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J OURNAL IN THIS ISSUE A Legacy of Leadership Preview of the 2007 Annual Conference Project Management Strategies for Medical Writers and Editors Oncology Basics Part II. Targeted Therapies THE OFFICIAL JOURNAL OF THE AMERICAN MEDICAL WRITERS ASSOCIATION Volume 22 Number 1 2007

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Page 1: Volume 22 Number 1 JOURNAL · 2018-04-01 · 6 41 table ofcontents volume 22• number 1• 2007 columns 34 melnick on writing 35 dear edie 55 page break amwa matters 41 web watch

JOURNAL

IN THIS ISSUE

A Legacy of Leadership

Preview of the 2007 Annual Conference

Project Management Strategies

for Medical Writers and Editors

Oncology Basics

Part II. Targeted Therapies

THE OFFICIAL JOURNAL OF THE AMERICAN MEDICAL WRITERS ASSOCIATION

Volume 22Number 1

2007

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The AMWA Journal is available as a PDF filein the Members Only area ofwww.amwa.org

The AMWA Journal expresses the interests, concerns, andexpertise of members. Its purpose is to inspire, motivate, inform,and educate them. The Journal furthers dialog among all mem-bers and communicates the purpose, goals, advantages, andbenefits of AMWA as a professional organization. Specifically,it functions to

➲ Publish articles on issues, practices, research theories,solutions to problems, ethics, and opportunities related to effective biomedical communication

➲ Enhance theoretical knowledge as well as applied skillsof biomedical communicators in the health sciences,government, and industry

➲ Address the membership’s professional developmentneeds by publishing the research results of educators and trainers of communications skills and by dissemi-nating information about relevant technologies and their applications

➲ Inform members of important biomedical topics, ethicalissues, emerging professional trends, and careeropportunities

➲ Report news about AMWA activities and theprofessional accomplishments of its departments, sec-tions, chapters, and members

The AMWA Journal is published 4 times a year by the AmericanMedical Writers Association (AMWA). For details aboutsubmissions, see “Instructions for Contributors” on page 56.

Subscription to the Journal is included with AMWA member-ship. Nonmember subscriptions cost $75 per year. Individualarchive copies can be purchased for $20 each, if available. Forinquiries regarding subscriptions, please contact AMWAheadquarters.

The opinions expressed by authors contributing to this journaldo not necessarily reflect the opinions of AMWA or the institu-tions with which the authors are affiliated. The associationaccepts no responsibility for the opinions expressed by contrib-utors to the Journal.

The AMWA Journal is indexed in the MLA InternationalBibliography and selectively indexed in the Cumulative Index toNursing and Allied Health Literature (CINAHL) print index, theCINAHL database, and the Cumulative Index of Journals inEducation (CIJE).

MISSION STATEMENTEditor

Editor, in memoriam

Chapter Corner Editor

Dear Edie ColumnistEditorial Consultant

Freelance Forum Panel

Media Reviews Editor

Melnick on Writing Columnist

Member Profiles Editor

Professional DevelopmentCo-Editors

Peer Reviewers andManuscript Editors

Proofreaders

Publications Committee

President, 2006-2007

Executive Director

Graphic Designer

Lori Alexander, MTPW, ELS

Ronald J. Sanchez

Tracey Fine, MS, ELS

Edie Schwager

Brian BassSherri Bowen, MA, ELSCathryn EvansDonna MiceliPhyllis MinickBarbara Rinehart, MS

Evelyn Kelly, PhD

Arnold Melnick, DO

Bettijane Eisenpreis

Deana Betterton-LewisNancy Dupre BarnesJoni St. JohnKristina Wasson-Blader, PhD

S. Kim Berman, MS, ELSSteven Casto, EdDJames Cozzarin, ELSToniann Derion, PhD, ELSRandall Fritz, DVM, ELSThomas Gegeny, MS, ELSNorman Grossblatt, ELS(D)Julia Cay Jones, PhDKaren Potvin Klein, MA, ELSJane Krauhs, PhD, ELSArkady Mak, PhD, MDDenise MasonerLaszlo NovakJude Richard, ELSMary Royer, MS, ELSNancy D. Taylor, PhD, ELSScott Thompson, BSAnne Marie Weber-Main, PhD

Elaine Crabtree, MA, ELSLaura FantauzziJill Irwin, BSME, MSEAmy Stephenson, MA

Melanie Fridl Ross, MSJ, ELS, chairChristina Chambers, MA, ELS Dominic De Bellis, PhDGlenn HerdlingMary KnatterudTracey Fine, MS, ELSGayle Nicholas Scott, PharmD, ELSSusan Siefert, ELS, CBC

James R. Cozzarin, ELS

Donna Munari, CAE

Amy Boches

American Medical Writers Association40 West Gude Drive, #101Rockville, MD 20850-1192

Phone: (301) 294-5303; Fax: (301) [email protected]

Copyright 2007, American Medical Writers Association.All rights reserved, worldwide. ISSN 1075-6361

JOURNAL

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6

41

TABLE OF CONTENTSVolume 22• Number 1• 2007

COLUMNS34 MELNICK ON WRITING

35 DEAR EDIE

55 PAGE BREAK

AMWA MATTERS41 WEB WATCH

43 NATIONAL NEWS

46 CHAPTER CORNER

52 MEMBER MUSINGS

56 INSTRUCTIONS FOR CONTRIBUTORS

DEPARTMENTS22 SCIENCE SERIES

29 PROFESSIONAL DEVELOPMENT

33 CALENDAR OF MEETINGS

38 MEDIA REVIEWS

FEATURES2 A Legacy of Leadership: AMWA’s 67th Annual Conference

4 What’s New in the 10th Edition of the AMA Manual of StyleBy Cheryl Iverson

6 2006 Conference Coverage

17 Project Management Strategies for Medical Writers and EditorsBy Candice M. Hughes, PhD

4

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2007

2 AMWA JOURNAL . VOL. 22, NO. 1, 2007

A Legacy of LeadershipAMWA’s 67th Annual ConferenceOctober 11–13, 2007Marriott Marquis, Atlanta, Georgia

Take advantage of the conference “price freeze”—registration and workshop fees for the 2007 Annual Conference will remain the same as the 2006 prices.

Full registration (early bird), $310Core workshops, $85 eachAdvanced workshops, $110 eachNoncredit workshops, $55 each

June 29Conference brochure posted on theAMWA Web site (www.amwa.org)

July 16Conference registration beginsHotel reservations accepted

($140 per night [single or double])

Note these dates!

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Wednesday, October 1010:00 AM–1:00 PM BELS certification examination

5:00 PM–6:00 PM Conference Coach Connection6:00 PM–8:00 PM Welcome Reception sponsored by RPS8:15 PM–9:30 PM Creative Readings

Thursday, October 119:00 AM–10:30 AM Keynote Address12:15 PM–1:45 PM John P. McGovern Medal Luncheon

5:30 PM–6:15 PM New Member Orientation6:45 PM–7:45 PM Chapter Meet & Greet8:00 PM–9:00 PM Coffee and Dessert Klatches

Friday, October 1212:15 PM–1:45 PM Walter C. Alvarez Award Luncheon

7:00 PM–9:00 PM Sablack Networking and Recognition Dinner

Saturday, October 138:00 AM–9:00 AM Breakfast with the Exhibitors5:30 PM–6:45 PM President’s Reception/Louisville Kickoff

AMWA JOURNAL . VOL. 22, NO. 1, 2007 3

We look forward to seeing you in Atlanta!

FUN FACTSABOUT ATLANTA

SPECIAL EVENTS REGISTRATION AND HOSPITALITY

POSTERS

EXHIBITS

AMWA BUSINESS-RELATED MEETINGS

BREAKFAST ROUNDTABLES, OPEN SESSIONS, AND WORKSHOPS

Tours are being planned for each day of the conference. Check the AMWA Web site for moreinformation on specific tours and times.

Wednesday, October 1011:00 AM–6:30 PM

Thursday-Saturday, October 11-137:00 AM–5:30 PM

Thursday, October 117:30 AM–8:45 AM Breakfast Roundtables

10:45 AM–12:00 PM Open Sessions2:00 PM–5:15 PM Open Sessions/Workshops

Friday, October 127:30 AM–8:45 AM Breakfast Roundtables

9:00 AM–12:00 PM Open Sessions/Workshops2:00 PM–5:15 PM Open Sessions/Workshops

Saturday, October 139:00 AM–12:00 PM Open Sessions/Workshops

2:00 PM–5:15 PM Open Sessions/Workshops

Thursday and Friday, October 11 and 127:00 AM–5:30 PM

Saturday, October 137:45 AM–3:30 PM7:45 AM–8:45 AM Visit with the Presenters

Wednesday, October 101:00 PM–4:00 PM 2006–2007 Board of Directors Meeting4:15 PM–5:00 PM Chapter Delegates Session

Friday, October 125:30 PM–6:30 PM Annual Business Meeting

Saturday, October 138:00 AM–8:45 AM 2007–2008 Board of Directors Meeting

9:00 AM–11:30 AM 2007–2008 Executive Committee Meeting

Thursday and Friday, October 11 and 128:00 AM–3:30 PM

Saturday, October 138:00 AM–1:30 PM

Coca-Cola® is a registered trademark of The Coca-Cola® Company.

• Capital and most populous city of the state of Georgia(nearly 5 million in the greater metropolitan area accord-ing to the July 2005 census)

• Originally named Terminus and then Marthaville beforesettling on Atlanta in 1845

• One of the key cities of the “New South,” having under-gone in recent years a transition from a city of regionalinfluence to one of international influence

• Average temperature of 62.4° F in October, perfect forviewing the fall foliage in the North Georgia mountains,just minutes away from the city

• Home of the largest aquarium in the world (The GeorgiaAquarium) with more than 100,000 animals and 8 milliongallons of fresh and marine water

• Home to fabulous shops, restaurants, and attractions suchas the Atlanta Zoo, CNN Center, and World of Coca-Cola®

• Every other street, plaza, or business establishment isnamed “Peachtree,” but good luck finding a peach tree in the city

• Progressive civil rights record with a reputation in the1960s as the “City Too Busy to Hate”

• Other nicknames for Atlanta: The A-T-L, Hotlanta, A-Town,and The Big Peach

• Celebrities from Atlanta: actresses Dakota Fanning andHolly Hunter, singers John Mayer and Ludacris, andAmerican Idol host Ryan Seacrest

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E ditors and authors eagerlyawait new editions of stylemanuals that they refer tofrequently because of all the

updates and added material that theywill contain. But there is also an ele-ment of anxiety in beginning to workwith a new edition because of all therelearning, or “learning anew,” that will be required to master the changes.Right after the question “When will the new edition be available?” followsclosely the question “What’s new?”Here is a short list of what’s new in the10th edition of the AMA Manual ofStyle, scheduled for publication inMarch by Oxford University Press.

Nothing has been deleted, newsections have been added, and existingsections have been expanded, so thechange in the “heft” of the book (anincrease of more than 300 pages) willbe noticeable. This edition contains acompletely new chapter on medicalindexes and 4 new subsections in theNomenclature chapter: molecularmedicine, ophthalmology, psychiatry,and radiology. The chapter on manu-script preparation has been split into 3 chapters—Manuscript Preparation,References, and Visual Presentation of Data—allowing expanded treatmentof all of these topics. A new subsectionon homonyms, idioms, colloquialisms,slang, euphemisms, and clichés hasbeen added to the chapter on grammar.

The design of the book is new; themore descriptive page headers and theexpanded index in this edition shouldmake this 1,000-page book easier to use.

Throughout the book, the changescreated by the greater movement toonline submission, review, publication,and reading are taken into considera-tion, from the editorial process itself to the inclusion of at least 50 examplesof online reference citation, updated

online resources in the areas ofnomenclature, display of data, ethicaland legal considerations, treatment ofcomputer terms, samples of onlineediting and coding, improved readabil-ity through typographical design, andupdated publishing and resourcesglossaries. When the print book ispublished, a companion Web site willoffer users more information about the book and the committee that wrote it, FAQs (frequently asked ques-tions) about the manual, and perhapssome small excerpts. An online versionof the book is in the planning stagesand will be forthcoming in the nextcouple of years.

The chapter that has perhapsexpanded the most in this edition isthat on ethical and legal considera-tions. In the 10th edition, this chapterwill include new policies on groupauthorship and identification of contri-butions of all authors; updates on con-flict of interest; new information oneditorial independence in the wake ofthe firings of the editor of JAMA andother general medical journals; updat-ed definitions of scientific misconduct;new information on data sharing andopen access; updates on copyright andtrademark, especially as they affectonline publishing; new case law onlibel and suggestions for minimizingthe risk of libel; new patient privacyconcerns in scientific publication;revised guidelines for advertising,including online advertising; andupdated information on author andeditor relations with the news mediaand early release of information to the public.

Policies have changed in someareas, as follows: • Table footnotes will now be super-

script lowercase letters, not super-script symbols such as asterisks

• Capitalization in line-art figures willmove from “title style” to “sentencestyle,” except for copy on the x- andy-axes

• In persons’ names, Jr and Sr will nolonger be set off by commas: JohnX. Editor, Sr, MD, will become JohnX. Editor Sr, MD

• State names will be expanded in thetext: Chicago, Illinois; in referencesand full addresses, 2-letter postalcodes will be used: Chicago, IL

• Journal references will include issuenumbers and the abbreviation forthe journal name will be that in useat the time the reference was pub-lished (eg, Br Med J or BMJ)

In addition, the policy on the use of SI units has been modified. In JAMAand the Archives Journals, laboratoryvalues for clinical chemistry analyses,hematologic tests, immunologic assays,metabolic and endocrine tests, thera-peutic drug monitoring, toxicology

4 AMWA JOURNAL . VOL. 22, NO. 1, 2007

WHAT’S NEW IN THE 10TH EDITION OF THE AMA MANUAL OF STYLE?

By Cheryl IversonChair, AMA Style Manual Committee

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@

AMWA JOURNAL . VOL. 22, NO. 1, 2007 5

determinations, and urinalysis will bereported by means of conventional lab-oratory units. For laboratory values,factors for converting conventionalunits to SI units will be provided in thearticle. In the text, the conversion factorshould be given once, at first mentionof the laboratory value, in parenthesesfollowing the conventional unit. Forarticles in which several laboratory val-ues are reported in text, the conversionfactors may be listed in a paragraph atthe end of the “Methods” section. Forfigures or tables, the conversion factorsshould be included in legends or infootnotes, respectively, but not in theabstract of the article.

In other areas, such as eponyms,the policy has remained the same andthe rationale has been reexamined. Fewchanges in policy have been introduced

in the chapter on punctuation, althoughnew (and in some cases, additional)examples have been added.

In much-used glossaries, such asthat in Correct and Preferred Usage andthat in Study Design and Statistics, somepolicies have changed (eg, biopsy isnow allowed as a verb) and many newentries have been added. For example,in Correct and Preferred Usage, entriesare now included on adherence, com-pliance; participant/subject; chief com-plaint/concern; impaired/intoxicated;and survivor/victim. In Study Designand Statistics, entries are now includedon C statistic, imputation, missing data,and propensity analysis, to name a few. Many new entries have also beenadded to the glossary of publishingterms, such as blog, bot, cookie, e-com-merce, and spider.

The work on this edition, as on the8th and 9th editions, was done by acommittee of 10 editors. Although each chapter has a principal author orauthors, the work on the book was trulya group effort, with every committeemember critiquing many drafts of every chapter. The book was also peerreviewed by editorial colleagues onJAMA and the Archives Journals andelsewhere in the United States andabroad. It is this group effort, of authorsand peer reviewers, that requires somuch time but that, we hope, makesthe book stronger and, after some timeto get acquainted, of greater use. Theproof of the pudding is in the eating.The value of a new edition of a stylemanual is in its daily use. Bon appetit!

AMWA Updateto Replace

Monthly Postal Mailings

By now, you have received your first AMWA

Update, AMWA’s new e-mail communication

vehicle for members. To keep communications

timely, reduce costs, and be more environmen-

tally friendly, the AMWA Update will be sent

monthly and, in April 2007, will replace the

monthly postal mailings that AMWA head-

quarters has typically sent. Be sure to read

your AMWA Update! It will keep you abreast

of upcoming Chapter conferences, AMWA’s

annual conference, new information and

resources on the Web site, and news about

AMWA’s Listservs. The AMWA Update will

also contain links and news to keep you up-to-

date on issues related to the profession.

Invitation to Take Part in AMWA Salary Survey

Participation will take approximately 10 minutes and will be anonymous

Who? All AMWA members, regardless of place ofemployment or type of communication service

What? A comprehensive survey of salary and otherdata of interest to a diverse group of administrators,writers, editors, and other medical communicators

When? The survey will begin April 18, 2007

Where? On a secure Web site.

What’s new? A raffle for survey

participants and more freelance questions

What else? Watch for details in an e-mail from AMWA

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6 AMWA JOURNAL . VOL. 22, NO. 1, 2007

By Dale E. Hammerschmidt, MD, FACP University of Minnesota School of Medicine

W hen I received the startling news that I was to be the 2006recipient of the Harold A. Swanberg Distinguished ServiceAward, I found it both humbling and gratifying. I did not

imagine that my work would attract the attention of the SwanbergCommittee. The work I have done has largely been directed toward arelatively small audience (the rhetoric of consent in research) or hashad almost the flavor of guerrilla warfare (eg, the editor ever remindingauthors that race is an ambiguous categorical variable and must bedefined, if one hopes to write science rather than anecdote).

At the time I found out about the award, a few very prominent cases of research fraud had just come to light, and the peer-review systemwas being harshly criticized in the lay press for its failure to detect andto prevent the publication of fabricated research. I had done some workrelated to the detection of fraud during my tenure as senior editor andthen as editor in chief of the Journal of Laboratory and ClinicalMedicine, and it was suggested that it would be good for me to addressthe issues of peer review and fraud in medical publishing as the topic ofmy Swanberg address. The title of this essay was chosen as a lightheart-ed metaphor for my position and the “bottom line” conclusion I willoffer. Cheese lovers among the readers will be aware that Limburger is a soft and very rich cheese that is often perceived as being a bit on theslimy side and distinctly malodorous. Emmenthaler, in contrast, is a

DEDICATION

When I gave the Swanberg address in October, a previous recipient of the award had just died.Because I was not aware of this until her obituaryappeared the following morning, I did not havethe opportunity to offer her a special tributefrom the podium. I would like to dedicate thisessay to the memory of Dr. Jane Hodgson, the1996 recipient of the Harold Swanberg Award.

I knew Jane Hodgson in the 1970s, but neverso well that I could use the word "friend" withoutfeeling a bit presumptuous. I was performingalternative selective service as the medical direc-tor of a community clinic dealing primarily inreproductive health issues; Jane was a respectedgynecologist in the community. Jane and herhusband (a surgeon) were advisors to our clinic,so we crossed paths fairly frequently. We sharedconcern for the unmet medical needs of women,especially in reproductive health; we were bothalso interested in the autonomy of adolescents.

Jane is most remembered for her stronglyheld view that the decision to have or to performan abortion is highly complex and highly case-specific, a decision that ordinarily belongs withinthe moral purview of the people most directlyinvolved. She performed abortions that shedeemed to be ethically acceptable, even if theydid not conform to strict abortion law Minnesotahad at the time. Her conviction (in a case deliber-ately testing that law) was vacated after the 1973Supreme Court decision in Roe vs. Wade. Itwould be unfortunate, however, to remember heronly as a pioneer advocate for the medical needsof women and for greater freedom in reproduc-tive care. Her concern for distributive justice inhealth care went far beyond that issue andinvolved her in programs to try to improve healthcare delivery in developing nations and in under-served communities within the United States.

Jane may have been a controversial figure,but she commanded respect—even among heropponents—for the courage of her convictions,for her willingness to argue positions rather thanchant slogans, and for the breadth of her com-mitment to justice in health care.

2006 CONFERENCE COVERAGE

*As presented at the 2006 AMWA Annual Conference, October 27, 2006.

HAROLD A. SWANBERG

ADDRESS*

The Swiss Cheese of Peer Review: It’s Emmenthaler, not Limburger

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 7

firm cheese that is somewhat nutty incharacter and is full of holes. I think theEmmenthaler is a better metaphor forpeer review; the process is indeed a bitnutty and full of holes, but I don't reallythink it stinks.

CONTEXT: THE CASEIn 2004 and 2005, 2 papers were pub-lished in Science describing the work of Professor Hwang Woo-Suk, a veteri-narian at the Seoul National Universityin South Korea. Dr. Hwang claimed thathis group had succeeded in establish-ing embryonic stem cell lines fromcloned human embryos. If true, thiswould have been a very important stepalong the road to making it possible touse early stem cells therapeutically. Theintroduction of stem cells into a recipi-ent is essentially a transplant on a verysmall scale; the immune system of therecipient will recognize that the cellsare foreign and will attack them. If itwere possible, however, to cloneembryos using nuclei from a patient’scells, the resultant stem cells would beimmunologically much closer to thepatient’s own cells and might be toler-ated just fine. The 2005 paper was rec-ognized by the editors as an extremelyimportant paper; it was reviewed intra-murally by members of the journal'seditorial board and also was seen byextramural referees; it was quicklyaccepted and was pre-published on the journal’s Web site.

The applause had not yet dieddown when questions began to arise.One of the members of the researchteam (a collaborator from outsideKorea) distanced himself from thepublication because of what weredescribed as ethical concerns. The firstethical concern voiced was related tothe source of the donor eggs, but as thestory unfolded, there were other ethicalconcerns related to data handling andto the inferences drawn. It eventuallybecame clear that there were not suffi-cient data to conclude that any of theembryonic stem cell lines was a legiti-mate descendant of a cell that was atrue clone. In other words, it wasn't atall clear that the claimed breakthroughhad been made. An intramural panel at

the Seoul National University conclud-ed that the necessary data to make thestory convincing had simply been fab-ricated. The papers were retracted inearly 2006, and Dr. Hwang is now ontrial for fraud.

As soon as this story broke, onebegan to see articles in the lay press,lamenting this failure of the peer-review system and suggesting that itfailed because it was inherently cor-rupt; the criticism was even sharper insome of the Web postings by patientadvocacy groups such as the Alliancefor Human Research Protection. Theeditor of Science, the journal in whichDr. Hwang published, observed thatpeer review was really incapable ofdetecting fraud if the fraud had beenskillfully crafted. It’s clear that differentpeople brought different expectationsto the discussion.

A MERCIFULLY BRIEF HISTORY OF PEER REVIEWPeer review is such a routine part of thescientific publication process now thatit is difficult to remember that it is arelatively recent development. Prior tothe late 1800s, most scientific publica-tion was in the form of monographs,proceedings of scholarly meetings, andproceedings of scholarly societies. Onepublished by finding the funds to pub-lish (which often meant finding a suit-able patron), or one published by beingadmitted to an honorific society, or onepublished because a member of such a society invited and sponsored yourpaper. In the late 1800s and early 1900s,we saw the rapid appearance of jour-nals that allowed open submission ofmanuscripts, without a requirement forsponsorship or membership in a socie-ty. As one simple example, the journalwhich I edited was founded in 1915 bya publishing company and did noteven have an affiliation with a scientificsociety until 30 years later.

In the early years of open-submis-sion journals, editors simply chosewhat they wanted to publish and pub-lished it. Of course, editors could notall be universal geniuses, so they wouldsometimes need the advice of a col-league in order to decide whether an

article were good enough or interestingenough to print. But there was not anexpectation that papers would routine-ly be submitted for extramural review,and there was no particular sense thata journal or a paper was of better quali-ty if peer review had been involved. It is amusing to reflect upon the fact thatAlbert Einstein’s most important paperson relativity did not go through peerreview; they were reportedly publishedbecause the editor thought the ideaspresented were so novel that they wouldoccasion highly productive debate.

Over the first half of the 20th centu-ry, peer review became a more com-mon part of the evaluation of manu-scripts for publication, simply becausethe number of scientific papers beingwritten became too great for editors tojudge without help. But the real rise ofpeer review as a credential came in theperiod immediately after the SecondWorld War. At that time, governmentfunding of research was increasing andthe government had to decide whatresearch it was going to support. It wasdecided that a scientific evaluation ofresearch proposals should be done byscholars in the field rather than by gov-ernment agents. Peer review rapidlybecame the norm. Implicit in the eval-uation of a research proposal is theevaluation of the investigator makingthe proposal—there is not a lot of pointin funding a researcher who won’t beable to carry out the project. In order toevaluate the credibility of a researchermaking a funding request, it was neces-sary to scrutinize that researcher’spublication corpus. A hierarchy quicklyemerged: primary scientific reportswere valued more highly than werereview articles or opinion pieces;papers that were published in journalsthat used peer review were valuedmore highly than papers that werepublished in other venues. Under thisselective pressure, it did not take longfor peer review to become the norm.

THE MECHANICS OF PEER REVIEWWhen a journal receives a manuscriptin open submission, it is typically sentto 2 or more external reviewers for theirevaluation. Those external reviewers

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are asked to answer several questions,and the list is quite homologous fromone journal to another:• Does the science appear to have

been done well? Was the questionwell framed; were the methodsappropriate; was the analysisappropriate?

• Do the data support the conclu-sions? If speculations are included,have they been identified as such?

• Are the observations novel? If theobservations are merely confirmato-ry of something that has alreadybeen published, is that confirmationso important that it warrants a sep-arate publication?

• Are the observations important?Does the work described in thepaper move science forward in auseful direction?

• Does the paper fit the scope andthe audience of the journal?

• Do you think we ought to publishit? If so, with what priority?

A few journals will add a questionor two to that basic list, for example:• Can the paper be made shorter or

clearer?• Did you spot any ethical concerns?

Were the use of animals and the useof human research subjects appro-priate?

Conspicuously absent from that list is the question: “Whaddaya sup-pose the chances are that this guy justmade it all up?” I have been doing peerreviews for roughly 35 years and Ispent 15 years actively soliciting them;I have yet to encounter this questionon a peer-review form. Quite simply,peer review was not introduced withthe idea of detecting and preventingfraud, and peer reviewers are not nowgiven that task by journals. Moreover,peer reviewers are chosen for theirexpertise in the science under discus-sion, rather than for their ability todetect irregularities. Finally, refereesare given neither the resources nor thetime that would be necessary to makea serious attempt at detecting andthereby deterring fraud.

Expecting peer review to detectfraud is a little bit like expecting yourmailman to detect your colon cancer. If you see your mailman often, he maynotice that you are losing weight andthat you have become pale. If you haveestablished a personal relationshipwith him, he may be bold enough toexpress concern. But he doesn’t havethe training or the time or the tools todetermine whether you are likely tohave a colon cancer; his silence on theissue, therefore, is of no real probativevalue.

