical trial Table 1. Information that Must Be Supplied
paper by editors from the International registries, but it remains to be seen When Registering a Clinical Trial on
Committee of Medical Journal Editors whether these journals will mandate ClinicalTrials.gov, a Publicly Accessible
Web site
(ICMJE) calling on physicians and aca- registration as a prerequisite for
demic centers to be more involved in publication. It should be noted that a • Title and Background Information
the research required for gaining mar- plethora of databases are available, Organization’s unique protocol
keting approval for drugs.11 At issue including ClinicalTrials.gov, number
was the journal editors’ uneasiness ClinicalStudyResults.org, and compa- Other identification numbers
about the ability of drug sponsors to ny-specific Web sites. The possibility Brief title intended for lay public
satisfactorily collect and honestly of multiple databases to be populated Official title of protocol
• Investigational New Drug (IND)
report information about the efficacy and checked is an issue that drug
Information (This information is not made
and, particularly, the safety of their sponsors must consider. public and is needed only if the protocol
product candidates. The ICMJE policy states that all involves an IND.)
In response to Davidoff and trials that commence enrollment as • Human Subject Review
colleagues1 and to growing public of July 1, 2005, must be posted before Documentation of Institutional Review
unease, the Pharmaceutical patient recruitment starts; trials that Board/EC board approval
Board approval number
Researchers and Manufacturers of were started before this date can be
Name of board, affiliation, name of
America (PhRMA) issued guidelines registered retrospectively, but registra-
chair, oversight committee
for the conduct of clinical trials and tion must be completed before • Sponsor and Collaborators with Sponsor
12
the publication of results. In these September 15, 2005, if the researchers • Study Description
guidelines, PhRMA members commit- wish to publish their work in an Brief summary
ted to the timely publication or com- ICMJE journal. Detailed description
munication of clinical trial results but Recently, PhRMA issued a news • Status
Study phase
did not commit to publishing the release stating that PhRMA member
Study type
results of all trials unless they were companies will post their studies to Overall recruitment status
medically important. The guidelines ClinicalTrials.gov15 as of July 1, 2005.16 Study start date, last follow-up date,
allowed delays in publication for the Under this policy, member companies data entry closure date, and study
purpose of protecting intellectual will voluntarily post information completion date
property and allowed drug sponsors to about all new hypothesis-testing • Study Design
review all manuscripts before their clinical trials by this date and will
Study type
Purpose
submission to a journal. post ongoing hypothesis-testing trials
Participant selection
In September 2004, the ICMJE by September 13, 2005. PhRMA also Control intervention
announced that, beginning in July joined with 3 other international phar- Intervention assignments
2005, they will not consider publishing maceutical associations (the European Endpoints
the results of any clinical trial that has Federation of Pharmaceutical Indus- Outcome
not been registered in a publicly acces- tries and Associations, the Interna- Timing of protocol (retrospective,
prospective, or both)
sible database as of that date.13 The tional Federation of Pharmaceutical
• Interventions
editors of the British Medical Journal Manufacturers and Associations, and Type (eg, drug, vaccine, behavior,
(BMJ), a member journal of the ICMJE, the Japanese Pharmaceutical Manu- device)
issued their own statement concerning facturers Association) in agreeing on Name (eg, epoetin alfa, self-hypnotic
clinical trial registries.14 The primary voluntary principles for disclosing relaxation)
difference between the 2 statements is information about clinical trials.17 • Eligibility
the recognition of appropriate trial reg- Criteria
Gender
istries. Although neither statement INFORMATION REQUIRED FOR
Age limits (minimum age, maximum
endorses a given registry, the ICMJE POSTING TRIALS AND TRIAL age)
requires trials to be listed on the reg- RESULTS Target number of subjects
istry operated by the NIH in the US Drug sponsors who wish to publish • Protocol location
(www.clinicaltrials.gov); the BMJ papers based on the results of their Facility
cites this registry and also a registry clinical trials in journals that adhere Recruitment status
Facility contact information
(www.cursi.co.uk) operated by Current to ICMJE standards will be required
• Other information
Science Ltd, a British publishing group to register their trials. Very specific
References (citations of publications
that manages BioMed Central, which information is required to register a related to the protocol)
provides immediate free access to trial (Table 1), and the trial is given a Link (to actual protocol or to citations)
peer-reviewed research. Other journals unique identifying number.

48 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 In the US, ClinicalTrials.gov is the competitors. Because all drug sponsors 5. Juni P, Nartey L, Reichenbach S, Sterchi
R, Dieppe PA, Egger M. Risk of cardio-
preferred Web site for posting clinical will be required to post clinical trial
vascular events and rofecoxib: cumula-
trials. This Web site, operated by the protocols and their results within a tive meta-analysis. Lancet. 2004;364:
NIH, was originally established to noti- narrow timeframe, companies that 2021-2029.
fy US citizens about trials funded by understand their data quickly and can 6. Foote M. Guidelines and policies for
medical writers in the biotech industry.
US Federal agencies. The Web site also capitalize on that knowledge to move An update on the controversy.
includes postings of trials submitted by their products forward will succeed in Biotechnol Annu Rev. 2004;10:259-264.
drug sponsors worldwide, particularly receiving marketing approval. Often, 7. Foote M. Review of current authorship
guidelines and the controversy regard-
clinical trial protocols submitted under drug sponsors spend millions of dollars ing publication of clinical trial data.
an Investigational New Drug over many years refining their clinical Biotechnol Annu Rev. 2003;9:303-313.
Application (IND). hypothesis for a product. With clinical 8. European Commission. Enterprise and
Industry Directorate-General. Guideline
Trial data may be entered into the hypotheses, endpoints, and statistical on the data fields from the European
ClinicalTrials.gov Web site by sponsors power made public, astute competitors clinical trials database (EudraCT) that
(ie, companies who hold IND applica- can easily determine how to design a may be included in the European data
base on Medicinal Products. Available
tions from the US FDA), by government better clinical trial with a competing at: http://pharmacos.eudra.org/F2/
or international agencies, or by princi- drug candidate and conceivably obtain pharmacos/docs/Doc2005/03_05/Draft_
pal investigators who are responsible marketing approval first. It is possible guid_EudraCT_data_20050303.pdf.
Accessed March 17, 2005.
for the overall clinical investigation. that the new guidelines will make clini- 9. Fair Access to Clinical Trials Act of 2004;
Those who wish to post trials must cal research more efficient. House of Representatives, HR 5252,
register, and registered data providers Consistent posting of clinical trials 108th Congress, 2nd Session. Available
at: http://olpa.od.nih.gov/tracking/
must update the information in a time- open for the enrollment of qualified
house%5Fbills/session2/default.asp.
ly manner. The information is usually patients should allow more patients to Accessed March 13, 2005.
provided to ClinicalTrials.gov as an gain access to trials for severe and life- 10. Fair Access to Clinical Trials Act of 2005,
US Senate S470. Available at:
HTTP upload of an XML-formatted file. threatening diseases. Consistent post-
http://olpa.od.nih.gov/tracking/109/
ClinicalTrials.gov does not charge a fee ing of clinical trial results, as published senate_bills/session1/s-470.asp.
for posting trials or for searching files; papers or summaries, will provide Accessed March 21, 2005.
11. Davidoff F, DeAngelis CD, Drazen JM,
therefore, the mandate of allowing patients, their families, and their care-
et al. Sponsorship, authorship, and
potential study subjects access to new givers with access to clinical trial results accountability. N Engl J Med. 2001;345:
medicines is ensured. Many drug spon- so that they can learn about the disease 825-826.
12. Pharmaceutical Research and Manu-
sors also have their own company-spe- and the treatment options. The result
facturers Association. PhRMA adopts
cific Web sites for posting clinical trials. of these actions can only improve the principles for conduct of clinical trials
When the clinical trial is completed discovery and delivery of new and and communication of clinical trial
results. Available at: http://www.phrma.
or if the trial is stopped for any reason, innovative therapies. AMWA is aware of
org/mediaroom/press/releases/20.06.
the results of the trial must be posted the implications of FDAMA 113 and 2002.427.cfm. Accessed May 28, 2003).
in a timely manner. Study subjects and other rules and regulations. The 2005 13. De Angelis C, Drazen JM, Frizelle FA,
researchers in general will be able to Annual Conference in Pittsburgh will et al. Clinical trial registration: a
statement from the International
look up a clinical trial and find a hyper- offer a session on this topic. Committee of Medical Journal Editors.
link to a journal article based on the Lancet. 2004;364:911-912.
results of the trial, a meeting abstract References 14. Abbasi K. Compulsory registration of
1. Office of the New York State Attorney clinical trials. BMJ. 2004;329:637-638.
of the results of the trial, or a summary 15. ClinicalTrials.gov. Protocol registration
General Eliot Spitzer. Major pharmaceu-
of the trial results. If no publication is tical firm concealed information. system. Available at: http://prsinfo.
available, the summary will take the Available at: http://www.oag.state.ny.us/ clinicaltrials.gov. Accessed March 17, 2005.
press/2004/jun/jun2b_04.html. 16. Pharmaceutical Research and Manufac-
form of the synopsis of a clinical study turers Association. Pharmaceutical
Accessed March 17, 2005.
report as suggested by the Common 2. GlaxoSmithKline Clinical Trial register. companies to make more information
Technical Document format. Because Available at: http://ctr.gsk.co.uk/ available about clinical trials. Available
welcome.asp. Accessed March 23, 2005. at: http://www.phrma.org/mediaroom/
each trial will have a unique identifier, press/releases/06.01.2005.1112.cfm.
3. Merck & Co. Merck announces voluntary
each publication based on that trial worldwide withdrawal of VIOXX .
® Accessed March 13, 2005.
will carry the same unique identifier. Available at: http://www.vioxx.com/ 17. Pharmaceutical Research and Manufac-
rofecoxib/vioxx/consumer/index.jsp. turers Association. International alliance
Accessed March 17, 2005. of pharmaceutical associations agrees
DISCUSSION AND CONCLUSIONS 4. Bombardier C, Laine L, Reicin A, et al. on principles for disclosing information.
Posting clinical trial protocols and clin- Comparison of upper gastrointestinal Available at: http://www.phrma.org/
toxicity of rofecoxib and naproxen in mediaroom/press/releases/06.01.2005.
ical trial results will make the process
patients with rheumatoid arthritis. 1114.cfm. Accessed March 13, 2005.
of drug development more transparent VIGOR Study Group. N Engl J Med. 2000;
to the public and to drug sponsors’ 343:1520-1528.

AMWA JOURNAL . VOL. 20, NO. 2, 2005 49

 COMMON STATISTICAL ERRORS EVEN YOU CAN FIND!*
PART 5: ERRORS IN REPORTS OF DIAGNOSTIC TESTS
By Tom Lang, MA
Tom Lang Medical Communications, Davis, California

T
his article is the fifth in a series in tions of “normal” are commonly used includes 2 standard deviations
1
which I describe several of the in medicine: above and below the mean; that is,
more common statistical errors A diagnostic definition of normal the range that includes the central
in the biomedical literature. The first is based on the range of measure- 95% of all the measurements.
article focused on 10 errors in descrip- ments over which the disease is However, the highest 2.5% and the
tive statistics and in interpreting prob- absent and beyond which it is likely lowest 2.5% of the scores—the
ability, or P values (AMWA J. 2003;18: to be present. Such a definition is “abnormal” scores—have no bio-
67-71); the second article described 9 desirable because it is clinically logic meaning; they are simply
errors in interpreting differences useful. A hematocrit level below uncommon in a disease-free popu-
between groups (AMWA J. 2003;18: 30% is one diagnostic definition of lation. In addition, many biologic
103-106); the third article addressed 5 anemia; a level above 50% is one test results are not normally dis-
errors in presenting statistical informa- diagnostic definition of poly- tributed, which can make extreme
tion in figures and tables (AMWA J. cythemia. scores more difficult to interpret.
2004;19:9-11); and the fourth article A therapeutic definition of normal A percentile definition of normal
focused on 3 errors in correlation and is based on the range of measure- expresses the normal range as the
regression (AMWA J. 2005;20:10-11). ments over which a therapy is not lower (or upper) percentage of the
Here, I describe 4 errors in reporting indicated and beyond which it is total range. For example, any value
the results of diagnostic tests. beneficial. Again, this definition is in the lower, say, 95% of all obser-
Diagnostic test characteristics— clinically useful. Only children of a vations may be defined as “nor-
sensitivity, specificity, predictive val- height below an established thresh- mal,” and only the upper 5% may
ues, likelihood ratios, and so on—are old might be given human growth be defined as “abnormal.” Again,
often misunderstood and are therefore hormone to prevent dwarfism, for this definition is based only on the
sometimes reported and interpreted instance. frequency of values and may have
incorrectly. In this article, I describe no clinical meaning.
the most common characteristics and Other definitions of normal are less A social definition of normal is
how to report them. useful, although they are common: based on popular beliefs about
A risk factor definition of normal what is “typical.” Desirable weight
ERROR #28. Not defining the meaning includes the range of measurements or the ability of a child to walk by a
or implications of “normal” and over which the risk of disease is certain age, for example, often have
“abnormal” test results decreased and beyond which the social definitions of “normal” that
A primary purpose of diagnostic test- risk is increased. This definition may or may not be medically
ing is to distinguish between “normal” assumes that altering the risk factor meaningful.
or healthy people and those who have alters the actual risk of disease. For
a disease. However, the meaning and example, with rare exceptions, high ERROR #29. Not reporting how uncer-
implications of “normal” and “abnor- serum cholesterol is not itself dan- tain test results were included when
mal” test results can vary and so they gerous; only the associated calculating the test’s characteristics
need to be defined. In fact, 6 defini- increased risk of heart disease Not all diagnostic tests give clear posi-
makes a high level “abnormal.” tive or negative results. Perhaps not all
*This series is based on 10 articles first trans- A statistical definition of normal of the barium dye was taken; perhaps
lated and published in Japanese by Yamada is based on measurements taken the bronchoscopy neither ruled out
Medical Information, Inc. (YMI, Inc.), of from a disease-free population. nor confirmed the diagnosis; perhaps
Tokyo, Japan. Copyright for the Japanese This definition usually assumes observers could not agree on the inter-
articles is held by YMI, Inc. The AMWA
that the test results are “normally pretation of clinical signs. Reporting
Journal gratefully acknowledges the role of
distributed,” that they form a “bell- the number and proportion of non-
YMI in making these articles available to
English-speaking audiences. shaped” curve. The “normal range” positive and non-negative results is
is the range of measurements that important because such results affect

50 AMWA JOURNAL . VOL. 20, NO. 2, 2005

the clinical usefulness of the test. Surprisingly, uncertain results are given period of time. In epidemiologic
Uncertain test results may be clas- almost always simply discarded. They studies, incidence may be expressed
sified according to 3 types2: are rarely reported, and there is no either as a proportion or as a rate.
3

Intermediate results are those that standard way to incorporate them into Incidence expressed as a proportion is
fall between a negative result and a the calculations of a test’s characteristics. called cumulative incidence, which is
positive result. In a tissue test based calculated as:
on the presence of cells that stain Error #30. Confusing sensitivity; Number of new cases of disease occurring
blue, “bluish” cells that are neither specificity; true-positive, false-posi- in a population during a specified period
x 1,000
unstained nor the required shade tive, true-negative, and false-negative Number of persons in the population
at risk for the development of the
of blue might be considered inter- results; and positive and negative disease during that period
mediate results. predictive values For example: The incidence of the disease
Indeterminate results are results Sensitivity, specificity, and positive and was 6002/125,767, or 0.048 per 1,000 people.
that indicate neither a positive nor negative predictive values are often
a negative finding. For example, misunderstood. The essential differ- Incidence density is expressed as
responses on a psychologic test ence is that sensitivity and specificity a rate and uses the concept of “person-
may not determine whether the indicate how well the test detects dis- years,” or the number of people fol-
respondent is or is not alcohol ease when the patient’s disease status is lowed times the number of years that
dependent. known. In contrast, predictive values each was followed. Incidence density
Uninterpretable results are pro- indicate the likelihood that a particular is calculated as:
duced when a test is not conducted patient will have a disease if the test Number of new cases in a population
according to specified performance result is positive (the positive predictive x 1,000
Disease-free person-years at risk
standards. Glucose levels from value) or will not have the disease if the
patients who did not fast overnight test result is negative (the negative pre- For example: Among 3 patients, one followed
up for 3 years, one for 5 years, and one for 6
may be uninterpretable, for example. dictive value). Predictive values also
years, 1 patient had a relapse. The incidence
assume that the prevalence of disease
of relapse is 0.07 (1 case of relapse/14 person-
How such results were counted is known (see later). years).
when calculating sensitivity and speci- Few tests are perfectly sensitive or
ficity should be reported. Counting the perfectly specific; most will give false- The key to understanding inci-
results as positive or negative or not positive results, false-negative results, dence is to remember that it is the
counting them at all, which often or both. Perhaps a more convenient number of new cases in a population
occurs, will cause test characteristics way to remember the true and false, that occur during a specified period.
to vary. The standard 2 x 2 table for positive and negative combinations is Any person in the denominator must
computing diagnostic sensitivity and as follows: have the potential to become part of
specificity does not include rows and True-positive results (sensitivity) the numerator.
columns for uncertain results (Figure indicate confirmed patients who Prevalence is the number of all the
1). Even a highly sensitive or specific now know that they have a disease people with a disease (not just new
test may be of little value if the results and can thus be treated appropri- cases) during a period of time divided
are uncertain much of the time. ately. by the total number of people at risk
True-negative results (specificity) for the disease during the same time:
Test Disease Disease Total indicate relieved people who now Prevalence =
Result Present Absent know they do not have a disease. Number of people in the population who
have the disease during a specified period
False-positive results indicate x 1,000
Positive a b a+b Number of people in the population
stigmatized people who will now be at risk for development of the disease or
who have the disease during that period
Negative c d c+d treated as having a disease but who
are actually healthy. References
Total a+c b+d a+b+c+d False-negative results indicate 1. Haynes RB. How to read clinical jour
Sensitivity = a/a+c “stealth” patients who actually have nals: II. To learn about a diagnostic test.
Specificity = d/b+d a disease but who are not believed Can Med Assoc J. 1981;124:703-10.
If the table reflects the prevalence of disease: to have the disease. 2. Simel DL, Feussner JR, Delong ER, Matchar
Positive predictive value = a/(a+b) DB. Intermediate, indeterminate, and
Negative predictive value = d/(c+d) uninterpretable diagnostic test results.
ERROR #31. Confusing incidence and
Med Decis Making. 1987;7:107-14.
Figure 1. Standard table for computing diag- prevalence
nostic test characteristics. The table does not 3. Gerstman BB. Epidemiology Kept Simple:
consider uncertain results, which often—and Incidence is the probability of a new An Introduction to Classic and Modern
inappropriately—are ignored. event occurring in a population over a Epidemiology. New York: Wiley-Liss, 1998.

AMWA JOURNAL . VOL. 20, NO. 2, 2005 51

 ONCOLOGY BASICS
PART 1. WHAT IS CANCER?
By MaryAnn Foote, PhD
Director, Global Regulatory Writing, Amgen Inc., Thousand Oaks, California

ABSTRACT To enhance learning, a glossary is often removed.

Cancer is the uncontrolled growth of included to to clarify words that are Malignant cancers are capable of
malignant cells, which if left unchecked, underlined in the text. Some readers spreading through the body by 2
can destroy organs or their functions. may benefit from a review of both cell mechanisms: invasion and metastasis.
Oncology, the study of cancer and its biology and human genetics in 2 arti- Invasion is the direct migration and
treatment, is very complex, as more cles published earlier in the AMWA penetration by cancer cells into neigh-
than 200 distinct forms of cancer have Journal.2,3 boring tissues. Metastasis refers to the
been identified and hundreds of This article is designed to guide ability of cancer cells to penetrate into
chemotherapeutic agents are approved biomedical communicators and should lymphatic and blood vessels, circulate
for the treatment of cancer. This article not be construed to provide any med- through the bloodstream, and invade
provides a review of the basic informa- ical advice or diagnostic information. normal tissues elsewhere in the body.
tion needed by a biomedical commu- Almost all cells in the body are sus-
nicator regarding cancer, its cause, its WHAT IS CANCER? ceptible to cancer, and more than 200
relationship to genetics, its diagnosis, The word “cancer” is derived from the distinct varieties of cancers have been
and its treatment. A glossary of terms Latin word for “crab.” Because many described. Most varieties of cancer are
is provided for reference. tumors, or clusters of cancer cells, are rare, and deaths due to cancer are
capable of wildly uncontrolled cell mainly attributable to only a few com-

T
he National Cancer Institute division, malignant tumors often are mon ones such as lung, breast, colon,
4
(NCI) estimated that 1,334,100 thought to have the silhouette of a skin, and blood cancers. Cancers are
people living in the US were crab, with many appendages radiating classified according to the type of tis-
diagnosed with some form of cancer from a central body. (Normally, cells sue and type of cell in which they
in 2003 and that 556,500 deaths were form orderly layers or sheets of tissue.) originate. For example, if the disease
attributed to cancer that year.1 The Other names for a tumor are lesion, is believed to have originated in the
popular media are replete with reports malignancy, mass, or neoplasm. tissues of the breast, the diagnosis
of cancer prevention through diet, Cancer cells are able to divide more may be breast cancer. The cancer may
lifestyle modification, or early detec- rapidly than normal cells and can dis- spread to other organs such as the
tion. Cancer remains a frightening place normal neighboring cells. lung, and the diagnosis would be
and mysterious disease that appears Intrinsic changes in cancer cell com- primary breast cancer with lung
to strike indiscriminately. position allow them to multiply with- metastases.
As biomedical communicators, we out the usual restraints placed on cells All cancers can be placed into 1 of
must understand the facts and avoid (ie, most cells must “obey” territorial 6 broad categories: carcinoma, sarco-
being swayed by sensationalism or limits placed on them by their neigh- ma, leukemia, lymphoma, melanoma,
rumors. Thus, it is important for bio- boring cells, but cancer cells do not); and glioma. The different types of can-
medical communicators to understand cancer cells appear to divide more cers are defined by the organ of the
the complex subject of oncology. In rapidly than normal cells and fewer body in which the cancer started.
this article, I attempt to provide basic daughter cells undergo apoptosis. Carcinomas originate in epithelial
information about cancer—what it is, When cells divide rapidly but keep tissues, such as the liver, lungs, glands
how it is diagnosed, how it spreads, within their normal territory and do (eg, prostate or thyroid), bladder,
and how it can be treated. The article is not invade the surrounding tissues, the kidney, breast, ovary, uterus, testes,
not meant to be definitive and com- cell cluster is referred to as a benign colon, skin, and brain. Approximately
plete, but it should provide a base for tumor. Usually, benign tumors pose no 80% of all cancer cases are carcinomas.
the reader to undertake further study threat, but if they are contained in an Sarcomas originate in bone, muscle,
on the topic. This article is the first in enclosed space, such as the cranial cartilage, fat, and fibrous tissue.
a 2-part series about oncology; the cavity, they can continue to increase Sarcomas are rare, representing
second article will highlight targeted in size and put pressure on an organ. approximately 1% of all cancers.
therapies and molecular oncology. For this reason, benign tumors are Leukemias originate in the bone

52 AMWA JOURNAL . VOL. 20, NO. 2, 2005

marrow; myeloma is a subset of DIAGNOSIS OF CANCER have a more normal appearance.
leukemia and is a cancer of plasma Cancers are diagnosed a variety of Based on these differences in micro-
cells. When cancers affect the blood or ways, again depending on the primary scopic appearance, oncologists assign
blood-forming organs, they are called source of the cancer. The biopsy, which a numerical grade to most cancers. In
myeloid; when the cancer involves involves surgically obtaining a small this grading system, a low number
other tissues that do not directly affect tissue sample and examining it under grade (grade I or II) refers to cancers
the formation of blood cells, it is a microscope, is often used to help with fewer cell abnormalities than
referred to as nonmyeloid. Lymphomas identify the primary cancer. A biopsy those with higher numbers (grade III
originate in the lymphatic system, ie, can be done on all tissues including or IV).
the lymph nodes. Melanomas are can- the bone marrow. When examined Disease progression is determined
cers that originate in skin cells called microscopically, cancer tissue has a by the size of the tumor and its inva-
melanocytes (although melanomas can distinctive appearance, including a sion into surrounding tissues, and
be found in organs other than skin), large number of dividing cells, varia- metastases to regional lymph nodes or
and gliomas are cancers of the nervous tion in the size and shape of cells and other regions of the body. Based on
tissue, ie, the brain and spinal cord. nuclei, loss of specialized cell features these criteria, the cancer is assigned a
Most organs of the body are com- and normal tissue organization, and stage. A patient’s chances for survival
posed of several types of tissue, which poorly defined tumor boundary. are better when cancer is detected at
means that each organ can be the site Microscopic examination of a a lower stage number.
of different types of cancers. For exam- biopsy specimen will sometimes detect Another diagnostic tool is the
ple, most cases of uterine cancer are a condition called hyperplasia. The cell endoscope, which can be used to
carcinomas and are found in the structure and orderly arrangement of examine major organs and the entire
endometrium of the uterus. Some uter- cells within the tissue remain normal, digestive system. Endoscopy is rou-
ine cancers, however, are found in the and the process of hyperplasia is tinely used to screen for the presence
muscle of the uterus, classifying them potentially reversible. Microscopic of colon cancer. Radiographs (ie,
as sarcomas. examination of a biopsy specimen can x-rays), ultrasonography, computed
detect another type of noncancerous axial tomography (CAT; often called
SYMPTOMS OF CANCER condition called dysplasia, an abnor- computed tomography or CT) scan,
Symptoms of cancer can be silent, par- mal type of excessive cell proliferation positron emission tomography (PET)
ticularly in the early stages of develop- characterized by loss of normal tissue scan, and magnetic resonance imaging
ment. Some symptoms are specific to arrangement and cell structure. Often (MRI) are other ways that tumors can
certain types of cancer, such as diffi- such cells revert to normal behavior, be detected. Additionally, blood tests
cult urination for prostate cancer or but occasionally they gradually may help to diagnose cancers. Some
flu-like symptoms and easy bruising become malignant. Because of their tumors have tumor markers that
for acute leukemias. Sudden weight potential for becoming malignant, include genetic markers, cellular and
loss, a thickening or lump, unexplained areas of dysplasia should be closely tissue markers, and circulating markers
bleeding, coughing, or a wound that monitored and sometimes require that can be detected in the blood
will not heal are some of the many treatment. The most severe cases of (Table 2). A blood test for prostate
symptoms that may be related to can- dysplasia are sometimes referred to as cancer measures the amount of
cer (Table 1). Often, symptoms are carcinoma in situ (“cancer in place”), prostate-specific antigen (PSA), a
nonspecific; that is, common to many which refers to an uncontrolled growth tumor marker.5,6 Higher-than-normal
other conditions. of cells that remains in the original concentrations of PSA may indicate
location. Carcinoma in situ may cancer. Recently, a blood test for
Table 1. Signs and Symptoms that May develop into an invasive, metastatic ovarian cancer, known as CA-125,
Indicate Cancer 4 7
malignancy and, therefore, is usually has become available. It should be
removed surgically, if possible. stressed that blood tests by themselves,
• Change in bowel or bladder habits Microscopic examination also pro- however, are inconclusive because
• Sore that will not heal vides information regarding the likely more than 300 markers have been
• Unusual bleeding or discharge behavior of a tumor and its responsive- identified but their relationships to
• Thickening or lump in the breast or ness to treatment. Cancers with highly cancer are not fully elucidated.
other part of the body abnormal cell appearance and large Presence of a tumor marker is not
• Indigestion or difficulty in swallowing numbers of dividing cells tend to grow conclusive proof that a tumor exists.
• Obvious change in a wart or a mole more quickly, spread to other organs
• Persistent cough or hoarseness more frequently, and be less responsive
to therapy than cancers whose cells