AN INSTRUCTIVE CASE FROM OUR SHOPMy personal interest in publicationfraud was heightened by an episodethat occurred at the Journal of Labora-tory and Clinical Medicine roughly adecade ago. We had published 2 papersby an author and had other works byhim under peer review. An extramuralreferee and a reader each expressedconcern that the author had producedan improbable number of single-author papers in a relatively short peri-od of time; each had involved fairlydetailed follow-up of a large number ofpatients. It seemed likely to the com-plainants that the author had eitherfabricated the manuscripts or deniedcredit and coauthorship to colleagueswho had worked with him on the stud-ies. Because the author had changedinstitutions several times in the 3 yearsbefore the complaint, there was noacademic authority to which we couldrefer these concerns. We ended updoing a rhetorical analysis of theauthor’s entire published corpus—49papers—and found a number of irrec-oncilable inconsistencies. (Much of theactual work of the rhetorical analysiswas carried out by my colleague fromthe University of Minnesota Depart-ment of Rhetoric, Prof. Alan Gross.) For example, in some cases the humanstudies would have had to have beendone before the animal studies onwhich they were reportedly based. Inothers, the work was done (allegedly)before the pathophysiologic mecha-nism under scrutiny had even beenproposed. We outlined the most

important of these inconsistencies in astatement of concern we prepared forpublication; we gave the author theopportunity to respond, and he did so.We published the 2 statements togeth-er and closed with the judgment thatthe response was insufficient and withthe announcement that the journalwithdrew its aegis from the publishedpapers.

Although this is an example thatpeer review can detect fraud, it's notexactly a cause for celebration. Afterall, the author had published 49 papersbefore he was caught—it wasn’t untilthe same referees had seen several ofhis papers that suspicion arose. Eachof the papers was individually quitecredible as a predictable next step in apromising line of research that wasbeing followed at many centers. It wasonly when all of the papers were takentogether that the fraud was recognized.Moreover, the withdrawal of journalaegis from these manuscripts did notundo the damage that they had done(they had clinical implications), and itdid not completely prevent continuedcitation of these papers by subsequentauthors.

Another instructive case is that ofDr. John Darsee. He published a num-ber of papers that purported to showrelatively predictable next steps upon a very promising line of investigation.Again, taken individually, the papersare very highly credible. They were notdetected as fraud by peer reviewers.The work was also not detected asfraud by Darsee’s more senior collabo-rators. The fact of fraud was eventuallyrecognized because someone noticedthat the researcher was reportingresults on far more animals than hehad actually purchased. The easiestexplanation was that he was in factdesigning experiments and carryingthem out through the pilot phase; oncehe was pretty sure how they were goingto turn out, corners were cut. It’s inter-esting to ask why his more senior col-leagues didn’t notice the problem; Ithink the answer may be quite simple.If you have among your trainees some-one who appears to be “a rising star,”you are anxious for that person to

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succeed and you enjoy basking in thereflected glory. Moreover, the naturaltendency is to trust people, especiallythose you have personally trained.

From these 2 cases and others thathave been published, a certain patternbegins to emerge; that pattern leads tothe conclusion that peer review notonly often fails to detect fraud—it actu-ally abets fraud. A successful fraudsterreports credible next steps rather thanthings that people will have troublebelieving; he may have preliminarydata to guide him. As a result, the find-ings are often confirmed by other labo-ratories, and the differences betweenhis findings and those of anotherresearcher may be small. Each time hesubmits one of his manuscripts forpublication, he gets one or more help-ful critiques. He is told how the studydesign might have been a bit better; heis cautioned about additional potentialexplanations for the findings, and hemay be told how to improve the statis-tical analysis. It's quite simple to bringthese messages to the generation offraudulent manuscripts as well asgenuine ones. Nothing could be easierthan adding another control group oradding another statistical analysis, ifyou're making it all up in the firstplace!

The published information aboutpeer review and fraud is very difficultto evaluate because it suffers fromascertainment bias. If peer reviewcatches a fraud and prevents its publi-cation, you usually don’t hear about it.This is partly because the level of sus-picion that would prevent publicationis much lower than the level of suspi-cion (read: evidence) at which onefeels comfortable making the casepublic. It is also because the journal’sstanding is different if it has neverpublished the author—you cannotretract the paper or withdraw aegisfrom it if you never published it. Sothere is a substantial body of actiontaken against fraud, but taken privatelyrather than openly. (Once such case isdiscussed in an essay in MinnesotaMedicine, cited in the RecommendedResources.)

WHAT’S PEER REVIEW GOOD FORANYWAY?To this point in the essay, I have arguedthat peer review was not designed todetect fraud, that it isn’t asked to detectfraud, and that it isn’t very good atdetecting fraud. Is it actually good atdoing what it’s supposed to do? Theanswer would seem to be a resounding“sort of.” There are difficulties in thequality of peer review that arise fromthe limited time reviewers have tospend on this uncompensated activity;there are difficulties that arise from theproblem (despite all good intentions)of divorcing oneself from one’s inher-ent biases.

One bias is fairly straightforward: it is easier to credit a manuscript thatcomes from a prestigious researchinstitution than it is to credit a verysimilar manuscript that comes from asmall liberal arts college or the devel-opment laboratory of a small company.Twenty years ago, there were a numberof studies done in which the institutionof origin was masked in a manuscript,or the manuscript’s cover materialdeliberately misstated its origin. Whensuch a doctored paper was then sent tomultiple reviewers, the putative insti-tution of origin was indeed found to bea predictor of the final publication rec-ommendation. Some journals haveexperimented with bringing these find-ings into practice, but that doesn’twork very well. It is only possible tomask the origin of perhaps a third ofmanuscripts. Most authors presenttheir work not only in the context of adeveloping field of knowledge, but alsowithin the context of a line of investi-gation being pursued at their institu-tion. That pattern—and even individ-ual writing styles—may be easily rec-ognized; most simply, an author oftencites himself and his immediate collab-orators quite frequently in the intro-duction and in the first few paragraphsof the discussion. If you’re closeenough to the field to be a good refer-ee, you will often recognize who wrotethe paper.

One may also have bias pertainingto the conclusions of the paper; thereis a natural tendency to give more

rigorous scrutiny to a paper with whichyou disagree then to a paper that sup-ports conclusions that are near anddear to your own heart. Several studieshave tried to get at this bias; one by Dr.Edzard Ernst (now at the University ofExeter) was published within our pagesat the Journal of Laboratory andClinical Medicine. Ernst was at thetime the editor of a physical medicineand rehabilitation journal. He deviseda manuscript concerning a rehabilita-tive technique about which there wassome disagreement. He deliberately“engineered” into the paper a numberof fairly obvious flaws and a number of unusual strengths. He sent the paper to a large number of reviewers, notingwhether they were proponents oropponents of the technique understudy. He found that referees whoseown publications agreed with the con-clusions of the paper were more likelyto spot the strengths, less likely to spotthe weaknesses, and more likely to give an overall favorable publicationscore than were referees who were inprior disagreement with the paper'sconclusions.

About 8 years ago, Fiona Godlee ofthe British Medical Journal reported astudy in which 8 substantive errorswere deliberately inserted into a man-uscript; each was an error that couldreasonably be expected to be noticedby a peer reviewer. She sent the paperto a very large number of referees, ofwhom 221 returned reviews. Sixteenpercent of those reviewers didn’t catcha single one of the errors; the medianreviewer found 2 errors; only a fewspotted 5 errors, and no one detectedmore than 5 errors. This may not bequite as bad as it sounds, because thereviewer is likely to stop looking onceenough errors have been found that it’sclear the recommendation will beagainst publication. But even with thatcaveat in mind, one gets the sensefrom studies like this that a lot of seri-ous errors slip through peer review.

A common complaint about peerreview is that it can be capricious.Once in a while, there may be a review-er who is capable of cruelty and oncein a while there may be an author who

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has provoked such a response in manyreviewers. But more commonly andmore substantively, one may (withoutmalice) get 2 or 3 reviews that differrather starkly in their evaluation andrecommendations. Is that a good thingor a bad thing or a little of each?Redundancy is a means of improvingerror detection, and discrepancy maybe a sign that redundancy has suc-ceeded. We asked at the Journal ofLaboratory and Clinical Medicine justhow consistent our reviews were. Mostof our manuscripts were sent to 2 ref-erees; they were asked to give theirfinal publication grade for a manu-script on a 5-point scale. At one end ofthe scale was the recommendation topublish the manuscript without revi-sion; at the other end of the scale wasthe recommendation to return a man-uscript to the author with no opportu-nity to revise and resubmit. We com-pared the recommendations of the 2reviewers for each manuscript return-ing during a several-month samplinginterval. We found that in 36% of thepairings, the referees gave the samefinal recommendation, another 26%differed by only a single step on thescale, and only 9% differed by morethan 2 steps. When we examined thewidely discrepant pairs, we found thatthere was almost always an explana-tion; the 2 most common were: (a) 1reviewer noticed a problem that theother missed, and (b) the 2 reviewersnoticed the same serious errors butdiffered in their optimism for repair. In4% of the discrepant pairs, the 2reviewers may not have shared thesame planetary origin.

WHERE IS ALL THIS GOING?In reviewing a number of features ofpeer review, several of which aredescriptors of problems with theprocess, I think the most importantsingle conclusion is that one shouldnot expect more of peer review than itcan really deliver. Peer review is a wayof getting advice from workers in thefield that can help an editor make agood decision about the acceptance orrejection of a manuscript. As soon asyou start expecting it to be the whole

process, or as soon as you start toexpect it to do things like detect fraud,disappointment will ensue.

That being said, I think it is quiteuseful to think about the ways in whichpeer review might be improved. Someof the potential improvements are inthe peer review system itself, and oth-ers are more general improvements inthe way research is monitored andpublished, providing tools other thanpeer review to address the problemsthat are poorly addressed by referees.

Perhaps one of the biggest thingsone can do is make the process moreopen. Traditionally, the identity ofreviewers is hidden from the authors of the paper under review; that makesit easier to do a sloppy review or a vitu-perative one. As an editor, I encour-aged reviewers to sign their reviews,but only a few percent did so. Ifreviews were routinely signed, thatwould put authors and referees on amore equal footing, a step likely toimprove both civility and quality.

One could also open the processbeyond the tight little circle of author,referee, and editor. One could makethe original submission available as aWeb posting, along with the reviewsand the author’s responses to thereviews. Some journals are alreadyexperimenting with this sort ofprocess, and one could imagine evendoing it before the final version hasbeen accepted for publication.

During our experience with theoccasional fraudster, we were struckthat several expressions of concern atseveral different journals had oftenbeen made before the weight of theevidence moved someone to do some-thing. That led us to a certain sympa-thy for the notion that disclosing peerreview to other journals might be agood thing. It could become a routineexpectation that authors would dis-close the other journals to which theyhad previously submitted a paper, andthat the previous journal would be freeto share its review with the editors nowconsidering it.

One could also try to depersonalizepeer review a bit. Journals alreadyoften try to avoid using reviewers who

are likely to be competitors or collabo-rators of the authors under scrutiny.Perhaps that can be taken a step fur-ther, and a cadre of reviewers could bedeveloped who would have expertisein study design issues and statisticalanalysis. Using such reviewers for aninitial scrutiny of a manuscript mightallow a journal to ask only very narrowand focused questions of people whomight have conflicts of interest inoffering a review.

One could also try to develop goodtechniques to monitor the process. Aneditor will certainly often say “Gee, thatwas a helpful review” or somethingconsiderably less friendly. Evaluatingthe reviews on a systematic basis andgetting those evaluations back to thereviewers could help referees to honetheir skills and to understand betterwhat it is that the authors and editorsneed of them.

YEAH, BUT…Although it may be possible with theseand other tools to make peer reviewmore helpful and more civil, there stillis that question of fraud that hasappeared a number of times in thisdiscussion. Improving peer review willnot be a complete solution to the prob-lem of fraud or to any of a number ofother problems that afflict the scientif-ic publication enterprise. It’s appropri-ate to mention a few steps that gobeyond peer review per se.

Improving institutional oversight ofresearch is probably the avenue thathas the most realistic chance to detectand derail fraud. The challenge in suchwork is to make the oversight effectivewhile not making it oppressive. If somany validation steps are added that aresearcher feels as though he is wear-ing concrete boots, it may not be sucha good thing.

It is a relatively simple matter torequire an author to certify that he hasthe skills and training and facilities tohave carried out the research he isdescribing in a manuscript.

It is already becoming relativelycommon for journals to require coau-thors to accept responsibility for themanuscript and to describe their indi-

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vidual contributions. This sort of requirement makes it moreawkward to grant a “courtesy” authorship to someone whosecontribution was quite oblique.

In discussing one of our fraud cases, we proposed that aguarantee of cooperation in retrospective reanalysis shouldroutinely be solicited. Such a guarantee could have a reason-able time limit (perhaps 5 years) and could promote alterna-tive scientific analysis and interpretation of a given set of dataas well as make those data available for examination if irregu-larities were alleged. As the cost of computer memory goesdown, data banking becomes a more realistic consideration.

CONCLUSIONPeer review is not really broken, and peer review has not real-ly failed to deliver on a promise. It was a pretty coarse tool tobegin with, and it has been blamed for things it cannot fix. Itneeds to be recognized for what it is and recognized for whatit is not. The context in which it functions is a process that hasa lot of room for improvement that could remove the unrea-sonable demands from peer review. Peer review itself could beimproved, generally by making it more open and making itmore liable to quality control.

To return to my thurophilic metaphor, I think peer reviewcan be likened to Emmenthaler rather than Limburger. Butmaybe we should aim higher, and try to move fromEmmenthaler to Gruyere. It will still be a little bit nutty, but itwill be more solid and will have fewer holes.*

*Although it is beyond the scope of my address and this essay, asimilar concern could be voiced about an increasingly recognizedproblem: the publication of drug and device studies that aredesigned with licensing and marketing questions in mind ratherthan with the most important clinical questions in mind. For thisissue, heightened awareness by editors and referees may be moreimportant than structural or procedural changes.

Recommended ResourcesErnst E, Resch KL. Reviewer bias: a blinded experimental study. J Lab Clin Med. 1994;124:146-148.

Godlee F. Making reviewers visible: openness, accountability, andcredit. JAMA. 2002;287:2762-2765.

Godlee F, Jefferson T (eds). Peer Review in Health Sciences.London; BMJ Books, 1999.

Hammerschmidt DE, Franklin M. The limits and power of peerreview. Minn Med. 2006;89.

Hammerschmidt DE, Gross AG. Allegations of impropriety inmanuscripts by Aws S. Salim: examination and withdrawal ofjournal aegis. The Executive Editorial Committee of the Journal of Laboratory and Clinical Medicine. J Lab Clin Med. 1994;123(6):795-799.

Smith R. Peer review: reform or revolution? [editorial]. BMJ. 1997;315:759-760.

Note: This editorial is a good overview of the problem of peerreview as perceived almost a decade ago; the fact that it is stillcurrent speaks to the difficulty of effecting change in a deeplyentrenched routine.

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2006 CONFERENCE COVERAGE

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HOW TO RECOGNIZE HIGH-QUALITY REVIEWS AND CLINICAL STUDIES

SpeakerTeresa RogstadMedical Analyst, Hayes, Inc.

By Deborah A. Early, PhD

Teresa Rogstad has been an AMWAmember for 3 years. As anemployee of Hayes, Inc., she

writes about new and emerging healthcare technologies for health care com-panies and hospitals. She started her 1-hour-long open session with an inter-esting quote from Robert Pirsig, Zenand the Art of Motorcycle Maintenance:“But even though Quality cannot bedefined, you know what Quality is!”

While the session did not deal withany additional aspects of motorcycles,the concept of quality bridges manyareas.

Rogstad successfully covered 3main areas in her presentation:• Understanding evidence-based

medicine (EBM)• Recognizing high-quality evidence• Locating high-quality evidence

The definition of EBM that Rogstadprovided initially came from theEvidence-Based Medicine WorkingGroup: “A new paradigm for medicalpractice is emerging. Evidence-basedmedicine deemphasizes intuition,unsystematic clinical experience, andpathophysiologic rationale as sufficientgrounds for clinical decision makingand stresses the examination of evi-dence from clinical research.”1

Rogstad explained that in place ofintuition clinicians could considerusing data; in place of clinical experi-ence they could use synthesized clinicalresearch; and in place of pathophysiol-ogy they could use patient-centeredoutcomes. She explained that the oldapproaches to medical practice hadnot been discarded, but deempha-

sized, and that the ideal is not alwayspossible.

Rogstad explained that medicalwriters should be able to recognizehigh-quality evidence in the form of 3factors: strong clinical studies, usefulclinical studies, and systematicreviews.

Strong clinical studies (strong in a methodologic sense) can be recog-nized by examining a number ofaspects including, but not limited to,the following:• Research design• Study conduct• Sample size• Sample selection• Analysis

A show of hands demonstrated thatmany in the audience were familiarwith the aspects of research design (eg,whether a trial is randomized). Rogstadexpanded on conduct by discussing,among other things, whether the trialis blinded and the comparator groupsare similar (in terms of clinical history,gender, and demographics). The fol-low-up can also give an indication ofthe strength of the study. If few trialparticipants were seen at the follow-up visit, the results are less reliable.Rogstad explained that optimum sam-ple size can reduce bias, but there is no magic number for sample size. Sheexplained that if the authors reportthat a power calculation was per-formed, this is an indication that theinvestigators were probably careful inthe design and analysis. The specificsof how to interpret power calculationswere not discussed. Other questionswriters can ask to try to establish thequality of trials include whether theoutcome measures are defined,whether statistical significance wascalculated, whether magnitude ofeffect was reported, and whether acontrol for known confounders wasundertaken.

Rogstad then moved on to discusshow one can try to identify useful

clinical studies. Writers need toexamine factors such as the following,she said:• Efficacy (whether a product/proce-

dure works in a controlled environ-ment) versus

• Statistical versus clinical signifi-cance

• Subgroup analysis• Short-term/long-term follow-up• Intermediate outcomes versus

health/patient-centered outcomes• Quality of life/quality-adjusted

life-years • Cost-effectiveness analysis

“In a research setting strict proto-cols are usually followed, but thesemay be very difficult or inappropriateto implement in practice, and record-keeping in practice is not always as it isfor a trial,” said Rogstad. She furtherexplained that there are important dif-ferences between clinical and statisti-cal significance and that writers shouldconsider clinically relevant resultsmore useful. A study of a treatment toreduce pain in a chronic condition thatmay eventually resolve on its own doesnot require long-term follow-up. Onthe other hand, for a study of some-thing like pancreatic transplantation,long-term follow-up is useful.

Published systematic reviews areanother type of clinical evidence. Theyare defined by the following:• Focused study question• Specific search strategy• Criteria specified for article selec-

tion• Critical appraisal of studies, includ-

ing formal quality assessment(analysis)

• Synthesis (may include meta-analysis)

Systematic reviews serve as a foun-dation for review articles, practiceguidelines, and health technologyassessments and can provide excellentsource material for medical writers.The authors of a systematic review

REPORTS FROM OPEN SESSIONS

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begin with a focused study questionthat defines what is important to knowand then look for studies that answerthat question. The examples Rogstadgave were “Is core decompressionmore effective than pain medication indelaying hip replacement?” and “Ispancreas transplantation effective inpreventing secondary complicationsfrom diabetes?”

Writers may need to be able tolocate high-quality evidence (clinicalliterature), not just be able to recognizeit. Rogstad commented that writersusually start with review material, andthen look for individual studies ifnecessary. Some writers may neverhave a need to look for individual stud-ies—but may have to interpret studiesidentified by others.

Using an example of “total kneereplacement” Rogstad showed how toconduct a PubMed search for usefulreview articles, with an emphasis onsystematic reviews. She also showedhow relevant practice guidelines andhealth technology assessments, whichideally are based on systematicreviews, could also be found at otheronline sites.

Four abstracts describing individ-ual studies on minimally invasive tech-niques for total knee arthroplasty werealso discussed, and the group attempt-ed to identify strengths and weakness-es in the studies by looking at the itemsRogstad had discussed, such as samplesize, control, follow-up, and whetherthe analysis was retrospective. Thisexercise provided an opportunity toillustrate principles with an emphasison ability to get a global sense of quali-ty rather than analyzing the study indetail. Several questions were raisedduring the practical part of the session.One member of the audience asked forcomment on the “intent-to-treat”analysis. This was considered a betterway to analyze the data because it bet-ter reflects how patients might respondin practice. Some discussion followedregarding different analytic techniquesfor dealing with a high loss to follow-up. In response to a question aboutunlimited analyses, Rogstad remarkedthat “data dredging is not consideredappropriate (subgroups need to bedefined ahead of time).” She added,“The more analyses are conducted, themore likely one is to find something

that is statistically significant.” A mem-ber of the audience reminded thegroup that such a result generates anew hypothesis that should be tested.

In closing, Rogstad expressed herhope that the discussion enabled writ-ers to see that there are principles theycan use to recognize high-quality clini-cal evidence. She concluded by onceagain quoting Pirsig, from Zen and theArt of Motorcycle Maintenance, butquestioning his premise: “But eventhough Quality cannot be defined, youknow what Quality is!”

References1. Evidence-Based Medicine Working

Group. Evidence-based medicine. Anew approach to teaching the prac-tice of medicine. JAMA. 1992;268(17):2420-2425.

Deborah Early is a freelance medical writerand president of the AMWA DelawareValley Chapter.

HOW TO TALK TO A STATISTICIAN:WHAT TO ASK FOR AND WHAT TODO IF YOU DON’T GET IT

SpeakerDanny A. Benau, PhDAssociate Professor of BiomedicalWriting, University of the Sciences inPhiladelphia, Philadelphia PA

By Patricia Rawn, BScPhm, PharmD

I n regulatory medical writing, themedical writer and statistician mustwork as a team. This open session,

led by Danny Benau, PhD, describedhow medical writers can work withstatisticians to save time and avoiderrors caused by retyping, copying, andpasting data from statistical outputs.

SAS: A Brief BackgroundIn order to frame the discussion, Dr.

Benau provided a brief overview of SASand SAS outputs. SAS is the industrystandard software program for statisti-cal analysis, and SAS outputs are datatables produced by statisticians usingSAS. Medical writers use these SAS out-puts in their reports. The software isreferred to simply as “SAS,” or, in Dr.Benau’s words, “SAS stands for SAS!”

Medical Writers and Statisticians:A Two-way StreetMedical writers and statisticians have agreat deal to offer each other (Table 1).

What to Ask forDr. Benau outlined 3 simple things thatmedical writers should request fromtheir statistician:• List the top 3 adverse events in each

treatment groupAlthough many writers locate thetop 3 adverse events by scanning a

table visually, this method is proneto human error. You can simplifythis process by asking your statisti-

• Minimize error potential and statisti-cian review time by requestingappropriate SAS outputs

• Assist in the development andreview of data analysis plans

What medical writers can do for statisticians

• Provide SAS outputs that will workwithin the framework of your report

• Evaluate whether your proposedanalysis is technically feasible

• Save you time in retyping or cuttingand pasting data

What statisticians can do for medical writers

Table 1. Relationship between statisti-cians and medical writers

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cian to write a program to displaythe top 3 adverse events. You canthen convert this table to text foryour report. This method reducestime and errors because it elimi-nates the steps of visually locatingthese adverse events and manuallytyping them into your report.

• Include the program and dataextraction date in each tableBy asking your statistician to auto-matically add the program name(ie, the version of SAS being used)and the date of data extraction toevery table, you are reducing therisk of accidentally using olderdata. You can also ask your statisti-cian to tell you whenever the tablesare changed so you can updateyour report.

• Provide a continuous table for in-text use SAS inserts page breaks into tablesby default. This can lead tounsightly tables with odd gaps. Toavoid this problem, ask your statis-tician to set an infinite or very long(eg, 5 miles) table length. You can

also request customizations such as not inserting percent symbolsafter each number in a table if these are not desired. This can save you time and reduce the risk that you will introduce an error while reformatting.

What You Can Do for Your StatisticianDr. Benau emphasized the importanceof giving something back to your stat-istician.

Reduced review time. Your statisti-cian is responsible for the data andmust review your report to ensure thedata are correct. You can greatly reducethe statistician’s review time by askingfor SAS outputs that closely reflect yourrequirements, thus minimizing theneed to retype or cut and paste data.

Editorial assistance. You can alsoassist your statistician by offering toedit the Data Safety Monitoring Boardpresentation and the StatisticalAnalysis Plan. Becoming involved atthis early stage will help you establish a relationship with your statisticiansooner in the process, provide a usefulservice for the statistician, and alsomake your statistician more aware of

your data formatting requirements.This in turn will make it easier torequest data outputs in the form yourequire.

Selected ResourcesDr. Benau recommended the following ref-erence as an excellent, basic introduction togenerating high-quality reports with SAS:

SAS® Reporting 101: REPORT, TABULATE,ODS, and Microsoft Office.Lauren Haworth, Genentech, Inc., South San Francisco, CA(www2.sas.com/proceedings/sugi28/071-28.pdf)

Other selected resources that Dr. Benau recommended included the following:

SAS citation guide (www.sas.com/presscenter/guidelines.html)

SAS0174 ODS Technology for Today’sDecision MakersSunil Gupta, Gupta Programming, Simi Valley, CA(www2.sas.com/proceedings/sugi30/260-30.pdf )

Presentation-Quality Tabular Output via ODS 1Brian T. Schellenberger, SAS (http://support.sas.com/rnd/base/topics/odsprinter/qual.pdf)

Patricia Rawn is a freelance medicalwriter in Toronto, Ontario.

14 AMWA JOURNAL . VOL. 22, NO. 1, 2007

WHAT EMPLOYERS LOOK FOR IN A FREELANCE

ModeratorLynne Lederman, PhDFreelance Medical Writer,Mamaroneck, NY

SpeakersKevin Flynn, MASenior Vice President, Medical Affairsand Scientific Services, Fusion MedicalEducation, Wakefield, MAEllen B. Lipman, MS, RTDirector of Professional Development,American Society of RadiologicTechnologists, Albuquerque, NMStephanie G. Phillips, PhDPresident, Project House Inc., Teaneck, NJD.D. Wolohan, BAEditor, ASRT Scanner, American Societyof Radiologic Technologists,Albuquerque, NM

By Julie M. Longlet

A re you wondering how to getyour first freelance assignment?Do you already have freelance

projects but are confused about whatyour clients want? In an open session, 4 panelists addressed the hiring of free-lance writers, making a good impres-sion as a freelance writer, and nurtur-ing your relationships with your clients.

HIRING WRITERSEllen B. Lipman, MS, RT, and D.D.Wolohan, BA, briefed the audience onopportunities for freelance writers atthe American Society of RadiologicTechnologists (ASRT). The ASRT pro-duces both scholarly publications anda member newsmagazine. RadiologicTechnology is the award-winningbimonthly journal that covers all disci-plines and specialties within medical

imaging. Radiation Therapist is pub-lished twice a year for membersspecifically interested in radiation ther-apy. Both publications include peer-reviewed research articles, continuingeducation articles, and other columnsof interest to ASRT members. Ms.Lipman recommended that potentialauthors first read the guide for authorson the ASRT Web site (www.asrt.org/content/Publications/ForWriters/Guide_For_Authors.aspx). Ms. Lipmanrequires a curriculum vitae and a writ-ing sample from freelances who wish tobe considered for an assignment.Although she generally selects thetopics, writers are welcome to suggesttopics relating to trends in medicalimaging.

The ASRT Scanner is the award-winning monthly member news-magazine. Ms. Wolohan looks for writ-ers with knowledge of medical imaging.