AMWA JOURNAL . VOL. 20, NO. 2, 2005 53

Table 2. Some Circulating Markers8 drinkers, the risk of cancer of the
esophagus is approximately 6 times
Marker Abbreviation Tumor Types greater than that for nonsmokers/non-
drinkers.4 For people who both smoke
Alpha-fetoprotein AFP Germ cell; hepatocellular
and drink, the risk of cancer is 40 times
Carcinoembryonic antigen CEA Gastrointestinal, colorectal, greater than that for nonsmokers/non-
breast drinkers. Alcohol cannot cause cancer
Human chorionic hCG Gestational trophoblastic; germ but can convert damaged cells into
gonadotropin cell; urothelial; gastrointestinal malignant cells. (This discussion is
Lactate dehydrogenase LDH Germ cell continued in the section, Genes and
Cancer: Is Cancer Hereditary?)
CA 125 — Ovarian Studies suggest that differences in
CA19.9 — Pancreatic; gastrointestinal; diet may play a role in determining
ovarian cancer risk. In contrast to the clear-cut
identification of tobacco, sunlight, and
RISK FACTORS FOR CANCER The use of tobacco products has alcohol, the exact identity of the
The biggest risk for the development been implicated in nearly 30% of dietary components that influence
of cancer is aging. The longer a person cancer-related deaths, making it the cancer risk has been difficult to deter-
lives, the more likely it is that some largest single cause of death from can- mine. Limiting fat consumption and
4
form of cancer will develop. Some cer. Cigarette smoking is responsible calorie intake appears to be one possi-
types of cancer are preventable (eg, for nearly all cases of lung cancer, and ble strategy to decrease the risk of
lung cancer from tobacco), while oth- smoking has been implicated in cancer some cancers because people who
ers types of cancer are caused by envi- of the mouth, larynx, esophagus, stom- consume large amounts of meat (rich
ronmental factors (eg, lung cancer in ach, pancreas, kidney, and bladder. in fat) and large numbers of calories
heavy smokers who use beta carotene Tobacco is the main environmental have an increased risk for cancer,
supplements) or by genetic factors (eg, risk factor for lung cancer, and it has especially for colon cancer.
MYC marker in lung cancer). Because been estimated that each cigarette
cancer usually requires a number of smoked shortens the smoker’s life by CAUSES OF CANCER
10
genetic mutations, the chances of 14 minutes. Cancer is a multifaceted disease, some-
developing cancer increases as a per- Skin cancer caused by exposure times the result of the unlucky conver-
son gets older because more time has to sunlight is the most frequently gence of genetics and environment.
4
been available for mutations to accu- observed type of human cancer. The etiology of cancer is different from
mulate. (This discussion is continued Because skin cancer is often easy to the risk of cancer. Avoidance of the
in the section, Genes and Cancer: Is cure, the danger posed by sunlight is causes (etiology) of cancer may greatly
Cancer Hereditary?) perhaps not taken seriously enough. reduce a person’s risk of cancer. For
In addition to chemicals and radia- Mortality may be low, but morbidity example, smoking is a cause of cancer;
tion, bacteria and a few viruses can can be high if the lesions must be not smoking reduces one’s risk of
trigger the development of cancer. The excised from a cosmetically sensitive cancer, even if he or she has a genetic
11
bacterium Helicobacter pylori, which area (ie, the face). Chronic exposure defect that is a predisposition to can-
can cause stomach ulcers, has been to radiation in sunlight and fair skin cer. Table 3 lists some causes of cancer.
associated with an increased risk for that is susceptible to sunburns appear
9
the development of gastric cancer. In to be the most important risk factors, GENES AND CANCER: IS CANCER
the case of cancer viruses, some of the with increasing frequency of exposure, HEREDITARY?
viral genetic information is inserted age, immune status, male gender, and All cancers are caused by a defect in a
into the chromosomes of the infected DNA repair disorders (such as xeroder- gene that allows the cell to proliferate
cell, causing the cell to become malig- ma pigmentosum) as other risk wildly. The genetic effect occurs
nant. Very strong evidence suggests factors.11 through small mutations in the DNA,
that the human papilloma viruses Drinking excessive amounts of little “hits” over many years.12 (Dr.
(HPV) are associated with most types alcohol is linked to an increased risk Alfred Knudson developed the “2-hit”
of cervical cancer (squamous and ade- for several kinds of cancer, especially theory of cancer; he was the McGovern
nocarcinomas), and results of several those of the mouth, throat, and esoph- Award recipient at the 1999 AMWA
4
large studies suggest that HPV infec- agus. The combination of alcohol and meeting in Philadelphia.) Not all can-
tion precedes the development of tobacco appears to be especially dan- cers are hereditary—actually only 5%
10
cervical cancer by 10 to 15 years. gerous: in heavy smokers or heavy of cancers are due to genetic inheri-

54 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 13
tance. People born with the defective normal cells can cause the cells to functional. If the second copy under-
gene must still be subjected to pro- become malignant by instructing cells goes mutation, cancer may then devel-
longed or repeated exposure to a to make proteins that stimulate exces- op because there no longer is any
carcinogen. sive cell growth and division. By pro- functional copy of the gene.
Chemicals (eg, from smoking), ducing abnormal versions or quantities A third class of genes implicated
radiation, viruses, and heredity all con- of cellular growth-control proteins, in cancer are called mismatch repair
tribute to the development of cancer oncogenes cause a cell's growth-sig- genes.14 Mismatch repair genes code
by triggering changes in a cell's genes. naling pathway to become hyperactive. for proteins whose normal function is
The chemicals that trigger changes are A cancer cell may contain 1 or more to correct errors that arise when cells
called initiators. Chemicals and radia- oncogenes, which means that 1 or duplicate their DNA before cell divi-
tion act by damaging genes, viruses more components in this pathway will sion. Mutations in mismatch repair
introduce their own genes into cells, be abnormal. Oncogenes are related to genes can lead to a failure in DNA
and heredity passes on alterations in proto-oncogenes, a family of normal repair, which in turn allows subse-
genes that make a person more sus- genes that code primarily for proteins quent mutations in tumor suppressor
ceptible to cancer. Genes are altered, involved in a cell’s normal growth. genes and proto-oncogenes to accu-
or “mutated,” in various ways as part of A second class of genes implicated mulate. People with a condition called
the mechanism by which cancer arises. in cancer are tumor suppressor genes. xeroderma pigmentosum have an
Several groups of genes have a role in Tumor suppressor genes are normal inherited defect in a mismatch repair
carcinogenesis. genes whose absence can lead to can- gene. As a result, the DNA damage that
The first group of genes implicated cer. Tumor suppressor genes instruct normally occurs when skin cells are
in the development of cancer are dam- cells to produce proteins that restrain exposed to sunlight cannot be effec-
aged genes, called oncogenes. Onco- cell growth and division. Because tively repaired, and so the incidence
genes are genes whose presence in tumor suppressor genes code for pro- of skin cancer is abnormally high for
certain forms and/or overactivity can teins that slow down cell growth and people with this condition. Certain
stimulate the development of cancer. division, the loss of such proteins forms of hereditary colon cancer also
Cell growth and division is normally allows a cell to grow and divide in an involve defects in DNA repair.
controlled by proteins called growth uncontrolled fashion. One particular Cancer often arises because of the
factors, which bind to receptors on the tumor suppressor gene codes for a accumulation of mutations involving
cell surface. This binding activates a protein called p53 that can trigger oncogenes, tumor suppressor genes,
series of enzymes inside the cell, which apoptosis. In cells that have undergone and mismatch repair genes. Colon can-
in turn activate special proteins called DNA damage, the p53 protein halts cell cer can begin with a defect in a tumor
transcription factors inside the cell's growth and division. If the damage suppressor gene that allows excessive
nucleus. The activated transcription cannot be repaired, the p53 protein cell proliferation. The proliferating
factors turn on genes required for cell eventually initiates cell suicide, thereby cells acquire subsequent mutations
growth and proliferation. Oncogenes in preventing the genetically damaged involving a mismatch repair gene, an
cell from growing out of oncogene, and several other tumor
Table 3. Causes of Cancer12 control. If a pair of tumor suppressor genes. The accumulated
Percentage of suppressor genes are damage yields a highly malignant,
Cancer-related either lost from a cell or metastatic tumor.
Cause Deaths
inactivated by mutation, Another type of gene involved in
Tobacco 30 their functional absence the development of cancer is the
Unhealthy diet and obesity 30 can cause cancer. telomerase gene. The ends of chromo-
Lack of exercise 5 Individuals who inherit somes are called telomeres, pieces of
Genetic inheritance 5 an increased risk for the DNA that allow the chromosome to
Viruses and bacteria 5
development of cancer survive functionally intact after a life-
Occupational carcinogens 5
Excessive alcohol consumption 3 often are born with one time of cell divisions.14 When cells
Reproductive history 3 defective copy of a tumor divide, little bits of DNA are lost from
Environmental pollution 2 suppressor gene. Because each telomere, and eventually cells are
Solar radiation and radon 2 genes come in pairs (one unable to divide. Errant telomere genes
Food additives and contaminants 1 inherited from each par- repair the ongoing damage from cell
Medical treatment (radiation, chemo- 1 ent), an inherited defect division and allow the cell to divide
therapy, immunosuppressants,
in one copy will not indefinitely.
hormone therapy)
cause cancer because the Whatever gene is involved, the
Other factors 8
other normal copy is still result is cancer, fed by relentless cell

AMWA JOURNAL . VOL. 20, NO. 2, 2005 55

division that has escaped the normal Table 4. Surgical Techniques Used to Treat Cancer4
constraints. The mass of cells eventual-
ly invades other tissues and organs and Cryosurgery Liquid nitrogen is used to freeze and kill abnormal cells. Usually
used to treat precancerous conditions, such as cervical dysplasia
disrupts their function. or hyperplasia.

TREATMENT FOR CANCER Electrosurgery High-frequency electric current is used to kill cells. Usually used
to treat cancers of the skin and mouth.
The primary and oldest treatment for
cancer is surgery, and several special Laser Used to relieve symptoms. Used to excise large tumors that press
on trachea or esophagus to allow easier breathing or eating.
surgical techniques can be used (Table
4). Surgery is used also in diagnosis Mohs Microscopically controlled surgery in which cancerous tissue
and staging to determine the extent is shaved off one layer at a time. Each layer is examined micro-
scopically and if the layer looks normal, no more excising is
and amount of disease. Patients may done. Mohs surgery helps to preserve the surrounding tissue
elect to have prophylactic surgery, and minimizes scarring.
which is done to remove tissue that is
Restorative/ Used to restore a patient’s appearance or the function of an
not malignant but which may become Reconstructive organ. Breast reconstruction is usually done after a mastectomy
malignant. Some women with a known and completion of chemotherapy, radiotherapy, or both.
mutation in the BRCA gene elect to
have prophylactic mastectomies of
healthy breasts to avoid breast cancer.4 Because normal cells repair faster, the cer. Like radiotherapy, chemotherapy
Curative surgery removes the tumor “weekend break” allows them to recov- targets rapidly dividing cells, usually
and is often done in conjunction with er, while the cancer cells die and are aiming to disrupt cell division. Most
chemotherapy or radiotherapy to naturally removed from the body. patients who have surgery to remove
achieve a cure. Palliative surgery is not Radiotherapy often incorporates drugs tumors also have chemotherapy to
done to cure cancer but is used to treat such as radioprotectors or radiosensi- “clean up” stray cancer cells in the
complications of advanced disease. For tizers to lessen damage to healthy tis- body. Various forms of chemotherapy
example, palliative surgery can debulk sue and improve the outcomes. exist and most are categorized as anti-
tumors that are blocking the function Hyperfractionated radiotherapy deliv- neoplastic therapy. Many types of
of organs. Palliative surgery is also ers radiation in smaller doses adminis- drugs are used as antineoplastic
used to treat pain that is difficult to tered every 4 to 6 hours, 2 or 3 times a therapy, including alkylating agents,
control in other ways. day. Hyperfractionated radiotherapy antimetabolites, and enzyme
Radiotherapy uses radiation to kill works well on tumors that are known inhibitors. Chemotherapy is given in
cells. Cells cycle through stages of divi- to divide extremely rapidly, particularly cycles, with a rest period between
sion: G0, G1, S, G2, and M. Radiation is those of the head and neck. Another cycles, and cycles can last from 3
most effective on cells in the dividing form of radiotherapy is internal radia- months to 3 years, depending on a
stages and less effective on cells in the tion, in which an implanted radioac- number of factors, including disease
“resting” phase of G0. The aim of radia- tive material is used to deliver a con- (ie, what type of cancer), drugs (eg,
tion therapy is to stop cancer cells tinuous dose of radiation over several antimetabolites or monoclonal anti-
from dividing, thus killing them and days. Unlike with other forms of bodies), and responses (ie, tumor
destroying the tumor. Unfortunately, radiotherapy, with internal radiation, shrinkage or progression). Chemo-
other rapidly dividing cells, such as sometimes grouped in the general therapy is generally given as 3 courses:
cells that line the mouth and hair cells, category of brachytherapy, the patient induction, consolidation, and mainte-
are often destroyed also, leading to is radioactive for a few days. Children nance. The number of cycles in each
mucositis and alopecia, respectively. under the age of 18 years must not visit course can vary. Chemotherapy is
Other rapidly dividing cells that are patients receiving internal radiation; further classified as adjuvant or neoad-
often destroyed are blood cells, leading others must remain at least 6 feet away juvant, if given after or before surgery,
to neutropenia, anemia, or thrombocy- and can only stay in the same room for respectively.
topenia when white cells, red cells, and 45 minutes. Some newer therapies are antian-
platelets, respectively, are damaged or Chemotherapy is the administra- giogenesis therapy and photodynamic
destroyed. Radiotherapy is a gradual tion of drugs to kill cancer cells. therapy. Tumors, like all cells in the
process, with the total dose measured Chemotherapeutic drugs can be body, need a rich blood supply to grow.
in grays given over an extended period administered as a pill, as an injection, Antiangiogenesis therapy involves the
of time. Very often, patients receive or as an intravenous infusion. Hundreds use of drugs to stop the formation of
radiotherapy every week day (ie, of chemotherapeutic drugs are used, new blood vessels, effectively limiting
Monday through Friday) for 6 weeks. alone or in combination, to treat can- the size of a tumor to a few millimeters

56 AMWA JOURNAL . VOL. 20, NO. 2, 2005

in diameter. Photodynamic therapy reality, “X” probably allows other fac- 12. Knudson AG. Mutation and cancer:
combines light and a photosensitizing tors to engage in the development of a statistical study of retinoblastoma. Proc
Natl Acad Sci USA. 1971;68:820-823.
agent (ie, a drug that is activated by cancer.
13. Teeley P, Bashe P. The Complete Cancer
light). The drug accumulates in the Extraordinary therapies have been Survival Guide. New York, NY;
target of interest, the diseased organ. developed in the past few decades that Doubleday; 2000.
When the drug is exposed to laser light employ the knowledge of cell physiolo- 14. Robinson MO. DNA repair pathways.
Mechanisms and defects in the mainte-
or another light source, chemicals are gy, chemistry, and genetics. We are
nance of genome stability. In: Bronchud
produced that destroy the cancer cells. aware of behavioral changes (eg, modi- MH, Foote MA, Peters WP, Robinson WP,
Photodynamic therapy is limited to fication of diets, avoiding tobacco and ed. Principles of Molecular Oncology.
areas close to the surface. A common alcohol) that can deter the develop- Totowa, NJ: Humana Press; 2000:257-270.

use of photodynamic therapy is for the ment of some cancers. The second
treatment of actinic keratosis, a pre- paper in this series will provide an GLOSSARY
cancerous skin condition caused by overview of molecular oncology, tar- adjuvant therapy
repeated and prolonged sun exposure. geted therapies, and other advance- Treatment used in addition to the
primary treatment, ie, chemotherapy
A solution is applied to the face or ments in the field of oncology.
or radiotherapy given after surgical
scalp and a special light is used to removal of a tumor to increase the
activate the drugs. chance of cure
Gene therapy is a new area of can- References alkylating agent
1. National Cancer Institute. Available at: A substance that acts on DNA and
cer treatment and is highly experimen-
http://progressreport.cancer.gov. interferes with replication by replacing
tal. The goal of gene therapy is to alter Accessed July 28, 2004. hydrogen atoms with itself
the genetic makeup of the tumor or 2. Foote MA. Basic cell biology for medical alopecia
of the body by inserting a desirable writers. AMWA J. 1999;14:8-16. Loss/absence of hair; side effect of
3. Foote MA. Basic Mendelian genetics for cancer treatment; hair often grows back
gene into the DNA of cells that have
medical writers. AMWA J. 2001;16:19-24. anemia
been removed from the patient. The 4. American Cancer Society. Available at: Abnormally low amount of red blood
removed cells are “reprogrammed” to www.cancer.org. Accessed July 27, 2004. cells
produce different proteins and then 5. Brawer MK. How to use prostate-specific antiangiogenesis
antigens in the early detection or screen Approach to prohibiting the formation
are injected into the patient’s body
ing for prostatic carcinoma. CA Cancer J of blood vessels
or into the tumor. In some cases, Phys. 1995;45:148-164. antimetabolite
the reprogrammed cells fortify the 6. Petricoin EF, Ornstein DK, Paweletz CP, Analog of the end product of a metabol-
patient’s immune system; in other et al. Serum proteomic patterns for ic pathway that causes feedback
detection of prostate cancer. J Natl inhibition but cannot replace the
cases, the reprogrammed cells sensi-
Cancer Inst. 2002;94:1576-1578. original product
tize cancer cells to antineoplastic 7. Petricoin EF, Ardekani AM, Hitt BA, et al. antineoplastic agent
agents. Use of proteomic patterns in serum to A drug that stops or slows the matura-
Bone marrow transplantation and identify ovarian cancer. Lancet. 2002; tion and spread of tumor cells
359:572-577. apoptosis
stem cell transplantation are often the
8. Horwich A, Ross G. Circulating tumor Programmed cell death that restricts the
primary therapy for leukemias and markers. In: Bronchud MH, Foote MA, number of cells in a tissue or an organ
lymphomas and are being used as Giaccone G, Olopade O, Workman P, eds. benign
experimental treatments for other Principles of Molecular Oncology. 2nd ed. Not malignant
Totowa, NJ: Humana Press; 2004:233-246. biopsy
cancers. Transplantation allows the
9. Savio A, Franzin G, Wotherspoon AC, Removal and examination of tissues
use of very intense chemotherapy with et al. Diagnosis and posttreatment from the living body
or without radiotherapy to better erad- follow-up of helicobacter pylori-positive bone marrow transplantation
icate tumor cells; the greater eradica- gastric lymphoma or mucosa-associated Treatment for cancer that involves
tion comes at the cost of the bone lymphoid-tissue–histology, polymerase removal of some of the patient’s or
chain-reaction, or both. Blood. 1996;87: a donor’s bone marrow, which is
marrow. Both bone marrow and stem 1255-1260. purged of cancer cells and stored; after
cell transplantation are complex, wor- 10. Bronchud MH. Selecting the right targets destruction of the patient’s bone mar-
thy of a paper on the topic alone. for cancer therapy. In: Bronchud MH, row through radiation and drugs, the
Foote MA, Giaccone G, Olopade O, stored bone marrow is transfused, finds
Workman, P, eds. Principles of Molecular it way back into the marrow cavity of
CONCLUDING REMARKS Oncology. 2nd ed. Totowa, NJ: Humana bones, and re-establishes bone marrow
Oncology is a complex area of study. Press; 2004:1-49. function
Research suggests that both genetic 11. Stratton MS, Stratton SP, Dionne SO, et al. brachytherapy
makeup and the environment, includ- Treatment of carcinogenesis. In: Radiotherapy in which the source of
Bronchud MH, Foote MA, Giaccone G, radiation is in a device implanted in the
ing behaviors, interact to allow cancers
Olopade O, Workman P, eds. Principles of body in or close to the area to be treated
to develop. It is difficult to state Molecular Oncology. 2nd ed. Totowa, NJ: carcinogen
unequivocally “X causes cancer”; in Humana Press; 2004:607-673. A substance that produces cancer

AMWA JOURNAL . VOL. 20, NO. 2, 2005 57

carcinoma invasion oncology
Malignant new growth composed of Infiltration and active destruction of The study of cancer and its therapies
epithelial cells tending to infiltrate the surrounding tissue, a characteristic of PET
surrounding tissues malignant tumors Positron emission tomography; special-
carcinoma in situ leukemia ized imaging technique that uses low-
Neoplasm in which cells are confined Any of several cancers of blood-forming dose radioactive sugar to measure
to the epithelium of origin without organs that result in the uncontrolled metabolic activity; very sensitive and is
invasion into other tissues production of abnormal white blood able to detect active tumor tissue
CAT (CT) scan cells photodynamic therapy
Computed axial tomography or com- lymphoma Use of drugs that are activated in the
puted tomography; imaging test in Neoplastic disorder of lymphoid tissue presence of a special light to kill rapidly
which many x-rays are taken from malignant dividing cancer cells
different angles of a part of the body; Refers to disease state that tends to plasma cell
images are combined by a computer progressively worsen and results in Specialized type of B cell involved in
to produce cross-sectional pictures of death immunity
internal organs maintenance therapy proto-oncogene
chemotherapy Extended treatment with chemotherapy A normal gene that with slight alteration
Use of drugs to destroy or incapacitate at less-frequent time periods than by mutation becomes an oncogene
cancer cells original chemotherapy (eg, once every radiograph
consolidation therapy 2 months rather than 3 times a week for Film produced by x-rays
Chemotherapy treatments given after 2 months) given to lessen the chance of radioprotector
induction chemotherapy to further return of cancer A substance applied or administered
reduce the number of cancer cells melanocyte before radiotherapy that helps minimize
dysplasia Epidermal cell that synthesizes the damage to normal healthy cells
Abnormality of development, particu- pigment melanin radiosensitizer
larly any alteration in size, shape, and melanoma Drugs used to enhance the effect of
organization of adult cells Tumor arising from melanocytic system radiation
endoscope of the skin radiotherapy
An instrument for the examination of metastasis Use of ionizing radiation to kill rapidly
the interior of hollow organs, such as Transfer of disease from one part of the dividing cancer cells
the bladder or colon body to another or from one organ to risk
enzyme inhibitor another that is not directly connected The probability of being harmed
Compound or chemical that stops the mismatch repair gene sarcoma
action of an enzyme Genes that recognize damaged DNA; A tumor arising in bone, muscle, or con-
etiology the protein encoded by the gene repairs nective tissue
Study or theory of factors that cause the damaged DNA stem cell transplantation
disease morbidity Treatment for cancer that involves
gene therapy State of having a disease removal of some of the patient’s or a
The process of introducing new genes mortality donor’s peripheral blood progenitor
into the DNA of a person’s cells to Death cells (also called stem cells); after
correct a genetic disease MRI destruction of the patient’s bone mar-
glioma Magnetic resonance imaging; procedure row through radiation and drugs, the
Tumor composed of nervous tissue in which a magnet linked to a computer collected progenitor cells are trans-
gray is used to create detailed pictures of fused, move back into the bone’s mar-
Unit of energy absorbed by 1 kg of areas inside the body row cavity, and re-establish bone mar-
matter; a measure of intensity of myeloid row function
radiotherapy Pertaining to or derived from bone mar- telomere
hyperfractionated radiotherapy row Stabilizing caps on ends of chromo-
Radiation given in smaller doses and mucositis somes; telomeres shorten whenever a
more than once a day Inflammation of the lining of the mouth cell divides. When the telomeres become
hyperplasia and digestive tract very small, the cell stops dividing.
Abnormal multiplication or increase in neoadjuvant therapy thrombocytopenia
the number of normal cells in normal Systemic treatment, such as chemother- Less than normal amounts of platelets
arrangement in a tissue apy or radiotherapy, used before surgery tumor
induction therapy to shrink the tumor and make it easier A new growth of tissue in which multi-
Treatment designed to be used as the to remove plication of cells is uncontrolled
first step toward shrinking the cancer neoplasm tumor marker
initiator Any new and abnormal growth, usually Proteins found in the blood; the amount
Gene or substance able to start the uncontrolled and progressive or level of the protein may correlate
process in question neutropenia with the type and activity of some
internal radiation Less than normal amount of white cancers
A type of therapy in which a radioactive blood cells tumor suppressor gene
substance is implanted into or close to oncogene Genes that suppress tumors through
the area needing treatment. Also called Gene found in chromosomes of tumor production of proteins
brachytherapy. cells whose activation is associated with ultrasonography
the transformation of normal cells into Use of high-frequency sound waves to
cancer cells visualize structures deep in the body