OPEN SESSIONS

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An important consideration when writ-ing articles and pitching ideas is thatASRT members like to see themselvesrepresented in the magazine, sheadded. The primary sections of themagazine include a cover story (1,500-2,000 words), a technology update sec-tion (750 words), and a member profile(1,200 words).

MAKING A GOOD FIRST IMPRESSIONYou have identified potential clientsand collected your writing samples.How do you make a good first impres-sion with a client? According toStephanie Phillips, PhD, the first ruleis, “Know your customer.” Your clienthas specific needs and wants, and asuccessful freelance writer will be ableto anticipate those. For example, isyour client someone who could write it better but doesn’t have the time (a“tough cookie”)? Or is your client aperson who doesn’t know or care aboutthe product and just wants somethingto give to a superior (the “sales type”)?Your final product will likely be differ-ent depending on the client, saidPhillips.

In the same way, you need to knowwhat your client values. For example,does he or she need reassuring? Or isthis person more concerned aboutmeeting the project objectives? Oneway to learn a client’s needs is to ask.Not only do you learn valuable infor-mation, you are also in a position toexplain how you can meet those needs.Phillips reminded attendees that theclient is seeking freelance workbecause he or she lacks the relevantexpertise and/or does not have thetime or the staff to complete theproject.

How do you get that first assign-ment? Phillips offered the followingpractical suggestions:• Identify appropriate clients and

send them a well written cover let-ter and a customized resume, high-quality writing samples, and a rec-ommendation from someone theyknow, if possible.

• Be available for the first assign-ment. If you think it is somethingyou cannot do, clarify the parts that

you can do. To receive futureassignments, do your best job onthe first assignment and do notquit in the middle of it.

• Ask about the budget for this joband whether the job is being putout for a bid, and price accordingly.

• Periodically remind clients of youravailability.

Phillips suggested the followingtips once you have that first assign-ment:• Be sure to get all of the specifica-

tions of a project (who is doing theliterature search, who is the targetaudience, what is the deadline).

• Follow the directions you are givenand incorporate the requestedchanges.

• Make deadlines and warn of antici-pated delays if you cannot meet thedeadline.

• Remember to back up your workfrequently, and have a contingencyplan if your computer crashes.

• Promote yourself by sendingreminders to the client and addingyour contact information to yoursignature.

The 3 best phrases a client can hearare, “Don’t worry,” “I’ll take care of it,”and “No problem,” said Phillips.

NURTURING THE CLIENTRELATIONSHIPThere is more to being a freelancewriter than producing high-quality,readable projects. Understanding thepsychology and group dynamics ofyour clients is necessary to achievesuccess as a freelance writer, accordingto Kevin Flynn, MA. Success includesmeeting your clients’ expectations ofquality, tapping into their core beliefs,and understanding what influencesyour client to behave in a certain way.

Most medical writers consider fac-tually accurate, grammatically correct,logical articles to be a sign of quality.However, Flynn argued that a high-quality product also includes intangi-bles, such as what the client thinksthey need when they need it. Forexample, your client may define quali-ty as a “correct interpretation” of themessage. But, the interpretation maydiffer according to the departmentyour client represents, such as market-ing, medical affairs, regulatory, or legal.Your work product may need to satisfyall of these points of view.

Second, most clients have corebeliefs about assessing the quality ofyour work that may be affected by per-sonality. One example is the “Ground-hog Day” client, who repeatedly makessmall changes to the “nearly final”

AMWA JOURNAL . VOL. 22, NO. 1, 2007 15

The following are some common questions that were answeredduring the session:

Q: What if all of my writing samples are considered confidential and/or proprietary?

A: It is best not to submit confidential writing samples, even if the sensitive information has been blacked out. One idea is to produce a nonconfidential writing sample for a client. The content of the writing sample is not as important as showing a prospective client that you can write.

Q: One of the tips was to give clients periodic reminders that you are available. How often is that?

A: It depends on the person. Phillips thought that every couple of months was a good period. Wolohan indicated that since she receives so much e-mail, once a month might be best to get her attention.

Q: Where do you find freelance writers?A: The AMWA freelance directory, recommendations from current freelance writers, newspaper

ads, and recommendations from AMWA members and their contacts. It helps when writers identify areas of expertise.

QA&

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WRITING ABOUT HEALTH ANDSAFETY AT WORK AND HOME

ModeratorAda P. Kahn, PhDPresident, Wordscope Associates,Evanston, IL

SpeakersPaulette MoulosPresident, Wordscope Associates,Evanston, ILSharon Lynn CampbellEVP and COO, Safety & Health ProgramsGroup, National Safety CouncilLori A. GettlefingerMarketing Manger, DuPont MedicalFabrics

By Ada P. Kahn, PhD

T his open session encouraged writ-ers to advocate for safe practicesin workplaces and homes. Topics

included how to avoid accidents, how toaccommodate safety needs of disabledpeople in workplaces, why protectivegear is essential for health care workers,and how stress affects health as well assafety.

Speaking first, Paulette Moulosemphasized how awareness and imple-mentation of safety precautions canreduce preventable accidents. Althoughmedia campaigns have promoted seatbelt usage, fatalities are statisticallyhigh among unbelted teenage drivers.Some young people seem to think it is“cool” to drive around unbelted.Moulos also noted that aging is a key

factor in accidents at home, particular-ly falls; in workplaces, worker inexperi-ence may contribute to accidents.Writers should emphasize the need forpreparedness in homes and work-places, and advocate for routine checksfor hazards and development of emer-gency plans wherever possible.

Sharon Lynn Campbell urged writ-ers to emphasize the challenges dis-abled people face on a daily basis. Sheexplained that media that call attentionto “super feats” do a disservice to thedisabled community. Instead, writersshould include the human side of mun-dane activities such as getting on a busor trying to visit friends in inaccessiblehouses. She also suggested developinga roster of experts with disabilities whocan speak from experience. Employersshould plan for the needs of disabledworkers in emergencies by providingsuch equipment as smoke detectors forthe hearing impaired and availableevacuation chairs. Plans for evacuationof animals in emergencies should alsobe considered, said Campbell.

Lori A. Gettlefinger discussed thereasons health care workers need spe-cially designed protective equipment.She noted that the level of protectionvaries by procedures and potentialrisks; for example, surgeons need frontand back protective gear. Gettlefingerpointed out that recently developedsurgical gowns and isolation apparelprotect against microorganisms andnewly recognized drug-resistantpathogens such as SARS and avian flu.

In selecting protective gear, hospitalsand other institutions must strike a bal-ance between protection and comfortof workers. She explained that charac-teristics of comfortable gear includethickness, flexibility, and appropriateweight of material. Comfort is essentialto ensure that equipment will be usedappropriately. Personal protectiveequipment should be selected after acareful review and matching of manu-facturer’s data and industry standardswith immediate needs.

Ada P. Kahn, PhD, highlighted stressas a threat to health and safety. Sourcesof stress vary between cultures as wellas types of work. Culture shock, inter-personal conflicts with work colleagues,job terminations, mergers, gender bias,and retirement are frequent sources ofstress. Controlling stress, said Kahn,helps avoid physical effects, particular-ly a weakened immune system. Con-structive suggestions included prioritiz-ing work and home life and reducingclutter to improve efficiency andmental well-being.

Ada Kahn is a freelance writer and the authorof Encyclopedia of Work-Related Injuries,Illnesses and Health Issues and Stress A-Z.

16 AMWA JOURNAL . VOL. 22, NO. 1, 2007

version of your draft, usually at thebehest of an unseen supervisor. Beliefsmay be affected by training. A clientwith a PhD degree may favor more sci-entific information in the article,whereas a client with an MD degreemay favor clinical information. Flynnadvised that you ask each client whathe or she expects to see in the finishedproduct as a way to help address theseissues.

Third, understanding the client’spolitical context is a big part of free-lance writing. Some of Flynn’s examples

caused visible cringing from the audi-ence. Do any of these sound familiar?• “Sorry, upper management changed

things. Again.”• “I didn’t say that!”• “I know I said that, but I changed

my mind.”• “That’s something you don’t need to

know right now.”

Unfortunately, even understandingall of these dynamics about your clientmay not result in success. Some clientsare disorganized, unappreciative, and

unrealistic. Flynn advised not to letthese clients take you away from proj-ects with good clients. Once you findgood clients, do everything you can tocontinue to work with them, such assending thank-you notes and beingavailable. Freelance writing is a peoplebusiness and you need to treat it thatway, said Flynn.

Julie Longlet is a Senior Science Writerwith the American Society of ClinicalOncology, Alexandria, VA.

Three videos from the 2006 Annual Con-ference are now available on the AMWAWeb site. Log on to see the videotapedpresentations from Keynote Speaker DaleC. Alverson, MD; the McGovern Awardwinner, A. John Rush, Jr., MD; and theAlvarez Award winner, Neil Shulman, MD.

videos @ www.amwa.org

OPEN SESSIONS

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 17

Medical writers and editorsoften do not think of them-selves as project managers.

However, to progress to the next stage,every project that crosses their desksneeds to be managed. Thus, “projectmanager” becomes another of themany hats writers and editors doneach day. Conscious, proactive projectmanagement improves efficiency,reduces work hours, and increasesaccuracy.

Variety is one of the most interest-ing aspects of project management.Responsibilities for editorial projectmanagers (EPMs), the processes theyfollow, and the internal resources avail-able to them vary widely in differenttypes of companies and even betweencompanies working on similar types ofprojects. In some companies, the EPMis a staff member, while in others theEPM is a freelance or consultant. (Theterm freelance will be subsequentlyused to refer to both freelances andconsultants.) The EPM may be an edi-tor/project manager or a writer/edi-tor/project manager. The informationconveyed in this article is based on myexperience performing editorial proj-ect management as a staff member at 4 small to medium-size medical educa-tion companies, consulting with amajor pharmaceutical company andmedical communication companies,and management at a firm that devel-ops pharmaceutical/health care sym-posia. The ability to adapt and modifyprocesses to fit each situation is theessence of good project management.Use the processes described in thisarticle as a starting point to developstrong, individualized project manage-ment procedures.

MISSION AND GOALS OF THEEDITORIAL PROJECT MANAGER The mission of each EPM is to shep-

herd his or her project from creation by a writer through a complex series of reviews by topic experts (generallyphysicians or other health careproviders), internal staff, and copyedi-tors. These reviews are followed byformatting by a graphic designer andadditional reviews by topic experts,continuing education (CE) reviewers(as needed), and copyeditors. All ofthese reviews are supervised by theEPM. Throughout this frequentlystressful and difficult process, the EPMensures that all players work smoothlyas a team and maintain good humor.The specific goals of good editorialproject management are the following:• Complete the project on schedule• Communicate clearly with team

members (eg, expert reviewers,copyeditors, graphic designers,account or other staff)

• Anticipate obstacles and find apath around them

• Ensure that the content is clearlywritten, is interesting to read, isaccurate, and incorporatesrequired topics

General project managers may alsobe responsible for overall project budg-eting and staffing but, in my experi-ence, this has not been common forEPMs. At some companies, especiallylarger ones, EPMs may control the edi-torial portion of the budget and staff.

The mission and goals of EPMslook simple on paper. However, it is the ferreting out of unspoken desires,meshing of conflicting needs, and cop-ing with day-to-day crises that makeachieving the goals a challenge. Theapplication of good project manage-ment strategies and tools can aid inovercoming obstacles to ensure an out-standing product is completed onschedule.

PROJECT INITIATIONProject initiation is one of the mostcritical information-gathering pointsfor an EPM. This initiation to the proj-ect can range from a hurried 5-minutephone call to the EPM to an hour-longinterdepartmental meeting. Regardlessof how a new project is introduced, theEPM must methodically read down hisor her checklist of questions (Table 1)and discuss them with the person initi-ating the project before beginningwork. Without answers to these key

PROJECT MANAGEMENT STRATEGIES FOR MEDICAL WRITERS AND EDITORS

By Candice M. Hughes, PhDHughes BioPharma Advisers LLC, Darien, CT

Table 1. Project Initiation Checklist

✓ What is the main topic? List any known subtopics.

✓ Who is the target audience?

✓ Is this a continuing education (CE) or promotional project?

✓ If a CE project, has a sponsor (a CE accrediting institution) been selected? If so, what is the name of the institution?

✓ Who is the corporate supporter?

✓ Have faculty been identified, or is the EPM identifying them?

✓ What is the honorarium provided for the faculty? (If applicable)

✓ What format will the program take?

✓ What is the desired length of the program?

✓ What are the start and end dates for the deliverables?

•Freelances will need to define deliverables

•Deliverables may be pre-set forinhouse staff; if not, ask

Additional questions for freelances:

✓ What is the fee?

✓ Are services other than project management needed?

✓ Will you be expected to work on-site?

✓ If writing is involved, does this fee include 1 or more rewrites?

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questions, the project could have prob-lems from the beginning, resulting inrewriting, time delays, and conflictwith account staff, the art department,and other team members.

The key to starting off on the rightfoot is to thoroughly understand theproject.1 A poorly defined topic orinaccurate specifications can result indisaster. The best defense against theseis to proactively ask questions. TheEPM should continue to gently drilldown to the core issues until topicsand specifications are clearly definedand understood or until the personassigning the job acknowledges theinformation gaps and agrees to obtainthe answers before or immediatelyfollowing project initiation. The EPMmust position the clarifying process asa means to achieving an outstandingproduct because if he or she is per-ceived as unwilling to cooperate or as a barrier to timely completion of theproject, the overall outcome will benegative.

The potential for pitfalls existsthroughout the lifespan of the project;some of the most dangerous occur atthe project initiation because veeringoff track at the start makes it nearlyimpossible to meet anticipated dead-lines and the end product may be ofpoor quality as well as late.

Pitfall: There is vagueness or vacilla-tion regarding the main topic or proj-ect specifications on the part of theeditor, account staff, or other personassigning the project.Solution: Ask probing questions toclarify the project parameters and, ifnecessary, bring the issue to the atten-tion of more senior management.Freelances may wish to pass on theproject if parameters are murky andquestions do not yield satisfactoryanswers.

Pitfall: There is dissent regarding themain topic or project specificationsamong a team of people assigning the job.Solution: Be alert for signs of conflict-ing wants and needs whenever finalsign-off/approval power resides in the

hands of more than 1 person. Seekways to communicate with the groupand guide discussion so issues areresolved before proceeding.

Once the project parameters areunderstood, the EPM’s mission is toplan, communicate, and control.Developing a plan or map of where theproject needs to be and when is essen-tial to meeting goals. Communicationis equally important. Throughout theproject, the EPM should provide feed-back to key players and should solicitinformation from them.2 Key playersmay include account staff, the editorialdirector, and other senior editorialstaff. Communication can be oral or bye-mail but should include periodicwritten status reports to the key play-ers. Control is vital since projects rarelyunfold according to the plan or sched-ule. For example, if a reviewer misses adeadline, the EPM must control the sit-uation by ensuring that the reviewerdoes provide comments within a dayor two. The EPM should then adjusttimelines by reducing time allotted forsubsequent steps and alert thosewhose timeline has been shortened sothat all work together and the deliverydate is met.

DEVELOPMENT OF THE CONTENTOUTLINEThe next step in the life of the projectis the development of an outline of thecontent. The staff EPM either createsthis outline in conjunction with thetopic expert or hires a freelance writerto create it with the topic expert. If afreelance EPM has been hired tomanage the project and write, then this person would create the outlinetogether with the topic expert. The out-line should be reviewed by all personswho will be signing off on the finalproduct, to ensure buy-in from allrelevant parties. Some individuals willgive little thought to orally expressedconcepts but seeing them in writingand being asked to sign off on themincreases their attentiveness andimproves the quality of their feedback.Once an acceptable outline has beencreated, a first draft of the manuscriptis developed.

DEVELOPMENT OF THE FIRSTMANUSCRIPT DRAFTThe first draft of the manuscript for the project may be created by a free-lance writer hired by a staff EPM, astaff writer, or a staff or freelance EPMwho doubles as a writer, depending oncompany resources and structure. Ifthe first draft is developed by a staff orfreelance writer, the EPM should clear-ly communicate the following to thewriter: • Due date• Topic• Audience• Goals and objectives• Format• Style• Program format• Promotional versus continuing

education

Providing this information to free-lances in a formal contract or letter ofagreement is best. The EPM gives thewriter the outline if the writer did notdevelop it. Some companies may givethe freelance writer copies of referencematerials, whereas others may expectthe freelance to provide theseresources. Once the writer clearlyunderstands the project and work hasbegun, regular communication regard-ing progress toward the deadline anddiscussion of obstacles is important. If the EPM has not worked with thefreelance previously, the EPM maywish to review the first few pages of the first draft to ensure that the writerhas understood the assignment andthat the quality of the work matchesexpectations.

REVIEW OF THE FIRST DRAFT All persons who have final sign-offauthority (including topic experts)should review the first draft. In hand-ing off the manuscript to each personfor review, the EPM should emphasizethat this is the reviewer’s primaryopportunity to make substantial con-tent changes, as the next major review(layout, the stage after the graphicartist has organized the content in adesign program) should be reserved for minor text or formatting changes.

18 AMWA JOURNAL . VOL. 22, NO. 1, 2007

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Asking all internal reviewers to signtheir name and date the copy and/ortracking sheet helps encourage them to take ownership for the content.Written comments or statementsregarding acceptance of content fromexternal reviewers are saved in case theinformation is needed to support laterdecisions.

During this stage, parameters maybe reassessed; this is common in thelifespan of any project. J. DavidsonFrame, a dean and professor of projectmanagement at the University of Man-agement and Technology, describes there-evaluation of projects as, “…a natu-ral occurrence referred to as the learn-ing effect.”3 He explains that a person’svision of a project sharpens as it pro-ceeds along the development path.However, he emphasizes that thelearning effect cannot be allowed toproceed unchecked. Regardless of thecause of the change in direction, theEPM needs to assess the rationalebehind the proposed changes and con-sider how these changes, if made, willimpact the timeline. To determine theimpact, the EPM should first identifysalvageable content and assess theneed for new content. He or she canthen develop at least 2 alternative sce-narios for completion of the projectthat highlight changes in cost and thetimeline and compare them with theparameters of the original projecttimeline and specifications. The nextstep is to take the scenario analyses tothe decision-maker(s) and gain accept-ance for a given scenario before mov-ing forward with it. The challenge is topresent the analyses in such a way that the decision-maker(s) and otherreviewers understand and accept therationale for the change in timelineand/or content direction, should thatbe necessary. The EPM should enu-merate all important external influ-ences for the decision-maker(s) anddiscuss the relative importance ofthese influences. Pitfalls are also possi-ble at this stage of the process.

Pitfall: Input from reviewers’ conflicts.Solution: Minor conflict can be han-dled by speaking one-on-one with

each reviewer to try to identify therationale behind the comments. Indeciding which changes to incorporatewhen conflict exists, the EPM needs toweigh the authority of each reviewer inguiding the content. Major conflictmay require a meeting with inhousereviewers and, if necessary, a confer-ence call that includes external review-ers. Freelance EPMs who work off-sitemay wish to request a face-to-facemeeting with their client or, if that isnot feasible, a conference call. Everyattempt should be made to reconcileconflicting opinions, but if that is notpossible, a single authority figureshould be identified who can endorse a revised plan of action.

Pitfall: A dramatic change occurs inthe direction of the content or in thespecifications of the project. On occa-sion, this type of change is dictated byexternal events, such as newly pub-lished data or a revised package insert.At other times, the change in directionarises simply because reviewers hadnot adequately thought out their needsat the initiation of the project. Seeingtheir concepts in typeface triggersbrainstorming, a new focus, andrewriting of the entire draft. Solution: Identify the rationale behindthe change. If change is necessary, gainagreement on the new timeline.

COPYEDITING OF THE MANUSCRIPTOnce the content for the manuscripthas been finalized, the EPM passes theproject to the copyeditor, who reviewsthe document and the previous ver-sions with reviewer comments toensure that all the comments havebeen addressed. Additionally, the copy-editor assesses the general flow anddetermines that no copy has beendropped during editing. If the projectis a CE course, the copyeditor shouldreview the questions to ensure that theanswers are still evident in the text. Ifrewriting has been extensive, errorsmay have been introduced. The morechanges that reviewers have made, thegreater the chance that errors wereintroduced, particularly under timelinepressures. The copyeditor should

review the content carefully to makesure that no material was overlookedor entered incorrectly during what isoften an intense rush to move the proj-ect to the layout phase (Table 2).

The EPM and the copyeditorshould keep communication linesopen and discuss any importantchanges before implementation.Frequent communication will makethe review smoother and more effi-cient, allowing the copyeditor to focuson areas that need work at that timeand to postpone work on areas that are less important or are subject tochange.

AMWA JOURNAL . VOL. 22, NO. 1, 2007 19

Table 2. Copyeditor Checks at FinalManuscript Stage

✓ Look for missing information

•Examples include continuing educa-tion (CE) disclosures, disclaimers, self-tests, and evaluations (compare withrecent printed pieces by the same CEprovider or use established template)

✓ Determine that the answers to the self-test questions are evident in the content;if unsure, query editor/writer

✓ Check all dosages against package inserts or verified source to ensure accuracy

✓ Examine references and determine whether all references

•Are complete

•Are written according to style 4 (couldalso be the company’s housestyle or a journal specific style)

•Match the text

Tip: Watch out for situations where the text states, “In this study, Smith and colleagues found…” but the reference is Jones, et al

•Are correctly numbered (remove textplaceholders before layout)

✓ Perform a cold read for general sense and flow

✓ Check faculty titles and affiliations against verified source

✓ Look for misspellings not picked up by spell check software and for grammatical errors

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20 AMWA JOURNAL . VOL. 22, NO. 1, 2007

Pitfall: Poor communication betweenthe EPM and the copyeditor results ininefficient work or lack of understand-ing of timelines that delays progressionto the layout stage.Solution: Engage copyeditor in a dia-logue regarding project parametersand timeline.

Pitfall: Lack of global work prioritiza-tion leads to the copyeditor not havingtime available to work on the project. Solution: Discuss the situation withmore senior staff such as the editorialdirector.

When an error-free version of themanuscript has been created, it is sentto the topic experts to approve. Themanuscript can be sent to CE review-ers at the CE accrediting institution atthis stage or at the next stage. Whenthe final manuscript has been devel-oped and all reviewers have signed off,the project can move to the layoutstage.

LAYOUT STAGEThe layout stage begins when the EPMpasses the final manuscript to the artdepartment. During the hand-offprocess, the EPM briefly reviews theproject with the designer, clarifies anyunusual formatting needs and, if nec-essary, highlights areas with missinginformation, while providing a date by which the missing information isexpected. Generally, it is best not tohave missing information at this stage.However, this may be unavoidable insome situations. Upon receiving thefirst layout from the art department,the EPM checks the following:• The first layout against the final

manuscript • All figures and tables against origi-

nal version of each• General flow, readability, and

attractiveness

The copyeditor also checks the lay-out content against contact informa-tion provided by expert reviewers(including name, title, and institution),e-mails from reviewers with key data,written communications from other

team members, and other informationprovided by the EPM. The copyeditorshould pay special attention to sym-bols, which often drop out or changeduring the layout process. The layoutshould be sent for internal and exter-nal reviews (including the topic expertand CE reviewer). The precise timing ofthese reviews depends on the overalltimeline. The optimal situation is forthe editorial and art staff to performsome basic cleanup of the layoutbefore sending it out for review.However, the copyeditor should notdevote large amounts of time to fine-tuning the layout before review, as thecopy could change.

Note that at the layout stage, thetimeline will be affected even moreseverely by major content changesthan it was at the manuscript stagebecause of the time that has beeninvested by staff in several depart-ments, including art and editorial. Inthe worst-case scenario, the EPM mayneed to start over by returning to themanuscript stage. Before making majorcontent changes, the EPM should con-vene a meeting or conference call withall the reviewers (including topicexperts) to discuss their changes andexplore the rationale behind them. Itmay be possible to reduce the numberof changes in the interest of decreasingthe impact on the timeline. Minorchanges can be addressed on an indi-vidual basis as needed.

Pitfall: The designer misunderstoodthe formatting style for the piece.Solution: This situation is usually easi-ly remedied by speaking with thedesigner and, if necessary, providingprinted examples of similar jobs.

Pitfall: One or more reviewers requestmajor content changes. This situationcan arise because some reviewers donot focus on the content until it seems“official” (ie, until it has the appear-ance of a printed piece). Solution: If a similar problem hasoccurred before with this reviewer orthe EPM has noticed signs of inatten-tion (such as few comments on drafts),the EPM should intervene early by tak-

ing steps to focus the reviewer’s atten-tion on the content. Before the piecemoves out of layout stage, all review-ers, including topic experts and CEreviewers, need to sign off.

FINAL PRE-PRESS CHECKSOnce any content issues have beenresolved, the EPM reads through thepiece once more and edits it for opti-mal content flow. Additionally, theEPM checks for missing content orerrors and ensures that figure and table placement is correct. All internaland external reviews, including the CE institution’s review, should havebeen completed and any changesincorporated.

At this stage, the EPM discusses the job with the copyeditor and thedesigner to ensure that his/her reviewsand changes are complete. Finally, theEPM checks whether revisions arebeing made to any other projects with-in the company that might have animpact on the current project. Thischeck is critical if the current project is part of a multicomponent programunder development. If no furtherchanges or reviews are needed, thepiece can be sent to the printer.

Sending the piece to the printer is a major accomplishment on the time-line. Once this occurs, the project isnearly complete. A sample copy(termed an iris) that shows what thefinal printed piece will look like is sentfrom the printer to the designer whoprovides this version to the EPM forreview. Both the EPM and the copyedi-tor should read the iris through once.Special points to focus on include sym-bol changes or dropouts and rebreak-ing of lines (termed re-ragging). If theEPM or copyeditor finds any differ-ences between the copy sent to theprinter and the copy the printer sentback (the iris), then the iris must bemarked to denote the changes neces-sary to make the 2 versions match.Reviews by other staff such as theaccount executive or editorial directormay be required. All reviews of the irisshould be completed within 1 day. Themarked copy is sent to the printer. Ifchanges were made, the printer sends

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 21

a revised copy to be checked. Note thatsome printers may provide the first on-press copy for review rather than a pre-press sample. Once the copy is correct,the piece is printed and distributed. Aftera brief pat on the back, the EPM shifts his or her focus to the next project.

CONCLUSIONEditorial project managers are the driv-ing force behind content development.Whether staff members, freelances, orconsultants, they are responsible formanaging the process of turning a con-cept into a final produced piece thatcould be print, CD, video, or Web-based.The challenge is that they must accom-plish this on an often intense schedule,while overcoming multiple obstacles and delivering high-quality work. Asdescribed in this article, the keys tomeeting this challenge are to plan,communicate, and control during every stage of the project.

The Freelance Forum

and Practical Matters

section will resume in

the June issue.

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References1. Mochal T, Mochal J. Lessons in

Project Management. Berkeley, CA:Apress; 2003.

2. Thomsett MC. The Little BlackBook of Project Management. NewYork, NY: American ManagementAssociation; 1990.

3. Frame JD. The New ProjectManage-ment. 2nd ed. SanFrancisco, CA: Jossey-Bass; 2002.

4. American Medical Association.Manual of Style. 9th ed.Philadelphia, PA: LippincottWilliams & Wilkins; 1998.

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SCIENCE SERIES

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AbstractSelecting the correct targets for cancer therapy can make an important difference in a patient’s clinical outcome.Targeted therapies attack tumors specifically and either donot harm normal tissues or harms them less than tradition-al cancer therapies. Several categories of targeted therapieshave been identified, including antiangiogenesis factorsand monoclonal antibodies. Some targeted therapies havebeen approved for marketing, and many others are in vari-ous phases of nonclinical and clinical development. Thisarticle is the second in a series discussing basic informationabout cancer and its treatment.

IntroductionPart I of this 2-part series1 presented basic informationabout cancer and described a variety of methods to rid thepatient’s body of cancer cells, including surgery, chemo-therapy, and radiation therapy. These techniques are veryeffective in most cases, but by their very nature are impre-cise. It is difficult to be sure that all cancer cells have beenremoved during surgery (ie, that clean margins have beenachieved) and nearly impossible to detect microscopic can-cer cells that have already spread to other parts of the bodythrough the lymphatic system or circulatory system. Bothchemotherapy and radiation therapy target rapidly dividingcells, which include both cancer cells and healthy prolifer-ating cells (such as hair follicles, bone marrow, and the lin-ing of the mouth). Because of this, alopecia, anemia, ormucositis may develop when healthy cells are subjected tochemotherapy or radiation therapy. Another serious sideeffect of chemotherapy or radiation therapy is neutropenia,which can predispose a patient to dangerous infections.Because of this imprecise and indiscriminate aspect ofchemotherapy and radiation therapy, oncologists have longsearched for ways to kill tumor cells but spare normal cells.Targeted cancer therapies use drugs that block the growthand spread of cancer by interfering with specific molecules,pathways, or processes in carcinogenesis and tumorgrowth.

This article discusses the basics of targeted cancer ther-apies. As with all articles in the Science Series, underlinedwords are defined further in the glossary, and interestedreaders are encouraged to use cited references and othersources to learn more about this new, exciting, but complex

topic. It may be useful to refer to the glossary that accom-panies Part I, as most terms defined in that article are notdefined here.

Definition of Targeted TherapyThe goal of targeted therapy is to specifically interruptsome aspect of the cancer cell’s life cycle while not interfer-ing with normal cells. Targeted therapies are often gene-based or protein-based treatments and typically have fewerside effects than traditional therapies. Many targeted thera-pies have been shown to be extremely effective in treatingspecific forms of cancer. Targeted therapies are not new orunique to oncology: they have an established utility in sev-eral clinical settings, including asthma (antitumor necrosisfactor [TNF]) and osteoporosis (bone-targeting nanocap-sules of liposomes). Hormone therapies, such as antiestro-gens (eg, tamoxifen) or inhibitors of testosterone produc-tion (eg, leuprolide) have been used successfully in thetreatment of patients with breast cancer or prostate cancer,respectively, for decades. New targeted therapies, however,are meant to be different because they preferentially targetthe tumor, rather than normal tissue, and because they aredesigned to be selective for the specific make-up of a givencancer, hitting those molecular targets that are principallyresponsible for the malignant phenotype of the cancer cells.

During the past 3 decades, scientists have learned muchabout the molecular aspects of cancer. More than 300 genesand their protein products have been identified and areknown to be directly or indirectly associated with the devel-opment of cancer.2 Using this information, scientists arenow in the process of exploring the roles of these molecular,gene, or protein markers in the diagnosis, prognosis, andtreatment of cancer. These markers are often referred to astumor markers. Tumor markers include circulating cancermarkers (proteins most often found in the blood but some-times in urine or tissue samples) and genetic markers(derived from cancer-associated genes or from DNAextracted from tumors with chromosomal instability)(Tables 1 and 2).3,4 Some of the best-known hereditarygenetic markers are found in breast cancers. BRCA1 andBRCA2 are breast cancer susceptibility genes, the mutantforms of which predispose to both breast and ovarian can-cers (Table 3).5 These 2 genes are found on 2 different chro-mosomes.

Oncology BasicsPart II. Targeted Therapies

By MaryAnn Foote PhD, and Miguel Bronchud, MDWestlake Village, CA, and Hospital of Granollers, Barcelona, Spain

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 23

It should be noted, however, that in spite of muchwork and expert panel reviews, very few markers arereliable and definitive for cancer.6 Rather than beingused in the diagnosis of cancer, tumor markers are mostoften used to track the course of a cancer after it devel-ops. We have introduced the concept of tumor markersto illustrate that cancer therapy can be made selective,ie, can be made to target the overproduction of mole-cules that are involved in carcinogenesis.

How Targeted Cancer Therapies WorkTargeted cancer therapies work by interfering with thegrowth and division of cancer cells. Different therapiesact at different points during the growth and develop-ment of cancer cells. Some targeted therapies act onproteins involved in signaling processes. By blockingthe signals that instruct cancer cells to divide in anunregulated manner, the targeted therapies can helpstop the growth of a tumor. Several targeted therapyagents have been approved by the United States Foodand Drug Administration (FDA) for marketing in theUnited States (Table 4). One of the first targeted therapyagents developed was imatinib mesylate, and it estab-lished a new paradigm for cancer treatment (seesidebar7 on page 27).

The novelty of the field and its technologies and theintricacies of the pathways make the topic of targetedtherapies very complex. Readers who are interested infurther research should review the references listed atthe end of the article.

Broad Classification of Targeted TherapiesOncogene InhibitorsMost cells carry proto-oncogenes that oversee cellgrowth and other cellular functions. Scientists havemapped the approximately 30,000 genes that are pres-ent in human DNA, and approximately 100 of thesegenes are now known to be proto-oncogenes.8 If aproto-oncogene is broken or damaged, it becomes anoncogene and instructs the cell to multiply rapidly, ahallmark of malignant cells. Currently, oncogeneinhibitors include tyrosine kinase inhibitors, epidermalgrowth factor receptor (EGFR) inhibitors, and vascularendothelial growth factor (VEGF) inhibitors. Otheroncogene inhibitors, interfering with other growth fac-tor receptor families or other relevant intracellularmolecular targets, such as specific transcription factors,are under study.

Several of the targeted therapy agents approved formarketing in the United States are oncogene inhibitors(eg, imatinib mesylate, erlotinib, and trastuzumab)(Table 4). Both small molecules and monoclonal anti-bodies can act as oncogene inhibitors. Antisenseoligonucleotides also can act as oncogene inhibitors,but none has been approved for clinical use in cancertherapy at the time of this writing.

Table 1. Some commonly used circulating cancer markers3

Marker Use Tumor Types

Alpha-fetoprotein (AFP) Diagnosis,tracking Testicular, liver

Carcinoembryonic antigen (CEA) Tracking Gastrointestinal, colorectal,

breast

Human chorionicgonadotropin (hCG) Tracking Gestational trophoblastic;

germ cell

Monoclonal immuno-globulin protein (M)

Diagnosis,tracking Multiple myeloma

Prostate-specific antigen(PSA)

Diagnosis,tracking Prostate

CA-125 Tracking Ovarian

CA-19.9 Tracking Pancreatic, gastrointestinal

Table 2. Some genetic markers (somatic mutations or chromosomaltranslocations) associated with specific cancers4

MarkerChromosome

LocationTumor Types Associated

with Mutations

APC 5q21 Familial adenomatous polyposis (FAP),colorectal cancer

BCL2 18q21 Non-Hodgkin’s lymphomas, acuteleukemias

BCL6 3q27Lymphomas; particularly associated with the transformation of follicular lym-phomas to diffuse large-cell lymphoma

BCL1*,PRAD1,CCND1

11q13Lymphoma and breast and head andneck cancers

BCR-ABL t(9;22)(q34;q11)Chronic myeloid leukemia (“t” refers to translocation of the gene fromchromosome 9 to chromosome 22)

FLT3 13q12 Acute myeloid leukemia (in 70-100% of patients)

HER-2/neu 17q21 Breast and endometrial cancers

MYC 8q24Lymphoma, small cell lung cancer,ovarian and breast cancers, and neuroblastomas in children

PTEN 10q23.3Melanoma; glioma; and renal cell,hepatocellular, cervical, head and neck, breast, and prostate cancers

REL 2p15;14Lymphomas, including a subset ofHodgkin’s lymphoma and diffuse large-cell lymphoma

RET 10q11.2 Multiple endocrine neoplasia type 2,familial medullary thyroid cancer

TP53 17p13.1

Almost all tumor types, especiallycancers of the colon, rectum, breast,lung, esophagus, stomach, liver, ovary, and urinary bladder

*The BCL1 gene codes for cyclin D1, a marker that enables a differential diagnosisof mantle cell lymphoma (a particularly aggressive form of lymphoma), beingpositive in more than 80% of cases.

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Apoptosis InducersMost normal cells are genetically programmed to die, aprocess called apoptosis. This programmed cell deathoccurs to allow healthy cells to replace old or diseased cellsor to simply eliminate unwanted superfluous cells duringgrowth and development. In contrast, cancer cells have“learned” to evade normal apoptosis and continue to sur-vive, increasing the size of a tumor and allowing it to metas-tasize. A key to this evasion is an increase in proteins, par-ticularly Bcl-2. Drugs that inhibit the production of Bcl-2promote apoptosis. Apoptosis-inducing therapies blockenzymes that help cancer cells survive and work to makecancer cells more vulnerable to chemotherapy. Other drugsin nonclinical development can trigger the process of apop-tosis after binding to so-called death receptors on cellmembranes, but they are also potentially very toxic to somenormal cells.

Cancer VaccinesAn intriguing hypothesis isthe use of tumor vaccinesto induce cancer-specificimmune responses in the host (the patient). Vaccinestraditionally have been usedto prevent illness, such asrubella (German measles),and work on the concept ofacquired immunity.Researchers are exploringways to create a vaccine usingmolecules extracted from apatient’s tumor. The extractedmolecules would be injectedinto the patient, along with an immunostimulant such asinterleukin-2 (IL-2). Afterinjection of the molecules, thepatient’s immune system isstimulated and destroys theantigen, the extracted mole-cules. The memory cells of theimmune system are thus

primed to recognize the same antigen in other tumor cellsin the body and to destroy them using normal immune sys-tem mechanisms, effectively ridding the body of the tumor.Although some success has been achieved in clinical trialswith this approach for some cancer types (colorectal cancerand melanoma), no cancer vaccine has received marketingapproval, except for vaccines against a carcinogenic virussuch as the hepatitis B virus (a virus that can lead to hepa-tocarcinomas or primary cancers of the liver). Recently, avaccine against human papillomavirus, the major cause of cervical cancer and genital warts, has received FDAapproval. These antiviral vaccines prevent rather than curecancer.

Angiogenesis InhibitorsTumors can become clinically relevant, ie, grow to larger

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Table 3. BRCA1 and BRCA2 in breast cancer 6

GeneChromosome

LocationAssociated Cancers

Associated Increased Risks

Prevalences

BRCA1 17q12-21Hereditary breast and ovarian cancer

Prostate, colon, liver, and bone cancers

White population, approximately 1% Black population, <1% Familial breast cancer population, 20-40% Women by age 32 years, 12%

BRCA2 13q12-13 Hereditary breast and ovariancancer, male breast cancer

Melanoma and cancers ofthe pancreas, gallbladder,pharynx, stomach, andprostate

White population, approximately 3% Black population, 1% Familial breast cancer population, 10-30%All breast cancers, <2% All male breast cancers, 14%

Table 4. Targeted therapy agents approved by the United States Food and Drug Administration*

Generic Name Trade Name Target Indication

bevacizumab Avastin Monoclonal antibody thatinhibits VEGF receptor Colorectal cancer

bortezomib Velcade Inhibitor of the 26S proteasome Multiple myeloma

cetuximab Erbitux Monoclonal antibody thattargets EGFR receptor Colorectal cancer

erlotinib Tarceva Inhibitor of EGFR and tyrosine kinase Nonsmall-cell lung cancer

gefitinib IressaInhibitor of EGFR and tyrosine kinase

Nonsmall-cell lung cancer,prostate cancer, head andneck cancer

imatinib mesylate Gleevec Small molecule that inhibitstyrosine kinase

Chronic myeloid leukemia,gastrointestinal stromaltumors

rituximab Mabthera, Rituxin CD-20 antigen Some types of B-cell non-Hodgkin’s lymphoma

trastuzumab Herceptin Monoclonal antibody thatbinds HER-2/neu receptor

Breast cancer, nonsmall-celllung cancer

*Further information is available in the package inserts for each product, which are provided by the manufacturer.EGFR = epidermal growth factor receptor, and VEGF = vascular endothelial growth factor.

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than 1 cubic millimeter, only if they have a supply of nutri-ents and oxygen and a mechanism to remove waste prod-ucts and carbon dioxide. In other words, a tumor grows if itcan develop a blood supply, a process known as angiogene-sis, first defined by Folkman.9 A blood supply also allowstumor cells to spread and develop into distant metastases.Angiogenesis is driven by the production of proangiogene-sis factors (factors that stimulate the production of newblood vessels [capillaries]) that overcome the effects ofantiangiogenesis factors (factors that inhibit the produc-tion of new capillaries). In a healthy human, angiogenesisoccurs during normal tissue growth and repair and preg-nancy. Dysregulation of angiogenesis, or the inappropriategrowth of new blood vessels, occurs in rheumatoid arthritis,cirrhosis, cardiovascular disease, diabetic retinopathy, andcancer.

Proangiogenesis factors include VEGF (seemingly theprimary factor), the fibroblast growth factor (FGF) family,platelet-derived endothelial cell growth factor, and tumornecrosis factor (TNF) α and β. Antiangiogenesis factorsinclude endostatin, angiostatin, interferons, and throm-bospondin-1 and 2. Of all the proangiogenesis factorsdiscovered to date, the VEGF family is the best-studied.10

VEGF is secreted by almost all cell types in the body and is overexpressed in most malignant tumors.11 When VEGFjoins with a receptor, a number of effects can occur, includ-ing increased endothelial cell production, increased sur-vival of endothelial cells through inhibiting of apoptosis,and reprogramming of gene expression. Antiangiogenesisproducts work by rather different mechanisms: • Targeting VEGF or VEGF receptors• Reducing VEGF expression on cell membranes by fusion

proteins• Using ribozymes to decrease receptor expression and

activation• Inhibiting tyrosine kinase to reduce receptor activation

and downstream signaling

Antiangiogenic agents also can be monoclonal antibod-ies or small molecules, such as the therapeutic moleculebevacizumab, which targets VEGF.

It should be noted that antiangiogenesis research is still quite young, with only about 5 years of clinical studiescompleted. Early studies have shown that antiangiogenicagents can have significant toxicities. Antiangiogenesistherapies continue to be pursued in spite of these toxicities,as many researchers believe that control of angiogenesis isone of the most promising targeted therapies, particularlyafter primary cancer surgery (eg, mastectomy for breastcancer or hemicolectomy for colon cancer). By targeting the angiogenesis process, it may be possible to delay oreven prevent the growth of micrometastases throughout the body after primary cancer surgery, ie, in the adjuvantsetting.

Monoclonal AntibodiesTreatment with monoclonal antibodies has become morecommon in recent years, as several such therapies havereceived marketing approval. These agents include ritux-imab, alemtuzumab, and gemtuzumab for some types ofleukemia and lymphoma and trastuzumab and cetuximabfor solid tumors.

Therapeutic monoclonal antibodies can exert theireffects through several mechanisms, using a variety ofstructural components. Some monoclonal antibodies blockthe interaction of important proteins or block the bindingof a ligand (eg, a growth factor) to a receptor, thus, mimick-ing ligand binding, which in turn alters signaling within thecell. Other monoclonal antibodies directly kill tumor cells,alone or with cytotoxic agents or radioisotopes.

Gene TherapyGene therapy is broadly defined as the transfer of geneticmaterial into a cell to transiently or permanently alter thecell’s phenotype. The goal of gene therapy in the oncologysetting is to alter the genetic makeup of the tumor or theentire body to halt or slow the disease process.

Gene therapy is accomplished by inserting a desirablegene into the DNA of cells from the patient, thus repro-gramming the progeny of the original transfected cells. Thereprogramming can include enabling the cells to producelarge amounts of specific proteins. Some research in genetherapy includes increasing the production of TNF for thetreatment of metastatic melanoma and increasing theproduction of IL-12 for the treatment of renal cell cancer.Another approach is to provide normal cells with increasedprotection from chemotherapy drugs or to increase the sen-sitivity of tumor cells to such drugs.

Some Common Cancers Treated with TargetedTherapiesPatients with some common cancers are experiencing thebenefits of targeted therapies that have been approved formarketing by regulatory agencies. The information provid-ed in this section is not meant to suggest possible therapies,and other treatment modalities are available and effectivefor these types of cancer. In addition to the approved target-ed therapy agents, many other targeted therapies are in var-ious stages of clinical development. We have chosen tofocus here on only marketed products for which extensivepeer-reviewed literature is available.

Breast CancerBreast cancers often contain receptors for estrogen, proges-terone, or both; such cancers are labeled as receptor posi-tive and require one or both of these hormones to grow. Themore hormone receptors a tumor contains, the more sensi-tive it is to estrogens or progesterone used to treat otherconditions, and thus, these agents should be avoided inwomen with breast cancer shown to have hormone recep-tors. Tumors with an abundance of these receptors often

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are less virulent than other tumors, and patients with thesetypes of tumors often have a better prognosis than patientswith tumors with few receptors. One targeted therapy avail-able for the treatment of breast cancer is tamoxifen, anestrogen blocker that is a partial agonist/antagonist.Patients who take tamoxifen after initial treatment forbreast cancer are known to have less chance of cancerrecurrence or spread to the contralateral breast or distantsites; however, tamoxifen should be taken for 5 years or lessin sequence with other estrogen inhibitors (such as the so-called peripheral aromatase inhibitors). Treatment shouldnot continue beyond 5 years because after this amount oftime, initially responsive tumors may become greatly resist-ant to tamoxifen, negating its good effects on tumor reduc-tion, serum cholesterol, and bone density.12

When patients must stop therapy with tamoxifen,another targeted therapy, an aromatase inhibitor such asanastrozole, can be used. Aromatase inhibitors also act bylowering the amount of estrogen in a woman’s body that is produced outside the ovaries, such as in muscle and fattissues.13

Breast cancer cells also express HER-2 and those breastcancer cells that overexpress HER-2 can be extremely viru-lent. HER-2 is not an estrogen-receptor gene but is a mem-ber of the EGFR superfamily whose molecular ligand is notknown. It could, in fact, turn out to be a receptor coactiva-tor rather than a true surface receptor for an extracellulargrowth factor. An anti-HER-2-humanized monoclonal anti-body, trastuzumab, was designed to disrupt the tumor cell’sability to multiply by disabling the errant HER-2 gene.14

Targeted therapy with trastuzumab has been used forpatients with early-stage and advanced metastatic breastcancer and is being investigated in the adjuvant setting.

Colorectal CancerWhile surgery is the preferred treatment for localized col-orectal cancer, 2 monoclonal antibodies currently are mar-keted for the treatment of advanced or metastatic colorectalcancer. As discussed earlier, bevacizumab is a monoclonalantibody that targets VEGF. The FDA has approved beva-cizumab in combination with 5-fluorouracil for the initialtreatment of patients with metastatic colorectal cancer.15

Bevacizumab acts as an antiangiogenic therapy, attackingnew blood vessels the tumor has formed, thus, cutting offits supply of nutrients.

Cetuximab is another monoclonal antibody directedagainst human epidermal growth factor receptor (HER-1/EGFR). Cetuximab also can cause the patient’s immunesystem to recognize the cancer cells as foreign and attackthem.16 Cetuximab is given either alone or in conjunctionwith chemotherapy agents.

Lung CancerThere are 2 major types of lung cancer: small cell lungcancer (SCLC) and nonsmall-cell lung cancer (NSCLC).Approximately 80% percent of people with lung cancer have

NSCLC, a form that generally grows more slowly than SCLC.Because the lungs are so vascular, lung cancers are prone tometastases and are difficult to treat.

Gefitinib and erlotinib are drugs used to treat lung can-cers; they target the EGFR gene mutation and can causeapoptosis, block action of tyrosine kinase, or both. Anotherform of targeted therapy is photodynamic therapy (PDT),approved by the FDA in 1998 for the treatment of early-stage NSCLC. This treatment involves the use of a photo-sensitizing agent (porfimer sodium), which is absorbed bythe cancer cells. When these treated cancer cells areexposed to a special laser light about 48 hours after por-fimer sodium has been injected, they are destroyed.

SummaryTraditional methods for treating cancer—chemotherapy,radiation therapy, and surgery—have been reasonably suc-cessful but are not without limitations. Traditional methodsoften are unable to disable all malignant cells because thetreatments are too toxic for patients or because small clus-ters of drug-resistant malignant cells seed throughout thepatient’s body. Advances in the understanding of cancer cellbiology and molecular biology have allowed the develop-ment of targeted therapies, or therapeutic agents that pin-point specific tumor cells but ignore or at least minimallydamage normal cells. Many targeted therapies remain con-cepts, such as gene therapy, while others, such as antiangio-genic agents, have received marketing approval for use inpatients with cancer. We firmly believe that new targetedtherapies, probably in combinations suited to each individ-ual cancer, will be developed only when researchers beginto think differently about cancer therapeutics, when bio-pharmaceutical companies commit the resources necessaryto develop new therapeutics that are unlike the currentlyavailable products, and when patients willingly allow them-selves to be part of new clinical trial procedures.

References1. Foote MA. Oncology basics: What is cancer. Part I. AMWA J.

2005;20:52-58.2. Bronchud MH, Foote MA, Giaccone G, Olopade O, Workman P,

eds. Principles of Molecular Oncology. 2nd ed. Totowa, NJ:Humana Press; 2004.

3. Horwich A, Ross G. Circulating tumor markers. In: BronchudMH, Foote MA, Giaccone G, Olopade O, Workman P, eds.Principles of Molecular Oncology. 2nd ed. Totowa, NJ: HumanaPress; 2004:233-246.

4. Aiello A, Tamborini E, Frattini M, et al. Genetic markers insporadic tumors. In: Bronchud MH, Foote MA, Giaccone G,Olopade O, Workman P, eds. Principles of Molecular Oncology.2nd ed. Totowa, NJ: Humana Press; 2004:73-150.

5. Grushko TA, Olopade OI. Genetic markers in breast tumors with hereditary predisposition. In: Bronchud MH, Foote MA,Giaccone G, Olopade O, Workman P, eds. Principles of MolecularOncology. 2nd ed. Totowa, NJ: Humana Press; 2004:151-179.

6. Grushko TA, Olopade OI. Genetic markers in breast tumors withhereditary predisposition. In: Bronchud MH, Foote MA,Giaccone G, Olopade O, Workman P, eds. Principles of MolecularOncology. 2nd ed. Totowa, NJ: Humana Press; 2004:151-179.

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Imatinib mesylate was a dramatic suc-cess for the first wave of molecularly tar-geted therapies. A precursor compoundwas identified in the late 1980s, but ithad low potency and poor specificity.Nevertheless, the precursor moleculewas the starting point for the synthesis of imatinib mesylate, a potent inhibitorof BCR-ABL, a fusion protein tyrosinekinase found in chronic myeloidleukemia (CML). CML is a clonal hema-topoietic stem cell disorder with 3 dis-tinct phases: chronic, accelerated, andblast. Progression of CML through the 3clinical phases is characterized at themolecular level by an accumulation ofabnormalities that eventually leave thecells unable to differentiate normally.Chief among these abnormalities is theBCR-ABL fusion protein, formed by areciprocal translocation between thelong arms of chromosomes 9 and 22,t(9:22)(q34;q11). The resultant transloca-tion is commonly referred to as thePhiladelphia chromosome.

BCR-ABL is crucial for the pathogen-esis of CML, activating a variety of intra-cellular signaling pathways that lead toalterations in cell proliferation, adhe-sion, and survival. BCR-ABL was an idealtarget for treatment of the high propor-tion of patients who have the correspon-ding genetic abnormality. Imatinibentered phase 1 trials, initially forpatients with chronic phase CML forwhom therapy with interferon-alpha(IFNα·) had failed. In the initial trial, acomplete hematologic response wasachieved in 98% of the patients (53 of54), and this response was maintained in96% of the patients (51 of 53). The drugwas extremely well tolerated and it had ahalf-life of 13 to16 hours, sufficiently

long to permit once-daily oral dosing. With such impressive levels of activi-

ty in patients with chronic phase CML,studies were started to include patientswith CML in accelerated phase and blastcrisis and also patients with relapsed orrefractory Philadelphia chromosome-positive acute lymphocytic leukemia.Response rates of 55% were obtained inboth patient groups, but these responsestended not to be durable. Patients withCML in blast crisis did better, with 18%having remission and continuing treat-ment with imatinib for as long as 1 year,but nearly all patients with the lymphoidphenotype had relapse between 1 and 4months. In phase 2 studies, imatinib wastested further in patients with interfer-on-refractory disease or disease in accel-erated phase or blast crisis, confirmingthe pattern of response seen in the phase1 studies. These studies formed the basisfor accelerated FDA approval of imatinibfor the first-line treatment of patientswith CML in December 2002.

The efficacy of imatinib as first-linetherapy for patients with CML has beenovershadowed by the emergence of clini-cal resistance. Despite high hematologicand cytogenetic response rates, primaryrefractoriness and acquired resistanceare increasingly seen in patients withCML, particularly patients with moreadvanced stages of the disease. Themechanisms of resistance have beenidentified as the acquisition or the selec-tion of specific point mutations withinseveral critical regions of the ABL kinasedomain and the overexpression of BCR-ABL, mainly as a result of gene amplifi-cation. X-ray crystallographic studieshave shown that the high selectivity andefficacy of imatinib are a result of bind-

ing and locking BCR-ABL in its inactive,auto-inhibited conformation.

Mutations seem to cause resistanceby inducing a transition from the inac-tive to the active state, a form in whichimatinib cannot bind, or by disturbingcritical contact points between imatiniband BCR-ABL. An increasing number ofmutations responsible for imatinibresistance have been identified. Imatinibresistance often coincides with the reac-tivation of kinase activity within theleukemic clone.

Therefore, therapeutic targeting ofBCR-ABL and its downstream pathwaysremains a valid therapeutic strategy.Different ABL mutants display differentdegrees of resistance to imatinib. Whilesome mutations confer a highly resistantphenotype, suggesting the strategy ofstopping treatment with imatinib andtrying a different therapeutic approach,others may be overcome simply byincreasing the dose. Several approachesand new compounds are being evaluat-ed, including a higher dose of imatinib,imatinib in combination with chemo-therapeutic agents, and more potentinhibitors of BCR-ABL that maintain theability to bind to and inhibit the mutantform. Routine testing of BCR-ABLsequences present in the tumor areincreasingly being incorporated intoclinical practice to enable rational, indi-vidualized therapeutic management ofpatients with CML.