58 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 HOW WRITERS CAN HELP READERS UNDERSTAND
HEALTH SCREENING TESTS*
By Jessica Ancker, ELS, MPH
Mailman School of Public Health, Columbia University, New York, NY

W
hen I listen to the radio in done for women with no signs or disease. (In biostatistical jargon, they
the morning, I often hear symptoms of breast cancer. In short, were asked for the positive predictive
advertisements for the the prevalence of a disease can affect value of a diagnostic test, given the
“full-body scan,” a computerized how a test result is interpreted and, in disease prevalence and the test’s sensi-
tomography (CT) image of the entire turn, influence what next steps are tivity and false-positive rate.) Half of
body that is supposed to screen for taken (eg, administer additional tests, the study participants were given the
almost any disease. According to the begin treatment, take no action). information presented as traditional
advertisement, this scan can detect To make informed health care deci- percentages, and half were given it
unsuspected diseases while they are sions, patients and providers need to presented as frequencies.
still at the treatable stage. One purvey- know that false test results can occur The 24 study participants who read
or of full-body scans told a reporter and what they mean. This article the information presented as tradition-
that he had found CT abnormalities in explains why the likelihood of a false al percentages did poorly at answering
every one of the hundreds of patients result differs by screening group (gen- the question. This information stated
1
he had tested. eral population versus individuals at that 0.3% of the population has the dis-
But does a blotch on a scan really higher risk for the disease). More ease, that only 50% of all people with
indicate something medically wrong? importantly, it discusses one approach, the disease have a positive test result,
When a friend of mine had an abdomi- the natural frequencies model, by and that 3% of the healthy population
nal CT because of a gastrointestinal which medical writers can more clearly will have a positive test result that is
problem, the image also revealed communicate information about false- actually inaccurate. When asked about
mysterious spots in her lower lungs. positive and false-negative results to the meaning of the diagnostic test
She underwent months of worry and patients and health care professionals. result, only 1 participant gave the right
painful medical procedures before her answer: that for a patient who has a
physicians concluded that the spots FREQUENCIES MAKE READERS positive test result, the chance of actu-
were harmless scar tissue from an old SMARTER ally having the disease is only 4.8%. As
infection. Any discussion of screening tests relies you can see by the calculations behind
My friend experienced a false-posi- on information about probabilities. this answer (see box on next page), if
tive test result: a result indicating the Unfortunately, many people have there is anything surprising about the
presence of disease in an individual difficulty understanding probabilities. finding, it is that even a single respon-
who does not actually have the condi- Psychologic studies have suggested dent got the answer right!
tion. Screening tests can also produce that we get confused, in part, because The remaining 24 study partici-
a false-negative result: a negative test probabilities are usually described in pants were presented with the same
result from an individual who really a way that is incompatible with the information but as frequencies rather
has the disease. (For more information human brain’s natural reasoning abili- than as probabilities. The information
3,4
on false-positive and false-negative test ties. Presumably, if writers present stated that 30 of 10,000 people tested
results, see article beginning on page statistical information in a way that actually have the disease, but only 15
50.) An important fact about screening exploits rather than challenges readers’ of those 30 will have a positive test
tests (but one that is little known to natural mental abilities, readers will be result. In addition, another 299 false-
patients) is that false-positive results less confused and understand more. positive results will occur with testing
become more common when tests are One way to make probabilities of the remaining 9,970 healthy people.
given to healthy people without risk easier to understand is to present them When the information is presented as
factors for the disease. For example, as frequencies rather than as percent- frequencies, it is easy to see that false-
3,4
most positive mammograms findings ages. Consider this example. In a positive results far outnumber true-
2 4
are actually false-positive results study by Hoffrage and colleagues, positive ones (299 compared with 15).
because mammography is routinely 48 faculty and students at Harvard With these numbers, it takes only a
Medical School were given information simple calculation, rather than a more
*Based on a poster presentation at the about a fictitious disease and its diag- detailed mathematical formula, to
American Medical Writers Association
nostic test. They were then asked how determine the test’s positive predictive
Annual Conference, Miami, FL, September
likely it was that a patient who had a value: 4.8% (15 ÷ 314) of people who
18-20, 2003.
positive test result actually had the had a positive test result really have the

AMWA JOURNAL . VOL. 20, NO. 2, 2005 59

 (1,000 x 0.002 = 2). The remaining 998
DOING THE MATH THE HARD WAY will not. The test has 99.9% sensitivity,
Bayes’ Theorem is a formula that can be used to calculate the probability that so both of those 2 infected people are
a person who has a positive test result really has the disease. likely to test positive (2 people x 99.9%
In this example, the disease occurs in 3 out of 1,000 people. The fictitious = 2 x 0.999 ≈ 2).
screening test is not very sensitive; it will identify only half of people with the Next, consider what would happen
disease. Also, 3 out of 100 healthy people will have a positive test result that if you gave the test to the remaining
is inaccurate. 998 healthy people. The false-positive
In statistical jargon: rate is 0.1%, and 998 x 0.001 ≈ 1, mean-
• The sensitivity of the test is 50% ing that 1 healthy person is likely to
• The false-positive rate is 3%. have a false-positive test result.
• The prevalence of disease is 0.3%. In total, you tested 1,000 people and
got 3 positive test results, but only 2
Bayes’ Theorem states that the probability of disease in a person with a positive are true-positive results (Figure 1).
test result is: Thus, in your article you could tell
(sensitivity)(prevalence) (0.50)(0.003) readers that, on average, 2 of 3 people
= = 0.048 who have a positive test result actually
(sensitivity)(prevalence) + (false positive rate)(1- prevalence) (0.50)(0.003) + (0.03)(0.997)
have procrastivirus. Perhaps readers
with no risk factors for procrastivirus
See the text for an easier way to calculate the same answer! who have a positive test result should
be advised to take a different type of
disease. Presenting the same informa- APPLYING THE NATURAL test to confirm the findings of the first
tion in frequencies improved readers’ FREQUENCIES MODEL WHEN test.
ability to understand it; 16 of the 24 WRITING ABOUT HEALTH Now consider what would happen
study participants came to the correct SCREENING TESTS if you administered the QUIKKIE-TEST
answer. Experiments such as the one by only to people at high risk for procras-
Gigerenzer et al. show that under- tivirus because of their poor study
WHY FREQUENCIES ARE BETTER standing is affected by the way quanti- habits (Figure 2). Imagine that in this
Gigerenzer et al. explain such findings tative information is presented. This high-risk group, the prevalence of pro-
by arguing that humans are well adapt- finding suggests that biomedical com- crastivirus is known to be 10%. Think
ed to reason about the frequencies of municators can play an important role about the following questions:
events that they experience but not in improving public understanding 1. Among 1,000 high-risk people,
about percentages, which are mathe- about screening tests. To see how, how many really have procras-
matical abstractions invented in his- imagine that you are writing an article tivirus?
3,4
torical times. Thus, formulas contain- about QUIKKIE-TEST, a home testing 2. Of those infected people, how
ing percentages are difficult to explain, kit that correctly identifies 99.9% of many will have a positive test
intuit, and remember. Reasoning is cases of the dreaded procrastivirus, a result that is accurate?
easier and more accurate when prob- disease that causes people to turn in 3. Of the remaining healthy people,
lems are presented as numbers or their AMWA homework assignments how many will have a positive
frequencies of events. late. (In statistical terms, QUIKKIE- test result that is inaccurate?
The researchers also argue that TEST is said to have a “sensitivity” of 4. What is the chance that some-
frequencies are easiest to understand 99.9%.) QUIKKIE-TEST also has a very body who has a positive test
when described in terms of a large low false-positive rate (0.1%), meaning result really has the virus?
group divided into subgroups. In the that it will wrongly produce a positive
Harvard study, for example, the num- result for 1 of 1,000 healthy people. You Answers:
bers were easiest to understand when check a respected federal Web site and 1. Of 1,000 people in this high-risk
described as a group of 10,000 people, discover that about 0.2% of the US group, 10% will be infected; 1,000
divided into a subgroup of 30 people population have the procrastivirus. In x 0.10 = 100 infected people.
with disease and another subgroup of your article, what should you tell your 2. Of 100 infected people, 99.9% will
9,970 people without disease. readers to do if they have a positive have a positive result; 100 x 0.999
Gigerenzer et al. call such numbers test result? = 100 true-positive results.
“natural frequencies.” Natural frequen- To begin, consider what would 3. Of the remaining 900 healthy
cies can also be thought of as fractions happen if you gave the test to 1,000 people, 0.1% will have a false-
that have the same denominator and people in the general population. The positive result; 900 x 0.001 = 1
sum to 1 (30/10,000 + 9,970/10,000 = prevalence of disease is 0.2%, so only 2 false-positive result.
10,000/10,000 = 1). people will really have the disease

60 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 4. After testing 1,000 people in the that a positive test result indicated training patients in quantitative
high-risk group, you have 100 disease. In short, we must ask whether reasoning to help them make better
10
true-positive results and 1 false- a person is at risk for the disease before medical decisions. A different
positive result. That means that we know how seriously to accept a approach that might ultimately reach
100 of every 101 people who have positive test result for that person. more patients would be for profession-
a positive result really have the al communicators—especially AMWA
disease. In other words, when a “REAL WORLD” BARRIERS TO members—to learn to present quanti-
person with poor study habits COMMUNICATION ABOUT FALSE tative health information in ways that
has a positive result, he or she SCREENING RESULTS can be more easily understood. This
almost certainly has the virus. Information about false-positive and article presents one way to do this.
false-negative results is not always pro-
vided to patients. In one study, only CONCLUSION
18% of patient education brochures All screening and diagnostic tests—
about breast cancer screening provid- from mammography and HIV tests to
ed any information about test sensitiv- the QUIKKIE-TEST—produce false-
5
ity and specificity; in another study, positive and false-negative results. For
test accuracy information appeared any test, the proportion of false-posi-
6
“only occasionally.” When one tive results is high when the disease is
researcher had HIV testing at 20 rare. The proportion of false-positive
centers in Germany, most of the AIDS findings will be highest when the test
counselors were unwilling to discuss is done to screen a healthy, low-risk
false-positive and false-negative population.
results, and many counselors claimed Sometimes, false results are noth-
that false results were impossible.4 Only ing worse than an annoyance. How-
1 counselor explained that a positive ever, in serious conditions such as
Figure 1. The QUIKKIE-TEST applied to the result in a low-risk individual was likely cancer or HIV infection, a false-posi-
general population.
to be false whereas a positive result tive result might cause serious emo-
from a high-risk individual was likely tional distress, even despair. False-pos-
to be genuine. None of the 78 informa- itive results can also mean additional
tional brochures available at the clinics unpleasant tests and unnecessary and
clearly explained these facts. The expensive medical treatment.
researcher reported that the AIDS Both patients and professionals are
counselors themselves (some of whom likely to understand information about
were physicians and the rest of whom false-positive and false-negative results
were social workers) appeared to be better when it is presented in natural
confused about the issues, making it frequencies than when presented as
impossible for them to provide clear percentages. Professional communica-
4
information to their patients. Some tors and educators can help by trans-
have argued that the accuracy of Pap lating percentages into natural frequen-
tests for cervical cancer is rarely dis- cies or by working with statisticians
cussed in clinical settings because or epidemiologists who can do so.
of a medical culture that patronizes Presenting information in this way will
patients and does not want to help us make readers smarter about
acknowledge uncertainty for fear of health screening and diagnostic tests.
Figure 2. The QUIKKIE-TEST applied to a
dissuading patients from undergoing
high-risk group. 7
screening. Acknowledgment
Even if clinicians do explain false- I thank Nancy Heim, Chief Medical
Notice how the prevalence of dis- positive and false-negative results, Illustrator at the Columbia Center for
ease strongly affects our interpretation patients sometimes have a difficult Biomedical Communication, for creating
of a test result. In the first situation time understanding the numbers. the illustrations.
described, the disease was rare in the Schwartz and Woloshin found that
general population, and so a positive many patients have poor quantitative References
8 1. US doctors offer full body scan. January
test result had only a 2 in 3 chance of reasoning skills (“numeracy”), and
2, 2001. BBC News home page. Available
indicating disease. In the second situa- that poor numeracy impairs patients’
at http://news.bbc.co.uk/1/hi/health/
tion, the disease was common in the ability to interpret information about
9
1097136.stm. Accessed July 23, 2003.
risk group, so we were virtually certain mammography. The authors proposed
continued on page 64

AMWA JOURNAL . VOL. 20, NO. 2, 2005 61

 AMWA’S 65 T H ANNUAL CONFERENCE

Dates: September 29 – October 1, 2005 topics with expert speakers who are
Location: Pittsburgh Hilton Hotel, leaders and innovators in their fields.
Pittsburgh PA Be sure to attend as many as you can.
Room Rate: $130/night Of course, AMWA’s core and advanced
Registration Fee: $310 for AMWA members curriculum workshops will continue to
be a major part of the conference’s
By Thomas Gegeny, MS, ELS offerings. This year, attendees can
Annual Conference Administrator choose from 85 workshops. In addi-
tion, new core curriculum workshops
2005 marks the return of AMWA’s flag- will debut at this year’s conference.
ship event, the annual conference, to Also available will be poster pre-
the east coast. Pittsburgh is one con- AMWA has organized tours not only of sentations, exhibits and booths, 2 days
ference that AMWA members will not cultural interest but also of scientific of breakfast roundtables, and a new
want to miss! Pittsburgh is an amazing interest, such as The Robotics Institute event: coffee and dessert klatches
city, with a rich history and an appeal at Carnegie Mellon University (informal discussions on selected
that will surprise many. There is much (www.ri.cmu.edu). topics—over coffee and dessert, of
to see and do in Pittsburgh, whether Best of all, the speakers and pro- course!) The award luncheons, dinners,
downtown (where the annual confer- grams lined up for this year’s annual and receptions will make the 2005
ence will be held) or in any number of conference will offer biomedical com- Annual Conference a memorable expe-
entertainment, cultural, and shopping municators an unparalleled opportuni- rience, to be sure.
districts. The city celebrates its diverse ty for learning, discussion, and profes- With plans underway and momen-
neighborhoods and picturesque water- sional development. The conference tum building for this year’s annual
ways and is a short distance from the schedule is filled with programs and conference, one thing is certain: con-
scenic Pennsylvania countrysides. sessions that are included in the cost ference goers will not leave Pittsburgh
Pittsburgh is truly a renaissance of registration. As one AMWA member disappointed! For the latest updates
city, with a vibrant arts scene (includ- said to me in an e-mail, “There’s and conference program listings, visit
ing the Carnegie Museum of Art and enough to keep me busy throughout AMWA’s Web site (www.amwa.org).
The Andy Warhol Museum) and world- the conference, even if I did not attend Registration brochures will be mailed
class scientific and medical research a single curriculum workshop!” to AMWA members by the end of June,
institutions (including the University Indeed, the conference open ses- and online registration should be avail-
of Pittsburgh Medical Center and sions and noncredit workshops are a able in the first week of July. See you in
Carnegie Mellon University). This year, collection of important and timely Pittsburgh!

62 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 OPEN SESSIONS SPECIAL INTEREST SESSIONS SHORT SESSIONS
Coordinated by Eleanor Mayfield Coordinated by Mary Royer Coordinated by Robert Bonk

The Open Sessions at this year’s annual As with Open Sessions, Special Interest Short sessions include 1-hour “How-to” ses-
conference cover a wide spectrum of Sessions are included in the cost of sions and 1.25-hour noncredit courses. Both
important topics and controversies conference registration. Each of these of these offerings are included in the cost of
affecting biomedical communication. sessions specifically focuses on one conference registration. The following short
The following open sessions are sched- of AMWA’s special areas of interest: sessions comprise this year’s great line-up:
uled at this year’s conference: Editing and writing, education, free-
lance, pharmaceutical, and public How to Make Your Web Site More Accessible
Seeking the Truth About the relations/marketing. The following to All Users
Environment and Your Health: sessions will be offered at the upcom-
Separating Truth From Fiction ing conference: How to Write for Children and Young Adults
Moderated by Donna Miceli
Style Manuals Update: Up-to-the- How to Understand and Overcome Writer’s
“Open Access” and the Future of Minute Information About the CSE Block
Scientific Publication and AMA Style Guides
Moderated by Joan Affleck Moderated by Ann Conti Morcos How to Make Microsoft Word Work for You

Withdrawing Drugs from the Market: The Global Schoolhouse: A New How to Establish Strong Partnerships With
Can It Be Prevented? Look at Distance Learning Freelance Writers to Prepare Clinical Study
Moderated by Barbara Snyder Moderated by Linda Benson Reports

Bioterrorism II (a sequel to last year’s Security in the Home Office How to Create a Style Guide for a Diverse
popular session) Moderated by Jim Hudson Writing Group
Moderated by Jennifer Grodberg
Reporting Clinical Trial Results: How to Measure Writing Skills
Privacy of Health Information: FDAMA 113 et al.
How to Take Medical Translations Into
HIPAA and Beyond Moderated by MaryAnn Foote and
Account While Writing—Saving Time and Cost
Moderated by Joan Nilson Art Gertel

How to Request Manuscript Revisions

Drugs Across Borders II: Industry, The Evolving Regulatory Climate
from Authors
Activists, and Regulatory Agency of CME: Updated Standards for
Viewpoints (an update of the informa- Commercial Support
How to Edit and Index—Last, But Not Least!
tion and issues explored at the 2004 Moderated by Karen Overstreet
Annual Conference)
Good Publication Practices
Moderated by MaryAnn Foote

Basic Concepts in Epidemiology

It’s Not All Hormones: New CREATIVE READINGS
Developments in Women’s Coordinated by Jim Cozzarin
Diabetes from A to Z
Health Care
Moderated by Pam Oestreicher Anyone who knows Jim is aware that
Treating Patients Well with Writing and
he’s a very creative, and sometimes
Language
Haunting Writing: Exorcising the unpredictable, individual. Expect more
Ghosts from MECC and Pharma than just “readings” from this year’s
Persuasive Portfolios for Prospective Clients
Publications session, as well as an emphasis on the
Moderated by Devora Mitrany creative. Anyone who doesn’t usually
Making Action Evident
attend Creative Readings might want
Technical Writing and Medical Writing: to reconsider for this year’s annual The Chemistry, Manufacturing, and Controls
Bridging the Gap conference! (CMC) Section of Regulatory Submissions
Moderated by Lili Velez
Writing for the Web

Templates, Technology, and Document

Granularity: What the Medical Writer
Needs to Know

AMWA JOURNAL . VOL. 20, NO. 2, 2005 63

 BREAKFAST ROUNDTABLES COFFEE AND DESSERT KLATCHES continued from page 61
Coordinated by Lori De Milto Coordinated by Adi Ferrara 2. Fletcher SW, Elmore JG. Mammo-
and Anita Frijhoff graphic screening for breast cancer.
N Engl J Med. 2003;348:672-1680.
More than 60 breakfast roundtables have This new session at the conference will 3. Gigerenzer G. Adaptive Thinking:
been scheduled for Thursday and Friday offer an opportunity for informal discus- Rationality in the Real World. New
morning at the annual conference! Far sions over coffee and dessert on topics York:Oxford; 2000.
too numerous to list here, a sampling of of interest to AMWA members such as 4. Hoffrage U, Lindsey S, Hertwig R,
topics is provided below. All of the hobbies, pastimes, current events, etc. Gigerenzer G. Communicating
roundtable topics will be listed online The following sessions are offered in this statistical information. Science. 2000;
at AMWA’s Web site, as well as in the year’s debut program. 290:2261-2262.
conference registration brochure. 5. Croft E, Barratt A, Butow P. Informa-
tion about tests for breast cancer:
Culture Shock: Anecdotes and Antidotes
What are we telling people? J Fam
It’s Feast or Famine. . . Or Is It? for Professionals Working With a Foreign
Pract. 2002;51(10):858-860.
Marketing Your Freelance Writing Culture
6. Slaytor EK, Ward JE. How risks of
Business
breast cancer and benefits of screen
Books on Creativity: What Do You Read ing are communicated to women:
Starting Out as a Medical Writer: How to to Inspire Your Writing? analysis of 58 pamphlets. BMJ.1998;
Generate Writing Samples 317:263-264.
Fun and Easy Camping Vacations 7. Anderson CM, Nottingham J. Bridging
Ethics in Pharmaceutical Publishing the knowledge gap and communicat-
Volunteerism: Non-writing, Sanity- ing uncertainties for informed
Amending Clinical Trial Protocols: Inducing Activities that Have Intrinsic consent in cervical cytology screen
Pearls of Wisdom for New Medical and Extrinsic Benefits ing; we need unbiased information
Writers and a culture change. Cytopathology.
Pet Ownership: Who Owns Whom? 1999;10:221-228.
8. Woloshin S, Schwartz LM, Moncur M,
Writing for the Web: Developing
Gabriel S, Tosteson ANA. Assessing
Content for Health Care Professionals Creative Writing: So, What Do You Do in
values for health: numeracy matters.
and Patients Your “Spare” Time as a Medical Writer?
Med Decis Making. 2001;21:382-390.
9. Schwartz LM, Woloshin S, Black WC,
Editors Are from Mars and Authors Are Crafting and Creativity Welch HG. The role of numeracy in
from Venus: Saving the Author-Editor understanding the benefit of screen
Relationship Clients of Different Stripes ing mammography. Ann Intern Med.
1997;127:966-972.
Medical Journalism Do’s & Don’ts: Tips The AMWA Laugh-In: Humor in Parallel; 10. Woloshin S, Schwartz LM. How can
for Successful Writing & Reporting Successfully Incorporating Humor into we help people make sense of med-
Your Daily and Professional Life ical data? Eff Clin Pract. 1999;2(4):
Alphabet Soup: Commonly Used 176-183.
Medical Abbreviations What I Like About Freelance Work

The Evolving Regulation of CME:

Challenges and Opportunities for
Writers

Covering a Scientific Conference

for Your Pharmaceutical Company:
An Idiot's Guide

Electronic Editing for Beginners

Career Opportunities in CROs

64 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 NINE POSTERS TO BE ON DISPLAY AT ANNUAL CONFERENCE
For the past 2 years, the AMWA Annual Conference has featured a poster session as a way to give members an opportunity
to bring new ideas and innovations to their peers. This year, 9 posters were selected for presentation, and they are included
here as an exciting preview of the session.
During the conference, posters will be on display 7:00 AM to 5:30 PM on Thursday, Friday, and Saturday. In addition,
conference attendees can meet authors to discuss the posters on Saturday, 7:45 AM to 8:45 AM.

INCREASING THE VISIBILITY OF tinue this initiative, we will provide peer review process for its content,
1 SCIENTIFIC EDITING SERVICES miniature versions of the bulletin and began featuring essays about
AT A RESEARCH INSTITUTION board to academic departments and immunization issues and synopses of
the academic programs office, which articles from the refereed literature.
AJ McArthur,1,* JC Jones,1 AE Williford,2 oversees the education and clinical An editorial board of immunization
DD Samulack1 training programs at St. Jude. In this experts generated content ideas that
Departments of 1Scientific Editing and manner, we are encouraging St. Jude were developed by a (non-physician)
Biomedical Communications, St. Jude
2
researchers to seek our services so that science writer. Drafts were then
Children’s Research Hospital, Memphis, we may help them improve their scien- reviewed by NNii’s physician editor
TN 38105 tific documents and thus improve their and two or more expert reviewers to
chances of publication or funding. assure accuracy and clarity—NNii’s
Scientific editing departments are not panel of reviewers includes over 60
typically found at research institutions; scientists, all leaders in vaccine
St. Jude Children’s Research Hospital DEVELOPING AN EVIDENCE- research and immunization policy.
(St. Jude) is one of only a few institu- 2 BASED, PHYSICIAN-REVIEWED A panel of lay reviewers was used to
tions in the United States that has such WEB SITE FOR THE GENERAL guarantee clarity of technical topics.
a department. During orientation at AUDIENCE
St. Jude, incoming faculty and postdoc- Results: NNii has been adding new
toral fellows are told that services pro- D Pineda, MS content weekly ranging from immu-
vided by the Department of Scientific Immunizations for Public Health (I4PH), nization basics to the latest research
Editing are available free of charge, Galveston, TX on vaccine safety. Coincidentally, the
yet many researchers do not seek the number of visitors to the site has more
department’s assistance or fully under- Background: Two-thirds of adults in than doubled—from 6,000 to 16,000 a
stand what these services entail. There- the US use the Internet; most have month. NNii’s Web site has been recog-
fore, to increase departmental visibility searched at some time for health infor- nized as user-friendly and informative
and stimulate interest in the depart- mation. However, not all health infor- site by its visitors, is referenced by
ment among the research staff, we mation on the Web is reliable. In 2000, major healthcare information sources
created a bulletin board and posted it a group of professional organizations and has received various Web awards.
in a high-traffic area adjacent to the created the National Network for
institution’s cafeteria. Because St. Jude Immunization Information (NNii) to Conclusion: The use of technical and
is a pediatric research institution, we provide reliable information about non-technical reviewers, along with a
patterned the bulletin board after a vaccines through its Web site (www. versatile design, has allowed NNii to
popular children’s board game. The immunizationinfo.org). During its first develop a successful Web site with accu-
bulletin board, The Game of Successful three years, NNii created educational rate and understandable information.
Writing, illustrates in a humorous materials, made experts available to
manner the potential pitfalls that can the media, and responded to misin-
occur during the preparation of manu- formation about vaccines. DOCUMENT TRACKING TOOLS
scripts and grant applications and 3 USING MICROSOFT OFFICE
shows that scientific editing can help Objective: Develop a Web site with
increase the probability of success of accurate and understandable, D Bell, ScD
those endeavors. The bulletin board evidence-based information about Clinical Operations and Biostatistical
also includes humorous (mildly self- immunizations. Analysis and Reporting, Critical
deprecating) testimonial quotes from Therapeutics, Inc., Lexington, MA
senior faculty members who regularly Methods: In early 2004, NNii reconfig-
use the department’s services. To con- ured its Web site, introduced a formal Medical Writers work on concurrent

AMWA JOURNAL . VOL. 20, NO. 2, 2005 65

writing projects with shifting and vari- HOW TO INSPIRE AUTHORS TO SUBMISSION DOCUMENTS:
able timelines. It is incumbent upon
4 WRITER BETTER MANUSCRIPTS:
5 STRIVING TOWARDS ICH
the Writer to produce quality docu- A PHYSICIAN-TARGETED, COMPLIANCE IN WRITING A
ments within the allotted timeframes WEB-BASED “WRITING FOR SUMMARY OF CLINICAL SAFETY
using limited resources. Effective tools PUBLICATION” MODULE (MODULE 2.7.4)
for monitoring the status of writing
projects are imperative. Heather Haley, MS, and Anne Marie Mary Ann Thomas, Sarah Van Belle,
We developed a departmental Weber-Main, PhD Michael Vanzieleghem, Deanna Kornacki
tracking system for Clinical Study Department of Family Medicine and Centocor, Inc.
Reports (CSRs) based on Microsoft Community Health Research Program,
(MS) Office software. Using Clinical University of Minnesota Twin Cities, With the advent of electronic submis-
Study Team milestones, the Writer Minneapolis, MN sions and the Common Technical
plotted the reports on an MS Word Document (CTD), regulatory medical
calendar with each report in a different As medical editors, our work is ulti- writers may encounter the request to
color font. Portions of the month were mately limited by the quality of manu- create a variety of summary docu-
color-coded if report timetables over- scripts we receive. We were looking for ments that comply with the Interna-
lapped. For example, calendar dates on ways to maximize editing resources in tional Conference on Harmonisation
which two reports were being written our two-person editing group, which (ICH) guidelines. These guidelines
simultaneously were highlighted in serves 60 family medicine faculty (a provide the framework for the modules
yellow, dates while three reports were mixture of MDs and PhDs). In turn, that are required as part of the submis-
written highlighted in red, and so on. our faculty expressed a desire to sion of the CTD. One of the sections
Relevant notes such as project team increase their publishing productivity within CTD Module 2 (CTD Summaries)
names appeared at the bottom. This by reducing the time to publication. In is the equivalent of the previously
approach allowed for resource needs our training approach, we sought to required Integrated Summary of Safety
and issues to be ascertained at a glance. shift our faculty’s understanding of and is now titled the Summary of
For individual CSRs, Excel work- research article development from a Clinical Safety (Module 2.7.4).
book templates were developed. formulaic approach (e.g., introductions This poster presentation will pro-
Worksheet data included report num- are literature reviews) to a rhetorical vide a summary of the basic structure
ber, task, person, end date, step, and approach (e.g., introductions create of the CTD. A brief overview of the
completed (yes/no). When a new CSR reader interest and establish the study contents of Module 2 will be present-
was undertaken, the report number significance through literature review ed. The focus of the presentation will
and starting date were entered. A work- and critique). An in-person writing be on the Summary of Clinical Safety
sheet function formula allowed a pre- seminar was impractical, given our (Module 2.7.4). Applicable ICH guide-
specified number of days for each step faculty’s conflicting schedules and lines (Efficacy – M4E) that assist in the
or task, and end dates were calculated dispersion across five geographically development of the template for a
based on the starting date. When a step separated clinics. Our solution to these Summary of Clinical Safety will be
was delayed, the date for that step was geographic and time demands was to reviewed. Each required section of
manually entered, causing the subse- create an electronic “Writing for Module 2.7.4 will be summarized. Tips
quent end dates to be automatically Publication” module, accessed via the on planning for the electronic links to
updated. Therefore, Medical Writing Internet. Module components include supportive documents, including other
was able to provide Management with a writing trouble shooting guide, anno- CTD modules, will be provided. Other
an updated timeline at a moment’s tated examples, and interactive exer- suggestions for developing and finaliz-
notice. cises. Our presentation will outline our ing an SCS may be discussed.
Whether the Medical Writer is free- insights from the development pro-
lance or part of a large department, cess, provide examples of content and
this method of tracking provides ease exercises, and share faculty response to FROM STATIC TO DYNAMIC: A
of communication between and the fledgling training module. 6 LARGE SCALE PROCESS FOR
among functions and takes little effort MAINTAINING A RESEARCH
to structure, execute, and update. The WEBSITE
tools involved are readily available to
any Medical Writer using the most Melissa Cooper, Greg Clarke and
common computer operating system. Jodi Braunton
University Health Network, Toronto,
Ontario, Canada

66 AMWA JOURNAL . VOL. 20, NO. 2, 2005

This project involved updating/creat- limits flexibility in terms of data pres- face-to-face “mock” reviews with
ing web profiles for 480 researchers at entation and input, and requires high (1) content reviewers–faculty who
University Health Network (UHN), levels of cross-departmental consisten- can comment on theories and
Canada’s largest hospital and the main cy in data definitions. methods relevant to the proposed
teaching hospital of the University of project; (2) generalist reviewers–
Toronto. Updating the profiles was a research-oriented faculty with
priority project within the re-design of CONSULT, COORDINATE, AND extensive knowledge of grant
the UHN Research website (www. 7 CRITIQUE: A THREE-STEP writing.
uhnresearch.ca), as data shows that METHOD FOR PRODUCING Faculty who complete these steps are
UHN’s researcher names are the most HIGHER QUALITY GRANT rewarded with priority access to
popular keyword searches for the site. PROPOSALS resources (editing, statistical, secretari-
A collaboration with UHN Research al support). Faculty who side-step the
Information Systems, this project used Anne Marie Weber-Main, PhD, process receive support on an “as
database-driven webpages written in Carole J. Bland, PhD available” basis.
PHP, and a relational database created Department of Family Medicine and Com-
using Oracle to house the data. munity Health, University of Minnesota Results and Conclusions: Since
Medical School, Minneapolis, MN employing these strategies, our depart-
Data sources: The profiles include ment has experienced dramatic
contact information, research interests, Background: In today’s tight research improvements in our grant hit rate and
keywords, publications, website links funding environment, only the crème NIH ranking (from 16 to 5). Faculty are
and images. Data was sourced from de la crème of grant proposals will pass introducing their projects to funding
existing profiles and a corporate data- muster. Medical writers/editors can be agency personnel via the concept
base with names, credentials and con- powerful allies in grants development, paper. Grant component specialists are
tact information. New modules were but our effectiveness is mediated by having early input into projects. Timely
added to this staff database to hold (1) adequate time to shepherd investi- mock reviews are becoming standard
profile-specific information. gators through multiple cycles of practice. The “threat” of an impending
review-rewriting, and (2) our knowl- review prompts reticent writers to keep
Data Collection: Data was confirmed edge of investigators’ content areas. drafting. Proposal editing is more tar-
and/or collected from researchers by geted, guided by mock reviewers’ com-
email. Based on feedback we entered Objectives: Increase the quality of our ments. Timelines ensure adequate time
or modified profile data using a cus- faculty’s proposals by encouraging the is blocked for editing.
tom front-end application. Final sign- establishment of timelines, early con-
off on profiles was obtained using a tact with “grant component specialists”
testing server to view new profiles. By (e.g., in research design, finance), and PUBLICATIONS IN A
time of launch we were successful in rigorous internal peer review prior to 8 REGULATORY ERA
obtaining 80% completion rate for submission.
profiles. Robert Achenbach, Cynthia Arnold,
Methods: With faculty input and depart- Scott Newcomer, James Barrett, Julie
Next Steps: Post-launch, our first prior- ment head approval, we launched a Thomas, Patti Shirey, Mary Ann Thomas,
ity is to obtain a near-100% completion three-step process: Mary Whitman
rate for profiles. Based on feedback on Consult: Investigators draft a brief Johnson & Johnson Centocor, Horsham, PA
the site we are also considering adding concept paper outlining the pro-
additional fields of information includ- ject’s aims, design, and significance. New guidances, either already devel-
ing, e.g., patent links. Finally, we are In a meeting of the investigator, oped or currently evolving, are begin-
investigating user attitudes towards research directors, and grant ning to alter the landscape of the pub-
implementing an “update-your-own- specialists, the initial concept is lication process for the pharmaceutical
profile” application. critiqued. industry and may eventually lead to
Coordinate: A timeline is devel- more rigorous scrutiny from peer-
Lessons Learned: Using PHP and data- oped, specifying deadlines for review journals and stronger regulation
base-driven technologies allows for sentinel events: completion of by the government. The American
easy manipulation of data and integra- first/second draft, mock review Medical Association and a group of
tion with enterprise-wide data struc- sessions, proposal editing, budget twelve top-tier medical journals
tures. This approach will likely reduce development. including the Journal of the American
hands-on maintainance time but also Critique: Drafts are cycled through Medical Association, the New England

AMWA JOURNAL . VOL. 20, NO. 2, 2005 67

Journal of Medicine, The Lancet, and vernacular the regulatory processes Committee [ARC], the Executive
the Annals of Internal Medicine have that have been recently adopted to Committee [EC], and the Board of
adopted the requirement that all pro- prevent inappropriate industry influ- Directors [BOD]), the interrelation-
tocols for investigational and marketed ence, lack of fair balance, and the per- ships of these bodies, the work that is
drugs in a public registry at their ception that clinical findings published done, and the opportunities that exist
inception as a prerequisite for subse- with pharmaceutical industry sponsor- for members to serve in the national
quent publication. Many journal edi- ship may be biased. organization. Here, we have repro-
tors and key opinion leaders have been duced the organizational chart of the
criticized for allowing the peer-review association published in those articles,
process to serve as the marketing force PATHWAYS TO THE PRESIDENCY: to further illustrate the various posi-
for the pharmaceutical industry. More 9 CHARTING YOUR COURSE tions in the national leadership. You
importantly, many feel that ethical THROUGH THE ORGANIZATIONAL may wonder where you fit into the
standards governing authorship, dupli- STRUCTURE OF AMWA structure of AMWA. Are you active in
cate publication, financial disclosure, your local chapter? If so, you may find
industry bias toward publishing exclu- James R. Cozzarin, ELS1; Karen Potvin yourself represented on the chart as
sively the results of positive studies, Klein, MA, ELS2; Marianne Mallia- one of the chapter officers or delegates
poor documentation, and acknowl- Hughes, ELS3 to the BOD. Are you serving on a
1 ®
edgements for ghost writing are being Pro ED COMMUNICATIONS, INC. , national committee? If so, you may
2
compromised, even in light of the Beachwood, OH, Wake Forest University find yourself in one of the many volun-
Good Publication Practices for Health Sciences, Winston-Salem, NC; teer positions listed under the various
3
Biomedical Manuscripts put forth by Texas Heart Institute, Houston, TX departments of the EC. Are you serving
the pharmaceutical industry itself and on the EC? the BOD? the ARC? If not,
the Uniform Requirements promulgat- AMWA’s Constitution and Bylaws, perhaps you would like to get there
ed by the International Committee of available on the AMWA Web site, detail some day. Do you have something vital
Medical Journal Editors. How will these the structure and governance of our to say? A new program you’d like to see
factors affect the perceptions of pub- association. Yet, many members are implemented? A novel idea that will
lished scientific findings among health not familiar with those documents. To revolutionize some aspect of the asso-
care professionals, the general public, further disseminate this valuable infor- ciation? Use this poster to pick your
and regulatory agencies, as well as the mation, we recently published a pair starting point, and chart your pathway
consequence of both publication and of articles in the AMWA Journal (see to the position where you can realize
scientific bias on developing medical AMWA J. 2004;19(4):167-174) designed your potential. Would you like to serve
practices? This presentation will high- to help AMWA members better under- as a national officer? as President?
light journal policies and the appropri- stand the structure of our association’s Chart your course today, identify the
ate guidances for scholarly publishing national governing bodies (the elected milestones you will need to pass on
and will review and explain in nonlegal officers, the Administrative Review your way, and set off on your journey.

Register for the Conference Online

Save time by registering for the annual conference on the AMWA Web site
(www.amwa.org). Registration will be available online in early July. The
registration brochure will also be available online, allowing you to review
descriptions of workshops and sessions. Be sure to register early to
get your first choice of workshops. Online registration is
not in real-time but will be processed in the order
received. You will receive an e-mail confirmation of registration
and choice of workshops and sessions.

68 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 RENOWNED PHYSICIAN, BERNARD FISHER, MD,
TO GIVE KEYNOTE ADDRESS

T
he keynote speaker at the 2005 strated no significant difference in the
Annual Conference will be outcome of patients treated with either
Bernard Fisher, MD, radical mastectomy or less radical
Distinguished Service Professor, procedures. Other 20-year findings
University of Pittsburgh. An interna- showed that lumpectomy plus radia-
tionally renowned cancer researcher tion therapy preserves the breast with
and Past Chair and Scientific Director no deleterious effect on distant dis-
of the National Surgical Adjuvant ease-free survival or survival. Dr. Fisher
Breast and Bowel Project (NSABP), Dr. also investigated the value of systemic
Fisher will present the address, “Forty- adjuvant chemotherapy and demon-
seven Years of Breast Cancer Research strated the worth of chemotherapy for
and Treatment: Some Extraordinary women with estrogen receptor-nega-
Highlights of My Journey.” tive tumors and of tamoxifen for
Dr. Fisher has played a major role women with estrogen receptor-positive
in helping to improve breast cancer tumors.
survival rates in Great Britain and the Dr. Fisher is a past president of the
US. Dr. Fisher began his laboratory American Society of Clinical Oncology University of Pennsylvania and at
investigations in the biology and treat- and vice president of the American the Post-Graduate Medical School
ment of cancer in 1958. The following Surgical Association. He has served on of Hammersmith Hospital, London,
year, he presented the first experimen- the editorial boards of several national- England.
tal evidence of the existence of “dor- ly known scientific journals and has Dr. Fisher subsequently joined the
mant” tumor cells and of the thesis given more than 1,000 invited lectures Faculty of Medicine at the University
that appropriate host perturbation can and published more than 565 papers of Pittsburgh. He was appointed
result in lethal metastases. In 1966, he (articles or book chapters). His honors Professor of Surgery in 1959 and
disproved the thesis that there is an and awards are numerous. A few of his Distinguished Service Professor in
orderly pattern of tumor cell dissemi- major and more recent awards include 1986. He was a Markle Scholar in
nation that is related to anatomical the Albert Lasker Medical Research Medical Science from 1953 to 1958
considerations. For more than a Award, the American Cancer Society and a Fulbright Appointee to Peru in
decade, Dr. Fisher’s investigations Medal of Honor, the Medallion for 1965. In 1977, the National Academy
determined the relationship of host Scientific Achievement in Surgery of of Sciences appointed him to a
factors to the development of metas- the American Surgical Association, the delegation that visited the People’s
tases, and his work was instrumental in National Health Council’s National Republic of China to evaluate research
altering the view of biology and treat- Medical Research Award, the Karnofsky and treatment of cancer. In 1986, he
ment of breast cancer. Award of the American Society of received the degree of Doctor of
In 1970, as an extension of his early Clinical Oncology, and the Joseph H. Science, Honoris Causa, from the
research, Dr. Fisher began to conduct Burchenal Clinical Research Award of Mount Sinai School of Medicine of the
randomized clinical trials to test his the American Association of Cancer City University of New York; in 2003,
hypotheses and evaluate various thera- Research. The list goes on and on. he received an Honorary Doctor of
peutic strategies for breast cancer. As a Dr. Bernard Fisher is a graduate Humanities degree from Carlow
result of the initial findings, a National of the University of Pittsburgh, where College, Pittsburgh. In 2004, he
Cancer Institute consensus panel rec- he earned both baccalaureate and received an Honorary Doctor of
ommended that women with stages I doctor of medicine degrees. He com- Sciences degree from Yale University.
and II breast cancer be treated with pleted his postgraduate training in He is a member of the National
breast-conserving surgery. Recently, Pittsburgh in the Harrison Depart- Academy of Sciences Institute of
additional 25-year findings demon- ment of Surgical Research at the Medicine.

AMWA JOURNAL . VOL. 20, NO. 2, 2005 69

 HONORARY FELLOWSHIPS

This year, the Fellowship Committee selected 2 individuals Association, and the Southern Christian Leadership Council.
to receive honorary fellowships in AMWA. Honorary fellow- In 1988, she was named WISE Woman of the Year by the
ships are awarded to nonmember(s) of AMWA for contribu- national Women’s Institute on Sports and Education and,
tions in any area of communication in the medical or allied in 1999, she was recognized with the Women’s Leadership
professions and sciences. The recipients are Bernard Fisher, Assembly’s Susan B. Anthony Woman of Vision Award.
MD, Distinguished Service Professor, University of Her interest in the medical field began during the 10
Pittsburgh, and Marilyn Brooks, medical editor for WTAE- years she worked at Wayne County General Hospital in
TV Pittsburgh. Eloise, Michigan, where she began as a ward runner and
A clinical cancer researcher for nearly 50 years, Dr. worked her way up to social investigations. She began her
Fisher has made enormous contributions in the field of broadcasting career as a general assignment reporter and
breast cancer. By coincidence, he was also selected to be worked in Detroit, Washington DC, Raleigh, and Nashville
this year’s Keynote Speaker (see page 69). before moving to Pittsburgh in 1984.
Marilyn Brooks created Health 4 Life, an Emmy-award A graduate of Duquesne School of Leadership and
winning public service program that educates viewers about Professional Advancement, Brooks recently completed her
health issues. She received the prestigious Cecil Writing master’s degree in communications and rhetorical studies
Award from the Arthritis Foundation, as well as honors from at McAnulty College. She also attended Columbia University
the National Kidney Foundation, the American Heart for postgraduate work in journalism.

Attending the Conference? GRANTS

Help bring the 2005 AMWA Annual Conference Specialist
to the membership through the AMWA Journal.
Add to your conference experience (not to
mention, your resume) by volunteering to write Jeremy Fields, Ph.D.
a brief summary of an open session or a special
guest’s lecture. If you’re interested, send an 29 years experience as a funded
e-mail to [email protected]. biomedical researcher
18 as a freelance medical writer

[email protected]
207-865-1478 (tel)
207-865-1479 (fax)

Clear, concise, coherent &

compelling proposals.

70 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 FREELANCE FORUM

Freelances just starting out and even those who have been freelancing for a few years have
many questions and concerns. The AMWA Journal is pleased to revive this regular feature
as a way to help freelances find answers and more information about topics of interest.

Q How valuable is it to list my information in the AMWA in the office next door to seek advice from, and there are no
Freelance Directory? colleagues to visit with over lunch. If you are going to be
contented in your life as a freelance, it is important that you
A The AMWA Freelance Directory is the only advertising take steps to avoid becoming isolated and lonely. Doing this
money I spend, and it is so well worth it! The cost of $75 a can be as simple as arranging to take an early morning or
year is far less than most businesses would pay for advertis- late afternoon walk with a friend or neighbor—but set a
ing. The impact of my directory listing has been tremen- time limit and stick to it. For example, I take a brisk early-
dous for my business. I usually receive at least 1 new con- morning walk with a friend just about every day. We always
tact a month (and sometimes more) as a result of my listing. take the same route, which takes about 35 minutes. While
I would say that about half of my contacts were looking for we walk, we talk almost nonstop about friends, family,
me because of my therapeutic areas of expertise, and the world events, whatever is on our minds, but when we arrive
other half were looking for writers in my geographic area back at our starting point, we say “goodbye,” and we’re both
(with a secondary focus on therapeutic area expertise). ready to get on with our day. Another good idea is to plan to
Potential clients can search for freelancers either of these meet a friend(s) or colleague(s) for lunch on a regular basis.
ways or by type of writing (pharmaceutical/regulatory, con- Once a week would be the ideal, but if time and/or money
tinuing medical education, patient education, etc). are important issues, try to do it at least once a month.
It is very easy to submit your listing to the Freelance Again, you should set a time limit so that you won’t end up
Directory, and you can modify it at any time—as often as “frittering” the day away and feeling guilty afterward.
you modify your CV as you add to your experience and Developing a “support group” of your peers is another
client base. In fact, you can use the HTML editor function way to make your life as a freelance more fulfilling and less
to paste your whole CV in the directory. One note of inter- isolating. Find some other freelances in your area and
est: I was unable to change my listing through my Netscape organize an informal group that meets monthly for lunch or
browser, but once I switched to Internet Explorer, I had no dinner to share information, problem solve, or just com-
problems. plain about difficult clients. Your local AMWA chapter is a
One challenging aspect of my directory listing is that I good place to begin recruiting members. I was a charter
get a lot of calls from recruiting agencies and headhunters. member of such a group when I lived in the Philadelphia
This can be an advantage on occasion, because sometimes I area and I always left our monthly luncheons feeling stimu-
can convince the recruiter to have the client consider me lated, renewed, and grateful for my life as a freelance. The
for contract work. Also, I have the opportunity to recom- Philadelphia group started with a core contingent of AMWA
mend people I know who might be looking for a full-time members, but word spread and the group soon expanded
opportunity. to include freelance writers and editors from other fields.
Overall, I highly recommend the online directory listing In addition to meeting monthly, members of a freelance
as an effective way to reach new clients. support group are “just a phone call away” when someone
— Sherri Bowen needs emergency advice or information.
— Donna Miceli

Q I enjoy the freedom I have as a freelance, but I miss the

daily interaction with my peers more than I thought I would. Q I am confused by all the business options for freelancing.
How do you cope with the isolation? Should I incorporate?