The development of imatinib is anexample of how the individualization ofanticancer therapy promises to yieldmore impressive results than the one-size-fits-all therapeutic approach of thepremolecular era.

An aside on drug development: Imatinib as a paradigm for cancer therapy7

7. Reid A, Baird R, Workman P. Emerging molecular therapies:Drugs interfering with signal transduction pathways. In:Bronchud MH, Foote MA, Giaccone G, Olopade O, Workman P,eds. Principles of Molecular Oncology. 3rd ed. Totowa, NJ:Humana Press; in press.

8. Ross DW. Introduction to Oncogenes and Molecular CancerMedicine. New York, NY: Springer-Verlag; 1998.

9. Folkman J. What is the evidence that tumours are angiogenesisdependent? J Natl Cancer Inst. 1990;82:4-6.

10. Tischer E, Mitchell R, Hartman T, et al. The human gene forvascular endothelial growth factor. Multiple protein forms areencoded through alternative exon splicing. J Biol Chem.1991;226:11947-11954.

11. Fidler IJ, Ellis LM. The implication of angiogenesis to the biolo-gy and therapy of cancer metastasis. Cell. 1994;79:185-188.

12. Howell A, Dodwell DJ, Anderson H, et al. Response after with-drawal of tamoxifen and progestogens in advanced breastcancer. Ann Oncol. 1992;3:611-617.

13. Ravdin P. Aromatase inhibitors for the endocrine adjuvanttreatment of breast cancer. Lancet. 2002;359:2126-2127.

14. Sliwkowski MX, Lofgren JA, Lewis GD, et al. Nonclinical studiesaddressing the mechanism of action of trastuzumab(Herceptin). Semin Oncol. 1999;26:60-70.

15. Presta LG, Chen H, O’Connor SJ, et al. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for thetherapy of solid tumors and other disorders. Cancer Res. 1997;57:4593-4539.

16. Herbst RS, Kim ES, Harari PM. IMC-C225, an anti-epidermalgrowth factor receptor monoclonal antibody, for treatment ofhead and neck cancer. Expert Opin Biol Ther. 2001;1:719-732.

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acquired immunity – Immunity from a particular disease statebrought about by result of infection or vaccinationagonist – Molecule that selectively binds to a specific receptor andtriggers a response in a cellalopecia – Loss/absence of hair; side effect of cancer treatment;hair usually grows backanemia – Less than normal amount of red blood cells; often ren-ders the patient weak and tiredangiogenesis – Development of new blood vessels (capillaries) thatallow tumor cells to access nutrients for their growthantagonist – Ligand (eg, growth factor) that inhibits function of an agonistantiangiogenesis – Inhibiting the formation of blood vessels (capillaries)antigen – Any molecule, not necessarily a protein or peptide, thatis capable of inducing a specific immune responseantisense oligonucleotides – Synthetic DNA or RNA that can block the production of faulty proteins. Antisense molecules aredesigned to interact with mRNA before it can be translated into theamino acids that compose proteins, preventing disease-associatedproteins from being made. These molecules are called antisense,because they are the opposite of the original RNA or DNA.apoptosis – Genetically determined (normal) process of cell self-destruction that eliminates DNA-damaged, superfluous, orunwanted cellscarcinogenesis – Process by which normal cells become cancercellsclean margins – Histopathological definition that describessurgical margins as ‘free of cancer cells’epidermal growth factor – A polypeptide hormone that stimulatescell proliferation especially of epithelial cells by binding to recep-tor proteins on the cell surfacefusion proteins – Proteins generated in the laboratory or withincancer cells themselves by linking together of gene fragments (eg, after chromosomal translocation) or their protein productsgene therapy – Transfer of selected genes into a patient to try toameliorate or cure a diseaseinterleukin – Largest group of cytokines; interleukins stimulatewhite blood cells to fight infections ligand – In general, a molecule or ion that can bind to and interactwith a protein moleculememory cell – A long-living lymphocyte that carries the antibodyor receptor for a specific antigen after a first exposure to the anti-gen and that remains in a less than mature state until stimulatedby a second exposure to the antigen, at which time it mounts amore effective immune response than a cell that has not beenexposed previouslymetastases – Tumors that are the result of the transfer of cancercells from a distant part of the body; generally occurs through thelymphatic and blood systemsmetastasize – Process of a tumor spreading to other areas of thebody that are not in direct contact with the tumormonoclonal antibody – An antibody derived from a single cell in large quantities for use against a specific antigen (eg, a cancer cell)mucositis – Inflammation of lining of mouth and digestive tract;oral mucositis impairs eating, swallowing, and talking

neutropenia – Low blood counts of granulocytes, the white cellsthat fight infectionsoncogene – Gene found in chromosomes of tumor cells whoseactivation is associated with the transformation of normal cellsinto cancer cellsphenotype – How an individual organism looks; phenotype isdetermined to a large extent by genotype, or by the identity of thealleles that an individual carries at one or more positions on thechromosomesproto-oncogene – Oversees cell function by producing growth fac-tors, growth factor receptors, or intracellular signalling molecules;if damaged, it can become an oncogenereceptor – Generally, a protein on the cell surface or in the cellinterior that has an affinity for a specific chemical group, molecule,or virusribozymes – RNA enzymes that catalyze site-specific cleavage ofRNAtransfect – To incorporate exogenous DNA into a mammalian celltumor markers – Molecules, proteins, or processes that differ fromthe norm in malignant cells, tissues, or fluids in patients with can-certyrosine kinase – Molecules, proteins, or processes that differ fromthe norm in malignant cells, tissues, or fluids in patients with can-cervaccine – Therapeutic protein made from the cells of the disease itis expected to prevent, but in a weakened and inactivated state;vaccines trigger the immune system to recognize the virulent formof the protein in subsequent encountersvascular endothelial growth factor – A protein that is a major fac-tor in promoting the growth of new blood vessels

28 AMWA JOURNAL . VOL. 22, NO. 1, 2007

Glossary

GRANTSSpecialist

Jeremy Fields, Ph.D.

29 years experience as a fundedbiomedical researcher

18 as a freelance medical writer

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

Clear, concise, coherent & compelling proposals.

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If you have a strong interest in science and a talent for writ-ing, medical communication offers many career opportuni-ties. A broad overview of the field was presented at theScope of Medical Communication open session at the 2006AMWA Annual Conference, where panelists representingvarious settings graciously shared their knowledge andexperience. Lois J. Baker, MS, Senior Health Sciences Editorat the State University of New York at Buffalo, served as themoderator. Melissa L. Bogen, ELS, Bogen Editorial Services,shared insights from her experiences as a freelance editor.Lori De Milto, MJ, Writer for Rent, spoke about opportuni-ties in freelance medical writing. Jane D. Stephenson, PhD,MBA, Bristol-Myers Squibb Company, provided a snapshotof the writing department at a pharmaceutical company,and Lili Fox Velez, PhD, Associate Professor, TowsonUniversity, spoke of her experiences working for medicalcommunication companies. This article is based on theinformation presented during this session as well as onadditional research and my own experience.

The demand for skilled writers and editors is high, as isthe earning potential, and the work can be both interestingand challenging.1 Medical writers translate medical and sci-entific information into prose, tables, and figures to producedocuments and presentations for a target audience. Medicaleditors enhance the clarity and quality of material producedby medical writers and others.

Some medical writers may have advanced scientific ormedical degrees and have worked as clinicians, pharmacists,or researchers; others may have degrees in English or jour-nalism and have worked as technical writers, journalists, oreditors.2,3 My current coworkers include a physician, formerbench scientists, nurses, clinical trials monitors, and recentgraduates from postdoctoral programs, as well as medicalwriters with advanced degrees and years of writing experi-ence. Before becoming a medical writer, I worked in thecomputer industry as a technical writer for 12 years.

What job opportunities are available in medical com-munication?The career opportunities in medical communication are asdiverse as the individuals: medical writer, science writer,video scriptwriter, medical editor, author’s editor, copyedi-tor, editorial assistant, managing editor, publications man-ager, and public relations specialist, among others.1,2

What do medical communicators produce?The products created or edited by professionals in medicalcommunication include the following:1,2,3

• Medical journalism—articles for newspapers and con-sumer magazines, documentaries, and health segmentsfor news shows

• Publications medical writing—manuscripts for scientif-ic journals as well as abstracts and posters for scientificmeetings

• Regulatory medical writing—research protocols, clini-cal study reports, investigational new drug applications,and investigator brochures for submission to regulatoryagencies

• Marketing writing—press releases and advertisementsfor pharmaceutical companies or health care institu-tions

• Academic medical writing—grants and proposals forresearchers at medical centers and academic institutions

• Continuing medical education—educational slide kits,print courses, lecture notes, symposia materials, andWeb site content to maintain or increase the knowledgeand skills of medical professionals

• Patient education—brochures, newsletters, and hand-outs for patients explaining medical procedures, conditions, or treatment options1,2

Who hires medical writers and editors?Employment opportunities include positions at pharmaceu-tical companies, contract research organizations (CROs),academic institutions, medical centers, journals, newspa-pers, and medical communication companies.1,2 Additional-ly, many medical writers and editors work as freelances, pro-viding services to several different companies and workingon a variety of projects.1,2 Most freelance medical writersand editors work for pharmaceutical companies, CROs, ormedical communication companies first to gain experience,network with colleagues, and build a list of potential clientsbefore becoming consultants.2

What skills are needed to be successful in medicalcommunication?Qualified candidates should have excellent writing skills and a strong background or interest in science.1,2 The idealmedical writer or editor is detail-oriented, proactive, well

Career Pathways in Medical CommunicationBy Deana G. Betterton-Lewis, BA

Medical Writing Department, Schwarz BioSciences, Inc., Research Triangle Park, NC

PROFESSIONAL DEVELOPMENT

AMWA JOURNAL . VOL. 22, NO. 1, 2007 29

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organized, able to gather and synthesize data, knowledge-able about at least one therapeutic area, or interested inlearning about new therapeutic areas or indications, familiarwith relevant style guides or guidelines, and able to writeappropriately for the target audience.2 For jobs in the phar-maceutical industry, candidates must understand the drugdevelopment process. Project management skills are essen-tial, because most jobs in medical communication involvesetting schedules, orchestrating review cycles, and solicitingfeedback from busy reviewers and authors.

How much can you earn as a medical writer or editor?According to the 2004 AMWA salary survey, the averageannual income for jobs in medical communication rangesfrom $50,000 to well over $100,000.4 How much you can earndepends on several factors: your level of education, years ofexperience, and the type of company you work for (eg, phar-maceutical company compared with CRO).4 Typically, thehighest salaries are earned by those with advanced degreesand many years of experience who work for pharmaceutical,communication, or advertising firms.4 (AMWA conducts asalary survey every 2 to 3 years, and one will be conductedthis April, with the findings reported later in the year.)

How can you find the right job?The opportunities in medical communication are almostlimitless. For those new to the field or looking for a change,the key is finding the right fit. The answers to some specificquestions may help you narrow down the choices:• Which area of medical communication and which

type of company are the best fits for your education,experience, background, and interests?

• Would you rather be writing for a lay audience or ascientific audience?

• Do you want to be involved in reporting the results ofcurrent research on new drugs?

• Is your interest in medical devices, biologic agents, orpharmacotherapy?

• Do you want to be part of an established medical writingdepartment with clearly defined policies and proceduresand experienced colleagues, or do you want the inde-pendence and responsibility of working for yourself?

To find your answers to these questions, start by net-working with colleagues already working in the field.However, the answers to some questions may only becomeclear with experience.

My own transition to medical writing involved a series of steps over several years. After following the advice of acolleague and joining AMWA, I attended the local chapterconference, where I learned about medical writing and start-ed networking with experienced medical writers and editors.I took an entry-level position at an academic research organ-ization editing research protocols, manuscripts, abstracts,and Web site content. After gaining some experience, Iworked on more challenging projects—writing abstracts,

30 AMWA JOURNAL . VOL. 22, NO. 1, 2007

To learn more about medical writing

• Read the essays on the scope of medical communication in AMWA’s Essays for Biomedical Communicators5,6

• Take courses in medical writing at a local university or anonline course offered by a remote university

• Join AMWA, attend chapter meetings, attend the nationalconference, and get involved

• Read relevant journals or magazines• Take college courses in anatomy and physiology, pharma-

cology, and statistics• Earn AMWA core and advanced curriculum certificates• Review style guides and books on medical writing

To break into the medical communication field

• Seek internship opportunities within pharmaceuticalcompanies or CROs, directly or through your university

• Apply for entry-level positions at CROs and academicinstitutions, which may be more likely to hire writers with less experience

• Apply for copyediting or proofreading positions at publish-ing companies or journal offices, which may be willing to hire less experienced editors with English or journalismdegrees

• If you have a degree or background in English, apply for acopyediting position

• If you have a degree in journalism, try writing an article for a consumer magazine

• Volunteer to write a newsletter or Web site article or a patient education brochure for a hospital, university, or nonprofit institution (this will provide you with a writing sample, which is quite helpful)

• Take an AMWA workshop focused on the type of writing that you are interested in, such as writing articles for consumer publications, writing a clinical study report, or grant writing, to gain more knowledge and experience

continued on page 32

creating newsletters for clinical trial investigators, writing apatient education manual, and eventually editing an entiretextbook. During this time, I obtained my AMWA core cur-riculum certificate and completed college courses in biolo-gy, chemistry, anatomy and physiology, pharmacology, sta-tistics, ethics, medical terminology, clinical trials researchand regulations, and protocol design. Then, a position thatseemed like a great fit for me became available—editingmanuscripts for a mid-size pharmaceutical company. Afterediting manuscripts for 6 months, I transitioned to publica-tions writing. Now, I work with investigators and clinicaldevelopment staff to prepare manuscripts based on theresults of clinical trials.

References1. Baker LJ, Bogen ML, De Milto L, Stephenson JD, Velez LF.

Scope of medical communication. Presented at: the 66thAnnual American Medical Writers Association Conference;October 26, 2006; Albuquerque, NM.

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A s regulatory bodies that govern the life sciencescome under increasing public pressure to enforcethe safe development and production of therapeutic

products that improve quality of life, the burden on firms tomeet these standards becomes greater and penalties fornoncompliance become ever more stiff. Companies mustdevelop procedures that describe all their processes, suchas initiating a clinical trial site, writing a clinical studyreport, putting together a Common Technical Document, or writing a journal manuscript. The documents a companyproduces, based on its procedural infrastructure, offer“proof” of compliant operations.

Training is always a critical component of compliantoperations. People who produce documentation mustunderstand the requirements—thus, training in both the“why” as well as the “how to” is equally important. A look atthe warning letters from the US Food and DrugAdministration (http://www.fda.gov/foi/foia2.htm) con-firms just how necessary training is, as companies are oftencited for failing to produce proof of employee education.Warning letters indicate that, for some companies, employ-ees have not demonstrated the “skills, education, and train-ing” to perform their jobs. Failure to produce adequatedocumentation is also a common citation, and 60% ofwarning letters point to faulty, incomplete, or missingdocumentation.

To help meet the training needs of industry, The Centerfor Professional Innovation & Education (CfPIE) offers a fullsuite of programs specifically for life sciences professionals.CfPIE’s faculty members are industry experts who directcourses that address the toughest compliance challenges.Among CfPIE’s extensive list of training programs are 5courses that specifically address how to develop soundwriting skills for the full range of documentation the indus-try requires, from the procedural “how to” documents com-panies must put in place, to correspondence, study reports,and publications: • Writing Effective Standard Operating Procedures and

other Process Documents• Introduction to Effective Medical Writing • Technical Writing for the Pharmaceutical, Medical

Device, and Biotech Industries• Writing in the Regulated Environment When English Is

Your Second Language • Effective Document Management for the

Pharmaceutical, Biotech & Medical Device Industries

Janet Gough, a member of AMWA, is the CourseDirector for these offerings. She has more than 20 years ofexperience teaching writing at the university level and as aconsultant helping firms develop document systems, pre-pare documentation, and conduct training. She also does afair share of writing herself. She has 10 books to her credit,including Write It Down: Guidance for Preparing Effectiveand Compliant Documentation, now in its 2nd edition(Taylor and Francis Books). She fully understands howcrucial good writing is in this industry. “Companies mayhave the best science and technology, but their primaryproof resides in the written word,” says Gough.

Mark Mazzie, Managing Director of CfPIE, with 15 yearsof experience in training and development within industry,concurs. “Clearly the need for documentation skills is enor-mous in this industry. CfPIE offers a comprehensive writingcurriculum for life science professionals. As firms recognizethe importance of trained writers, our classes are usuallyfull, with waiting lists. They are very popular and supportthe writing requirements of the industry.”

CfPIE delivers more than 250 public courses annually in Malvern, PA, Costa Mesa, CA, and Dublin, Ireland. TheCenter offers an equal number of customized, client-siteprograms in the United States and internationally. CfPIE’sstrength is that classes are small, with typically no morethan 20 participants, ensuring that individual needs areaddressed.

For course schedules, onsite program questions, orgeneral inquiries, contact CfPIE directly by phone at (610) 688-1708 or e-mail at [email protected]. Or, visit theCenter online at www.cfpie.com to see how it can provideeducation for your staff, keep your firm compliant, andimprove your bottom line.

Write It Down…Every Step of the WayBy Bill Beyer

Director of Marketing, The Center for Professional Innovation & Education

The Center for Professional Innovation & Education (CfPIE) gives writers the skills they need to produce effective and compliant documentation.

AMWA JOURNAL . VOL. 22, NO. 1, 2007 31

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Call for Short Storiesfor the Prose for Papa Contest

If you write short stories, consider submitting them to theProse for Papa competition, part of the third annualErnest Hemingway Festival. The winner of the competi-tion receives the following:

• Award of $500 • Recognition during the festival• Publication of the story in the festival magazine

Submitted work must be original, unpublished shortfiction (no longer than 2,600 words or 10 pages double-spaced). The deadline for submission is June 1,2007. The stories will be judged by Daniel Orozco, fea-tured writer on National Public Radio.

The festival will be held September 20-23 in Sun Valley,Idaho, where the legendary author hunted and wrote onand off for 22 years and where he is laid to rest. Designedto be a well-rounded celebration of the author’s life in theWood River Valley, the festival features include lecturesand panel discussions by national scholars, a tour ofHemingway sites, museum displays, a film festival, and a“Hemingway in Idaho” slide presentation.

Send your entry, along with a nonrefundable $10 entry fee (made payable to SVKCVB), to

Prose for Papa ATTN: Sue Bailey PO Box 2420 Sun Valley, ID 83353

For more details on thecompetition and the festival, visit

www.ernesthemingwayfestival.org orsend an e-mail to [email protected].

32 AMWA JOURNAL . VOL. 22, NO. 1, 2007

AMWA offers a variety of opportunities for medicalcommunicators to enhance their professional skillsand knowledge. AMWA’s educational program isa cornerstone of the association’s commitment toproviding high-quality continuing education formedical communicators. Individuals can earn acore curriculum certificate in 1 of 5 designated spe-cialties and can also earn an advanced curriculumcertificate. (See page 52 for a list of AMWA mem-bers who earned a curriculum certificate in 2006.)

AMWA also established the Professional Develop-ment Certificate (PDC) as a means for individuals todemonstrate a commitment to their professionaldevelopment. Since the development of this pro-gram in 2004, several members have earned aPDC (see page 53 for a list of recipients).

Both the curriculum certificates and the PDC areopen to nonmembers as well as members.Information about AMWA’s education programsand certificates are available on the AMWA Website (www.amwa.org).

continued from page 30PR

OFE

SSIO

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EVEL

OPM

ENT

Sunday, April 15, 20071-4 PM

Pacific Grove, CA(AMWA Northern California

Chapter Conference)➔Register by March 25, 2007

Friday, April 27, 20071-4 PM

Kingston, Ontario, Canada(AMWA Canada Chapter Conference)

➔Register by April 6, 2007

Board of Editors in the

Life Sciences(BELS)

Certification Examinations

Friday, May 4, 20071-4 PM

Seattle, WA(AMWA Northwest

Chapter Conference)➔Register by April 13, 2007

Saturday, May 19, 20071-4 PM

Austin, TX(CSE Annual Meeting)

➔Register by April 28, 2007

Wednesday, October 10, 200710 AM-1 PMAtlanta, GA

(AMWA Annual Conference)

➔Register by September 29, 2007

Contact: Leslie E. Neistadt, ELSE-mail: [email protected]

Phone: (706) 576-3322www.bels.org

2. AMWA Delaware Valley Chapter. Toolkit for new medicalwriters. Available at: www.amwa.dvc.org/gettingstarted/toolkit.shtml. Accessed on October 31, 2006.

3. Evans CD. Medical communications in the pharmaceuticalindustry. In: Witte FM, Taylor ND, eds. Essays for BiomedicalCommunicators: Volume 1 of Selected AMWA Workshops.Rockville, MD: American Medical Writers Association;2001:13-16.

4. Gray T, Hamilton CW. Findings from the 2004 AMWA salarysurvey. AMWA J. 2004;19(4):145-151.

5. Witte FM, Taylor ND, eds. Essays for Biomedical Communi-cators: Volume 1 of Selected AMWA Workshops. Rockville,MD: American Medical Writers Association; 2001.

6. Witte FM, Taylor ND, eds. Essays for Biomedical Communi-cators: Volume 2 of Selected AMWA Workshops. Rockville,MD: American Medical Writers Association; 1997.

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CALENDAR OF MEETINGS

AMWA JOURNAL . VOL. 22, NO. 1, 2007 33

American Medical Writers Association67th Annual ConferenceOctober 11-13, 2007Atlanta, GA

68th Annual ConferenceOctober 23-25, 2008Louisville, KY

American Society of IndexersAnnual ConferenceMay 23-27, 2007Philadelphia, PAContact: American Society of Indexers10200 West 44th Avenue, Suite 304Wheat Ridge, CO 80033 Phone: (303) 463-2887; Fax: (303) 422-8894E-mail: [email protected]

American College of Clinical PharmacyAnnual MeetingOctober 14-17, 2007Denver, CO Contact: ACCP3101 Broadway, Suite 650Kansas City, MO 64111Phone: (816) 531-2177; Fax: (816) 531-4990E-mail: [email protected] www.accp.com

American Public Health AssociationAnnual MeetingNovember 3-7, 2007Washington, DC Contact: American Public Health Association800 I Street, NWWashington, DC 20001Phone: (202) 777-2742; Fax: (202) 777-2534E-mail: [email protected] www.apha.org/meetings

American Society of Journalists and AuthorsAnnual ConferenceApril 20-22, 2007New York, NYContact: American Society of Journalists and Authors1501 Broadway, Suite 302New York, NY 10036Phone: (212) 997-0947; Fax: (212) 937-2315www.asja.org

Association for Women in CommunicationsOctober 4-6, 2007Lake Buena Vista, FLContact: Association for Women inCommunications3337 Duke StreetAlexandria, VA 22314Phone: (703) 370-7436; Fax: (703) 370-7437 [email protected]

Council of Science EditorsCSE Annual MeetingMay 18-22, 2007Austin, TXContact: CSE Headquartersc/o Drohan Management Group12100 Sunset Hills Road, Suite 130Reston, VA 20190 Phone: (703) 437-4377; Fax: (703) 435-4390E-mail: [email protected] www.councilscienceeditors.org

Drug Information Association43rd Annual MeetingJune 17-21, 2007Atlanta, GAContact: Cheryl BuckageDrug Information Association800 Enterprise Road, Suite 200Horsham, PA 19044-3595Phone: (215) 442-6194; Fax: (215) 442-6199E-mail: [email protected]

Health Academy, Public Relations Society of AmericaAnnual ConferenceMay 4-5, 2007Washington, DCContact: Health Academy33 Maiden Lane, 11th FloorNew York, NY 10038-5150Phone: (212) 460-1461; Fax: (212) 995-0757E-mail: [email protected]

Health and Science CommunicationsAssociation48th International ConferenceJune 14-16, 2007Toronto, CanadaContact: Health and ScienceCommunications Association39 Wedgewood Drive, Suite AJewett City, CT 06351Phone: (860) 376-5915; Fax: (860) 376-6621E-mail: [email protected]

International Society for MedicalPublication Professionals3rd Annual MeetingApril 23-25, 2007Philadelphia, PAContact: International Society for MedicalPublication ProfessionalsPhone: (914) 945-0507; Fax: (914) 945-0307E-mail: [email protected]

National Association of Science WritersWorkshops, Council for the Advancement of Science Writing New Horizons MeetingOctober 19-23, 2007Seattle, WA Contact: Diane McGurganCASWPO Box 910Hedgesville, WV 25427Phone: (304) 754-5077E-mail: [email protected]

Plain Language Association InternationalOctober 11-14, 2007Amsterdam, The NetherlandsContact: : Plain Language AssociationInternationalE-mail: [email protected]

Regulatory Affairs Professionals SocietyAnnual Conference & ExhibitionSeptember 24-27, 2007Boston, MA Contact: RAPS11300 Rockville Pike, Suite 1000Rockville, MD 20852Phone: (301) 770-2920; Fax: (301) 770-2924E-mail: [email protected]

Society of National Association Publications2007 Annual Publications ManagementConference June 14, 2007Washington, DC Contact: Society of National AssociationPublications8405 Greensboro Dr., #800McLean, VA 22102Phone: (703) 506-3285; Fax: (703) 506-3266E-mail: [email protected]

Society for Scholarly Publishing29th Annual MeetingJune 6-8, 2007San Francisco, CAContact: Society for Scholarly Publishing10200 W. 44th Avenue, Suite 304Wheat Ridge, CO 80033Phone: (303) 422-3914; Fax: (303) 422-8894 www.sspnet.org

Society for Technical Communication54th Annual ConferenceMay 13-16, 2007Minneapolis, MNContact: Society for TechnicalCommunication901 North Stuart Street, Suite 904Arlington, VA 22203Phone: (703) 522-4114; Fax: (703) 522-2075E-mail: [email protected]

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Times, they are a-changin’?Seems like they are, including the Times—The New

York Times that is.Recent reports (The Nation and other publications)

herald the demise of the written news media. Theynote that circulation (and readership) is down andprofits are dropping. And news gathering staffs arebeing decimated. The Los Angeles Times, the BostonGlobe, Akron Beacon Journal, the San Jose MercuryNews and the Dallas Morning News are among thepublications indicating less readership, and they arestarting to reduce their news staffs. Even venerablemagazines, like Time and Business Week, appear to bein this dangerous vortex. We are in an era of worship ofthe bottom line; it is a paean to Wall Street.

Not long ago, the emeritus book editor of theMiami Herald did a comprehensive piece frighteninglycalled “The Waning Power of Books,” reflecting on thedecreased reading of books and the decreased power ofbooks to influence our lives.

At the same time, Google and Apple are postingincreasing and major profits. What does it all mean?What does it mean to medical writing? Professing that Iam not a maven on the subject, I might conjecture afew thoughts.

Simultaneous with these scary events, the numberof medical books and the number of published (andsubmitted) medical articles seem to keep increasing.So much so that a single reader, no matter how inter-ested or talented, cannot keep up with the pace, evenwithin narrow specialty fields. Have we reached a pointthat we can call “glut”?

It is logical to assume that what’s happening in thenews and book fields will have an impact on medicalwriting. Are we producing too many medical articles?Are they all germane? Are they all significant? Will pro-

duction costs soon produce a cutback (even with print-on-demand), and will medicine benefit or suffer withthat? Will the number of medical writers decrease—slowly or suddenly? (When I started, there were a fewhundred members of AMWA, now there are more then5,000—a phenomenal increase. Will they—we—all beable to continue in this field? Or will this field itself dis-appear—or just diminish?)

I have written before of the nebulous reliability ofelectronic dissemination of information. Mixed withaccurate information, incorrect information can beposted, be picked up by people looking for absoluteinformation, and then wiped off with a single click,leaving everyone high and dry. A former editor of theAnnals of Internal Medicine once said that researchdoes not become research until you can see it in print.

Maybe we need to publish (print and distribute)only summaries or abstracts (the official ones) in fewerand fewer publications, so that complete dissemina-tion of pertinent information continues at the sametime as the decrease in number of publications occurs.We can then keep all the original articles in electronicfiles, ever available for specific reference purposes.(The bump I just felt on my head was academia wield-ing its big club.)

So I fear for accuracy in news—including medicine.I fear for medical writers’ jobs. I even fear for nationalliteracy. I fear for writers, for would-be writers, and forsome-day-hope-to-be writers.

What do I propose? I am not a guru who can devisean answer or stop the storm or hold back the waves.The best I can do is press the button and sound thealarm. We all need to be alert to what’s happening andall of us must look for solutions.

My cry is not “The sky is falling! The sky is falling!” I cry for all of us to maintain continued vigilance.

34 AMWA JOURNAL . VOL. 22, NO. 1, 2007

What Is the Future of Medical Writing?By Arnold Melnick, DO

MELNICK ON WRITING

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DEAR EDIE

Institutional affiliations are given for information and conven-ience only. The views expressed, being solely those of the corre-spondents, do not represent those of any institution named or ofthe American Medical Writers Association. All queries, unlessotherwise specified, were received and replied to by e-mail.

DEAR EDIE: I was struggling with the word “via.” When is itbest or appropriate to use it instead of “by”? For example,here is the subhead of a Methods section for a manuscript I was editing: “Generation of Mutant Mice via GeneTrapping.” Here is a sentence under the subheading: “Themouse genes were mutated by gene trapping as previouslydescribed [authors, year].” I’d appreciate your assistancewith this conundrum. Thanks.

BILL SONNENBERG, PHDThe Woodlands, Texas

DEAR BILL: Thanks for an interesting problem in usage. I share your queasiness about using “via” instead of “by.”Actually, of course, it’s Latin, but has been so integrated intothe language for centuries that it’s no longer written in ital-ics. “Via” originally meant “by way of,” that is, in transporta-tion. In more recent times, it has come to mean in the vul-gate “by means of” or “by way of.” I have never used theword except in a transportation context, but I guess I mustbow to what has been used by E. B. White and John Updike,among hordes of others, to mean “through,” “by,” or anyother preposition that comes to their minds.

If there is a problem with “by,” why not just say “by meansof”? I don’t see why the subhead should use “via” when it’sso plain that the cited sentence says it all by just using “by.”I’d go with “by” or “by means of.” The latter is more med-ically precise and is only two more words.

DEAR EDIE: I read in your column (AMWA J, Vol. 21, No. 3,2006) about use of the slash. I see it all the time with regardto nausea/vomiting, when the word “or” should be used.

Another recent use in medical journals, even more bother-some to me, is Grade 3/4 adverse events. Actually, they dosum the Grade 3 and 4 events (for example, the incidence ofGrade 3/4 neutropenia was 56%). I suppose that using a

hyphen might serve well, since the incidence of Grade 3-4neutropenia was 56%.

We are not reporting the ratio of Grade 3 over Grade 4events. I believe that we’re reporting the total of Grade 3and Grade 4 events. So wouldn’t the use of a hyphen bemore correct? Do you think that the reader would misinter-pret Grade 3-4 events as anything other than inclusive?

KRISTI A. BOEHMUS Oncology Research, Inc.

Houston, Texas

DEAR KRISTI: Use (overuse or abuse) of the slash is sotroublesome because it’s so imprecise and confusing. Withregard to the phrase “nausea/vomiting,” it’s self-descriptive(not to make a pun). I’d write “nausea or vomiting or both.”That covers all bases, and there is no mistaking the meaning.

I can’t understand why people are reluctant to use “and” or“or” where these little words are so patently appropriate.The addition of those tiny words would obviate potentiallyhazardous or even lethal nosocomial mistakes.

So far as the adverse events are concerned, I’d write Grade 3and Grade 4 events, rather than use a hyphen, which mightdenote that 3 and 4 are intertwined. They're not; they're justadded together.

DEAR EDIE: I recently noted that a researcher referred to“recalcitrant” patients, meaning nonresponders. For exam-ple: “Drug therapy has been suggested for patients recalci-trant to conservative therapies.” Is this a correct use of theword or should it read something like “Drug therapy hasbeen suggested for patients who do not respond to conser-vative therapies”?

There doesn’t seem to be a medical-type definition of this inDorland’s Illustrated Medical Dictionary, and my CanadianOxford dictionary just defines “recalcitrant” as resisting dis-cipline or authority; obstinately disobedient or difficult tomanage or operate. Thanks so much for your help.

I wish your columns were indexed somewhere so that I

There is no such thing as a simple explanation.

By Edie Schwager

AMWA JOURNAL . VOL. 22, NO. 1, 2007 35

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could quickly look up whether or not you’ve already coveredthis topic. This would be a terrific addition to the AMWAWeb site.

LEIGH-ANN TOPFERCanadian Agency for Drugs and

Technologies in Health (CADTH)Edmonton, Alberta, Canada

DEAR LEIGH-ANN: Your query highlights the subtleties and nuances of English usage. “Recalcitrant” carries with ita pejorative tone. Such a person is as exactly described inyour dictionary. That’s a person being described, not acourse of treatment. How can a regimen be obstinate?

I much prefer your suggestion, since it refers precisely to thetreatment, which, after all, is the point. A nonresponder (nohyphen, please) has little choice when treatment fails. It’sthe treatment that is unsuccessful, not the patient. A patientwho does not respond to a particular or certain treatmentdoes not have a character or personality flaw.

There is no medical definition of “recalcitrant” or need forone. It’s an ordinary, nonmedical word.

A long time ago an industrious, clever, and kindly AMWAmember actually indexed several years of my column,unbeknownst to me. When she broached the subject to me,I was inordinately pleased, but said regretfully that it wouldbe an exercise in futility. I would be the only person able touse such a valuable index, since the potential user wouldalso have to have access to the physical issues or photo-copies of the columns, or to the Internet. That’s an impossi-bility for AMWA, because even a few years of columnswould take up an incredible, unconscionable amount ofspace on our Web site. Unfortunately, I still don’t have theindexing work that was finished.

DEAR EDIE: My writing group writes documents to supportthe research and development of oncology products. I hearsome people throwing around the terms “relapsed” and“refractory” almost interchangeably. I know this can’t beright. It’s my understanding that a patient relapses and adisease is refractory.

Can you comment on the correct usage of these terms andgive some examples? Thanks!

CHARLENE A. TUCKERCephalon, Inc.

Frazer, Pa.

DEAR CHARLENE: Without any context, it’s difficult for meto criticize. However, the two meanings are so disparate thatI am dismayed when people use them synonymously orinterchangeably.

Definitions of “relapse”: Dorland’s: The return of a diseaseafter its apparent cessation.” Stedman’s Medical Dictionary:“relapsing; recurring; said of a disease or its manifestationsthat returns in a new attack after an interval of improve-ment.” Webster’s Third New International Dictionary: “to slip or fall back into a former state (as of illness, vice).” Itsexample: “He relapsed when allowed out of bed.” Mosby’sMedical and Nursing Dictionary: “to exhibit again thesymptoms of a disease from which a patient appears tohave recovered.”

Definitions of “refractory”: Mosby’s: “resistant to treatment,as of a disease. Synonym: intractable.” Dorland’s: “resistantto treatment.” Webster’s Third: “resistant to treatment orcure. Its example: “a refractory fulminating lesion.”

My two cents: “Her migraine seemed at first to be refractoryto the many standard treatments.” “The patient relapsedinto a coma.”

DEAR EDIE: One of our faculty members, an erudite sur-geon fluent in several languages, criticized a resident forsaying something along these lines: “We divided the resultsinto tertiles [high-volume, mid-volume, and low-volumegroups].” He explained that you can only “divide” somethinginto two groups, presumably because the “di-” from Latinmeans two, so he advised using the word “split” for tertiles.

Both of my respected dictionaries (Dorland’s and AmericanHeritage) unequivocally refer to “dividing” into more thanjust two groups. Is there some new trend to reserve “divide”for just two, à la “bisect”?

Another question: A Latin-trained AMWA member insists(wrongly, in my opinion) on using “major” and “minor” onlyin the singular. For instance, she would allow “The majorgoal of this study was to . . .; the minor goal was to . . .” She frowns on the plural: “The major goals in this studywere to . . .; the minor goals were to . . .” To me, her take onthe singular is not in sync with modern English.

MARY KNATTERUDUniversity of Minnesota Medical School

Minneapolis, Minn.

DEAR MARY: That faculty member, although erudite andfluent in many languages, knows all about surgery, but Iabsolutely disagree with his English usage. The “di” in“divide” comes from dividere, Latin for “dis-,” apart, andvidere, to “separate into two or more parts, areas, groups.”That definition is given in Webster’s Third as “to split up”and an example given is to “divide the city into wards.” Itwould be a small city indeed to have only two wards. So theprefix dis- means apart, not “two.” “Di-” can frequentlymean two, but not in the case of “divide.”

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 37

Things can be divided into innumerable parts (unless it’s aninheritance, in which case that would be rather complicat-ed). I recommend that you show the entry in Webster’sThird to your learned physician to validate your and myopinion. He is using folk (I call it fake) etymology.

Sidebar: I have never seen the word “tertile,” nor could Ifind it in any dictionary. I am constrained to guess what itmeans, but is there such a word? Did someone coin it onthe basis of quartile, quintile, etc.? “Sextile” (sex gets intoeverything) means either “relating to 60 degrees” or “theaspect of two heavenly bodies when 60 degrees distant from each other.” “Septile” refers to the “septa,” the plural of septum.

As for “major,” Theodore M. Bernstein wrote the followingin The Careful Writer:

As an adjective in the comparative [not the superlative;italics mine] degree, major properly should not be usedas a synonym for important, weighty, serious, great,basic, or fundamental. But by undiscriminating writersit often is. Not only is the word overused [so true!], butin addition it frequently is accompanied by qualifiersthat should not attend a comparative: “King John” is anextremely major work”; . . . “The total body technique in the treatment of cancer so far has been too major anundertaking to repeat.” Strictly speaking, major meansgreater [not greatest] in importance (or in standing,size, value, quality, or the like) than others of the samekind. When we speak of a “major poet,” we are, orshould be, thinking of him in comparison with others in his field. No doubt it is uses like these that led to thebelief that the word meant important or great. It shouldalso be noted that since the word is a comparative adjec-tive, it usually should not be preceded by the; one mightspeak of “a major poet,” but not of “the major poet.”

So much for the “major goal.” And “the minor (also a com-parative adjective) goal.” I could accept “the main goals.”The problem with some usage “experts” is that they mistakethe (Latin) degrees of comparison. “Major” (in both Englishand Latin) is the comparative of the Latin magnus, whichmeans great. The comparative (not the superlative) “minor”(ditto) is the same in Latin (from the verb minuere, tolessen), and means smaller, inferior, less.

Studying, learning, and remembering English usage are noteasy. Did anyone ever say they were?

DEAR EDIE: There is some confusion in our editorialdepartment about the use of “compared with” and “as com-pared with.” Can you explain when it is appropriate to usethe former or the latter? According to the core curriculum

grammar workbook by Flo Witte with the collaboration ofNancy Taylor, it is a mistake to write the following, forexample: “On average, larger mothers give birth to heavierbabies compared with smaller women.”

That sentence would compare the heavier babies withsmaller women, which is undoubtedly not what the writerintended. Flo said the sentence could be written correctly in two ways: “On average, compared with smaller women,larger women give birth to heavier babies.” “On average,larger mothers give birth to heavier babies than smallerwomen do.”

We write a lot of comparison sentences, so the “than” for-mula would become repetitive very quickly!

But would it also be correct to write the following sen-tence?: “On average, larger mothers give birth to heavierbabies as compared with smaller women.” Thanks for anyclarification you can provide on this issue.

SHAYNA MUCKERHEIDEVerusMed

Scottsdale, Ariz.

DEAR SHAYNA: There’s nothing wrong grammatically withthe alternative sentence you cite ending with “as comparedwith smaller women.” It’s just that its location at the end ofthe sentence is awkward. The “than” version is much moreeuphonious and graceful. In addition, it’s one word as com-pared with three. The “than” form would become much lessmonotonous and repetitive than “as compared with.”

Flo Witte’s second sentence is precise and unmistakable.“On average, larger mothers give birth to heavier babiesthan smaller women do.” I prefer it to the first sentencecited in the workbook, and also to this final sentence: “Onaverage, larger mothers give birth to heavier babies as com-pared with smaller women.” The word “than” shows a clearcomparison.

I’d go with Flo.

Edie Schwager, a freelance writer, workshop teacher, and med-ical editor, lives in Philadelphia. She is the author of MedicalEnglish Usage and Abusage and Better Vocabulary in 30 Minutesa Day. Queries and comments, which may be edited, should be sent directly to her (see Instructions for Contributors) inpublishable form and preferably by e-mail. Edie answersqueries as soon as possible.

To avoid back-and-forth messages, please include permissionto publish, if so desired, with the questions or comments. Forverification, correspondents must supply all addresses, espe-cially the city and state of the correspondent or the affiliate.The name of the affiliate and other data may be publishedunless Edie is otherwise directed. Her e-mail address [email protected].

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MEDIA REVIEWS

38 AMWA JOURNAL . VOL. 22, NO. 1, 2007

The following reviews are of the 3 books that received first-place honorsin the 2006 AMWA Medical Book Awards competition.

An Introduction to Clinical Emergency MedicineSwaminatha V. Mahadevan, MD, and Gus M. Garmel, MD, editorsNew York: Cambridge University Press, 2005. xix + 798 pp.$75.00 (paperback)

I remember a favorite resident from my medical schoolstint in the emergency department. Calm, positive, wellorganized, and lucid, he led us step by step through therequisite thinking and procedures. Encouraged rather thanintimidated, we learned a lot and wanted to keep learning.

An Introduction to Clinical Emergency Medicinereminds me of this resident. Edited by 2 emergency physi-cians active in teaching students and residents at theStanford University School of Medicine, this book is inform-ative, accessible, and inviting. Both the text and the illustra-tions contribute to this success.

The book, which lists more than 70 contributors, con-sists of 4 sections. The first, “Principles of EmergencyMedicine,” begins with a chapter on the approach to thepatient and then addresses such topics as airway manage-ment, resuscitation, shock, trauma, pre-hospital care, andpain management. The second section, constituting thebulk of the book, contains 32 chapters, each on theapproach to a presenting complaint. This section is organ-ized alphabetically, beginning with a chapter on abdominalpain and ending with one on weakness. Structuring most ofthe book this way, rather than by type of diagnosis, parallelshow patients present and so tends to aid clinicians. Alsohelpful to clinicians, within the chapters the portions onthe medical history are structured around questions to ask.The third section of the book, “Unique Issues in EmergencyMedicine,” addresses child, elder, and other abuse; ethicaland legal issues; environmental emergencies; and occupa-tional exposures. The final section consists of extensiveappendixes, including instructions for performing proce-

dures and guidance for interpret-ing laboratory tests.

Both verbally and visually, thebook has many strengths. The textis readably written, and ample useof headings facilitates access.Although by different authors, the

chapters are consistent in format; an especially nice featureis the “Pearls, pitfalls, and myths” segment with which thechapters typically end. The reference lists appear quite cur-rent, and the index has sufficient spacing for easy consulta-tion. In addition, the book makes effective use of tables,drawings, flow charts, photographs, radiographs, and othergraphics. Each chapter employs a different pale hue as anaccent (for example, in margins and tables), thus addingcohesiveness to individual chapters, differentiating themfrom their neighbors, and perhaps representing the varietyinherent in emergency medicine.

Well suited for consultation in a hectic emergencydepartment and also for study in quieter environs, AnIntroduction to Clinical Emergency Medicine reflects ahighly successful collaboration among the editors, authors,illustrator, designer, and others. Thanks to their thoughtand care, the book is a fine resource for physicians in train-ing and can aid others caring for urgent-care as well asemergency-care patients. In addition, medical writers mayfind it a useful reference work.

— Barbara Gastel, MD, ELS(H)

Barbara, a faculty member at Texas A&M University, chaired thePhysicians Category Committee for the 2005-2006 book awards.She thanks fellow committee members Paul Dougherty, MD,of Bloomfield, MI, and Amy Givler, MD, of Monroe, LA, andemergency physician Garry Gore, MD, for contributing ideas tothis review.

First Place, Physicians Category

First Place, Allied Health Category

Phlebotomy Handbook: Blood Collection Essentials Diana Garza, EdD, MT (ASCP), and Kathleen Becan-McBride Upper Saddle River, NJ: Prentice Hall, 2005. 592 pp. $52.40 (paperback)

This is the seventh edition of the most authoritative andup-to-date reference on collecting specimens in health

care—not just blood, althoughthe primary focus here is onvenipuncture, but a variety ofother types of specimens as well.The role of “blood collector” isnow performed by nurses, med-ical assistants, and respiratory

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 39

First Place, Trade Category

Living with Lymphoma (A Patient’s Guide)Elizabeth M. Adler, PhDBaltimore, MD: Johns Hopkins University Press, 2005. 424 pp.$50.00 (hardcover), $19.95 (paperback)

Living with Lymphoma provides comprehensive, under-standable, and insightful explanations about several typesof lymphomas. It is an invaluable resource to preparepatients to become knowledgeable about their disease.

Author Adler’s language is simplified as much as possi-ble without sacrificing biologic details, scientific exactness,and specificity. Well organized sections include informationon types of the disease, diagnosis, signs and symptoms,procedures, treatments, and toxicities and side effects asso-ciated with different types of chemotherapy.

Living with Lymphoma is also a very readable accountof the author’s personal battle with lymphoma. As a neuro-biologist, Alder had the advantage of a medical backgroundwith which to grasp overwhelming information from healthprofessionals. Still, she had to face myriad decisions and thecontinuing psychologic effects of her changing life follow-ing the diagnosis of cancer. By including a sense of humoras a survival strategy, Adler and her husband coped throughdiagnosis, treatment, and recovery.

Lymphoma, a type of cancer, isa heterogeneous group of disordersthat originate in lymphocytes, themajor components of the immunesystem. Understanding differencesin prognosis and treatments withinthe types of lymphoma is impor-tant, and explanations are included

throughout the book. Currently there are 2 major divisionsin the group of diseases known as lymphoma. Hodgkinlymphoma (formerly known as/and still frequently calledHodgkin’s disease), and the non-Hodgkin lymphomas. Morethan a dozen distinct diseases make up lymphoma. Adleremphasizes that in diagnosing the disease, staging isimportant, as well as the presence or absence of certainsymptoms.

Care partners of the patient will find the book helpful inproviding understanding and support. The book includesan excellent glossary and well prepared index.

— Ada P. Kahn, MPH, PhD

Ada, who is President of Wordscope Associates, Evanston, IL, wasChair of the Trade Category Committee for the 2005-2006 MedicalBook Awards. She thanks fellow committee members LindaFelcone, of Princeton, NJ; Helen Hodgson, PhD, of Draper, UT;Loraine Schacher, of San Diego, CA; and Michele Vivirito, ofThousand Oaks, CA.

technicians as well as lab technicians; the authors recognizethat decreasing patient stress and pain, improving cus-tomer service and communication skills, and streamliningprocesses are integral to good training. Such training resultsin a more patient-sensitive role and improved interpersonalskills to deal effectively with patients, their families, andhealth care teams.

The wealth of information provided by the authors rais-es this book above the level of a “how to” manual. Safety is a primary theme, and communication and sensitivity arealso highlighted; an overview of anatomy and body systemsis provided, along with informative sections on equipment,special procedures, point-of-care testing, and legal issues.The text is well organized and informative, with a thoroughtable of contents, index, and 12 appendices that focus onspecial concerns such as vital signs, finding a job, andessential Spanish phrases. Students who are preparing forthe national exam will find that the interactive CD-ROMincluded with the book is an indispensable study guide.

The book’s size (about 8 by 10 inches), while comfort-able to hold, allows for exceptionally detailed color illustra-tions. The back cover features a chart showing differenttypes of specimen tubes (with different colored tops) and aconcise description of diagnostic tests that may be donewith specimens collected in each of the tubes. A larger ver-sion of the same chart is included as a wall poster. Eachchapter includes case studies for the reader to ponder, andstudy questions underscore each lesson.

— Dan Fernandez, Sandy Evans, and Kristina Anderson

Dan, of Seattle, WA, works full time as a paralegal and freelancecopyeditor with legal and medical experience. He chaired theAllied Health Category committee for the 2005-2006 book awards,He thanks fellow committee members Sandy Evans, RN, BA, andKristina Anderson for their contributions to the review. Sandy, wholives in Tulalip, WA, is a medical writer and technical productionlead with SHPS Inc., a consumer health management company.Kristina, who lives in Albuquerque, NM, is a writer, editor, consult-ant, and founder of EasyRead Copywriting, LLC.

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40 AMWA JOURNAL . VOL. 22, NO. 1, 2007

WEBSITE REVIEWS

OmniMedicalSearch.com(www.omnimedicalsearch.com)

OmniMedicalSearch.com bills itself as “a metasearchengine for the medical search engines.” When you submit asearch term, your query is sent, simultaneously, to 32 data-bases—including PubMed, MedLine, and the Centers forDisease Control and Prevention—instead of searching thewhole World Wide Web, as it is when you use Google orYahoo. According to its “about” section, the site is intendedfor consumers and is run by Jason L. Morrow, with address-es in Romania and Arkansas.

On the home page, visitors are presented with a simpleinterface—a search box with a drop-down menu and searchbutton and 4 tabs across the top (see screenshot). I searchedfor hypertension from the main search box and got 29results; the first 10 results were from a mix of fairly rep-utable sources, including healthline.com, the NationalInstitutes of Health, FamilyDoctor.com, and the MayoClinic. Each search result includes a link to the result, a 1-or 2-sentence excerpt, and a source. Surrounding the actualsearch results were pitches from OmniMedicalSearch.comto download their search bar (a plug-in for your browser),visit their subsidiary OmniMedicalShop.com, or tell a friendabout OmniMedicalSearch.com. There was also 1 small,animated advertisement for HeartZine, which is a con-sumer-focused Web magazine.

Choosing the “News” tab cleared my search term, whichwas inconvenient. Forging ahead, I ran the same search forhypertension, selecting “All News Sources” from the drop-down box (the other choices were to restrict my search tospecific sources, such as AMA News, BBC Health, orPhysician’s Weekly). There were 173 news results, of whichat least the first 10 appeared to be mostly relevant and cur-rent (I did not explore past that point).

Other search options are an image search (which,frankly, is not nearly as useful as Google’s image search) and a “Web2” search, which restricts itself to theoretically

noncommercial sites in the .org, .gov, ac.uk, and .edudomains. My Web2 search for hypertension returned 74results, and the second result was a “page not found” link toa rather dubious British site offering cottages for rent.

There are a number of user-unfriendly aspects of thissite, including the following:• No way to specify how many search results to display

on each page• Clicking on a search result opens a new window• No way to tell or specify how search results are sorted

(eg, by date, relevance, or source)

I would not use this search engine again, primarilybecause of the navigational issues mentioned but alsobecause I would not feel confident that the searches werereturning comprehensive, trustworthy results. In my view,OmniMedicalSearch.com offers nothing unique, and whatit does offer is poorly presented.

— Lisa D. Lines, ELS

Lisa is a research analyst and medical writer at Boston HealthEconomics.

The AMWA Journal Science Series helps bring basicinformation on scientific topics to members. Send yourproposals for manuscripts to MaryAnn Foote, PhD,Science Series Editor, at [email protected].

IF YOU’RE KNOWLEDGEABLE IN A SCIENTIFIC AREA,

WE NEED YOUR HELP.

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Check out the AMWA Web site’s new design! The site has been streamlined to improve navigation andtechnology and has a new, fresh, look. Members can now login to the Members Only area from the home page. In theMembers Only area, you can view your educational curricu-lum records, update your membership information, or con-nect to other member resources such as Harrison’s Online,current and back issues of the AMWA Journal, the JobsOnline, and the membership and freelance directories.

New Information for Workshop Leaders Added to Web SiteThe Web site now offers in-depth information for memberswho wish to learn more about becoming an AMWA work-shop leader and developing a new workshop. To access thisinformation, click on “Education/Certificates” and then on“Information for Workshop Leaders.” There you will find thefollowing links:Becoming a Workshop Leader• General Information • Leading an Established Credit Workshop • Steps in Planning a Successful Workshop • Tips for Presenting Successful Workshops

Developing a New Workshop• Proposing a New Topic • Presenting a New Workshop for the First Time • Developing a Noncredit Workshop into a Credit

Workshop • Guidelines for Writing Workshop Titles and Descriptions • Core and Advanced Workshop Outline Template • Core Workshop Outline Example • Detailed Workshop Proposal Example • Framework for Developing a Basic Science Workshop

Members are encouraged to get involved in AMWA’seducational program. Developing and leading workshops isa great way to participate in and contribute to AMWA.

New Listservs ActivatedDuring the past few months, AMWA has upgraded the Free-lance, Writing-Editing, and Pharmaceutical e-mail discus-sion lists with new Listserv software. The upgraded softwareenables subscribers to receive messages in digest form andarchive posts by subject. The archive resides in the MembersOnly area of the Web site and, although not yet available, will be accessible to all members for searching by subject.

As an AMWA member, you can choose to subscribe toany of AMWA’s Listservs by visiting the AMWA Web site,clicking on “Membership,” selecting “Membership AccountUpdate,” logging in, and scrolling down to the section of the page for managing Listserv subscriptions. There, you can select the lists to which you wish to subscribe and indi-cate whether you wish to receive messages in digest mode.To unsubscribe, send an e-mail requesting to be unsub-scribed to [email protected]; be sure to specify thename of the list to which you wish to unsubscribe (this is important because there are several different lists). Theinstructions for unsubscribing are on the AMWA Web site.

AMWA’s Listservs are open forums for AMWA membersto freely share their knowledge and questions about medicalcommunication. Lively and candid exchanges are encour-aged; however, subscribers must adhere to the followingsimple guidelines:• Always use a relevant subject line and stay on topic.• Be courteous and respectful. Inappropriate language

or personal attacks are not allowed. • Do not post messages seeking or advertising employ-

ment or freelance opportunities.

Remember, every message posted will be received as an e-mail by every subscriber to the list; this could include your clients or employers! Once sent, messages cannot berecalled, and all posts are permanently archived.