A There is no question about it, working from home can A Deciding whether to incorporate your freelance busi-
be isolating. On the one hand, it is easier to concentrate ness is as much a personal decision as it is a financial one.
and work more efficiently without the interruptions found I recommend that no one make that decision without the
in a typical office setting; on the other hand, there is no one advice of an accountant—a vital member of the business

AMWA JOURNAL . VOL. 20, NO. 2, 2005 71

team no freelance should be without. know some people who prefer to use an attorney. I don’t
Turning your freelance business into a “real business” believe it matters whether you use an accountant or attor-
offers potential advantages both for you and your clients. ney to help you incorporate, as long as the price is reason-
For the freelance, incorporation can provide a level of liabil- able and the job is done right.
ity protection for your personal assets, although it certainly — Brian Bass
does not absolve you from the moral obligations of our
craft. For the client, it makes it easier to do business with
you because corporations do not have to be tracked for Q How important is a Web site in marketing a freelance
1099 purposes. business?
Incorporation also provides an excellent framework for
the mindset of being a successful freelance. Being able to A Like any marketing endeavor, a Web site is one part of
work from home, choose your own hours, and select your a larger whole. Marketing must consist of a variety of
clients and projects, are freedoms that lure many to the communication avenues to get the word out and convince
freelance life. For some people, these freedoms can breed buyers. I don’t think any freelance should rely on any one
complacency. It is crucial to success that a freelance always method of advertising their services and expect to generate
conduct business in a business-like manner. The trappings optimal results. However, because electronic communica-
and rigors of running an incorporated business are con- tion is now so commonplace, I think a Web site is an inte-
stant reminders that freelancing is a business and that as gral part of the entire marketing picture.
freelances we are providing a service to our clients. Likewise, I originally did not create my Web site to get business.
incorporation sends a subliminal message of confidence to Rather, I created it as a quick way to weed out the wheat
clients about your permanence and commitment. You can (actual purchasers of freelance services) from the chaff
still go to work in your bunny slippers, as long as your mind (headhunters, resume collectors, agencies wanting multiple
knows where you fit in the food chain and you treat what bids but not yet having the job, etc). I built my Web site at
you do as a profession instead of a hobby. a time in my freelance career when I had most of the busi-
Freelances who decide to explore the incorporation ness I needed from referral (which by the way, is one of the
route further are likely to discover more questions to be best ways to get business). I was spending a great deal of
answered. Once again, your accountant will help you sort time compiling special requests for information about
through the options and make the best choices based on myself and my services, along with samples of my work.
your current situation and long-term goals. For example, This diverted my attention and time from paid work. I
today there are many more choices for setting up your decided if I could send people to a Web site for a general
business than there were even just 10 years ago. overview, if there truly was interest, the client would get
When I incorporated in 1989, my only options were to back to me for more specifics. This is similar to the way a
become a C-corp, which is a full-blown corporation, or an real estate agent would handle potential home buyers.
S-corp, in which all company revenue flows through to the The agent would send the potential buyers a listing and
individual. For me at the time, an S-corp was the best ask them to do a “drive by.” If they like the house then they
choice, and it remains the right choice for me now. How- make an appointment to see inside. My Web site is my
ever, today freelances also have the option of setting up as drive by.
an LLC (limited liability company), which can then be Not being Web savvy, I had a college-age Web guru
further delineated as a corporation, partnership, or propri- design my Web site for me under my direction. She used
etorship. C-corps, S-corps, and LLCs each offer different my letterhead and logo for the basics. The site includes my
protections and different potential financial advantages. picture, a resume, list of topics, samples, and links to jour-
Choosing the one that will be right for you depends upon nal articles I have written. I suggest freelancers visit lots of
your unique situation and income. Depending upon your Web sites of writers to get a sense of what can be included.
circumstance, the right choice might even be to not formal- While the intent of my Web site was to handle requests for
ize your business arrangement. This may be true if your samples, in recent years it has also generated work, although
income from freelance is below a certain level or if you not a lot. I link to the AMWA site—a must—and my site can
freelance as a part-time endeavor. be found with various search engines.
Once you have made your decision to incorporate, you Do you have to have a Web site? If you have all the
will need to choose a company name and file a lot of paper- business you want, probably not. But consider your compe-
work. I personally prefer to leave this to the professionals, tition. How many medical writers in your area doing your
such as an accountant or lawyer, just as I prefer my clients type of writing have a Web site? Evaluate whether you are
leave the medical writing to professional medical writers losing business because you don’t have one. Or, as in my
like myself. My accountant assisted me with everything case, evaluate the time savings it can have for you if you
from my name search to the final incorporation papers. I design it not just to attract interest, but to solve the prob-

72 AMWA JOURNAL . VOL. 20, NO. 2, 2005

lem of convincing individuals of your expertise. Remember
the old adage, time is money. And never forget the basics of AMWA’s Self-Study Workshop
marketing. Constantly prospect, especially when you are
most busy. Use various marketing techniques. And network,
network, network. I suggest you network about creating a
new Web site. Good luck.
Education is an important
— Barbara Rinehart
aspect of your profession, and
your time is valuable. A self-
study workshop allows you to
About the Freelance Forum Panel: Sherri Bowen, MA, ELS, has study at your own pace—the
been a freelance medical writer since 1995, mostly working with perfect answer to fitting an
the pharmaceutical industry. She began her career in medical
educational opportunity into
writing as a student extern at the University of Texas, M. D.
Anderson Cancer Center in Houston, where she was trained in your already busy schedule!
editing manuscripts for scientific publication. After earning her
Master’s degree in English, she went back to scientific editing Basic Grammar and Usage for Biomedical
and she later accepted a job with Norwich Eaton (now Procter & Communicators is the first in a series of self-study
Gamble) after placing a “job wanted” ad on the bulletin board
at the 1987 AMWA Annual Conference. There, she branched out
workshops available from AMWA. The self-study
into regulatory writing, which she continued with Pharmaco format consists of a workbook and an
(now PPD), a contract research organization. Donna Miceli has accompanying CD-ROM. Designed for profes-
been a freelance medical writer for about 15 years. She holds a sionals at all levels of experience, it is an excellent
degree in journalism and worked as a freelance writer, including
writing a weekly newspaper column, while raising her 4 chil-
tool for improving or refreshing grammatical skills.
dren. Her interest in medical writing began when she took a job It will remain a valuable resource for biomedical
as assistant director of public relations at a large hospital in communicators for many years.
Buffalo, NY. When her husband was transferred to Philadelphia
in 1989, she decided to return to freelancing and specialize in
health care communication. Her medical writing experience
The self-study workshop is available to AMWA
includes books, pharmaceutical sales training materials, scien- members at a discounted price of $155.
tific meeting coverage, health care newsletters, video scripts, and Purchasers who complete the workshop can earn
marketing materials. Brian Bass is president of Bass Advertising core curriculum credit. To order, contact Kendall/
and Marketing, Inc., in Robbinsville, NJ, which provides medical
Hunt Publishers at 800-338-8290 (e-mail:
writing solutions to firms specializing in medical communica-
tion, education, and advertising. Barbara Rinehart has been a [email protected]), or visit AMWA’s Web
freelance medical writer for more than 12 years. Her extensive site at www.amwa.org.
scientific background enables her to cover all therapeutic areas.
Many of her articles are indexed in Medline, while others are
used extensively in continuing medical education, training, Don’t delay; order your copy today!
and promotional efforts.
Other members of the Freelance Forum panel include
Cathryn Evans and Phyllis Minick. Cathryn originated the
Freelance Forum in 1994 and served as the only writer for the
feature for almost 7 years. She is the sole proprietor of Chandos
Communications and is the subject of the Member Profile in
this issue (see page 99). Phyllis served for 19 years as the head
of the editorial office at Scripps Research Institute, in La Jolla,
California, before establishing PM Publication Consultants.
She was one of the first members of the San Diego Professional
Editors Network (SD/PEN), a group started to provide a way for
freelance editors to share information and advice.

➲ Get an expert opinion from the Freelance Forum Panel!

Send your question to [email protected].

AMWA JOURNAL . VOL. 20, NO. 2, 2005 73

 INSTRUCTIONS PFOR CONTRIBUTORS
RACTICAL MATTERS

Writing Press Releases That Grab Media Attention

By Lois Baker

P
ress releases are the primary means of getting big The headline and lead are the 2 most crucial compo-
news to the public at large. Few developments will nents. They should be concise, informative, and engaging.
make your CEO or boss happier, other than a major If they are convoluted, poorly composed, and uninteresting,
stock boost, than seeing the company’s or institution’s the harried reporter will hit “delete” in a hurry. Make every
name in print. word count in the headline. Use active verbs, present tense,
Press releases are a different animal than most medical and alliteration if appropriate. Reporters are lovers of
writing, however. They require a specific writing style and words; otherwise they would be accountants. Avoid using
have their own rules and format. (Note the short sentences jargon, medical or otherwise, if at all possible.
and brief paragraphs.) Before we talk about form, however,
let’s talk about function. Keep these points in mind if you Consider this headline and lead:
hope to garner media attention. Brachytherapy Is an Effective Treatment for Breast Cancer
A press release is written for the press. Consequently, “Brachytherapy is an effective modality of treatment for
you need to follow AP style, not AMA style. breast cancer, according to a new study presented October
The purpose of a press release is to circulate actual 8, 2002, at the American Society for Therapeutic Radiology
news. The New York Times will not be interested in hear- and Oncology’s Annual Meeting in New Orleans.”
ing about your new CEO unless it’s Steve Jobs. Save it for
your local media. Now consider this headline, subhead, and lead:
Proper targeting is essential. Major media outlets have Brachytherapy Zaps Breast Cancer
reporters who cover specific subjects, or beats. If you Common Prostate Cancer Treatment May Also Help Women
have major financial news, send your release to the “A radiation therapy that uses tiny implants to zap prostate
financial editor, or better yet, to a financial reporter you cancer tumors from inside the body may also help prevent
have cultivated. breast cancers from coming back after surgery.”
Send your releases by e-mail. Nearly all press releases
these days are transmitted electronically. Good media If you were a reporter, which would you find more
guides, such as Bacon’s media directories and Bulldog engaging and informative? Number 2, hands down.
Reporter’s National PR Pitch Books provide names and The press release “middle” expands on the information
e-mail addresses. in the headline and the lead. It usually contains the follow-
ing information:
Now, on to form: Think of a press release as a story, with Brief discussion of the condition, problem, or drug
a beginning, middle, and end. The “beginning” is the most discovery being investigated or reported; may involve
import aspect of the release. It comprises several essential quotes from researcher or primary source.
components: Description of research and methods, if reporting on
Headline. Should get main idea across in the fewest research. You don’t need to include every detail; just
number of words: aims to capture the reader’s interest enough so the reader can make sense of the results.
immediately. This section might cover the context of the study, its
Dateline. City and state of the releasing institution. purpose, how it was conducted, number of people or
Lead. The first paragraph, ideally only 1 sentence: animals involved. If human subjects were used, indicate
encapsulates the primary news/study finding. the structure of study (case-control? randomized?
Second lead. If needed, expands on the lead or reports prospective? blinded?).
a second major finding. Summary of results, including statistics, using lay lan-
Comment from chief researcher/expert/spokesperson guage. This is a more detailed, but still brief review of
on the relevance and significance of the findings, news, the findings you have mentioned in the lead.
event, etc. continued on page 76

74 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 Successful Outsourcing in Medical Communication
By Cynthia L. Hooper, MA, and Janet A. Zucker, PhD

T
he cost of delivering innovative medicines continues tions for both the sponsor and CRO staff should be clearly
to rise, and pharmaceutical companies need to expressed and defined. Do not assume that expectations
optimize drug development processes. Outsourcing and assumptions are shared; clarify all points and discuss
clinical development is an effective way to ensure resource concerns. Minutes from the project initiation meeting
flexibility. should include a list of deliverables with the responsibility
The outsourcing of medical communication services to for each deliverable assigned to either the sponsor or the
contract research organizations (CROs) is becoming more CRO.
common and can add efficiencies in time and resources An overall process flowchart should be generated that
when managed successfully. Forming a sponsor/CRO part- identifies specific responsibilities and outlines the steps
nership with mutual expectations for high-quality docu- for completion of the documents. It is important to ensure
ments is the key to successfully managing these services. alignment with all team members before finalizing a
After 4 years of working together on outsourced regula- process flowchart. Identifying decision-makers early in the
tory communications projects, including a major submis- project and involving specific team members at the appro-
sion package, we have identified several key factors for priate time will make the process more efficient.
ensuring a positive and effective sponsor/CRO partnership. Timelines for completion of documents should be
created together. Jointly establishing document timelines
Plan Early allows for sponsor needs to be met while considering
A project initiation meeting is essential for establishing a sponsor and CRO processes. Sharing the responsibility for
good working relationship between the sponsor and the optimizing the timeline creates commitment, ownership,
CRO. For fully outsourced programs that include multiple accountability, and partnership.
documents, the sponsor should schedule a face-to-face Sponsors have a company-specific vocabulary, which
team meeting that includes staff involved with medical should be shared with the CRO. The sponsor should supply
communication, data management, statistics, and project a company style guide and a brief product-specific style
management. For smaller projects (for example, a single sheet to the CRO staff to assist them in understanding the
document), the project initiation meeting may be conduct- sponsor’s terms and expectations for documents. The prod-
ed during a teleconference and may only include medical uct-specific style sheet should be updated periodically dur-
communication staff. The sponsor should provide the fol- ing the project.
lowing information to CRO staff prior to the project initia-
tion meeting: Clarify How the Team Will Communicate
Background information on the compound and disease Communication is very important in the success of a proj-
state ect. Point people for contact between the sponsor and CRO
Overall clinical plan should be identified, both for the overall project and for
Study protocols or design expectations each functional group. The types of meetings (for example,
Guidance on process teleconference, face-to-face, video conferences, Web con-
Templates and standard operating procedures to be ferences) that the team determines are necessary, who
used should be included at the meetings, and how frequently
Draft timeline, including any known limiting factors the meetings will occur should be established at the project
initiation meeting. Both sponsor and CRO staff need to
Both sponsor and CRO staff should prepare for the proj- ensure accessibility for the prompt resolution of questions.
ect initiation meeting by providing a list of key deliverables,
a summary of their understanding of their role in the proj- Create a Collaborative Relationship
ect, the expertise that they will bring to the project, and the The most beneficial decision a sponsor and CRO can make
risks for the project, with mitigation strategies to overcome is to create a collaborative relationship. Both sponsor and
the risks. CRO staff should consider themselves as members of 1
team, working together toward a mutually beneficial goal.
Establish Roles, Responsibilities, and Expectations This collaborative attitude allows for open and honest dis-
The project initiation meeting provides an opportunity for cussions when issues arise and facilitates a problem-solving
open discussion where questions on the roles and responsi- approach to issues. Both sponsor and CRO staff need to
bilities of the sponsor and CRO are addressed. The expecta- remain flexible to changes that would enhance the relation-

AMWA JOURNAL . VOL. 20, NO. 2, 2005 75

ship and create more efficient processes. Mutual respect and Writing Presss Releases continued from page 74
trust are essential to a collaborative relationship and are expec-
The “ending” wraps the information into a neat
tations of a successful team. Sponsor and CRO staff should
package. It should include:
acknowledge each other’s expertise and how it contributes to the
A final word from researchers or an expert sum-
success of the project, and they should share the challenges and
ming up the findings and noting the next step in
successes of the project.
the research or project, if the researcher or expert
Cynthia Hooper is senior scientific communications associate, Global has something pertinent to add.
Medical Communications, at Eli Lilly and Company, Indianapolis, IN. A list of additional authors/researchers/contribu-
Janet Zucker is director of medical and scientific writing, Regulatory tors.
and Technical Services, at Quintiles, Inc., Research Triangle Park, NC. The funding source, if applicable.

This format, combined with polished and gram-

matical writing, should bring the attention your
GUIDELINES FOR SUCCESSFUL OUTSOURCING news deserves.
IN MEDICAL COMMUNICATION On a final note, here are some pitfalls to avoid
when composing your press release:
Partnership management Create a collaborative team attitude: Too much scientific jargon
a sponsor/CRO team Inaccurate reporting of statistics
Maintain a positive attitude through Missing the main point
good relationships Breaking a journal embargo
Communicate expectations and
Not talking to the researcher/expert/spokesper-
assumptions
Ask questions, identify problems, and son
proactively address issues Not targeting your release
Remain flexible to change Including too much or too little information
Involve the right people at the right
times Lois Baker is senior health sciences editor at the
Identify the decision-makers early
Mutually respect and trust each University at Buffalo State University of New York
team member’s contribution (SUNY).
Maintain the consistency of the team
Accept ownership and accountability
Celebrate the team’s successes

Roles and expectations Establish roles and responsibilities at

the initiation of the program
Establish expectations for quality and
efficiency
Clarify and prioritize details
Document agreements

Communication Decide on the types of communica-

tion to be used (e-mail, phone
calls, scheduled status meetings).
Establish how frequently communica-
tion should occur (weekly, biweek-
ly, monthly)
Determine if face-to-face or team-
building meetings are needed

Technology Identify the authoring tools to be used

Determine how training and guidance
will be provided

Writing strategies Create a program-specific model

document or document outline
Use electronic output when available
Use and maintain project-specific
style guides

76 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 REPORTS FROM OTHER MEETINGS

Conflict of Interest and Scientific Publication:

A Synopsis of the CSE Retreat
By Claudia Clark

A retreat by the Council of Science Editors with funding from managing COI? Are they sufficient? Can we draw any con-
the Greenwall Foundation, the American Heart Association, clusions from current practices and come up with better
and the American Society of Clinical Oncology strategies?
October 29-31, 2004 After the keynote address on Friday evening, other pre-
Hyatt Lodge at the McDonald’s Campus, Oak Brook, Illinois sentations started the following morning and continued
Retreat cochairs: Jessica Ancker and Annette Flanagin until about noon on Sunday. (The retreat program can be
viewed at www.CouncilScienceEditors.org.) Presentations

I
n science, conflict of interest (COI) refers to “situations ran consecutively and lasted 10 to 25 minutes. A 10-minute
in which financial or other personal considerations may question-and-answer session followed each presentation
compromise, or have the appearance of compromising, or group of presentations. To promote open discussion of
an investigator's professional judgment in conducting or the issues, all participants were guaranteed that what they
1
reporting research”, according to guidelines of the said would not be quoted or paraphrased without their per-
Association of American Medical Colleges. The Council of mission. That made for thought-provoking presentations
Science Editors,2 the World Association of Medical Editors,3 and lively discussions. Speakers and other participants
and others also have defined and delineated COI. discussed study results, recounted anecdotes, and
Researchers, reviewers, editors, journals, institutions, and expressed a variety of opinions.
funders all can have COIs.
To address COI in scientific publication, the Council of FRIDAY, 29 OCTOBER
Science Editors held a retreat on 29-31 October 2004. The Evening Session: Keynote Address: Conflict of Interest
Greenwall Foundation, the American Heart Association Policies in Science and Medical Journals
(AHA), and the American Society of Clinical Oncology sup- Presented by Sheldon Krimsky, Professor of Urban and
ported the retreat with $20,000 in grants. The grants made Environmental Policy and Planning, Tufts University
the attendance of four international editors possible and
helped to fund the speakers. Sheldon Krimsky provided an overview of the topic of COI
The goal, as stated in the program, was for participants in science and medical journals. Krimsky has been studying
to discuss “the effects of financial conflicts on scientific the interface between science and technology, ethics, and
research and editorial and publication decisions, and to public policy for more than 30 years. He is the author of
review and debate current strategies for managing conflicts more than 140 reviews and essays and seven books on the
of interest in scientific publication”. The 78 attendees—in- subject. His most recent book, Science in the Private
cluding editors, researchers, representatives of private and Interest: Has the Lure of Profits Corrupted Biomedical
government funding agencies, representatives of pharma- Research? published in 2003, focuses on COIs in biomedical
ceutical companies, legal experts, and journalists—dis- research.
cussed and debated such questions as the following: What Through examples and published studies, including
constitutes a COI for an author, reviewer, editor, or institu- some of his own, Krimsky posed a series of questions, such
tion? What are the effects of COI on scientific research and as the following, and offered some partial answers:
publication? What policies and procedures are in place for How have journals responded to COIs? One of Krimsky’s
studies showed that 16% of the 1396 high-impact jour-
This report originally appeared in Science Editor, the periodical of nals that he and his coauthor selected had COI policies
the Council of Science Editors (www.CouncilScienceEditor.org). in 1997.
Science-and-mathematics writer Claudia Clark prepared the report What types of COI policies do journals have? Journals’
while a Science Editor intern. COI statements to authors vary widely. They include
one-sentence requests for information (for example,

AMWA JOURNAL . VOL. 20, NO. 2, 2005 77

 “The journal requests information about the authors’ were not made available to JAMA by the paper’s authors, all
professional and financial affiliations that may be per- of whom were either employees of the drug’s manufacturer
ceived to have biased the presentation.”), lists of COIs or paid consultants.
that the authors must check off, and more complex Lisa Bero, professor of clinical pharmacy and health
statements with multiple questions. policy at the University of California, San Francisco, gave
How well do authors comply with COI policies? In a the next presentation, which focused on how academic
study of 181 peer-reviewed journals with COI policies, institutions manage their faculties’ financial disclosures.
authors of 0.5% of the articles had something to dis- She noted that disclosure (as opposed to restrictions or
close. In a study of 192 writers of a total of 44 clinical bans) is the most commonly used means of dealing with
guidelines, 90 of the 100 writers who responded “had COI in universities; this is not surprising, she said, given the
financial ties to companies whose drugs were either culture of academic institutions, where “bias is considered
considered or recommended in the guidelines they to be conscious” and therefore manageable. Bero discussed
wrote”. However, a COI was reported in only one of the work in which she found that studies funded by private
44 guidelines written. sponsors were about five times as likely to have favorable
Why is disclosure of COIs important? It is especially results as studies funded by nonprivate sponsors. And
important because of the increasing financial links these, she noted, were the results of studies in which there
between for-profit corporations and the research com- was disclosure! She also discussed a 1981 study that
munity and because journals are the “gatekeepers of demonstrated an association between second-hand smoke
certified knowledge”. and lung cancer and the tobacco-industry-funded study
created to refute it. To hide the connection to the tobacco
Krimsky concluded his remarks by drawing an analogy industry in the second study, not all authors were disclosed,
between COIs in scientific publishing and the Enron affair, and the disclosures that were published were misleading.
in which the energy giant Enron Corporation, in collusion Bero concluded that disclosure does not prevent bias.
with its accounting firm, Arthur Andersen, released false Drummond Rennie, deputy editor of JAMA and a pro-
financial reports that hid serious problems. He noted that fessor in the Department of Medicine in the Institute for
“we no longer tolerate disclosures of auditing companies Health Policy Studies, University of California, San
that audit financial houses [but] have other financial rela- Francisco, gave a thoughtful presentation titled “Why What
tionships with those houses. . . . So we have to decide in the We Think Works Doesn’t”. He said that we need money to
publishing arena when disclosure is enough and when pro- flow to inventors and developers of new drugs. The problem
hibition is appropriate.” comes when that money flows from the manufacturers of
the new drugs to those who test them by conducting trials
SATURDAY, 30 OCTOBER in humans. The public must be able to trust those who test
Morning Session: Evidence and Experiences of drugs to conduct the most appropriate tests and to report
Researchers and Institutions their results faithfully. But in this new world, because of the
Moderated by Faith McLellan, North American Senior direct influence of money, the trust between the public, sci-
Editor, The Lancet, and President, Council of Science entific journals, and clinical researchers has been repeated-
Editors ly broken by monetary interests competing for the loyalty
and attention of the researchers. A basic problem was
The morning began with a presentation by Cary P Gross, exemplified by what happened when JAMA published, in
associate professor of internal medicine at the Yale 1990, an editorial calling some postvaccination neurologic
University School of Medicine, who discussed the preva- problems “a myth”. First, a newspaper pointed out that the
lence and seriousness of financial COIs. He said that the researcher had worked for a vaccine manufacturer, but
existence of a COI doesn’t necessarily lead to bias. He did, there was no disclosure of that. The researcher then admit-
however, describe how COI can lead to bias at each step in ted that he was wrong to sign the JAMA forms stating that
the bench-to-bedside process of clinical research: during he had no such conflicts. And finally, none of those who
study design, participant recruitment, study conduct, data wrote to protest his failure to disclose his financial conflicts
analysis and interpretation, publication and dissemination, declared any financial conflicts themselves, although
and interpretation and synthesis of evidence. He illustrated almost all, when pressed, admitted to having testified on
with such examples as the Celecoxib (Celebrex) Long-term this very issue for money on numerous occasions. That
Arthritis Safety Study of 2000. A paper on the study, submit- episode and others show that we are simply unable to see
ted to JAMA with 6 months of data, indicated a lower inci- our own conflicts, although we are quick to see them in oth-
dence of “ulcer complications” among Celebrex users than ers: “You have a conflict, but I don’t. I’m pure, but you’re
among users of other nonsteroidal anti-inflammatory not.” Rennie discussed a problem with disclosure: the bury-
drugs. In fact, 12-month data showing a less favorable result ing of the receipt of one huge sum of money from one

78 AMWA JOURNAL . VOL. 20, NO. 2, 2005

sponsor among pages listing relatively trivial connections. “reasonable” profit. In response to a question about bringing
To reestablish trust, Rennie said, he has long supported the the PhRMA Principles on Conduct of Clinical Trials up to
creation of an independent agency to do drug testing and date, Antony said that PhRMA had revised the document in
supports a publicly accessible registry of all clinical trials June 2004 and that future revisions could be expected.
initiated. The final speaker of the session was Joan P Schwartz,
The final speaker of the session was C. K. (Tina) Gunsalus, assistant director of the Office of Intramural Research at the
adjunct professor and special counsel at the University of National Institutes of Health (NIH). She indicated how COI is
Illinois. Gunsalus presented examples of COI problems that addressed in the NIH intramural-research program. She also
cropped up repeatedly in university settings over a 20-year presented a draft of new guidelines for preventing financial
period and concluded that universities have not been and COI in human-subjects research at NIH. The draft outlined
are not likely to be able to solve the problems as they present prohibited activities of scientific staff and their immediate
themselves in our current funding and policy environment. families, such as receiving honoraria from commercial spon-
Unless journals take a stand, she concluded, we will not see sors of their research, and listed guidelines for handling NIH
much substantial change; the actors with the ability and intellectual property and royalties. She finished by outlining
the will to make changes are journal editors, ideally acting the NIH rules established to safeguard the objectivity of NIH-
collectively. funded research.

Midmorning Session: The Experiences, Concerns, and Afternoon Session: Regulatory and Legal Concerns
Policies of Funders Moderated by C. K. (Tina) Gunsalus, Adjunct Professor and
Moderated by Catherine D. DeAngelis, Editor-in-Chief, JAMA Special Counsel, University of Illinois

After a short break, the discussion moved on to funders’ The afternoon sessions began with three speakers discussing
experiences, policies, and concerns. The first speaker was regulatory and legal issues. Steven Nissen, of the Section of
Rita Redberg, professor of medicine and director of Women’s Clinical Cardiology at the Cleveland Clinic, spoke about the
Cardiovascular Services at the University of California, San Food and Drug Administration (FDA) regulation process. As a
Francisco, School of Medicine. As a member of the AHA member of the FDA Cardiovascular and Renal Drug Advisory
Scientific Publishing Committee and chair of the AHA COI Committee, Nissen has had opportunities to compare actual
working group, Redberg discussed the AHA COI standards for trial data submitted to FDA with data reported in scientific
research funding, scientific publishing, scientific statements, journals. He listed some ways in which researchers have
and professional education. She noted that over the last few manipulated their results to report more favorable results to
years, the COI working group has been “working on tighten- journals: serious adverse effects are incompletely reported,
ing COI standards”; for example, it has “better defined what inappropriate emphasis is placed on nonprespecified sub-
is conflict, in terms of levels of money”, and verified that COI groups, and unfavorable results are not reported. Nissen
disclosures are being gathered. She recalled the summer 2004 made a number of suggestions: Researchers should give edi-
publication of the updated National Cholesterol Education tors and reviewers the study protocol and statistical analysis
Program (NCEP) guidelines–endorsed by AHA–which was fol- plan; in industry-sponsored studies, editors should demand
lowed by mass-media criticism of the NCEP’s failure to reveal an independent data analysis (by an academic coordinating
the financial ties of guideline-committee members. Upon center, for example); and editors should require commercial
becoming aware of the situation, the AHA focused on ensur- sponsors to place data into the public domain in 5 years.
ing that its COI standards—which include publishing disclo- Also, Nissen said, editors should be aware that some of
sures with guidelines—were being applied and increased the researchers’ “real conflicts” are not financial; for example, the
amount of formal discussion about COIs. researcher’s ego might be involved, the funder of the study
Paul T. Antony, chief medical officer of Pharmaceutical may be a potential employer, or the researcher may want to
Research and Manufacturers of America (PhRMA), presented please the sponsor.
a pharmaceutical-industry perspective. He noted that phar- James R. Ferguson, partner in the law firm Mayer, Brown,
maceutical companies recoup research and development Rowe & Maw, spoke about the growing use of patents in bio-
costs on only three of 10 medicines. He also expressed indus- medical research, in particular DNA patents held by universi-
try concerns about clinical-trial registration proposals that ties. Although patents can serve as an incentive for research,
weakened intellectual-property protection. Antony talked he recognized some people’s concern that patents can
about the “implied contract” between the individual and the impede rather than promote biomedical research by prevent-
pharmaceutical industry: In exchange for industry’s accept- ing use of the results of the research; several observers have
ing regulation and sharing innovation to the extent that it is noted that as universities have become more aggressive in
financially feasible, the pharmaceutical industry has a right enforcing their patents, they have also become more vulnera-
to treat some information as proprietary and to achieve a ble to patent-infringement claims.4 Still, Ferguson said, “we

AMWA JOURNAL . VOL. 20, NO. 2, 2005 79

shouldn’t be quick to eliminate the patent system” without scientific journals spoke about the COI policies of their
replacing it with a better one. He noted that the Federal journals. The speakers were Faith McLellan, senior editor of
Trade Commission and other government agencies have The Lancet; Catherine D. DeAngelis, editor-in-chief of
proposed changes to improve the system, such as having JAMA; Juan Carlos Lopez, editor of Nature Medicine; Katrina
the Patent and Trademark Office apply a higher burden of Kelner, deputy editor, life sciences, of Science; Rita Hanson,
proof for granting managing editor of
patents or providing
alternatives to litigation
“The heart of research lies in altruism Environmental Health
Perspectives; and Martin
to those who would and trust. Without that we’re doomed.” Blume, editor-in-chief
challenge the validity of at the American
Catherine D. DeAngelis
patents. Physical Society (APS).
Richard Painter, professor at the University of Illinois Most gave examples of COIs at their journals. Although a
College of Law, began by addressing an issue raised earlier few editors, particularly Blume, noted nonfinancial COIs,
in the day: whether and, if so, under what conditions a jour- the discussion centered on financial issues. Highlights of
nal has the right to sanction an author who has violated its the discussion included the following:
COI policy. He noted that one approach to misconduct is to Most editors noted that their journals had either created
refuse to publish work by an author for some period, after or updated their COI policies in recent years. But differ-
which the journal editor might exercise higher scrutiny ences in addressing COIs were notable, in part because
when reviewing the author’s work. Painter stressed that he different journals face different issues. Blume noted that
would not publish a notice of such action and that the less APS has both the means and the time that medical jour-
said to other people, the better, from the standpoint of nals do not have to replicate questionable results and
reducing liability exposure in a possible action for libel or publish corrections: “No lives are at stake.”
restraint of trade. The editor, however, could respond to Journals owners differ in their attitudes toward accept-
another journal’s inquiry about the author with such a ing funding. For example, Lopez noted that, to fund
comment as “we don’t feel comfortable publishing that special supplements for which no money is appropriat-
author’s work”. Furthermore, because truth of the matter ed in the annual budget, Nature approaches commer-
asserted is a defense against an action for libel, Painter said cial and noncommercial funders. JAMA does not.
that a journal should keep documentation of the author’s Another issue was access to original data. JAMA requires
violation and be able to prove it. that at least one author without any commercial fund-
Painter then turned to the issue of insider trading. This, ing have full access to the data.
he said, is a potential problem for journals that either have Differences existed with respect to disclosure, the focus
embargo policies for journalists or send out prepublication of much of the discussion. All six editors agreed that
information to a select group of subscribers. In either case, some type of disclosure was necessary, perhaps to
if the material is used for financial gain, the journal is inform readers and let them decide for themselves, as
exposed to charges of facilitating insider trading; therefore, Lopez noted, or to act as a deterrent. Disclosure may
Painter does not favor embargo policies. With respect to also help to establish trustworthiness, which DeAngelis
prepublication materials sent out to some subscribers, his said is critical: “The heart of research lies in altruism
solution, which drew an appreciative chuckle from the and trust. Without that we’re doomed.” But there the
audience, would be to send out any of this material to the policies parted ways. What was to be disclosed varied.
largest base possible, essentially getting the information Most of the six editors agreed that employment by a
into the public domain. funder or stock held in a funder’s company was a COI
that a researcher should disclose. But, McLellan asked,
Midafternoon Session: Journal Policies and Experiences is it a COI for a researcher to own, or apply for, a patent
Moderated by Annette Flanagin, Managing Senior Editor, for a product related to his or her research if the
JAMA researcher’s institution requires this (as an increasing
number do)? Who was to disclose COIs also varied: The
A session on journal policies and experiences followed. The Lancet, among others, requires reviewers, as well as
retreat cochairs, Annette Flanagin, managing senior editor authors, to disclose COIs. In addition, it was noted that
at JAMA, and Jessica Ancker, of the Mailman School of editors are expected to disclose conflicts of interest or
Public Health, Columbia University, began the session by recuse themselves.
presenting some data on current journal COI policies. Of 84 Where should the line be drawn? Again, it depends on
high-impact-factor journals they reviewed, only 28 (33%) whom you ask. For example, during his keynote
publish COI policies in or with the instructions for authors. address, Krimsky had noted that in 2002, the New
After Flanagin and Ancker’s presentation, editors of six England Journal of Medicine, after 10 years of not

80 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 accepting review articles and editorials from authors among science journal editors as to what constitutes a COI
with financial ties to industry, began doing so from would be helpful, along with full disclosure of COIs. That
authors who earn up to $10,000 annually in speaking information would help newspapers to decide what to
and consulting fees from a company that manufactures publish.
a product written about in the article. (Editors of the Noting that “the appearance of conflict is as big as the
journal found that it had become difficult to find actual thing”, Snigdha Prakash, a reporter with National
experts who had no financial ties.5) Public Radio, spoke about how journalists approach and
Methods differed for encouraging compliance: When manage COI. She noted that some COIs are obvious and
submitting papers to Science, authors must complete an others are not. In any case, “not only must [journalists] be
online form that requires them to answer questions fair and balanced; the public must believe they are.” Why
about COI; some other journals still require submission does COI in scientific publication interest her? As a journal-
of a paper form with a signature. Deterrents to nondis- ist, she said, she has the job of understanding the issues
closure also varied: Some journals publish a retraction and asking tough questions. “We know that money talks”,
and an online notice if prepublication disclosure of a she said. “But what is it saying? . . . If [scientific-journal edi-
COI would have resulted in the article’s being rejected. tors] don’t know or try to know, how can I?”
Of the journals represented at the session, only
Environmental Health Perspectives prohibits researchers Midmorning Session: Wrapup Session
guilty of willful failure to disclose COIs from publishing Moderated by Drummond Rennie, Annette Flanagin, and
in its pages; the prohibition lasts for 3 years. Jennifer Ancker
Is disclosure sufficient? Most of the editors agreed with
earlier presenters in saying that, although necessary, it The final session was devoted to refining a list of questions,
is not sufficient. Many examples attest to that, as the generated by Flanagin and Ancker, that science editors
speakers demonstrated. At the very least, they said, sys- could ask themselves when updating or creating COI poli-
tematic research should be performed on the effective- cies for their journals. The resulting “consensus document”
ness of disclosure and other methods in discouraging is ultimately to serve as a framework, not a prescription. It
noncompliance; the methods could include prohibiting will appear in a forthcoming issue of Science Editor and on
the publication of papers for which COIs exist. Kelner the CSE Web site.
stated that the peer-review process and the replication
of data might be more powerful than disclosure in vali- Acknowledgment
dating data. And, as Rennie noted, “naming and sham- I am grateful to the speakers for feedback on their sections
ing” researchers who fail to disclose can be more effec- of this report.
tive than more severe measures, which may not be war-
ranted. Not all researchers, it was noted, fail to disclose References
out of bad intent; they may do so out of ignorance. (For 1. Guidelines for dealing with faculty conflicts of commitment and
example, guidelines may be too vague or too narrow or conflicts of interest in research. Adopted by the Executive
Council of the Association of American Medical Colleges
may lack examples; it is not always obvious what a “rele-
February 22, 1990. www.aamc.org/research/dbr/coi.htm.
vant” conflict is.) It was observed that editors have some
Accessed 22 November 2004.
responsibility for educating authors about COI. 2. Editorial policy statements approved by the Council of Science
Editors board of directors. www.councilofscienceeditors.org.
SUNDAY, 31 OCTOBER Accessed 23 November 2004.
Morning Session: Policies, Experiences, and Interests of 3. World Association of Medical Editors recommendations on
the News Media publication ethics policies for medical journals.
Moderated by Annette Flanagin, Managing Senior Editor, www.wame.org/pubethicrecom.htm#conflicts. Accessed 22
November 2004.
JAMA
4. Eisenberg RS. Patent swords and shields. Science 2003;299:
1018-9
Sunday began with presentations by two journalists on COI 5. Drazen JM, Curfman GD. Financial associations of authors.
issues and the media. Lindsey Tanner, a medical writer with N Engl J Med 2002;346:1901-2.
the Associated Press who covers about a dozen journals in
the Chicago area, began by speaking about the standards
of integrity in the news media. Although editors want every
financial tie reported, she said, not all such ties are equal—
for example, earning a small one-time fee from a company
differs from owning stock in a company—and the reader
may find long disclosures boring. She feels that a consensus

AMWA JOURNAL . VOL. 20, NO. 2, 2005 81

 2005-2006 AMWA Slate of Officers

Each year, the slate of AMWA officers is chosen by the The following candidates were approved by the Board of
nominating committee, which consists of the President- Directors at its spring 2005 meeting:
Elect (who serves as chair) and 6 voting members who are
not members of the executive committee (EC). The nomi- PRESIDENT-ELECT
nating committee receives from AMWA headquarters the The President-Elect must be a Fellow of AMWA and must
names and biographies of all members meeting the criteria have held several positions on the EC or must have served on
for the 3 elective offices: President-Elect, Secretary, and the EC for at least 3 years; in either case, he or she must have
Treasurer. Each member of the committee selects the top 3 been a member of the EC the year immediately before being
potential candidates for each office, with further discussion nominated to the position.
yielding 1 candidate for each position. The names of these
candidates are then presented to the Board of Directors for James R. Cozzarin, ELS, is cur-
approval at its spring meeting. rently serving as Secretary and
The President-Elect chair of the constitution and
automatically assumes the bylaws committee, following a
office of President at the term as administrator of the
annual business meeting Annual Conference in 2004 and
held during the annual 2 successful terms as adminis-
conference of the following trator of development. Since
year. The 2005-2006 AMWA joining AMWA in 1995, Jim has
President will be Susan E. served at the local level as Ohio
Siefert, ELS, CBC, supervi- Valley Chapter president, vice
sor of medical writing at president, Deer Creek conference administrator and regis-
Cyberonics, Inc., of trar, and chair of that chapter’s popular Kaleidoscope
Houston, Texas. A member Session. Jim has created and led noncredit and credit work-
of AMWA since 1990, Susan shops at many local and national conferences, including
has held numerous chapter the Asilomar conference, and has been a breakfast round-
offices, including the presidency of the Ohio Valley chapter, table leader and open session chair.
and has also served on several committees at the national Named an AMWA Fellow in 2002, Jim has served AMWA
level. She has led roundtable sessions and educational at the national level for more than 9 years. He was a dele-
workshops at AMWA conferences and has been a delegate gate to the Board of Directors for the Ohio Valley Chapter
to the Board of Directors and a member of its EC, serving as for several years and has been a member of several national
the annual conference administrator for the 2001 Annual committees, including the membership and budget and
Conference in Norfolk, Virginia. She was named a Fellow of finance committees, as well as several ad hoc committees,
AMWA in 2002. including the member forum task force and the elections
Susan graduated from the University of Texas at task force. An editor of AMWA’s self-study modules, Jim has
Arlington. She is accredited by the Board of Editors in the also served for more than 7 years as a manuscript editor
Life Sciences as a life sciences editor and by the Business and peer reviewer for the AMWA Journal. Jim has earned
Marketing Association as a Certified Business Communi- both his core and advanced curriculum certificates. A cre-
cator. Before joining Cyberonics, Susan held positions at dentialed editor in the life sciences, Jim has been a member
Memorial Health University Health System in Savannah, of the Board of Editors in the Life Sciences since 1998 and
Georgia; Letterman Army Institute of Research in San has been a member of the Council of Science Editors since
Francisco; Supreme Headquarters Allied Powers Europe 2002. He was awarded membership in Who’s Who in
(NATO) in Brussels, Belgium; Japan University in Fujisawa, America in 2005 and 2004, Who’s Who in the World in 2004,
Japan; and St. Mary’s University in San Antonio, Texas. She and International Who’s Who of Professionals in 1999.
received the Commander’s Award for Civilian Service in Previously a junior high and high school English teacher
recognition of her contributions to the quality of scientific and law book editor, Jim is currently an editorial manager at
publications at Letterman Army Institute of Research. Pro ED COMMUNICATIONS, INC., in Beachwood, Ohio, a
health science communications firm servicing a global
pharmaceutical client base, where he has been employed
for more than 10 years.

82 AMWA JOURNAL . VOL. 20, NO. 2, 2005

SECRETARY then, she worked at a medical communications company,
The Secretary is generally a Fellow of AMWA and must have taught pharmacy courses, was a clinical pharmacist, and
served in several capacities on the EC within the 5 years was a clinical research scientist at a major pharmaceutical
immediately preceding nomination to the position. company. She is accredited by the Board of Editors in the
Life Sciences as a life sciences editor. She holds a doctor
Sue Hudson currently serves as of pharmacy degree from the University of the Sciences
the education administrator and in Philadelphia and a bachelor of science degree in phar-
as a member of the constitution macy from the University of North Carolina at Chapel Hill.
and bylaws committee. She was
awarded fellowship in 2004. A Procedure for Additional Nominations
member of AMWA since 1997, According to AMWA’s Bylaws (Article III.1b), additional
Sue has served AMWA in many nominations for President-Elect, Secretary, or Treasurer
capacities on the national level, may be made by any member whose dues and special
including workshop coordinator assessments are current, provided that any such nomina-
(2004), education committee tion is submitted in writing to the secretary of AMWA at
(2003-2004), annual conference least 30 days before the annual business meeting (at
coordinator (2002), administra- the annual conference [September 30, 2005]). Such a
tor of chapters (2001-2002), and the nominating committee nomination must state clearly the qualifications of the
(1999-2001). She has also led roundtables, workshops, and candidate, must be signed by 50 members in good
moderated open sessions at the annual conference. At the standing as of December 31 of the previous year, and
chapter level, she is past president of the Pacific Southwest must be accompanied by a letter from the candidate
Chapter and directed the West Coast regional conference at stating that he or she is willing to serve if elected.
Asilomar in 1999, 2001, and 2003, and 2005. Sue earned a
bachelor’s degree in journalism at the University of
Minnesota and currently collaborates with her husband in
their freelance business, Medical Writing Associates, in
Simi Valley, California.

TREASURER
The Treasurer must have served on the budget and finance
committee within the 5 years preceding nomination to the
position.

Cindy W. Hamilton,
PharmD, ELS, an AMWA
member since 1984, has
completed 2 terms as
Treasurer. She coordinated
the 2003 Annual Confer-
ence in Miami and handled
the local arrangements
for the 2001 Annual
Conference in Norfolk.
In 2002, she was adminis-
trator of chapters. She
chaired the task force that, in 2002, developed a position
statement on the contributions of medical writers to
scientific publications. Cindy was instrumental in organiz-
ing a satellite group of AMWA members in southeastern
Virginia, and she has also led AMWA workshops and
breakfast roundtables.
Since 1990, she has been principal of Hamilton House,
a medical writing and editing firm in Virginia Beach. Before

AMWA JOURNAL . VOL. 20, NO. 2, 2005 83

 PROFESSIONAL DEVELOPMENT RESOURCES

AMWA Debuts the Professional Development Certificate

By Karen Potvin Klein, MA, ELS
Administrator of Publications

P
erhaps you’re a veteran of AMWA’s educational pro- although this program is designed for AMWA members, it is
grams. You display your completed curriculum cer- also available to nonmembers who meet the requirements
tificates in your workspace, and you even completed and pay the nonmember fee.
the advanced certificate program. Or maybe you’d like an Every effort has been made to ensure that applying for a
alternative to the core and advanced curriculum programs, PDC is straightforward. When you’re ready to apply, gather
and you’re looking for new ways to document to clients or up your documentation, complete the PDC form, and mail
your employer your continued commitment to (and partici- it to AMWA headquarters with a check for $45 ($150 for
pation in) professional development. How can you do that nonmembers). A nominal submission fee was selected to
through AMWA? ensure that AMWA covers its processing costs without
AMWA’s leaders have heard this question from a num- imposing too great a financial burden on applicants.
ber of long-time members, and have been working on how Your AMWA education committee, officers, and execu-
1
best to answer it. We’re pleased to announce the arrival of a tive committee have developed, refined, and pilot-tested
new program to meet your needs: the Professional the PDC concept over 2 years. “I’m thrilled to see the PDC
Development Certificate (PDC). Here’s how it works. come to life,” says Jill Shuman, a member of the education
Every 2 years, you may earn a PDC by accruing points committee who led the initial development of the PDC pro-
for professional development activities. The application gram. “The PDC will provide a new way for members to
form and directions for its completion are included here demonstrate their commitment to biomedical communica-
(page 85) and are available in the Education/Development tion, as well as providing a quantifiable metric to document
section of the AMWA Web site (www.amwa.org). The form professional growth.”
details a variety of professional activities for which appli- “We’re very pleased to offer this new program,” adds
cants can accrue points. Some examples include attending AMWA president Dominic De Bellis. “I’m looking forward to
an AMWA chapter meeting (worth 5 points), co-leading an hearing members’ feedback about the PDC and how it
AMWA workshop (worth 10 points), or completing a rele- enhances their membership in AMWA.”
vant university-level course (worth 15 points). A total of 50 The education committee will review each PDC applica-
points, earned over the 2-year period, is required to earn a tion and determine whether the required elements are in
PDC. place. They will contact applicants if there are any ques-
For the purposes of validation, documentation must be tions regarding what was submitted. If everything is in
provided with the completed application. For example, if order, the next thing you know, you’ll be the proud owner
you have attended an AMWA chapter meeting, you should of an AMWA Professional Development Certificate.
provide proof of attendance (a signed receipt or voucher When can you start? Right now! You can submit proof of
that includes the chapter, location of the meeting, and the qualifying activities accomplished between January 1, 2003,
date). If you completed a university-level course relevant to and December 31, 2004. Or, you can start your 2-year peri-
biomedical communication in the last 2 years, attach the od on January 1, 2004, and submit your application at the
transcript to your PDC application. end of 2005. After that period, you can gather your creden-
As the examples suggest, most of the activities that tials for the next 2-year segment and apply again to earn a
qualify members for a PDC are AMWA events. However, new PDC and reflect your ongoing professional journey and
there is a place for acknowledgment of professional activi- accomplishments.
ties outside of AMWA, and some of these (for example,
attending a relevant conference other than an AMWA one) References
are included among the choices available. 1. Witte F. Farewell message from Flo Witte. AMWA J. 2004;19(2):
Completing an AMWA core or advanced curriculum 137-138.

certificate is not a requirement for the PDC. In addition,

84 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 American Medical Writers Association (AMWA)
Professional Development Certificate (PDC)
Certificate Application for Year Ending 200__

Note: You must earn at least 50 points to qualify for a PDC. You can earn a PDC once every 2 years.

Name AMWA Membership Number

Address Daytime phone

Fax

E-mail

Have you received a PDC before? yes no

If yes, when did you receive your most recent PDC?

Application Instructions
1. Complete the form on the next page. Be sure to fill in the 3 middle columns for the qualifying activities in which
you have participated.

2. Attach originals or clearly legible photocopies of verification documents to this form as required.

3. Check to see that the year of participation appears on all verification documents.

4. For published articles or books, verify that the name of the publication and date on which the article was
published appear on attached articles. If the item is longer than 10 published pages, include a copy of title page,
table of contents (TOC), sample section, and proof of your contribution.

5. Review all qualifying activities to ensure that they occurred within the 2-year period preceding the application.
Qualifying activities performed after January 1, 2004, can be included in your application. For example, attending
a meeting in 2004 would count toward an application for the year ending December 31, 2005, but a meeting in
2003 would not. Points cannot be carried over from one 2-year period to the next.

6. Make a copy of your application for your files. Applications and supporting documents will not be returned.

7. Mail your completed application and verification documents, and a check for the nonrefundable application
fee of $45 ($150 for nonmembers), to
Professional Development Certificate
American Medical Writers Association
40 West Gude Drive, Suite 101
Rockville, MD 20850-1192
Faxed or electronic applications cannot be accepted because attachments may not be legible.

8. Please allow at least 8 weeks for processing the application.

AMWA JOURNAL . VOL. 20, NO. 2, 2005 85

AMWA Professional Development Certificate Application—List of Qualifying Activities
Point No. of Total Verification Required
Activity for Which Credit Is Sought Value Instances Points Date(s) (Original or Photocopy) Notes

Signed voucher or
Attending an AMWA chapter meeting You are responsible for obtaining
5 receipt, or cancelled
or annual conference proof of attendance.
check (or equivalent)
Chairing or serving on a national Committee or delegates’
AMWA committee or subcommittee 5 list or membership
or on the national Board of Directors confirmation letter

Attending a 3-hour AMWA noncredit Credit workshops cannot be

5 Registration receipt
workshop applied to the PDC.

Reviewing a new core, advanced, or You must be officially appointed

5 Copy of the review
noncredit workshop for AMWA as a reviewer.

Leading a roundtable or presenting Relevant page in AMWA

a poster at an AMWA annual 5 annual conference
conference program or equivalent

Examples: conferences of the

Attending a non-AMWA conference
Council of Science Editors, Drug
in scientific communication 5 Registration receipt
Information Association, National
(maximum 1 per PDC application)
Association of Science Writers

Editing a chapter in a published book,

Copy of published Your editorial contribution
or an article of 1,000 words or more
5 article or chapter with must be acknowledged in the
published in the AMWA Journal or
proof of contribution published book or article.
another peer-reviewed journal

Serving for 1 year as an AMWA

List of chapter officers or
chapter officer or AMWA Journal peer 10
AMWA Journal masthead
reviewer, editor, or proofreader
Coordinating annual conference Relevant page in the
workshops, open sessions, or 10 annual conference
roundtables program or equivalent
You may be the sole author or
Writing a chapter in a published book,
Copy of article or coauthor, or your medical
or an article of 1,000 words or more
10 chapter with proof of writing contribution may be
published in the AMWA Journal or
contribution acknowledged in the published
another peer-reviewed journal
book or article.
Co-leading an AMWA workshop or Relevant page in the
speaking in an open session at a 10 conference program or If you lead 2 sessions of the
national or chapter conference equivalent same workshop, or more than
Relevant page in the 1 workshop or open session,
Leading an AMWA workshop at a you may count each one.
15 conference program or
national or chapter conference
equivalent
Applicable courses include those
Completing a relevant university- in communication, medicine or
level course (maximum 1 per PDC 15 Transcript science, statistics, and epidemiol-
application) ogy. Course must carry 3 semester
credit hours or equivalent.
Teaching a relevant university-level
Relevant catalog page or
course (maximum 1 per PDC 20
equivalent
application)
Copy of title page, TOC, Your editorial contribution
Editing a published book of 100
15 sample section, and must be acknowledged in the
pages or more
proof of contribution published article or book.
You may be the sole author or
Copy of title page, TOC, coauthor, or your medical
Writing a published book of 100
25 sample section, and writing contribution may be
pages or more
proof of contribution acknowledged in the published
article or book.

Total Points Earned

86 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 Board of Editors in the Life Sciences
SCIENCE IN SOCIETY Certification Examinations

JOURNALISM AWARDS September 28, 2005

Pittsburgh, PA
Registration deadline: September 7, 2005
The Science in Society Journalism Awards were estab-
lished by the National Association of Science Writers October 22, 2005
(NASW) as a way to recognize investigative or interpretive Washington, DC
reporting about the sciences and their impact. The awards Registration deadline: October 1, 2005
have no subsidy from any professional or commercial inter-
Contact: Leslie E. Neistadt, ELS
est and are considered especially prestigious because Hughston Sports Medicine Foundation, Inc.
entries are judged by accomplished peers. 6262 Veterans Parkway
Columbus, GA 31909
Separate cash prizes of $1,000 and certificates will be phone: (706) 576-3322; fax: (706) 576-3348
awarded for writing judged best in each of these 6 e-mail: [email protected]
categories: 1. Newspaper, 2. Magazine, 3. Television, 4. www.bels.org

Radio, 5. Book, 6. Web. Entries must be postmarked by

July 1, 2005. There is no submission fee.

Any writer (or team) is eligible to submit up to 3 entries in WORDS OF WISDOM

each category. Material may be a single article or broad-
cast or a series. Series will be considered to be single Think Strategically:
entries. Work must be written or spoken in English, intend- All Sales Are Not Good Sales
ed for the lay person, and first published or broadcast The naïve assumption is that all sales are good sales.
between June 1, 2004, and May 31, 2005, except for There are bad customers and there are bad sales. For
books, which must have a 2004 copyright date and may each of your customers, ask yourself, ‘How much is it
be published any time that year. costing me to deliver my service to this customer?’ Look
at your real costs: not what you charge but your actual
costs. Is it costing you more than you are getting from
Judges are looking for material that describes advances in
it? Is the customer so demanding, does the customer
sciences but more importantly, material that explores or require so much attention to detail or so much hand
explicates the role or ramifications within the broader holding that you should say, ‘Unless we increase how
society. Previous winners have demonstrated innovative much I’m being paid, I don’t want to sell to you’? And
reporting beyond the science itself and into its ethical prob- there may be customers who you would not deal with
lems and social effects. on weeks when you are very busy, although you may
be very willing to work for them at other times.
More information about the awards is available on the I recall having interviewed a banker who had an abu-
NASW Web site (www.nasw.org). Questions about sive customer. He had a lot of money so he felt he could
submissions can be sent to Diane McGurgan, NASW exec- yell and shout. She told him, ‘We don’t want your busi-
utive director, at [email protected] or at 304-754-5077. ness.’ She took a risk financially for her bank, and her
superiors supported her.
Send entries to: If you are somewhat successful and are feeling over-
National Association of Science Writers whelmed, remember to sit back and think strategically.
P.O. Box 890 Cherry pick. Balance your work portfolio. Winnow
Hedgesville, WV 25427 your clients. Refer less lucrative projects to newer writ-
ers; that keeps the client happy. Now you are making
yourself a good referral source.
Barbara Bird, PhD, Associate Professor of Management,
Kogod School of Business, American University

AMWA JOURNAL . VOL. 20, NO. 2, 2005 87

 INSTRUCTIONS S TUDENT
FOR CONTRIBUTORS
CENTER
This new feature of the Student Section is designed to provide students and beginning medical writers
with insights in embarking on a career in biomedical communication. Through interviews, medical
writers early in their career will describe their experience with getting their first job and experienced
medical writers will offer advice and guidance on preparing for a job as a biomedical communicator.