Questions regarding AMWA Listservs can be sent toRonnie Streff ([email protected]), Communications &Technology Specialist at AMWA headquarters.

We encourage you to participate on the AMWA Listservs;we hope they provide a useful and informative means ofcommunicating and connecting with your fellow AMWAmembers!

The AMWA Web Site (www.AMWA.org)Has a NENEW LW LOOKOOK for 2007

WEB WATCH

AMWA JOURNAL . VOL. 22, NO. 1, 2007 41

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42 AMWA JOURNAL . VOL. 22, NO. 1, 2007

Seeking the latest science news?

Visit the Children’s Hospital Boston online News

Room for embargoed news releases on basic

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scientist with interactive research features.

Also find links to Children’s Hospital Boston publi-

cations with stories about patients, clinicians, and

the latest innovations and medical technologies.

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NATIONAL NEWS

AMWA JOURNAL . VOL. 22, NO. 1, 2007 43

G reetings from Northeast Ohio! As I write this col-umn, we are in the midst of yet another bout withOld Man Winter. (Lake-effect snow is not for the

faint of heart!) Nevertheless, the fond memory of our recentExecutive Committee (EC) meeting warms my heart andraises my spirits. I am grateful that so many talented anddedicated members have embraced the opportunity toeffect a positive change within the association!

In this column, I will report on the winter EC meeting,held on January 19 and 20 in Atlanta, Georgia. Despitenumerous flight delays due to inclement weather, it was agenuine pleasure to meet in the magnificent MarriottMarquis—the site of our next annual conference. What abeautiful venue! Those AMWA members lucky enough to beable to join us in Atlanta will doubtless enjoy the incrediblesights of this year’s host city.

More on the annual conference later. First, let me sharesome highlights of the EC meeting. AMWA secretary, TomGegeny, who chairs the Constitution and Bylaws Commit-tee, brought the minutes of the October 28 EC meetingbefore the group for approval and shared the minutes of theOctober 25 and 28 Board of Directors (BOD) meetings forour information and comment preparatory to BOD reviewand approval this spring.

Our treasurer, Cindy Hamilton, next shared the quarter-ly treasurer’s report, and I am pleased to report that thefinancial status of our association is sound. In October,Cindy, in concert with the Budget & Finance Committee,which she chairs, helped us take advantage of our financialhealth by proposing several initiatives. These are coming tofruition thanks to the hard work of dozens of your AMWAcolleagues. Watch for announcements of these programs inthe near future! In addition, Donna Munari worked dili-gently to prepare a preliminary budget for fiscal year 2007-2008, providing the EC the rare treat of reviewing the budg-et during this meeting. Much valuable discussion ensued,setting the financial background against which conversa-tions about additional programs was set.

President-elect Sue Hudson, who chairs the NominatingCommittee, presented next year’s slate of officers to anenthusiastic response. The slate will be presented to the

BOD for its consideration andvote at the spring meeting.

Immediate Past PresidentSusan Siefert shared her plans regarding the annual confer-ence Keynote Address. Watch for an exciting announcementin an upcoming issue of the AMWA Update !

What is the AMWA Update? This new e-bulletinlaunched in January, thanks to the combined efforts of theWeb and Internet Technology (WIT) Committee and RonnieStreff at headquarters. The Update brings you timelyannouncements of AMWA activities, combining multiple e-mail blasts into a single, monthly communication (seepage 5 for more information). Watch for the next issue of the Update coming soon to your desktop! Mary Royer, WITAdministrator, is showing amazing progress in other areasas well. After a brief database error was rectified, the free-lance Listserv has successfully launched; additionalListservs will launch on a regular, scheduled basis, with an exciting new Listserv soon to be available to memberswho subscribe to the Freelance Directory.

Scott Metsger, Awards Administrator, next discussed thestatus of AMWA’s several competitive and honorary awards.All awards subcommittees have been staffed and arealready hard at work. In addition, it was announced that wehave obtained a sponsor for the competitive student schol-arship award, which will now be moved permanently intothe Awards Department.

Chapter and membership issues were brought to thegroup by Vicki White, Administrator of that department,who shared the good news that member retention levels arestill rising, and that we are on track to break our member-ship numbers again this year as former members return,active members renew, and new members join our associa-tion. At the October meeting, Vicki led the chapter delegatesin a lively discussion; she is looking forward to working withthese insightful and dedicated chapter volunteers again atthe spring BOD meeting.

Excitement is also building in the Department ofEducation, ably led by Barbara Snyder. Our 2007 on-siteworkshops have commenced, chapter conferences arebeing scheduled, and production is well under way on our

Report From the Winter Executive CommitteeMeeting: Two Days in Atlanta

From Your AMWA PresidentJames R. Cozzarin, ELS

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next distance-learning module (on schedule to launch atthe Atlanta annual conference in 2007). As if that were notenough, Barbara and her team are currently developingother programs that will enable us to better recognize thevaluable contributions of our workshop leaders, offer novelworkshops to those enrolled in our certificate programs,and provide unique informational outreach to membersacross the association, regardless of geography. Barbara andI will share more details on these exciting new programs asthey become available!

Judi Pepin, Administrator of Development, reported onthe many and various activities of the Development com-mittee who, with Shari Lynn at headquarters, are workinghard to obtain nondues revenue to supplement the budget,support annual conference and other programs, and other-wise help keep our annual dues as low as possible.

You may have noticed that the cover of this publicationhas undergone a redesign, breathing new life into this flag-ship publication of our association. The content of theJournal continues to evolve as well, due in no small part tothe efforts led by Editor Lori Alexander. Melanie Ross,Administrator of Publications, reported that other publica-tions are also under way, and that her public relations sub-committee is also gaining momentum in their internal andexternal public relations efforts. Of note, Melanie plans tocontinue to publicize AMWA’s annual conference commu-nity outreach efforts in Atlanta, as we did in Albuquerque.More on that effort to come!

Our Administrator of the Annual Conference, MicheleVivirito, has mobilized a veritable army of volunteer chairsand committee members who have already well begun theHerculean task of organizing the Atlanta conference.Michele shared many of the results of these labors with theEC, and if early indicators are any measure of future suc-cess, this is shaping up to be our best, most exciting, andmost fun conference ever.

As you may have heard, we offered a record-breakingnumber of workshops in Albuquerque. Not one to shrinkfrom a challenge, Karen Klein, this year’s Annual ConferenceWorkshops Coordinator and EC member at large, hasdedicated herself to raising that bar yet again in Atlanta.Working with Dane Russo at headquarters, Karen is seekingto provide the most diverse and innovative curriculum pro-gram ever. Of course, she can only complete this task withthe generous assistance of our volunteer workshop lead-ers—the true strength of AMWA’s educational program.

Donna Munari presented her report on the activities of the headquarters team (Kathie Bauerle-Berg, MelanieCanahaute, Norine Downs, Bonnie Green, Shari Lynn, DaneRusso, and Ronnie Streff), sharing the successes her ablestaff are achieving almost daily as they work to support theAdministrative Review Committee (ARC), EC, and BOD intheir efforts to provide our members with high-qualityinformation, education, and programs that enhance thevalue of membership.

But even when the EC meeting ended, our work was notdone! The group began our regularly scheduled review ofAMWA’s strategic plan. We examined our strategic goals andobjectives, ensuring that each item supported AMWA’s mis-sion and vision statements. We will conclude these efforts atthe summer EC meeting in July.

These, then, are some highlights, a brief glimpse at theincredible number of programs and policies, developmentsand decisions, ideas and innovations that reflect the effortand enthusiasm the EC exhibited over 2 days in Atlanta. Iapplaud the group for their work to date and am eager tosee the fruits of their ongoing efforts as we seek to serveyou, our colleagues in AMWA.

44 AMWA JOURNAL . VOL. 22, NO. 1, 2007

Taking Care of BusinessAs we start our year together, I thought it might behelpful to provide a brief overview of how the asso-ciation’s business gets done.

The elected officers comprise the AdministrativeReview Committee (ARC), which typically meets withthe Executive Director (Donna Munari) in conjunc-tion with each meeting of the Executive Committee(EC) and Board of Directors (BOD). The ARC dis-cusses plans, resources, and accomplishments ofheadquarters (HQ) staff; acts as a grievance com-mittee for HQ staff; reviews the Executive Director’sperformance; and—if appropriate—reviews docu-ments prepared for distribution and/or publication.The ARC considers other issues as well, reporting tothe EC and BOD as appropriate.

The elected officers, along with the departmentaladministrators and a member at large, comprise theEC, which meets 4 times per year (on the Saturdayof the annual conference, in the winter, in the spring[in conjunction with the BOD meeting], and in thesummer). The EC conducts the business of the asso-ciation and, between meetings of the BOD, per-forms those functions of the Board not specificallyvested in the Board.

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 45

Thanks to our generous members, the Endowment Fund MatchingCampaign that was launched at the 2006 Annual Conference inAlbuquerque was a resounding success. In the MatchingCampaign, all donations made by individuals and chapters byDecember 31, 2006, were matched by AMWA. A total of $14,110was received in contributions, which means that the fund grew by$28,220 in just 2 months. With these contributions, we have sur-passed our initial goal of $85,000 and, as of January 17, 2007, theEndowment Fund has received more than $100,200!

A special thank-you to all of the individuals and chapters whohave given to the Endowment Fund in the past, gave during theMatching Campaign, and plan on continuing to give each year.Your support to help finance activities consistent with AMWA’smission through this self-sustaining fund will promote the devel-opment of new member benefits and services to keep our organi-zation fiscally strong and moving toward the future. Informationon the fund and a contribution form are available on the AMWAWeb site (www.amwa.org).

AMWA Endowment Fund Reaches—Exceeds—Goal By Judi Pepin, PhD

Administrator of Development, 2006-2007

Matching Campaign Gifts Previous Gifts Gift Level

$5,000 or more (Leadership Level)

$1,500 to $2,999 (Silver Level)

$1,000 to $1,499 (Bronze Level)

$500 to $999

$250 to $499

$100 to $249

Up to $100

Nondisclosed

Donor

Empire State-Metro NewYork Chapter

Southeast Chapter

Delaware Valley ChapterFlorida ChapterLori Alexander, MTPW,

ELS

Ohio Valley ChapterPacific Southwest Chapter

Bass Advertising andMarketing

Robert E. Brylawski, MDLeeAnn ChastainMaria H. CraigJennifer Fissekis, MA, ELSRandall Fritz, DVM, ELSThomas Gegeny, MS, ELSJane Krauhs, PhD, ELSRhonda Porterfield, MDGaylord Throckmorton,

PhD

Lanie Adamson, MSJulie Crider, PhDBettijane EisenpreisAnne B. Giordani, PhDLydia Green, RPhJune Oshiro, PhD, MSRebecca Palmer, MSNaomi Ruff, PhD, ELSCarol Squires, MAHilah B. ThomasStephen To, MBABarbara Zimmerman, PhD

Cindy Hamilton, PharmD,ELS

Paul Mamula, PhDLaura Singer

Gift Level

$5,000 or more

$1,000 to $1,499

$500 to $999

$250 to $499

$100 to $249

Gift Level

Up to $100

Nondisclosed

Donor

Empire State-Metro New YorkChapter

Delaware Valley Chapter (3gifts)

Empire State-Metro New YorkChapter

Greater Chicago Area Chapter Pacific Southwest Chapter (2

gifts)Mid-Atlantic Chapter

Ohio Valley ChapterNorthwest ChapterMarianne Mallia, ELS (2 gifts)Phyllis MinickSouthwest Chapter

Lori Alexander, MTPW, ELSBrian Bass Lori De Milto Kevin FlynnJane Krauhs (2 gifts)Max Losi, PhD Arnold Melnick, DO J. Maitland YoungRobert N. Young, MD

AMWA Board of Directors, Spring Meeting 2004

Florida ChapterGreater Chicago Area ChapterIndiana ChapterAlamada BarrettAmanda BarrettBetty J. B. Cohen, PhD Meher M. Dustoor, PhDBettijane Eisenpreis (2 gifts)Jennifer Fissekis, MA, ELSDoris E. FletcherDouglas Haneline, PhD (2 gifts)Craig L. KoskelaHarold Laufman, MD, PhD Kathleen Louden, ELS Marjorie A. MurrayBarbara Rinehart Elizabeth and Richard Smith Stephen To, BA, MBARobert N. Young, MD

Donor

Leonard BerlowDenise BuckleyJean CainNatasha CalderMichael L. CocoRitalinda D’Andrea, PhDJackie Dial Ellen Drake, BA, CMTMaria Essig Jeremy FieldsLee GanawaySherree GeyerKaren HarropRebecca KerkoffJean LargisCindy G. Mabe, BSNEllen McCaffreyCassie M. McCrary, PharmDJack D. McCarthy, MDKaren L. McKeown, PhDAnne NealeKathryn NelsonAntoinette SevensmaMargaret WilkinsonRuth Wyler-PlautBarbara Zimmerman, PhD

Marijke Adams, PharmD, PhDSusan Aiello, DVM, ELS

(2 gifts)Linda W. BaileyAlayne BakkenLorrie BeauchampJoan Brodovsky, MS, ELSAnita Frijhoff, PhDJoseph GiaconiaMelanie Goodman DanteToni L. GoldfarbBarbara C. Good, PhDCindy Hamilton, PharmD, ELSWilliam KadishEileen A. McCaffreyCarol B. ShichmanJ. Elizabeth Coolidge-StolzChristine TheisenMichele Vivirito (2 gifts)Gennyne WalkerKathy Whitman

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Hosting local chapter conferences and events can providetangible benefits to members and significant income for thechapter; however, members’ busy professional and person-al lives present a challenge in attracting attendees. Ourexperience in organizing events and conferences for theGreater Chicago Area Chapter (GCAC) has shown that selec-tion of interesting workshops and/or topics, a desirablelocation, ease of registration, and clever promotion are allfundamental in planning a successful, well-attended event.We like to think of our guiding principles as the “Three Cs”:conversations, convenience, and connections. What followsis a brief description of each of these concepts and somepractical suggestions on how to use them in planning yournext educational or social event.

Selecting a Topic/CourseConversations: “What’s everyone talking about?”AMWA’s members comprise a discerning and eclecticcrowd, making the choice of a compelling topic perhaps thegreatest challenge in planning a chapter event. The decisioncan be simplified by determining what topics AMWA mem-bers may already be talking about in their conversationswith each other. Open sessions held at AMWA annual con-ferences can be a great resource for determining timely top-ics of interest. At the 2005 conference, Cheryl Iverson, Chairof the AMA Manual of Style Committee, drew a large crowdwith her presentation on the changes in the upcoming edi-tion of the AMA Manual of Style. The GCAC invited Cherylto give her dynamic presentation and to take questionsfrom chapter members at a local event the following year,and members responded enthusiastically.

The AMWA Journal is another valuable resource foridentifying topics that are of interest at the national leveland for generating ideas for potential topics at a chapterevent. A published conversation about the pros and cons ofa scientific versus nonscientific background became a topicof ardent discussion among GCAC’s medical writers at adinner and panel discussion held in 2006. Given members’familiarity with this timeless debate, the event was well-attended and favorably received.

Another practical approach is to consider areas of inter-est common to all members’ medical writing disciplines.

Since medical writers and editors are continually seekingways to hone their craft, the GCAC hosted a panel discus-sion highlighting opportunities for continuing education inmedical writing and editing. Members actively participatedin the question-and-answer portion of the evening, whichproved to be a lively and enlightening discussion. In someinstances, however, choosing 1 topic that is of interest toeveryone may not always be feasible. Offering an assort-ment of topics over time with the diversity of members’interests and disciplines in mind may be beneficial. TheManual of Procedures for AMWA Chapters provided onAMWA’s Web site (www.amwa.org) includes a “ProgramSuggestions” section that highlights examples of events thathave been successful in the past and may provide inspira-tion for other chapter events.

Factors in selecting workshops for a conference areslightly different from those in selecting a topic for anevent. For instance, the selection of workshops is depend-ent not only on the curriculum offered by AMWA but alsoon the popularity and availability of instructors. Networkingwith other members at the annual conferences can be help-ful in determining which workshops and/or instructorsmembers have found to be particularly captivating. Thereputation of an instructor can be a significant draw for aconference, but the diversity of workshops that they teachalso requires consideration. Since many instructors teachonly 1 or 2 workshops, this can further limit the workshopsto be offered. A list of instructors and the workshops that

Enhancing Your ChapterAttracting Attendees to Chapter Events

By Kelly Briggman and Caryn KimEvents Chair/President-Elect and Education Chair for the Greater Chicago Area Chapter

CHAPTER CORNER

46 AMWA JOURNAL . VOL. 22, NO. 1, 2007

Using AMWA Web Site Resources

Generally speaking, a well-organized event is a well-attendedevent. The AMWA Web site offers various resources whichcan be of assistance in better planning and preparing for your local chapter events.

• Chapter Conference Curriculum Handbook• Publicity Kit• Manual of Procedures for AMWA Chapters

– Refer to Program Suggestions– Refer to Helpful Hints for Managing a Dinner

Meeting

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they teach can be found in the Chapter ConferenceCurriculum Handbook on AMWA’s Web site. Chapter organ-izers are also encouraged to check with headquarters toobtain general information regarding instructors’ evalua-tions and/or teaching awards.

If workshops are selected carefully, a chapter confer-ence can also draw members from outside the local chapterand even nonmembers. Many AMWA members make aneffort to complete a core or advanced curriculum certificatein a short period of time, so it is helpful to avoid duplicatingworkshops offered at other chapter conferences. It is also agood idea to check workshops offered in previous years toavoid repetition from year to year. Offering general work-shops usually achieves quick enrollment, but maintaining abalance across disciplines is best. Because advanced work-shops draw from a smaller pool of eligible members, it isadvisable to limit the number offered; however, the avail-ability of 1 workshop can be enticing for individuals outsidethe chapter who are limited to 2 advanced workshops at thenational conference and may be willing to travel to pursuean advanced certificate.

Location and RegistrationConvenienceThe GCAC covers a large urban area, so convenient highwayaccess or access via public transportation is generally aconsideration in picking the location of an event or confer-ence. Nevertheless, choosing a dynamic or unique settingcan outweigh travel inconveniences, especially if efforts aremade to host events in various geographic locations toaccommodate all members of the chapter.

When choosing a conference location, besides the obvi-ous appeal of a professional setting that is conducive toclassroom learning, consider offering a setting that includesother services such as free food and parking. Any attempt tominimize attendees’ expenses will help draw more people.Also keep in mind the accessibility and affordability ofnearby accommodations. Consider a location near hotelsoffering free shuttle service to and from the airport or con-ference location.

Obtaining information and registering for the event or conference should be made as easy as possible. The“Connections” section provides helpful ideas for ways to

put this into practice.

Promoting an Event/ConferenceConnectionsWhen promoting a chapter conference orevent, the GCAC has found it beneficial touse a variety of communication methods inorder to connect with as many people aspossible, both inside and outside of theAMWA membership. Perhaps the easiestway to connect with a large group is viaelectronic sources. The GCAC begins thepromotion process of an event by sendingan e-mail announcement to local chaptermembers. Depending on the topic, an addi-tional e-mail may be sent to a subset of thechapter (eg, freelances) to elaborate on therelevance of the topic to their specialty. Inthe case of a chapter conference, AMWAmembers across the globe receive an e-mailannouncement from AMWA headquarters.Besides giving the most important detailsabout upcoming events, e-mails include alink to the GCAC Web site, which is also avaluable electronic communication tool.The Web site has the added benefit of beingavailable to nonmembers who are searchingfor information about medical writing. TheGCAC Web site includes a chapter calendarwith links to upcoming event details, andphotographs and summaries of past eventsare posted in order to give those who areconsidering attending a chapter event a

AMWA JOURNAL . VOL. 22, NO. 1, 2007 47

Selecting a Topic/Workshop: Think Conversations

Event • Refer to the AMWA Journal for potential event topics• Vary the types of events offered and subjects covered

Event/Conference• Take note of topics/workshops discussed at the

Annual Conference• Consider common areas of interest across all disciplines

Conference

• Avoid repeating workshops at conferences acrosschapters and from year to year

• Consider popularity of instructors and workshops thatthey teach

Location and Registration: Think Convenience

Event • Offer opportunities across different geographic areaswithin the chapter borders

Event/Conference • Choose a location that is easily accessible • Ensure that the registration process is simple

Conference• Consider a site with free food and parking• Keep in mind accessibility (perhaps free shuttle service)

and affordability of local accommodations

Getting the Word Out: Think Connections

Event/Conference

• Announce upcoming events via e-mail • Post details for both past and future events on the

chapter Web site• Extend personal invitations to colleagues and other

chapter members• Promote future events at current events by making an

announcement or distributing flyers• Notify educators at local colleges or universities• Cross-promote events with other writing and editing

organizations

The “Three Cs” of Planning Chapter Events

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48 AMWA JOURNAL . VOL. 22, NO. 1, 2007

better idea of what they may experience.Other traditional methods of communication used to

attract attendees may be considered old-fashioned, buttheir effectiveness is timeless. Postcards can easily beposted on a bulletin board or tucked inside a day planneras a reminder to RSVP. Spreading the news by networkingwith friends and colleagues can also encourage undecid-ed members to attend. Once the chapter has an event inprogress, cross-promoting upcoming chapter activities isan efficient way to get the word out. This can be done inmany ways, from simply making an announcement at anetworking dinner to placing flyers on attendees’ chairsat a chapter conference to distributing postcards at theAnnual Conference Chapter Meet & Greet.

When looking to draw from an expanded potentialaudience, there are several methods for connecting withthose outside of AMWA. One way to ensure that the infor-mation is released to a wide audience in a relatively shortamount of time is to submit a press release. AMWA offershelpful suggestions on how to do this in the Publicity Kitthat is available on the AMWA Web site. Depending onthe topic, it may also be beneficial to notify educators atlocal colleges or universities of the upcoming event andits relevance to their students. In addition, considercross-promoting conferences and events with other localorganizations for writers and editors.

In ConclusionWith so many professional and personal activities vyingfor AMWA members’ time, attracting attendees to chapterevents can be a challenge. Whether your next chapterevent is a conference, a networking dinner, an electionmeeting, or a potluck lunch, the principles of the “ThreeCs” will help you plan and promote a successful, well-attended event that chapter members will be talkingabout for a long time to come.

Resources forAMWA Chapter OfficersBy Victoria White, MA, ELSAdministrator of Chapters/Membership, 2006-2007

If you have just become a chapter officer or don’t yetknow everything there is to know about managinglocal AMWA activities, head to the AMWA Web site(www.amwa.org) for some assistance.

Click on “Chapters” on the left-hand side of thehome page (www.amwa.org) to reveal a list of helpfullinks. There you will find the Chapter Manual ofProcedures, which provides ideas for chapter pro-grams, suggested duties for officers, Web site guide-lines, sample financial statements, information aboutchapter delegate participation in the Board ofDirectors, and a list of whom in the national office to contact for assistance with a variety of questions.

Also on the Web site, look for the “Tips forChapters” link. That page offers a list of articlesrelated to chapters that have appeared in the AMWAJournal. The articles cover such topics as setting up a chapter Web site, cultivating new leaders, andorganizing a chapter or regional conference.

If you are organizing a conference, be sure to clickon the link for the Chapter Conference CurriculumHandbook. The handbook provides a thoroughoverview of factors you should consider as you devel-op your program.

Interested in getting some publicity for chapteractivities? The AMWA Web site has a publicity kit forchapters, with a sample press release to issueannouncements about the election of chapter officers.

The AMWA Web site has many resources for offi-cers, but sometimes there is no substitute for the real-world experience of fellow AMWA members. As achapter officer, you are eligible to participate in an e-mail list that is designed to foster the sharing ofchapter management tips across geographic bound-aries. Why struggle with a problem when someone else has already developed a solution?

If you have any questions or suggestions or want to participate in the chapter officer e-mail list, pleasecontact me at [email protected].

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 49

On July 22, 2006, the Southwest Chapter toured the BodyWorlds 3 exhibit at the Houston Museum of NaturalScience. Sixty-one enthusiastic chapter members andtheir families attended the event, organized by AnitaFrijhoff, Program Chair, and Ruth SoRelle, AssistantProgram Chair. We invited 3 anatomy professorsfrom area universities to serve as our tour guides tohelp enhance this educational experience. Theywere Franz Mong, PhD, and Lawrence M. Ross,MD, PhD, of the Department of Neurobiology andAnatomy, The University of Texas Health ScienceCenter at Houston, and Cassius Bordelon, Jr, PhD,of the Department of Molecular and Cellular Biology,Baylor College of Medicine, Houston.

Body Worlds 3 is an anatomical exhibit of real humanbodies completely stripped of skin and preserved in life-like poses through the process of plastination, a polymerpreservation method invented by Dr. Gunther vonHagens. Initially, some participants felt intimidated bythe macabre specimens, which were posed “action–fig-ure style,” revealing well preserved muscles, bundles ofnerves, and colored resin-infused blood vessels.But our tour guides eased our anxieties by turn-ing our attention to the anatomic details andartistic aspects of these figures. They pointedout that the different positions of the specimensallowed us to see the interactions of variousanatomical structures.

The displays were unique. Some specimensseemed to greet us with lively gestures. Others

appeared to be engaged in various activities. Forinstance, in one display several specimens were sit-

ting upright in chairs at a table “playing” cards. “TheHorse and Rider” was an elaborate display in

which the “rider” sat atop a horse, which hadalso been preserved with the plastinationmethod. In this display, the rider held thehorse’s preserved brain in one outstretchedhand and his own preserved brain in his otherhand. Both specimens were so fantasticallypreserved that individual muscle fibers could

be seen. The horse was “captured” inmid-gallop with all 4 legs off the ground.

The entire display was held aloft by 1 sup-port hidden under the horse’s tail. Many otherspecimens were very creative, such as the dancerwhose preserved muscles were “frozen” in an

artistic moment. Many of us were awed by these specimens prepared

primarily for medical education but transformed withgreat skill into something akin to fine arts. Although we

completed the entire tour in less than 2 hours,most of us needed the rest of the day to assimi-late this overwhelming and educational experi-ence. This was one fantastic Saturday event forthe Southwest Chapter!

Hanson Yu, PhD, is President of UniTech Systems and ascientific consultant of the company’s Toxicology Groupin El Paso, TX. Currently, he is also the newsletter editorforthe AMWA Southwest Chapter.

It began on a lazy afternoon in August 2006, when AMWACarolinas Chapter members Jenny Walker and Tracey Finemet for brunch and then browsed in a nearby bookstore.“There was an entire wall of books that were recommendedfor book clubs,” says Fine. “We were going through thatwall, and wishing we had a book club, and it just sort ofnaturally came up, ‘why don’t we just start one?’”

That’s exactly what they did, and today, thanks to theirfounding efforts, the OTC Readers is up and running andshows every sign of becoming an institution. The group hasheld 2 meetings so far, with attendance at the second meet-ing nearly double that of the first (7, 13, p = 0.00001).