Voices of Experience
By Heather Haley, MS
University of Minnesota-Twin Cities, Minneapolis, MN

➲ Interviewee: Alyssa Biorn, PhD

Editor, Section of Scientific intentions for finding an editing job. It didn’t directly result
Publications in me getting this job, but it helped me in lots of other ways.
Mayo Clinic, Rochester, MN If I had been familiar with AMWA at that point, that would
have been a great resource.

AMWA: How long did it take you to find this position?

Alyssa: About a year and a half, which included some
AMWA: How did you become “pre-search” time as well. Once I decided that I definitely
interested in medical writing wanted to make the career change from research to editing,
as a career? I figured that no one would hire me without experience.
Alyssa: I always liked writing and editing, but I thought I While doing my postdoctoral work, I got some freelance
wanted to be a professor. At a career development seminar editing jobs on the side in order to gain that experience. I
in graduate school, a science editor came in to talk and I got those side jobs by telling everyone I knew that I wanted
was really excited by what she was saying. I thought, “I to edit; eventually several opportunities came up, and those
could definitely do that.” But it sort of stayed in the back of were the key to getting my permanent job. After I started
my mind. In about my second year of postdoctoral work, I “moonlighting,” I probably waited about 6 months before
went to another career development seminar, this time by a I started actively job searching, and after that point it took
chemistry professor at a small university. As I listened to about a year.
him, I had a revelation of “This is NOT what I want!” I never
did love the lab work and actually was happiest when I was AMWA: What surprised you most when you first started
writing my dissertation. From then on, I totally changed my working at Mayo Clinic?
mind-set and decided that editing or writing was what I Alyssa: How much I thought I knew that I actually didn’t. I
wanted to do. thought I was a pretty good editor, but I had had no formal
training. I was, I guess, an instinctive editor. If it sounded
AMWA: What is your education and work background? wrong, I changed it. I didn’t know that there were such spe-
Alyssa: I have a BA in biology from a liberal arts college—St. cific rules for certain aspects of punctuation and usage. I
Olaf College in Minnesota—and a PhD in biochemistry was mostly going off what I remembered from high school.
from Iowa State University. After graduate school, I did 4 I hadn’t really heard of a “style book,” so I was surprised to
years of postdoctoral work before I came to Mayo. hear that different institutions and organizations had their
own ways of doing things and their own “rules.” It was a
AMWA: How did you job search for your first position? steep learning curve at the beginning.
Alyssa: I used Science Online—they have a great search
and alert function. I set it to send me an e-mail me if a job AMWA: What is a typical workday like for you?
ad came up with edit* or writ* in the text. I also read Alyssa: We have a pretty unique workflow in our office, so
through the ads in Science directly on occasion, but that I see things at different stages. I could be working on the
was about it. I also told almost everyone I knew about my first edit of a new paper, going over a copy that has been

88 AMWA JOURNAL . VOL. 20, NO. 2, 2005

proofread, seeing the author’s revised copy and incorpo-
rating their answers to my queries, or reading proofs Students Attending
from the journal. I like it best when I work on several
different papers during the day.
the 2005 AMWA
Annual Conference
AMWA: What do you find most rewarding about your
work? If you’re a student who is planning to
Alyssa: I like that I’m helping the physicians get their attend this year’s annual conference,
work published. And it’s a good feeling to hear that the you have an opportunity to be pub-
journal reviewers said, "This is a well-written paper." I lished in the AMWA Journal. We
also learn something new every day, which is my favorite want to publish accounts of students’
thing. experiences at the conference in the
Student Center section of upcoming
AMWA: What do you find most challenging? issues of the Journal. Your reports will
Alyssa: At first, the change from the social lab environ- not only help us to provide a forum
ment where I was on my feet all day to sitting all day for our student members but will also
working at a computer by myself was an adjustment. help promote the value of the con-
Now when I’m editing, sometimes I wish the author was ference to other students. If you are
right there so I could just ask them what they are trying interested in this opportunity, send an
to say. Instead, it sometimes takes several rounds of my e-mail to the AMWA Journal editor
queries and their answers to finally get things sorted out. at [email protected].

AMWA: What resources do you recommend for someone

in their first medical writing position?
Alyssa: I have a couple recommendations. 1) Get a style
book! And use it. We use the AMA Manual of Style, 9th
ed., but others are used in different places. You can
Students: We Want
choose the one that is most used in your field. 2) A good to Hear From You!
medical dictionary like Dorland’s or Stedman’s. I use
Dorland’s online every day. 3) I like Garner’s Modern
American Usage. 4) I use Google at least 10 times a day The Student Center is designed to meet the
and wouldn’t want to do my job without it anymore. 5) needs of students interested in a career in
Take advantage of AMWA—classes, lectures, meeting
biomedical communication. Tell us what
people.
you’d like to see in this section, volunteer to
AMWA: Any final advice for people just starting out or
write an article, or let us know of your accom-
looking to transition into medical writing?
Alyssa: If you think you can do it [be a writer or editor], plishments. Send your ideas to Heather Haley,
you probably can. That was my feeling, even though I Student Center Editor, at [email protected].
hadn’t had any classes in science writing. If you do have
an opportunity to take some of those classes or get a
degree in it, that would obviously be helpful, but if you
don’t, don’t let that stop you. Try to find other opportuni-
ties to gain that experience. And definitely make your
intentions known to anybody who will listen—you never
know who might pop out of the woodwork to help you.

If you’re a newer medical writer (less than 3 years’ experi-

ence) who would like to share your experiences starting
out, please contact Heather Haley at [email protected]

AMWA JOURNAL . VOL. 20, NO. 2, 2005 89

Comments on “European Medical Writers Association (EMWA) Guidelines
on the Role of Medical Writers in Developing Peer-reviewed Publications”
By MaryAnn Foote, PhD, Cynthia W. Hamilton, PharmD, ELS, and Marianne Mallia-Hughes, ELS
AMWA Task Force on the Contributions of Medical Writers to Scientific Publications

The following Letter to the Editor and Authors’ Reply were published in response to the article “European Medical Writers
Association (EMWA) Guidelines on the Role of Medical Writers in Developing Peer-reviewed Publications,” by Jacobs and
Wagner.1 The Letter and Reply appeared in Current Medical Research Opinion [2005;21 (5):703-704] and are reprinted with
permission from Stan Heimberger, PhD, MBA, Publisher & Editorial Director, Current Medical Research and Opinion.

LETTER TO THE EDITOR response to FDA-drafted guidelines that would have severe-
Comments on European Medical Writers Association ly restricted the role of medical writers in the pharmaceuti-
3 4
(EMWA) guidelines on the role of medical writers in cal industry . When the FDA issued its final report , medical
developing peer-reviewed publications writers were not mentioned. However, the controversy did
not end, which prompted development of written guide-
Dear Sir, lines by groups such as the International Committee of
5
We applaud both the European Medical Writers Medical Journal Editors , the International Conference on
6 7
Association (EMWA) for preparing guidelines regarding Harmonization (ICH) , PhRMA , the Good Publication
8 2
the role of medical writers in developing peer-reviewed Practice for Pharmaceutical Companies (GPP) , AMWA ,
1
publications and Current Medical Research and Opinion and, now EMWA .
1
for publishing these important guidelines . We would like to With the addition of EMWA’s guidelines, there is no
point out, however, that these are not the first guidelines of longer a shortage of guidelines. Many articles have also
this type. been published on the subject, some of which were cited
1
In 2003, the American Medical Writers Association by EMWA . Although a comprehensive list is beyond the
2
(AMWA) developed, published , and publicized the follow- scope of this letter, we believe readers might be interested
9-12
ing position statement on the contributions of biomedical in a few additional articles .
communicators to scientific publications. It’s time to put words into action. We challenge our
fellow biomedical communicators to confirm their ability
AMWA recognizes the valuable contribution of the to make an important contribution by working together to
biomedical communicator to the publication team. educate all involved parties and to encourage compliance
Biomedical communicators who contribute sub- with guidelines such as those proposed by EMWA.
stantially to the writing or editing of a manuscript
should be acknowledged with their permission and MaryAnn Footea, Cindy W. Hamiltonb and Marianne
with disclosure of any pertinent professional or finan- Mallia-Hughesc
a
cial relationships. In all aspects of the publication Past president of AMWA and member of AMWA Task Force
process, the biomedical communicator should adhere on the Contributions of Medical Writers to Scientific
2 Publications; Director, Global Medical Writing, Amgen,
to the AMWA code of ethics .
Thousand Oaks, CA, USA. Email: [email protected]
b
Chairperson, AMWA Task Force on the Contributions of
Specifically, AMWA’s Code of Ethics, which dates back to Medical Writers to Scientific Publications; Hamilton House,
AMWA’s founding in 1940, states: “Biomedical communica- Virginia Beach, VA, USA
c
tors should apply objectivity, scientific accuracy and rigor, Past president of AMWA and member of AMWA Task Force
and fair balance while conveying pertinent information in on the Contributions of Medical Writers to Scientific
all media.” AMWA’s Code of Ethics also states:”Biomedical Publications; Manager, Scientific Publications, Texas Heart
Communicators should accept an assignment only when Institute, Houston, TX, USA
working in collaboration with a qualified specialist in the
area, or when they are adequately prepared to undertake References
1. Jacobs A, Wager E. European Medical Writers Association
the assignment by training, experience, or ongoing study.”
(EMWA) guidelines on the role of medical writers in developing
AMWA and other groups, including the Pharmaceutical
peer-reviewed publications. Curr Med Res Opin 2005; 21:317-21
Research and Manufacturers of America (PhRMA), have 2. Hamilton CW, Royer MG. AMWA Position Statement on the
been involved in this issue since the early 1990s, when they Contributions of Medical Writers to Scientific Publications.
met with the FDA to discuss the role of medical writers—in AMWA Journal 2003; 18:13-5

90 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 3. Food and Drug Administration. Regulation of drug-company- AUTHORS’ REPLY
sponsored activities in scientific or educational contexts (draft
proposed policy, October 8, 1991). Division of Drug Marketing, Dear Sir,
Advertising, and Communications (HFD-240), Rockville, MD We are grateful to Foote et al. both for their interest in our
4. Food and Drug Administration. Guidance for industry:
guidelines and for the useful extra information and refer-
Industry-supported scientific and educational activities pub-
ences they provide.
lished by FDA. Federal Register 1997; 62:64073-100
5. International Committee of Medical Journal Editors. Uniform We agree entirely with their statement that “It’s time to
requirements for manuscripts submitted to biomedical journals. put words into action”. Guidelines now exist for pharma-
2003. Available from: www.icmje.org/index.html [Accessed 23 ceutical companies and medical writers to ensure that pub-
April 2004] lications are produced to a high ethical standard, and the
6. International Conference on Harmonisation, Guidance for challenge now is to ensure that such guidelines are fol-
Industry, E6 Good Clinical Practice: Consolidated Guidance, lowed. We encourage journals to refer to these guidelines in
April 1996, http://www.ifpma.org/pdfifpma/e6.pdf
their instructions for authors, pharmaceutical companies to
7. Pharmaceutical Research and Manufacturers of America
develop publication policies based on these guidelines, and
(PhRMA). Principles on conduct of clinical trials and communi-
cation of clinical trial results. 2004:1-54. Available from: medical writers to follow these guidelines in their work.
www.phrma.org/publications/publications/2004-06-30.1035.pdf
[Accessed 28 February 2004] Adam Jacobsa and Elizabeth Wagerb
a
8. Wager E, Field EA, Grossman L. Good publication practice for Director, Dianthus Medical Ltd, London, UK.
pharmaceutical companies. Curr Med Res Opin 2003; 19:149-54 Email: [email protected]
b
9. Brennan TA. Buying editorials. N Engl J Med 1994; 331:673-5; Publications consultant, Sideview, Princes Risborough, UK
discussion 676
10. Foote M. Review of current authorship guidelines and the
controversy regarding publication of clinical trial data. Biotech
Ann Rev 2003; 9:303-13
11. Foote M. Guidelines and policies for medical writers. DIA
Forum 2004; 40:36-9
12. Griffin J. Clinical trial data: Ownership, access, and publication.
Clin Res 2002; 2:12-2

AMWA JOURNAL . VOL. 20, NO. 2, 2005 91

 INSTRUCTIONS FOR CCHAPTER NEWS
ONTRIBUTORS

Chapter Report
Health Care Financing Is Topic of Keynote Session
at Asilomar Conference
By Cathleen Josaitis, PhD, MBA

Paul Torrens, MD, MPH, Professor of Health Services, Dr. Torrens described how the balance of power
School of Public Health, University of California Los between health care providers and insurance plans has
Angeles, led the Keynote Session at the Pacific Southwest shifted. Before 1980, providers controlled the delivery of
Chapter’s recent regional conference at Asilomar. Dr. health care in a fee-for-service system. Insurers and
Torrens’ talk was titled “Health Care Financing and What employers had little input and simply paid the bills. After
We Can Do About It.” 1980, the balance shifted in favor of insurers as they intro-
Dr. Torrens began by asking, “Why do tens of millions duced capitation (fixed payments to providers regardless
of Americans lack access to adequate health care when of services performed). This economically driven model
medical spending consumes over 1.7 trillion dollars per achieved cost control by shifting financial risk back to the
year, about 1/7 of the US gross domestic product (GDP)?” providers and giving insurers greater (some say too much)
The problem, he said, is not insufficient spending—Canada influence over treatment decisions.
funds health care for 100% of its population while spending Education of the public and medical communities can
5% less of GDP than the US. Rather, the issue is efficiency help the system function better for patients, said Dr.
of spending. In a highly interactive session, Dr. Torrens Torrens, and biomedical communicators can contribute.
explained that the key to understanding the American He identified several goals of education: boosting enroll-
health care system is to realize that “there is no system,” ment rates among those who are eligible for government-
with the result that financing, not necessarily medical need, funded health plans, informing patients of their right to
determines whether health care is received. appeal insurers’ denials of their claims, reducing rates of
US health care is financed through a convoluted patch- smoking and obesity, increasing the utilization of generic
work of private insurers and government sources whose drugs, and limiting unnecessary consumption of medical
complexities daunt even experts in the field. Depending on services. He also called on public policy makers to advocate
whether one is employed, over or under age 65, poor, a vet- for stronger government regulation of insurance plans and
eran, or injured in the workplace, one may be eligible for for the rights of small businesses and the unemployed.
privately or publicly financed care at a private provider of Dr. Torrens ended with an appeal for universal health
choice, a private hospital, a public emergency room, a VA coverage, either single-payer or multipayer. Highlighting
hospital, or a designated private provider. Furthermore, an the societal and public health consequences of inadequate
individual may be eligible for one, several, or none of these health care for the uninsured, he concluded that “we may
provider options, said Dr. Torrens. In this uncoordinated be in different boats, but we’re all in the same ocean.”
system, an estimated 10-14% of medical spending goes for
administrative costs. Public emergency rooms function as Cathleen Josaitis is a principal at BioComm LLC Medical
providers of last resort for the uninsured, affecting the eco- Communications, based in Laguna Beach, CA.
nomic viability of public hospitals. Patient “out-of-pocket”
expenses (14% of overall spending in 2003) have a dispro-
portionate impact on the older population and the poor.

92 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 MEMBER NEWS CHAPTER CONFERENCES

Susan F. Rudy, MSN, CRNP, CORLN, has been Empire State-Metro NY

appointed Editor in Chief of
June 11, 2005
ORL-Head and Neck Nursing,
Niagra Falls, NY
the journal of the Society of
Otorhinolaryngology and Head-
Neck Nurses (SOHN). Susan is a Medical Journalism: From Choosing a Topic
research nurse practitioner Through Polishing the Piece (EW/FL) [211]
(otolaryngology, head and neck Barbara Gastel, MD, MPH
surgery) at the National Insti- Business Aspects of a Freelance Career (FL) [301]
tute on Deafness and Other Mary Royer, ELS and Cindy Hamilton, PharmD, ELS
Communication Disorders, National Institutes of Health
Contact: Mary Royer
(Intramural Program), in Bethesda, MD. In addition to
(607) 539-7681
serving as Associate Editor, ORL-Head and Neck Nursing,
since 1998, Ms. Rudy has had extensive experience as an [email protected]
author and recently self-published Nuances of Nasal &
Sinus Self-Help, written for the layperson with disorders
affecting the nose and sinuses. Indiana Chapter
June 18, 2005
Indianapolis, IN
New Members with BELS Certification
The following 13 AMWA members recently passed the Punctuation for Clarity and Style (G) [106]
certification test given by the Board of Editors in the Life Nancy D. Taylor
Sciences (BELS). The tests were administered on March Ethics of Authorship and Editorship
12, in Boston, MA, and on April 9, in Oakland, CA. (See (EW/PH) [205]
page 87 for dates of upcoming BELS examinations and Nancy D. Taylor
registration deadlines.) The Synergy of Style, Substance and Audience
(ADV) [711]
Delaware Valley Chapter Northern California Chapter
R. Elliott Churchill
Gregory C. Cuca, MS, ELS Jack Aslanian, MD, ELS
Contact: Diana Fisher
Westfield, NJ Oakland, CA
(317) 651-8632 [email protected]
Sunny Bishop, MA, ELS
Empire State—Metro New
Carmichael, CA
York Chapter
Laura A. Fantauzzi, ELS Krista L. Conger, PhD, ELS Greater Chicago Area Chapter
Albany, NY Columbia Falls, MT August 12, 2005
Amy Plofker, ELS Lincolnshire, IL
Northwest Chapter
Sleepy Hollow, NY
Diana Burke, RN, ELS
Organizing the Biomedical Paper
Livermore, CA
Indiana Chapter (EW/FL) [213]
Peggy Emard, ELS
Pacific Southwest Marianne Mallia-Hughes, ELS
Greenwood, IN
Jennifer A. Fissekis, MA, ELS Advanced Writing (ADV) [706]
San Diego, CA Marianne Mallia-Hughes, ELS
New England Chapter
Lonnie K. Christiansen, ELS Sharon Reynolds, ELS Sentence Structure and Patterns (G) [109]
Newburyport, MA San Francisco, CA Flo Witte, MA, ELS
Punctuation for Clarity and Style (G) [106]
Zachary Schwartz, MS, ELS
Flo Witte, MA, ELS
Boston, MA
Contact: Elisabeth Wann
Susan I. Spitz, MD, ELS
[email protected]
Newton, MA

AMWA JOURNAL . VOL. 20, NO. 2, 2005 93

Maurice S. Peizer, Helped Develop
Medical Abbreviations: 26,000
AMWA Logo, Deceased
Conveniences at the Expense of
Maurice S. Peizer, of the Empire State-Metro New York Communication and Safety.
chapter, died on January 20, 2005, at the age of 92. Mr.
Peizer was active in AMWA at the chapter and national
12th Edition,
levels, serving at various times as chapter president, Board Author, Neil M Davis, ISBN 0-931431-12-3
of Directors delegate, co-chair of the membership com-
mittee, and chair of the Swanberg and Eric Martin Award Attention: Writers and Editors:
committees. For his contributions, he was named an Let us help you avoid making or causing
AMWA Fellow in 1975, and in addition received the
mistakes and errors.
President’s Award in 1981. However, his most enduring
legacy to AMWA may be his work on creating our organi-
Before you use or coin an abbreviation you
zation’s logo. Mr. Peizer, who was assistant creative direc-
tor of the McAdams Advertising Agency, chaired a special should see what other meanings it might have.
committee that designed 4 prototype logos. These were ESLD = end-stage liver disease
then voted on by the membership, and the current logo end-stage lung disease
was selected in 1975. LFD = lactose-free diet
M. J. “Red” Schiffrin, AMWA President in 1973, had this
to say about his friend Mr. Peizer: “He was always there,
low fat diet
always dependable. You just took it for granted that when low fiber diet
an assignment was given to him, you would be confident BO = bowel open
that the task would be well done, and on time!” bowel obstruction
Arnold Melnick, who was AMWA President the year
the logo was created, commented, “Maury was quiet and
You should know what abbreviations are on
unassuming, in spite of his considerable talent. Always a
loyal AMWA supporter, he was truly a sweet man and a the Joint Commission on Accreditation of
gentle man.” Healthcare Organizations’ “Do Not Use” list.
Mr. Peizer is survived by his wife of 53 years, Marjorie. (U for unit; QD and OD for once daily; qod for every other
Condolences can be sent to Mrs. Peizer at 135 Sunrise day; trailing zeros [1.0 mg] etc)
Terrace, Cedar Grove, NJ 07009.
This 2005 book is current and
comprehensive and covers the issues
above (26,000 meanings shown).
IN THE NEXT ISSUE...
Included in the price of the book is a
Enhancements to the AMWA Journal continue, 2-year, single-user access to the web
and there is something for everyone, from version, which is updated monthly.
students to seasoned medical writers.

Don’t miss the September issue Price: $24.95 plus $5 s & h

of the AMWA Journal for
• Helpful advice in the new
Neil M Davis Associates
Freelance Forum and the continuing 2049 Stout Drive, B-3
Practical Matters Warminster PA 18974-3861
• Guidance on ethical issues in the Case Phone 1 888 333 1862 or 1 215 442 7430
Studies section FAX 1 888 333 4915 or 1 215 442 7432
• Resources for professional development Email [email protected]
• More details on the 2005 Annual Secure Web site www.medabbrev.com
Conference

94 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 DEAR EDIE

There is no such thing as a simple explanation.

By Edie Schwager

Institutional affiliations are given for information and con- these possibilities, that is, a person with diabetes, a diabetic
venience only. The views expressed, being solely those of the person, and a diabetic, is not necessarily “straining at a
correspondents, do not represent those of any institution gnat.” And it is not irrelevant to medical writing require-
named or of the American Medical Writers Association. All ments. Guidelines of the journal Diabetes Care, for instance,
queries were received by e-mail unless otherwise indicated. state that “the term diabetic should not be used as a noun.”

DEAR EDIE: I’ve learned that in sentences such as the Thanks very much for the chance to discuss this interesting
following, you are not supposed to put a comma before issue.
“as well,” but I don’t know where to find the rule in writing. SHEILA FEIT, MD
Do you know? Syosset, N.Y.

Fracture resistance depends on bone strength, as well DEAR SHEILA: Thank you so much for your message. My
as reduction and stabilization of bone turnover. column was created (and, I’m happy to say, still exists) to
KELLY JAMESON answer queries but also to provide a forum for readers to
Merck & Co., Inc. differ or agree with me, correct me, add to my and their
Upper Gwynedd, Pa. store of knowledge, or set me straight. To quote Ms. Anon.,
“nobody’s perfect.”
DEAR KELLY: So far as I know, the only “rule” is that editori-
al judgment rules. The rhythm of the sentence is an impor- My response to Jackie Dial was written from my personal
tant consideration. Since the sentence you cite is rather viewpoint as a borderline diabetic. My disorder (functional
lengthy, I would use the comma, although it’s not absolutely hypoglycemia) is completely controlled by diet alone, and
necessary. Commas are used to take a breath, to give the so my life doesn’t revolve around insulin injections, nor
reader a chance to digest (the pause that refreshes). There around my being diabetic.
are several thoughts in the sentence, and the comma is a
good respite. Readers must always remember that my responses are
only my considered opinions—just that, nothing more.
Correspondents may choose to go along with me or not.
I’ve been down this road many times and over decades,
DEAR EDIE: As an endocrinologist and medical writer, I discussing references to “alcoholics” and “people with alco-
was interested in your response to a letter concerning use holism.” In my opinion, the latter such phrase trivializes
of the term “diabetic” [AMWA J. 2005, 19(4):18]. this dreadful disorder and the person affected as one with
a single character attribute. One might equally trivialize the
There is a subtle difference between using “diabetic” as a entire personality of an individual, referring offhandedly to
noun (The doctor treated a diabetic) and as an adjective her or him as a “person with charm” (a charming person),
(The doctor treated a diabetic patient). This issue is not as if that were the only worthwhile piece of information to
confined to diabetes, as there is a distinct trend to identify know about her or him. Of course, some might believe that
patients as persons, and not as their diseases. The analogy the opposite is true—that “alcoholics” is dismissive. But I
you provide, that of an obese patient, is not quite apt know for an incontrovertible fact that that’s how these per-
because you use “obese” as an adjective. A better analogy is sons refer to themselves, undoubtedly feeling that “people
“The doctor specialized in treating the obese.” I believe that with alcoholism” is artificial and affected. Incidentally,
at least some obese persons (or persons with obesity) because there is no cure for alcoholism, these individuals
would object to being thus addressed. refer to themselves—somewhat wryly if it’s applicable—as
recovering (not “reformed,” please!) alcoholics.
It’s true that this issue has spawned a trend of describing
patients as “persons with X disease,” which some may find You say that “there is a distinct trend to identify patients as
cumbersome or politically correct. Distinguishing between persons, and not as their diseases.” In fact, this laudable

AMWA JOURNAL . VOL. 20, NO. 2, 2005 95

concern far antedates any current trend. By training and Now to the knots and controversy. Here’s what Allan M.
instinctual empathy, responsible physicians, including (and Siegal and William G. Connolly (authors of The New York
perhaps notably) Doctors of Osteopathy, have always treat- Times Manual of Style and Usage, 1999) have to say. Please
ed the patient holistically. keep in mind that I disagree with these mavunim (the actual
plural of “maven”) only as to the hyphen. I tried to persuade
The people connected with or writing about any particular Siegal, soon after publication of this excellent manual, to
disorder may have a tendency to prettify their work. This change his view on the comma in the newspaper and in the
may be an admirable trait for writers in certain genres, but manual hereafter, but to no avail so far. I don’t think they
is inadvisable for serious medical writers and editors. Since read my column or books (only my e-mails), so the coinci-
the era of Old English, the use of nouns as adjectival modi- dence of opinion between us on these other “racial” or
fiers has been firmly entrenched (The Merriam-Webster “ethnic” issues is quite remarkable. Need I add that my
Dictionary of English Usage, 1989, p. 145, under “Attribu- writings precede the aforesaid publication by many years.
tive”). So with idiom. Will we now call that well-known
soap opera “Those Who Are Young and Restless”? I can African-American, black. Try to determine and use the
understand the desire to treat people’s sensibilities tenderly, term preferred by the group of persons being described
and I try to do that. But my main objective is to strive [my emphasis]. When no preference is known, the
toward clarity and preciseness in general or medical usage. writer should choose. But use black when the reference
In pleasing all, one pleases none. is not only to people of African descent but also to those
whose more immediate roots are in the Caribbean or
I appreciate and commend the desire of the people at South America. Use more specific terms—Nigerian-
Diabetes Care, and all the others who write and edit such American; Jamaican-American—when they are
publications, to treat such humans (an adjective used as a appropriate.
noun) as suffering or affected patients. But I cannot agree
with them. I firmly believe that overrefinement and prettifi- This entry echoes my views, particularly as to sensitivity
cation should be avoided in medical and general English (except, as I’ve said, for the hyphen). People who were
usage. born in South America or the Caribbean or numerous other
areas resent being termed “African American” because they
Will others jump into the fray and add to our knowledge, weren’t born in Africa or their roots weren’t there. Most of
empathy, and understanding of this question? Thank you the people from those areas with whom I’ve spoken prefer
again for a most fascinating letter and for your moderate being called “black.”
approach to this controversial issue.
I usually write “African American” for fear of offending
many United States-born people of color, but use “black”
in my speech for convenience. When I’m in doubt, my
DEAR EDIE: I can’t find a definitive source on whether to preference is to use “blacks” if the nativity of the group or
use “black” or “African-American.” I assumed that “black” person is unknown or indeterminate. If you’re in doubt,
was best to use, but when I made the change from “African- use “African American”; if the person you’re speaking
American” to “black,” a supervisor said that several people with corrects you gently (“I’m from Haiti”), rejoice in the
in the department found “black” offensive. subtlety.