The OTC-ers discussed their first book, Basket Case byCarl Hiassen, at the group’s inaugural meeting inSeptember. It was a light, summery novel that all presentenjoyed, so there wasn’t a great deal of discussion. That lefttime for participants to establish some of the club’s groundrules, such as meeting bimonthly, with an attendee pickingthe next restaurant meeting site and the next tome to beconsumed and digested.

The second OTC session was an entirely different affair.With 13 readers of Jodi Picoult’s My Sister’s Keeper in atten-dance, the pizza dinner needed no added spice, as a livelyand occasionally heated discussion ensued. The book’s end-

CHAPTER REPORTS

The Ponderer© Gunther von Hagens,

Institute for Plastination,Heidelberg, Germany,

www.bodyworlds.com

Southwest Chapter Toured Body Worlds 3 at the Houston Museum of Natural ScienceBy Hanson Yu, PhD

Taken As Directed, No Adverse Effects!The AMWA Carolinas Chapter OTC Readers Group

By Ernie Hood

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50 AMWA JOURNAL . VOL. 22, NO. 1, 2007

ing (read it for yourself and see what you think) was partic-ularly controversial. Next up on the OTC formulary?Middlesex, the Pulitzer Prize-winning, gender-bendingnovel by Jeffrey Eugenides. As one ecstatic reviewer put it,“To call Middlesex a coming-of-age novel about a hermaph-rodite would be like calling The Odyssey a story about someguy on a boat. Middlesex is nothing short of epic....”

Why “OTC?” The idea is for the reading to be “nonpre-scribed and nonprofessional,” according to Walker, whocame up with the name (the abbreviation that stands forover-the-counter drugs). The books selected for the groupare to be recreational. “As medical writers, all day long weread all this material that we have to read for our jobs, butoutside of work, we all like to read novels,” says Fine. “Also,we thought it might be a way to get other people in thechapter to participate in something they would think is fun.”

Another key to the group’s success has been its open-door policy—all are welcome to attend, whether chaptermembers or not, whether medical writers or not. Thegroup’s credo says it all: Nonprescribed reading for theprofessional medical writer—and friends.

When I get a little money, I buy books; and if any is left, I buyfood and clothes.

– Desiderius Erasmus (1465-1536)

Ernie Hood is a freelance science writer based in Hillsborough,NC. He also produces and hosts “Radio In Vivo,” on WCOM-FM,Carrboro, NC, an interview program focusing on scientificactivities and personalities from the Research Triangle Park area and beyond. Podcasts are available at http://communityradio.coop/Podcasts/Radio-In-Vivo.xml.

Pacific Southwest ChapterApril 15-18, 2007Asilomar Conference GroundsPacific Grove, CAStatistics for Medical Writers and Editors (G)[110]Bart HarveyUnderstanding Sample Size and Study Power(ADV) [729]Bart HarveySentence Structure and Patterns (G) [109]Susan E. AielloEssentials of Copyediting (EW) [204]Susan E. AielloContact: Sue [email protected]

Canada ChapterApril 28-29, 2007Radisson HotelKingston, ON, CanadaProject Management (PH) [411]Art GertelElectronic Regulatory Submissions (PH)[406]Art GertelMaking Effective Slides (EW) [210]Bart Harvey and Lawrence GiraudiWriting Abstracts (EW/PH) [221]Howard M. Smith and Carolyn BrownEstimating—The Key to Making Money

(NC)Jennifer LathamWorking with the Pharmaceutical

Advertising Advisory Board (PAAB) (NC)Ray Chesesiuk➔The Canada Chapter will host the BELSexam preceding the conference on Friday,April 27.

Contact: Julie Bishop [email protected](613) 747-3679

New England ChapterMay 5, 2007Sturbridge Host Hotel & Conference CenterSturbridge, MAEffective Paragraphing (G) [103]Susan E. AielloTables and Graphs [pharm. approach] (G)

[111]Jennifer Ann FissekisEssentials of Copyediting (EW) [204]Susan E. AielloThe Internet: How and Where to Find the

Information You Seek (EW/FL) [232]Thomas P. GegenyMicrosoft Office™ for Presentations:

Creating Figures, Slides, and Posters (NC)Laurie B. LaRussoThe Writer’s Role in Video, CD-ROM, andWeb-based Programs (NC)

Thea ChalowContact: Judy Linn [email protected](508) 358-7071

Carolinas ChapterMay 4, 2007Friday Center for Continuing EducationChapel Hill, NCBasics of Human Anatomy and Physiology

(G) [227]MaryAnn FooteWriting the Final Report of Clinical Trial

(PH) [414][406]Howard SmithStatistics for Medical Writers and Editors (G)[110]Bart Harvey Understanding Sample Size and Study

Power (ADV) [729]Bart HarveyContact: Tara [email protected]

Northwest ChapterMay 5, 2007Talaris Conference CenterSeattle, WACourses TBDContact: Adi [email protected]➔The Northwest Chapter will host the BELS exam preceding the conference onFriday, May 4.

Mid-Atlantic ChapterMay 19, 2007Residence Inn by Marriott,Alexandria-Old Town, Alexandria, VAElectronic Regulatory Submissions (PH) [406]Art GertelStrategies for Improving Document Quality

for Pharmaceutical CommumicationsManagers (ADV) [722]

Art GertelBibliographic Resources for Medical

Communicators (G) [102]Joan NilsonComputer Searching the Medical Literature

(ADV) [707]Joan NilsonContact: Jean Picarelli [email protected] (703) 902-1304 or (703) 963-5770

Rocky Mountain ChapterNiwot InnNiwot, CO (near Boulder, CO)Writing and Designing Materials for Patient

Education (EW/PRAM) [224]Thomas A. LangImproving Comprehension: Theories and

Research Findings (EW/ED) [207]Thomas A. LangContact: Julie [email protected](303) 554-5814

2007 Chapter Conferences

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 51

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Curriculum Certificates Earned in 2006The following AMWA members completed the requirements for an advanced or a core curriculum certificate in 2006.

52 AMWA JOURNAL . VOL. 22, NO. 1, 2007

Advanced CurriculumCertificatesWendy Alexander-Adams, ELSMargaret M. Boe, RNCrescence M. Bookstein, PhDJodi Braunton, MALaura Hale Brockway, ELSChristina W. Chambers, MA,

ELSElaine Crabtree, MA, ELSSvetlana V. Dominguez, BAMeher M. Dustoor, PhDDeborah S. Frisby, MAMaxine A. Gere, MSAnna J. Hagen, PhD, ELSShirley Hilden, PhDLila J. LandeJ. Donna LeBlanc, MS, ELSAngela J. McArthur, PhD, ELSPamela E. McDaniel, RPhRuth A. MuenzenGayle Nicholas Scott,

PharmD, ELSSusan C. Short, BSAnn M. SuttonCindy Taylor, PhDElaine B. TaylorVicki VemuriAlice J. West

Core CurriculumCertificatesEditing/WritingKimberly B. Aamodt, PharmDSusan AbrahamCheryl Ann Alexander, PhDNicola BondBarbara A. BoughtonMerridy Bradley, BSc, MMslDouglas D. Bratman, BAKelly M. Briggman, BAKristy BrunskillCatherine A. CarfagnaTing H. Chang, PhDCorie M. Coffman, BSAshley W. Collinsworth, BAMelissa Cooper, MScBriget M. da Graca, MS

Tejal DalalAlyssa R. Dallas, BAJean Picarelli DzierzakJohn EllisonPeter M. FairfieldMary L. Fitzgerald, MS, RNChristopher FronekJulia R. Gage, PhDTeresa GreenstreetAndrew R. GroundsHeather A. Haley, MSMichelle Grimaud HausScott HulkaDeborah A. Hutchins, PhD,

ELSNancy J. JacobsCatherine M. Jarrell, MASusanne Justice, BSCarol L. KasperTerry KeyserNicole C. Kouvel, PharmDDiane J. Lattanzio, MPHPatricia Lightfoot, PhDHenry Masters IIIDavid Lee Mitchell IVRebecca J. Nelson, MARebecca O’Dell, BSKristi A. Overgaard, BScStephen N. Palmer, PhD, ELSBarbara A. Payne, PharmDCarol A. Pearce, BA, MFALori Keys Pender, MPH, ELSTim PeoplesJanice L. Perry, RN, BSNDavid M. Peterson, PharmDMargaret K. PlummerPrudence L. Roaf, MPHMason W. Robbins, MS, CCRPRegina RosenTegra A. Rosera, MA, MSDebra Sachs, MSSharon L. SchwochEllen Shen, PhDElaine G. Sherman, BSMichelle ShuffettAlexis SimmonsMelanie A. Simpson, PhDGarrett D. SparksGerald V. Stanton, MD

Ann Stedronsky, BALeigh Ann Topfer, MLSTerry TriminghamMargaret B. Tueth, BSN, MAFredrick W. Vansaun, MDAnne von RosenbachJane Warren, MTPWKristina M. Wasson-Blader,

PhDDiane M. WoldenAlison F. Woo, MS, ELSSusan WoodSusan M. ZeilingaHolly B. Zoog, PhD

FreelanceCheryl L. Bunch, PharmD,

BCPSRuth Martinez, RPhJoanne M. McAndrews, PhDJennifer E. Withers, ELSSandra C. Woodhead-Lyons,

BSc

MultidisciplinaryTamara D. Ball, MDAnna Binda, PhDLonnie K. Christiansen, ELSRebecca A. Complin, BS,

RDMSAdi Ferrara, BSAnita F. W. Frijhoff, PhDJohn G. Hand, Jr, BAEmma J. Hitt, PhDCynthia L. Hooper, MAAndra Kennah, PA, MSBrita Lehmann, MD, PhDDenise E. Masoner, MS, MBAFrances McFarland Horne,

PhD, MAVivian McGee, MTSCTari L. NeifferMonica Nicosia, PhDJoi S. Ninomoto, PharmDCheri L. Osteen, PhDKatherine Ott, MSW, ELSPaula K. PriceLaura E. Singer

Dorothy Takacs, MS, BASylvia Phuong TatKristi B. Weber, BS, MT

PharmaceuticalElizabeth A. Agostinelli, MARoberta S. Allen, PhDCatherine E. Baj-Lindsey,

PsyD, RNPatricia K. Bartling, MLS, MSJanice Jamison Beck, BSNBeverly A. Beebe, BATorrance Brooksfuller, MAJason M. BruenKate R. Buchert, MScNatasha M. Calder, MAKaren A. Clossey, MSEHDiana L. Fisher, MSElizabeth C. Froom, PharmDHisako Fujii, DVM, PhDKathleen A. GardnerJulie A. Gelderloos, PhDValerie L. Gerlach, PhDKaren R. Hartman, PhDTerry L. JopkeShahnaz B. Khan, MPHNancy La Sota, MN, RNSherri L. LipperJennifer G. MartinShruthi Mukund, BSDiane Murphy, MBARuth M. Noland, PharmDMary E. PritchardCheryl Purdie, RNMark W. Rogers, BASteve L. RoperErica F. Schirmer, MS, MBASujata Shah, BSDee A. Simmons, RN, BAElizabeth StikerMan-yee Tang, MSSharon Tellyer, DVM, ELSRuth A. Tickel-Logan, MSRita C. Tomlin, MTJane Warren, MTPW

Public Relations/Advertising/MarketingGregory Cuca, MS, ELS

MEM

BER

ACCO

MPL

ISHM

ENTS

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AMWA Members Earning New BELS Certificates

AMWA JOURNAL . VOL. 22, NO. 1, 2007 53

Kristen J. Brunskill, ELS Aurora, CO

Natasha Calder, ELSSeabrook, TX

Charlotte Crowder, MPH, ELSBrooksville, ME

Elizabeth Endres, ELSSeattle, WA

Lori Engelhardt, MA, ELSMalden, MA

Hope J. Lafferty, MA, ELS New York, NY

Vanessa F. LeFevre, MS, ELSCambridge, MA

Lisa Lines, ELSMaynard, MA

Alice V. Luddington, ELSMahwah, NJ

Camille S. Martin, ELSAthens, GA

Anne Mattarella, ELSPlacitas, NM

Sharon Schwoch, ELSBoulder, CO

Gertrude Stoddert, ELSTampa, FL

Deborah L. von Rechenberg, ELSWaltham, MA

Holly A. Wagner, ELS Webberville, MI

Dana D. Wise, PhD, ELSTucson, AZ

Jeanie F. Woodruff, ELSNassau Bay, TX

At the 2006 AMWA Annual Conference inAlbuquerque, 17 AMWA members passedthe certification examination given by theBoard of Editors in the Life Sciences (BELS).(See page 32 for dates of upcoming BELSexaminations.)

MEM

BERACCOM

PLISHMENTS

AMWA Members Earn Professional Development Certificates

Lanie Adamson, MSSusan Bairnsfather, BScDiane Bell, ScDLisa C. Blatt, MAChristina Chambers, MA,

ELSElliott Churchill, MS, MABrenda Clapper, PhD Wim D’Haeze, PhD Deborah A. Early , PhDGenevieve-Anne Gaudreau,

MSc, MBAThomas Gegeny, MS, ELSBarbara C. Good, PhD Jennifer Grodberg, PhDDouglas Haneline, PhDBart Harvey, MD, PhDJane M. Krauhs, PhD, ELSDevora Krischer, ELSAnita P. Kuan, PhDDana J. Lawrence, DCLisa M. Lines, ELS

Deborah Ann McClellan,PhD

Arnold Melnick, DO Jennifer L. Minigh, PhDGary D. Novack, PhDHelen Osborne, Med,

OTR/LElizabeth A. Pector, BA, MD Judith M. Pepin, PhDWilliam Perlman, PhDRhana Pike, MA, ELSTimothy Pingelton, MFA Barbara Rinehart, MS Frances Smith, PhD Barbara Snyder, MA Wendell C. Taylor, PhD,

MPHMelinda Tanzola, PhDRuth “Sam” UhlAnne Marie Weber-Main,

PhD

By Barbara Snyder, MAAdministrator of Education, 2006-2007

AMWA’s Professional Development Certificate (PDC)is a great way for you to demonstrate to youremployer or your clients that you are committed toprofessional development beyond the scope of yourregular job. You can earn a PDC by participating inqualifying activities such as attending chapter meet-ings, serving on committees, attending non-AMWAconferences, teaching, writing, and other similaractivities. Each of the 20 qualifying activities has apoint value, which ranges from 5 to 25. You can earna PDC every 2 years by accruing 50 points duringthat period.

The following members have earned a PDC sincethe program was established in 2004.

Check out the AMWA Web site (www.amwa.org) todownload the application form and a voucher toverify chapter meeting attendance. The EducationCommittee will review each submitted application to verify that it is complete and correct. Successfulapplicants will receive certificates approximately 8weeks after submitting the application.

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54 AMWA JOURNAL . VOL. 22, NO. 1, 2007

F rom the beginning, Art Gertel’s career has been onenot so much of opportunity sought as opportunityaccepted. In the words of that immortal sage, Yogi

Berra: “When you reach a fork in the road—take it.”On a career path as a bench scientist, Art was doing

early pharmaceutical product testing for a small contractlaboratory to put himself through graduate school, when hewas asked to write up the study reports in support of get-ting approval for clinical testing. “Writing has always beeneffortless for me, so I said yes. It seemed like a very nicesymbiosis between the science, which I was intrinsicallyinterested in, and the writing, which was easy,” he says.

After 2 increasingly responsible jobs as a science writer,he applied for a position at the Revlon Health Care Group inTuckahoe, New York, whose director of medical writing wasMax Losi, later president of AMWA. Losi asked him to cometo an AMWA annual conference in Kansas City for the inter-view and Gertel, who had never heard of AMWA, came,joined, had the interview, and got the job.

“I had been at Revlon a few years when thePharmaceutical Section Chair of AMWA resigned, and Maxasked whether I would fill in,” he says. “Once I said yes, Icouldn’t escape. They must have realized that I lack the NOgene, so I just kept digging myself deeper and deeper intothe inner workings of the organization.”

In 1988, Art became director of medical communicationfor Schering-Plough in Kenilworth, NJ, a position he heldfor the next 11 years. During his tenure, the departmentgrew from a skeleton staff of 4 to about 32 people. “I thinkwe had one of the class regulatory medical writing depart-ments in the industry,” he says.

Since 1998, he has held increasingly senior manage-ment-level positions in the pharmaceutical industry. Forthe past 5 years, he has been Vice President of theBeardsworth Consulting Group, Flemington, NJ, a contractresearch organization, in charge of medical writing, regula-tory affairs, quality assurance, and strategic development.

Like most of AMWA’s top leaders, Art has always madetime for the organization, despite his busy career. Afterholding a number of Board-level positions and teaching atvirtually every annual conference, he served as President in1997-1998. Two presidential accomplishments in which hetakes pride were strengthening international ties and creat-ing a discipline for the budgeting and planning process.

“One of my soap box issues is that we are a global pro-fession and we should act like a global profession,” he says.In 1992, he represented AMWA at a conference of medicalwriters in Brussels and attempted to persuade the group tobecome an AMWA affiliate. “Half the people in attendance

walked out of the room inprotest,” he says. “They feltthat AMWA was trying tostick its big foot into Europeand take over what theyviewed as a European

organization, a clear case of ‘reverse colonialism.’”He refused to give up. In 1994, the European Medical

Writers Association (EMWA) was formally created and hewas appointed to AMWA’s International Task Force, becom-ing its Chair the following year. He has attended everyEMWA annual meeting since its founding, and the organi-zation awarded him its first fellowship.

“Art Gertel was instrumental in helping establish anindependent European Medical Writers Association,” com-ments Dr. Barry Drees, a former EMWA President. “I wasclosely involved in this process from the European side andwas always inspired and motivated by Art’s vision, enthusi-asm, and energy. I developed an immense respect for thekind of man that Art is and am honored to say that hebecame a good friend.”

Art’s involvement in AMWA’s budget process beganwhen, as President-Elect, he was charged with helping todevelop a budget for the coming year. He introducedAMWA to systematic budgeting and Excel spreadsheets. AsPresident, he invited a financial planner to help the organi-zation maximize its investments and endowed the BartlebyFund, to be used for promotion and development ofAMWA.

In the years since his presidency, Art has remained avital force in AMWA, serving on key committees and theJournal Advisory Board and leading workshops at annualconferences, including the last one.

“AMWA really takes to heart the spirit of sharing andhelping people to develop their professional skills.Members feel an obligation to nurture fledgling medicalwriters. I think that’s wonderful and so unusual in thisworld of protectiveness and self-aggrandizement,” he says.

“Art is the pesky little brother I never had,” says AMWAPast President Barbara Good. “He’s funny, he’s smart, he’ssmooth, he’s a great diplomat, he’s a good teacher, and hehas all kinds of esoteric knowledge that he’s always surpris-ing you with. In all the years I’ve known him, he’s been likethat and never changed. We sort of grew up on theExecutive Committee together and have a lot of in-commonmemories of the people who ran AMWA in the '80s and '90s.I consider my friendship with him one of the best I’ve madein AMWA.”

Member Profile: Art GertelBy Bettijane Eisenpreis

MEM

BER

PROF

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AMWA JOURNAL . VOL. 22, NO. 1, 2007 55

“Swing?” my son, Erik, says to me in a tone that holds both a question and a command. We are going to his grandmother’s house and have just come through a trail in the woods. At the end of the trail is a swing that Erik considers an old friend, one he wants to stay with awhile.

On this particular day I am in a hurry. A deadline for a manuscript looms, and I have yet to synthe-size the current data on viral resistance to nucleoside therapies for chronic hepatitis B and lay it out as athought leader would. My mother-in-law offered to watch Erik while I get a few more hours of work in.As Erik settles into the back and forth of the bucket swing, I think about how much time we are wasting.

But as my son points to the swing next to him, which happens to be for big people, I can’t help butbe grateful for the invitation. He is rapidly approaching 2 years. Already he is independently walkingaround, eating, and making friends. He will soon be extending invitations to these friends and not tome, the person who gets milk for him at 3 in the morning and makes sure he has clean clothes to wearand a dry bottom beneath them.

It is a chilly December afternoon in North Carolina. As I sit down on the swing, the wooden struc-ture supporting it groans. A leaf blower is humming on a neighboring street, and the smell of motor oilis in the air.

I swing opposite my son—he is facing the street, and I face the woods. He smiles at me for this trick.The tip of his nose is red, and his hands are tucked into the pockets of his fleece jacket. Putting hishands in his pockets is a new skill. Every one of these new skills brings the thrill of pride and the stab of heartbreak to me.

Yet still, I have work to do. This project is for a new client, one that I’d like to work with in the future.The story with this manuscript was the same for the last manuscript and will be the same for the nextone, too—the client wants it good, fast, and within budget. I have always delivered on past assignments,but will I be able to again?

The swing continues to creak with each advance and retreat. The leaves have fallen for the year.There are dried up black-eyed Susans across the street. The orange light casts a long shadow of my son.As he watches it move back and forth, I tell him, “shadow.”

With no one to push him, Erik and the swing come to rest. I stand up and ask him, “Don’t you wantto go to Grandma’s house?” I need to get back. I am supposed to be working, not wasting time.

“Swing,” he says to me as he nods his head. His blue eyes are watery from the cold but unwavering.This deadline will come and go, as will this day and my son. I nod, give him a push, and sit back

down next to him. And then I swing.

In this issue of the AMWA Journal, we introduce Page Break as a new column that describes the challenges—and rewards—ofbalancing work and home life. The essays presented in Page Break will not provide tips on how to find that balance; there willbe no bullet lists, no outlines, and no references cited. Instead, in this space will be scenes that illustrate the ways in which med-ical communicators honor commitments to their jobs, families, and themselves. Page Break was conceived by Jennifer King,PhD, ELS, of the Carolinas Chapter, who is president of her own company, August Editorial, Inc., in Durham, NC, and is themother of a young son. In recognition of the need for work/home life balance for medical writers in a variety of settings, essays inPage Break will alternate between those written by King, who works part-time, and those written by an AMWA member who isemployed full-time. That writer will be introduced in the June issue of the Journal.

Wasting TimeBy Jennifer King, PhD, ELS

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56 AMWA JOURNAL . VOL. 22, NO. 1, 2007

INSTRUCTIONS FOR CONTRIBUTORS

The AMWA Journal encourages the sub-mission of manuscripts and suggestionsfor content for its recurring sections.

Feature Articles: Original compositionsthat are timely and relevant for medicalwriters and editors (approximately 3,000words).

Practical Matters: Articles that provideadvice to medical writers and editors atall levels of experience and in all types of practice settings (approximately 700-1,000 words).

Science Series: Articles that provide anoverview of a specific anatomical orphysiologic topic or of a particulardisease (approximately 3,000 words).Send suggestions for content to ScienceSeries Editor MaryAnn Foote, PhD, [email protected].

Case Studies: Scenarios providing adviceon dealing with ethical dilemmas inmedical writing and editing. Sendsuggestions for content to the editor [email protected].

Sounding Board: Forum for members’opinions on topics relevant to medicalwriting and editing (approximately 1,000words).

Career Development: Information oneducational programs, writing competi-tions, and career development for med-ical writers and editors of all levels ofexperience. Send suggestions for contentto the Editor at [email protected].

Chapter Corner: Forum for chapters toshare experiences and expertise. Sendsuggestions for content to ChapterCorner Editor, Tracey Fine, MS, ELS, [email protected].

Member Musings: Forum for members to share personal essays (related tomedical writing and editing) and creative work, as well as news aboutmember achievements. Send writtenwork and member news to the editor at [email protected].

Freelance Forum: Send questions to the editor at [email protected].

Media Reviews: Send suggestions forbooks, videos, CD-ROMs, and Web sitesto the Media Reviews Editor, Evelyn Kelly,PhD, at [email protected].

Dear Edie: Send questions on Englishusage to Edie Schwager, Dear EdieColumn Editor, at [email protected] 4404 Sherwood Road, Philadelphia, PA19131-1526.

Letters to the Editor: Comment on topicspublished in the AMWA Journal (approxi-mately 500 words or less). Send all lettersto the editor at [email protected].

MANUSCRIPT SUBMISSIONManuscripts are accepted for considera-tion with the understanding that theyhave not been published elsewhere andare not under review elsewhere.

Submit the manuscript as a Word docu-ment attached to an e-mail to the editor([email protected]).Include the following information in the e-mail:• Name, address, phone and fax num-

bers, and e-mail address of the author to whom correspondenceshould be sent

• Written permission of author(s) andpublisher(s) to use any material pub-lished previously (figures, tables, orquotations of more than 100 words)

Hard copies of figures, if necessary,should be sent (with complete documen-tation of the manuscript they accompa-ny) by postal mail to

Lori Alexander, MTPW, ELS Editor, AMWA JournalAmerican Medical Writers Association40 West Gude Drive #101Rockville, MD 20850-1192

COPYRIGHT POLICYThe authors of manuscripts contained in the AMWA Journal grant to AMWAexclusive worldwide first publicationrights and further grant a nonexclusivelicense for other uses of the manuscriptsfor the duration of their copyright in alllanguages, throughout the world, in allmedia. Copyright ownership of thesearticles remains with the authors. Readersof the manuscripts in the AMWA Journalmay copy them without the copyrightowner’s permission, if the author andpublisher are acknowledged in the copyand copy is used for educational, non-profit purposes.

REVIEW AND PRODUCTION PROCESSManuscripts are reviewed by the editorand at least 2 additional reviewers.Decisions of the editor are final. Allsubmitted material is subject to editingand copyediting. Authors will receive theedited version of the manuscript beforepublication, and all queries and editorialchanges should be carefully reviewed atthis time. Authors are responsible for thecontent of their entire work, includingchanges made during the editorialprocess and approved by the correspon-ding author.

Information on style and manuscript

preparation is provided in the complete

set of Instructions for Contributors on

the AMWA Web site (www.amwa.org).

➲ Please refer to the detailed set of instructions for contributors on the AMWA Web site (www.amwa.org).

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Advertisements in this Issue Page

Guidebook to Better Medical Writing 11

ExpertLink 21

Jeremy Fields, PhD 28

Children’s Hospital Boston Online News Room 42

Johns Hopkins University 42

RPS, Inc. 51

Deadlines for Ads in theAMWA Journal

2007Issue 3 - June 15, 2007Issue 4 - September 15, 2007

2008Issue 1 - December 15, 2007Issue 2 - March 15, 2008

Display Advertising Rates

Full page . . . . . . . . . . . . . . . . . . . $750(63⁄4 x 91⁄4 inches or smaller)

Inside back cover. . . . . . . . . . . . $950One-half page . . . . . . . . . . . . . . $450(31⁄4 x 91⁄4 inches, vertical or63⁄4 x 45⁄8 inches, horizontal)

One-quarter page . . . . . . . . . . . $290(31⁄4 x 45⁄8 inches, vertical only)

Competitive frequency discounts available.

AMWA freelance rate . . . . . . . . $125(one-quarter page)

All advertising is subject to acceptance

by the American Medical Writers

Association and should be for products

and services relevant to professional

medical communicators.

AMWA appreciates the generous support provided by its corporate sponsors.

CORPORATE SPONSORSADVERTISING

SUSTAINING MEMBERS

RPS, Inc. (www.rpsweb.com)

SUPPORTING MEMBERS

Complete Healthcare Communications, Inc. (www.chcinc.com)

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