Also, is “Hispanic” or “Latino” correct? The question about Hispanism is equally touchy. Here’s
DEBRA G. SHARE what Siegal and Connolly have to say on that subject:
Merck & Co., Inc.
Whitehouse Station, N.J Hispanic (n. and adj.) means descended from a
Spanish-speaking land or culture. It may apply to many
groups of Americans—to Puerto Ricans, for example,
DEAR DEBRA: What a difference a hyphen makes! I’ve or Texans of Mexican origin—as well as to immigrants
dealt in print with this knotty and controversial question from Latin America or Spain. It does not denote a race;
many, many times for more than 20 years. I don’t use a Hispanics may be of any race. [Ed. note: Of course,
hyphen in “African American,” because that tiny piece of they’re correct; see the Statistical Abstract of the United
punctuation would denote that members of the population States for verification. Every table on ethnicity carries an
in question were born in Africa and then immigrated to asterisk explaining that Hispanics may be of any race.]
the United States. Omission of the hyphen (a subtlety, to
be sure, but then all nuances are by definition subtle) indi- Perhaps because of the ic ending, some writers prefer to
cates that members of a particular group were born in the avoid Hispanic as a noun (Hispanics or Hispanic). But
United States. avoidance of the noun should not take conspicuous

96 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 forms—wooden phrases, for example, like Hispanic DEAR EDIE: Your “Incidental Intelligence” contribution to
people or Hispanic residents. If Hispanic occurs in a the AMWA Journal (Vol. 19, No. 3, 2004, p. 114) regarding
series of ethnic designations, all should be modifiers the nine different pronunciations of the combination of
(black, Hispanic and Asian-American neighborhoods) letters OUGH reminded me of a story about George
or none should. Bernard Shaw. Always highly critical of the English lan-
guage, he is reported to claim that GHOTI is pronounced
“fish.” This arises from the pronunciation of “cough,”
[Ed. note: ¶ ] Latino, a synonym originally favored in “women,” and “nation.”
the Southwest and the West, is gaining in use elsewhere,
but for now [1999] Hispanic remains more widely pre- Of course, you may well have known this one already, but I
ferred. When writing about specific people or groups, just wanted to be sure.
choose the term they prefer [my emphasis]. And when a KARL RAAB
more specific identification is available—Cuban, Puerto Bratislava, Slovakia
Rican, Mexican-American—use it. Take care with
Spanish-speaking and Spanish-surnamed because
Hispanics do not necessarily speak the language and DEAR KARL: As you surmised, I’ve been aware of the “fish”
some have other kinds of names. . . . story ever since I became an editor, and undoubtedly much
earlier. I’ve been an English-language-lover all my life. No
I admire the NYTMSU greatly (especially when the authors word of this allusion to fish appears in Bartlett’s Familiar
agree with me), and use it constantly. The manual contains Quotations, since the story may be apocryphal. However,
a lot of good information, sense—and sensitivity. I prefer it to be true. Shaw was on fire to reform the English
language, and went to all lengths to mock its inconsisten-
cies and absurdities. Bartlett’s has two pages of his fulmina-
tions about its flaws, but omits the “fish” attribution.
DEAR EDIE: Have you tackled “matching placebo” yet? We
must call William Safire’s “Squad Squad” for redundancy on As we all know, Shaw was unsuccessful in his reform move-
this. The term “placebo” is etymologically one degree of ment. Much as I admire and guffaw at his outrageous prose,
separation from “placate,” from the Latin placare, to please. I couldn’t have gone along with his desire for such radical
changes. Some change is a good thing for those of us who
There is a vesper called Placebo Domino, which is not an believe in improvement, but only if it simplifies life (and
operatic sugar pill. The placebo is given to please or humor usage), not complicates it even more. English usage
the patient. Now, if I’m entering a placebo-controlled trial remains its own unregenerate, raffish self in many ways,
of, say, topical minoxidil for alopecia, receiving a non- but fortunately does change with the times. It’s up to us to
matching placebo—say a gel, a pill, or a painful IM injec- improve it.
tion—would certainly not please me. (Not to speak of the
questionable ethics of such a trial!)

What’s your take?

STEPHEN GUTKIN Edie Schwager, a freelance writer, medical editor, and teacher,
Rete Biomedical Communications Corp. lives in Philadelphia. She is the author of Medical English Usage
Ridgewood, N.J. and Abusage (Greenwood Publishing Group/Oryx Press) and
Better Vocabulary in 30 Minutes a Day (Career Press). Queries,
which should be in publishable form and may be edited,
should be sent directly to her (addresses in Instructions for
DEAR STEPHEN: I confess that I’m baffled by the term
Contributors), preferably by e-mail. Ms. Schwager answers
“matching placebo.” I have never seen it in the literature. e-mail queries as quickly as possible by e-mail. To avoid back-
What does it mean—that two placebos are used in the same and-forth messages, please include permission to publish with
investigational trial? A gel, pill, or intramuscular injection the questions or comments. The correspondent must provide
would hardly classify as placebos. all addresses, especially the city and state. The name of the
affiliated organization, if any, will be published unless Ms.
Perhaps your vesper, Placebo Domino, with the words Schwager is otherwise directed. Please note her current e-mail
reversed, could be utilized by the pizza company. address: [email protected].

AMWA JOURNAL . VOL. 20, NO. 2, 2005 97

 MELNICK ON WRITING
I Despair!
By Arnold Melnick, DO

(from an e-mail from AMWA Past President Milton “Red” Schiffrin)

“ Am I the only one who is appalled by what is happening to the English language? It’s enough that
granddaughters and their friends use ‘like’ as every other spoken word, but to find language man-
gled here at University House is too much for me.
Let me explain. About 40% of the residents here once were members of a university faculty. [An
in-house newsletter stated] ‘be sure your garbage bag is tightly sealed before you put it in the shoot.’
A proofreading committee was formed in an attempt to repair the situation. The announcement of
the start of this group began, ‘Thanks goes to the…’
Again, am I the only one who fears what is happening?
No Cheers,
RED ”

Dear Red:
No, you are not alone! I despair, too! grave) when his grandchild first said “you” instead of
“thou.” But enough people made that change, and it
(Surgeon-General’s Warning: This column is written by an became part of our standard English. Some baseball fan
interested and concerned party, with absolutely no train- once applied “struck out” to a non-sport situation, then it
ing in semantics or linguistics, but a long life of observing became a standard expression (and maybe some purists,
the English language.) like Red and me, became appalled). On the other hand,
Yes, those things disturb me as well – and it does not what ever happened to “Twenty-three skidoo” and “Oh, you
lessen with the years. That’s why I wrote in Science Editor a kid” and “sharp” (clothes and style)? That same fadeout is
few months ago “Each to Their Own Taste (Grr…).” That also happening right now to today’s popular “cool.”
article played on this most common error of speech and I would have predicted that the repetitive use of “like”
writing, quoting several examples from reputable, educat- (which bothers Red and me) would become accepted
ed, important people and from national ads and journals. English, but it seems to be fading (praise be!).
After a heart-wrenching litany, I asked, “Are we ready for a So I believe that variations in speech that are incorrect
change? Are we ready to concede? Maybe the answer…is to English may become totally accepted if repeated often
do both: accept it grudgingly …and also look to writers to enough (ain’t?). However, there are several four-letter words
modify the statements they quote.” (Many of these mistakes that are abominable today but were socially acceptable
are quotes from other persons.) (and correct) a long time ago. But they came into disrepute.
In essence, I suggested that perhaps we ought to accept So what causes grammatical errors ultimately to be
this error, facing the fact that an overwhelming percentage accepted as correct or others to fade out? If I knew, I’d put it
of the American population, in speech and writing, uncon- together with the “repeated use” premise and come up with
sciously perpetuate it. I’m ambivalent! a Melnick’s Theory. Until then, there are merely the musings
That exercise, and your letter, stimulated my theory of a concerned speaker and writer, trying to assuage my
about these aberrations. I believe that sometimes common own appalled senses.
speech errors actually introduce changes into our language. Meanwhile, thanks, Red. We can cry on each other’s
I suspect that Shakespeare spun (before he went to his shoulders—while we continue to say “thou.”

98 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 MEMBER PROFILE
Cathryn Evans
By Bettijane Eisenpreis

I
t is serendipitous that Cathryn Evans’ name Her work with AMWA continued, expand-
shares initials with the words “continuing edu- ing to include the freelance arena. From 1994
cation.” No two words could better describe through 2001, she wrote the “Freelance Forum”
the passion of this former AMWA president. column for the AMWA Journal, and she now
“Since I first joined AMWA, not a year has gone serves on the panel for this revived feature (see
by that I have not taken some kind of course,” page 71). She has led such AMWA workshops as
Evans says. “They weren’t all at AMWA, but AMWA The Business of Freelancing, Selling Yourself as
inspired me to do it. At annual meetings, I would a Freelance, Video Production for the Pharma-
take workshops every day. Education, to me, is ceutical Industry and The Scope of Medical
critical to keep your mind and spirit alive, and Communications. In 1992, she received the
AMWA opened my eyes to this.” Golden Apple Award for consistent excellence
Evans, who lives in the mid-Peninsula area of California, in presenting and teaching.
is expert at manufacturing lemonade from lemons. Origi- Evans is sole proprietor of Chandos Communications.
nally a technical writer, she lost her job when the aerospace “At one point, we had 7 or 8 full-time employees, plus a
industry took a nosedive. “People with PhDs couldn’t get a number of part-timers,” she says. She began working out of
clerical job. I took a job at Syntex as a medical secretary, her home but soon expanded into an office building, where
working for an Australian physician, Alister Brass, who later the company stayed for nearly 15 years. “A few years ago, I
became the editor of the Australian Medical Journal. His decided to move the office home,” she said. While she miss-
primary function was to write and coauthor medical es the daily interaction with other people, her home office
papers. Within a year, I suggested that he create a medical has given her freedom to indulge her passion in lifelong
communications department; he asked me to draft a pro- learning.
posal, which he edited but didn’t change substantively. “Once I stopped paying high rent for an office, I decided
The proposal was approved; the Medical Communications to go back to school. I became a certified practitioner of
department was established; and I became a medical editor shiatsu and acupressure,” she says. “In 2003, I lived in India
and managed the budget for the first 3 years.” for 2 months and completed my certification as a yoga
Dr. Brass suggested that Evans join AMWA, and the rest instructor. This year, I’m a teaching assistant in a profes-
is history. In addition to taking as many courses as she could, sional certification course, ‘The Fundamentals of Acupres-
she became an active member from the start. She devel- sure,’ in Palo Alto. When you teach someone else, you
oped outlines for the initial core of courses for the pharma- learn more. It shows you what you know and what you
ceutical section core curriculum. In 1979, she became an don’t know. This also has been one of the major benefits of
AMWA Fellow and a member of the executive committee. teaching courses for AMWA.”
She served as sections coordinator before being elected Former AMWA President Ted Berland, a longtime
vice president, president-elect, and, in 1982, president. friend and colleague, says, “When I first met Cathryn, at
“I was the first person to put on a profitable regional an AMWA board meeting, I was struck by her physical
seminar for the organization,” she says. “When I was chair- beauty and asked her if she were a model, as well as a
man of the pharmaceutical section, we organized 2 semi- medical writer. She said that, yes, she had done some
nars, one in New York and one in Chicago. We made some modeling. Remembering an insignificant fact I once read
money for AMWA—but more important, we set the prece- about professional models, I then confidently said, ‘Then
dent for midyear regional conferences.” you must have big feet.’
In 1981, Evans left Syntex to start her own company, “I mention this because her feet and hands worked very
Chandos Communications. Working in a wide variety of hard for AMWA as she took on more and more tasks and
media, the company produces medical communication responsibilities, including the national presidency,” Berland
projects targeted to diverse audiences. Her client list reads continues. “Even when we disagreed—which was often—
like a “who’s who” of pharmaceutical companies and health she maintained her calm and dignity. Her shoes were not
organizations. She credits AMWA with helping her establish easy to fill when she stepped down. Also, her outward good
her freelance business. “I met a lot of people through looks merely reflected the lovely person inside. She is a
AMWA, and the organization proved a key source of con- model—a paradigm of what an AMWA president should be.”
tacts,” she says.

AMWA JOURNAL . VOL. 20, NO. 2, 2005 99

 INSTRUCTIONS FORMCEDIA REVIEWS
ONTRIBUTORS

The Chicago Guide to Communicating Science emphasizes that every writer

Scott L. Montgomery must plan for additional revi-
Chicago, IL: University of Chicago Press, 2003. 228 pages. $40 sions, both on a time man-
(clothbound), $15 (paper) agement level and on an
emotional level (to deal with
Although Scott Montgomery did not write The Chicago the pain of being criticized).
Guide to Communicating Science specifically for medical Two technical suggestions
writers, AMWA members can benefit from reading it. The from this book were particu-
author states that without good communication, there is larly useful in my own work
no good science, and by extension, no good medicine. as a freelance scientific
Montgomery recommends that writers apprentice them- writer. To maximize the
selves to master writers by modeling their writing after chance that a figure will be
examples in their specialty written 50 to 100 years ago. He acceptable to a journal editor,
suggests that for medical writers, Pasteur’s work provides Montgomery suggests enlarg-
good models to imitate. The author also emphasizes the ing a figure from the journal to which you plan to submit
importance of being selective in what you include in your your article to match the size of the figure you have
medical writing. “To persuade and convince a highly critical designed. Then make sure that components such as type
audience, authors cannot simply brain dump information size and line thickness are similar. The author also suggests
onto paper.” that, when preparing slide sets, the writer should make a
The author believes that, however dry the subject mat- slide outlining the presentation. Before each subsection of
ter, scientific communication must tell a story to draw in the presentation, repeat the outline slide with the subhead
the reader. He likens the structure of well-crafted scientific for that section highlighted in another color to presage
communications to an hourglass, recommending that the what will be discussed next.
writer begin with general concepts (what is already known For AMWA members, “Dealing With the Press” may be
about a medical problem), then move into more specific the most important chapter. AMWA membership includes
concepts (how the current research fills a specific gap in many individuals who started as bench scientists and now
knowledge), and then expand the discussion to include write for the pharmaceutical industry. But many AMWA
general concepts such as the clinical implications of the members are freelances who write exclusively for con-
new research. sumers. Montgomery, a geologist who has published both
Chapter 4, “Writing Well, a Few Basics” discusses bread- peer-reviewed and popular works about science, appreci-
and-butter writing, that which is good enough to get the job ates that journalists are craftspeople. This chapter will help
done. Chapter 5 then focuses on opportunities for creativity all AMWA members understand the competing priorities of
and elegance in scientific writing. The author analyzes lan- scientists and journalists.
guage in paragraphs culled from papers on subjects such as Montgomery is an advocate who supports the AMWA
astronomy and geology. By their very distance from medical position statement that biomedical communicators who
subjects, the examples highlight the concepts of varying contribute substantially to the writing or editing of a manu-
rhythm, enhancing flow, and using a diverse vocabulary. script should be acknowledged. “Writing is the doing of sci-
These analyses demonstrate to medical writers that techni- ence. It takes expertise to take scattered data and organize
cal language can include more than “just the facts, ma’am” it, make it intelligible, make it eloquent, and do it within a
and can thereby be pleasurable to read. To sensitize the certain time frame…If you write an article, your name
writer’s ear to elegance of language, Montgomery recom- belongs on it. You could do research all day long, but if it is
mends either reciting well-written passages or copying not published in an intelligible form, it is essentially worth-
them out in longhand. less.” Montgomery defines publications as “scientific capi-
One chapter describes how editors choose articles to tal,” and as creators of those assets, medical writers deserve
be published in a peer-reviewed journal, but the process to have interest properly credited to their accounts.
would be equally applicable to editors who assign free- — Jane Neff Rollins, MSPH
lances to write consumer publications. The author rightly
points out that no matter how many drafts you write and A former epidemiologist, Ms. Rollins is now a freelance scientific
revise before submission, to an editor, all articles are con- writer whose clients include biotechnology and pharmaceutical
sidered first drafts to the review process. Montgomery companies and medical education agencies.

100 AMWA JOURNAL . VOL. 20, NO. 2, 2005

What Dying People Want. Practical Wisdom for they are and who they have
the End of Life become. He notes how they
David Kuhl, MD begin to pay attention to the
New York, NY: Public Affairs, 2003. 296 pages, $14.00 inner voice that guides them
and to understand the person
David Kuhl, MD, describes his purpose for writing What within who they had ignored.
Dying People Want as providing a guide for people who The book has some gems
have a terminal illness, who know someone who has a ter- on death and dying, a subject
minal illness, or who choose to enhance their understand- that most of us would rather
ing of the dying process. A palliative care physician, he is not think about. In an out-
concerned that although medical science has made great standing appendix item,
strides to alleviate the physical pain of those with a termi- “Talking to Terminally Ill
nal illness, Western medicine has been slow to help the Patients: Guidelines for
physical and spiritual distress of those who know that they Physicians,” he discusses 11
are dying. He emphasizes that the long process of dying is a things the doctor can do when
frightening time, but we must remember that dying people breaking the news to a dying patient. The importance of
are still living. touch and speaking clearly and simply are emphasized.
Kuhl bases his book on a series of interviews with peo- The idea of interviewing people who are dying and
ple with AIDS or cancer. He includes people from all class- telling their stories is a unique approach. Kuhl sprinkled the
es, occupations, and family circumstances. Chapters 1 writing with allusions to literature and poetry, which added
through 4 explore the anxiety of waiting for the diagnosis, interest. However, I found the stories somewhat long,
receiving the bad news, and the prospect of physical pain. involved, and tedious and preferred his expository analyses
Kuhl laments how most people shun the dying and says of how to communicate and converse with dying people.
that health care professionals especially are guilty of caus- As a student of psychology, I have studied the classics of
ing iatrogenic suffering through their insensitivity and lack death and dying and find Kuhl’s practical information about
of communication skills. Chapters 5 through 9 pertain to communication a fine addition to the literature. The author
psychologic and spiritual themes of life review, speaking the provides useful information that can benefit health profes-
truth, longing to belong, self-realization, and transcen- sionals. However, I do not think he met his goal of reaching
dence. For example, Kuhl has his patients draw a 6-inch line the average person facing terminal illness.
representing birth to death. On the line they will review the Kuhl encourages finding new life in the process of
major events in their lives: school, vocation, marriage, etc. dying. For that reason, medical writers can benefit from
Then the patient focuses on the line between the present reading the book for both personal and professional
and death, answering the question, “How may I best enhancement.
embrace life in the time that remains?” — Evelyn B. Kelly, PhD
His detailed interviews reveal day-to-day experiences
and thoughts of individuals facing the end of life. By talking Evelyn Kelly resides in Ocala, FL.
with them, he concludes that they develop a sense of who

AMWA JOURNAL . VOL. 20, NO. 2, 2005 101

 INSTRUCTIONS
C ALENDAR
FOR COF MEETINGS
ONTRIBUTORS

American Medical Writers Association Canadian Science Writers Association European Medical Writers Association
65th Annual Conference 34th Annual Conference November 18-20, 2005
September 29-October 1, 2005 Sustainability and Emerging Science: Munich, Germany
Pittsburgh, PA Shaping Our Next Century Contact: European Medical Writers
June 18-21, 2005 Association
66th Annual Conference Jasper, Alberta, Canada Baarerstrasse 110C, 7th Floor
October 26-28, 2006 Contact: Kristina Bergen, P.O. Box 2246
Albuquerque, NM Administrative Director 6302 Zug, Switzerland
PO Box 75, Station A E-mail: [email protected]
American Academy for the Toronto, Ontario M5W 1A2 www.emwa.org
Advancement of Science phone: (800) 796-8595
February 16-20, 2006 e-mail: [email protected] National Association of Science Writers
St. Louis, MO www.sciencewriters.ca Workshops/Council for the
Contact: American Academy for the Advancement of Science Writing New
Advancement of Science Council for the Advancement of Horizons Meeting
1200 New York Avenue NW Science Writing October 22-26, 2005
Washington, DC 2005 43rd Annual Briefing Pittsburgh, PA
phone: (202) 326-6400 New Horizons in Science Contact: Diane McGurgan
e-mail: [email protected] October 23-26, 2005 phone: (304) 754-5077
www.aaas.org Baltimore, MD e-mail: [email protected]
Contact: Diane McGurgan www.casw.org
American Association of Dental Editors Phone: (304) 754-5077
2005 Annual Conference e-mail: [email protected] Public Relations Society of America
October 5-6, 2005 www.casw.org International Conference
Baltimore, MD October 22-25, 2005
Contact: American Association of Council of Science Editors Miami Beach, FL
Dental Editors Annual Meeting Contact: PRSA
750 North Lincoln Memorial Drive, May 19-23, 2006 33 Irving Place
Suite 422 Atlanta, GA New York, NY 10003-2376
Milwaukee, WI 53202 Contact: CSE Headquarters phone: (212) 995-2230; fax: (212) 995-0757
phone: (414) 272-2759; fax: (414) 272-2754 c/o Drohan Management Group www.prsa.org
e-mail: [email protected] 12100 Sunset Hills Road, Suite 130
www.dentaleditors.org Reston, VA 20190 Regulatory Affairs Professionals Society
phone: (703) 437-4377; fax: (703) 435-4390 Annual Conference
Association for Business e-mail: [email protected] October 16-19, 2005
Communication www.councilscienceeditors.org Baltimore, MD
70th Annual Convention Contact: RAPS
October 20-22, 2005 Drug Information Association 11300 Rockville Pike, Suite 1000
New Orleans, LA 41st Annual Meeting Rockville, MD 20852
Contact: Dr. Robert J. Myers June 26-30, 2005 phone: (301) 770-2920; fax: (301) 770-2924
Executive Director Washington, DC e-mail: [email protected]
Baruch College, CUNY Contact: Cheryl Buckage www.raps.org
Box B8-240 Drug Information Association
One Bernard Baruch Way 800 Enterprise Road, Suite 200 Society for Technical Communication
New York, NY 10010 Horsham, PA 19044-3595 52nd Annual Meeting
phone: (646) 312-3727; fax: (646) 349-5297 phone: (215) 442-6194; fax: (215) 442-6199 May 8-11, 2005
e-mail: [email protected] e-mail: [email protected] Seattle, WA
www.businesscommunication.org www.diahome.org Contact: STC
901 N. Stuart Street, Suite 904
Arlington, VA 22203-1822
phone: (703) 522-4114; fax: (703) 522-2075
e-mail: [email protected]
www.stc.org

102 AMWA JOURNAL . VOL. 20, NO. 2, 2005

 INSTRUCTIONS FOR CONTRIBUTORS

The AMWA Journal is the official publication of the American Medical Writers Association (AMWA). Delivered quarterly to
AMWA members and journal subscribers, the AMWA Journal is designed to be an authoritative, comprehensive source of
information about the knowledge, skills, and opportunities in the field of biomedical communication worldwide. This goal
is accomplished by the publishing of articles, columns, features, news, and interviews in the field of biomedical communica-
tion. Topics should be relevant to one of the following AMWA sections: writing and editing; education; public relations,
advertising, and marketing; pharmaceutical; and freelance.

Feature Articles should be original compositions, no longer members who have found useful Web sites should send an
than 3,000 words, that are timely and relevant for an audi- e-mail to [email protected].
ence of professional biomedical communicators. Topics of
interest are likely to be found in any setting in which such Dear Edie column includes letters from biomedical com-
professionals work. Relevant tables and figures that help municators on English usage and Dear Edie’s responses.
convey the message of the text are encouraged. Send all correspondence directly to Edie Schwager, Dear
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